Notice2026-07507
Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees
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Published
April 17, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements contained in regulations governing the use of radioactive drugs for basic informational research.
Full Text
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<title>Federal Register, Volume 91 Issue 74 (Friday, April 17, 2026)</title>
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[Federal Register Volume 91, Number 74 (Friday, April 17, 2026)]
[Notices]
[Pages 20659-20661]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07507]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-3099]
Agency Information Collection Activities; Proposed Collection;
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection requirements
contained in regulations governing the use of radioactive drugs for
basic informational research.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 16, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 16, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for
[[Page 20660]]
information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-3099 for ``Radioactive Drug Research Committees.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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) 796-1244,
<a href="/cdn-cgi/l/email-protection#9ececcdfcdeafff8f8def8faffb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="59090b180a2d383f3f193f3d387731312a773e362f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Radioactive Drug Research Committees--21 CFR 361.1
OMB Control Number 0910-0053--Extension
This information collection request supports regulations 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. 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 must not 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 (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
FDA 2915 (Report on Research Use of Radioactive Drugs--Study Summary).
We developed a guidance for industry and researchers 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>. The guidance 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). The guidance 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 FDA-approved RDRC. All
Agency guidance documents are issued consistent with our good guidance
practice regulations at 21 CFR 10.115.
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.
[[Page 20661]]
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 in Sec. 361.1(a) 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 applicable statutes and regulations specified under 21
CFR 361.1 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.
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 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 55 1 55 1....................................... 55
(Form FDA 2914: Membership Summary) \2\.
Sec. 361.1(c)(3) reports (Form FDA 2915: 35 9 324 3.5..................................... 1,134
Study Summary) \3\.
Sec. 361.1(d)(8) adverse events............. 10 1 10 .5 (30 minutes)......................... 5
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Total..................................... .............. .............. 389 ........................................ 1,194
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ <a href="https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf">https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf</a>.
\3\ <a href="https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf">https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf</a>.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeepers records
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Sec. 361.1(c)(2) RDRC....................... 55 4 220 10...................................... 2,200
Sec. 361.1(d)(5) human research subjects.... 35 9 324 .75 (45 minutes)........................ 243
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Total..................................... .............. .............. 544 ........................................ 2,443
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall decrease of 52 hours and a corresponding decrease of 97
responses. This is attributed to the Agency receiving fewer submissions
over the last few years due to decreased subject enrollment during the
pandemic.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07507 Filed 4-16-26; 8:45 am]
BILLING CODE 4164-01-P
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