Notes on 21 U.S.C. § 355 : US Code - Notes

Search Notes on 21 U.S.C. § 355 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 505, 52 Stat. 1052; Pub. L. 86-507,
Sec. 1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87-781, title I,
Secs. 102(b)-(d), 103(a), (b), 104(a)-(d)(2), Oct. 10, 1962, 76
Stat. 781-783, 784, 785; Pub. L. 92-387, Sec. 4(d), Aug. 16, 1972,
86 Stat. 562; Pub. L. 98-417, title I, Secs. 101, 102(a)-(b)(5),
103, 104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L.
102-282, Sec. 5, May 13, 1992, 106 Stat. 161; Pub. L. 103-80, Sec.
3(n), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
115, 117, 119, 120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315,
2316, 2318, 2324; Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title
IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584;
Pub. L. 107-109, Sec. 15(c)(1), Jan. 4, 2002, 115 Stat. 1420; Pub.
L. 108-155, Sec. 2(b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-
173, title XI, Secs. 1101(a), (b), 1102(a), 1103(a), Dec. 8, 2003,
117 Stat. 2448, 2452, 2457, 2460.)
REFERENCES IN TEXT
The General Schedule, referred to in subsec. (n)(6), is set out
under section 5332 of Title 5, Government Organization and
Employees.
AMENDMENTS
2003 - Subsec. (b)(1). Pub. L. 108-155, in second sentence,
substituted "(F)" for "and (F)" and inserted ", and (G) any
assessments required under section 355c of this title" before
period at end.
Subsec. (b)(3). Pub. L. 108-173, Sec. 1101(b)(1)(A), added par.
(3) and struck out former par. (3) which, in subpar. (A), required
an applicant making a certification under par. (2)(A)(iv) to
include statement that applicant will give notice to each owner of
the patent which is the subject of the certification and to the
holder of the approved application, in subpar. (B), directed that
notice state that an application has been submitted and include a
detailed statement of the applicant's opinion that the patent is
not valid or will not be infringed, and, in subpar. (C), provided
that if an application is amended, notice shall be given when the
amended application is submitted.
Subsec. (b)(4), (5). Pub. L. 108-173, Sec. 1101(b)(1)(B), added
par. (4) and redesignated former par. (4) as (5).
Subsec. (c)(3). Pub. L. 108-173, Sec. 1101(b)(2)(A), substituted
"by applying the following to each certification made under
subsection (b)(2)(A) of this section" for "under the following" in
introductory provisions.
Subsec. (c)(3)(C). Pub. L. 108-173, Sec. 1101(b)(2)(B)(iii),
which directed the substitution of "subsection (b)(3) of this
section" for "paragraph (3)(B)" in third sentence, could not be
executed because such words do not appear. See note below.
Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(VI), in concluding
provisions, struck out "Until the expiration of forty-five days
from the date the notice made under paragraph (3)(B) is received,
no action may be brought under section 2201 of title 28 for a
declaratory judgment with respect to the patent. Any action brought
under such section 2201 shall be brought in the judicial district
where the defendant has its principal place of business or a
regular and established place of business." after "expediting the
action."
Pub. L. 108-173, Sec. 1101(b)(2)(B)(i), (ii)(I), in first
sentence of introductory provisions, substituted "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" for
"unless an action is brought for infringement of a patent which is
the subject of the certification before the expiration of forty-
five days from the date the notice provided under paragraph (3)(B)
is received" and, in second sentence of introductory provisions,
substituted "subsection (b)(3) of this section" for "paragraph
(3)(B)".
Subsec. (c)(3)(C)(i). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i)
which read as follows: "if before the expiration of such period the
court decides that such patent is invalid or not infringed, the
approval may be made effective on the date of the court decision,".
Subsec. (c)(3)(C)(ii). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl.
(ii) which read as follows: "if before the expiration of such
period the court decides that such patent has been infringed, the
approval may be made effective on such date as the court orders
under section 271(e)(4)(A) of title 35, or".
Subsec. (c)(3)(C)(iii). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(IV), substituted "as provided in clause (i); or"
for "on the date of such court decision."
Subsec. (c)(3)(C)(iv). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(V), added cl. (iv).
Subsec. (c)(3)(D), (E). Pub. L. 108-173, Sec. 1101(b)(2)(C), (D),
added subpar. (D) and redesignated former subpar. (D) as (E).
Subsec. (j)(2)(B). Pub. L. 108-173, Sec. 1101(a)(1)(A), added
subpar. (B) and struck out former subpar. (B) which, in cl. (i),
required that an applicant making a certification under subpar.
