21 U.S. Code § 355 - New drugs

The 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 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—

in the case where human efficacy studies are not ethical or feasible, of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim; or

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 (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 (i)

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 (D)

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.

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 (G)

For purposes of this paragraph, the reviewing division is the division responsible for the review of an section 262 of title 42 (including all scientific and medical matters, chemistry, manufacturing, and controls).

If the applicant only made a certification described in clause (i) or (ii) of subsection (b)(2)(A) or in both such clauses, the approval may be made effective immediately.

If the applicant made a certification described in clause (iii) of subsection (b)(2)(A), 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), 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) is received, an action is brought for infringement of the (i) if before the expiration of such period the district court decides that the (I)

the date of a settlement order or consent decree signed and entered by the court of appeals stating that the (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;

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 (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 In such an action, each of the parties shall reasonably cooperate in expediting the action.

(I) In general.— No action may be brought under section 2201 of title 28 by an applicant referred to in subsection (b)(2) for a declaratory judgment with respect to a (aa)

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).

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 (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 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 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 (ii) Counterclaim to infringement 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).

An applicant shall not be entitled to damages in a civil action under clause (i) or a counterclaim under clause (ii).

If an section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any otherSeptember 24, 1984 , no (iii)

If an section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in anotherSeptember 24, 1984 , and if such (iv)

If a supplement to an 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 (v)

If an section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in anotherJanuary 1, 1982 , and ending on September 24, 1984 , theSeptember 24, 1984 .

the average time for completion of review under subparagraph (A) or section 262(a)(2)(E) of title 42;

The Secretary) finds that there is an imminent hazard to the public health, he may suspend the approval of suchsection 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 thesection 355–1(g)(2)(D) of this title.

Orders of the department designated by the (h) Appeal from order

An appeal may be taken by the applicant from an order of the section 2112 of title 28. Upon the filing of such substantial evidence, shall be conclusive. If any 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 theSupreme 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 (i) Exemptions of drugs for research; discretionary and mandatory conditions; direct reports to Secretary

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 (C)

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 (B)

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 section 282 of title 42.

information to show that the conditions of use prescribed, recommended, or suggested in the new drug have been previously approved for a (ii)

if the listed new drug is different and the section 321(p) of this title, and such other information respecting the different active ingredient with respect to which the (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 listednew drug is different and the (iv)

(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each (I)

state that an bioavailability or bioequivalence studies has been submitted under this subsection for the (II)

include a detailed statement of the factual and legal basis of the opinion of the applicant that the (C) If a (i)

The bioavailability and bioequivalence studies needed for approval of such (C) Any agreement regarding the parameters of design and size of bioavailability and bioequivalence studies of a (i)

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 (D)

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.

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 (G)

For purposes of this paragraph, the reviewing division is the division responsible for the review of an (4) Subject to paragraph (5), the (A)

the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the (B)

that the different active ingredient is an active ingredient of a listed section 321(p) of this title,

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.

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 (I) if before the expiration of such period the district court decides that the (aa)

the date of a settlement order or consent decree signed and entered by the court of appeals stating that the (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;

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 (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 In such an action, each of the parties shall reasonably cooperate in expediting the action.

The term “180-day exclusivity period” means the 180-day period ending on the day before the date on which an (bb) First applicant.—

As used in this subsection, the term “substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of asubstantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the (cc) Substantially complete application.—

The term “tentative approval” means notification to an applicant by thesection 355a of this title, or there is a 7-year period of exclusivity for the listedsection 360cc of this title.

Subject to subparagraph (D)(iv), if the competitive generic therapy for which any first approved applicant has commenced commercial marketing, thecompetitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.

The exclusivity period under subclause (I) shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause (I).

for which there are no unexpired patents or exclusivities on the list of products described in section 355(j)(7)(A) of this title at the time of submission.

is for a competitive generic therapy that is approved on the first day on which anycompetitive generic therapy is approved;

is not eligible for a 180-day exclusivity period under clause (iv) for thecompetitive generic therapy; and

(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 (aa)

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).

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 (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 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 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 (ii) Counterclaim to infringement 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).

An applicant shall not be entitled to damages in a civil action under clause (i) or a counterclaim under clause (ii).

(i) Definition of forfeiture event.— In this subparagraph, the term “ (I) Failure to market.— The (aa) the earlier of the date that is—

30 months after the date of submission of the (bb) with respect to the tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred:

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 (CC)

The patents with respect to which that applicant submitted a certification qualifying the applicant for the 180-day exclusivity period.

