US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 355a

Pediatric studies of drugs

(a)

Definitions

As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies.

(b)

Market exclusivity for new drugs

(1)

In general

section 355(b)(1) of this titleExcept as provided in paragraph (2), if, prior to approval of an application that is submitted under , the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)—
(A)
(i)
(I)
section 355 of this title the period referred to in subsection (c)(3)(E)(ii) of , and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively; or
(II)
the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and
(ii)
section 360bb of this titlesection 360cc(a) of this title if the drug is designated under for a rare disease or condition, the period referred to in is deemed to be seven years and six months rather than seven years; and
(B)
(i)
if the drug is the subject of—
(I)
section 355 of this title a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or
(II)
section 355 of this title a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of ,
section 355(c)(3) of this titlesection 355(j)(5)(B) of this titlethe period during which an application may not be approved under or shall be extended by a period of six months after the date the patent expires (including any patent extensions); or
(ii)
section 355 of this titlesection 355(c)(3) of this titlesection 355(j)(5)(B) of this title if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of , and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under or shall be extended by a period of six months after the date the patent expires (including any patent extensions).
(2)

Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(4) is made later than 9 months prior to the expiration of such period.

(c)

Market exclusivity for already-marketed drugs

(1)

In general

section 355(b)(1) of this titleExcept as provided in paragraph (2), if the Secretary determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and makes a written request to the holder of an approved application under for pediatric studies (which shall include a timeframe for completing such studies), the holder agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)—
(A)
(i)
(I)
section 355 of this title the period referred to in subsection (c)(3)(E)(ii) of , and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectiv ely; or
(II)
the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and
(ii)
section 360bb of this titlesection 360cc(a) of this title if the drug is designated under for a rare disease or condition, the period referred to in is deemed to be seven years and six months rather than seven years; and
(B)
(i)
if the drug is the subject of—
(I)
section 355 of this title a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or
(II)
section 355 of this title a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of ,
section 355(c)(3) of this titlesection 355(j)(5)(B)(ii) of this titlethe period during which an application may not be approved under or shall be extended by a period of six months after the date the patent expires (including any patent extensions); or
(ii)
section 355 of this titlesection 355(c)(3) of this titlesection 355(j)(5)(B) of this title if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of , and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under or shall be extended by a period of six months after the date the patent expires (including any patent extensions).
(2)

Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(4) is made later than 9 months prior to the expiration of such period.

(d)

Conduct of pediatric studies

(1)

Request for studies

(A)

In general

section 355(i) of this titlesection 355(b)(1) of this titlesection 355(b)(1) of this titleThe Secretary may, after consultation with the sponsor of an application for an investigational new drug under , the sponsor of an application for a new drug under , or the holder of an approved application for a drug under , issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such request to conduct pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such studies. If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates.

(B)

Single written request

A single written request—
(i)
may relate to more than one use of a drug; and
(ii)
may include uses that are both approved and unapproved.
(2)

Written request for pediatric studies

(A)

Request and response

(i)

In general

If the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the intention of the applicant or holder to act on the request by—
(I)
indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the request; or
(II)
indicating that the applicant or holder does not agree to the request and stating the reasons for declining the request.
(ii)

Disagree with request

If, on or after , the applicant or holder does not agree to the request on the grounds that it is not possible to develop the appropriate pediatric formulation, the applicant or holder shall submit to the Secretary the reasons such pediatric formulation cannot be developed.

(B)

Adverse event reports

An applicant or holder that, on or after , agrees to the request for such studies shall provide the Secretary, at the same time as the submission of the reports of such studies, with all postmarket adverse event reports regarding the drug that is the subject of such studies and are available prior to submission of such reports.

(3)

Action on submissions

The Secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submission.

(4)

Meeting the studies requirement

Not later than 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary’s only responsibility in accepting or rejecting the reports shall be to determine, within the 180-day period, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing.

(5)

Effect of subsection

section 331(j) of this titlesection 552 of title 5section 1905 of title 18Nothing in this subsection alters or amends or or .

(6)

Consultation

section 247d–6a of title 42section 247d–6b of title 42section 247d–6d of title 42With respect to a drug that is a qualified countermeasure (as defined in ), a security countermeasure (as defined in ), or a qualified pandemic or epidemic product (as defined in ), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section.

