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

[[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. 98-20596 Filed 7-31-98; 8:45 am]

BILLING CODE 4160-01-F