21 U.S.C. § 355 : US Code - Section 355: New drugs

Search 21 U.S.C. § 355 : US Code - Section 355: New drugs

    (a) Necessity of effective approval of application
      No person shall introduce or deliver for introduction into
    interstate commerce any new drug, unless an approval of an
    application filed pursuant to subsection (b) or (j) of this section
    is effective with respect to such drug.
    (b) Filing application; contents
      (1) Any person may file with the Secretary an application with
    respect to any drug subject to the provisions of subsection (a) of
    this section. Such person shall submit to the Secretary as a part
    of the application (A) full reports of investigations which have
    been made to show whether or not such drug is safe for use and
    whether such drug is effective in use; (B) a full list of the
    articles used as components of such drug; (C) a full statement of
    the composition of such drug; (D) a full description of the methods
    used in, and the facilities and controls used for, the manufacture,
    processing, and packing of such drug; (E) such samples of such drug
    and of the articles used as components thereof as the Secretary may
    require; (F) specimens of the labeling proposed to be used for such
    drug, and (G) any assessments required under section 355c of this
    title. The applicant shall file with the application the patent
    number and the expiration date of any patent which claims the drug
    for which the applicant submitted the application or which claims a
    method of using such drug and with respect to which a claim of
    patent infringement could reasonably be asserted if a person not
    licensed by the owner engaged in the manufacture, use, or sale of
    the drug. If an application is filed under this subsection for a
    drug and a patent which claims such drug or a method of using such
    drug is issued after the filing date but before approval of the
    application, the applicant shall amend the application to include
    the information required by the preceding sentence. Upon approval
    of the application, the Secretary shall publish information
    submitted under the two preceding sentences. The Secretary shall,
    in consultation with the Director of the National Institutes of
    Health and with representatives of the drug manufacturing industry,
    review and develop guidance, as appropriate, on the inclusion of
    women and minorities in clinical trials required by clause (A).
      (2) An application submitted under paragraph (1) for a drug for
    which the investigations described in clause (A) of such paragraph
    and relied upon by the applicant for approval of the application
    were not conducted by or for the applicant and for which the
    applicant has not obtained a right of reference or use from the
    person by or for whom the investigations were conducted shall also
    include - 
        (A) a certification, in the opinion of the applicant and to the
      best of his knowledge, with respect to each patent which claims
      the drug for which such investigations were conducted or which
      claims a use for such drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under paragraph (1) or subsection (c) of
      this section - 
          (i) that such patent information has not been filed,
          (ii) that such patent has expired,
          (iii) of the date on which such patent will expire, or
          (iv) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new drug for which the
        application is submitted; and

        (B) if with respect to the drug for which investigations
      described in paragraph (1)(A) were conducted information was
      filed under paragraph (1) or subsection (c) of this section for a
      method of use patent which does not claim a use for which the
      applicant is seeking approval under this subsection, a statement
      that the method of use patent does not claim such a use.

      (3) Notice of opinion that patent is invalid or will not be
    infringed. - 
        (A) Agreement to give notice. - An applicant that makes a
      certification described in paragraph (2)(A)(iv) shall include in
      the application a statement that the applicant will give notice
      as required by this paragraph.
        (B) Timing of notice. - An applicant that makes a certification
      described in paragraph (2)(A)(iv) shall give notice as required
      under this paragraph - 
          (i) if the certification is in the application, not later
        than 20 days after the date of the postmark on the notice with
        which the Secretary informs the applicant that the application
        has been filed; or
          (ii) if the certification is in an amendment or supplement to
        the application, at the time at which the applicant submits the
        amendment or supplement, regardless of whether the applicant
        has already given notice with respect to another such
        certification contained in the application or in an amendment
        or supplement to the application.

        (C) Recipients of notice. - An applicant required under this
      paragraph to give notice shall give notice to - 
          (i) each owner of the patent that is the subject of the
        certification (or a representative of the owner designated to
        receive such a notice); and
          (ii) the holder of the approved application under this
        subsection for the drug that is claimed by the patent or a use
        of which is claimed by the patent (or a representative of the
        holder designated to receive such a notice).

        (D) Contents of notice. - A notice required under this
      paragraph shall - 
          (i) state that an application that contains data from
        bioavailability or bioequivalence studies has been submitted
        under this subsection for the drug with respect to which the
        certification is made to obtain approval to engage in the
        commercial manufacture, use, or sale of the drug before the
        expiration of the patent referred to in the certification; and
          (ii) include a detailed statement of the factual and legal
        basis of the opinion of the applicant that the patent is
        invalid or will not be infringed.

      (4)(A) An applicant may not amend or supplement an application
    referred to in paragraph (2) to seek approval of a drug that is a
    different drug than the drug identified in the application as
    submitted to the Secretary.
      (B) With respect to the drug for which such an application is
    submitted, nothing in this subsection or subsection (c)(3) of this
    section prohibits an applicant from amending or supplementing the
    application to seek approval of a different strength.
      (5)(A) The Secretary shall issue guidance for the individuals who
    review applications submitted under paragraph (1) or under section
    262 of title 42, which shall relate to promptness in conducting the
    review, technical excellence, lack of bias and conflict of
    interest, and knowledge of regulatory and scientific standards, and
    which shall apply equally to all individuals who review such
    applications.
      (B) The Secretary shall meet with a sponsor of an investigation
    or an applicant for approval for a drug under this subsection or
    section 262 of title 42 if the sponsor or applicant makes a
    reasonable written request for a meeting for the purpose of
    reaching agreement on the design and size of clinical trials
    intended to form the primary basis of an effectiveness claim or,
    with respect to an applicant for approval of a biological product
    under section 262(k) of title 42, any necessary clinical study or
    studies. The sponsor or applicant shall provide information
    necessary for discussion and agreement on the design and size of
    the clinical trials. Minutes of any such meeting shall be prepared
    by the Secretary and made available to the sponsor or applicant
    upon request.
      (C) Any agreement regarding the parameters of the design and size
    of clinical trials of a new drug under this paragraph that is
    reached between the Secretary and a sponsor or applicant shall be
    reduced to writing and made part of the administrative record by
    the Secretary. Such agreement shall not be changed after the
    testing begins, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (D) by the director of the reviewing division, that
      a substantial scientific issue essential to determining the
      safety or effectiveness of the drug has been identified after the
      testing has begun.

      (D) A decision under subparagraph (C)(ii) by the director shall
    be in writing and the Secretary shall provide to the sponsor or
    applicant an opportunity for a meeting at which the director and
    the sponsor or applicant will be present and at which the director
    will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by, the
    field or compliance division personnel unless such field or
    compliance division personnel demonstrate to the reviewing division
    why such decision should be modified.
      (F) No action by the reviewing division may be delayed because of
    the unavailability of information from or action by field personnel
    unless the reviewing division determines that a delay is necessary
    to assure the marketing of a safe and effective drug.
      (G) For purposes of this paragraph, the reviewing division is the
    division responsible for the review of an application for approval
    of a drug under this subsection or section 262 of title 42
    (including all scientific and medical matters, chemistry,
    manufacturing, and controls).
      (6) An application submitted under this subsection shall be
    accompanied by the certification required under section
    282(j)(5)(B) of title 42. Such certification shall not be
    considered an element of such application.
    (c) Period for approval of application; period for, notice, and
      expedition of hearing; period for issuance of order
      (1) Within one hundred and eighty days after the filing of an
    application under subsection (b) of this section, or such
    additional period as may be agreed upon by the Secretary and the
    applicant, the Secretary shall either - 
        (A) approve the application if he then finds that none of the
      grounds for denying approval specified in subsection (d) of this
      section applies, or
        (B) give the applicant notice of an opportunity for a hearing
      before the Secretary under subsection (d) of this section on the
      question whether such application is approvable. If the applicant
      elects to accept the opportunity for hearing by written request
      within thirty days after such notice, such hearing shall commence
      not more than ninety days after the expiration of such thirty
      days unless the Secretary and the applicant otherwise agree. Any
      such hearing shall thereafter be conducted on an expedited basis
      and the Secretary's order thereon shall be issued within ninety
      days after the date fixed by the Secretary for filing final
      briefs.

      (2) If the patent information described in subsection (b) of this
    section could not be filed with the submission of an application
    under subsection (b) of this section because the application was
    filed before the patent information was required under subsection
    (b) of this section or a patent was issued after the application
    was approved under such subsection, the holder of an approved
    application shall file with the Secretary the patent number and the
    expiration date of any patent which claims the drug for which the
    application was submitted or which claims a method of using such
    drug and with respect to which a claim of patent infringement could
    reasonably be asserted if a person not licensed by the owner
    engaged in the manufacture, use, or sale of the drug. If the holder
    of an approved application could not file patent information under
    subsection (b) of this section because it was not required at the
    time the application was approved, the holder shall file such
    information under this subsection not later than thirty days after
    September 24, 1984, and if the holder of an approved application
    could not file patent information under subsection (b) of this
    section because no patent had been issued when an application was
    filed or approved, the holder shall file such information under
    this subsection not later than thirty days after the date the
    patent involved is issued. Upon the submission of patent
    information under this subsection, the Secretary shall publish it.
      (3) The approval of an application filed under subsection (b) of
    this section which contains a certification required by paragraph
    (2) of such subsection shall be made effective on the last
    applicable date determined by applying the following to each
    certification made under subsection (b)(2)(A) of this section:
        (A) If the applicant only made a certification described in
      clause (i) or (ii) of subsection (b)(2)(A) of this section or in
      both such clauses, the approval may be made effective
      immediately.
        (B) If the applicant made a certification described in clause
      (iii) of subsection (b)(2)(A) of this section, the approval may
      be made effective on the date certified under clause (iii).
        (C) If the applicant made a certification described in clause
      (iv) of subsection (b)(2)(A) of this section, the approval shall
      be made effective immediately unless, before the expiration of 45
      days after the date on which the notice described in subsection
      (b)(3) of this section is received, an action is brought for
      infringement of the patent that is the subject of the
      certification and for which information was submitted to the
      Secretary under paragraph (2) or subsection (b)(1) of this
      section before the date on which the application (excluding an
      amendment or supplement to the application) was submitted. If
      such an action is brought before the expiration of such days, the
      approval may be made effective upon the expiration of the thirty-
      month period beginning on the date of the receipt of the notice
      provided under subsection (b)(3) of this section or such shorter
      or longer period as the court may order because either party to
      the action failed to reasonably cooperate in expediting the
      action, except that - 
          (i) if before the expiration of such period the district
        court decides that the patent is invalid or not infringed
        (including any substantive determination that there is no cause
        of action for patent infringement or invalidity), the approval
        shall be made effective on - 
            (I) the date on which the court enters judgment reflecting
          the decision; or
            (II) the date of a settlement order or consent decree
          signed and entered by the court stating that the patent that
          is the subject of the certification is invalid or not
          infringed;

          (ii) if before the expiration of such period the district
        court decides that the patent has been infringed - 
            (I) if the judgment of the district court is appealed, the
          approval shall be made effective on - 
              (aa) the date on which the court of appeals decides that
            the patent is invalid or not infringed (including any
            substantive determination that there is no cause of action
            for patent infringement or invalidity); or
              (bb) the date of a settlement order or consent decree
            signed and entered by the court of appeals stating that the
            patent that is the subject of the certification is invalid
            or not infringed; or

            (II) if the judgment of the district court is not appealed
          or is affirmed, the approval shall be made effective on the
          date specified by the district court in a court order under
          section 271(e)(4)(A) of title 35;

          (iii) if before the expiration of such period the court
        grants a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent is
        invalid or not infringed, the approval shall be made effective
        as provided in clause (i); or
          (iv) if before the expiration of such period the court grants
        a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent has been
        infringed, the approval shall be made effective as provided in
        clause (ii).

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action.
        (D) Civil action to obtain patent certainty. - 
          (i) Declaratory judgment absent infringement action. - 
            (I) In general. - No action may be brought under section
          2201 of title 28 by an applicant referred to in subsection
          (b)(2) of this section for a declaratory judgment with
          respect to a patent which is the subject of the certification
          referred to in subparagraph (C) unless - 
              (aa) the 45-day period referred to in such subparagraph
            has expired;
              (bb) neither the owner of such patent nor the holder of
            the approved application under subsection (b) of this
            section for the drug that is claimed by the patent or a use
            of which is claimed by the patent brought a civil action
            against the applicant for infringement of the patent before
            the expiration of such period; and
              (cc) in any case in which the notice provided under
            paragraph (2)(B) relates to noninfringement, the notice was
            accompanied by a document described in subclause (III).

            (II) Filing of civil action. - If the conditions described
          in items (aa), (bb), and as applicable, (cc) of subclause (I)
          have been met, the applicant referred to in such subclause
          may, in accordance with section 2201 of title 28, bring a
          civil action under such section against the owner or holder
          referred to in such subclause (but not against any owner or
          holder that has brought such a civil action against the
          applicant, unless that civil action was dismissed without
          prejudice) for a declaratory judgment that the patent is
          invalid or will not be infringed by the drug for which the
          applicant seeks approval, except that such civil action may
          be brought for a declaratory judgment that the patent will
          not be infringed only in a case in which the condition
          described in subclause (I)(cc) is applicable. A civil action
          referred to in this subclause shall be brought in the
          judicial district where the defendant has its principal place
          of business or a regular and established place of business.
            (III) Offer of confidential access to application. - For
          purposes of subclause (I)(cc), the document described in this
          subclause is a document providing an offer of confidential
          access to the application that is in the custody of the
          applicant referred to in subsection (b)(2) of this section
          for the purpose of determining whether an action referred to
          in subparagraph (C) should be brought. The document providing
          the offer of confidential access shall contain such
          restrictions as to persons entitled to access, and on the use
          and disposition of any information accessed, as would apply
          had a protective order been entered for the purpose of
          protecting trade secrets and other confidential business
          information. A request for access to an application under an
          offer of confidential access shall be considered acceptance
          of the offer of confidential access with the restrictions as
          to persons entitled to access, and on the use and disposition
          of any information accessed, contained in the offer of
          confidential access, and those restrictions and other terms
          of the offer of confidential access shall be considered terms
          of an enforceable contract. Any person provided an offer of
          confidential access shall review the application for the sole
          and limited purpose of evaluating possible infringement of
          the patent that is the subject of the certification under
          subsection (b)(2)(A)(iv) of this section and for no other
          purpose, and may not disclose information of no relevance to
          any issue of patent infringement to any person other than a
          person provided an offer of confidential access. Further, the
          application may be redacted by the applicant to remove any
          information of no relevance to any issue of patent
          infringement.

