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21 U.S.C. § 360a–1 — Clinical trials
Federal law — U.S. Code and appendices · legal_authorities
**(a) Review and revision of guidance documents**
(1) **In general** — The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall review and, as appropriate, revise not fewer than 3 guidance documents per year, which shall include—
(A) reviewing the guidance documents of the Food and Drug Administration for the conduct of clinical trials with respect to antibacterial and antifungal drugs; and
(B) as appropriate, revising such guidance documents to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of antibacterial and antifungal drugs under chapter V of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 351](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351&num=0&edition=prelim) et seq.).
(2) **Issues for review** — At a minimum, the review under paragraph (1) shall address the appropriate animal models of infection, in vitro techniques, valid microbiological surrogate markers, the use of noninferiority versus superiority trials, trial enrollment, data requirements, and appropriate delta values for noninferiority trials.
(3) **Rule of construction** — Except to the extent to which the Secretary makes revisions under paragraph (1)(B), nothing in this section shall be construed to repeal or otherwise effect the guidance documents of the Food and Drug Administration.
**(b) Recommendations for investigations**
(1) **Request** — The sponsor of a drug intended to be designated as a qualified infectious disease product may request that the Secretary provide written recommendations for nonclinical and clinical investigations which the Secretary believes may be necessary to be conducted with the drug
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**(a) Review and revision of guidance documents**
(1) **In general** — The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall review and, as appropriate, revise not fewer than 3 guidance documents per year, which shall include—
(A) reviewing the guidance documents of the Food and Drug Administration for the conduct of clinical trials with respect to antibacterial and antifungal drugs; and
(B) as appropriate, revising such guidance documents to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of antibacterial and antifungal drugs under chapter V of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 351](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351&num=0&edition=prelim) et seq.).
(2) **Issues for review** — At a minimum, the review under paragraph (1) shall address the appropriate animal models of infection, in vitro techniques, valid microbiological surrogate markers, the use of noninferiority versus superiority trials, trial enrollment, data requirements, and appropriate delta values for noninferiority trials.
(3) **Rule of construction** — Except to the extent to which the Secretary makes revisions under paragraph (1)(B), nothing in this section shall be construed to repeal or otherwise effect the guidance documents of the Food and Drug Administration.
**(b) Recommendations for investigations**
(1) **Request** — The sponsor of a drug intended to be designated as a qualified infectious disease product may request that the Secretary provide written recommendations for nonclinical and clinical investigations which the Secretary believes may be necessary to be conducted with the drug before such drug may be approved under section 505 of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 355](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim)) for use in treating, detecting, preventing, or identifying a qualifying pathogen, as defined in section 505E of such Act [[21 U.S.C. 355f](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355f&num=0&edition=prelim)].
(2) **Recommendations** — If the Secretary has reason to believe that a drug for which a request is made under this subsection is a qualified infectious disease product, the Secretary shall provide the person making the request written recommendations for the nonclinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request, would be necessary for approval under section 505 of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 355](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim)) of such drug for the use described in paragraph (1).
**(c) Qualified infectious disease product** For purposes of this section, the term “qualified infectious disease product” has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355f(g)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355f/g&num=0&edition=prelim)], as added by section 801 of this Act.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
A drug or device shall be deemed to be adulterated—
**(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture**
(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 351
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Standards to enable electronic exchange**
(1) **In general** — The Secretary shall adopt standards for transactions, and data elements for such transactions, to enable health information to be exchanged electronically, that are appropriate for—
(A) the financial and administrative transactions described in paragraph (2); and
(B) other financial and administrative transactions determined appropriate by the Secretary, consistent with the goals of improving the operation of the health care system and reducing administrative costs, and subject to the requirements under paragraph (5).
(2) **Transactions** — The transactions referred to in paragraph (1)(A) are transactions with respect to the following:
(A) Health claims or equivalent encounter information.
(B) Health claims attachments.
(C) Enrollment and disenrollment in a health plan.
(D) Eligibility for a health plan.
(E) Health care payment and remittance advice.
(F) Health plan premium payments.
(G) First report of injury.
(H) Health claim status.
(I) Referral certification and authorization.
(J) Electronic funds transfers.
(3) **Accommodation of specific providers** — The standards adopted by the Secretary under paragraph (1) shall accommodate the needs of different types of health care providers.
(4) **Requirements for financial and administrative transactions**
(A) *In general* — The standards and associated operating rules adopted by the Secretary shall—
(i) to the extent feasible and appropriate, enable determination of an individual’s eligibility and financial responsibility for specific services prior to or at the point of care;
(ii) be comprehensive, requiring minimal augmentation by paper or other communications;
(iii) provide for timely acknowledg
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1320d–2
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Extension** If the Secretary approves an application pursuant to [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or the 7-year period described in [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&num=0&edition=prelim), as applicable, shall be extended by 5 years.
**(b) Relation to pediatric exclusivity** Any extension under subsection (a) of a period shall be in addition to any extension of the period under [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim) with respect to the drug.