(A)(vii)(IV) include in the application a statement that notice
would be given to each owner of the patent and the holder of the
approved application, in cl. (ii), required that notice would state
that an application had been submitted and that it would include a
detailed statement of the basis of the applicant's opinion, and, in
cl. (iii), directed that notice of an amended application be given
when the amended application had been submitted.
Subsec. (j)(2)(D). Pub. L. 108-173, Sec. 1101(a)(1)(B), added
subpar. (D).
Subsec. (j)(5)(B). Pub. L. 108-173, Sec. 1101(a)(2)(A)(i),
substituted "by applying the following to each certification made
under paragraph (2)(A)(vii)" for "under the following" in
introductory provisions.
Subsec. (j)(5)(B)(iii). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second
sentence of subsec. (j)(5)(B)(iii) by striking "Until the
expiration" and all that follows in the matter after and below
subclause (IV), was executed by striking "Until the expiration of
forty-five days from the date the notice made under paragraph
(2)(B)(i) is received, no action may be brought under section 2201
of title 28, for a declaratory judgment with respect to the patent.
Any action brought under section 2201 shall be brought in the
judicial district where the defendant has its principal place of
business or a regular and established place of business." after
"expediting the action." in concluding provisions, to reflect the
probable intent of Congress.
Pub. L. 108-173, Sec. 1101(a)(2)(A)(ii)(I), in introductory
provisions, substituted "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" for
"unless an action is brought for infringement of a patent which is
the subject of the certification before the expiration of forty-
five days from the date the notice provided under paragraph
(2)(B)(i) is received".
Subsec. (j)(5)(B)(iii)(I). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former
subcl. (I) which read as follows: "if before the expiration of such
period the court decides that such patent is invalid or not
infringed, the approval shall be made effective on the date of the
court decision,".
Subsec. (j)(5)(B)(iii)(II). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former
subcl. (II) which read as follows: "if before the expiration of
such period the court decides that such patent has been infringed,
the approval shall be made effective on such date as the court
orders under section 271(e)(4)(A) of title 35, or".
Subsec. (j)(5)(B)(iii)(III). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(cc), substituted "as provided in subclause
(I); or" for "on the date of such court decision."
Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).
Subsec. (j)(5)(B)(iv). Pub. L. 108-173, Sec. 1102(a)(1), added
cl. (iv) and struck out former cl. (iv) which read as follows: "If
the application contains a certification described in subclause
(IV) of paragraph (2)(A)(vii) and is for a drug for which a
previous application has been submitted under this subsection
continuing such a certification, the application shall be made
effective not earlier than one hundred and eighty days after -
"(I) the date the Secretary receives notice from the applicant
under the previous application of the first commercial marketing
of the drug under the previous application, or
"(II) the date of a decision of a court in an action described
in clause (iii) holding the patent which is the subject of the
certification to be invalid or not infringed,
whichever is earlier."
Subsec. (j)(5)(C). Pub. L. 108-173, Sec. 1101(a)(2)(B), (C),
added subpar. (C). Former subpar. (C) redesignated (E).
Subsec. (j)(5)(D). Pub. L. 108-173, Sec. 1102(a)(2), added
subpar. (D).
Pub. L. 108-173, Sec. 1101(a)(2)(B), redesignated subpar. (D) as
(F).
Subsec. (j)(5)(E), (F). Pub. L. 108-173, Sec. 1101(a)(2)(B),
redesignated subpars. (C) and (D) as (E) and (F), respectively.
Subsec. (j)(8)(A). Pub. L. 108-173, Sec. 1103(a)(1), added
subpar. (A) and struck out former subpar. (A) which read as
follows: "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."
Subsec. (j)(8)(C). Pub. L. 108-173, Sec. 1103(a)(2), added
subpar. (C).
2002 - Subsec. (i)(1)(D). Pub. L. 107-109 added subpar. (D).
1999 - Subsec. (m). Pub. L. 106-113 substituted "United States
Patent and Trademark Office" for "Patent and Trademark Office of
the Department of Commerce".
1997 - Subsec. (b)(1). Pub. L. 105-115, Sec. 115(b), inserted at
end "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)."
Subsec. (b)(4). Pub. L. 105-115, Sec. 119(a), added par. (4).
Subsec. (c)(4). Pub. L. 105-115, Sec. 124(a), added par. (4).
Subsec. (d). Pub. L. 105-115, Sec. 115(a), inserted at end "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."
Subsec. (i). Pub. L. 105-115, Sec. 117, inserted "(1)" after
"(i)", redesignated former pars. (1) to (3) as subpars. (A) to (C),
respectively, of par. (1), added pars. (2) to (4), and struck out
closing provisions which read as follows: "Such regulations 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
they deem it not feasible or, in their professional judgment,
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."
Subsec. (j)(2)(A)(i). Pub. L. 105-115, Sec. 119(b)(2)(A),
substituted "paragraph (7)" for "paragraph (6)".
