[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39913-39914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14262]


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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: Submit written comments (including recommendations) on the 
collection of information by August 3, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to 
www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0053. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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--21 CFR 361.1

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. This information collection request supports those 
regulations. Specifically, Sec.  361.1 (21 CFR 361.1) sets forth 
specific regulations about establishing and composing radioactive drug 
research committees (RDRCs) and their role in approving and monitoring 
basic research studies using 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 regulations and 
include studies of metabolism, human physiology, pathophysiology, or 
biochemistry.
    Section 361.1(c)(2) requires that each RDRC will select a chairman, 
who will sign all applications, minutes, and reports of the committee. 
Each committee will meet at least once each quarter in which research 
activity has been authorized or conducted. Minutes will be kept and 
will include the numerical results of votes on protocols involving use 
in human subjects. Under Sec.  361.1(c)(3), each RDRC will submit an 
annual report to FDA. The annual report will include the names and 
qualifications of the members of and of any consultants used by the 
RDRC, using Form FDA 2914 entitled ``Radioactive Drug Research 
Committee Report on Research Use of Radioactive Drugs Membership 
Summary.'' The annual report will also include a summary of each study 
conducted during the preceding year, using Form

[[Page 39914]]

FDA 2915 entitled ``Radioactive Drug Research Committee Report on 
Research Use of Radioactive Drugs Study Summary.''
    Under Sec.  361.1(d)(5), each investigator will 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, based on a pregnancy test, be confirmed as not pregnant.
    Under Sec.  361.1(d)(8), the investigator will immediately report 
to the RDRC all adverse effects associated with use of the drug, and 
the committee will 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 the regulations 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 or 
chairpersons of each individual RDRC, investigators, and participants 
in the studies. The burden estimates are based on our experience with 
these reporting and recordkeeping requirements and the number of 
submissions we received under the regulations over the past 3 years.
    In the Federal Register of January 21, 2020 (85 FR 3390), we 
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\ \2\
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                                                                   Number of
      21 CFR section and applicable form           Number of     responses per   Total  annual        Average burden  per response          Total hours
                                                  respondents     respondent       responses
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Sec.   361.1(c)(3) reports and (c)(4) approval              62               1              62  1.......................................              62
 (Form FDA 2914: Membership Summary) \3\.
Sec.   361.1(c)(3) reports (Form FDA 2915:                  40              10             434  3.5.....................................           1,519
 Study Summary) \4\.
Sec.   361.1(d)(8) adverse events.............              10               1              10  .5 (30 minutes).........................               5
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............             506  ........................................           1,586
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.
\3\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
\4\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.


                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                                   Number of
                21 CFR section                     Number of      records per    Total  annual     Average  burden per  recordkeeping       Total hours
                                                 recordkeepers   recordkeepers     responses
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Sec.   361.1(c)(2) RDRC.......................              62               4             248  10......................................           2,480
Sec.   361.1(d)(5) human research subjects....              40              10             434  .75 (45 minutes)........................             326
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............             682  ........................................           2,806
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.

    We have adjusted our estimate for the information collection to 
reflect an annual decrease of 525 hours and 147 responses since last 
OMB review. This adjustment corresponds to fewer submissions we have 
received under the information collection over the last few years.

    Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14262 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P