[Federal Register Volume 64, Number 30 (Tuesday, February 16, 1999)]
[Proposed Rules]
[Pages 7561-7562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3634]
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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Draft Guidance for Industry on Developing Medical Imaging Drugs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; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Availability of guidance; extension of comment period.
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[[Page 7562]]
SUMMARY: The Food and Drug Administration (FDA) is extending until
April 14, 1999, the comment period for the draft guidance for industry
entitled ``Developing Medical Imaging Drugs and Biologics.'' FDA
published a notice of availability of the draft guidance in the Federal
Register of October 14, 1998 (63 FR 55067). FDA is taking this action
in response to requests for an extension.
DATES: Written comments on the draft guidance may be submitted by April
14, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Drug Information Branch (HFD-210), Center for Drug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, Jr., Center for
Drug Evaluation and Research (HFD-160), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-443-3500, 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 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 in
the diagnosis and monitoring of diseases. 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.
In a notice published in the Federal Register of January 5, 1999
(64 FR 457), FDA reopened the comment period on the draft guidance
until February 12, 1999.
At a January 25, 1999, public meeting on the draft guidance
requested by the Council on Radionuclides and Radiopharmaceuticals
(CORAR), a representative of Bracco Diagnostics Inc. (Bracco) requested
that FDA extend the comment period on the draft guidance to allow
manufacturers of contrast media to attempt to reach consensus and
submit comments on the draft guidance. On January 27, 1999, FDA
received letters from Bracco and from CORAR's legal counsel requesting
that the agency extend the comment period.
In response to these requests, FDA has decided to extend the
comment period on the draft guidance until April 14, 1999, to allow the
public more time to review and comment on its contents. FDA also
intends to hold another public meeting to discuss the draft guidance
prior to the close of the comment period.
Interested persons may, on or before April 14, 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 should 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: February 9, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-3634 Filed 2-12-99; 8:45 am]
BILLING CODE 4160-01-F