Subsec. (j)(3). Pub. L. 105-115, Sec. 119(b)(1)(B), added par.
(3). Former par. (3) redesignated (4).
Subsec. (j)(4). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(B),
redesignated par. (3) as (4) and in introductory provisions
substituted "paragraph (5)" for "paragraph (4)". Former par. (4)
redesignated (5).
Subsec. (j)(4)(I). Pub. L. 105-115, Sec. 119(b)(2)(C),
substituted "paragraph (6)" for "paragraph (5)".
Subsec. (j)(5), (6). Pub. L. 105-115, Sec. 119(b)(1)(A),
redesignated pars. (4) and (5) as (5) and (6), respectively. Former
par. (6) redesignated (7).
Subsec. (j)(7). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(D),
redesignated par. (6) as (7) and in subpar. (C) substituted
"paragraph (6)" for "paragraph (5)" in two places. Former par. (7)
redesignated (8).
Subsec. (j)(8), (9). Pub. L. 105-115, Sec. 119(b)(1)(A),
redesignated pars. (7) and (8) as (8) and (9), respectively.
Subsec. (n). Pub. L. 105-115, Sec. 120, added subsec. (n).
1993 - Subsec. (j)(6)(A)(ii). Pub. L. 103-80, Sec. 3(n)(1)(A),
substituted "Secretary" for "Secretry".
Subsec. (j)(6)(A)(iii). Pub. L. 103-80, Sec. 3(n)(1)(B), inserted
comma after "published by the Secretary".
Subsec. (k)(1). Pub. L. 103-80, Sec. 3(n)(2), substituted
"section. Regulations" for "section: Provided, however, That
regulations".
1992 - Subsec. (j)(8). Pub. L. 102-282 added par. (8).
1984 - Subsec. (a). Pub. L. 98-417, Sec. 102(b)(1), inserted "or
(j)" after "subsection (b)".
Subsec. (b). Pub. L. 98-417, Secs. 102(a)(1), 103(a), designated
existing provisions of subsec. (b) as par. (1) thereof and
redesignated existing cls. (1) through (6) of such par. (1) as cls.
(A) through (F) thereof, respectively, inserted requirement that
the applicant 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 by asserted if a person not licensed
by the owner engaged in the manufacture, use, or sale of the drug,
that the applicant amend the application to include such
information 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, and that upon approval of the application, the
Secretary publish the information submitted, and added pars. (2)
and (3).
Subsec. (c). Pub. L. 98-417, Secs. 102(a)(2), (b)(2), 103(b),
designated existing provisions of subsec. (c) as par. (1) thereof
and in par. (1) as so designated substituted "subsection (b) of
this section" for "this subsection" and redesignated former pars.
(1) and (2) as subpars. (A) and (B), respectively, and added pars.
(2) and (3).
Subsec. (d)(6), (7). Pub. L. 98-417, Sec. 102(a)(3)(A), added cl.
(6) relating to the failure of the application to contain the
patent information prescribed by subsec. (b) of this section, and
redesignated former cl. (6) as (7).
Subsec. (e). Pub. L. 98-417, Sec. 102(a)(3)(B), in first
sentence, added a new cl. (4) relating to the failure to file the
patent information prescribed by subsec. (c) of this section within
30 days after the receipt of written notice from the Secretary
specifying the failure to file such information, and redesignated
former cl. (4) as (5).
Pub. L. 98-417, Sec. 102(b)(3), (4), in second sentence, inserted
in provisions preceding cl. (1) "submitted under subsection (b) or
(j) of this section" and in cl. (1) substituted "under subsection
(k) of this section or to comply with the notice requirements of
section 360(k)(2) of this title" for "under subsection (j) of this
section or to comply with the notice requirements of section
360(j)(2) of this title".
Subsecs. (j), (k). Pub. L. 98-417, Sec. 101, added subsec. (j)
and redesignated former subsec. (j) as (k).
Subsec. (k)(1). Pub. L. 98-417, Sec. 102(b)(5), substituted
"under subsection (b) or (j) of this section" for "pursuant to this
section".
Subsecs. (l), (m). Pub. L. 98-417, Sec. 104, added subsecs. (l)
and (m).
1972 - Subsec. (e). Pub. L. 92-387 inserted "or to comply with
the notice requirements of section 360(j)(2) of this title" in cl.
(1) of second sentence relating to the maintenance of records.
1962 - Subsec. (a). Pub. L. 87-781, Sec. 104(a), inserted "an
approval of" before "an application".
Subsec. (b). Pub. L. 87-781, Sec. 102(b), inserted "and whether
such drug is effective in use" after "is safe for use".
