[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Proposed Rules]
[Page 24491-24492]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-10]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 361
[Docket No. 2004N-0432]
Radioactive Drugs for Certain Research Uses; Public Meeting;
Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening until July
11, 2005, the comment period on the questions raised and issues
addressed in the notice of public meeting, published in the Federal
Register of October 5, 2004 (69 FR 59569), on the use of certain
radioactive drugs for research purposes without an investigational new
drug application (IND) under the conditions set forth in FDA
regulations. We are taking this action in response to requests to
extend the comment period and to allow additional time to review agency
guidance on a related matter.
DATES: Submit written or electronic comments on the notice and/or
public meeting by July 11, 2005.
ADDRESSES: You may submit comments, identified by Docket No. 2004N-
0432, by any of the following methods:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-
0432 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and docket number for this proceeding. All comments received will be
posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For detailed instructions
on submitting comments, see the ``Comments'' heading in the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
and insert Docket No. 2004N-0432 into the ``Search'' box and follow the
prompts, or go to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
A transcript of the public meeting is available for review at the
Division of Dockets Management and on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.
FOR FURTHER INFORMATION CONTACT: Maria R. Walsh, Center for Drug
Evaluation and Research (HFD-103), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3139, FAX: 301-480-3761, e-
mail: walsh@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 5, 2004 (69 FR 59569), we
announced a public meeting to be held on November 16, 2004, to discuss
research on radioactive drugs that is conducted under Sec. 361.1 (21
CFR 361.1). Under Sec. 361.1, certain radioactive drugs (drugs that
exhibit spontaneous disintegration of unstable nuclei with the emission
of nuclear particles or photons) are considered generally recognized as
safe and effective under specified conditions of use when administered
to human research subjects for certain basic research uses. These uses
include studies intended to obtain basic information regarding the
metabolism (including pharmacokinetics, distribution, and localization)
of a radioactive drug or regarding human physiology, pathophysiology,
or biochemistry, but not studies intended for immediate therapeutic,
diagnostic, or similar purposes or studies intended to determine the
safety and effectiveness
[[Page 24492]]
of the drug. When conducted in accordance with Sec. 361.1, clinical
investigations of radioactive drugs are not subject to the requirements
for INDs stated in 21 CFR part 312.
To facilitate discussion at the public meeting and assist us in our
review of this matter, we invited comments on several questions we set
forth in the Federal Register notice concerning the application of
Sec. 361.1. Interested persons were invited to present information at
the public meeting and were given until January 16, 2005, to submit
comments on the notice.
We held the public meeting on November 16, 2004. Subsequent to the
public meeting, we received requests from the American College of
Nuclear Physicists, the Society of Nuclear Medicine, and others that we
extend the comment period on the notice on Sec. 361.1 so that persons
can consider the issues raised in the notice and at the public meeting
in light of the information in the draft guidance on exploratory INDs
that we expected to issue in the near future. We published a notice of
availability of that draft guidance in the Federal Register of April
14, 2005 (70 FR 19764).
In response to these requests, we have decided to reopen the
comment period on the questions and issues stated in the October 5,
2004, notice and discussed at the November 16, 2004, public meeting.
This will allow interested persons more time to review and comment on
these issues in light of the information in the draft guidance on
exploratory INDs.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper 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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Transcripts
You can examine a transcript of the November 16, 2004, public
meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
or at the Division of Dockets Management (see ADDRESSES), Monday
through Friday between 9 a.m. and 4 p.m. You may also request a copy of
the transcript from the Freedom of Information Office (HFI-35), Food
and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD
20857, at a cost of 10 cents per page or on CD at a cost of $14.25
each.
Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9326 Filed 5-9-05; 8:45 am]
BILLING CODE 4160-01-S