Document ID: FDA-2010-N-0583-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Radioactive Drug Research Committees
Posted Date: 2011-03-03T05:00Z

[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11786-11788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4741]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0583]

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 April 
4, 2011.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. 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: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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

[[Page 11787]]

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 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 whether 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 November 30, 2010 (75 FR 74059), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. 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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                                                                                                   Annual
                                                                                   Number of     frequency    Total annual    Hours per
                21 CFR section                              Forms                 respondents       per         responses      response     Total hours
                                                                                                  response
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361.1(c)(3) and (4)..........................  FDA 2914.......................              80          1                80          1                80
361.1(c)(3)..................................  FDA 2915.......................              50          6.8             340          3.5           1,190
361.1(d)(8)..................................  ...............................              50          6.8             340          0.1              34
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    Total....................................  ...............................  ..............  ...........  ..............  ...........           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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                                                              Annual                      Hours
             21 CFR section                  Number of    frequency per   Total annual     per      Total hours
                                           recordkeepers  recordkeeping      records     records
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361.1(c)(2).............................              80            4               320   10               3,200
361.1(d)(5).............................              50            6.8             340    0.75              255
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    Total...............................  ..............  .............  ..............  .......           3,455
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 11788]]

    Dated: February 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4741 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P