          (ii) Counterclaim to infringement action. - 
            (I) In general. - If an owner of the patent or the holder
          of the approved application under subsection (b) of this
          section for the drug that is claimed by the patent or a use
          of which is claimed by the patent brings a patent
          infringement action against the applicant, the applicant may
          assert a counterclaim seeking an order requiring the holder
          to correct or delete the patent information submitted by the
          holder under subsection (b) of this section or this
          subsection on the ground that the patent does not claim
          either - 
              (aa) the drug for which the application was approved; or
              (bb) an approved method of using the drug.

            (II) No independent cause of action. - Subclause (I) does
          not authorize the assertion of a claim described in subclause
          (I) in any civil action or proceeding other than a
          counterclaim described in subclause (I).

          (iii) No damages. - An applicant shall not be entitled to
        damages in a civil action under clause (i) or a counterclaim
        under clause (ii).

        (E)(i) If an application (other than an abbreviated new drug
      application) submitted under subsection (b) of this section for a
      drug, no active ingredient (including any ester or salt of the
      active ingredient) of which has been approved in any other
      application under subsection (b) of this section, was approved
      during the period beginning January 1, 1982, and ending on
      September 24, 1984, the Secretary may not make the approval of
      another application for a drug for which the investigations
      described in clause (A) of subsection (b)(1) of this section and
      relied upon by the applicant for approval of the application were
      not conducted by or for the applicant and for which the applicant
      has not obtained a right of reference or use from the person by
      or for whom the investigations were conducted effective before
      the expiration of ten years from the date of the approval of the
      application previously approved under subsection (b) of this
      section.
        (ii) If an application submitted under subsection (b) of this
      section for a drug, no active ingredient (including any ester or
      salt of the active ingredient) of which has been approved in any
      other application under subsection (b) of this section, is
      approved after September 24, 1984, no application which refers to
      the drug for which the subsection (b) application was submitted
      and for which the investigations described in clause (A) of
      subsection (b)(1) of this section and relied upon by the
      applicant for approval of the application were not conducted by
      or for the applicant and for which the applicant has not obtained
      a right of reference or use from the person by or for whom the
      investigations were conducted may be submitted under subsection
      (b) of this section before the expiration of five years from the
      date of the approval of the application under subsection (b) of
      this section, except that such an application may be submitted
      under subsection (b) of this section after the expiration of four
      years from the date of the approval of the subsection (b)
      application if it contains a certification of patent invalidity
      or noninfringement described in clause (iv) of subsection
      (b)(2)(A) of this section. The approval of such an application
      shall be made effective in accordance with this paragraph except
      that, if an action for patent infringement is commenced during
      the one-year period beginning forty-eight months after the date
      of the approval of the subsection (b) application, the thirty-
      month period referred to in subparagraph (C) shall be extended
      by such amount of time (if any) which is required for seven and
      one-half years to have elapsed from the date of approval of the
      subsection (b) application.
        (iii) If an application submitted under subsection (b) of this
      section for a drug, which includes an active ingredient
      (including any ester or salt of the active ingredient) that has
      been approved in another application approved under subsection
      (b) of this section, is approved after September 24, 1984, and if
      such application contains reports of new clinical investigations
      (other than bioavailability studies) essential to the approval of
      the application and conducted or sponsored by the applicant, the
      Secretary may not make the approval of an application submitted
      under subsection (b) of this section for the conditions of
      approval of such drug in the approved subsection (b) application
      effective before the expiration of three years from the date of
      the approval of the application under subsection (b) of this
      section if the investigations described in clause (A) of
      subsection (b)(1) of this section and relied upon by the
      applicant for approval of the application were not conducted by
      or for the applicant and if the applicant has not obtained a
      right of reference or use from the person by or for whom the
      investigations were conducted.
        (iv) If a supplement to an application approved under
      subsection (b) of this section is approved after September 24,
      1984, and the supplement contains reports of new clinical
      investigations (other than bioavailabilty (!1) studies) essential
      to the approval of the supplement and conducted or sponsored by
      the person submitting the supplement, the Secretary may not make
      the approval of an application submitted under subsection (b) of
      this section for a change approved in the supplement effective
      before the expiration of three years from the date of the
      approval of the supplement under subsection (b) of this section
      if the investigations described in clause (A) of subsection
      (b)(1) of this section and relied upon by the applicant for
      approval of the application were not conducted by or for the
      applicant and if the applicant has not obtained a right of
      reference or use from the person by or for whom the
      investigations were conducted.

        (v) If an application (or supplement to an application)
      submitted under subsection (b) of this section for a drug, which
      includes an active ingredient (including any ester or salt of the
      active ingredient) that has been approved in another application
      under subsection (b) of this section, was approved during the
      period beginning January 1, 1982, and ending on September 24,
      1984, the Secretary may not make the approval of an application
      submitted under this subsection and for which the investigations
      described in clause (A) of subsection (b)(1) of this section and
      relied upon by the applicant for approval of the application were
      not conducted by or for the applicant and for which the applicant
      has not obtained a right of reference or use from the person by
      or for whom the investigations were conducted and which refers to
      the drug for which the subsection (b) application was submitted
      effective before the expiration of two years from September 24,
      1984.

      (4) A drug manufactured in a pilot or other small facility may be
    used to demonstrate the safety and effectiveness of the drug and to
    obtain approval for the drug prior to manufacture of the drug in a
    larger facility, unless the Secretary makes a determination that a
    full scale production facility is necessary to ensure the safety or
    effectiveness of the drug.
    (d) Grounds for refusing application; approval of application;
      "substantial evidence" defined
      If the Secretary finds, after due notice to the applicant in
    accordance with subsection (c) of this section and giving him an
    opportunity for a hearing, in accordance with said subsection, that
    (1) the investigations, reports of which are required to be
    submitted to the Secretary pursuant to subsection (b) of this
    section, do not include adequate tests by all methods reasonably
    applicable to show whether or not such drug is safe for use under
    the conditions prescribed, recommended, or suggested in the
    proposed labeling thereof; (2) the results of such tests show that
    such drug is unsafe for use under such conditions or do not show
    that such drug is safe for use under such conditions; (3) the
    methods used in, and the facilities and controls used for, the
    manufacture, processing, and packing of such drug are inadequate to
    preserve its identity, strength, quality, and purity; (4) upon the
    basis of the information submitted to him as part of the
    application, or upon the basis of any other information before him
    with respect to such drug, he has insufficient information to
    determine whether such drug is safe for use under such conditions;
    or (5) evaluated on the basis of the information submitted to him
    as part of the application and any other information before him
    with respect to such drug, there is a lack of substantial evidence
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the proposed labeling thereof; or (6) the application
    failed to contain the patent information prescribed by subsection
    (b) of this section; or (7) based on a fair evaluation of all
    material facts, such labeling is false or misleading in any
    particular; he shall issue an order refusing to approve the
    application. If, after such notice and opportunity for hearing, the
    Secretary finds that clauses (1) through (6) do not apply, he shall
    issue an order approving the application. As used in this
    subsection and subsection (e) of this section, the term
    "substantial evidence" means evidence consisting of adequate and
    well-controlled investigations, including clinical investigations,
    by experts qualified by scientific training and experience to
    evaluate the effectiveness of the drug involved, on the basis of
    which it could fairly and responsibly be concluded by such experts
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the labeling or proposed labeling thereof. If the
    Secretary determines, based on relevant science, that data from one
    adequate and well-controlled clinical investigation and
    confirmatory evidence (obtained prior to or after such
    investigation) are sufficient to establish effectiveness, the
    Secretary may consider such data and evidence to constitute
    substantial evidence for purposes of the preceding sentence.
    (e) Withdrawal of approval; grounds; immediate suspension upon
      finding imminent hazard to public health
      The Secretary shall, after due notice and opportunity for hearing
    to the applicant, withdraw approval of an application with respect
    to any drug under this section if the Secretary finds (1) that
    clinical or other experience, tests, or other scientific data show
    that such drug is unsafe for use under the conditions of use upon
    the basis of which the application was approved; (2) that new
    evidence of clinical experience, not contained in such application
    or not available to the Secretary until after such application was
    approved, or tests by new methods, or tests by methods not deemed
    reasonably applicable when such application was approved, evaluated
    together with the evidence available to the Secretary when the
    application was approved, shows that such drug is not shown to be
    safe for use under the conditions of use upon the basis of which
    the application was approved; or (3) on the basis of new
    information before him with respect to such drug, evaluated
    together with the evidence available to him when the application
    was approved, that there is a lack of substantial evidence that the
    drug will have the effect it purports or is represented to have
    under the conditions of use prescribed, recommended, or suggested
    in the labeling thereof; or (4) the patent information prescribed
    by subsection (c) of this section was not filed within thirty days
    after the receipt of written notice from the Secretary specifying
    the failure to file such information; or (5) that the application
    contains any untrue statement of a material fact: Provided, That if
    the Secretary (or in his absence the officer acting as Secretary)
    finds that there is an imminent hazard to the public health, he may
    suspend the approval of such application immediately, and give the
    applicant prompt notice of his action and afford the applicant the
    opportunity for an expedited hearing under this subsection; but the
    authority conferred by this proviso to suspend the approval of an
    application shall not be delegated. The Secretary may also, after
    due notice and opportunity for hearing to the applicant, withdraw
    the approval of an application submitted under subsection (b) or
    (j) of this section with respect to any drug under this section if
    the Secretary finds (1) that the applicant has failed to establish
    a system for maintaining required records, or has repeatedly or
    deliberately failed to maintain such records or to make required
    reports, in accordance with a regulation or order under subsection
    (k) of this section or to comply with the notice requirements of
    section 360(k)(2) of this title, or the applicant has refused to
    permit access to, or copying or verification of, such records as
    required by paragraph (2) of such subsection; or (2) that on the
    basis of new information before him, evaluated together with the
    evidence before him when the application was approved, the methods
    used in, or the facilities and controls used for, the manufacture,
    processing, and packing of such drug are inadequate to assure and
    preserve its identity, strength, quality, and purity and were not
    made adequate within a reasonable time after receipt of written
    notice from the Secretary specifying the matter complained of; or
    (3) that on the basis of new information before him, evaluated
    together with the evidence before him when the application was
    approved, the labeling of such drug, based on a fair evaluation of
    all material facts, is false or misleading in any particular and
    was not corrected within a reasonable time after receipt of written
    notice from the Secretary specifying the matter complained of. Any
    order under this subsection shall state the findings upon which it
    is based. The Secretary may withdraw the approval of an application
    submitted under this section, or suspend the approval of such an
    application, as provided under this subsection, without first
    ordering the applicant to submit an assessment of the approved risk
    evaluation and mitigation strategy for the drug under section 355-
    1(g)(2)(D) of this title.
    (f) Revocation of order refusing, withdrawing or suspending
      approval of application
      Whenever the Secretary finds that the facts so require, he shall
    revoke any previous order under subsection (d) or (e) of this
    section refusing, withdrawing, or suspending approval of an
    application and shall approve such application or reinstate such
    approval, as may be appropriate.
    (g) Service of orders
      Orders of the Secretary issued under this section shall be served
    (1) in person by any officer or employee of the department
    designated by the Secretary or (2) by mailing the order by
    registered mail or by certified mail addressed to the applicant or
    respondent at his last-known address in the records of the
    Secretary.
    (h) Appeal from order
      An appeal may be taken by the applicant from an order of the
    Secretary refusing or withdrawing approval of an application under
    this section. Such appeal shall be taken by filing in the United
    States court of appeals for the circuit wherein such applicant
    resides or has his principal place of business, or in the United
    States Court of Appeals for the District of Columbia Circuit,
    within sixty days after the entry of such order, a written petition
    praying that the order of the Secretary be set aside. A copy of
    such petition shall be forthwith transmitted by the clerk of the
    court to the Secretary, or any officer designated by him for that
    purpose, and thereupon the Secretary shall certify and file in the
    court the record upon which the order complained of was entered, as
    provided in section 2112 of title 28. Upon the filing of such
    petition such court shall have exclusive jurisdiction to affirm or
    set aside such order, except that until the filing of the record
    the Secretary may modify or set aside his order. No objection to
    the order of the Secretary shall be considered by the court unless
    such objection shall have been urged before the Secretary or unless
    there were reasonable grounds for failure so to do. The finding of
    the Secretary as to the facts, if supported by substantial
    evidence, shall be conclusive. If any person shall apply to the
    court for leave to adduce additional evidence, and shall show to
    the satisfaction of the court that such additional evidence is
    material and that there were reasonable grounds for failure to
    adduce such evidence in the proceeding before the Secretary, the
    court may order such additional evidence to be taken before the
    Secretary and to be adduced upon the hearing in such manner and
    upon such terms and conditions as to the court may seem proper. The
    Secretary may modify his findings as to the facts by reason of the
    additional evidence so taken, and he shall file with the court such
    modified findings which, if supported by substantial evidence,
    shall be conclusive, and his recommendation, if any, for the
    setting aside of the original order. The judgment of the court
    affirming or setting aside any such order of the Secretary shall be
    final, subject to review by the Supreme Court of the United States
    upon certiorari or certification as provided in section 1254 of
    title 28. The commencement of proceedings under this subsection
    shall not, unless specifically ordered by the court to the
    contrary, operate as a stay of the Secretary's order.
    (i) Exemptions of drugs for research; discretionary and mandatory
      conditions; direct reports to Secretary
      (1) The Secretary shall promulgate regulations for exempting from
    the operation of the foregoing subsections of this section drugs
    intended solely for investigational use by experts qualified by
    scientific training and experience to investigate the safety and
    effectiveness of drugs. Such regulations may, within the discretion
    of the Secretary, among other conditions relating to the protection
    of the public health, provide for conditioning such exemption upon -
     
        (A) the submission to the Secretary, before any clinical
      testing of a new drug is undertaken, of reports, by the
      manufacturer or the sponsor of the investigation of such drug, of
      preclinical tests (including tests on animals) of such drug
      adequate to justify the proposed clinical testing;
        (B) the manufacturer or the sponsor of the investigation of a
      new drug proposed to be distributed to investigators for clinical
      testing obtaining a signed agreement from each of such
      investigators that patients to whom the drug is administered will
      be under his personal supervision, or under the supervision of
      investigators responsible to him, and that he will not supply
      such drug to any other investigator, or to clinics, for
      administration to human beings;
        (C) the establishment and maintenance of such records, and the
      making of such reports to the Secretary, by the manufacturer or
      the sponsor of the investigation of such drug, of data (including
      but not limited to analytical reports by investigators) obtained
      as the result of such investigational use of such drug, as the
      Secretary finds will enable him to evaluate the safety and
      effectiveness of such drug in the event of the filing of an
      application pursuant to subsection (b) of this section; and
        (D) the submission to the Secretary by the manufacturer or the
      sponsor of the investigation of a new drug of a statement of
      intent regarding whether the manufacturer or sponsor has plans
      for assessing pediatric safety and efficacy.