Subsec. (c). Pub. L. 87-781, Sec. 104(b), substituted provisions
requiring the Secretary, within 180 days after filing an
application, or such additional period as the Secretary and the
applicant agree upon, to either approve the application, if meeting
the requirements of subsec. (d) of this section, or give notice of
opportunity for hearing on question of whether such application is
approvable, and providing that if applicant requests hearing in
writing within 30 days, the hearing shall begin within 90 days
after expiration of said 30 days, unless the Secretary and
applicant agree otherwise, that such hearing shall be expedited,
and that the Secretary's order shall be issued within 90 days after
date for filing final briefs, for provisions which had an
application become effective on the sixtieth day after filing
thereof unless prior thereto the Secretary postponed the date by
written notice to such time, but not more than 180 days after
filing, as the Secretary deemed necessary to study and investigate
the application.
Subsec. (d). Pub. L. 87-781, Sec. 102(c), inserted references to
subsec. (c), added cls. (5) and (6), provided that if after notice
and opportunity for hearing, the Secretary finds that cls. (1) to
(6) do not apply, he shall approve the application, and defined
"substantial evidence" as used in this subsection and subsec. (e)
of this section.
Subsec. (e). Pub. L. 87-781, Sec. 102(d), amended subsec. (e)
generally, and among other changes, directed the Secretary to
withdraw approval of an application if by tests, other scientific
data or experience, or new evidence of clinical experience not
contained in the application or available at the time of its
approval, the drug is shown to be unsafe, or on the basis of new
information, there is shown a lack of substantial evidence that the
drug has the effect it is represented to have, and provided that if
the Secretary, or acting Secretary, finds there is an imminent
hazard to the public health, he may suspend approval immediately,
notify the applicant, and give him opportunity for an expedited
hearing, that the Secretary may withdraw approval if the applicant
fails to establish a system for maintaining required records, or
has repeatedly or deliberately failed to maintain records and make
reports, or has refused access to, or copying or verification of
such records, or if the Secretary finds on new evidence that the
methods, facilities and controls in the manufacturing, processing,
and packing are inadequate to assure and preserve the drugs'
identity, strength, quality and purity, and were not made adequate
within a reasonable time after receipt of written notice thereof,
or finds on new evidence, that the labeling is false or misleading
and was not corrected within a reasonable time after receipt of
written notice thereof.
Subsec. (f). Pub. L. 87-781, Sec. 104(c), substituted provisions
requiring the Secretary to revoke any previous order under subsecs.
(d) or (e) of this section refusing, withdrawing, or suspending
approval of an application and to approve such application or
reinstate such approval, for provisions which required him to
revoke an order refusing effectiveness to an application.
Subsec. (h). Pub. L. 87-781, Sec. 104(d)(1), (2), inserted "as
provided in section 2112 of title 28", and "except that until the
filing of the record the Secretary may modify or set aside his
order", substituted "or withdrawing approval of an application
under this section" for "to permit the application to become
effective, or suspending the effectiveness of the application",
"United States court of appeals for the circuit" for "district
court of the United States within any district", "Court of Appeals
for the District of Columbia Circuit" for "District Court for the
District of Columbia", "transmitted by the clerk of the court to"
for "served upon", and "by the Supreme Court of the United States
upon certiorari or certification as provided in section 1254 of
title 28" for "as provided in sections 225, 346, and 347 of title
28, as amended, and in section 7, as amended, of the Act entitled
'An Act to establish a Court of Appeals for the District of
Columbia', approved February 9, 1893", and eliminated "upon" before
"any officer designated", "a transcript of" before "the record" and
"and decree" before "of the court affirming".
Subsec. (i). Pub. L. 87-781, Sec. 103(b), inserted "the foregoing
subsections of" after "operation of", and "and effectiveness" after
"safety", and provided that the regulations may condition
exemptions upon the submission of reports of preclinical tests to
justify the proposed clinical testing, upon the obtaining by the
manufacturer or sponsor of the investigation of a new drug of a
signed agreement from each of the investigators that patients to
whom the drug is administered will be under his supervision or
under investigators responsible to him, and that he will not supply
such drug to any other investigator, or to clinics, for
administration to human beings, or upon the establishment and
maintenance of records and reports of data obtained by the
investigational use of such drug, as the Secretary finds will
enable him to evaluate the safety and effectiveness of such drug,
and provided that the regulations shall condition an exemption upon
the manufacturer or sponsor of the investigation requiring that
experts using such drugs certify that they will inform humans to
whom such drugs or any controls connected therewith are
administered, or their representatives, and will obtain the consent
of such people where feasible and not contrary to the best
interests of such people, and that reports on the investigational
use of drugs are not required to be submitted directly to the
Secretary.
Subsec. (j). Pub. L. 87-781, Sec. 103(a), added subsec. (j).
