Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 33755-33756 [2014-13787]
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Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014 / Notices
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters for Discussion: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to,’’ Health Promotion and Disease
Prevention Research Centers: Special Interest
Project Competitive Supplements DP14–011–
A, initial review.’’
Contact Person for More Information: M.
Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F–80, Atlanta, Georgia 30341,
Telephone: (770) 488–3585, EEO6@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Mailstop F–80, Atlanta, Georgia 30341,
Telephone: (770) 488–3585, EEO6@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2014–13662 Filed 6–11–14; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Good Laboratory
Practice Regulations for Nonclinical
Studies
BILLING CODE 4163–18–P
AGENCY:
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2014–13660 Filed 6–11–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0075]
Food and Drug Administration,
HHS.
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
rmajette on DSK7SPTVN1PROD with NOTICES
The meeting announced below
concerns Health Promotion and Disease
Prevention Research Centers: Special
Interest Project Competitive
Supplements DP14–011, initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 9:30 a.m.–6:00 p.m., July
8, 2014 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters for Discussion: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to, ‘‘Health Promotion and Disease
Prevention Research Centers: Special Interest
Project Competitive Supplements DP14–011,
initial review.’’
Contact Person for More Information: M.
Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
21:18 Jun 11, 2014
Jkt 232001
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the 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
invites comments on the information
collection provisions of FDA’s good
laboratory practice (GLP) regulations for
nonclinical laboratory studies.
DATES: Submit either electronic or
written comments on the collection of
information by August 11, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
Centers for Disease Control and
Prevention
VerDate Mar<15>2010
Notice.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
33755
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), 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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
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.
SUPPLEMENTARY INFORMATION:
Good Laboratory Practice Regulations
for Nonclinical 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, 360(b), 360(e)) 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
E:\FR\FM\12JNN1.SGM
12JNN1
33756
Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014 / Notices
for these studies and to provide an
adequate degree of consumer protection,
the Agency issued 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.
Part 58 requires testing facilities
engaged in conducting toxicological
studies to retain, and make available to
regulatory officials, records regarding
compliance with good laboratory
practices. 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.
Recordkeeping is necessary to
document the conduct of nonclinical
laboratory studies of FDA-regulated
products to ensure the quality and
integrity of the resulting final study
report on which a regulatory decision
may be based. Written SOPs and records
of actions taken are essential for testing
facilities to implement GLP’s effectively.
Further, they are essential for FDA to be
able to determine a testing facility’s
compliance with the GLP regulations in
part 58.
Description of Respondents: The
likely respondents collecting this
information are contract laboratories,
sponsors of FDA-regulated products,
universities, or government agencies.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Average burden
per
recordkeeping
Total annual
records
Total hours
58.29(b); Personnel ....................................................
58.35(b)(1)–(b)(6) and (c); Quality assurance ...........
58.35(b)(7); Quality assurance ...................................
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 .........................................................
58.185; Nonclinical laboratory study results ..............
58.195; Retention of records ......................................
300
300
300
300
20
270.76
60.25
60
6,000
81,228
18,075
18,000
0.21 (13 minutes)
3.36
1
0.09 (5 minutes)
1,260
279,926
18,075
1,620
300
300
300
301.8
62.7
5
90,540
18,810
1,500
0.14 (8 minutes)
0.13(8 minutes)
11.8
12,676
2,445
17,700
300
300
300
300
300
1
15.33
15.38
60.25
251.5
300
4,599
4,614
18,075
75,450
4.25
6.8
32.7
27.65
3.9
Total ....................................................................
........................
..........................
........................
1 There
ACTION:
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.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fax or email written comments
on the collection of information by July
14, 2014.
DATES:
Food and Drug Administration
[Docket No. FDA–2013–D–0984]
Food and Drug Administration,
VerDate Mar<15>2010
21:18 Jun 11, 2014
Jkt 232001
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0045. Also
include the FDA docket number found
ADDRESSES:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Specification of the Unique
Facility Identifier System for Drug
Establishment Registration
HHS.
in brackets in the heading of this
document.
Notice.
SUMMARY:
[FR Doc. 2014–13787 Filed 6–11–14; 8:45 am]
rmajette on DSK7SPTVN1PROD with NOTICES
1,311,157
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
1,275
31,273
150,878
499,774
294,255
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution (OMB Control Number
0910–0045)
In the Federal Register of September
6, 2013 (78 FR 54899), FDA announced
the availability of a draft guidance for
industry entitled ‘‘Specification of the
Unique Facility Identifier (UFI) System
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33755-33756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0075]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Good Laboratory Practice Regulations for Nonclinical
Studies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 invites comments on the information collection
provisions of FDA's good laboratory practice (GLP) regulations for
nonclinical laboratory studies.
DATES: Submit either electronic or written comments on the collection
of information by August 11, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
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.
Good Laboratory Practice Regulations for Nonclinical 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, 360(b), 360(e)) 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
[[Page 33756]]
for these studies and to provide an adequate degree of consumer
protection, the Agency issued 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.
Part 58 requires testing facilities engaged in conducting
toxicological studies to retain, and make available to regulatory
officials, records regarding compliance with good laboratory practices.
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.
Recordkeeping is necessary to document the conduct of nonclinical
laboratory studies of FDA-regulated products to ensure the quality and
integrity of the resulting final study report on which a regulatory
decision may be based. Written SOPs and records of actions taken are
essential for testing facilities to implement GLP's effectively.
Further, they are essential for FDA to be able to determine a testing
facility's compliance with the GLP regulations in part 58.
Description of Respondents: The likely respondents collecting this
information are contract laboratories, sponsors of FDA-regulated
products, universities, or government agencies.
FDA estimates the burden of this collection of information as
follows:
Table 1--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
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b); Personnel........................... 300 20 6,000 0.21 (13 minutes) 1,260
58.35(b)(1)-(b)(6) and (c); Quality assurance. 300 270.76 81,228 3.36 279,926
58.35(b)(7); Quality assurance................ 300 60.25 18,075 1 18,075
58.63(b) and (c); Maintenance and calibration 300 60 18,000 0.09 (5 minutes) 1,620
of equipment.
58.81(a)-(c); SOPs............................ 300 301.8 90,540 0.14 (8 minutes) 12,676
58.90(c) and (g); Animal care................. 300 62.7 18,810 0.13(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
58.185; Nonclinical laboratory study results.. 300 60.25 18,075 27.65 499,774
58.195; Retention of records.................. 300 251.5 75,450 3.9 294,255
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 1,311,157
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13787 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P