      (2) Subject to paragraph (3), a clinical investigation of a new
    drug may begin 30 days after the Secretary has received from the
    manufacturer or sponsor of the investigation a submission
    containing such information about the drug and the clinical
    investigation, including - 
        (A) information on design of the investigation and adequate
      reports of basic information, certified by the applicant to be
      accurate reports, necessary to assess the safety of the drug for
      use in clinical investigation; and
        (B) adequate information on the chemistry and manufacturing of
      the drug, controls available for the drug, and primary data
      tabulations from animal or human studies.

      (3)(A) At any time, the Secretary may prohibit the sponsor of an
    investigation from conducting the investigation (referred to in
    this paragraph as a "clinical hold") if the Secretary makes a
    determination described in subparagraph (B). The Secretary shall
    specify the basis for the clinical hold, including the specific
    information available to the Secretary which served as the basis
    for such clinical hold, and confirm such determination in writing.
      (B) For purposes of subparagraph (A), a determination described
    in this subparagraph with respect to a clinical hold is that - 
        (i) the drug involved represents an unreasonable risk to the
      safety of the persons who are the subjects of the clinical
      investigation, taking into account the qualifications of the
      clinical investigators, information about the drug, the design of
      the clinical investigation, the condition for which the drug is
      to be investigated, and the health status of the subjects
      involved; or
        (ii) the clinical hold should be issued for such other reasons
      as the Secretary may by regulation establish (including reasons
      established by regulation before November 21, 1997).

      (C) Any written request to the Secretary from the sponsor of an
    investigation that a clinical hold be removed shall receive a
    decision, in writing and specifying the reasons therefor, within 30
    days after receipt of such request. Any such request shall include
    sufficient information to support the removal of such clinical
    hold.
      (4) Regulations under paragraph (1) shall provide that such
    exemption shall be conditioned upon the manufacturer, or the
    sponsor of the investigation, requiring that experts using such
    drugs for investigational purposes certify to such manufacturer or
    sponsor that they will inform any human beings to whom such drugs,
    or any controls used in connection therewith, are being
    administered, or their representatives, that such drugs are being
    used for investigational purposes and will obtain the consent of
    such human beings or their representatives, except where it is not
    feasible or it is contrary to the best interests of such human
    beings. Nothing in this subsection shall be construed to require
    any clinical investigator to submit directly to the Secretary
    reports on the investigational use of drugs. The Secretary shall
    update such regulations to require inclusion in the informed
    consent documents and process a statement that clinical trial
    information for such clinical investigation has been or will be
    submitted for inclusion in the registry data bank pursuant to
    subsection (j) of section 282 of title 42.
    (j) Abbreviated new drug applications
      (1) Any person may file with the Secretary an abbreviated
    application for the approval of a new drug.
      (2)(A) An abbreviated application for a new drug shall contain - 
        (i) information to show that the conditions of use prescribed,
      recommended, or suggested in the labeling proposed for the new
      drug have been previously approved for a drug listed under
      paragraph (7) (hereinafter in this subsection referred to as a
      "listed drug");
        (ii)(I) if the listed drug referred to in clause (i) has only
      one active ingredient, information to show that the active
      ingredient of the new drug is the same as that of the listed
      drug;
        (II) if the listed drug referred to in clause (i) has more than
      one active ingredient, information to show that the active
      ingredients of the new drug are the same as those of the listed
      drug, or
        (III) if the listed drug referred to in clause (i) has more
      than one active ingredient and if one of the active ingredients
      of the new drug is different and the application is filed
      pursuant to the approval of a petition filed under subparagraph
      (C), information to show that the other active ingredients of the
      new drug are the same as the active ingredients of the listed
      drug, information to show that the different active ingredient is
      an active ingredient of a listed drug or of a drug which does not
      meet the requirements of section 321(p) of this title, and such
      other information respecting the different active ingredient with
      respect to which the petition was filed as the Secretary may
      require;
        (iii) information to show that the route of administration, the
      dosage form, and the strength of the new drug are the same as
      those of the listed drug referred to in clause (i) or, if the
      route of administration, the dosage form, or the strength of the
      new drug is different and the application is filed pursuant to
      the approval of a petition filed under subparagraph (C), such
      information respecting the route of administration, dosage form,
      or strength with respect to which the petition was filed as the
      Secretary may require;
        (iv) information to show that the new drug is bioequivalent to
      the listed drug referred to in clause (i), except that if the
      application is filed pursuant to the approval of a petition filed
      under subparagraph (C), information to show that the active
      ingredients of the new drug are of the same pharmacological or
      therapeutic class as those of the listed drug referred to in
      clause (i) and the new drug can be expected to have the same
      therapeutic effect as the listed drug when administered to
      patients for a condition of use referred to in clause (i);
        (v) information to show that the labeling proposed for the new
      drug is the same as the labeling approved for the listed drug
      referred to in clause (i) except for changes required because of
      differences approved under a petition filed under subparagraph
      (C) or because the new drug and the listed drug are produced or
      distributed by different manufacturers;
        (vi) the items specified in clauses (B) through (F) of
      subsection (b)(1) of this section;
        (vii) a certification, in the opinion of the applicant and to
      the best of his knowledge, with respect to each patent which
      claims the listed drug referred to in clause (i) or which claims
      a use for such listed drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under subsection (b) or (c) of this section -
       
          (I) that such patent information has not been filed,
          (II) that such patent has expired,
          (III) of the date on which such patent will expire, or
          (IV) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new drug for which the
        application is submitted; and

        (viii) if with respect to the listed drug referred to in clause
      (i) information was filed under subsection (b) or (c) of this
      section for a method of use patent which does not claim a use for
      which the applicant is seeking approval under this subsection, a
      statement that the method of use patent does not claim such a
      use.

    The Secretary may not require that an abbreviated application
    contain information in addition to that required by clauses (i)
    through (viii).
      (B) Notice of opinion that patent is invalid or will not be
    infringed. - 
        (i) Agreement to give notice. - An applicant that makes a
      certification described in subparagraph (A)(vii)(IV) shall
      include in the application a statement that the applicant will
      give notice as required by this subparagraph.
        (ii) Timing of notice. - An applicant that makes a
      certification described in subparagraph (A)(vii)(IV) shall give
      notice as required under this subparagraph - 
          (I) if the certification is in the application, not later
        than 20 days after the date of the postmark on the notice with
        which the Secretary informs the applicant that the application
        has been filed; or
          (II) if the certification is in an amendment or supplement to
        the application, at the time at which the applicant submits the
        amendment or supplement, regardless of whether the applicant
        has already given notice with respect to another such
        certification contained in the application or in an amendment
        or supplement to the application.

        (iii) Recipients of notice. - An applicant required under this
      subparagraph to give notice shall give notice to - 
          (I) each owner of the patent that is the subject of the
        certification (or a representative of the owner designated to
        receive such a notice); and
          (II) the holder of the approved application under subsection
        (b) of this section for the drug that is claimed by the patent
        or a use of which is claimed by the patent (or a representative
        of the holder designated to receive such a notice).

        (iv) Contents of notice. - A notice required under this
      subparagraph shall - 
          (I) state that an application that contains data from
        bioavailability or bioequivalence studies has been submitted
        under this subsection for the drug with respect to which the
        certification is made to obtain approval to engage in the
        commercial manufacture, use, or sale of the drug before the
        expiration of the patent referred to in the certification; and
          (II) include a detailed statement of the factual and legal
        basis of the opinion of the applicant that the patent is
        invalid or will not be infringed.

      (C) If a person wants to submit an abbreviated application for a
    new drug which has a different active ingredient or whose route of
    administration, dosage form, or strength differ from that of a
    listed drug, such person shall submit a petition to the Secretary
    seeking permission to file such an application. The Secretary shall
    approve or disapprove a petition submitted under this subparagraph
    within ninety days of the date the petition is submitted. The
    Secretary shall approve such a petition unless the Secretary finds -
     
        (i) that investigations must be conducted to show the safety
      and effectiveness of the drug or of any of its active
      ingredients, the route of administration, the dosage form, or
      strength which differ from the listed drug; or
        (ii) that any drug with a different active ingredient may not
      be adequately evaluated for approval as safe and effective on the
      basis of the information required to be submitted in an
      abbreviated application.

      (D)(i) An applicant may not amend or supplement an application to
    seek approval of a drug referring to a different listed drug from
    the listed drug identified in the application as submitted to the
    Secretary.
      (ii) With respect to the drug for which an application is
    submitted, nothing in this subsection prohibits an applicant from
    amending or supplementing the application to seek approval of a
    different strength.
      (iii) Within 60 days after December 8, 2003, the Secretary shall
    issue guidance defining the term "listed drug" for purposes of this
    subparagraph.
      (3)(A) The Secretary shall issue guidance for the individuals who
    review applications submitted under paragraph (1), which shall
    relate to promptness in conducting the review, technical
    excellence, lack of bias and conflict of interest, and knowledge of
    regulatory and scientific standards, and which shall apply equally
    to all individuals who review such applications.
      (B) The Secretary shall meet with a sponsor of an investigation
    or an applicant for approval for a drug under this subsection if
    the sponsor or applicant makes a reasonable written request for a
    meeting for the purpose of reaching agreement on the design and
    size of bioavailability and bioequivalence studies needed for
    approval of such application. The sponsor or applicant shall
    provide information necessary for discussion and agreement on the
    design and size of such studies. Minutes of any such meeting shall
    be prepared by the Secretary and made available to the sponsor or
    applicant.
      (C) Any agreement regarding the parameters of design and size of
    bioavailability and bioequivalence studies of a drug under this
    paragraph that is reached between the Secretary and a sponsor or
    applicant shall be reduced to writing and made part of the
    administrative record by the Secretary. Such agreement shall not be
    changed after the testing begins, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (D) by the director of the reviewing division, that
      a substantial scientific issue essential to determining the
      safety or effectiveness of the drug has been identified after the
      testing has begun.