(e)

Notice of determinations on studies requirement

(1)

In general

section 355 of this titleThe Secretary shall publish a notice of any determination, made on or after , that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of for a drug will be subject to the provisions of this section. Such notice shall be published not later than 30 days after the date of the Secretary’s determination regarding market exclusivity and shall include a copy of the written request made under subsection (b) or (c).

(2)

Identification of certain drugs

The Secretary shall publish a notice identifying any drug for which, on or after , a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population (or specified subpopulation) if the pediatric formulation for such drug is not introduced onto the market within one year after the date that the Secretary publishes the notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30 days after the date of the expiration of such one year period.

(f)

Internal review of written requests and pediatric studies

(1)

Internal review

section 355d of this titleThe Secretary shall utilize the internal review committee established under to review all written requests issued on or after , in accordance with paragraph (2).

(2)

Review of written requests

The committee referred to in paragraph (1) shall review all written requests issued pursuant to this section prior to being issued.

(3)

Review of pediatric studies

The committee referred to in paragraph (1) may review studies conducted pursuant to this section to make a recommendation to the Secretary whether to accept or reject such reports under subsection (d)(4).

(4)

Activity by committee

The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee.

(5)

Documentation of committee action

For each drug, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (2) or (3), which members of the committee participated in such activity.

(6)

Tracking pediatric studies and labeling changes

The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public, in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration—
(A)
section 284m of title 42 the number of studies conducted under this section and under ;
(B)
the specific drugs and drug uses, including labeled and off-labeled indications, studied under such sections;
(C)
the types of studies conducted under such sections, including trial design, the number of pediatric patients studied, and the number of centers and countries involved;
(D)
the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons such formulations were not developed;
(E)
the labeling changes made as a result of studies conducted under such sections;
(F)
an annual summary of labeling changes made as a result of studies conducted under such sections for distribution pursuant to subsection (k)(2); and
(G)
information regarding reports submitted on or after .
(7)

Informing internal review committee

The Secretary shall provide to the committee referred to in paragraph (1) any response issued to an applicant or holder with respect to a proposed pediatric study request.

(g)

Limitations

Notwithstanding subsection (c)(2), a drug to which the six-month period under subsection (b) or (c) has already been applied—
(1)
may receive an additional six-month period under subsection (c)(1)(A)(i)(II) for a supplemental application if all other requirements under this section are satisfied, except that such drug may not receive any additional such period under subsection (c)(1)(B); and
(2)
may not receive any additional such period under subsection (c)(1)(A)(ii).
(h)

Relationship to pediatric research requirements

section 355c of this titleExclusivity under this section shall only be granted for the completion of a study or studies that are the subject of a written request and for which reports are submitted and accepted in accordance with subsection (d)(4). Written requests under this section may consist of a study or studies required under .

(i)

Labeling changes

(1)

Priority status for pediatric applications and supplements

section 355 of this titleAny application or supplement to an application under proposing a labeling change as a result of any pediatric study conducted pursuant to this section—
(A)
shall be considered to be a priority application or supplement; and
(B)
shall be subject to the performance goals established by the Commissioner for priority drugs.
(2)

Dispute resolution

(A)

Request for labeling change and failure to agree

If, on or after , the Commissioner determines that the sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling for the drug that is the subject of the application, not later than 180 days after the date of submission of the application—
(i)
the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner determines to be appropriate; and
(ii)
if the sponsor of the application does not agree within 30 days after the Commissioner’s request to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Committee.
(B)

Action by the Pediatric Advisory Committee

Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory Committee shall—
(i)
review the pediatric study reports; and
(ii)
make a recommendation to the Commissioner concerning appropriate labeling changes, if any.
(C)

Consideration of recommendations

The Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30 days after receiving the recommendation, make a request to the sponsor of the application to make any labeling change that the Commissioner determines to be appropriate.

(D)

Misbranding

If the sponsor of the application, within 30 days after receiving a request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the Commissioner may deem the drug that is the subject of the application to be misbranded.

(E)

No effect on authority

Nothing in this subsection limits the authority of the United States to bring an enforcement action under this chapter when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.

