[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39913-39914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14262]
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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) 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 August 3, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to
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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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--21 CFR 361.1
OMB Control Number 0910-0053--Extension
Under sections 201, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to
issue regulations governing the use of radioactive drugs for basic
scientific research. This information collection request supports those
regulations. 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 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 entitled ``Radioactive Drug Research
Committee 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
[[Page 39914]]
FDA 2915 entitled ``Radioactive Drug Research Committee Report on
Research Use of Radioactive Drugs Study Summary.''
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.
In the Federal Register of January 21, 2020 (85 FR 3390), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
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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 62 1 62 1....................................... 62
(Form FDA 2914: Membership Summary) \3\.
Sec. 361.1(c)(3) reports (Form FDA 2915: 40 10 434 3.5..................................... 1,519
Study Summary) \4\.
Sec. 361.1(d)(8) adverse events............. 10 1 10 .5 (30 minutes)......................... 5
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Total..................................... .............. .............. 506 ........................................ 1,586
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.
\3\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
\4\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeepers responses
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Sec. 361.1(c)(2) RDRC....................... 62 4 248 10...................................... 2,480
Sec. 361.1(d)(5) human research subjects.... 40 10 434 .75 (45 minutes)........................ 326
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Total..................................... .............. .............. 682 ........................................ 2,806
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.
We have adjusted our estimate for the information collection to
reflect an annual decrease of 525 hours and 147 responses since last
OMB review. This adjustment corresponds to fewer submissions we have
received under the information collection over the last few years.
Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14262 Filed 7-1-20; 8:45 am]
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