[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70329-70330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0337]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Radioactive Drug 
Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
10, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0053. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4816.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Radioactive Drug Research Committees--(OMB Control Number 0910-0053)--
Extension

    Under sections 201, 505, and 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to 
issue regulations governing the use of radioactive drugs for basic 
scientific research. Section 361.1 (21 CFR 361.1) sets forth specific 
regulations regarding the establishment and composition of Radioactive 
Drug Research Committees and their role in approving and monitoring 
basic research studies utilizing radiopharmaceuticals. No basic 
research study involving any administration of a radioactive drug to 
research subjects is permitted without the authorization of an FDA 
approved Radioactive Drug Research Committee (Sec.  361.1(d)(7)). The 
type of research that may be undertaken with a radiopharmaceutical drug 
must be intended to obtain basic information and not to carry out a 
clinical trial for safety or efficacy. The types of basic research 
permitted are specified in the regulation, and include studies of 
metabolism, human physiology, pathophysiology, or biochemistry.
    Section 361.1(c)(2) requires that each Radioactive Drug Research 
Committee shall select a chairman, who shall sign all applications, 
minutes, and reports of the committee. Each committee shall meet at 
least once each quarter in which research activity has been authorized 
or conducted. Minutes shall be kept and shall include the numerical 
results of votes on protocols involving use in human subjects. Under 
Sec.  361.1(c)(3), each Radioactive Drug Research Committee shall 
submit an annual report to FDA. The annual report shall include the 
names and qualifications of the members of, and of any consultants used 
by, the Radioactive Drug Research Committee, using FDA Form 2914, and a 
summary of each study conducted during the proceeding year, using FDA 
Form 2915.
    Under Sec.  361.1(d)(5), each investigator shall obtain the proper 
consent required

[[Page 70330]]

under the regulations. Each female research subject of childbearing 
potential must state in writing that she is not pregnant, or on the 
basis of a pregnancy test be confirmed as not pregnant.
    Under Sec.  361.1(d)(8), the investigator shall immediately report 
to the Radioactive Drug Research Committee all adverse effects 
associated with use of the drug, and the committee shall then report to 
FDA all adverse reactions probably attributed to the use of the 
radioactive drug.
    Section 361.1(f) sets forth labeling requirements for radioactive 
drugs. These requirements are not in the reporting burden estimate 
because they are information supplied by the Federal Government to the 
recipient for the purposes of disclosure to the public (5 CFR 
1320.3(c)(2)).
    Types of research studies not permitted under this regulation are 
also specified, and include those intended for immediate therapeutic, 
diagnostic, or similar purposes or to determine the safety or 
effectiveness of the drug in humans for such purposes (i.e., to carry 
out a clinical trial for safety or efficacy). These studies require 
filing of an investigational new drug application (IND) under 21 CFR 
part 312, and the associated information collections are covered in OMB 
control number 0910-0014.
    The primary purpose of this collection of information is to 
determine if the research studies are being conducted in accordance 
with required regulations and that human subject safety is assured. If 
these studies were not reviewed, human subjects could be subjected to 
inappropriate radiation or pharmacologic risks.
    Respondents to this information collection are the chairperson(s) 
of each individual Radioactive Drug Research Committee, investigators, 
and participants in the studies.
    The burden estimates are based on FDA's experience with these 
reporting and recordkeeping requirements over the past few years and 
the number of submissions received by FDA under the regulations.
    In the Federal Register of September 21, 2007 (72 FR 54044), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
            21 CFR Section                    Forms           Respondents        per Response        Responses           Response         Total Hours
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361.1(c)(3) and (c)(4)                           FDA 2914                 80                  1                 80                  1                 80
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361.1(c)(3)                                      FDA 2915                 50                6.8                340                3.5              1,190
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361.1(d)(8)                             .................                 50                6.8                340                0.1                 34
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Total Reporting                         .................  .................  .................  .................  .................              1,304
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                            No. of        Annual Frequency
           21 CFR Section               Recordkeepers    per Recordkeeping  Hours per  Record     Total Hours
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361.1(c)(2)                                          80                  4                 10                800
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361.1(d)(5)                                          50                6.8                .75                 38
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Total Recordkeeping                   .................  .................  .................                838
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23977 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S