[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]
BILLING CODE 4160-01-F
