[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16272-16274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0583]


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 May 15, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 15, 2023. 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.

[[Page 16273]]

     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:
     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.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0583 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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

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, section 
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 (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 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

[[Page 16274]]

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. 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.
    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.
    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 and FDA form              Number of     responses per   Total annual     Average burden per response (in hours)     Total hours
                                                 respondents     respondent       responses
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Sec.   361.1(c)(3) reports and (c)(4)                      56               1              56  1........................................              56
 approval (Form FDA 2914: Membership Summary)
 \2\.
Sec.   361.1(c)(3) reports (Form FDA 2915:                 37              10             370  3........................................           1,110
 Study Summary) \3\.
Sec.   361.1(d)(8) adverse events............              10               1              10  0.5 (30 minutes).........................               5
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............             436  .........................................           1,171
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
\3\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.


                                                   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  (in     Total hours
                                                recordkeepers   recordkeeper       records                       hours)
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Sec.   361.1(c)(2) RDRC......................              56               4             224  10.......................................           2,240
Sec.   361.1(d)(5) human research subjects...              37              10             370  0.75 (45 minutes)........................             278
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............             594  .........................................           2,518
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 \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have adjusted our estimate for the information collection to 
reflect an annual decrease of 703 hours and 158 responses since OMB's 
last approval. We attribute this adjustment to a decrease from 3.5 
hours to 3 hours per response for public reporting burden for Form FDA-
2915: Study Summary to match 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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05357 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P


