Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies, 82906-82907 [2023-26044]
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Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average burden per
response
Total hours
Focus groups ...........................................................
Customer comment cards/forms ..............................
Small discussion groups ..........................................
Customer satisfaction surveys .................................
Usability studies .......................................................
3,000
1,500
800
20,000
1,100
1
1
1
1
1
3,000
1,500
800
20,000
1,100
1.75 ...........................
0.25 (15 minutes) ......
1.75 ...........................
0.33 (20 minutes) ......
1 ................................
5,250
375
1,400
6,600
1,100
Total ..................................................................
........................
........................
........................
....................................
14,725
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we increased the
number of respondents for focus groups,
customer comment cards/forms,
customer satisfaction surveys, and
usability studies. This adjustment
results in an overall burden increase of
6,234 hours.
by using the search function. The OMB
control number for this information
collection is 0910–0119. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2023–26043 Filed 11–24–23; 8:45 am]
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, PRAStaff@
fda.hhs.gov.
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Good Laboratory Practice
Requirements for Nonclinical
Laboratory Studies—21 CFR Part 58
[Docket No. FDA–2023–N–2894]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice Requirements for Nonclinical
Laboratory Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Notice.
SUMMARY: The Food and Drug
Administration (FDA, we, or the
Agency) 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 December
27, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
VerDate Sep<11>2014
17:43 Nov 24, 2023
Jkt 262001
OMB Control Number 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
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
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.
In the Federal Register of August 8,
2023 (88 FR 53492), we published a 60day notice soliciting comment on the
proposed collection of information. One
comment was received underscoring the
critical nature of language translations
in information exchange between
international communities but did not
suggest any modifications to our burden
estimates.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\27NON1.SGM
27NON1
82907
Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses
per
respondent
Total
annual
responses
Average
burden
per response
Total
hours
§ 58.35(b)(7); Quality assurance unit ...................................
§ 58.185; Reporting of nonclinical laboratory study results
300
300
60.25
60.25
18,075
18,075
1
27.65
18,075
499,774
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 BURDEN1
Number of
recordkeepers
21 CFR section
§ 58.29(b); Personnel ..................................................
§ 58.35(b)(1)–(6), and (c); Quality assurance unit ......
§ 58.63(b) and (c); Maintenance and calibration of
equipment.
§ 58.81(a)–(c); SOPs ...................................................
§ 58.90(c) and (g); Animal care ...................................
§ 58.105(a) and (b); Test and control article characterization.
§ 58.107(d); Test and control article handling .............
§ 58.113(a); Mixtures of articles with carriers .............
§ 58.120; Protocol ........................................................
§ 58.195; Retention of records ....................................
Total ......................................................................
1 There
Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26044 Filed 11–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Declaration Under the Public
Readiness and Emergency
Preparedness Act for
Countermeasures Against Ebolavirus
and/or Ebola Disease and
Marburgvirus and/or Marburg Disease
khammond on DSKJM1Z7X2PROD with NOTICES
Total
annual
records
Average
burden
per recordkeeping
Total
hours
300
300
300
20
270.76
60
6,000
81,228
18,000
.21 (13 minutes) .....
3.36 ........................
.09 (5 minutes) ......
1,260
272,926
1,620
300
300
300
301.80
62.70
5
90,540
18,810
1,500
.14 (8 minutes) ......
.13 (8 minutes) ......
11.8 ........................
12,676
2,445
17,700
300
300
300
300
1
15.33
15.38
251.50
300
4,599
4,614
75,450
4.25 ........................
6.8 ..........................
32.7 ........................
3.9 ..........................
1,275
31,273
150,878
294,255
........................
........................
........................
................................
786,308
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
ACTION:
Number of
records per
recordkeeper
Notice of amendment.
SUMMARY: The Secretary issues this
amendment pursuant to section 319F–3
of the Public Health Service Act to
amend the Declaration for
Countermeasures against Marburgvirus
and/or Marburg Disease to cover both
VerDate Sep<11>2014
17:43 Nov 24, 2023
Jkt 262001
Ebolaviruses and Marburgviruses and
republishes the declaration, as
amended. The amended republished
Declaration clarifies that the disease
threat includes Ebolaviruses and
Marburgviruses, updates the title of the
Declaration, expands the Covered
Countermeasures, and extends the
effective time period.
