Food and Drug Administration Amendments Act of 2007
Public Law 110–85, as amended
Food and Drug Administration Amendments Act of 2007
85
117–328
Statute Compilation
United States House of Representatives
Office of the Legislative Counsel
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
GPO Statute Compilations USLM converter, version 20210527.1
2023-02-24
Prescription Drug User Fee Amendments of 2007
Medical Device User Fee Amendments of 2007
Food and Drug Administration Amendments Act of 2007
Pediatric Medical Device Safety and Improvement Act of 2007
Pediatric Research Equity Act of 2007
Best Pharmaceuticals for Children Act of 2007
16871
110
2007-09-27
Food and Drug Administration Amendments Act of 2007
[(Public Law 110–85)]
[As Amended Through P.L. 117–328, Enacted December 29, 2022]
[Currency: This publication is a compilation of the text of Public Law 110–85. It was last amended by the public law listed in the As Amended Through note above and below at the bottom of each page of the pdf version and reflects current law through the date of the enactment of the public law listed at https://www.govinfo.gov/app/collection/comps/]
[Note: While this publication does not represent an official version of any Federal statute, substantial efforts have been made to ensure the accuracy of its contents. The official version of Federal law is found in the United States Statutes at Large and in the United States Code. The legal effect to be given to the Statutes at Large and the United States Code is established by statute (1 U.S.C. 112, 204).]

AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1.
[21 U.S.C. 301 note]

SHORT TITLE.
This Act may be cited as the “Food and Drug Administration Amendments Act of 2007”.
SEC. 2.

TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1.
Short title.
* * * * * * *
TITLE I—
PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
* * * * * * *
Sec. 106.
Sunset dates.
* * * * * * *
TITLE II—
MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
* * * * * * *
Subtitle A—
Fees Related to Medical Devices
* * * * * * *
Sec. 217.
Sunset clause.
* * * * * * *
TITLE III—
PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
* * * * * * *
Sec. 305.
Demonstration grants for improving pediatric device availability.
* * * * * * *
TITLE I—

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
SEC. 101.

SHORT TITLE; REFERENCES IN TITLE; FINDING.
(a)

Short Title.—
This title may be cited as the “Prescription Drug User Fee Amendments of 2007”.
* * * * * * *
SEC. 106.

SUNSET DATES.
(a)
[21 U.S.C. 379g note]

Authorization.—
The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012.
(b)
[21 U.S.C. 379h–2 note]

Reporting Requirements.—
The amendment made by section 105 ceases to be effective January 31, 2013.
* * * * * * *
TITLE II—

MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
SEC. 201.
[21 U.S.C. 301 note]

SHORT TITLE; REFERENCES IN TITLE; FINDING.
(a)

Short Title.—
This title may be cited as the “Medical Device User Fee Amendments of 2007”.
* * * * * * *
Subtitle A—

Fees Related to Medical Devices
* * * * * * *
SEC. 217.
[21 U.S.C. 379i note]

SUNSET CLAUSE.
The amendments made by this subtitle cease to be effective October 1, 2012, except that section 738A of the Federal Food, Drug, and Cosmetic Act (regarding annual performance and financial reports) ceases to be effective January 31, 2013.
* * * * * * *
TITLE III—

PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
SEC. 301.
[21 U.S.C. 301 note]

SHORT TITLE.
This title may be cited as the “Pediatric Medical Device Safety and Improvement Act of 2007”.
* * * * * * *
SEC. 305.
[42 U.S.C. 282 note]

DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY.
(a)

In general.—
(1)

Request for proposals.—
Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development.
(2)

Determination on grants or contracts.—
Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section.
(b)

Application.—
A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require.
(c)

Use of Funds.—
A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by—
(1)
encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
(2)
mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;
(3)
connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;
(4)
assessing the scientific and medical merit of proposed pediatric device projects;
(5)
providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and
(6)
providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.
(d)

Coordination.—
(1)

National institutes of health.—
Each consortium that receives a grant or contract under this section shall—
(A)
coordinate with the National Institutes of Health’s pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and
(B)
provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest.
(2)

Food and drug administration.—
Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use.
(3)

Effectiveness and outcomes.—
Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium.
(e)

Authorization of appropriations.—
There are authorized to be appropriated to carry out this section $1,610,959 for the period beginning on October 1, 2022 and ending on December 23, 20221.
^1
Section 3104 of division FF of Public Law 117-328 attempts to amend subsection (e) by striking “$1,107,534 for the period beginning on October 1, 2022, and ending on December 23, 2022” and inserting “$7,000,000 for each of fiscal years 2023 through 2027”. This amendment does not execute due to a prior amendment made by section 304 of division C of Public Law 117-229.
* * * * * * *