      (D) A decision under subparagraph (C)(ii) by the director shall
    be in writing and the Secretary shall provide to the sponsor or
    applicant an opportunity for a meeting at which the director and
    the sponsor or applicant will be present and at which the director
    will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by, the
    field or compliance office personnel unless such field or
    compliance office personnel demonstrate to the reviewing division
    why such decision should be modified.
      (F) No action by the reviewing division may be delayed because of
    the unavailability of information from or action by field personnel
    unless the reviewing division determines that a delay is necessary
    to assure the marketing of a safe and effective drug.
      (G) For purposes of this paragraph, the reviewing division is the
    division responsible for the review of an application for approval
    of a drug under this subsection (including scientific matters,
    chemistry, manufacturing, and controls).
      (4) Subject to paragraph (5), the Secretary shall approve an
    application for a drug unless the Secretary finds - 
        (A) the methods used in, or the facilities and controls used
      for, the manufacture, processing, and packing of the drug are
      inadequate to assure and preserve its identity, strength,
      quality, and purity;
        (B) information submitted with the application is insufficient
      to show that each of the proposed conditions of use have been
      previously approved for the listed drug referred to in the
      application;
        (C)(i) if the listed drug has only one active ingredient,
      information submitted with the application is insufficient to
      show that the active ingredient is the same as that of the listed
      drug;
        (ii) if the listed drug has more than one active ingredient,
      information submitted with the application is insufficient to
      show that the active ingredients are the same as the active
      ingredients of the listed drug, or
        (iii) if the listed drug has more than one active ingredient
      and if the application is for a drug which has an active
      ingredient different from the listed drug, information submitted
      with the application is insufficient to show - 
          (I) that the other active ingredients are the same as the
        active ingredients of the listed drug, or
          (II) that the different active ingredient is an active
        ingredient of a listed drug or a drug which does not meet the
        requirements of section 321(p) of this title,

      or no petition to file an application for the drug with the
      different ingredient was approved under paragraph (2)(C);
        (D)(i) if the application is for a drug whose route of
      administration, dosage form, or strength of the drug is the same
      as the route of administration, dosage form, or strength of the
      listed drug referred to in the application, information submitted
      in the application is insufficient to show that the route of
      administration, dosage form, or strength is the same as that of
      the listed drug, or
        (ii) if the application is for a drug whose route of
      administration, dosage form, or strength of the drug is different
      from that of the listed drug referred to in the application, no
      petition to file an application for the drug with the different
      route of administration, dosage form, or strength was approved
      under paragraph (2)(C);
        (E) if the application was filed pursuant to the approval of a
      petition under paragraph (2)(C), the application did not contain
      the information required by the Secretary respecting the active
      ingredient, route of administration, dosage form, or strength
      which is not the same;
        (F) information submitted in the application is insufficient to
      show that the drug is bioequivalent to the listed drug referred
      to in the application or, if the application was filed pursuant
      to a petition approved under paragraph (2)(C), information
      submitted in the application is insufficient to show that the
      active ingredients of the new drug are of the same
      pharmacological or therapeutic class as those of the listed drug
      referred to in paragraph (2)(A)(i) and that the new drug can be
      expected to have the same therapeutic effect as the listed drug
      when administered to patients for a condition of use referred to
      in such paragraph;
        (G) information submitted in the application is insufficient to
      show that the labeling proposed for the drug is the same as the
      labeling approved for the listed drug referred to in the
      application except for changes required because of differences
      approved under a petition filed under paragraph (2)(C) or because
      the drug and the listed drug are produced or distributed by
      different manufacturers;
        (H) information submitted in the application or any other
      information available to the Secretary shows that (i) the
      inactive ingredients of the drug are unsafe for use under the
      conditions prescribed, recommended, or suggested in the labeling
      proposed for the drug, or (ii) the composition of the drug is
      unsafe under such conditions because of the type or quantity of
      inactive ingredients included or the manner in which the inactive
      ingredients are included;
        (I) the approval under subsection (c) of this section of the
      listed drug referred to in the application under this subsection
      has been withdrawn or suspended for grounds described in the
      first sentence of subsection (e) of this section, the Secretary
      has published a notice of opportunity for hearing to withdraw
      approval of the listed drug under subsection (c) of this section
      for grounds described in the first sentence of subsection (e) of
      this section, the approval under this subsection of the listed
      drug referred to in the application under this subsection has
      been withdrawn or suspended under paragraph (6), or the Secretary
      has determined that the listed drug has been withdrawn from sale
      for safety or effectiveness reasons;
        (J) the application does not meet any other requirement of
      paragraph (2)(A); or
        (K) the application contains an untrue statement of material
      fact.

      (5)(A) Within one hundred and eighty days of the initial receipt
    of an application under paragraph (2) or within such additional
    period as may be agreed upon by the Secretary and the applicant,
    the Secretary shall approve or disapprove the application.
      (B) The approval of an application submitted under paragraph (2)
    shall be made effective on the last applicable date determined by
    applying the following to each certification made under paragraph
    (2)(A)(vii):
        (i) If the applicant only made a certification described in
      subclause (I) or (II) of paragraph (2)(A)(vii) or in both such
      subclauses, the approval may be made effective immediately.
        (ii) If the applicant made a certification described in
      subclause (III) of paragraph (2)(A)(vii), the approval may be
      made effective on the date certified under subclause (III).
        (iii) If the applicant made a certification described in
      subclause (IV) of paragraph (2)(A)(vii), the approval shall be
      made effective immediately unless, before the expiration of 45
      days after the date on which the notice described in paragraph
      (2)(B) is received, an action is brought for infringement of the
      patent that is the subject of the certification and for which
      information was submitted to the Secretary under subsection
      (b)(1) or (c)(2) of this section before the date on which the
      application (excluding an amendment or supplement to the
      application), which the Secretary later determines to be
      substantially complete, was submitted. If such an action is
      brought before the expiration of such days, the approval shall be
      made effective upon the expiration of the thirty-month period
      beginning on the date of the receipt of the notice provided under
      paragraph (2)(B)(i) or such shorter or longer period as the court
      may order because either party to the action failed to reasonably
      cooperate in expediting the action, except that - 
          (I) if before the expiration of such period the district
        court decides that the patent is invalid or not infringed
        (including any substantive determination that there is no cause
        of action for patent infringement or invalidity), the approval
        shall be made effective on - 
            (aa) the date on which the court enters judgment reflecting
          the decision; or
            (bb) the date of a settlement order or consent decree
          signed and entered by the court stating that the patent that
          is the subject of the certification is invalid or not
          infringed;

          (II) if before the expiration of such period the district
        court decides that the patent has been infringed - 
            (aa) if the judgment of the district court is appealed, the
          approval shall be made effective on - 
              (AA) the date on which the court of appeals decides that
            the patent is invalid or not infringed (including any
            substantive determination that there is no cause of action
            for patent infringement or invalidity); or
              (BB) the date of a settlement order or consent decree
            signed and entered by the court of appeals stating that the
            patent that is the subject of the certification is invalid
            or not infringed; or

            (bb) if the judgment of the district court is not appealed
          or is affirmed, the approval shall be made effective on the
          date specified by the district court in a court order under
          section 271(e)(4)(A) of title 35;

          (III) if before the expiration of such period the court
        grants a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent is
        invalid or not infringed, the approval shall be made effective
        as provided in subclause (I); or
          (IV) if before the expiration of such period the court grants
        a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent has been
        infringed, the approval shall be made effective as provided in
        subclause (II).

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action.
        (iv) 180-day exclusivity period. - 
          (I) Effectiveness of application. - Subject to subparagraph
        (D), if the application contains a certification described in
        paragraph (2)(A)(vii)(IV) and is for a drug for which a first
        applicant has submitted an application containing such a
        certification, the application shall be made effective on the
        date that is 180 days after the date of the first commercial
        marketing of the drug (including the commercial marketing of
        the listed drug) by any first applicant.
          (II) Definitions. - In this paragraph:
            (aa) 180-day exclusivity period. - The term "180-day
          exclusivity period" means the 180-day period ending on the
          day before the date on which an application submitted by an
          applicant other than a first applicant could become effective
          under this clause.
            (bb) First applicant. - As used in this subsection, the
          term "first applicant" means an applicant that, on the first
          day on which a substantially complete application containing
          a certification described in paragraph (2)(A)(vii)(IV) is
          submitted for approval of a drug, submits a substantially
          complete application that contains and lawfully maintains a
          certification described in paragraph (2)(A)(vii)(IV) for the
          drug.
            (cc) Substantially complete application. - As used in this
          subsection, the term "substantially complete application"
          means an application under this subsection that on its face
          is sufficiently complete to permit a substantive review and
          contains all the information required by paragraph (2)(A).
            (dd) Tentative approval. - 
              (AA) In general. - The term "tentative approval" means
            notification to an applicant by the Secretary that an
            application under this subsection meets the requirements of
            paragraph (2)(A), but cannot receive effective approval
            because the application does not meet the requirements of
            this subparagraph, there is a period of exclusivity for the
            listed drug under subparagraph (F) or section 355a of this
            title, or there is a 7-year period of exclusivity for the
            listed drug under section 360cc of this title.
              (BB) Limitation. - A drug that is granted tentative
            approval by the Secretary is not an approved drug and shall
            not have an effective approval until the Secretary issues
            an approval after any necessary additional review of the
            application.

      (C) Civil action to obtain patent certainty. - 
        (i) Declaratory judgment absent infringement action. - 
          (I) In general. - No action may be brought under section 2201
        of title 28 by an applicant under paragraph (2) for a
        declaratory judgment with respect to a patent which is the
        subject of the certification referred to in subparagraph
        (B)(iii) unless - 
            (aa) the 45-day period referred to in such subparagraph has
          expired;
            (bb) neither the owner of such patent nor the holder of the
          approved application under subsection (b) of this section for
          the drug that is claimed by the patent or a use of which is
          claimed by the patent brought a civil action against the
          applicant for infringement of the patent before the
          expiration of such period; and
            (cc) in any case in which the notice provided under
          paragraph (2)(B) relates to noninfringement, the notice was
          accompanied by a document described in subclause (III).

          (II) Filing of civil action. - If the conditions described in
        items (aa), (bb), and as applicable, (cc) of subclause (I) have
        been met, the applicant referred to in such subclause may, in
        accordance with section 2201 of title 28, bring a civil action
        under such section against the owner or holder referred to in
        such subclause (but not against any owner or holder that has
        brought such a civil action against the applicant, unless that
        civil action was dismissed without prejudice) for a declaratory
        judgment that the patent is invalid or will not be infringed by
        the drug for which the applicant seeks approval, except that
        such civil action may be brought for a declaratory judgment
        that the patent will not be infringed only in a case in which
        the condition described in subclause (I)(cc) is applicable. A
        civil action referred to in this subclause shall be brought in
        the judicial district where the defendant has its principal
        place of business or a regular and established place of
        business.
          (III) Offer of confidential access to application. - For
        purposes of subclause (I)(cc), the document described in this
        subclause is a document providing an offer of confidential
        access to the application that is in the custody of the
        applicant under paragraph (2) for the purpose of determining
        whether an action referred to in subparagraph (B)(iii) should
        be brought. The document providing the offer of confidential
        access shall contain such restrictions as to persons entitled
        to access, and on the use and disposition of any information
        accessed, as would apply had a protective order been entered
        for the purpose of protecting trade secrets and other
        confidential business information. A request for access to an
        application under an offer of confidential access shall be
        considered acceptance of the offer of confidential access with
        the restrictions as to persons entitled to access, and on the
        use and disposition of any information accessed, contained in
        the offer of confidential access, and those restrictions and
        other terms of the offer of confidential access shall be
        considered terms of an enforceable contract. Any person
        provided an offer of confidential access shall review the
        application for the sole and limited purpose of evaluating
        possible infringement of the patent that is the subject of the
        certification under paragraph (2)(A)(vii)(IV) and for no other
        purpose, and may not disclose information of no relevance to
        any issue of patent infringement to any person other than a
        person provided an offer of confidential access. Further, the
        application may be redacted by the applicant to remove any
        information of no relevance to any issue of patent
        infringement.

        (ii) Counterclaim to infringement action. - 
          (I) In general. - If an owner of the patent or the holder of
        the approved application under subsection (b) of this section
        for the drug that is claimed by the patent or a use of which is
        claimed by the patent brings a patent infringement action
        against the applicant, the applicant may assert a counterclaim
        seeking an order requiring the holder to correct or delete the
        patent information submitted by the holder under subsection (b)
        or (c) of this section on the ground that the patent does not
        claim either - 
            (aa) the drug for which the application was approved; or
            (bb) an approved method of using the drug.

          (II) No independent cause of action. - Subclause (I) does not
        authorize the assertion of a claim described in subclause (I)
        in any civil action or proceeding other than a counterclaim
        described in subclause (I).

        (iii) No damages. - An applicant shall not be entitled to
      damages in a civil action under clause (i) or a counterclaim
      under clause (ii).

      (D) Forfeiture of 180-day exclusivity period. - 
        (i) Definition of forfeiture event. - In this subparagraph, the
      term "forfeiture event", with respect to an application under
      this subsection, means the occurrence of any of the following:
          (I) Failure to market. - The first applicant fails to market
        the drug by the later of - 
            (aa) the earlier of the date that is - 
              (AA) 75 days after the date on which the approval of the
            application of the first applicant is made effective under
            subparagraph (B)(iii); or
              (BB) 30 months after the date of submission of the
            application of the first applicant; or

            (bb) with respect to the first applicant or any other
          applicant (which other applicant has received tentative
          approval), the date that is 75 days after the date as of
          which, as to each of the patents with respect to which the
          first applicant submitted and lawfully maintained a
          certification qualifying the first applicant for the 180-day
          exclusivity period under subparagraph (B)(iv), at least 1 of
          the following has occurred:
              (AA) In an infringement action brought against that
            applicant with respect to the patent or in a declaratory
            judgment action brought by that applicant with respect to
            the patent, a court enters a final decision from which no
            appeal (other than a petition to the Supreme Court for a
            writ of certiorari) has been or can be taken that the
            patent is invalid or not infringed.
              (BB) In an infringement action or a declaratory judgment
            action described in subitem (AA), a court signs a
            settlement order or consent decree that enters a final
            judgment that includes a finding that the patent is invalid
            or not infringed.
              (CC) The patent information submitted under subsection
            (b) or (c) of this section is withdrawn by the holder of
            the application approved under subsection (b) of this
            section.

          (II) Withdrawal of application. - The first applicant
        withdraws the application or the Secretary considers the
        application to have been withdrawn as a result of a
        determination by the Secretary that the application does not
        meet the requirements for approval under paragraph (4).
          (III) Amendment of certification. - The first applicant
        amends or withdraws the certification for all of the patents
        with respect to which that applicant submitted a certification
        qualifying the applicant for the 180-day exclusivity period.
          (IV) Failure to obtain tentative approval. - The first
        applicant fails to obtain tentative approval of the application
        within 30 months after the date on which the application is
        filed, unless the failure is caused by a change in or a review
        of the requirements for approval of the application imposed
        after the date on which the application is filed.
          (V) Agreement with another applicant, the listed drug
        application holder, or a patent owner. - The first applicant
        enters into an agreement with another applicant under this
        subsection for the drug, the holder of the application for the
        listed drug, or an owner of the patent that is the subject of
        the certification under paragraph (2)(A)(vii)(IV), the Federal
        Trade Commission or the Attorney General files a complaint, and
        there is a final decision of the Federal Trade Commission or
        the court with regard to the complaint from which no appeal
        (other than a petition to the Supreme Court for a writ of
        certiorari) has been or can be taken that the agreement has
        violated the antitrust laws (as defined in section 12 of title
        15, except that the term includes section 45 of title 15 to the
        extent that that section applies to unfair methods of
        competition).
          (VI) Expiration of all patents. - All of the patents as to
        which the applicant submitted a certification qualifying it for
        the 180-day exclusivity period have expired.