(j)

Other labeling changes

If, on or after , the Secretary determines that a pediatric study conducted under this section does or does not demonstrate that the drug that is the subject of the study is safe and effective, including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary shall order the labeling of such product to include information about the results of the study and a statement of the Secretary’s determination.

(k)

Dissemination of pediatric information

(1)

In general

Not later than 210 days after the date of submission of a report on a pediatric study under this section, the Secretary shall make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted under subsection (b) or (c).

(2)

Dissemination of information regarding labeling changes

Beginning on , the Secretary shall include as a requirement of a written request that the sponsors of the studies that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(6)(F) distribute, at least annually (or more frequently if the Secretary determines that it would be beneficial to the public health), such information to physicians and other health care providers.

(3)

Effect of subsection

section 331(j) of this titlesection 552 of title 5section 1905 of title 18Nothing in this subsection alters or amends or or .

(l)

Adverse event reporting

(1)

Reporting in first 18-month period

section 393a of this titleBeginning on , during the 18-month period beginning on the date a labeling change is approved pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics established under . In considering the reports, the Director of such Office shall provide for the review of the reports by the Pediatric Advisory Committee, including obtaining any recommendations of such Committee regarding whether the Secretary should take action under this chapter in response to such reports.

(2)

Reporting in subsequent periods

Following the 18-month period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee regarding whether the Secretary should take action in response to such reports.

(3)

Preservation of authority

Nothing in this subsection shall prohibit the Office of Pediatric Therapeutics from providing for the review of adverse event reports by the Pediatric Advisory Committee prior to the 18-month period referred to in paragraph (1), if such review is necessary to ensure safe use of a drug in a pediatric population.

(4)

Effect

The requirements of this subsection shall supplement, not supplant, other review of such adverse event reports by the Secretary.

(m)

section 355(j) of this title Clarification of interaction of market exclusivity under this section and market exclusivity awarded to an applicant for approval of a drug under

section 355(j)(5)(B)(iv) of this titlesection 355(j) of this titleIf a 180-day period under overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under entitled to the 180-day period under that section loses a portion of the 180-day period to which the applicant is entitled for the drug, the 180-day period shall be extended from—
(1)
the date on which the 180-day period would have expired by the number of days of the overlap, if the 180-day period would, but for the application of this subsection, expire after the 6-month exclusivity period; or
(2)
the date on which the 6-month exclusivity period expires, by the number of days of the overlap if the 180-day period would, but for the application of this subsection, expire during the six-month exclusivity period.
(n)

Referral if pediatric studies not submitted

(1)

In general

section 355d of this titleBeginning on , if pediatric studies of a drug have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request under subsection (d) and if the Secretary, through the committee established under , determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall carry out the following:
(A)
section 262 of title 42section 355c(b) of this title For a drug for which a listed patent has not expired, or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of has not ended, make a determination regarding whether an assessment shall be required to be submitted under .
(B)
section 262 of title 42section 284m of title 42 For a drug that has no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of apply, the Secretary shall refer the drug for inclusion on the list established under for the conduct of studies.
(C)
section 247d–6a of title 42section 247d–6b of title 42section 247d–6d of title 42 For a drug that is a qualified countermeasure (as defined in ), a security countermeasure (as defined in ), or a qualified pandemic or epidemic product (as defined in ), in addition to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs.
(2)

Public notice

section 355c of this titleThe Secretary shall give the public notice of a decision under paragraph (1)(A) not to require an assessment under and the basis for such decision.

(3)

Effect of subsection

section 331(j) of this titlesection 552 of title 5section 1905 of title 18Nothing in this subsection alters or amends or or .

(o)

Prompt approval of drugs when pediatric information is added to labeling

(1)

General rule

section 355 of this titlesection 352 of this titlesection 355(j)(5)(F) of this titlesection 355(c)(3)(E) of this titlesection 360cc(a) of this titlesection 355f of this titleA drug for which an application has been submitted or approved under subsection (b)(2) or (j) of shall not be considered ineligible for approval under that section or misbranded under on the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling pertaining to pediatric use when the omitted indication or other aspect is protected by patent, or by exclusivity under clause (iii) or (iv) of , clause (iii) or (iv) of , or , or by an extension of such exclusivity under this section or .

