Food and Drug Administration Revitalization Act
PL 101-635 (S.845), enacted 11/28/1990

PUBLIC LAW 101-635—NOV. 28, 1990 
104 STAT. 4583 
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. 
(a) SHORT TITLE.—This Act may be cited £is the "Food and Drug 
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 £is 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 consid-
ered 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 
Nov. 28, 1990 
[S. 845] 
Food and Drug 
Administration 
Revitalization 
Act. 
21 u s e 301 note. 
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-
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 lab-
oratory 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 
Government 
contracts. 
21 u s e 379b. 
39-194 O - 91 
QL 3 Part 6 
104 STAT. 4584 
PUBLIC LAW 101-635—NOV. 28, 1990 
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. 
Government 
"(c) DONATIONS.—In Carrying out this section, the Secretary shall 
property. 
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: 
21 use 379c. 
"SEC. 711. RECOVERY AND RETENTION OF FEES FOR FREEDOM OF 
INFORMATION REQUESTS. 
"(a) IN GENERAL.—The Secretary, acting through the Commis-
sioner of Food and Drugs, may— 
"(1) set and charge fees, in accordeuice with section 
552(aX4XA) of title 5, United States Code, to recover all reason-
able 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 (aXD. 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(aX4)(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: 
PUBLIC LAW 101-635—NOV. 28, 1990 
104 STAT. 4585 
"SEC. 903. SCIENTIFIC REVIEW GROUPS. 
21 USC 394. 
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 clsissification 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. 
21 USC 379d. 
"(a) IN GENERAL.—The Secretary, acting through the Commis-
sioner 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. 
LEGISLATIVE HISTORY—S. 845: 
SENATE REPORTS: No. 101-242 (Coram, on Labor and Human Resources). 
CONGRESSIONAL RECORD, Vol. 136 (1990): 
Oct. 24, considered and passed Senate. 
Oct. 27, considered and passed House.