**(c) Limitations** Subsection (a) does not apply to the approval of—
(1) a supplement to an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired;
(2) a subsequent application filed with respect to a product approved under [section 355 of this title](https://uscode.house
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355f
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Federal law — U.S. Code and appendices · legal_authorities
Page 155
TITLE 21—FOOD AND DRUGS
§ 351
tion of an article of food that was the subject
of a recall under section 350l(b) of this title or
a public health advisory described in para-
graph (1).
(Pub. L. 111–353, title II, § 206(f), Jan. 4, 2011, 124
Stat. 3943.)
Editorial Notes
REFERENCES IN TEXT
Subsection (a), referred to in par. (1), means subsec.
(a) of section 206 of Pub. L. 111–353.
CODIFICATION
Section was enacted as part of the FDA Food Safety
Modernization Act, and not as part of the Federal
Food, Drug, and Cosmetic Act which comprises this
chapter.
Statutory Notes and Related Subsidiaries
CONSTRUCTION
Nothing in this section to be construed to alter juris-
diction and authorities established under certain other
Acts or in a manner inconsistent with international
agreements to which the United States is a party, see
sections 2251 and 2252 of this title.
§ 350m. Requirements for critical food
(a) Notification of meaningful disruption for crit-
ical food
(1) In general
A manufacturer of a critical food (as defined
in section 321(ss) of this title) shall notify the
Secretary of a permanent discontinuance in
the manufacture or an interruption of the
manufacture of such food that is likely to lead
to a meaningful disruption in the supply of
such food in the United States, and the rea-
sons for such discontinuance or interruption,
as soon as practicable, but not later than 5
business days after such discontinuance or
such interruption.
(2) Distribution of information
Not later than 5 calendar days after receiv-
ing a notification under paragraph (1), if the
Secretary has determined that such dis-
continuance or interruption has resulted, or is
likely to result, in a shortage of such critical
food, the Secretary shall distribute, to t
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 351
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 351. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 186
TITLE 21—FOOD AND DRUGS
§ 355
§ 355. New drugs
(a) Necessity of effective approval of application
No person shall introduce or deliver for intro-
duction into interstate commerce any new drug,
unless an approval of an application filed pursu-
ant to subsection (b) or (j) is effective with re-
spect to such drug.
(b) Filing application; contents
(1)(A) Any person may file with the Secretary
an application with respect to any drug subject
to the provisions of subsection (a). Such persons
shall submit to the Secretary as part of the ap-
plication—
(i) full reports of investigations which have
been made to show whether such drug is safe
for use and whether such drug is effective in
use;
(ii) a full list of the articles used as compo-
nents of such drug;
(iii) a full statement of the composition of
such drug;
(iv) a full description of the methods used in,
and the facilities and controls used for, the
manufacture, processing, and packing of such
drug;
(v) such samples of such drug and of the arti-
cles used as components thereof as the Sec-
retary may require;
(vi) specimens of the labeling proposed to be
used for such drug;
(vii) any assessments required under section
355c of this title; and
(viii) the patent number and expiration date
of each patent for which a claim of patent in-
fringement could reasonably be asserted if a
person not licensed by the owner of the patent
engaged in the manufacture, use, or sale of the
drug, and that—
(I) claims the drug for which the applicant
submitted the application and is a drug sub-
stance (active ingredient) patent or a drug
product (formulation or composition) pat-
ent; or
(II) claims a method of using such drug for
which approval is sought or has been granted
in the application.
(B) If an a
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 355. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 260
TITLE 21—FOOD AND DRUGS
§ 355d
reports, including recommendations therein, regarding
the topics addressed in the reports under this section,
including with respect to—
‘‘(A) improving public access to information from
pediatric studies conducted under such sections 355a
and 355c of this title; and
‘‘(B) improving the timeliness of pediatric studies
and pediatric study planning under such sections 355a
and 355c of this title.’’
Statutory Notes and Related Subsidiaries
RULE OF CONSTRUCTION
Nothing in amendment by Pub. L. 115–52 to limit the
authority of the Secretary of Health and Human Serv-
ices to issue written requests under section 355a of this
title or section 262(m) of Title 42, The Public Health
and Welfare, or to negotiate or implement amendments
to such requests proposed by applicants, see section
504(e) of Pub. L. 115–52, set out as a note under section
355c of this title.
DEFINITION OF ‘‘SECRETARY’’
The term ‘‘Secretary’’ as used in this section means
the Secretary of Health and Human Services, see sec-
tion 503 of Pub. L. 112–144, set out as a note under sec-
tion 355a of this title.
§ 355d. Internal committee for review of pedi-
atric plans, assessments, deferrals, deferral
extensions, and waivers
The Secretary shall establish an internal com-
mittee within the Food and Drug Administra-
tion to carry out the activities as described in
sections 355a(f) and 355c(f) of this title. Such in-
ternal committee shall include employees of the
Food and Drug Administration, with expertise
in pediatrics (including representation from the
Office of Pediatric Therapeutics), biopharma-
cology, statistics, chemistry, legal issues, pedi-
atric ethics, neonatology, and the appropriate
expertise pertaining to the pediatric product
under revi
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355f
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 355f. This identifies an authority to review, not proof of applicability.