(2)

Labeling

section 355(j)(5)(F) of this titlesection 355(c)(3)(E) of this titlesection 360cc of this titlesection 355 of this titleNotwithstanding clauses (iii) and (iv) of , clauses (iii) and (iv) of , or , the Secretary may require that the labeling of a drug approved pursuant to an application submitted under subsection (b)(2) or (j) of that omits a pediatric indication or other aspect of labeling as described in paragraph (1) include—
(A)
a statement that, because of marketing exclusivity for a manufacturer—
(i)
the drug is not labeled for pediatric use; or
(ii)
in the case of a drug for which there is an additional pediatric use not referred to in paragraph (1), the drug is not labeled for the pediatric use under paragraph (1); and
(B)
a statement of any appropriate pediatric contraindications, warnings, precautions, or other information that the Secretary considers necessary to assure safe use.
(3)

Preservation of pediatric exclusivity and extensions

This subsection does not affect—
(A)
the availability or scope of exclusivity under—
(i)
this section;
(ii)
section 355 of this title for pediatric formulations; or
(iii)
section 360cc of this title ;
(B)
section 355f of this title the availability or scope of an extension to any such exclusivity, including an extension under this section or ;
(C)
section 355 of this title the question of the eligibility for approval under of any application described in subsection (b)(2) or (j) of such section that omits any other aspect of labeling protected by exclusivity under—
(i)
section 355(j)(5)(F) of this title clause (iii) or (iv) of ;
(ii)
section 355(c)(3)(E) of this title clause (iii) or (iv) of ; or
(iii)
section 360cc(a) of this title ; or
(D)
section 355 of this titlesection 360cc of this title except as expressly provided in paragraphs (1) and (2), the operation of or .

June 25, 1938, ch. 675, § 505APub. L. 105–115, title I, § 111111 Stat. 2305Pub. L. 107–109115 Stat. 1408Pub. L. 108–155117 Stat. 1941Pub. L. 108–173, title XI, § 1104117 Stat. 2461Pub. L. 110–85, title V, § 502(a)(1)121 Stat. 876Pub. L. 111–148, title VII, § 7002(g)(2)(B)124 Stat. 820Pub. L. 112–144, title V126 Stat. 1039Pub. L. 113–5, title III, § 307(a)127 Stat. 191Pub. L. 114–255, div. A, title III, § 3102(2)130 Stat. 1156Pub. L. 115–52, title V, § 505(a)131 Stat. 1046Pub. L. 117–9, § 1(b)(2)135 Stat. 258(, as added , , ; amended , §§ 2, 4, 5(b)(2), 7–11(a), 18(a), 19, , , 1411, 1413–1415, 1423, 1424; , §§ 2(b)(2), 3(a), (b)(1), , ; , , ; , , ; , , ; , §§ 501(a), 502(a)(1), (b), 509(a), , , 1040, 1047; , , ; , , ; –(b)(2)(A), title VI, § 608, , , 1050; , , .)

Editorial Notes

Amendments

Pub. L. 117–92021—Subsec. (c)(1)(A)(i)(II). substituted “(c)(3)(E)” for “(c)(3)(D)”.

Pub. L. 115–52, § 505(b)(2)(A)2017—Subsecs. (b), (c). , substituted “subsection (d)(4)” for “subsection (d)(3)” in introductory provisions of par. (1) and in par. (2).

Pub. L. 115–52, § 505(b)(1)Subsec. (d)(3) to (6). , added par. (3) and redesignated former pars. (3) to (5) as (4) to (6), respectively.

Pub. L. 115–52, § 505(b)(2)(A)Subsec. (f)(3). , substituted “subsection (d)(4)” for “subsection (d)(3)”.

Pub. L. 115–52, § 505(a)Subsec. (f)(7). , added par. (7).