1960 - Subsec. (g). Pub. L. 86-507 inserted "or by certified
mail" after "registered mail".
EFFECTIVE DATE OF 2003 AMENDMENTS
Pub. L. 108-173, title XI, Sec. 1101(c), Dec. 8, 2003, 117 Stat.
2456, provided that:
"(1) In general. - Except as provided in paragraphs (2) and (3),
the amendments made by subsections (a) and (b) [amending this
section] apply to any proceeding under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending on or
after the date of the enactment of this Act [Dec. 8, 2003]
regardless of the date on which the proceeding was commenced or is
commenced.
"(2) Notice of opinion that patent is invalid or will not be
infringed. - The amendments made by subsections (a)(1) and (b)(1)
apply with respect to any certification under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) submitted on or after
August 18, 2003, in an application filed under subsection (b) or
(j) of that section or in an amendment or supplement to an
application filed under subsection (b) or (j) of that section.
"(3) Effective date of approval. - The amendments made by
subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to
any patent information submitted under subsection (b)(1) or (c)(2)
of section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) on or after August 18, 2003."
Pub. L. 108-173, title XI, Sec. 1102(b), Dec. 8, 2003, 117 Stat.
2460, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendment made by subsection (a) [amending this section] shall be
effective only with respect to an application filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) after the date of the enactment of this Act [Dec. 8, 2003]
for a listed drug for which no certification under section
505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
enactment of this Act.
"(2) Collusive agreements. - If a forfeiture event described in
section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an
applicant, the applicant shall forfeit the 180-day period under
section 505(j)(5)(B)(iv) of that Act without regard to when the
first certification under section 505(j)(2)(A)(vii)(IV) of that Act
for the listed drug was made.
"(3) Decision of a court when the 180-day exclusivity period has
not been triggered. - With respect to an application filed before,
on, or after the date of the enactment of this Act [Dec. 8, 2003]
for a listed drug for which a certification under section
505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
enactment of this Act and for which neither of the events described
in subclause (I) or (II) of section 505(j)(5)(B)(iv) of that Act
(as in effect on the day before the date of the enactment of this
Act) has occurred on or before the date of the enactment of this
Act, the term 'decision of a court' as used in clause (iv) of
section 505(j)(5)(B) of that Act means a final decision of a court
from which no appeal (other than a petition to the Supreme Court
for a writ of certiorari) has been or can be taken."
Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
otherwise provided, see section 4 of Pub. L. 108-155, set out as an
Effective Date note under section 355c of this title.
EFFECTIVE DATE OF 1999 AMENDMENT
Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
113, set out as a note under section 1 of Title 35, Patents.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1984 AMENDMENT
Section 105 of Pub. L. 98-417 provided that:
"(a) The Secretary of Health and Human Services shall promulgate,
in accordance with the notice and comment requirements of section
553 of title 5, United States Code, such regulations as may be
necessary for the administration of section 505 of the Federal
Food, Drug, and Cosmetic Act [this section], as amended by sections
101, 102, and 103 of this Act, within one year of the date of
enactment of this Act [Sept. 24, 1984].
"(b) During the period beginning sixty days after the date of the
enactment of this Act [Sept. 24, 1984], and ending on the date
regulations promulgated under subsection (a) take effect,
abbreviated new drug applications may be submitted in accordance
with the provisions of section 314.2 of title 21 of the Code of
Federal Regulations and shall be considered as suitable for any
drug which has been approved for safety and effectiveness under
section 505(c) of the Federal Food, Drug, and Cosmetic Act [subsec.
(c) of this section] before the date of the enactment of this Act.
If any such provision is inconsistent with the requirements of
section 505(j) of the Federal Food, Drug, and Cosmetic Act, the
Secretary shall consider the application under the applicable
requirements of such section. The Secretary of Health and Human
Services may not approve such an abbreviated new drug application
which is filed for a drug which is described in sections
505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and
Cosmetic Act, except in accordance with such section."
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-387 effective on first day of sixth month
beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
out as a note under section 360 of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282
Amendment by Pub. L. 102-282 not to preclude any other civil,
criminal, or administrative remedy provided under Federal or State
law, including any private right of action against any person for
the same action subject to any action or civil penalty under an
amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
282, set out as a note under section 335a of this title.
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
EFFECT OF AMENDMENT BY PUB. L. 108-173 ON ABBREVIATED NEW DRUG
APPLICATIONS
Pub. L. 108-173, title XI, Sec. 1103(b), Dec. 8, 2003, 117 Stat.
2461, provided that: "The amendment made by subsection (a)
[amending this section] does not alter the standards for approval
of drugs under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j))."
FEDERAL TRADE COMMISSION REVIEW
Pub. L. 108-173, title XI, subtitle B, Dec. 8, 2003, 117 Stat.
