[Federal Register: December 19, 1997 (Volume 62, Number 244)] [Notices] [Page 66636] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr19de97-92] [[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