Notice2023-17154
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 153 (Thursday, August 10, 2023)</title>
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54324-54326]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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, <a href="/cdn-cgi/l/email-protection#97c7c5d6c4e3f6f1f1d7f1f3f6b9ffffe4b9f0f8e1"><span class="__cf_email__" data-cfemail="712123302205101717311715105f1919025f161e07">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/73820/download">https://www.fda.gov/media/73820/download</a>; and Form FDA 2915, entitled, ``Report
on Research Use of Radioactive Drugs: Study Summary,'' available at
<a href="https://www.fda.gov/media/71805/download">https://www.fda.gov/media/71805/download</a>.
We also developed the guidance document entitled, ``Radioactive
Drug Research Committee: Human Research Without An Investigational New
Drug Application'' (August 2010), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application</a>, 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
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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.
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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
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