[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Rules and Regulations]
[Page 66522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 94N-0421]


Revocation of Regulation on Positron Emission Tomography Drug 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; revocation.

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SUMMARY: The Food and Drug Administration (FDA) is revoking a 
regulation on positron emission tomography (PET) radiopharmaceutical 
drug products. The regulation permits FDA to approve requests from 
manufacturers of PET drugs for exceptions or alternatives to provisions 
of the current good manufacturing practice (CGMP) regulations. FDA is 
taking this action in accordance with provisions of the Food and Drug 
Administration Modernization Act of 1997 (Modernization Act). Elsewhere 
in this issue of the Federal Register, FDA is publishing a notice 
revoking two notices concerning certain guidance documents on PET drugs 
and the guidance documents to which the notices relate.

EFFECTIVE DATE: December 21, 1997.

FOR FURTHER INFORMATION CONTACT: Brian L. Pendleton, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5649.

SUPPLEMENTARY INFORMATION: On November 21, 1997, President Clinton 
signed into law the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115). Section 121(c)(1)(A) of the Modernization Act 
directs FDA to develop appropriate procedures for the approval of PET 
drugs as well as CGMP requirements for such drugs, taking into account 
any relevant differences between not-for-profit institutions that 
compound PET drugs and commercial manufacturers. FDA is to establish 
these procedures and requirements not later than 2 years after the date 
of enactment. In doing so, the agency must consult with patient 
advocacy groups, professional associations, manufacturers, and persons 
licensed to make or use PET drugs.
    Under section 121(c)(2) of the Modernization Act, FDA cannot 
require the submission of new drug applications or abbreviated new drug 
applications for compounded PET drugs that are not adulterated under 
section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351(a)(2)(C)) for a period of 4 years after the date of 
enactment, or 2 years after the date that the agency adopts special 
approval procedures and CGMP requirements for PET drugs, whichever is 
longer.
    Section 121(d) of the Modernization Act requires FDA, within 30 
days of enactment, to publish in the Federal Register a notice 
terminating the application of FDA's final rule, published in the 
Federal Register of April 22, 1997 (62 FR 19493), permitting the agency 
to approve requests from manufacturers of PET drug products for 
exceptions or alternatives to provisions of FDA's CGMP regulations (21 
CFR 211.1(d)). FDA already has received one such request for an 
exception or alternative to the CGMP requirements for PET drugs in the 
form of a citizen petition submitted by Case Western Reserve University 
(CWRU) (Docket No. 97P-0198/CP1). As required by the Modernization Act, 
the final rule on exceptions and alternatives is hereby revoked, which 
also renders the CWRU citizen petition moot. The information and views 
presented in the CWRU citizen petition will be considered as a part of 
the rulemaking proceeding to establish appropriate CGMP requirements 
for PET drugs under section 121(c)(1)(A)(ii) of the Modernization Act.
    Section 121(d) of the Modernization Act also directs FDA to 
terminate the application of two notices concerning certain guidance 
documents on PET drugs. Elsewhere in this issue of the Federal 
Register, FDA is publishing a notice revoking these two notices and the 
guidance documents to which the notices relate.
    The revocation of the final rule on CGMP exceptions or alternatives 
for PET drugs is effective December 21, 1997.
    In accordance with section 121(c)(1)(A) of the Modernization Act, 
FDA intends to begin the development of new PET drug approval 
procedures and CGMP requirements immediately and will obtain 
appropriate public input during this process.

List of Subjects in 21 CFR Part 211

    Drugs, Labeling, Laboratories, Packaging and containers.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
211 is amended as follows:

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED 
PHARMACEUTICALS

     1. The authority citation for 21 CFR part 211 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 
374.


Sec. 211.1  [Amended]

    2. Section 211.1 Scope is amended by removing paragraph (d).

    Dated: December 16, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-33187 Filed 12-18-97; 8:45 am]
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