Pub. L. 115–52, § 505(b)(2)(A)Subsec. (h). , substituted “subsection (d)(4)” for “subsection (d)(3)”.

oPub. L. 115–52, § 608(1)Subsec. (). , struck out “under section 355(j)” after “approval of drugs” in heading.

oPub. L. 115–52, § 608(2)section 355 of this titlesection 355(j) of this titlesection 355(j)(5)(F) of this titlesection 355(c)(3)(E) of this titlesection 360cc(a) of this titlesection 355f of this titlesection 355(j)(5)(F) of this titleSubsec. ()(1). , substituted “under subsection (b)(2) or (j) of ” for “under ” and “, or by exclusivity under clause (iii) or (iv) of , clause (iii) or (iv) of , or , or by an extension of such exclusivity under this section or ” for “or by exclusivity under clause (iii) or (iv) of ”.

oPub. L. 115–52, § 608(3)section 355(c)(3)(E) of this titlesection 360cc of this titlesection 355(j)(5)(F) of this titlesection 355 of this titlesection 355(j) of this titleSubsec. ()(2). , in introductory provisions, inserted “clauses (iii) and (iv) of , or ,” after “,” and substituted “drug approved pursuant to an application submitted under subsection (b)(2) or (j) of ” for “drug approved under ”.

oPub. L. 115–52, § 608(4)Subsec. ()(3). , amended par. (3) generally. Prior to amendment, text read as follows: “This subsection does not affect—

“(A) the availability or scope of exclusivity under this section;

section 355 of this title“(B) the availability or scope of exclusivity under for pediatric formulations;

section 355(j) of this titlesection 355(j)(5)(F) of this title“(C) the question of the eligibility for approval of any application under that omits any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of ; or

section 355 of this title“(D) except as expressly provided in paragraphs (1) and (2), the operation of .”

Pub. L. 114–2552016—Subsec. (p). struck out subsec. (p) which related to Institute of Medicine study.

Pub. L. 113–5, § 307(a)(1)2013—Subsec. (d)(5). , added par. (5).

Pub. L. 113–5, § 307(a)(2)Subsec. (n)(1)(C). , added subpar. (C).

Pub. L. 112–144, § 502(b)2012—Subsec. (d)(1)(A). , inserted at end “If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates.”

Pub. L. 112–144, § 502(a)(1)Subsec. (h). , amended subsec. (h) generally. Prior to amendment, text read as follows: “Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section.”

Pub. L. 112–144, § 509(a)(1)Subsec. (k)(2). , substituted “subsection (f)(6)(F)” for “subsection (f)(3)(F)”.

lPub. L. 112–144, § 509(a)(2)(A)Subsec. ()(1). , substituted “first 18-month period” for “year one” in heading and “18-month” for “one-year” in text.

lPub. L. 112–144, § 509(a)(2)(B)Subsec. ()(2). , substituted “periods” for “years” in heading and “18-month period” for “one-year period” in text.

lPub. L. 112–144, § 509(a)(2)(C)Subsec. ()(3), (4). , (D), added par. (3) and redesignated former par. (3) as (4).

Pub. L. 112–144, § 509(a)(3)(A)Subsec. (n). , substituted “submitted” for “completed” in heading.

Pub. L. 112–144, § 509(a)(3)(B)(i)Subsec. (n)(1). , substituted “have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request” for “have not been completed” in introductory provisions.

Pub. L. 112–144, § 509(a)(3)(B)(ii)section 262 of title 42section 355c(b) of this titleSubsec. (n)(1)(A). , inserted “, or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of has not ended” after “expired” and struck out at end “Prior to making such a determination, the Secretary may not take more than 30 days to certify whether the Foundation for the National Institutes of Health has sufficient funding at the time of such certification to initiate and fund all of the studies in the written request in their entirety within the timeframes specified within the written request. Only if the Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for the National Institutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the Secretary shall consider whether assessments shall be required under for such drug.”

Pub. L. 112–144, § 509(a)(3)(B)(iii)section 262 of title 42Subsec. (n)(1)(B). , substituted “no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of apply,” for “no listed patents or has 1 or more listed patents that have expired,”.

oPub. L. 112–144, § 509(a)(4)Subsec. ()(2)(B). , amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “a statement of any appropriate pediatric contraindications, warnings, or precautions that the Secretary considers necessary.”

Pub. L. 112–144, § 501(a)Subsec. (q). , struck out subsec. (q). Text read as follows: “A drug may not receive any 6-month period under subsection (b) or (c) unless—

“(1) on or before , the Secretary makes a written request for pediatric studies of the drug;

section 355(b) of this title“(2) on or before , an application for the drug is accepted for filing under ; and

“(3) all requirements of this section are met.”