All of the patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired.

The 180-day exclusivity period described in subparagraph (B)(iv) shall be forfeited by 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)—

The 180-day exclusivity period described in subparagraph (B)(v) shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within 75 days after the date on which the approval of the first approved applicant’scompetitive generic therapy is made effective.

If an section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any otherSeptember 24, 1984 , no (iii)

If an section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in anotherSeptember 24, 1984 , and if such (iv)

If an section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in anotherJanuary 1, 1982 , and ending on September 24, 1984 , theSeptember 24, 1984 .

(I) With respect to an section 353(b) of this title for which the sole difference from a listedsection 314.94(a)(9) of title 21, Code of Federal Regulations (or any successor regulations), thesection 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to another approved drug product in the prescription drug product section of the list under this paragraph as follows:

such request for a therapeutic equivalence evaluation is being sought with respect to a listed drug product section of the list under this paragraph and is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the (BB)

(D) In the case of a listed Patent Trial and Appeal Board of the United States Patent and Trademark Office or by a court, from which no appeal has been, or can be, taken, if the holder of the applicable (i)

the Patent Trial and Appeals Board or court, as applicable, except that the180-day exclusivity period under paragraph (5)(B)(iv) that relies on a certification described in paragraph (2)(A)(vii)(IV).

The term “bioavailability” means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a (ii)

For a 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 (B) A (i)

for which there are not more than 3 approved drug products listed under paragraph (7) and for which there are no blocking patents and exclusivities; or

To qualify for priority review under this paragraph, not later than 60 days prior to the submission of an Secretary) sections of such (C)

The Food and Drug Administration , and update at least once every 6 months, a list of all patents and periods of exclusivity under this chapter have expired and for which no (13)

In the case of any persons to whom such regulations or orders are applicable, of similar information received or otherwise obtained by the (2)

convene a committee of experts, including individuals who are recognized in the field of protecting (C) Establishment of the postmarket risk identification and analysis system.—

for risk identification and analysis based on electronic health 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);

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 (iv) Complementary approaches.— To the extent the active postmarket risk identification and analysis system under this subsection is not sufficient to gather (I)

existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or successor databases.

Such analysis shall not disclose individually identifiable health information when presenting such (C) Public process for priority questions.— At least biannually, the Food and Drug Administration on—

when such risk identification is not sufficient, postapproval studies and clinical trials under subsection (o)(3).

(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 (I)

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 (V)

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 (II)

violates the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996;

violates sections 552 or 552a of title 5 with regard to the privacy of individually-identifiable beneficiary health information; or

discloses individually identifiable health information when presenting 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—

the qualified entity shall establish appropriate security measures to maintain the confidentiality and privacy of such (II)

The entity shall continue to comply with the confidentiality and privacy requirements under this paragraph with respect to all (II) Disposition of data.—

conduct regular screenings 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; and [4]

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; and

guidelines, developed with input from experts qualified by scientific training and experience to evaluate the safety and effectiveness of (ii)

(A) Action package.— The section 262 of title 42 on the Internet Web site of the Food and Drug Administration —

for a section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other (II)

for a biological product, no active ingredient of which has been approved in any other section 262 of title 42; and

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 (B) Immediate publication of summary review.—

A summary review that documents conclusions from all reviewing disciplines about the (v) The Division Director and Office Director’s decision document which includes—

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.

For the purpose of providing expert scientific advice and recommendations to the section 262 of title 42, theNovember 21, 1997 , or both.

The section 394 of this title to a director of a center or successor entity within the Food and Drug Administration .

members who are qualified by training and experience to evaluate the safety and effectiveness of the (B)

members with diverse expertise in such fields as clinical and administrative medicine, pharmacy, pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;

Panel members (other than officers or employees of the United section 5703 of title 5, for persons in the Government service employed intermittently.

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.

The covered application is in effect as of the date on which thenew safety information.

The responsible person to conduct a study under this paragraph, unless the (ii) Postapproval clinical trials

The responsible person to conduct a clinical trial under this paragraph, unless the (E) Notification; timetables; periodic reports

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 proposedFood and Drug Administration Amendments Act of 2007.