        (ii) Forfeiture. - The 180-day exclusivity period described in
      subparagraph (B)(iv) shall be forfeited by a first applicant if a
      forfeiture event occurs with respect to that first applicant.
        (iii) Subsequent applicant. - If all first applicants forfeit
      the 180-day exclusivity period under clause (ii) - 
          (I) approval of any application containing a certification
        described in paragraph (2)(A)(vii)(IV) shall be made effective
        in accordance with subparagraph (B)(iii); and
          (II) no applicant shall be eligible for a 180-day exclusivity
        period.

      (E) If the Secretary decides to disapprove an application, the
    Secretary shall give the applicant notice of an opportunity for a
    hearing before the Secretary on the question of whether such
    application is approvable. If the applicant elects to accept the
    opportunity for hearing by written request within thirty days after
    such notice, such hearing shall commence not more than ninety days
    after the expiration of such thirty days unless the Secretary and
    the applicant otherwise agree. Any such hearing shall thereafter be
    conducted on an expedited basis and the Secretary's order thereon
    shall be issued within ninety days after the date fixed by the
    Secretary for filing final briefs.
      (F)(i) If an application (other than an abbreviated new drug
    application) submitted under subsection (b) of this section for a
    drug, no active ingredient (including any ester or salt of the
    active ingredient) of which has been approved in any other
    application under subsection (b) of this section, was approved
    during the period beginning January 1, 1982, and ending on
    September 24, 1984, the Secretary may not make the approval of an
    application submitted under this subsection which refers to the
    drug for which the subsection (b) application was submitted
    effective before the expiration of ten years from the date of the
    approval of the application under subsection (b) of this section.
      (ii) If an application submitted under subsection (b) of this
    section for a drug, no active ingredient (including any ester or
    salt of the active ingredient) of which has been approved in any
    other application under subsection (b) of this section, is approved
    after September 24, 1984, no application may be submitted under
    this subsection which refers to the drug for which the subsection
    (b) application was submitted before the expiration of five years
    from the date of the approval of the application under subsection
    (b) of this section, except that such an application may be
    submitted under this subsection after the expiration of four years
    from the date of the approval of the subsection (b) application if
    it contains a certification of patent invalidity or noninfringement
    described in subclause (IV) of paragraph (2)(A)(vii). The approval
    of such an application shall be made effective in accordance with
    subparagraph (B) except that, if an action for patent infringement
    is commenced during the one-year period beginning forty-eight
    months after the date of the approval of the subsection (b)
    application, the thirty-month period referred to in subparagraph
    (B)(iii) shall be extended by such amount of time (if any) which is
    required for seven and one-half years to have elapsed from the date
    of approval of the subsection (b) application.
      (iii) If an application submitted under subsection (b) of this
    section for a drug, which includes an active ingredient (including
    any ester or salt of the active ingredient) that has been approved
    in another application approved under subsection (b) of this
    section, is approved after September 24, 1984, and if such
    application contains reports of new clinical investigations (other
    than bioavailability studies) essential to the approval of the
    application and conducted or sponsored by the applicant, the
    Secretary may not make the approval of an application submitted
    under this subsection for the conditions of approval of such drug
    in the subsection (b) application effective before the expiration
    of three years from the date of the approval of the application
    under subsection (b) of this section for such drug.
      (iv) If a supplement to an application approved under subsection
    (b) of this section is approved after September 24, 1984, and the
    supplement contains reports of new clinical investigations (other
    than bioavailability studies) essential to the approval of the
    supplement and conducted or sponsored by the person submitting the
    supplement, the Secretary may not make the approval of an
    application submitted under this subsection for a change approved
    in the supplement effective before the expiration of three years
    from the date of the approval of the supplement under subsection
    (b) of this section.
      (v) If an application (or supplement to an application) submitted
    under subsection (b) of this section for a drug, which includes an
    active ingredient (including any ester or salt of the active
    ingredient) that has been approved in another application under
    subsection (b) of this section, was approved during the period
    beginning January 1, 1982, and ending on September 24, 1984, the
    Secretary may not make the approval of an application submitted
    under this subsection which refers to the drug for which the
    subsection (b) application was submitted or which refers to a
    change approved in a supplement to the subsection (b) application
    effective before the expiration of two years from September 24,
    1984.
      (6) If a drug approved under this subsection refers in its
    approved application to a drug the approval of which was withdrawn
    or suspended for grounds described in the first sentence of
    subsection (e) of this section or was withdrawn or suspended under
    this paragraph or which, as determined by the Secretary, has been
    withdrawn from sale for safety or effectiveness reasons, the
    approval of the drug under this subsection shall be withdrawn or
    suspended - 
        (A) for the same period as the withdrawal or suspension under
      subsection (e) of this section or this paragraph, or
        (B) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

      (7)(A)(i) Within sixty days of September 24, 1984, the Secretary
    shall publish and make available to the public - 
        (I) a list in alphabetical order of the official and
      proprietary name of each drug which has been approved for safety
      and effectiveness under subsection (c) of this section before
      September 24, 1984;
        (II) the date of approval if the drug is approved after 1981
      and the number of the application which was approved; and
        (III) whether in vitro or in vivo bioequivalence studies, or
      both such studies, are required for applications filed under this
      subsection which will refer to the drug published.

      (ii) Every thirty days after the publication of the first list
    under clause (i) the Secretary shall revise the list to include
    each drug which has been approved for safety and effectiveness
    under subsection (c) of this section or approved under this
    subsection during the thirty-day period.
      (iii) When patent information submitted under subsection (b) or
    (c) of this section respecting a drug included on the list is to be
    published by the Secretary, the Secretary shall, in revisions made
    under clause (ii), include such information for such drug.
      (B) A drug approved for safety and effectiveness under subsection
    (c) of this section or approved under this subsection shall, for
    purposes of this subsection, be considered to have been published
    under subparagraph (A) on the date of its approval or September 24,
    1984, whichever is later.
      (C) If the approval of a drug was withdrawn or suspended for
    grounds described in the first sentence of subsection (e) of this
    section or was withdrawn or suspended under paragraph (6) or if the
    Secretary determines that a drug has been withdrawn from sale for
    safety or effectiveness reasons, it may not be published in the
    list under subparagraph (A) or, if the withdrawal or suspension
    occurred after its publication in such list, it shall be
    immediately removed from such list - 
        (i) for the same period as the withdrawal or suspension under
      subsection (e) of this section or paragraph (6), or
        (ii) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

    A notice of the removal shall be published in the Federal Register.
      (8) For purposes of this subsection:
        (A)(i) The term "bioavailability" means the rate and extent to
      which the active ingredient or therapeutic ingredient is absorbed
      from a drug and becomes available at the site of drug action.
        (ii) For a drug that is not intended to be absorbed into the
      bloodstream, the Secretary may assess bioavailability by
      scientifically valid measurements intended to reflect the rate
      and extent to which the active ingredient or therapeutic
      ingredient becomes available at the site of drug action.
        (B) A drug shall be considered to be bioequivalent to a listed
      drug if - 
          (i) the rate and extent of absorption of the drug do not show
        a significant difference from the rate and extent of absorption
        of the listed drug when administered at the same molar dose of
        the therapeutic ingredient under similar experimental
        conditions in either a single dose or multiple doses; or
          (ii) the extent of absorption of the drug does not show a
        significant difference from the extent of absorption of the
        listed drug when administered at the same molar dose of the
        therapeutic ingredient under similar experimental conditions in
        either a single dose or multiple doses and the difference from
        the listed drug in the rate of absorption of the drug is
        intentional, is reflected in its proposed labeling, is not
        essential to the attainment of effective body drug
        concentrations on chronic use, and is considered medically
        insignificant for the drug.

        (C) For a drug that is not intended to be absorbed into the
      bloodstream, the Secretary may establish alternative,
      scientifically valid methods to show bioequivalence if the
      alternative methods are expected to detect a significant
      difference between the drug and the listed drug in safety and
      therapeutic effect.

      (9) The Secretary shall, with respect to each application
    submitted under this subsection, maintain a record of - 
        (A) the name of the applicant,
        (B) the name of the drug covered by the application,
        (C) the name of each person to whom the review of the chemistry
      of the application was assigned and the date of such assignment,
      and
        (D) the name of each person to whom the bioequivalence review
      for such application was assigned and the date of such
      assignment.

    The information the Secretary is required to maintain under this
    paragraph with respect to an application submitted under this
    subsection shall be made available to the public after the approval
    of such application.
      (10)(A) If the proposed labeling of a drug that is the subject of
    an application under this subsection differs from the listed drug
    due to a labeling revision described under clause (i), the drug
    that is the subject of such application shall, notwithstanding any
    other provision of this chapter, be eligible for approval and shall
    not be considered misbranded under section 352 of this title if - 
        (i) the application is otherwise eligible for approval under
      this subsection but for expiration of patent, an exclusivity
      period, or of a delay in approval described in paragraph
      (5)(B)(iii), and a revision to the labeling of the listed drug
      has been approved by the Secretary within 60 days of such
      expiration;
        (ii) the labeling revision described under clause (i) does not
      include a change to the "Warnings" section of the labeling;
        (iii) the sponsor of the application under this subsection
      agrees to submit revised labeling of the drug that is the subject
      of such application not later than 60 days after the notification
      of any changes to such labeling required by the Secretary; and
        (iv) such application otherwise meets the applicable
      requirements for approval under this subsection.

      (B) If, after a labeling revision described in subparagraph
    (A)(i), the Secretary determines that the continued presence in
    interstate commerce of the labeling of the listed drug (as in
    effect before the revision described in subparagraph (A)(i))
    adversely impacts the safe use of the drug, no application under
    this subsection shall be eligible for approval with such labeling.
    (k) Records and reports; required information; regulations and
      orders; access to records
      (1) In the case of any drug for which an approval of an
    application filed under subsection (b) or (j) of this section is in
    effect, the applicant shall establish and maintain such records,
    and make such reports to the Secretary, of data relating to
    clinical experience and other data or information, received or
    otherwise obtained by such applicant with respect to such drug, as
    the Secretary may by general regulation, or by order with respect
    to such application, prescribe on the basis of a finding that such
    records and reports are necessary in order to enable the Secretary
    to determine, or facilitate a determination, whether there is or
    may be ground for invoking subsection (e) of this section.
    Regulations and orders issued under this subsection and under
    subsection (i) of this section shall have due regard for the
    professional ethics of the medical profession and the interests of
    patients and shall provide, where the Secretary deems it to be
    appropriate, for the examination, upon request, by the persons to
    whom such regulations or orders are applicable, of similar
    information received or otherwise obtained by the Secretary.
      (2) Every person required under this section to maintain records,
    and every person in charge or custody thereof, shall, upon request
    of an officer or employee designated by the Secretary, permit such
    officer or employee at all reasonable times to have access to and
    copy and verify such records.
      (3) Active postmarket risk identification. - 
        (A) Definition. - In this paragraph, the term "data" refers to
      information with respect to a drug approved under this section or
      under section 262 of title 42, including claims data, patient
      survey data, standardized analytic files that allow for the
      pooling and analysis of data from disparate data environments,
      and any other data deemed appropriate by the Secretary.
        (B) Development of postmarket risk identification and analysis
      methods. - The Secretary shall, not later than 2 years after
      September 27, 2007, in collaboration with public, academic, and
      private entities - 
          (i) develop methods to obtain access to disparate data
        sources including the data sources specified in subparagraph
        (C);
          (ii) develop validated methods for the establishment of a
        postmarket risk identification and analysis system to link and
        analyze safety data from multiple sources, with the goals of
        including, in aggregate - 
            (I) at least 25,000,000 patients by July 1, 2010; and
            (II) at least 100,000,000 patients by July 1, 2012; and

          (iii) convene a committee of experts, including individuals
        who are recognized in the field of protecting data privacy and
        security, to make recommendations to the Secretary on the
        development of tools and methods for the ethical and scientific
        uses for, and communication of, postmarketing data specified
        under subparagraph (C), including recommendations on the
        development of effective research methods for the study of drug
        safety questions.

        (C) Establishment of the postmarket risk identification and
      analysis system. - 
          (i) In general. - The Secretary shall, not later than 1 year
        after the development of the risk identification and analysis
        methods under subparagraph (B), establish and maintain
        procedures - 
            (I) for risk identification and analysis based on
          electronic health data, in compliance with the regulations
          promulgated under section 264(c) of the Health Insurance
          Portability and Accountability Act of 1996, and in a manner
          that does not disclose individually identifiable health
          information in violation of paragraph (4)(B);
            (II) for the reporting (in a standardized form) of data on
          all serious adverse drug experiences (as defined in section
          355-1(b) of this title) submitted to the Secretary under
          paragraph (1), and those adverse events submitted by
          patients, providers, and drug sponsors, when appropriate;
            (III) to provide for active adverse event surveillance
          using the following data sources, as available:
              (aa) Federal health-related electronic data (such as data
            from the Medicare program and the health systems of the
            Department of Veterans Affairs);
              (bb) private sector health-related electronic data (such
            as pharmaceutical purchase data and health insurance claims
            data); and
              (cc) other data as the Secretary deems necessary to
            create a robust system to identify adverse events and
            potential drug safety signals;

            (IV) to identify certain trends and patterns with respect
          to data accessed by the system;
            (V) to provide regular reports to the Secretary concerning
          adverse event trends, adverse event patterns, incidence and
          prevalence of adverse events, and other information the
          Secretary determines appropriate, which may include data on
          comparative national adverse event trends; and
            (VI) to enable the program to export data in a form
          appropriate for further aggregation, statistical analysis,
          and reporting.

