[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Draft Guidance for Industry on Developing Medical Imaging Drugs 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April 14, 1999, the comment period for the draft guidance for industry 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published a notice of availability of the draft guidance in the Federal 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DATES: Written comments on the draft guidance may be submitted by April 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 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]
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