[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Notices]
[Page 66636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33188]



[[Page 66636]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 94D-0422 and 93N-0005]


Revocation of Certain Guidance Documents on Positron Emission 
Tomography Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is revoking two notices 
regarding guidance documents affecting positron emission tomography 
(PET) radiopharmaceutical drug products. The guidance documents address 
FDA's regulatory approach to PET drug products and current good 
manufacturing practice (CGMP) requirements for such products. FDA is 
revoking these notices along with the guidance documents to which the 
notices relate in accordance with provisions of the Food and Drug 
Administration Modernization Act of 1997 (the Modernization Act). 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
revocation of a final rule.

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 Modernization Act (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 (NDA's) or abbreviated 
new drug applications (ANDA's) 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 terminate the application of two notices that 
were published in the Federal Register on February 27, 1995 (60 FR 
10593 and 10594). One notice is entitled ``Regulation of Positron 
Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public 
Workshop'' (60 FR 10594). The notice included a guidance document 
entitled ``Regulation of PET Radiopharmaceuticals.'' This guidance 
document, among other things, stated that a manufacturer of a PET drug 
was required to obtain FDA approval of an NDA or ANDA in accordance 
with 21 CFR part 314.
    In the other notice, FDA announced the availability of its ``Draft 
Guideline on the Manufacture of Positron Emission Tomography 
Radiopharmaceutical Drug Products'' (60 FR 10593). In the Federal 
Register of April 22, 1997 (62 FR 19580), FDA published a notice of 
availability of a final version of this guidance entitled ``Guidance 
for Industry: Current Good Manufacturing Practices for Positron 
Emission Tomographic (PET) Drug Products; Availability.'' The agency is 
hereby revoking these notices as well as the draft and final guidance 
documents on CGMP's for PET drugs.
    Section 121(d) of the Modernization Act also directs FDA to 
terminate the application of a 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 is announcing the revocation of this rule in a final 
rule published elsewhere in this issue of the Federal Register.
    The notices and corresponding guidance documents discussed 
previously are revoked 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.

    Dated: December 16, 1997.
William B. Schultz,
Deputy Commissioner for Policy,
[FR Doc. 97-33188 Filed 12-18-97; 8:45 am]
BILLING CODE 4160-01-F