          (ii) Timeliness of reporting. - The procedures established
        under clause (i) shall ensure that such data are accessed,
        analyzed, and reported in a timely, routine, and systematic
        manner, taking into consideration the need for data
        completeness, coding, cleansing, and standardized analysis and
        transmission.
          (iii) Private sector resources. - To ensure the establishment
        of the active postmarket risk identification and analysis
        system under this subsection not later than 1 year after the
        development of the risk identification and analysis methods
        under subparagraph (B), as required under clause (i), the
        Secretary may, on a temporary or permanent basis, implement
        systems or products developed by private entities.
          (iv) Complementary approaches. - To the extent the active
        postmarket risk identification and analysis system under this
        subsection is not sufficient to gather data and information
        relevant to a priority drug safety question, the Secretary
        shall develop, support, and participate in complementary
        approaches to gather and analyze such data and information,
        including - 
            (I) approaches that are complementary with respect to
          assessing the safety of use of a drug in domestic populations
          not included, or underrepresented, in the trials used to
          approve the drug (such as older people, people with
          comorbidities, pregnant women, or children); and
            (II) existing approaches such as the Vaccine Adverse Event
          Reporting System and the Vaccine Safety Datalink or successor
          databases.

          (v) Authority for contracts. - The Secretary may enter into
        contracts with public and private entities to fulfill the
        requirements of this subparagraph.

      (4) Advanced analysis of drug safety data. - 
        (A) Purpose. - The Secretary shall establish collaborations
      with public, academic, and private entities, which may include
      the Centers for Education and Research on Therapeutics under
      section 299b-1 of title 42, to provide for advanced analysis of
      drug safety data described in paragraph (3)(C) and other
      information that is publicly available or is provided by the
      Secretary, in order to - 
          (i) improve the quality and efficiency of postmarket drug
        safety risk-benefit analysis;
          (ii) provide the Secretary with routine access to outside
        expertise to study advanced drug safety questions; and
          (iii) enhance the ability of the Secretary to make timely
        assessments based on drug safety data.

        (B) Privacy. - Such analysis shall not disclose individually
      identifiable health information when presenting such drug safety
      signals and trends or when responding to inquiries regarding such
      drug safety signals and trends.
        (C) Public process for priority questions. - At least
      biannually, the Secretary shall seek recommendations from the
      Drug Safety and Risk Management Advisory Committee (or any
      successor committee) and from other advisory committees, as
      appropriate, to the Food and Drug Administration on - 
          (i) priority drug safety questions; and
          (ii) mechanisms for answering such questions, including
        through - 
            (I) active risk identification under paragraph (3); and
            (II) when such risk identification is not sufficient,
          postapproval studies and clinical trials under subsection
          (o)(3).

        (D) Procedures for the development of drug safety
      collaborations. - 
          (i) In general. - Not later than 180 days after the date of
        the establishment of the active postmarket risk identification
        and analysis system under this subsection, the Secretary shall
        establish and implement procedures under which the Secretary
        may routinely contract with one or more qualified entities to -
        
            (I) classify, analyze, or aggregate data described in
          paragraph (3)(C) and information that is publicly available
          or is provided by the Secretary;
            (II) allow for prompt investigation of priority drug safety
          questions, including - 
              (aa) unresolved safety questions for drugs or classes of
            drugs; and
              (bb) for a newly-approved drugs,(!2) safety signals from
            clinical trials used to approve the drug and other
            preapproval trials; rare, serious drug side effects; and
            the safety of use in domestic populations not included, or
            underrepresented, in the trials used to approve the drug
            (such as older people, people with comorbidities, pregnant
            women, or children);


            (III) perform advanced research and analysis on identified
          drug safety risks;
            (IV) focus postapproval studies and clinical trials under
          subsection (o)(3) more effectively on cases for which reports
          under paragraph (1) and other safety signal detection is not
          sufficient to resolve whether there is an elevated risk of a
          serious adverse event associated with the use of a drug; and
            (V) carry out other activities as the Secretary deems
          necessary to carry out the purposes of this paragraph.

          (ii) Request for specific methodology. - The procedures
        described in clause (i) shall permit the Secretary to request
        that a specific methodology be used by the qualified entity.
        The qualified entity shall work with the Secretary to finalize
        the methodology to be used.

        (E) Use of analyses. - The Secretary shall provide the analyses
      described in this paragraph, including the methods and results of
      such analyses, about a drug to the sponsor or sponsors of such
      drug.
        (F) Qualified entities. - 
          (i) In general. - The Secretary shall enter into contracts
        with a sufficient number of qualified entities to develop and
        provide information to the Secretary in a timely manner.
          (ii) Qualification. - The Secretary shall enter into a
        contract with an entity under clause (i) only if the Secretary
        determines that the entity has a significant presence in the
        United States and has one or more of the following
        qualifications:
            (I) The research, statistical, epidemiologic, or clinical
          capability and expertise to conduct and complete the
          activities under this paragraph, including the capability and
          expertise to provide the Secretary de-identified data
          consistent with the requirements of this subsection.
            (II) An information technology infrastructure in place to
          support electronic data and operational standards to provide
          security for such data.
            (III) Experience with, and expertise on, the development of
          drug safety and effectiveness research using electronic
          population data.
            (IV) An understanding of drug development or risk/benefit
          balancing in a clinical setting.
            (V) Other expertise which the Secretary deems necessary to
          fulfill the activities under this paragraph.

        (G) Contract requirements. - Each contract with a qualified
      entity under subparagraph (F)(i) shall contain the following
      requirements:
          (i) Ensuring privacy. - The qualified entity shall ensure
        that the entity will not use data under this subsection in a
        manner that - 
            (I) violates the regulations promulgated under section
          264(c) of the Health Insurance Portability and Accountability
          Act of 1996;
            (II) violates sections 552 or 552a of title 5 with regard
          to the privacy of individually-identifiable beneficiary
          health information; or
            (III) discloses individually identifiable health
          information when presenting drug safety signals and trends or
          when responding to inquiries regarding drug safety signals
          and trends.

        Nothing in this clause prohibits lawful disclosure for other
        purposes.
          (ii) Component of another organization. - If a qualified
        entity is a component of another organization - 
            (I) the qualified entity shall establish appropriate
          security measures to maintain the confidentiality and privacy
          of such data; and
            (II) the entity shall not make an unauthorized disclosure
          of such data to the other components of the organization in
          breach of such confidentiality and privacy requirement.

          (iii) Termination or nonrenewal. - If a contract with a
        qualified entity under this subparagraph is terminated or not
        renewed, the following requirements shall apply:
            (I) Confidentiality and privacy protections. - The entity
          shall continue to comply with the confidentiality and privacy
          requirements under this paragraph with respect to all data
          disclosed to the entity.
            (II) Disposition of data. - The entity shall return any
          data disclosed to such entity under this subsection to which
          it would not otherwise have access or, if returning the data
          is not practicable, destroy the data.

        (H) Competitive procedures. - The Secretary shall use
      competitive procedures (as defined in section 132 of title 41) to
      enter into contracts under subparagraph (G).
        (I) Review of contract in the event of a merger or acquisition.
      - The Secretary shall review the contract with a qualified entity
      under this paragraph in the event of a merger or acquisition of
      the entity in order to ensure that the requirements under this
      paragraph will continue to be met.
        (J) Coordination. - In carrying out this paragraph, the
      Secretary shall provide for appropriate communications to the
      public, scientific, public health, and medical communities, and
      other key stakeholders, and to the extent practicable shall
      coordinate with the activities of private entities, professional
      associations, or other entities that may have sources of drug
      safety data.

      (5) The Secretary shall - 
        (A) conduct regular, bi-weekly screening of the Adverse Event
      Reporting System database and post a quarterly report on the
      Adverse Event Reporting System Web site of any new safety
      information or potential signal of a serious risk identified by
      Adverse (!3) Event Reporting System within the last quarter;

        (B) report to Congress not later than 2 year (!4) after
      September 27, 2007, on procedures and processes of the Food and
      Drug Administration for addressing ongoing post market safety
      issues identified by the Office of Surveillance and Epidemiology
      and how recommendations of the Office of Surveillance and
      Epidemiology are handled within the agency; and

        (C) on an annual basis, review the entire backlog of postmarket
      safety commitments to determine which commitments require
      revision or should be eliminated, report to the Congress on these
      determinations, and assign start dates and estimated completion
      dates for such commitments.
    (l) Public disclosure of safety and effectiveness data and action
      package
      (1) Safety and effectiveness data and information which has been
    submitted in an application under subsection (b) of this section
    for a drug and which has not previously been disclosed to the
    public shall be made available to the public, upon request, unless
    extraordinary circumstances are shown - 
        (A) if no work is being or will be undertaken to have the
      application approved,
        (B) if the Secretary has determined that the application is not
      approvable and all legal appeals have been exhausted,
        (C) if approval of the application under subsection (c) of this
      section is withdrawn and all legal appeals have been exhausted,
        (D) if the Secretary has determined that such drug is not a new
      drug, or
        (E) upon the effective date of the approval of the first
      application under subsection (j) of this section which refers to
      such drug or upon the date upon which the approval of an
      application under subsection (j) of this section which refers to
      such drug could be made effective if such an application had been
      submitted.

      (2) Action Package for Approval. - 
        (A) Action package. - The Secretary shall publish the action
      package for approval of an application under subsection (b) or
      section 262 of title 42 on the Internet Web site of the Food and
      Drug Administration - 
          (i) not later than 30 days after the date of approval of such
        application for a drug no active ingredient (including any
        ester or salt of the active ingredient) of which has been
        approved in any other application under this section or section
        262 of title 42; and
          (ii) not later than 30 days after the third request for such
        action package for approval received under section 552 of title
        5 for any other drug.

        (B) Immediate publication of summary review. - Notwithstanding
      subparagraph (A), the Secretary shall publish, on the Internet
      Web site of the Food and Drug Administration, the materials
      described in subparagraph (C)(iv) not later than 48 hours after
      the date of approval of the drug, except where such materials
      require redaction by the Secretary.
        (C) Contents. - An action package for approval of an
      application under subparagraph (A) shall be dated and shall
      include the following:
          (i) Documents generated by the Food and Drug Administration
        related to review of the application.
          (ii) Documents pertaining to the format and content of the
        application generated during drug development.
          (iii) Labeling submitted by the applicant.
          (iv) A summary review that documents conclusions from all
        reviewing disciplines about the drug, noting any critical
        issues and disagreements with the applicant and within the
        review team and how they were resolved, recommendations for
        action, and an explanation of any nonconcurrence with review
        conclusions.
          (v) The Division Director and Office Director's decision
        document which includes - 
            (I) a brief statement of concurrence with the summary
          review;
            (II) a separate review or addendum to the review if
          disagreeing with the summary review; and
            (III) a separate review or addendum to the review to add
          further analysis.

          (vi) Identification by name of each officer or employee of
        the Food and Drug Administration who - 
            (I) participated in the decision to approve the
          application; and
            (II) consents to have his or her name included in the
          package.

        (D) Review. - A scientific review of an application is
      considered the work of the reviewer and shall not be altered by
      management or the reviewer once final.
        (E) Confidential information. - This paragraph does not
      authorize the disclosure of any trade secret, confidential
      commercial or financial information, or other matter listed in
      section 552(b) of title 5.
    (m) "Patent" defined
      For purposes of this section, the term "patent" means a patent
    issued by the United States Patent and Trademark Office.
    (n) Scientific advisory panels
      (1) For the purpose of providing expert scientific advice and
    recommendations to the Secretary regarding a clinical investigation
    of a drug or the approval for marketing of a drug under this
    section or section 262 of title 42, the Secretary shall establish
    panels of experts or use panels of experts established before
    November 21, 1997, or both.
      (2) The Secretary may delegate the appointment and oversight
    authority granted under section 394 of this title to a director of
    a center or successor entity within the Food and Drug
    Administration.
      (3) The Secretary shall make appointments to each panel
    established under paragraph (1) so that each panel shall consist of
    - 
        (A) members who are qualified by training and experience to
      evaluate the safety and effectiveness of the drugs to be referred
      to the panel and who, to the extent feasible, possess skill and
      experience in the development, manufacture, or utilization of
      such drugs;
        (B) members with diverse expertise in such fields  as  clinical
       and  administrative  medicine, pharmacy, pharmacology,
      pharmacoeconomics, biological and physical sciences, and other
      related professions;
        (C) a representative of consumer interests, and a
      representative of interests of the drug manufacturing industry
      not directly affected by the matter to be brought before the
      panel; and
        (D) two or more members who are specialists or have other
      expertise in the particular disease or condition for which the
      drug under review is proposed to be indicated.

