Document ID: FDA-2010-N-0583-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Radioactive Drug
Research Committees
Posted Date: 2017-07-18T04:00Z

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32828-32829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15000]

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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 or we) 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 August 
17, 2017.

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: Jonnalynn Capezutto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
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 (RDRCs) 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.

[[Page 32829]]

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 and the number of submissions received 
by FDA under the regulations over the past 3 years.
    In the Federal Register of April 25, 2017 (82 FR 19052), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    We therefore estimate the burden of this collection of information 
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
     21 CFR Section/Form FDA         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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361.1(c)(3) (Reports) and (c)(4)              69               1              69               1              69
 (Approval); Form FDA 2914
 (Membership Summary)...........
361.1(c)(3) (Reports); Form FDA               35              14             490             3.5           1,715
 2915 (Study Summary)...........
361.1(c)(8) (Adverse Events)....              10               1              10           * 0.5               5
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    Total.......................  ..............  ..............             569  ..............           1,789
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
* 30 minutes.

                               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              14             490          * 0.75             368
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    Total.......................  ..............  ..............             766  ..............           3,128
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
* 45 minutes.

    Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15000 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P