Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 57935-57936 [2014-22986]
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57935
Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices
amount for judicial review changes to
$1,464.80 based on the 46.480 percent
increase over the initial threshold
amount of $1,000. This amount was
rounded to the nearest multiple of $10,
resulting in the CY 2015 AIC threshold
amount of $1,460.00 for judicial review.
CY 2011
ALJ Hearing .............................................................................................
Judicial Review ........................................................................................
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
Dated: September 11, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
BILLING CODE 4120–01–P
$130
1,300
$130
1,350
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0540. The
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
[FR Doc. 2014–22981 Filed 9–25–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2007–N–0037]
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Animal Drug
User Fees and Fee Waivers and
Reductions
[Docket No. FDA–2011–N–0075]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry: Animal Drug
User Fees and Fee Waivers and
Reductions’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
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.
On July
08, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry: Animal
Drug User Fees and Fee Waivers and
Reductions’’ to OMB for review and
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:14 Sep 25, 2014
Food and Drug Administration,
HHS.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice Regulations for Nonclinical
Studies
AGENCY:
Notice.
Jkt 232001
ACTION:
Notice.
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
(PRA).
DATES: Fax written comments on the
collection of information by October 27,
2014.
ADDRESSES: 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
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
In the following table we list the CYs
2011 through 2015 threshold amounts.
CY 2012
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22625 Filed 9–25–14; 8:45 am]
C. Summary Table of Adjustments in
the AIC Threshold Amounts
CY 2013
$140
1,400
CY 2014
$140
1,430
CY 2015
$150
1,460
OMB control number 0910–0119. Also
include the FDA 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: 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 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, 360b, 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.
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
E:\FR\FM\26SEN1.SGM
26SEN1
57936
Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices
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 nonclincial
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 GLPs 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.
In the Federal Register of June 12,
2014 (79 FR 33755), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received. On its own initiative,
however, the Agency is now including
two burden tables rather than only the
one included in its 60-day notice. While
this does not change the Agency’s
burden estimate, FDA believes that
distinguishing between reporting
elements and recordkeeping elements
more clearly reflects the requirements
associated with this information
collection.
FDA estimates the burden of this
collection of information as follows:
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
60.25
18,075
1
18,075
300
60.25
18,075
27.65
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 Section
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
58.29(b); Personnel ...............................
58.35(b)(1)–(b)(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
20
6,000
0.21 (13 minutes)
1,260
300
270.76
81,228
3.36
272,926
300
300
300
60
301.8
62.7
18,000
90,540
18,810
.09 (5 minutes)
0.14 (8 minutes)
0.13 (8 minutes)
1,620
12,676
2,445
300
5
1,500
11.8
17,700
300
1
300
4.25
1,275
300
300
300
15.33
15.38
251.5
4,599
4,614
75,450
6.8
32.7
3.9
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.
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2014–22986 Filed 9–25–14; 8:45 am]
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19:14 Sep 25, 2014
Jkt 232001
PO 00000
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26SEN1
]]>Agencies
[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57935-57936]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22986]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0075]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice Regulations for Nonclinical Studies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (PRA).
DATES: Fax written comments on the collection of information by October
27, 2014.
ADDRESSES: 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 oirasubmission@omb.eop.gov.
All comments should be identified with the OMB control number 0910-
0119. Also include the FDA 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: 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 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, 360b, 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.
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
[[Page 57936]]
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 nonclincial
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 GLPs 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.
In the Federal Register of June 12, 2014 (79 FR 33755), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. On its own
initiative, however, the Agency is now including two burden tables
rather than only the one included in its 60-day notice. While this does
not change the Agency's burden estimate, FDA believes that
distinguishing between reporting elements and recordkeeping elements
more clearly reflects the requirements associated with this information
collection.
FDA estimates the burden of this collection of information as
follows:
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.35(b)(7); Quality assurance unit...................... 300 60.25 18,075 1 18,075
58.185; Reporting of nonclinical laboratory study results 300 60.25 18,075 27.65 499,774
----------------------------------------------------------------------------------------------
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 Number of records Total annual Average burden
21 CFR Section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b); Personnel...................................... 300 20 6,000 0.21 (13 minutes) 1,260
58.35(b)(1)-(b)(6) and (c); Quality assurance unit....... 300 270.76 81,228 3.36 272,926
58.63(b) and (c); Maintenance and calibration of 300 60 18,000 .09 (5 minutes) 1,620
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
58.195; Retention of records............................. 300 251.5 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.
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22986 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P
