[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Proposed Rules]
[Pages 24491-24492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9326]


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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://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. 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://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://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://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: [email protected].

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://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