Notice2023-16925
Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
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 8, 2023
Issuing agencies
Health and Human Services Department
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection applicable to the Good Laboratory Practice Requirements for Nonclinical Laboratory Studies established in Agency regulations.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 151 (Tuesday, August 8, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53492-53494]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16925]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2894]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Good Laboratory Practice Requirements for Nonclinical
Laboratory Studies
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 and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on information collection applicable to the Good
Laboratory Practice Requirements for Nonclinical Laboratory Studies
established in Agency regulations.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 10, 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 October 10, 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>.
<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-2023-N-2894 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Good Laboratory Practice
Requirements for Nonclinical Laboratory Studies.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#d686849785a2b7b0b096b0b2b7f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="623230233116030404220406034c0a0a114c050d14">[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 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
[[Page 53493]]
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.
Good Laboratory Practice Requirements for Nonclinical Laboratory
Studies--21 CFR Part 58
OMB Control No. 0910-0119--Extension
Sections 409, 505, 512, and 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348, 355, 360b, and 360e) and related statutes
require manufacturers of food additives, human drugs and biological
products, animal drugs, and medical devices to demonstrate the safety
and utility of their product by submitting applications to FDA for
research or marketing permits. Such applications contain, among other
important items, full reports of all studies done to demonstrate
product safety in man and/or other animals. In order to ensure adequate
quality control for these studies and to provide an adequate degree of
consumer protection, the Agency issued good laboratory practice (GLP)
regulations for nonclinical laboratory studies in part 58 (21 CFR part
58). The regulations specify minimum standards for the proper conduct
of safety testing and contain sections on facilities, personnel,
equipment, standard operating procedures (SOPs), test and control
articles, quality assurance, protocol and conduct of a safety study,
records and reports, and laboratory disqualification, and include
information collection provisions.
Part 58 requires testing facilities engaged in conducting
toxicological studies to retain, and make available to regulatory
officials, records regarding compliance with GLPs. Records are
maintained on file at each testing facility and examined there
periodically by FDA inspectors. The GLP regulations require that, for
each nonclinical laboratory study, a final report be prepared that
documents the results of quality assurance unit inspections, test and
control article characterization, testing of mixtures of test and
control articles with carriers, and an overall interpretation of
nonclinical laboratory studies. The GLP regulations also require
written records pertaining to: (1) personnel job descriptions and
summaries of training and experience; (2) master schedules, protocols
and amendments thereto, inspection reports, and SOPs; (3) equipment
inspection, maintenance, calibration, and testing records; (4)
documentation of feed and water analyses and animal treatments; (5)
test article accountability records; and (6) study documentation and
raw data.
Description of Respondents: Respondents to the collection of
information are sponsors of nonclinical laboratory studies that support
or are intended to support applications for research or marketing
permits for products regulated by FDA.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average
21 CFR part respondents per annual burden per Total hours
respondent responses response
----------------------------------------------------------------------------------------------------------------
58.35(b)(7); Quality assurance unit............ 300 60.25 18,075 1 18,075
58.185; Reporting of nonclinical laboratory 300 60.25 18,075 27.65 499,774
study results.................................
----------------------------------------------------------------
Total...................................... ........... ........... ........... ........... 517,849
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
58.29(b); Personnel........... 300 20 6,000 .21 (13 mins.).. 1,260
58.35(b)(1)-(6), and (c); 300 270.76 81,228 3.36............ 272,926
Quality assurance unit.
58.63(b) and (c); Maintenance 300 60 18,000 .09 (5 mins.)... 1,620
and calibration of equipment.
58.81(a)-(c); SOPs............ 300 301.80 90,540 .14 (8 mins.)... 12,676
58.90(c) and (g); Animal care. 300 62.70 18,810 .13 (8 mins.)... 2,445
58.105(a) and (b); Test and 300 5 1,500 11.8............ 17,700
control article
characterization.
58.107(d); Test and control 300 1 300 4.25............ 1,275
article handling.
58.113(a); Mixtures of 300 15.33 4,599 6.8............. 31,273
articles with carriers.
58.120; Protocol.............. 300 15.38 4,614 32.7............ 150,878
58.195; Retention of records.. 300 251.50 75,450 3.9............. 294,255
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 786,308
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 53494]]
Based on an evaluation of the information collection, we are
retaining the currently approved estimates. Our assumptions made
regarding the time needed for the respective activities is based on our
experience with the information collection and informal communications
with respondents.
Dated: August 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16925 Filed 8-7-23; 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 August 8, 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.