For each study or clinical trial required to be conducted under this paragraph, 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, theresponsible person to periodically report to theresponsible person to investigate a safety issue, theresponsible person to periodically report to thesection 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 (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 (4) Safety labeling changes requested by Secretary

submit a supplement proposing changes to the approved new safety information, including changes to boxed warnings, contraindications, warnings, precautions, or adverse reactions, or new effectiveness information; or

Upon receipt of such supplement, the (D) Discussions

Such discussions shall not extend for more than 30 days after the response to the notification under subparagraph (B), unless the (E) Order

Within 15 days of the conclusion of the discussions under subparagraph (D), the responsible person or the holder of the approvedresponsible person or the holder of the approved (F) Dispute resolution

Within 5 days of receiving an order under subparagraph (E), the responsible person or the holder of the approved (G) Violation

If the responsible person or the holder of the approvedresponsible person or holder shall be considered to be in violation of this subsection. If at the conclusion of any dispute resolution procedures theresponsible person or holder shall be in violation of this subsection.

Notwithstanding subparagraphs (A) through (F), if the (I) Rule of construction

This paragraph shall not be construed to affect the responsibility of the responsible person or the holder of the approved 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).

a risk evaluation and mitigation strategy is required under section 355–1 of this title with respect to thesection 355–1 of this title, including requirements regarding assessments of approved strategies.

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).

(A) Determination The section 262(k) of title 42 because of any request to take any form of action relating to the (i)

the request is in writing and is a 10.35 of title 21, Code of Federal Regulations (or any successor regulations); and

If the filing of an 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 petition.

The 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 persons or organizations inserted in the first and second blank space, respectively.

The 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 persons or organizations inserted in the first and second blank space, respectively.

during the 150-day period referred to in paragraph (1)(F), the section 10.45(d) of title 21, Code of Federal Regulations (or any successor regulation); or

For purposes of this subsection, the term “section 262(k) of title 42.

For purposes of this subsection, other than paragraph (1)(A)(i), the term “ (r) Postmarket drug safety information for patients and providers

a link to a list of each part 208 of title 21, Code of Federal Regulations (or any successor regulations), is required;

publicly available information about implemented RiskMAPs and risk evaluation and mitigation strategies under subsection (o);

preparing and making publicly available on the Internet website established under paragraph (1) best practices for section 262 of title 42;

providing educational materials for patients and providers about the appropriate means of disposing of expired, damaged, or unusable medications; and

The section 262 not later than 21 days after the date the (4) Private sector resources

To ensure development of the Internet Web site by the date described in paragraph (1), the (5) Authority for contracts

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.

a section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other (B)

a biological product, no active ingredient of which has been approved in any other section 262 of title 42; or

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 authorized generic drug entered the market); and

update the list quarterly to include each authorized generic drug included in an annual report submitted to the (B) Notification

The authorized generic drug included in an annual report submitted to theJanuary 1, 1999 .

is marketed, sold, or distributed directly or indirectly to retail class of trade under a different (u) Certain drugs containing single enantiomers

(1) In general For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) a single enantiomer that is contained in a racemic (A)

does not rely on any clinical investigations (other than bioavailability studies) that are part of an (B) the (i)

Until the date that is 10 years after the date of approval of a non-racemictherapeutic category in which the racemic (B) Labeling

For purposes of this subsection, the term “therapeutic category” means a therapeutic category identified in the list developed by the Unitedsection 1395w–104(b)(3)(C)(ii) of title 42 and as in effect on September 27, 2007 .

The election referred to in paragraph (1) may be made only in an September 27, 2007 , and before October 1, 2027 .

Notwithstanding any provision of the Food and Drug Administration Modernization Act of 1997 or any other provision of law, a sponsor of a (B) Application; antibiotic drug described

An antibiotic drug described in this clause is an antibiotic drug that was the subject of an section 357 of this title (as in effect 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—

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

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

An antibiotic drug described in this clause is an antibiotic drug that was the subject of 1 or more section 357 of this title (as in effect before November 21, 1997 ), none of which was approved by the (3) Limitations

Paragraphs (1)(A) and (2)(A) shall not be construed to entitle a [5] (1)(B)(i) or (2)(B)(i), as applicable, to any market exclusivities or (B) Conditions of use

Paragraphs (1)(A) and (2)(A)(i) shall not apply to any condition of use for which the October 8, 2008 .