    Scientific, trade, and consumer organizations shall be afforded an
    opportunity to nominate individuals for appointment to the panels.
    No individual who is in the regular full-time employ of the United
    States and engaged in the administration of this chapter may be a
    voting member of any panel. The Secretary shall designate one of
    the members of each panel to serve as chairman thereof.
      (4) The Secretary shall, as appropriate, provide education and
    training to each new panel member before such member participates
    in a panel's activities, including education regarding requirements
    under this chapter and related regulations of the Secretary, and
    the administrative processes and procedures related to panel
    meetings.
      (5) Panel members (other than officers or employees of the United
    States), while attending meetings or conferences of a panel or
    otherwise engaged in its business, shall be entitled to receive
    compensation for each day so engaged, including traveltime, at
    rates to be fixed by the Secretary, but not to exceed the daily
    equivalent of the rate in effect for positions classified above
    grade GS-15 of the General Schedule. While serving away from their
    homes or regular places of business, panel members may be allowed
    travel expenses (including per diem in lieu of subsistence) as
    authorized by section 5703 of title 5, for persons in the
    Government service employed intermittently.
      (6) The Secretary shall ensure that scientific advisory panels
    meet regularly and at appropriate intervals so that any matter to
    be reviewed by such a panel can be presented to the panel not more
    than 60 days after the matter is ready for such review. Meetings of
    the panel may be held using electronic communication to convene the
    meetings.
      (7) Within 90 days after a scientific advisory panel makes
    recommendations on any matter under its review, the Food and Drug
    Administration official responsible for the matter shall review the
    conclusions and recommendations of the panel, and notify the
    affected persons of the final decision on the matter, or of the
    reasons that no such decision has been reached. Each such final
    decision shall be documented including the rationale for the
    decision.
    (o) Postmarket studies and clinical trials; labeling
      (1) In general
        A responsible person may not introduce or deliver for
      introduction into interstate commerce the new drug involved if
      the person is in violation of a requirement established under
      paragraph (3) or (4) with respect to the drug.
      (2) Definitions
        For purposes of this subsection:
        (A) Responsible person
          The term "responsible person" means a person who - 
            (i) has submitted to the Secretary a covered application
          that is pending; or
            (ii) is the holder of an approved covered application.
        (B) Covered application
          The term "covered application" means - 
            (i) an application under subsection (b) for a drug that is
          subject to section 353(b) of this title; and
            (ii) an application under section 262 of title 42.
        (C) New safety information; serious risk
          The terms "new safety information", "serious risk", and
        "signal of a serious risk" have the meanings given such terms
        in section 355-1(b) of this title.
      (3) Studies and clinical trials
        (A) In general
          For any or all of the purposes specified in subparagraph (B),
        the Secretary may, subject to subparagraph (D), require a
        responsible person for a drug to conduct a postapproval study
        or studies of the drug, or a postapproval clinical trial or
        trials of the drug, on the basis of scientific data deemed
        appropriate by the Secretary, including information regarding
        chemically-related or pharmacologically-related drugs.
        (B) Purposes of study or clinical trial
          The purposes referred to in this subparagraph with respect to
        a postapproval study or postapproval clinical trial are the
        following:
            (i) To assess a known serious risk related to the use of
          the drug involved.
            (ii) To assess signals of serious risk related to the use
          of the drug.
            (iii) To identify an unexpected serious risk when available
          data indicates the potential for a serious risk.
        (C) Establishment of requirement after approval of covered
          application
          The Secretary may require a postapproval study or studies or
        postapproval clinical trial or trials for a drug for which an
        approved covered application is in effect as of the date on
        which the Secretary seeks to establish such requirement only if
        the Secretary becomes aware of new safety information.
        (D) Determination by Secretary
          (i) Postapproval studies
            The Secretary may not require the responsible person to
          conduct a study under this paragraph, unless the Secretary
          makes a determination that the reports under subsection
          (k)(1) and the active postmarket risk identification and
          analysis system as available under subsection (k)(3) will not
          be sufficient to meet the purposes set forth in subparagraph
          (B).
          (ii) Postapproval clinical trials
            The Secretary may not require the responsible person to
          conduct a clinical trial under this paragraph, unless the
          Secretary makes a determination that a postapproval study or
          studies will not be sufficient to meet the purposes set forth
          in subparagraph (B).
        (E) Notification; timetables; periodic reports
          (i) Notification
            The Secretary shall notify the responsible person regarding
          a requirement under this paragraph to conduct a postapproval
          study or clinical trial by the target dates for communication
          of feedback from the review team to the responsible person
          regarding proposed labeling and postmarketing study
          commitments as set forth in the letters described in section
          101(c) of the Food and Drug Administration Amendments Act of
          2007.
          (ii) Timetable; periodic reports
            For each study or clinical trial required to be conducted
          under this paragraph, the Secretary shall require that the
          responsible person submit a timetable for completion of the
          study or clinical trial. With respect to each study required
          to be conducted under this paragraph or otherwise undertaken
          by the responsible person to investigate a safety issue, the
          Secretary shall require the responsible person to
          periodically report to the Secretary on the status of such
          study including whether any difficulties in completing the
          study have been encountered. With respect to each clinical
          trial required to be conducted under this paragraph or
          otherwise undertaken by the responsible person to investigate
          a safety issue, the Secretary shall require the responsible
          person to periodically report to the Secretary on the status
          of such clinical trial including whether enrollment has
          begun, the number of participants enrolled, the expected
          completion date, whether any difficulties completing the
          clinical trial have been encountered, and registration
          information with respect to the requirements under section
          282(j) of title 42. If the responsible person fails to comply
          with such timetable or violates any other requirement of this
          subparagraph, the responsible person shall be considered in
          violation of this subsection, unless the responsible person
          demonstrates good cause for such noncompliance or such other
          violation. The Secretary shall determine what constitutes
          good cause under the preceding sentence.
        (F) Dispute resolution
          The responsible person may appeal a requirement to conduct a
        study or clinical trial under this paragraph using dispute
        resolution procedures established by the Secretary in
        regulation and guidance.
      (4) Safety labeling changes requested by Secretary
        (A) New safety information
          If the Secretary becomes aware of new safety information that
        the Secretary believes should be included in the labeling of
        the drug, the Secretary shall promptly notify the responsible
        person or, if the same drug approved under subsection (b) is
        not currently marketed, the holder of an approved application
        under subsection (j).
        (B) Response to notification
          Following notification pursuant to subparagraph (A), the
        responsible person or the holder of the approved application
        under subsection (j) shall within 30 days - 
            (i) submit a supplement proposing changes to the approved
          labeling to reflect the new safety information, including
          changes to boxed warnings, contraindications, warnings,
          precautions, or adverse reactions; or
            (ii) notify the Secretary that the responsible person or
          the holder of the approved application under subsection (j)
          does not believe a labeling change is warranted and submit a
          statement detailing the reasons why such a change is not
          warranted.
        (C) Review
          Upon receipt of such supplement, the Secretary shall promptly
        review and act upon such supplement. If the Secretary disagrees
        with the proposed changes in the supplement or with the
        statement setting forth the reasons why no labeling change is
        necessary, the Secretary shall initiate discussions to reach
        agreement on whether the labeling for the drug should be
        modified to reflect the new safety information, and if so, the
        contents of such labeling changes.
        (D) Discussions
          Such discussions shall not extend for more than 30 days after
        the response to the notification under subparagraph (B), unless
        the Secretary determines an extension of such discussion period
        is warranted.
        (E) Order
          Within 15 days of the conclusion of the discussions under
        subparagraph (D), the Secretary may issue an order directing
        the responsible person or the holder of the approved
        application under subsection (j) to make such a labeling change
        as the Secretary deems appropriate to address the new safety
        information. Within 15 days of such an order, the responsible
        person or the holder of the approved application under
        subsection (j) shall submit a supplement containing the
        labeling change.
        (F) Dispute resolution
          Within 5 days of receiving an order under subparagraph (E),
        the responsible person or the holder of the approved
        application under subsection (j) may appeal using dispute
        resolution procedures established by the Secretary in
        regulation and guidance.
        (G) Violation
          If the responsible person or the holder of the approved
        application under subsection (j) has not submitted a supplement
        within 15 days of the date of such order under subparagraph
        (E), and there is no appeal or dispute resolution proceeding
        pending, the responsible person or holder shall be considered
        to be in violation of this subsection. If at the conclusion of
        any dispute resolution procedures the Secretary determines that
        a supplement must be submitted and such a supplement is not
        submitted within 15 days of the date of that determination, the
        responsible person or holder shall be in violation of this
        subsection.
        (H) Public health threat
          Notwithstanding subparagraphs (A) through (F), if the
        Secretary concludes that such a labeling change is necessary to
        protect the public health, the Secretary may accelerate the
        timelines in such subparagraphs.
        (I) Rule of construction
          This paragraph shall not be construed to affect the
        responsibility of the responsible person or the holder of the
        approved application under subsection (j) to maintain its label
        in accordance with existing requirements, including subpart B
        of part 201 and sections 314.70 and 601.12 of title 21, Code of
        Federal Regulations (or any successor regulations).
      (5) Non-delegation
        Determinations by the Secretary under this subsection for a
      drug shall be made by individuals at or above the level of
      individuals empowered to approve a drug (such as division
      directors within the Center for Drug Evaluation and Research).
    (p) Risk evaluation and mitigation strategy
      (1) In general
        A person may not introduce or deliver for introduction into
      interstate commerce a new drug if - 
          (A)(i) the application for such drug is approved under
        subsection (b) or (j) and is subject to section 353(b) of this
        title; or
          (ii) the application for such drug is approved under section
        262 of title 42; and
          (B) a risk evaluation and mitigation strategy is required
        under section 355-1 of this title with respect to the drug and
        the person fails to maintain compliance with the requirements
        of the approved strategy or with other requirements under
        section 355-1 of this title, including requirements regarding
        assessments of approved strategies.
      (2) Certain postmarket studies
        The failure to conduct a postmarket study under section 356 of
      this title, subpart H of part 314, or subpart E of part 601 of
      title 21, Code of Federal Regulations (or any successor
      regulations), is deemed to be a violation of paragraph (1).
    (q) Petitions and civil actions regarding approval of certain
      applications
      (1) In general
        (A) Determination
          The Secretary shall not delay approval of a pending
        application submitted under subsection (b)(2) or (j) because of
        any request to take any form of action relating to the
        application, either before or during consideration of the
        request, unless - 
            (i) the request is in writing and is a petition submitted
          to the Secretary pursuant to section 10.30 or 10.35 of title
          21, Code of Federal Regulations (or any successor
          regulations); and
            (ii) the Secretary determines, upon reviewing the petition,
          that a delay is necessary to protect the public health.

        Consideration of the petition shall be separate and apart from
        review and approval of any application.
        (B) Notification
          If the Secretary determines under subparagraph (A) that a
        delay is necessary with respect to an application, the
        Secretary shall provide to the applicant, not later than 30
        days after making such determination, the following
        information:
            (i) Notification of the fact that a determination under
          subparagraph (A) has been made.
            (ii) If applicable, any clarification or additional data
          that the applicant should submit to the docket on the
          petition to allow the Secretary to review the petition
          promptly.
            (iii) A brief summary of the specific substantive issues
          raised in the petition which form the basis of the
          determination.
        (C) Format
          The information described in subparagraph (B) shall be
        conveyed via either, at the discretion of the Secretary - 
            (i) a document; or
            (ii) a meeting with the applicant involved.
        (D) Public disclosure
          Any information conveyed by the Secretary under subparagraph
        (C) shall be considered part of the application and shall be
        subject to the disclosure requirements applicable to
        information in such application.
        (E) Denial based on intent to delay
          If the Secretary determines that a petition or a supplement
        to the petition was submitted with the primary purpose of
        delaying the approval of an application and the petition does
        not on its face raise valid scientific or regulatory issues,
        the Secretary may deny the petition at any point based on such
        determination. The Secretary may issue guidance to describe the
        factors that will be used to determine under this subparagraph
        whether a petition is submitted with the primary purpose of
        delaying the approval of an application.
        (F) Final agency action
          The Secretary shall take final agency action on a petition
        not later than 180 days after the date on which the petition is
        submitted. The Secretary shall not extend such period for any
        reason, including - 
            (i) any determination made under subparagraph (A);
            (ii) the submission of comments relating to the petition or
          supplemental information supplied by the petitioner; or
            (iii) the consent of the petitioner.
        (G) Extension of 30-month period
          If the filing of an application resulted in first-applicant
        status under subsection (j)(5)(D)(i)(IV) and approval of the
        application was delayed because of a petition, the 30-month
        period under such subsection is deemed to be extended by a
        period of time equal to the period beginning on the date on
        which the Secretary received the petition and ending on the
        date of final agency action on the petition (inclusive of such
        beginning and ending dates), without regard to whether the
        Secretary grants, in whole or in part, or denies, in whole or
        in part, the petition.
        (H) Certification
          The Secretary shall not consider a petition for review unless
        the party submitting such petition does so in written form and
        the subject document is signed and contains the following
        certification: "I certify that, to my best knowledge and
        belief: (a) this petition includes all information and views
        upon which the petition relies; (b) this petition includes
        representative data and/or information known to the petitioner
        which are unfavorable to the petition; and (c) I have taken
        reasonable steps to ensure that any representative data and/or
        information which are unfavorable to the petition were
        disclosed to me. I further certify that the information upon
        which I have based the action requested herein first became
        known to the party on whose behalf this petition is submitted
        on or about the following date: __________. If I received or
        expect to receive payments, including cash and other forms of
        consideration, to file this information or its contents, I
        received or expect to receive those payments from the following
        persons or organizations: _____________. I verify under penalty
        of perjury that the foregoing is true and correct as of the
        date of the submission of this petition.", with the date on
        which such information first became known to such party and the
        names of such persons or organizations inserted in the first
        and second blank space, respectively.
        (I) Verification
          The Secretary shall not accept for review any supplemental
        information or comments on a petition unless the party
        submitting such information or comments does so in written form
        and the subject document is signed and contains the following
        verification: "I certify that, to my best knowledge and belief:
        (a) I have not intentionally delayed submission of this
        document or its contents; and (b) the information upon which I
        have based the action requested herein first became known to me
        on or about __________. If I received or expect to receive
        payments, including cash and other forms of consideration, to
        file this information or its contents, I received or expect to
        receive those payments from the following persons or
        organizations: _____. I verify under penalty of perjury that
        the foregoing is true and correct as of the date of the
        submission of this petition.", with the date on which such
        information first became known to the party and the names of
        such persons or organizations inserted in the first and second
        blank space, respectively.
      (2) Exhaustion of administrative remedies
        (A) Final agency action within 180 days
          The Secretary shall be considered to have taken final agency
        action on a petition if - 
            (i) during the 180-day period referred to in paragraph
          (1)(F), the Secretary makes a final decision within the
          meaning of section 10.45(d) of title 21, Code of Federal
          Regulations (or any successor regulation); or
            (ii) such period expires without the Secretary having made
          such a final decision.
        (B) Dismissal of certain civil actions
          If a civil action is filed against the Secretary with respect
        to any issue raised in the petition before the Secretary has
        taken final agency action on the petition within the meaning of
        subparagraph (A), the court shall dismiss without prejudice the
        action for failure to exhaust administrative remedies.
        (C) Administrative record
          For purposes of judicial review related to the approval of an
        application for which a petition under paragraph (1) was
        submitted, the administrative record regarding any issue raised
        by the petition shall include - 
            (i) the petition filed under paragraph (1) and any
          supplements and comments thereto;
            (ii) the Secretary's response to such petition, if issued;
          and
            (iii) other information, as designated by the Secretary,
          related to the Secretary's determinations regarding the
          issues raised in such petition, as long as the information
          was considered by the agency no later than the date of final
          agency action as defined under subparagraph (2)(A), and
          regardless of whether the Secretary responded to the petition
          at or before the approval of the application at issue in the
          petition.
      (3) Annual report on delays in approvals per petitions
        The Secretary shall annually submit to the Congress a report
      that specifies - 
          (A) the number of applications that were approved during the
        preceding 12-month period;
          (B) the number of such applications whose effective dates
        were delayed by petitions referred to in paragraph (1) during
        such period;
          (C) the number of days by which such applications were so
        delayed; and
          (D) the number of such petitions that were submitted during
        such period.
      (4) Exceptions
        This subsection does not apply to - 
          (A) a petition that relates solely to the timing of the
        approval of an application pursuant to subsection
        (j)(5)(B)(iv); or
          (B) a petition that is made by the sponsor of an application
        and that seeks only to have the Secretary take or refrain from
        taking any form of action with respect to that application.
      (5) Definitions
        (A) Application
          For purposes of this subsection, the term "application" means
        an application submitted under subsection (b)(2) or (j).
        (B) Petition
          For purposes of this subsection, other than paragraph
        (1)(A)(i), the term "petition" means a request described in
        paragraph (1)(A)(i).
    (r) Postmarket drug safety information for patients and providers
      (1) Establishment
        Not later than 1 year after September 27, 2007, the Secretary
      shall improve the transparency of information about drugs and
      allow patients and health care providers better access to
      information about drugs by developing and maintaining an Internet
      Web site that - 
          (A) provides links to drug safety information listed in
        paragraph (2) for prescription drugs that are approved under
        this section or licensed under section 262 of title 42; and
          (B) improves communication of drug safety information to
        patients and providers.
      (2) Internet Web site
        The Secretary shall carry out paragraph (1) by - 
          (A) developing and maintaining an accessible, consolidated
        Internet Web site with easily searchable drug safety
        information, including the information found on United States
        Government Internet Web sites, such as the United States
        National Library of Medicine's Daily Med and Medline Plus Web
        sites, in addition to other such Web sites maintained by the
        Secretary;
          (B) ensuring that the information provided on the Internet
        Web site is comprehensive and includes, when available and
        appropriate - 
            (i) patient labeling and patient packaging inserts;
            (ii) a link to a list of each drug, whether approved under
          this section or licensed under such section 262, for which a
          Medication Guide, as provided for under part 208 of title 21,
          Code of Federal Regulations (or any successor regulations),
          is required;
            (iii) a link to the registry and results data bank provided
          for under subsections (i) and (j) of section 282 of title 42;
            (iv) the most recent safety information and alerts issued
          by the Food and Drug Administration for drugs approved by the
          Secretary under this section, such as product recalls,
          warning letters, and import alerts;
            (v) publicly available information about implemented
          RiskMAPs and risk evaluation and mitigation strategies under
          subsection (o);
            (vi) guidance documents and regulations related to drug
          safety; and
            (vii) other material determined appropriate by the
          Secretary;

