21 U.S.C. § 355c–1

(a)

In general

July 9, 2012Not later than four years after , and every five years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting on the Internet Web site of the Food and Drug Administration, a report on the implementation of sections 355a and 355c of this title.

(b)

Each report under subsection (a) shall include—

(1)

July 9, 2012 an assessment of the effectiveness of sections 355a and 355c of this title in improving information about pediatric uses for approved drugs and biological products, including the number and type of labeling changes made since , and the importance of such uses in the improvement of the health of children;

(2)

section 355c of this title section 355c of this title the number of required studies under such that have not met the initial deadline provided under such , including—

(A)

the number of deferrals and deferral extensions granted and the reasons such extensions were granted;

(B)

the number of waivers and partial waivers granted; and

(C)

section 355c of this title the number of letters issued under subsection (d) of such ;

(3)

July 9, 2012section 355c of this title an assessment of the timeliness and effectiveness of pediatric study planning since , including the number of initial pediatric study plans not submitted in accordance with the requirements of subsection (e) of such and any resulting rulemaking;

(4)

section 355a of this titleJuly 9, 2012 the number of written requests issued, accepted, and declined under such since , and a listing of any important gaps in pediatric information as a result of such declined requests;

(5)

section 355a of this title a description and current status of referrals made under subsection (n) of such ;

(6)

section 284m of title 42 an assessment of the effectiveness of studying biological products in pediatric populations under such sections 355a and 355c of this title and ;

(7)

(A)

the efforts made by the Secretary to increase the number of studies conducted in the neonatal population (including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe); and

(B)

the results of such efforts;

(8)

(A)

section 284m of title 42 the number and importance of drugs and biological products for children with cancer that are being tested as a result of the programs under such sections 355a and 355c of this title and under ; and

(B)

any recommendations for modifications to such programs that would lead to new and better therapies for children with cancer, including a detailed rationale for each recommendation;

(9)

any recommendations for modification to such programs that would improve pediatric drug research and increase pediatric labeling of drugs and biological products;

(10)

an assessment of the successes of and limitations to studying drugs for rare diseases under such sections 355a and 355c of this title;

(11)

section 355c of this title an assessment of the impact of the amendments to such made by the FDA Reauthorization Act of 2017 on pediatric research and labeling of drugs and biological products and pediatric labeling of molecularly targeted drugs and biological products for the treatment of cancer;

(12)

1 See References in Text note below.

section 262(m) of title 42 an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act, regarding earlier submission of pediatric studies under sections 355a and 355c of this title and , including—

(A)

section 355(b)(1) of this title section 262(a) of title 42 section 355a of this title section 262(m) of title 42 the average length of time after the approval of an application under or before studies conducted pursuant to such , 355c of this title, or are completed, submitted, and incorporated into labeling;

(B)

the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request;

(C)

the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies;

(D)

section 355(b)(1) of this title section 262(a) of title 42 the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under or ; and

(E)

the average number, and range of numbers, of amendments to written requests issued, and the time the Secretary requires to review and act on proposed amendments to written requests;

(13)

section 355a of this title section 262(m) of title 42 section 355c(d)(1) of this title a list of sponsors of applications or holders of approved applications who received exclusivity under such or such after receiving a letter issued under such for any drug or biological product before the studies referred to in such letter were completed and submitted;

(14)

section 355c of this title a list of assessments and investigations required under such ;

(15)

section 355a of this title section 355c of this titleAugust 18, 2017 how many requests under such for molecular targeted cancer drugs, as defined by subsection (a)(1)(B) of such , approved prior to 3 years after , have been issued by the Food and Drug Administration, and how many such requests have been completed; and

(16)

the Secretary’s assessment of the overall impact of the amendments made by section 504 of the FDA Reauthorization Act of 2017 on the conduct and effectiveness of pediatric cancer research and the orphan drug program, as well any subsequent recommendations.

(c)

Stakeholder comment

At least 180 days prior to the submission of each report under subsection (a), the Secretary shall consult with representatives of patient groups (including pediatric patient groups), consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report including suggestions for modifications that would improve pediatric drug research and pediatric labeling of drugs and biological products.

Pub. L. 112–144, title V, § 508July 9, 2012126 Stat. 1045 Pub. L. 115–52, title V, § 504(d)Aug. 18, 2017131 Stat. 1044(, , ; , , .)

Editorial Notes

References in Text

Pub. L. 115–52Aug. 18, 2017131 Stat. 1005 section 355c of this title section 301 of this titleThe FDA Reauthorization Act of 2017, referred to in subsec. (b)(11), (16), is , , . Section 504 of the Act amended this section and . For complete classification of this Act to the Code, see Short Title of 2017 Amendment note set out under and Tables.

section 505(c) of Pub. L. 115–52 section 355a of this title section 262(m) of Title 42Section 505C–1 of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(12), probably means , the FDA Reauthorization Act of 2017, which is set out as a note under . The Federal Food, Drug, and Cosmetic Act does not contain a section 505C–1, and section 505(c) of the FDA Reauthorization Act of 2017 relates to the development and implementation of a plan for earlier submission of pediatric studies under sections 355a and 355c of this title and , The Public Health and Welfare.

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

Pub. L. 115–522017—Subsec. (b)(11) to (16). added pars. (11) to (16) and struck out former par. (11) which read as follows: “an assessment of the Secretary’s efforts to address the suggestions and options described in any prior report issued by the Comptroller General, Institute of Medicine, or the Secretary, and any subsequent 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

Pub. L. 115–52 section 355a of this title section 262(m) of Title 42 section 504(e) of Pub. L. 115–52 section 355c of this titleNothing in amendment by to limit the authority of the Secretary of Health and Human Services to issue written requests under or , The Public Health and Welfare, or to negotiate or implement amendments to such requests proposed by applicants, see , set out as a note under .

Definition of “Secretary”

section 503 of Pub. L. 112–144 section 355a of this titleThe term “Secretary” as used in this section means the Secretary of Health and Human Services, see , set out as a note under .