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 (w) Deadline for determination on certain petitions

The section 314.161 of title 21, Code of Federal Regulations (or any successor regulations), no later than 270 days after the date the (x) Date of approval in the case of recommended controls under the CSA

(2) Date of approval For purposes of this section, with respect to an date of approval” shall mean the later of—

The sponsor of a contrast agent for which an new use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section 360j(p)(1) of this title.

(2) Review of supplement In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of (A)

review information and applicable medical imaging device pursuant to section 360e, 360(k), or 360c(f)(2) of this title so long as the sponsor of such applicable medical imaging device has provided to the sponsor of the contrast agent a right of reference.

the term “new use” means a use of a contrast agent that is described in the approvedapplicable medical imaging device described in section 360j(p) of this title, but that is not described in the approved contrast agent; and

(z) [6] Nonclinical test defined For purposes of this section, the term “nonclinical test” means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a (1)

With respect to a clinical investigation of a new drug that is a phase 3 study, as defined in section 312.21(c) of title 21, Code of Federal Regulations (or successor regulations), or, as appropriate, another pivotal study of a (2) Such diversity action plan shall include—

On the initiative of the drug), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.

No diversity action plan shall be required for a submission described in section 360bbb of this title.

[1] So in original. Probably should be .

[2] So in original. Probably should be ”.

[3] So in original. Probably should be preceded by “the”.

[4] So in original. The word “and” probably should not appear.

[5] So in original. Probably should be “subparagraph”.

[6] So in original. Two subsecs. (z) have been enacted.

[7] See Delayed Applicability of Amendment note below.

For delayed applicability of subsection (z) of this section as added by section 3601(a) of Pub. L. 117–328, see Effective Date of 2022 Amendment note below.

Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (k)(3)(C)(i)(I), (4)(G)(i)(I), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of Title 42, The Public Health and Welfare.

The General Schedule, referred to in subsec. (n)(5), is set out under section 5332 of Title 5, Government Organization and Employees.

The Food and Drug Administration Modernization Act of 1997, referred to in subsec. (v)(1)(A), (2)(A), (4), is Pub. L. 105–115, Nov. 21, 1997 , 111 Stat. 2296. Section 125 of the Act amended sections 321, 331, 335a, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, section 45C of Title 26, Internal Revenue Code, section 156 of Title 35,section 8126 of Title 38, Veterans’ Benefits, repealed sections 356 and 357 of this title, and enacted provisions set out as a note under this section. For complete classification of this Act to the Code, see Short Title of 1997 Amendment note set out under section 301 of this title and Tables.

The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (v)(4), is Pub. L. 98–417, Sept. 24, 1984 , 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.

The Controlled Substances Act, referred to in subsec. (x)(1), is title II of Pub. L. 91–513, Oct. 27, 1970 , 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

In subsec. (k)(4)(H), “section 132 of title 41” substituted for “section 4(5) of the Federal Procurement Policy Act” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011 , 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Subsec. (j)(10)(A)(i) to (iii). Pub. L. 117–328, § 3224, added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows:

“(i) the Pub. L. 117–328, § 3105(1), inserted “(other thanPub. L. 117–328, § 3105(2), substituted “ October 1, 2027 ” for “ December 24, 2022 ”.

Pub. L. 117–229 substituted “ December 24, 2022 ” for “ December 17, 2022 ”.

Pub. L. 117–180 substituted “December 17” for “October 1”.

Subsec. (z). Pub. L. 117–328, § 3601(a), added subsec. (z) relating to diversity action plan for clinical studies.

Pub. L. 117–328, § 3209(a)(2), added subsec. (z) definingPub. L. 116–290, § 2(a)(1), amended par. (1) generally. Prior to amendment, par. (1) related to requirements for filing anPub. L. 116–290, § 2(b)(1), inserted at beginning “Not later than 30 days after thePub. L. 117–9, § 1(a)(1)(A), substituted “active moiety (as defined by thesection 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” wherever appearing.

Pub. L. 116–290, § 2(g)(1), substituted “subsection (b)(1)(A)(i)” for “clause (A) of subsection (b)(1)” wherever appearing.

Subsec. (c)(3)(E)(i). Pub. L. 117–9, § 1(b)(1)(A), struck out cl. (i) which read as follows: “If anJanuary 1, 1982 , and ending on September 24, 1984 , thePub. L. 116–290, § 2(g)(2), substituted “clauses (ii) through (vi) of subsection (b)(1)(A)” for “clauses (B) through (F) of subsection (b)(1)”.