2461, provided that:
"SEC. 1111. DEFINITIONS.
"In this subtitle:
"(1) ANDA. - The term 'ANDA' means an abbreviated drug
application, as defined under section 201(aa) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 321(aa)].
"(2) Assistant attorney general. - The term 'Assistant Attorney
General' means the Assistant Attorney General in charge of the
Antitrust Division of the Department of Justice.
"(3) Brand name drug. - The term 'brand name drug' means a drug
for which an application is approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)],
including an application referred to in section 505(b)(2) of such
Act [21 U.S.C. 355(b)(2)].
"(4) Brand name drug company. - The term 'brand name drug
company' means the party that holds the approved application
referred to in paragraph (3) for a brand name drug that is a
listed drug in an ANDA, or a party that is the owner of a patent
for which information is submitted for such drug under subsection
(b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 355(b), (c)].
"(5) Commission. - The term 'Commission' means the Federal
Trade Commission.
"(6) Generic drug. - The term 'generic drug' means a drug for
which an application under section 505(j) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355(j)] is approved.
"(7) Generic drug applicant. - The term 'generic drug
applicant' means a person who has filed or received approval for
an ANDA under section 505(j) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 355(j)].
"(8) Listed drug. - The term 'listed drug' means a brand name
drug that is listed under section 505(j)(7) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].
"SEC. 1112. NOTIFICATION OF AGREEMENTS.
"(a) Agreement With Brand Name Drug Company. -
"(1) Requirement. - A generic drug applicant that has submitted
an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(2)(A)(vii)(IV)] and a brand name drug company
that enter into an agreement described in paragraph (2) shall
each file the agreement in accordance with subsection (c). The
agreement shall be filed prior to the date of the first
commercial marketing of the generic drug that is the subject of
the ANDA.
"(2) Subject matter of agreement. - An agreement described in
this paragraph between a generic drug applicant and a brand name
drug company is an agreement regarding -
"(A) the manufacture, marketing or sale of the brand name
drug that is the listed drug in the ANDA involved;
"(B) the manufacture, marketing, or sale of the generic drug
for which the ANDA was submitted; or
"(C) the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(5)(B)(iv)] as it applies to such ANDA or to
any other ANDA based on the same brand name drug.
"(b) Agreement With Another Generic Drug Applicant. -
"(1) Requirement. - A generic drug applicant that has submitted
an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(2)(A)(vii)(IV)] with respect to a listed drug
and another generic drug applicant that has submitted an ANDA
containing such a certification for the same listed drug shall
each file the agreement in accordance with subsection (c). The
agreement shall be filed prior to the date of the first
commercial marketing of either of the generic drugs for which
such ANDAs were submitted.
"(2) Subject matter of agreement. - An agreement described in
this paragraph between two generic drug applicants is an
agreement regarding the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355(j)(5)(B)(iv)] as it applies to the ANDAs with which
the agreement is concerned.
"(c) Filing. -
"(1) Agreement. - The parties that are required in subsection
(a) or (b) to file an agreement in accordance with this
subsection shall file with the Assistant Attorney General and the
Commission the text of any such agreement, except that such
parties are not required to file an agreement that solely
concerns -
"(A) purchase orders for raw material supplies;
"(B) equipment and facility contracts;
"(C) employment or consulting contracts; or
"(D) packaging and labeling contracts.
"(2) Other agreements. - The parties that are required in
subsection (a) or (b) to file an agreement in accordance with
this subsection shall file with the Assistant Attorney General
and the Commission the text of any agreements between the parties
that are not described in such subsections and are contingent
upon, provide a contingent condition for, or are otherwise
related to an agreement that is required in subsection (a) or (b)
to be filed in accordance with this subsection.
"(3) Description. - In the event that any agreement required in
subsection (a) or (b) to be filed in accordance with this
subsection has not been reduced to text, each of the parties
involved shall file written descriptions of such agreement that
are sufficient to disclose all the terms and conditions of the
agreement.
"SEC. 1113. FILING DEADLINES.
"Any filing required under section 1112 shall be filed with the
Assistant Attorney General and the Commission not later than 10
business days after the date the agreements are executed.
"SEC. 1114. DISCLOSURE EXEMPTION.
"Any information or documentary material filed with the Assistant
Attorney General or the Commission pursuant to this subtitle shall
be exempt from disclosure under section 552 of title 5, United
States Code, and no such information or documentary material may be
made public, except as may be relevant to any administrative or
judicial action or proceeding. Nothing in this section is intended
to prevent disclosure to either body of the Congress or to any duly
authorized committee or subcommittee of the Congress.
"SEC. 1115. ENFORCEMENT.
