[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Draft Guidance for Industry on Developing Medical Imaging Drugs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February 12, 1999, the comment period for the draft guidance for
industry entitled ``Draft Guidance for Industry on Developing Medical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DATES: Written comments on the draft guidance may be submitted by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Drug Information Branch (HFD-210), Center for Drug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draft guidance document for industry entitled ``Developing Medical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