Subsec. (j)(5)(F). Pub. L. 117–9, § 1(a)(1)(B), substituted “active moiety (as defined by thesection 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” wherever appearing.

Subsec. (l)(2)(A)(i). Pub. L. 117–9, § 1(a)(1)(C)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “not later than 30 days after thesection 262 of title 42; and”.

Subsec. (l)(2)(A)(ii). Pub. L. 117–9, § 1(a)(1)(C)(ii), inserted “or biological product” before period at end.

“(2) if the Food and Drug Administration advisory committee prior to the approval of thePub. L. 117–9, § 1(a)(1)(E), in introductory provisions, substituted “active moiety (as defined by thesection 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” and “same active moiety” for “same active ingredient”.

2018—Subsec. (o)(4)(A). Pub. L. 115–271, § 3041(b)(1), substituted “safety or new effectiveness information” for “safety information” in heading and “If theCongress , notwithstanding error in text directed to be stricken.

Subsec. (o)(4)(B)(i). Pub. L. 115–271, § 3041(b)(2), inserted “, or new effectiveness information” after “adverse reactions”.

Subsec. (o)(4)(C). Pub. L. 115–271, § 3041(b)(3), substituted “safety or new effectiveness information” for “safety information”.

Subsec. (o)(4)(E). Pub. L. 115–271, § 3041(b)(4), substituted “safety or new effectiveness information” for “safety information”.

Subsec. (j)(11), (12). Pub. L. 115–52, § 801, added pars. (11) and (12).

Subsec. (k)(5). Pub. L. 115–52, § 901(a), made technical amendments to directory language of Pub. L. 114–255, § 3075(a). See 2016 Amendment notes below.

Subsec. (u)(4). Pub. L. 115–52, § 601, substituted “2022” for “2017”.

Subsec. (d). Pub. L. 114–255, § 3101(a)(2)(B)(i), substituted “marketing approval” for “premarket approval” in last sentence.

Subsec. (i)(4). Pub. L. 114–255, § 3024(b), substituted “except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings” for “except where it is not feasible or it is contrary to the best interests of such human beings”.

Subsec. (k)(5)(A). Pub. L. 114–255, § 3075(a)(1), as amended by Pub. L. 115–52, § 901(a)(1), substituted “screenings” for “, bi-weekly screening”.

Pub. L. 114–255, § 3102(1)(A), inserted “and” after the semicolon.

Subsec. (k)(5)(B). Pub. L. 114–255, § 3075(a)(2), as amended by Pub. L. 115–52, § 901(a), substituted “; and” for period at end.

Pub. L. 114–255, § 3102(1)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: “report to Congress not later than 2 year 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”.

Subsec. (q)(5)(A). Pub. L. 114–255, § 3101(a)(2)(B)(ii), substituted “subsection (b)(2) or (j) of this section or section 262(k) of title 42” for “subsection (b)(2) or (j) of the Act or 262(k) of title 42”.

Subsec. (r)(2)(D). Pub. L. 114–255, § 3075(b), substituted “and making publicly available on the Internet website established under paragraph (1) best practices forsection 262 of title 42” for “, by 18 months after approval of aPub. L. 114–89 added subsec. (x).

2013—Subsec. (b)(5)(B). Pub. L. 113–5 substituted “size—” for “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.”, added cls. (i) and (ii), and designated last two sentences as concluding provisions.

2012—Subsec. (d). Pub. L. 112–144, § 905, inserted at end “ThePub. L. 112–144, § 1135(1)(A), substituted “subsection (b)(2) or (j) of this section or section 262(k) of title 42” for “subsection (b)(2) or (j)” in introductory provisions.

Subsec. (q)(1)(F). Pub. L. 112–144, § 1135(1)(B), substituted “150 days” for “180 days” in introductory provisions.

Subsec. (q)(2)(A). Pub. L. 112–144, § 1135(2)(A), substituted “150” for “180” in heading.

Subsec. (q)(4). Pub. L. 112–144, § 1135(3), designated existing provisions as subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), and added subpar. (B).

Subsec. (q)(5)(A). Pub. L. 112–144, § 1135(4), substituted “subsection (b)(2) or (j) of the Act or 262(k) of title 42” for “subsection (b)(2) or (j)”.

Subsec. (u)(1)(A)(ii)(II). Pub. L. 112–144, § 1101(b), inserted “clinical” after “any”.