          (C) providing access to summaries of the assessed and
        aggregated data collected from the active surveillance
        infrastructure under subsection (k)(3) to provide information
        of known and serious side-effects for drugs approved under this
        section or licensed under such section 262;
          (D) preparing, by 18 months after approval of a drug or after
        use of the drug by 10,000 individuals, whichever is later, a
        summary analysis of the adverse drug reaction reports received
        for the drug, including identification of any new risks not
        previously identified, potential new risks, or known risks
        reported in unusual number;
          (E) enabling patients, providers, and drug sponsors to submit
        adverse event reports through the Internet Web site;
          (F) providing educational materials for patients and
        providers about the appropriate means of disposing of expired,
        damaged, or unusable medications; and
          (G) supporting initiatives that the Secretary determines to
        be useful to fulfill the purposes of the Internet Web site.
      (3) Posting of drug labeling
        The Secretary shall post on the Internet Web site established
      under paragraph (1) the approved professional labeling and any
      required patient labeling of a drug approved under this section
      or licensed under such section 262 not later than 21 days after
      the date the drug is approved or licensed, including in a
      supplemental application with respect to a labeling change.
      (4) Private sector resources
        To ensure development of the Internet Web site by the date
      described in paragraph (1), the Secretary may, on a temporary or
      permanent basis, implement systems or products developed by
      private entities.
      (5) Authority for contracts
        The Secretary may enter into contracts with public and private
      entities to fulfill the requirements of this subsection.
      (6) Review
        The Advisory Committee on Risk Communication under section
      360bbb-6 of this title shall, on a regular basis, perform a
      comprehensive review and evaluation of the types of risk
      communication information provided on the Internet Web site
      established under paragraph (1) and, through other means, shall
      identify, clarify, and define the purposes and types of
      information available to facilitate the efficient flow of
      information to patients and providers, and shall recommend ways
      for the Food and Drug Administration to work with outside
      entities to help facilitate the dispensing of risk communication
      information to patients and providers.
    (s) Referral to advisory committee
      Prior to the approval of a drug no active ingredient (including
    any ester or salt of the active ingredient) of which has been
    approved in any other application under this section or section 262
    of title 42, the Secretary shall - 
        (1) refer such drug to a Food and Drug Administration advisory
      committee for review at a meeting of such advisory committee; or
        (2) if the Secretary does not refer such a drug to a Food and
      Drug Administration advisory committee prior to the approval of
      the drug, provide in the action letter on the application for the
      drug a summary of the reasons why the Secretary did not refer the
      drug to an advisory committee prior to approval.
    (t) Database for authorized generic drugs
      (1) In general
        (A) Publication
          The Commissioner shall - 
            (i) not later than 9 months after September 27, 2007,
          publish a complete list on the Internet Web site of the Food
          and Drug Administration of all authorized generic drugs
          (including drug trade name, brand company manufacturer, and
          the date the authorized generic drug entered the market); and
            (ii) update the list quarterly to include each authorized
          generic drug included in an annual report submitted to the
          Secretary by the sponsor of a listed drug during the
          preceding 3-month period.
        (B) Notification
          The Commissioner shall notify relevant Federal agencies,
        including the Centers for Medicare & Medicaid Services and the
        Federal Trade Commission, when the Commissioner first publishes
        the information described in subparagraph (A) that the
        information has been published and that the information will be
        updated quarterly.
      (2) Inclusion
        The Commissioner shall include in the list described in
      paragraph (1) each authorized generic drug included in an annual
      report submitted to the Secretary by the sponsor of a listed drug
      after January 1, 1999.
      (3) Authorized generic drug
        In this section, the term "authorized generic drug" means a
      listed drug (as that term is used in subsection (j)) that - 
          (A) has been approved under subsection (c); and
          (B) is marketed, sold, or distributed directly or indirectly
        to retail class of trade under a different labeling, packaging
        (other than repackaging as the listed drug in blister packs,
        unit doses, or similar packaging for use in institutions),
        product code, labeler code, trade name, or trade mark than the
        listed drug.
    (u) Certain drugs containing single enantiomers
      (1) In general
        For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if
      an application is submitted under subsection (b) for a non-
      racemic drug containing as an active ingredient (including any
      ester or salt of the active ingredient) a single enantiomer that
      is contained in a racemic drug approved in another application
      under subsection (b), the applicant may, in the application for
      such non-racemic drug, elect to have the single enantiomer not be
      considered the same active ingredient as that contained in the
      approved racemic drug, if - 
          (A)(i) the single enantiomer has not been previously approved
        except in the approved racemic drug; and
          (ii) the application submitted under subsection (b) for such
        non-racemic drug - 
            (I) includes full reports of new clinical investigations
          (other than bioavailability studies) - 
              (aa) necessary for the approval of the application under
            subsections (c) and (d); and
              (bb) conducted or sponsored by the applicant; and

            (II) does not rely on any investigations that are part of
          an application submitted under subsection (b) for approval of
          the approved racemic drug; and

          (B) the application submitted under subsection (b) for such
        non-racemic drug is not submitted for approval of a condition
        of use - 
            (i) in a therapeutic category in which the approved racemic
          drug has been approved; or
            (ii) for which any other enantiomer of the racemic drug has
          been approved.
      (2) Limitation
        (A) No approval in certain therapeutic categories
          Until the date that is 10 years after the date of approval of
        a non-racemic drug described in paragraph (1) and with respect
        to which the applicant has made the election provided for by
        such paragraph, the Secretary shall not approve such non-
        racemic drug for any condition of use in the therapeutic
        category in which the racemic drug has been approved.
        (B) Labeling
          If applicable, the labeling of a non-racemic drug described
        in paragraph (1) and with respect to which the applicant has
        made the election provided for by such paragraph shall include
        a statement that the non-racemic drug is not approved, and has
        not been shown to be safe and effective, for any condition of
        use of the racemic drug.
      (3) Definition
        (A) In general
          For purposes of this subsection, the term "therapeutic
        category" means a therapeutic category identified in the list
        developed by the United States Pharmacopeia pursuant to section
        1395w-104(b)(3)(C)(ii) of title 42 and as in effect on
        September 27, 2007.
        (B) Publication by Secretary
          The Secretary shall publish the list described in
        subparagraph (A) and may amend such list by regulation.
      (4) Availability
        The election referred to in paragraph (1) may be made only in
      an application that is submitted to the Secretary after September
      27, 2007, and before October 1, 2012.
    (v) Antibiotic drugs submitted before November 21, 1997
      (1) Antibiotic drugs approved before November 21, 1997
        (A) In general
          Notwithstanding any provision of the Food and Drug
        Administration Modernization Act of 1997 or any other provision
        of law, a sponsor of a drug that is the subject of an
        application described in subparagraph (B)(i) shall be eligible
        for, with respect to the drug, the 3-year exclusivity period
        referred to under clauses (iii) and (iv) of subsection
        (c)(3)(E) and under clauses (iii) and (iv) of subsection
        (j)(5)(F), subject to the requirements of such clauses, as
        applicable.
        (B) Application; antibiotic drug described
          (i) Application
            An application described in this clause is an application
          for marketing submitted under this section after October 8,
          2008, in which the drug that is the subject of the
          application contains an antibiotic drug described in clause
          (ii).
          (ii) Antibiotic drug
            An antibiotic drug described in this clause is an
          antibiotic drug that was the subject of an application
          approved by the Secretary under section 357 of this title (as
          in effect before November 21, 1997).
      (2) Antibiotic drugs submitted before November 21, 1997, but not
        approved
        (A) In general
          Notwithstanding any provision of the Food and Drug
        Administration Modernization Act of 1997 or any other provision
        of law, a sponsor of a drug that is the subject of an
        application described in subparagraph (B)(i) may elect to be
        eligible for, with respect to the drug - 
            (i)(I) the 3-year exclusivity period referred to under
          clauses (iii) and (iv) of subsection (c)(3)(E) and under
          clauses (iii) and (iv) of subsection (j)(5)(F), subject to
          the requirements of such clauses, as applicable; and
            (II) the 5-year exclusivity period referred to under clause
          (ii) of subsection (c)(3)(E) and under clause (ii) of
          subsection (j)(5)(F), subject to the requirements of such
          clauses, as applicable; or
            (ii) a patent term extension under section 156 of title 35,
          subject to the requirements of such section.
        (B) Application; antibiotic drug described
          (i) Application
            An application described in this clause is an application
          for marketing submitted under this section after October 8,
          2008, in which the drug that is the subject of the
          application contains an antibiotic drug described in clause
          (ii).
          (ii) Antibiotic drug
            An antibiotic drug described in this clause is an
          antibiotic drug that was the subject of 1 or more
          applications received by the Secretary under section 357 of
          this title (as in effect before November 21, 1997), none of
          which was approved by the Secretary under such section.
      (3) Limitations
        (A) Exclusivities and extensions
          Paragraphs (1)(A) and (2)(A) shall not be construed to
        entitle a drug that is the subject of an approved application
        described in subparagraphs (!5) (1)(B)(i) or (2)(B)(i), as
        applicable, to any market exclusivities or patent extensions
        other than those exclusivities or extensions described in
        paragraph (1)(A) or (2)(A).

        (B) Conditions of use
          Paragraphs (1)(A) and (2)(A)(i) shall not apply to any
        condition of use for which the drug referred to in subparagraph
        (1)(B)(i) or (2)(B)(i), as applicable, was approved before
        October 8, 2008.
      (4) Application of certain provisions
        Notwithstanding section 125, or any other provision, of the
      Food and Drug Administration Modernization Act of 1997, or any
      other provision of law, and subject to the limitations in
      paragraphs (1), (2), and (3), the provisions of the Drug Price
      Competition and Patent Term Restoration Act of 1984 shall apply
      to any drug subject to paragraph (1) or any drug with respect to
      which an election is made under paragraph (2)(A).