
[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Pages 24442-24443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09773]



[[Page 24442]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 May 30, 
2014.

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 emailed 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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 (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 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.
    In the Federal Register of January 27, 2014 (79 FR 4348), 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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                                                    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                  69               1              69              1                69
 2914..........................
361.1(c)(3); Form FDA 2915.....              48              10             480              3.5           1,680
361.1(d)(8)....................              10               5              50          \2\ 0.5              25
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    Total......................  ..............  ..............  ..............  ...............           1,774
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.


[[Page 24443]]


                               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
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361.1(c)(2)....................              69               4             276           10             2,760
361.1(d)(5)....................              35              18             630        \2\ 0.75            472.5
                                --------------------------------------------------------------------------------
    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.
\2\ 45 minutes.


    Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09773 Filed 4-29-14; 8:45 am]
BILLING CODE 4160-01-P


