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

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.

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

November 16, 1998, the comment period on a proposed 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 for diagnosis and monitoring. 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 November 16, 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. FDA

provided until August 5, 1998, to submit comments on the proposed rule.

In the Federal Register of August 3, 1998 (63 FR 41219), FDA

extended the comment period on the proposed rule until October 15,

1998, to allow interested persons additional time to submit comments on

the proposed rule. FDA finds it appropriate to further extend the

comment period to November 16, 1998, to permit interested persons the

opportunity to consider the proposed rule in light of the agency's

draft guidance for industry entitled ``Developing Medical Imaging Drugs

and Biologics.'' Notice of the availability of this draft guidance is

published elsewhere in this issue of the Federal Register.

Interested persons may, on or before November 16, 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: October 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-27494 Filed 10-13-98; 8:45 am]

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