[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Proposed Rules]
[Page 457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-72]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 315 and 601

[Docket No. 98D-0785]


Draft Guidance for Industry on Developing Medical Imaging Drugs 
and Biologics; Availability; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Availability of guidance; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
February 12, 1999, the comment period for the draft guidance for 
industry entitled ``Draft Guidance for Industry on Developing Medical 
Imaging Drugs and Biologics'' that appeared in the Federal Register of 
October 14, 1998 (63 FR 55067). FDA is taking this action in response 
to a request for an extension.

DATES: Written comments on the draft guidance may be submitted by 
February 12, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), 1401 Rockville Pike, Rockville, MD 
20852-1448, FAX 888-CBERFAX or 301-827-3844. Send two self-addressed 
adhesive labels to assist the office in processing your request. Submit 
written comments to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    Robert K. Leedham, Center for Drug Evaluation and Research (HFD-
160), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-7510, or
    George Q. Mills, Center for Biologics Evaluation and Research (HFM-
573), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-5097.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 14, 1998 
(63 FR 55067), FDA published a notice announcing the availability of a 
draft guidance document for industry entitled ``Developing Medical 
Imaging Drugs and Biologics.'' The draft guidance is intended to assist 
developers of drug and biological products used for medical imaging, as 
well as radiopharmaceutical drugs used in disease diagnosis, in 
planning and coordinating the clinical investigations of, and 
submitting various types of applications for, such products. The draft 
guidance also provides information on how the agency would interpret 
and apply provisions in proposed regulations, published in the Federal 
Register of May 22, 1998 (63 FR 28301), for in vivo 
radiopharmaceuticals used for diagnosis and monitoring. The draft 
guidance applies to medical imaging drugs that are used for diagnosis 
and monitoring and that are administered in vivo. The draft guidance is 
not intended to apply to possible therapeutic uses of these drugs or to 
in vitro diagnostic products. Interested persons were given until 
December 14, 1998, to submit written comments on the draft guidance.
    FDA received a letter, dated December 4, 1998, from Alan M. 
Kirschenbaum, legal counsel for the Council on Radionuclides and 
Radiopharmaceuticals, requesting that the agency extend the comment 
period on the draft guidance by 60 days.
    The draft guidance introduces several new and highly technical 
issues. Therefore, the agency has decided to reopen the comment period 
on the draft guidance until February 12, 1999, to allow the public more 
time to review and comment on its contents.
    Interested persons may, on or before February 12, 1999, submit to 
the Dockets Management Branch (address above) written comments on the 
draft guidance document. 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. The draft guidance document and received comments may 
be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: December 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-72 Filed 1-4-99; 8:45 am]
BILLING CODE 4160-01-F