Pub. L. 111–1482010—Subsec. (p)(4) to (6). added pars. (4) to (6) and struck out former pars. (4) and (5) which read as follows:

section 355c of this title“(4) review and assess the pediatric studies of biological products as required under subsections (a) and (b) of ; and

“(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics.”

Pub. L. 110–852007— amended section generally. Prior to amendment, text consisted of subsecs. (a) to (n) relating to pediatric studies of drugs, including market exclusivity, conduct of pediatric studies, delay of effective date for certain applications, notice of determinations on studies requirement, limitations, research requirements, labeling supplements, dissemination of information, prompt approval of drugs, report to Congress not later than , and sunset provisions.

Pub. L. 108–173, § 1104(1)2003—Subsec. (b)(1)(A)(i). , substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places.

Pub. L. 108–173, § 1104(2)Subsec. (b)(1)(A)(ii). , substituted “(j)(5)(F)” for “(j)(5)(D)”.

Pub. L. 108–155, § 3(a)Subsec. (b)(2). , substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places.

Pub. L. 108–173, § 1104(1)Subsec. (c)(1)(A)(i). , substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places.

Pub. L. 108–173, § 1104(2)Subsec. (c)(1)(A)(ii). , substituted “(j)(5)(F)” for “(j)(5)(D)”.

Pub. L. 108–155, § 3(a)Subsec. (c)(2). , substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places.

Pub. L. 108–173, § 1104(3)Subsec. (e). , substituted “355(j)(5)(F)” for “355(j)(5)(D)”.

Pub. L. 108–155, § 2(b)(2)Subsec. (h). , substituted “pediatric research requirements” for “regulations” in heading and “by a provision of law (including a regulation) other than this section” for “pursuant to regulations promulgated by the Secretary” in text.

Pub. L. 108–155, § 3(b)(1)Subsec. (i)(2). , struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee” wherever appearing.

lPub. L. 108–173, § 1104(3)Subsec. (). , substituted “355(j)(5)(F)” for “355(j)(5)(D)” wherever appearing.

Pub. L. 107–109, § 19(2)2002—Subsec. (a). , (3), redesignated subsec. (g) as (a). Former subsec. (a) redesignated (b).

Pub. L. 107–109, § 19(1)(A)Subsec. (a)(1)(A). , (B), substituted “(j)(5)(D)(ii)” for “(j)(4)(D)(ii)” in two places in cl. (i) and “(j)(5)(D)” for “(j)(4)(D)” in cl. (ii).

Pub. L. 107–109, § 19(2)Subsec. (b). , (3), redesignated subsec. (a) as (b).

Pub. L. 107–109, § 2(1), struck out heading and text of subsec. (b). Text read as follows: “Not later than 180 days after , the Secretary, after consultation with experts in pediatric research shall develop, prioritize, and publish an initial list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. The Secretary shall annually update the list.”

Pub. L. 107–109, § 2(2)Subsec. (c). , in introductory provisions, inserted “determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and” after “the Secretary” and struck out “concerning a drug identified in the list described in subsection (b) of this section” after “such studies)”.

Pub. L. 107–109, § 19(1)(A)Subsec. (c)(1)(A). , (B), substituted “(j)(5)(D)(ii)” for “(j)(4)(D)(ii)” in two places in cl. (i) and “(j)(5)(D)” for “(j)(4)(D)” in cl. (ii).

Pub. L. 107–109, § 19(4)Subsec. (d)(1). , substituted “subsection (b) or (c)” for “subsection (a) or (c)” in introductory provisions.

Pub. L. 107–109Subsec. (d)(2). , §§ 18(a), 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)” and inserted “In reaching an agreement regarding written protocols, the Secretary shall take into account adequate representation of children of ethnic and racial minorities.” after first sentence.

Pub. L. 107–109, § 19(4)Subsec. (d)(3). , substituted “subsection (b) or (c)” for “subsection (a) or (c)”.

Pub. L. 107–109, § 4Subsec. (d)(4). , added par. (4).

Pub. L. 107–109, § 19(1)(C)Subsec. (e). , (4), substituted “section 355(j)(5)(D)” for “section 355(j)(4)(D)” and “subsection (b) or (c)” for “subsection (a) or (c)”.