DATES: The amendment is effective as of
January 1, 2024.
FOR FURTHER INFORMATION CONTACT: L.
Paige Ezernack, Office of the Assistant
Secretary for Preparedness and
Response, Office of the Secretary, U.S.
Department of Health and Human
Services, 200 Independence Avenue
SW, Washington, DC 20201; 202–260–
0365, PREPAct@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes
the Secretary of the U.S. Department of
Health and Human Services (the HHS
Secretary) to issue a Declaration to
provide liability immunity to certain
individuals and entities (Covered
Persons) against any claim of loss
caused by, arising out of, relating to, or
resulting from the manufacture,
distribution, administration, or use of
medical countermeasures (Covered
Countermeasures), except for claims
involving ‘‘willful misconduct’’ as
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
defined in the PREP Act. Under the
PREP Act, a Declaration may be
amended as circumstances warrant.
The PREP Act was enacted on
December 30, 2005, as Public Law 109–
148, Division C, 2. It amended the
Public Health Service (PHS) Act, adding
section 319F–3, which addresses
liability immunity, and section 319F–4,
which creates a compensation program.
These sections are codified at 42 U.S.C.
247d–6d and 42 U.S.C. 247d–6e,
respectively. Section 319F–3 of the PHS
Act has been amended by the Pandemic
and All-Hazards Preparedness
Reauthorization Act (PAHPRA), Public
Law 113–5, enacted on March 13, 2013,
and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public
Law 116–136, enacted on March 27,
2020, to expand Covered
Countermeasures under the PREP Act.
The PREP Act Declaration for
Countermeasures Against Marburgvirus
and/or Marburg Disease was first issued
effective November 25, 2020. (85 FR
79198 (December 9, 2020)). The PREP
Act Declaration for Ebola Virus Disease
Vaccines was first issued December 3,
2014 (79 FR 73315 (Dec.10, 2014)), and
amended December 3, 2015 (80 FR
76541 (Dec. 9, 2015)), December 3, 2016
(81 FR 89471 (Dec. 12, 2016)), and
December 1, 2018 (84 FR 764 (Jan. 31,
2019)). The Declaration for Ebola Virus
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82906-82907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26044]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2894]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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, we, or the Agency) 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 December 27, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://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 0910-0119. Also include the FDA docket
number found in brackets in the heading of this document.
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,
[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.
Good Laboratory Practice Requirements for Nonclinical Laboratory
Studies--21 CFR Part 58
OMB Control Number 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.
In the Federal Register of August 8, 2023 (88 FR 53492), we
published a 60-day notice soliciting comment on the proposed collection
of information. One comment was received underscoring the critical
nature of language translations in information exchange between
international communities but did not suggest any modifications to our
burden estimates.
We estimate the burden of this collection of information as
follows:
[[Page 82907]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sec. 58.35(b)(7); Quality 300 60.25 18,075 1 18,075
assurance unit.................
Sec. 58.185; Reporting of 300 60.25 18,075 27.65 499,774
nonclinical laboratory 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
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 58.29(b); Personnel................... 300 20 6,000 .21 (13 minutes)......................... 1,260
Sec. 58.35(b)(1)-(6), and (c); Quality 300 270.76 81,228 3.36..................................... 272,926
assurance unit.
Sec. 58.63(b) and (c); Maintenance and 300 60 18,000 .09 (5 minutes).......................... 1,620
calibration of equipment.
Sec. 58.81(a)-(c); SOPs.................... 300 301.80 90,540 .14 (8 minutes).......................... 12,676
Sec. 58.90(c) and (g); Animal care......... 300 62.70 18,810 .13 (8 minutes).......................... 2,445
Sec. 58.105(a) and (b); Test and control 300 5 1,500 11.8..................................... 17,700
article characterization.
Sec. 58.107(d); Test and control article 300 1 300 4.25..................................... 1,275
handling.
Sec. 58.113(a); Mixtures of articles with 300 15.33 4,599 6.8...................................... 31,273
carriers.
Sec. 58.120; Protocol...................... 300 15.38 4,614 32.7..................................... 150,878
Sec. 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.
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: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26044 Filed 11-24-23; 8:45 am]
BILLING CODE 4164-01-P
