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21 U.S.C. § 356b — Reports of postmarketing studies
Federal law — U.S. Code and appendices · legal_authorities
**(a) Submission**
(1) **In general** — A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary.
(2) **Accelerated approval** — Notwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under [section 356(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c&num=0&edition=prelim), including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.
(3) **Agreements prior to effective date** — Any agreement entered into between the Secretary and a sponsor of a drug, prior to November 21, 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1).
**(b) Consideration of information as public information** Any information pertaining to a report descr
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Source location: Title 21, Chapter 9, § 356b; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Submission**
(1) **In general** — A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary.
(2) **Accelerated approval** — Notwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under [section 356(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c&num=0&edition=prelim), including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.
(3) **Agreements prior to effective date** — Any agreement entered into between the Secretary and a sponsor of a drug, prior to November 21, 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1).
**(b) Consideration of information as public information** Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary—
(1) to identify the sponsor; and
(2) to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study.
**(c) Status of studies and reports** The Secretary shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies—
(1) that sponsors have entered into agreements to conduct; and
(2) for which reports have been submitted under subsection (a)(1).
**(d) Disclosure** If a sponsor fails to complete an agreed upon study required by this section by its original or otherwise negotiated deadline, the Secretary shall publish a statement on the Internet site of the Food and Drug Administration stating that the study was not completed and, if the reasons for such failure to complete the study were not satisfactory to the Secretary, a statement that such reasons were not satisfactory to the Secretary.
**(e) Notification** With respect to studies of the type required under [section 356(c)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c/2/A&num=0&edition=prelim) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete by its deadline a study under any of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify practitioners who prescribe such drug or biological product of the failure to complete such study and the questions of clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as altering the requirements of the types of studies required under [section 356(c)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c/2/A&num=0&edition=prelim) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to those of such type.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Designation of a drug as a breakthrough therapy**
(1) **In general** — The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a “breakthrough therapy”.)
(2) **Request for designation** — The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim)].
(3) **Designation**
(A) *In general* — Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.
(B) *Actions* — The actions to
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
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Federal law — U.S. Code and appendices · legal_authorities
For purposes of this subpart:
(1) The term “human drug application” means an application for—
(A) approval of a new drug submitted under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim), or
(B) licensure of a biological product under subsection (a) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distribute
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Types of fees** Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) **Human drug application fee**
(A) *In general* — Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:
(i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval.
(ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).
(B) *Payment* — The fee required by subparagraph (A) shall be due upon submission of the application.
(C) *Exception for previously filed application* — If a human drug application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application for the same product by the same person (or the person’s licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(D) *Refund of fee if application refused for filing or withdrawn before filing* — The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application which is refused for filing or withdrawn without a waiver before filing.
(E) *Fees for applications previously refused for filing or withdrawn before filing* — A human drug application that was submitted but was refuse
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Federal law — U.S. Code and appendices · legal_authorities
Page 282
TITLE 21—FOOD AND DRUGS
§ 356b
(ii) The Secretary may designate a cat-
egory of such changes for the purpose of
providing that, in the case of a change
that is in such category, the holder in-
volved may commence distribution of the
drug involved upon the receipt by the Sec-
retary of a supplemental application for
the change.
(iii) If the Secretary disapproves the sup-
plemental application, the Secretary may
order the manufacturer to cease the dis-
tribution of the drugs that have been made
with the manufacturing change.
(June 25, 1938, ch. 675, § 506A, as added Pub. L.
105–115, title I, § 116(a), Nov. 21, 1997, 111 Stat.
2313.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE
Pub. L. 105–115, title I, § 116(b), Nov. 21, 1997, 111 Stat.
2315, provided that: ‘‘The amendment made by sub-
section (a) [enacting this section] takes effect upon the
effective date of regulations promulgated by the Sec-
retary of Health and Human Services to implement
such amendment, or upon the expiration of the 24-
month period beginning on the date of the enactment
of this Act [Nov. 21, 1997], whichever occurs first.’’
§ 356b. Reports of postmarketing studies
(a) Submission
(1) In general
A sponsor of a drug that has entered into an
agreement with the Secretary to conduct a
postmarketing study of a drug shall submit to
the Secretary, within 1 year after the approval
of such drug and annually thereafter until the
study is completed or terminated, a report of
the progress of the study or the reasons for the
failure of the sponsor to conduct the study.
The report shall be submitted in such form as
is prescribed by the Secretary in regulations
issued by the Secretary.
(2) Accelerated approval
Notwithstanding paragraph (1), a sponsor of
a drug ap
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 356b
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