Notice2023-05357
Agency Information Collection Activities; Proposed Collection; 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
March 16, 2023
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
<html>
<head>
<title>Federal Register, Volume 88 Issue 51 (Thursday, March 16, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16272-16274]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05357]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <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 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:
<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>.
[[Page 16273]]
<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 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 <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: 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,
<a href="/cdn-cgi/l/email-protection#431311021037222525032527226d2b2b306d242c35"><span class="__cf_email__" data-cfemail="c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0">[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, 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 <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
[[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping (in Total hours
recordkeepers recordkeeper records hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 16, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.