Pub. L. 107–109, § 19(2)Subsec. (g). , (3), (5), redesignated subsec. (h) as (g) and substituted “subsection (b) or (c)” for “subsection (a) or (b)” in introductory provisions. Former subsec. (g) redesignated (a).

Pub. L. 107–109, § 7, inserted “(including neonates in appropriate cases)” after “pediatric age groups”.

Pub. L. 107–109, § 19(2)Subsec. (h). , (3), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).

Pub. L. 107–109, § 19(2)lSubsec. (i). , (3), redesignated subsec. () as (i). Former subsec. (i) redesignated (h).

Pub. L. 107–109, § 19(2)Subsec. (j). , (3), redesignated subsec. (m) as (j). Former subsec. (j) redesignated (n).

Pub. L. 107–109, § 8section 355(b)(1) of this title, added subsec. (j) and struck out heading and text of former subsec. (j). Text read as follows: “A drug may not receive any six-month period under subsection (a) or (c) of this section unless the application for the drug under is submitted on or before . After , a drug shall receive a six-month period under subsection (c) of this section if—

“(1) the drug was in commercial distribution as of ;

“(2) the drug was included by the Secretary on the list under subsection (b) of this section as of ;

“(3) the Secretary determines that there is a continuing need for information relating to the use of the drug in the pediatric population and that the drug may provide health benefits in that population; and

“(4) all requirements of this section are met.”

Pub. L. 107–109, § 19(2)Subsec. (k). , (3), redesignated subsec. (n) as (k). Former subsec. (k) redesignated (m).

lPub. L. 107–109, § 19(2)ollSubsec. (). , (3), redesignated subsec. () as (). Former subsec. () redesignated (i).

Pub. L. 107–109, § 5(b)(2)l, added subsec. ().

Pub. L. 107–109, § 19(2)Subsec. (m). , (3), redesignated subsec. (k) as (m). Former subsec. (m) redesignated (j).

Pub. L. 107–109, § 9, added subsec. (m).

Pub. L. 107–109, § 19(4)Subsec. (n). , which directed substitution of “subsection (b) or (c)” for “subsection (a) or (c)” in subsec. (m), was executed by making the substitution in introductory provisions of subsec. (n), to reflect the probable intent of Congress.

Pub. L. 107–109, § 19(2), (3), redesignated subsec. (j) as (n). Former subsec. (n) redesignated (k).

Pub. L. 107–109, § 10, added subsec. (n).

oPub. L. 107–109, § 19(2)olSubsec. (). , (3), redesignated subsec. () as ().

Pub. L. 107–109, § 11(a)o, added subsec. ().

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Pub. L. 112–144, title V, § 509(g)126 Stat. 1050

“(1)

Application .—

21 U.S.C. 355aNotwithstanding any provision of section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (, 355c) stating that a provision applies beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 [] or the date of the enactment of the Pediatric Research Equity Act of 2007 [], any amendment made by this Act to such a provision applies beginning on the date of the enactment of this Act [].
“(2)

Transitional rule for adverse event reporting .—

l21 U.S.C. 355allWith respect to a drug for which a labeling change described under section 505A()(1) or 505B(i)(1) of the Federal Food, Drug, and Cosmetic Act (()(1); 355c(i)(1)) is approved or made, respectively, during the one-year period that ends on the day before the date of enactment of this Act [], the Secretary [of Health and Human Services] shall apply section 505A() and section 505B(i), as applicable, to such drug, as such sections were in effect on such day.”
, , , provided that:

Effective Date of 2007 Amendment

Pub. L. 110–85, title V, § 502(a)(2)121 Stat. 885

“(A)

In general .—

21 U.S.C. 355aThe amendment made by this subsection [amending this section] shall apply to written requests under section 505A of the Federal Food, Drug, and Cosmetic Act () issued on or after the date of the enactment of this Act [].
“(B)

Certain written requests .—

lA written request issued under section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been accepted and for which no determination under subsection (d)(2) of such section has been made before such date of enactment, shall be subject to such section 505A, except that such written requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), ()(1), and (n) of section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on or after the date of the enactment of this Act.”
, , , provided that:

Effective Date of 2003 Amendment

Pub. L. 108–155section 4 of Pub. L. 108–155section 355c of this titleAmendment by effective , except as otherwise provided, see , set out as an Effective Date note under .

