[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Proposed Rules]
[Pages 5338-5339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. 98N-0040]


Developing Regulations for In Vivo Radiopharmaceuticals Used for 
Diagnosis and Monitoring; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Developing Regulations for In Vivo 
Radiopharmaceuticals Used for Diagnosis and Monitoring.'' The purpose 
of the public meeting is to provide a forum for FDA to gather 
information for the development of new regulations for the review of 
radiopharmaceutical applications as required by the Food and Drug 
Administration Modernization Act of 1997 (the FDAMA).

DATES: Submit written comments by March 4, 1998. The meeting will be 
held on February 27, 1998, 8 a.m. to 4 p.m.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. The meeting will be held at the Parklawn Bldg., 
conference rooms D and E, 5600 Fishers Lane, Rockville, MD 20857.
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, FAX 301-443-
3874, e-mail ``[email protected]''.

SUPPLEMENTARY INFORMATION: Section 122 of the FDAMA (Pub. L. 105-115) 
requires the Secretary of Health and Human Services to issue proposed 
rules governing the evaluation and approval of radiopharmaceuticals 
within 180 days after the date of enactment of the FDAMA after 
soliciting input from patient advocacy groups, physicians licensed to 
use radiopharmaceuticals, regulated industry, and interested members of 
the public. Accordingly, FDA is holding a public meeting to solicit 
public input.
    Comments: If attendance at the meeting is not possible, interested 
parties may submit written comments to the Dockets Management Branch 
(address above). 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. FDA will consider all comments 
received at the meeting and submitted to the docket in drafting 
proposed rules for the regulation of radiopharmaceuticals. FDA invites 
interested parties to comment on any aspect of the regulation of 
radiopharmaceuticals.
    In general, comments should address how FDA should cover the safety 
and effectiveness of radiopharmaceuticals in its regulations, as well 
as any identifiable characteristics that might distinguish them from 
other articles intended for use in the diagnosis and monitoring of 
diseases, or manifestations of diseases, in humans. Also, because the 
FDAMA requires that certain factors be included in a rule governing the 
evaluation and approval of radiopharmaceuticals, FDA invites comments 
on the following topics: (1) How should the proposed use of a 
radiopharmaceutical in the practice of medicine determine the nature 
and extent of safety and effectiveness evaluations; (2) what general 
characteristics of a radiopharmaceutical should be considered in the 
preclinical and clinical pharmacological and toxicological evaluations 
of a radiopharmaceutical (including the radionuclide as well as the 
ligand and carrier components, i.e., nonradioactive components); (3) 
how should the estimated absorbed radiation dose in

[[Page 5339]]

humans be determined and considered; and (4) under what circumstances 
might an approved indication for marketing refer to manifestations of 
disease (biochemical, physiological, anatomic, or pathological 
processes) common to, or present in, one or more disease states?
    Interested parties may want to review section 122 of the FDAMA and 
a draft regulation for radiopharmaceuticals submitted by the Council on 
Radionuclides and Radiopharmaceuticals (CORAR). Both the FDAMA and the 
CORAR proposal have been filed under the docket number found in the 
heading of this document, and they are available on the Internet.
    Electronic Access: Persons with access to the Internet may obtain 
the FDAMA and the CORAR proposal using the World Wide Web (www) by 
connecting to ``www.fda.gov/cber/misc.htm''.
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
fax number) and written material and requests to make oral 
presentations, by February 18, 1998, to Gloria S. Blankenship, Center 
for Biologics Evaluation and Research (HFM-43), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-1310, FAX 301-827-3079, e-mail 
``[email protected]''. Registration at the site will be done on 
a space available basis on the day of the public meeting beginning at 
7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Gloria Blankenship (address above) at least 7 days before the 
meeting.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.

    Dated: January 26, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-2322 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F