Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice for Nonclinical Laboratory Studies, 77219-77220 [2020-26502]
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Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
Finally, the National Adult Protective
Services Association (NAPSA)
conducted a survey of State APS
programs in 2012, and the National
Association of State Units on Aging and
Disability (NASUAD) fielded a survey to
its members, which are not APS
programs, in January 2018 intended to
update findings from the NAPSA 2012
survey. Since the survey replicates the
original NAPSA survey, the questions in
it are not focused on APS practice and
are not directed at the same respondents
as the proposed survey. As noted, a few
topics in the original survey overlap
with the proposed instrument, but the
wording and focus of the few questions
on similar topics are different. From this
analysis, we conclude the proposed APS
Practice Survey will yield vital
information on APS practice not
available from other sources.
Proposed Collection Efforts
The APS Practice Survey will collect
state- and territory-specific practices for
states between July and September
2017. Following their pretest of the
survey instrument, pilot respondents
participated in focus groups in which
they provided recommendations on data
collection procedures, views on the
availability of data being requested, and
estimates of the burden to each state and
territory for completion of the survey. It
is assumed that nearly every state and
territory will participate and that time to
develop a response will be similar to the
experience of states during the pilot test.
ACL has calculated the following
burden estimates based on the results of
the survey pilot test.
To review and comment on the
proposed data collection, please visit
the ACL public input site at https://
www.acl.gov/about-acl/public-input.
Estimated Program Burden
ACL estimates the annual burden
associated with this collection of
information as follows:
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
APS Practice Survey .......................................................................................
56
1
3.50
196
Estimated Total Annual Burden
Hours: 196.
Submit written comments
(including recommendations) on the
collection of information by December
31, 2020.
DATES:
Dated: November 25, 2020.
Lance Robertson,
Administrator and Assistant Secretary for
Aging.
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1671]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice for Nonclinical Laboratory
Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or 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.
SUMMARY:
VerDate Sep<11>2014
18:11 Nov 30, 2020
Jkt 253001
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.
ADDRESSES:
[FR Doc. 2020–26514 Filed 11–30–20; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES4
all aspects of APS casework practice,
including staffing, intake, investigation,
service planning and delivery, and
quality assurance. Across these areas,
the survey will collect information on
practices such as community
partnerships and use of assessment
tools.
The APS Practice Survey will be
administered online using
SurveyMonkey or a similar commercial
survey-programming tool. The online
survey will include data validation
routines to minimize errors or
unintentional omissions and will
include appropriate skip patterns to
reduce burden. Respondents will be
state and territory APS agencies,
including APS agencies in the District of
Columbia, Puerto Rico, Guam, Northern
Marianas Islands, Virgin Islands, and
American Samoa. No personally
identifiable information will be
collected.
A pilot version of The APS Practice
Survey was tested in nine (9) diverse
77219
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Good Laboratory Practice 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,
E:\FR\FM\01DEN1.SGM
01DEN1
77220
Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
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.
In the Federal Register of July 24,
2020 (85 FR 44900), FDA published a
60-day notice requesting public
comment on the proposed collection of
information.
One comment was received that
encouraged implementation of
automated collection methods and
analytical software to evaluate results.
FDA appreciates this comment and
continually seek ways to employ
efficient collection methods using our
limited resources. The comment
suggested no revision to our burden
estimate.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR part
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
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 BURDEN 1
Number of
recordkeepers
21 CFR part
Average
burden per
recordkeeping
Total annual
records
Total hours
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 ............................................
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
Total ...........................................................................
........................
........................
........................
...........................
786,308
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, FDA has made no
adjustments to our burden estimate.
Dated: November 24, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
khammond on DSKJM1Z7X2PROD with NOTICES4
Number of
records per
recordkeeper
[FR Doc. 2020–26502 Filed 11–30–20; 8:45 am]
BILLING CODE 4164–01–P
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2019–N–1845]
Fixed-Quantity Unit-of-Use Blister
Packaging for Certain ImmediateRelease Opioid Analgesics for
Treatment of Acute Pain;
Establishment of a Public Docket;
Request for Comments; Reopening of
the Comment Period and Provision of
Additional Information and Analysis
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:11 Nov 30, 2020
Jkt 253001
Notice; reopening of the
comment period.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for and
providing additional information and
analysis regarding the notice entitled
‘‘Fixed-Quantity Unit-of-Use Blister
Packaging for Certain ImmediateRelease Opioid Analgesics for
Treatment of Acute Pain; Establishment
of a Public Docket; Request for
Comments’’ that appeared in the
Federal Register of May 31, 2019. The
Agency is taking this action to provide
additional information and to allow
E:\FR\FM\01DEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Pages 77219-77220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26502]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1671]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice for Nonclinical Laboratory Studies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or 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 31, 2020.
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 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,
[[Page 77220]]
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.
In the Federal Register of July 24, 2020 (85 FR 44900), FDA
published a 60-day notice requesting public comment on the proposed
collection of information.
One comment was received that encouraged implementation of
automated collection methods and analytical software to evaluate
results. FDA appreciates this comment and continually seek ways to
employ efficient collection methods using our limited resources. The
comment suggested no revision to our burden estimate.
FDA estimates the burden of this information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
21 CFR part Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b); Personnel............................ 300 20 6,000 .21 (13 minutes)....................... 1,260
58.35(b)(1)-(6) and (c); Quality assurance unit 300 270.76 81,228 3.36................................... 272,926
58.63(b) and (c); Maintenance and calibration 300 60 18,000 .09 (5 minutes)........................ 1,620
of equipment.
58.81(a)-(c); SOPs............................. 300 301.80 90,540 .14 (8 minutes)........................ 12,676
58.90(c) and (g); Animal care.................. 300 62.70 18,810 .13 (8 minutes)........................ 2,445
58.105(a) and (b); Test and control article 300 5 1,500 11.8................................... 17,700
characterization.
58.107(d); Test and control article handling... 300 1 300 4.25................................... 1,275
58.113(a); Mixtures of articles with carriers.. 300 15.33 4,599 6.8.................................... 31,273
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.
Based on a review of the information collection since our last
request for OMB approval, FDA has made no adjustments to our burden
estimate.
Dated: November 24, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26502 Filed 11-30-20; 8:45 am]
BILLING CODE 4164-01-P
