[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54324-54326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17154]


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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, Agency, 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: Submit written comments (including recommendations) on the 
collection of information by September 11, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three

[[Page 54325]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 240-994-7399, [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

OMB Control Number 0910-0053--Extension

    This information collection request supports the implementation of 
statutory and regulatory requirements and associated Agency forms. 
Sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321, 355, and 371) establish provisions under which FDA 
issues regulations governing the use of radioactive drugs for basic 
scientific research. 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, including 
reporting, recordkeeping, and labeling requirements. 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.
    To assist respondents with the applicable reporting requirements, 
we developed Form FDA 2914 entitled, ``Report on Research Use of 
Radioactive Drugs: Membership Summary,'' available at https://www.fda.gov/media/73820/download; and Form FDA 2915, entitled, ``Report 
on Research Use of Radioactive Drugs: Study Summary,'' available at 
https://www.fda.gov/media/71805/download.
    We also developed the guidance document entitled, ``Radioactive 
Drug Research Committee: Human Research Without An Investigational New 
Drug Application'' (August 2010), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application, which provides information to help determine whether 
research studies may be conducted under an FDA-approved RDRC, or 
whether research studies must be conducted under an investigational new 
drug application (IND). It also offers answers to frequently asked 
questions on conducting research with radioactive drugs, and provides 
information on the membership, functions, and reporting requirements of 
an RDRC approved by FDA. All Agency guidance documents are issued 
consistent with our good guidance practice regulations at 21 CFR 
10.115.
    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 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 or 
chairpersons of each individual RDRC, investigators, and participants 
in the studies.
    In the Federal Register of March 16, 2023 (88 FR 16272), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We 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; FDA form or activity          Number of      responses per     Total annual           Average burden per response           Total
                                                   respondents       respondent       responses                                                   hours
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Sec.   361.1(c)(3) reports and (c)(4) approval;               56                1               56  1..........................................       56
 Form FDA 2914 (Membership Summary).
Sec.   361.1(c)(3) reports; Form FDA 2915                     37               10              370  3..........................................    1,110
 (Study Summary).
Sec.   361.1(d)(8); adverse events.............               10                1               10  0.5 (30 mins)..............................        5
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...............  ...............  ...............  ...........................................    1,171
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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
          21 CFR section; and activity              Number of       records per      Total annual         Average burden per recordkeeping        Total
                                                  recordkeepers    recordkeepers       records                                                    Hours
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Sec.   361.1(c)(2); RDRC maintains meeting                    56            10.61              594  4.239......................................    2,518
 minutes involving use in human research
 subjects.
Sec.   361.1(d)(5); RDRC obtains consent of
 human research subjects.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...............  ...............  ...............  ...........................................    2,518
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 54326]]

    The burden attributed to recordkeeping activities is assumed to be 
distributed among the individual elements and averaged among 
respondents. In the burden estimate, we assume an average burden per 
record of 10 hours for the RDRC respondents to maintain meeting minutes 
and 0.75 hours (45 minutes) for a subset of the respondents (37 RDRCs) 
to obtain consent of human research subjects.
    Section 361.1(f) sets forth labeling requirements for radioactive 
drugs. These requirements are not in the 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)).
    Our estimated burden for the information collection reflects an 
overall decrease of 703 hours and a corresponding decrease of 158 
responses. We attribute this adjustment to a decrease in the average 
burden per response, from 3.5 hours to 3 hours per response, associated 
with the public reporting burden for Form FDA 2915. The decrease is 
based on our program experience and matches the burden hours reflected 
on the form. In addition, this adjustment is also attributable to the 
Agency receiving fewer submissions over the last few years.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17154 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P