Effective Date of 2002 Amendment

Pub. L. 107–109, § 11(b)115 Stat. 1416

21 U.S.C. 355(j)“The amendment made by subsection (a) [amending this section] takes effect on the date of enactment of this Act [], including with respect to applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act () that are approved or pending on that date.”
, , , provided that:

Construction of 2007 Amendments on Pediatric Studies

Pub. L. 110–85, title IX, § 901(e)121 Stat. 942

section 262 of Title 4221 U.S.C. 355a21 U.S.C. 355c“This title [enacting sections 353c, 355–1, 355e, 360a, and 360bbb–6 of this title, amending sections 331, 333, 334, 352, 355, and 381 of this title and , The Public Health and Welfare, and enacting provisions set out as notes under sections 331, 352, and 355 of this title] and the amendments made by this title may not be construed as affecting the authority of the Secretary of Health and Human Services to request pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act [] or to require such studies under section 505B of such Act [].”
, , , provided that:

Plan for Earlier Submission of Pediatric Studies

Pub. L. 115–52, title V, § 505(c)131 Stat. 1046

21 U.S.C. 355d21 U.S.C. 355a42 U.S.C. 262(m)“The Secretary of Health and Human Services, acting through the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act () shall, not later than one year after the date of enactment of this Act [], develop and implement a plan to achieve, when appropriate, earlier submission of pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act () or section 351(m) of the Public Health Service Act (). Such plan shall include recommendations to achieve—
“(1)
21 U.S.C. 355c(e)(2)(C) earlier discussion of proposed pediatric study requests and written requests with sponsors, and if appropriate, discussion of such requests at the meeting required under section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (), as amended by section 503(a);
“(2)
21 U.S.C. 355(b)(1) earlier issuance of written requests for a pediatric study under such section 505A, including for investigational new drugs prior to the submission of an application under section 505(b)(1) of such Act (); and
“(3)
shorter timelines, when appropriate, for the completion of studies pursuant to a written request under such section 505A or such section 351(m).”
, , , provided that:

Draft Guidance for Neonatal Studies

Pub. L. 115–52, title V, § 505(d)(2)131 Stat. 1047

“Not later than 2 years after the date of enactment of this Act [], the Secretary shall issue draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products.”
, , , provided that:

Communication With Pediatric Review Committee

Pub. L. 112–144, title V, § 503126 Stat. 1040

21 U.S.C. 355d21 U.S.C. 355a“Not later than 1 year after the date of enactment of this Act [], the Secretary of Health and Human Services (referred to in this title [see Tables for classification] as the ‘Secretary’) shall issue internal standard operating procedures that provide for the review by the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act () of any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (, 355c). Such internal standard operating procedures shall be made publicly available on the Internet Web site of the Food and Drug Administration.”
, , , provided that:

Access to Data

Pub. L. 112–144, title V, § 504126 Stat. 1040

21 U.S.C. 355a21 U.S.C. 355a(k)“Not later than 3 years after the date of enactment of this Act [], the Secretary [of Health and Human Services] shall make available to the public, including through posting on the Internet Web site of the Food and Drug Administration, the medical, statistical, and clinical pharmacology reviews of, and corresponding written requests issued to an applicant, sponsor, or holder for, pediatric studies submitted between , and , under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act () for which 6 months of market exclusivity was granted and that resulted in a labeling change. The Secretary shall make public the information described in the preceding sentence in a manner consistent with how the Secretary releases information under section 505A(k) of the Federal Food, Drug, and Cosmetic Act ().”
, , , provided that:

Report on Pediatric Exclusivity Program

Pub. L. 107–109, § 16115 Stat. 1421Pub. L. 108–155, § 3(b)(4)117 Stat. 1942, , , as amended by , , , required the Comptroller General, not later than , and in consultation with the Secretary of Health and Human Services, to submit to Congress a report on specified issues concerning the effectiveness of the pediatric exclusivity program.

Study by General Accounting Office

Pub. L. 107–109, § 18(b)115 Stat. 1423section 355a of this title, , , required the Comptroller General, not later than , to conduct a study relating to the representation of children of ethnic and racial minorities in studies under and to submit a report to Congress describing the findings of the study.