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Public Law 101-635

101st Congress

An Act

To amend the Federal Food, Drug, and Cosmetic Act to revitalize the Food and Drug
Administration, 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. SHORT TITLE; TABLE OF CONTENTS.

Nov. 28, 1990 [S. 845]

Food and Drug
Administration
Revitalization

Act.

(a) SHORT TITLE.-This Act may be cited as the "Food and Drug 21 USC 301 note. Administration Revitalization Act".

(b) TABLE OF CONTENTS.-The table of contents is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. References to the Federal Food, Drug, and Cosmetic Act.

TITLE I-CONSOLIDATED ADMINISTRATIVE AND LABORATORY FACILITY

Sec. 101. Consolidated administrative and laboratory facility.

TITLE II-RECOVERY AND RETENTION OF FEES FOR FOIA REQUESTS Sec. 201. Recovery and retention of fees for FOIA requests.

TITLE III-SCIENTIFIC REVIEW GROUPS

Sec. 301. Scientific review groups.

TITLE IV-AUTOMATION OF FDA

Sec. 401. Automation of FDA.

SEC. 2. REFERENCES TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. Except as otherwise specifically provided, whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

TITLE I-CONSOLIDATED

ADMINISTRA

TIVE AND LABORATORY FACILITY

SEC. 101. CONSOLIDATED ADMINISTRATIVE AND LABORATORY FACILITY. Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end thereof the following new section:

"SEC. 710. CONSOLIDATED ADMINISTRATIVE AND LABORATORY FACIL- Government

ITY.

"(a) AUTHORITY.-The Secretary, in consultation with the Administrator of the General Services Administration, shall enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration administrative and laboratory facility.

"(b) AWARDING OF CONTRACT.-The Secretary shall solicit contract proposals under subsection (a) from interested parties. In awarding contracts under such subsection, the Secretary shall review such

contracts.
21 USC 379b.

39-194 O 91 QL 3 Part 6

Government property.

21 USC 379c.

proposals and give priority to those alternatives that are the most cost effective for the Federal Government and that allow for the use of donated land, federally owned property, or lease-purchase arrangements. A contract under this subsection shall not be entered into unless such contract results in a net cost savings to the Federal Government over the duration of the contract, as compared to the Government purchase price including borrowing by the Secretary of the Treasury.

"(c) DONATIONS.-In carrying out this section, the Secretary shall have the power, in connection with real property, buildings, and facilities, to accept on behalf of the Food and Drug Administration gifts or donations of services or property, real or personal, as the Secretary determines to be necessary.

"(d) AUTHORIZATION OF APPROPRIATIONS.-There are authorized to be appropriated to carry out this section $100,000,000 for fiscal year 1991, and such sums as may be necessary for each of the subsequent fiscal years, to remain available until expended.".

TITLE II-RECOVERY AND RETENTION OF
FEES FOR FOIA REQUESTS

SEC. 201. RECOVERY AND RETENTION OF FEES FOR FOIA REQUESTS.

Chapter VII (21 U.S.C. 371 et seq.) (as amended by section 101 of this Act) is further amended by adding at the end thereof the following new section:

"SEC. 711. RECOVERY AND RETENTION OF FEES FOR FREEDOM OF INFORMATION REQUESTS.

"(a) IN GENERAL.-The Secretary, acting through the Commissioner of Food and Drugs, may

"(1) set and charge fees, in accordance with section 552(a)(4)(A) of title 5, United States Code, to recover all reasonable costs incurred in processing requests made under section 552 of title 5, United States Code, for records obtained or created under this Act or any other Federal law for which responsibility for administration has been delegated to the Commissioner by the Secretary;

"(2) retain all fees charged for such requests; and

"(3) establish an accounting system and procedures to control receipts and expenditures of fees received under this section. "(b) USE OF FEES.-The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provisions of this Act.

"(c) WAIVER OF FEES.-Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5, United States Code.".

TITLE III-SCIENTIFIC REVIEW GROUPS

SEC. 301. SCIENTIFIC REVIEW GROUPS.

Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end thereof the following new section:

"SEC. 903. SCIENTIFIC REVIEW GROUPS.

Without regard to the provisions of title 5, United States Code, governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may

"(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this Act);

and

"(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.".

TITLE IV-AUTOMATION OF FDA

SEC. 401. AUTOMATION OF FDA.

Chapter VII (21 U.S.C. 371 et seq.) (as amended by sections 101 and 201 of this Act) is further amended by adding at the end thereof the following new section:

"SEC. 712. AUTOMATION OF FOOD AND DRUG ADMINISTRATION.

"(a) IN GENERAL.-The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this Act.

"(b) AUTHORIZATION OF APPROPRIATIONS.-There are authorized to be appropriated each fiscal year such sums as are necessary to carry out this section.".

