[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Proposed Rules]
[Pages 5338-5339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-2322]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 ``Murphyd@CBER.FDA.GOV''.
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
``Blankenship@CBER.FDA.GOV''. 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