Subsec. (u)(4). Pub. L. 112–144, § 1101(a), substituted “2017” for “2012”.

2010—Subsec. (b)(5)(B). Pub. L. 111–148, § 7002(d)(1), inserted “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” before period at end of first sentence.

2009—Subsec. (n)(2). Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 394 of this title.

2008—Subsec. (q)(1)(A). Pub. L. 110–316, § 301, inserted concluding provisions.

Subsec. (v). Pub. L. 110–379 added subsec. (v).

Subsec. (l). Pub. L. 110–85, § 916, designated existing provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), and added par. (2).

Subsec. (n)(4) to (8). Pub. L. 110–85, § 701(b), redesignated pars. (5) to (8) as (4) to (7), respectively, and struck out former par. (4) which read as follows: “Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate family of such member could gain financially from the advice given to theSubsecs. (o), (p). Pub. L. 110–85, § 901(a), added subsecs. (o) and (p).

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, § 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 thePub. L. 108–173, § 1101(b)(1)(B), added par. (4) and redesignated former par. (4) as (5).

Subsec. (c)(3). Pub. L. 108–173, § 1101(b)(2)(A), substituted “by applying the following to each certification made under subsection (b)(2)(A)” for “under the following” in introductory provisions.

Subsec. (c)(3)(C). Pub. L. 108–173, § 1101(b)(2)(B)(iii), which directed the substitution of “subsection (b)(3)” for “paragraph (3)(B)” in third sentence, could not be executed because such words do not appear. See note below.

Pub. L. 108–173, § 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 thePub. L. 108–173, § 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) is received, an action is brought for infringement of thePub. L. 108–173, § 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 suchPub. L. 108–173, § 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 suchsection 271(e)(4)(A) of title 35, or”.

Subsec. (c)(3)(C)(iii). Pub. L. 108–173, § 1101(b)(2)(B)(ii)(IV), substituted “as provided in clause (i); or” for “on the date of such court decision.”

Subsec. (c)(3)(D), (E). Pub. L. 108–173, § 1101(b)(2)(C), (D), added subpar. (D) and redesignated former subpar. (D) as (E).

Subsec. (j)(2)(B). Pub. L. 108–173, § 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 thePub. L. 108–173, § 1101(a)(1)(B), added subpar. (D).

Subsec. (j)(5)(B). Pub. L. 108–173, § 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, § 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 theCongress .

Pub. L. 108–173, § 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 thePub. L. 108–173, § 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 suchPub. L. 108–173, § 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 suchsection 271(e)(4)(A) of title 35, or”.

Subsec. (j)(5)(B)(iii)(III). Pub. L. 108–173, § 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)(iv). Pub. L. 108–173, § 1102(a)(1), added cl. (iv) and struck out former cl. (iv) which read as follows: “If thePub. L. 108–173, § 1101(a)(2)(B), (C), added subpar. (C). Former subpar. (C) redesignated (E).

Subsec. (j)(5)(E), (F). Pub. L. 108–173, § 1101(a)(2)(B), redesignated subpars. (C) and (D) as (E) and (F), respectively.

Subsec. (j)(8)(A). Pub. L. 108–173, § 1103(a)(1), added subpar. (A) and struck out former subpar. (A) which read as follows: “The term Pub. L. 108–173, § 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 Department of Commerce ”.

Subsec. (d). Pub. L. 105–115, § 115(a), inserted at end “If thePub. L. 105–115, § 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 suchPub. L. 105–115, § 119(b)(2)(A), substituted “paragraph (7)” for “paragraph (6)”.

Subsec. (j)(3). Pub. L. 105–115, § 119(b)(1)(B), added par. (3). Former par. (3) redesignated (4).

Subsec. (j)(4). Pub. L. 105–115, § 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, § 119(b)(2)(C), substituted “paragraph (6)” for “paragraph (5)”.

Subsec. (j)(5), (6). Pub. L. 105–115, § 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, § 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, § 119(b)(1)(A), redesignated pars. (7) and (8) as (8) and (9), respectively.

1993—Subsec. (j)(6)(A)(ii). Pub. L. 103–80, § 3(n)(1)(A), substituted Pub. L. 103–80, § 3(n)(1)(B), inserted comma after “published by theSubsec. (k)(1). Pub. L. 103–80, § 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, § 102(b)(1), inserted “or (j)” after “subsection (b)”.