"(a) Civil Penalty. - Any brand name drug company or generic drug
applicant which fails to comply with any provision of this subtitle
shall be liable for a civil penalty of not more than $11,000, for
each day during which such entity is in violation of this subtitle.
Such penalty may be recovered in a civil action brought by the
United States, or brought by the Commission in accordance with the
procedures established in section 16(a)(1) of the Federal Trade
Commission Act (15 U.S.C. 56(a) [15 U.S.C. 56(a)(1)]).
"(b) Compliance and Equitable Relief. - If any brand name drug
company or generic drug applicant fails to comply with any
provision of this subtitle, the United States district court may
order compliance, and may grant such other equitable relief as the
court in its discretion determines necessary or appropriate, upon
application of the Assistant Attorney General or the Commission.
"SEC. 1116. RULEMAKING.
"The Commission, with the concurrence of the Assistant Attorney
General and by rule in accordance with section 553 of title 5,
United States Code, consistent with the purposes of this subtitle -

"(1) may define the terms used in this subtitle;
"(2) may exempt classes of persons or agreements from the
requirements of this subtitle; and
"(3) may prescribe such other rules as may be necessary and
appropriate to carry out the purposes of this subtitle.
"SEC. 1117. SAVINGS CLAUSE.
"Any action taken by the Assistant Attorney General or the
Commission, or any failure of the Assistant Attorney General or the
Commission to take action, under this subtitle shall not at any
time bar any proceeding or any action with respect to any agreement
between a brand name drug company and a generic drug applicant, or
any agreement between generic drug applicants, under any other
provision of law, nor shall any filing under this subtitle
constitute or create a presumption of any violation of any
competition laws.
"SEC. 1118. EFFECTIVE DATE.
"This subtitle shall -
"(1) take effect 30 days after the date of the enactment of
this Act [Dec. 8, 2003]; and
"(2) shall apply to agreements described in section 1112 that
are entered into 30 days after the date of the enactment of this
Act."
REPORT ON PATIENT ACCESS TO NEW THERAPEUTIC AGENTS FOR PEDIATRIC
CANCER
Pub. L. 107-109, Sec. 15(d), Jan. 4, 2002, 115 Stat. 1421,
provided that: "Not later than January 31, 2003, the Secretary of
Health and Human Services, acting through the Commissioner of Food
and Drugs and in consultation with the Director of the National
Institutes of Health, shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report on
patient access to new therapeutic agents for pediatric cancer,
including access to single patient use of new therapeutic agents."
DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS
Section 118 of Pub. L. 105-115 provided that: "Within 12 months
after the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall issue guidance that describes
when abbreviated study reports may be submitted, in lieu of full
reports, with a new drug application under section 505(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and with a
biologics license application under section 351 of the Public
Health Service Act (42 U.S.C. 262) for certain types of studies.
Such guidance shall describe the kinds of studies for which
abbreviated reports are appropriate and the appropriate abbreviated
report formats."
REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND CURRENT GOOD
MANUFACTURING PRACTICES FOR POSITRON EMISSION TECHNOLOGY
Section 121(c) of Pub. L. 105-115 provided that:
"(1) Procedures and requirements. -
"(A) In general. - In order to take account of the special
characteristics of positron emission tomography drugs and the
special techniques and processes required to produce these drugs,
not later than 2 years after the date of enactment of this Act
[Nov. 21, 1997], the Secretary of Health and Human Services shall
establish -
"(i) appropriate procedures for the approval of positron
emission tomography drugs pursuant to section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
"(ii) appropriate current good manufacturing practice
requirements for such drugs.
"(B) Considerations and consultation. - In establishing the
procedures and requirements required by subparagraph (A), the
Secretary of Health and Human Services shall take due account of
any relevant differences between not-for-profit institutions that
compound the drugs for their patients and commercial
manufacturers of the drugs. Prior to establishing the procedures
and requirements, the Secretary of Health and Human Services
shall consult with patient advocacy groups, professional
associations, manufacturers, and physicians and scientists
licensed to make or use positron emission tomography drugs.
"(2) Submission of new drug applications and abbreviated new drug
applications. -
"(A) In general. - Except as provided in subparagraph (B), the
Secretary of Health and Human Services shall not require the
submission of new drug applications or abbreviated new drug
applications under subsection (b) or (j) of section 505 (21
U.S.C. 355), for compounded positron emission tomography drugs
that are not adulterated drugs described in section 501(a)(2)(C)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(C)) (as amended by subsection (b)), for a period of 4
years after the date of enactment of this Act [Nov. 21, 1997], or
for 2 years after the date on which the Secretary establishes
procedures and requirements under paragraph (1), whichever is
longer.