Approved November 28, 1990.

21 USC 394.

21 USC 379d.

LEGISLATIVE HISTORY-S. 845:

SENATE REPORTS: No. 101-242 (Comm. on Labor and Human Resources).
CONGRESSIONAL RECORD, Vol. 136 (1990):

Oct. 24, considered and passed Senate.
Oct. 27, considered and passed House.

Nov. 28, 1990 [S. 1859]

[blocks in formation]

To restructure repayment terms and conditions for loans made by the Secretary of the Interior to the Wolf Trap Foundation for the Performing Arts for the reconstruction of the Filene Center in Wolf Trap Farm Park in Fairfax County, Virginia, 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. REPAYMENT OF LOANS MADE WITH RESPECT TO WOLF TRAP
FARM PARK.

Section 4(b) of the Wolf Trap Farm Park Act (16 U.S.C. 284c(b)) is amended

(1) by inserting "(1)" after "(b)"; and

(2) by inserting at the end the following:

"(2)(A) The term of the loans made pursuant to paragraph (1) which are outstanding on the effective date of this paragraph may not exceed the 25-year period beginning on such date. The remaining obligation of such loans shall be paid in equal annual installments, commencing June 1, 1991, except that for the first 3 payments, the payment shall be $215,000 each year. In addition, such payments (including the first 3 payments) may be reduced in any year by a credit not to exceed $60,000 annually. Such credit shall equal 100 percent of the market value of public service tickets determined at prevailing Foundation box office prices. Such credit shall be allowed only for tickets contributed to entities holding a status referred to in section 501(c)(3) of the Internal Revenue Code of 1986.

"(B)(i) Unpaid interest on such amount which accrued before the effective date of this paragraph is hereby forgiven.

"(ii) Notwithstanding paragraph (1), there shall be no interest on the loan referred to in subparagraph (A) after the effective date of this paragraph if, within 120 days after such date, the Foundation modifies its agreement with the Secretary to implement this paragraph, paragraph (3), and section 5(c)(4). If such agreement is not modified within the 120-day period, interest shall accrue from the effective date of this paragraph in accordance with paragraph (1).

"(C) Notwithstanding any other provision of law, amounts paid to the Secretary pursuant to this paragraph may be retained until expended by the Secretary, in consultation with the Foundation, for the maintenance of structures, facilities, and equipment of the Park. "(D) The Secretary shall, within 120 days after the effective date of this paragraph, submit a payment schedule to the Foundation specifying the amount of each annual payment to be made by the Foundation pursuant to this paragraph.

"(3) If the Foundation is in default on its obligations under this subsection for more than 60 consecutive days, the Secretary, acting in the public interest, shall terminate the cooperative agreement described in section 5. In the event of a major catastrophe or severe economic situation, the Secretary may submit to the Committee on

Interior and Insular Affairs of the United States House of Rep-
resentatives and the Committee on Energy and Natural Resources
of the United States Senate a recommendation that this paragraph
be temporarily suspended. In submitting such a request, the Sec-
retary shall submit clear evidence of the financial status of the
Foundation.".

SEC. 2. PROHIBITION ON COMMINGLING FOUNDATION FUNDS AND PARK
FUNDS.

Section 5(c) of the Wolf Trap Farm Park Act (16 U.S.C. 284d(c)) is amended

(1) by striking "and" at the end of paragraph (2);

(2) by striking the period at the end of paragraph (3) and inserting "; and"; and

(3) by adding after paragraph (3) the following:

"(4) the Foundation will maintain accounts for Foundation activities outside of the Park separate from Foundation accounts for presentation of performing arts and related programs presented at the Center and other areas of the Park.".

SEC. 3. STUDY OF PARK FUTURE.

The Wolf Trap Farm Park Act (16 U.S.C. 284 et seq.) is amended by adding at the end the following:

"SEC. 13. STUDY.

16 USC 284 note.

"The Secretary, acting jointly with the Foundation, shall conduct a study and analysis of the operations and management practices which are being used to carry out the purposes of this Act. The study shall include analysis of the management relationship between the Foundation and the Park, a delineation of the operational responsibilities of the Foundation and the Park, and an analysis of the financial condition of the Foundation. Not later than 2 years Reports. after the date of enactment of this section, the Secretary shall submit a report of such study and analysis to the Committee on Interior and Insular Affairs of the United States House of Representatives and the Committee on Energy and Natural Resources of the United States Senate.".

SEC. 4. EFFECTIVE DATES.

(a) The amendments made by sections 1 and 2 shall take effect on the date on which the Wolf Trap Foundation for the Performing Arts modifies its agreements entered into pursuant to the Wolf Trap

16 USC 284c note.

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