[Federal Register Volume 63, Number 198 (Wednesday, October 14, 1998)]
[Proposed Rules]
[Page 55067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27494]


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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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