Document ID: FDA-2007-N-0383-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities: Proposed Collection;
Comment Request; Radioactive Drug Research Committees
Posted Date: 2014-01-27T05:00Z

[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Notices]
[Pages 4348-4350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01463]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0383]

Agency Information Collection Activities: Proposed Collection; 
Comment Request; Radioactive Drug Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 4349]]

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
contained in regulations governing the use of radioactive drugs for 
basic informational research.

DATES: Submit either electronic or written comments on the collection 
of information by March 28, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (RDRC) 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 RDRC (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 RDRC 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 RDRC 
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 RDRC, using Form FDA 2914, and a summary of each study 
conducted during the preceding year, using Form FDA 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 RDRC 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 RDRC, 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 4350]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
     21 CFR sections/forms         Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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361.1(c)(3)&(4); Form FDA 2914              69               1              69  1...............              69
361.1(c)(3); Form FDA 2915....              48              10             480  3.5.............           1,680
361.1(d)(8)...................              10               5              50  0.5 (30 minutes)              25
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,774
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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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                                                   Number of                     Average burden
        21 CFR section             Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
361.1(c)(2)...................              69               4             276  10..............           2,760
361.1(d)(5)...................              35              18             630  0.75............           472.5
                                                                                (45 minutes)....
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         3,232.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: January 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01463 Filed 1-24-14; 8:45 am]
BILLING CODE 4160-01-P