Subsec. (b). Pub. L. 98–417, §§ 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 thePub. L. 98–417, §§ 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)” 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, § 102(a)(3)(A), added cl. (6) relating to the failure of thePub. L. 98–417, § 102(a)(3)(B), in first sentence, added a new cl. (4) relating to the failure to file thePub. L. 98–417, § 102(b)(3), (4), in second sentence, inserted in provisions preceding cl. (1) “submitted under subsection (b) or (j)” and in cl. (1) substituted “under subsection (k) or to comply with the notice requirements of section 360(k)(2) of this title” for “under subsection (j) or to comply with the notice requirements of section 360(j)(2) of this title”.

Subsecs. (j), (k). Pub. L. 98–417, § 101, added subsec. (j) and redesignated former subsec. (j) as (k).

Subsec. (k)(1). Pub. L. 98–417, § 102(b)(5), substituted “under subsection (b) or (j)” for “pursuant to this section”.

Subsecs. (l), (m). Pub. L. 98–417, § 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, § 104(a), inserted “an approval of” before “anPub. L. 87–781, § 102(b), inserted “and whether suchPub. L. 87–781, § 104(b), substituted provisions requiring thePub. L. 87–781, § 102(c), inserted references to subsec. (c), added cls. (5) and (6), provided that if after notice and opportunity for hearing, thePub. L. 87–781, § 102(d), amended subsec. (e) generally, and among other changes, directed thePub. L. 87–781, § 104(c), substituted provisions requiring thePub. L. 87–781, § 104(d)(1), (2), inserted “as provided in section 2112 of title 28”, and “except that until the filing of the record theSupreme 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, § 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 aPub. L. 87–781, § 103(a), added subsec. (j).

1960—Subsec. (g). Pub. L. 86–507 inserted “or by certified mail” after “registered mail”.

“Sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z), 360j(g)(9)], as added by section 3601, shall apply only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under this section [see section 3602(a), (b) of Pub. L. 117–328, set out below].”

“Subparagraph (D) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), as added by paragraph (1), applies only with respect to a decision described in such subparagraph that is issued on or after the date of enactment of this Act [ Jan. 5, 2021 ].”

“The amendment made by subsection (a) [amending this section] shall apply to any section 314.161 of title 21, Code of Federal Regulations (or any successor regulations), on or after the date of enactment of this Act [ July 9, 2012 ].”

“The amendments made by this section [enacting section 379d–1 of this title and amending this section] shall take effect on October 1, 2007 .”

Amendment by sections 901(a), 903, and 905(a) of Pub. L. 110–85 effective 180 days after Sept. 27, 2007 , see section 909 of Pub. L. 110–85, set out as a note under section 331 of this title.

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.

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 “(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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) on or after August 18, 2003 .”

Except as provided in paragraph (2), the amendment made by subsection (a) [amending this section] shall be effective only with respect to an 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 “(2) Collusive agreements.—

With respect to an Dec. 8, 2003 ] for a listedPub. 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.

Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999 , see section 1000(a)(9) [title IV, § 4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, 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.

The section 553 of title 5, UnitedFederal 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 ].

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 drugsection 314.2 of title 21 of the Code of Federal Regulations and shall be considered as suitable for anyFederal 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, theFederal Food, Drug, and Cosmetic Act, except in accordance with such section.”

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.

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.

“Nothing in this section [amending this section] or the amendment made by this section shall be construed to prohibit the lawful disclosure or use of Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(k)], as added by subsection (a).”

Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative remedy provided under Federal orPub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.

“Not later than 1 year after the date of enactment of this Act [ Dec. 29, 2022 ], theFederal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) regarding—

Not later than 3 years after the date of enactment of this Act [ Dec. 29, 2022 ], theFederal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensure under section 351 of the Public Health Service Act (42 U.S.C. 262) of antifungal therapies designed to treat coccidioidomycosis (commonly known as Valley Fever).

Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant to subsection (a), the “(c) Workshop.—

To assist entities developing preventive vaccines for fungal infections and coccidioidomycosis, the Guidance on Diversity Action Plans for Clinical Studies

“(a) In General.— The “(1) the format and content of the diversity action plans required by sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z); 360j(g)(9)) (as amended by section 3601) pertaining to the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations, and may include characteristics such as geographic location and socioeconomic status, including with respect to—

demographic information, which may include age group, sex, race, geographic location, socioeconomic status, and ethnicity;

potential barriers to enrolling diverse participants, such as patient population size, geographic location, and socioeconomic status; and

an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel;

considerations for the public posting by a sponsor of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website, as appropriate;

criteria that the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z)(4), 360j(g)(9)(C)] (as amended by section 3601); and

any updates needed to be made to a diversity action plan referred to in paragraph (1) to help meet goals referred to in paragraph (1)(A); and

if the sponsor does not expect to meet goals referred to in paragraph (1)(A), the sponsor’s reasons for why the sponsor does not expect to meet such goals.

not later than 12 months after the date of enactment of this Act [ Dec. 29, 2022 ], issue new draft guidance or update existing draft guidance described in subsection (a); and

not later than 9 months after closing the comment period on such draft guidance, finalize such guidance.”

“(a) In General.— Beginning not later than 2 years after the date of enactment of this Act [ Dec. 29, 2022 ], and each year thereafter, theCongress , and publish on the public website of the Food and Drug Administration , a report that—

summarizes, in aggregate, the diversity action plans received pursuant to section 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z), 360j(g)(9)], as added by section 3601; and

for Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360e; 360(k); and 360(f)(2) [probably means “360c(f)(2)”]), or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), whether the clinical studies conducted with respect to such “(B)

the reasons provided, if any, for why enrollment goals from submitted diversity action plans were not met.

“(a) Guidance.— Not later than 1 year after the date of enactment of this Act [ Dec. 29, 2022 ], the “(1)

With respect to Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological productPublic Health Service Act (42 U.S.C. 262), and to support an investigational use exemption submission under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C. 262(a)(3)). Such guidance shall include considerations for the inclusion, in suchFederal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), and considerations for standards and methodologies for collection and analysis of real world evidence included in such “(2)

With respect to Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 360e), to support an investigational use exemption submission under section 520(g) of such Act (21 U.S.C. 360j(g)), and to support a determination by thePublic Health Service Act (42 U.S.C. 263a) (including the category described under subsection (d)(3) of such section). Such guidance shall include considerations for the inclusion, in suchFederal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), including considerations related to a determination under section 353(d)(3) of the Public Health Service Act (42 U.S.C. 263a(d)(3)), and considerations for standards and methodologies for collection and analysis of real world evidence included in such “(b) Report to Congress.— Not later than 2 years after the end of the public health emergency declared by the Public Health Service Act (42 U.S.C. 247d) on January 31, 2020 , with respect to COVID–19, theSenate and the Committee on Energy and Commerce of the House of Representatives on—

the number of Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262), for which an authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) was previously granted;

for which real world evidence was submitted and determined to be insufficient to support a regulatory decision; and

Nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 1905 of title 18, Unitedsection 552 of title 5, UnitedFreedom of Information Act’).”

“(a) Public Meetings.— Not later than one year after the date of enactment of this Act [ Oct. 24, 2018 ], the “(1)

the manner by which the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;

the Public Law 114–255) [set out as a note below]), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experienceFederal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction;

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction.

“(b) Guidance.— Not less than one year after the public meetings are conducted under subsection (a) the “(1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the “(A)

may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction;

considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and

considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition;

the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence;

“(3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing “(A)

alternative Public Law 114–255) [set out as a note below]) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), including patient registries and patient reported outcomes, as appropriate, to support product “(B)

ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing “(C)

endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use;

the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a “(c) Definitions.— In this section—

the term ‘opioid-sparing’ means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain.”

“Not less than one year after the date of enactment of this Act [ Oct. 24, 2018 ], theFood and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of aFood and Drug Administration may apply this section [amending this section and section 355–1 of this title] and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety Annual Report on Inspections

“Not later than 120 days after the end of each fiscal year, the Food and Drug Administration information related to inspections of facilities necessary for approval of aFederal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or approval of a21 U.S.C. 360e) that were conducted during the previous fiscal year. Such information shall include the following:

“(1) The median time following a request from staff of the Food and Drug Administration reviewing an “(A)

The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the “(3)

The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting related to conditions observed by the “(4)

The number of facilities that failed to implement adequate corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation for an Report on Patient Experience Drug Development

For purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the “(b) Guidance Addressing Use of Novel Clinical Trial Designs.—

the use of complex adaptive and other novel trial designs, including how such clinical trials proposed or submitted help to satisfy the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));