Human drugs and biological products: In vivo radiopharmaceuticals used for diagnosis and monitoring; evaluation and approval,

[Federal Register: August 3, 1998 (Volume 63, Number 148)]

[Proposed Rules]

[Page 41219-41220]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr03au98-19]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 315 and 601

[Docket No. 98N-0040]

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

Summary: The Food and Drug Administration (FDA) is extending to

[[Page 41220]]

October 15, 1998, the comment period on a proposal rule that was published in the Federal Register of May 22, 1998 (63 FR 28301). The document proposed to amend the drug and biologics regulations by adding provisions that would clarify the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases. The agency is taking this action to provide interested persons additional time to submit comments to FDA on the proposed rule.

DATES: Written comments by October 15, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Dano B. Murphy, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210, or 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: In the Federal Register of May 22, 1998 (63 FR 28301), FDA published a proposed rule to amend the drug and biologics regulations by adding provisions that would clarify the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases. The proposed regulations would describe certain types of indications for which FDA may approve diagnostic radiopharmaceuticals. The proposed rule would also include criteria that the agency would use to evaluate the safety and effectiveness of a diagnostic radiopharmaceutical under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Interested persons were given until August 5, 1998, to submit comments on the proposed rule. Due to the technical nature of the proposed rule, FDA has decided to extend the comment period until October 15, 1998, to allow interested persons additional time to submit comments on the proposed rule.

Interested persons may, on or before October 15, 1998, submit to the Dockets Management Branch (address above) written comments regarding this proposed rule. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

Dated: July 28, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination.

[FR Doc. 98-20596Filed7-31-98; 8:45 am]

BILLING CODE 4160-01-F