"(B) Exception. - Nothing in this Act [see Short Title of 1997
Amendment note set out under section 301 of this title] shall
prohibit the voluntary submission of such applications or the
review of such applications by the Secretary of Health and Human
Services. Nothing in this Act shall constitute an exemption for a
positron emission tomography drug from the requirements of
regulations issued under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i))."
"COMPOUNDED POSITRON EMISSION TOPOGRAPHY DRUG" DEFINED
Section 121(e) of Pub. L. 105-115 provided that: "As used in this
section [amending sections 321 and 351 of this title and enacting
provisions set out as notes under this section and section 351 of
this title], the term 'compounded positron emission tomography
drug' has the meaning given the term in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)."
REQUIREMENTS FOR RADIOPHARMACEUTICALS
Section 122 of Pub. L. 105-115 provided that:
"(a) Requirements. -
"(1) Regulations. -
"(A) Proposed regulations. - Not later than 180 days after
the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services, after consultation with
patient advocacy groups, associations, physicians licensed to
use radiopharmaceuticals, and the regulated industry, shall
issue proposed regulations governing the approval of
radiopharmaceuticals. The regulations shall provide that the
determination of the safety and effectiveness of such a
radiopharmaceutical under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C. 262) shall include
consideration of the proposed use of the radiopharmaceutical in
the practice of medicine, the pharmacological and toxicological
activity of the radiopharmaceutical (including any carrier or
ligand component of the radiopharmaceutical), and the estimated
absorbed radiation dose of the radiopharmaceutical.
"(B) Final regulations. - Not later than 18 months after the
date of enactment of this Act, the Secretary shall promulgate
final regulations governing the approval of the
radiopharmaceuticals.
"(2) Special rule. - In the case of a radiopharmaceutical, the
indications for which such radiopharmaceutical is approved for
marketing may, in appropriate cases, refer to manifestations of
disease (such as biochemical, physiological, anatomic, or
pathological processes) common to, or present in, one or more
disease states.
"(b) Definition. - In this section, the term
'radiopharmaceutical' means -
"(1) an article -
"(A) that is intended for use in the diagnosis or monitoring
of a disease or a manifestation of a disease in humans; and
"(B) that exhibits spontaneous disintegration of unstable
nuclei with the emission of nuclear particles or photons; or
"(2) any nonradioactive reagent kit or nuclide generator that
is intended to be used in the preparation of any such article."
SPECIAL RULE
Section 123(f) of Pub. L. 105-115 provided that: "The Secretary
of Health and Human Services shall take measures to minimize
differences in the review and approval of products required to have
approved biologics license applications under section 351 of the
Public Health Service Act (42 U.S.C. 262) and products required to
have approved new drug applications under section 505(b)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1))."
TRANSITION
Section 125(d) of Pub. L. 105-115 provided that:
"(1) In general. - An application that was approved by the
Secretary of Health and Human Services before the date of the
enactment of this Act [Nov. 21, 1997] for the marketing of an
antibiotic drug under section 507 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 357), as in effect on the day before the
date of the enactment of this Act, shall, on and after such date of
enactment, be considered to be an application that was submitted
and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and
approved for safety and effectiveness under section 505(c) of such
Act (21 U.S.C. 355(c)), except that if such application for
marketing was in the form of an abbreviated application, the
application shall be considered to have been filed and approved
under section 505(j) of such Act (21 U.S.C. 355(j)).
"(2) Exception. - The following subsections of section 505 (21
U.S.C. 355) shall not apply to any application for marketing in
which the drug that is the subject of the application contains an
antibiotic drug and the antibiotic drug was the subject of any
application for marketing received by the Secretary of Health and
Human Services under section 507 of such Act (21 U.S.C. 357) before
the date of the enactment of this Act [Nov. 21, 1997]:
"(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii),
(j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
"(ii) The third and fourth sentences of subsection (b)(1)
(regarding the filing and publication of patent information); and
"(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if
the investigations 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.
"(3) Publication. - For purposes of this section, the Secretary
is authorized to make available to the public the established name
of each antibiotic drug that was the subject of any application for
marketing received by the Secretary for Health and Human Services
under section 507 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 357) before the date of enactment of this Act [Nov. 21,
1997]."
TERMINATION OF ADVISORY PANELS
Advisory panels established after Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period beginning on the
date of their establishment, unless, in the case of a panel
established by the President or an officer of the Federal
Government, such panel is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of a panel
established by Congress, its duration is otherwise provided for by
law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86
Stat. 770, 776, set out in the Appendix to Title 5, Government
Organization and Employees.
APPEALS TAKEN PRIOR TO OCTOBER 10, 1962
Section 104(d)(3) of Pub. L. 87-781 made amendments to subsec.
(h) of this section inapplicable to any appeal taken prior to Oct.
10, 1962.
(!1) So in original. Probably should be "bioavailability".