Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 9025-9026 [2011-3464]
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9025
Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices
substantially reduce the paperwork
burden associated with maintaining
FDA required records.
The respondents will be businesses
and other for-profit organizations, State
or local governments, Federal Agencies,
and nonprofit institutions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
11.100 ..................................................................................
4,500
1
4,500
1
4,500
Total ..............................................................................
........................
........................
........................
........................
4,500
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
Annual
frequency per
recordkeeping
11.10 ....................................................................................
11.30 ....................................................................................
11.50 ....................................................................................
11.300 ..................................................................................
2,500
2,500
4,500
4,500
1
1
1
1
2,500
2,500
4,500
4,500
20
20
20
20
50,000
50,000
90,000
90,000
Total ..............................................................................
........................
........................
........................
........................
280,000
21 CFR section
1 There
Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
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
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) 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
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:10 Feb 15, 2011
Jkt 223001
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 solicits comments on
the good laboratory practice (GLP) for
nonclinical laboratory studies
regulations.
Submit either electronic or
written comments on the collection of
information by April 18, 2011.
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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
DATES:
[FR Doc. 2011–3465 Filed 2–15–11; 8:45 am]
ACTION:
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Governmentwide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
AGENCY:
Total annual
records
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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, 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
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.
E:\FR\FM\16FEN1.SGM
16FEN1
9026
Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices
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
for these studies and to provide an
adequate degree of consumer protection,
the Agency issued GLP regulations. 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.
The GLP regulations contain
requirements for the reporting of 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 contain recordkeeping
requirements relating to the conduct of
safety studies. Such records include:
(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.
The information collected under GLP
regulations is generally gathered by
testing facilities routinely engaged in
conducting toxicological studies and is
used as part of an application for a
research or marketing permit that is
voluntarily submitted to FDA by
persons desiring to market new
products. The facilities that collect this
information are typically operated by
large entities, e.g., contract laboratories,
sponsors of FDA-regulated products,
universities, or government agencies.
Failure to include the information in a
filing to FDA would mean that Agency
scientific experts could not make a valid
determination of product safety. FDA
receives, reviews, and approves
hundreds of new product applications
each year based on information
received. The recordkeeping
requirements are necessary to document
the proper conduct of a safety study, to
assure the quality and integrity of the
resulting final report, and to provide
adequate proof of the safety of regulated
products. FDA conducts onsite audits of
records and reports during its
inspections of testing laboratories to
verify reliability of results submitted in
applications.
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 REPORTING BURDEN 1
Number of
respondents
21 CFR section
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
58.35(b)(7) .................................................................
58.185 ........................................................................
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 section
Annual
frequency per
recordkeeping
Total annual
records
Hours per
record
Total hours
58.29(b) ......................................................................
58.35(b)(1)–(b)(6) and (c) ..........................................
58.63(b) and (c) .........................................................
58.81(a)–(c) ................................................................
58.90(c) and (g) .........................................................
58.105(a) and (b) .......................................................
58.107(d) ....................................................................
58.113(a) ....................................................................
58.120 ........................................................................
58.195 ........................................................................
300
300
300
300
300
300
300
300
300
300
20
270.76
60
301.8
62.7
5
1
15.33
15.38
251.5
6,000
81,228
18,000
90,540
18,810
1,500
300
4,599
4,614
75,450
0.21
3.36
0.09
0.14
0.13
11.8
4.25
6.8
32.7
3.9
1,260
272,926
1,620
12,676
2,445
17,700
1,275
31,273
150,878
294,255
Total ....................................................................
..........................
..........................
..........................
..........................
786,308
mstockstill on DSKH9S0YB1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Governmentwide,
electronic docket management system.
VerDate Mar<15>2010
17:10 Feb 15, 2011
Jkt 223001
Electronic submissions will be accepted
by FDA through FDMS only.
PO 00000
Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3464 Filed 2–15–11; 8:45 am]
BILLING CODE 4160–01–P
Frm 00031
Fmt 4703
Sfmt 9990
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9025-9026]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3464]
-----------------------------------------------------------------------
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) 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 solicits comments on the good laboratory practice
(GLP) for nonclinical laboratory studies regulations.
DATES: Submit either electronic or written comments on the collection
of information by April 18, 2011.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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, 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
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.
[[Page 9026]]
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 for these studies and to provide an adequate degree of
consumer protection, the Agency issued GLP regulations. 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.
The GLP regulations contain requirements for the reporting of 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 contain recordkeeping requirements
relating to the conduct of safety studies. Such records include: (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.
The information collected under GLP regulations is generally
gathered by testing facilities routinely engaged in conducting
toxicological studies and is used as part of an application for a
research or marketing permit that is voluntarily submitted to FDA by
persons desiring to market new products. The facilities that collect
this information are typically operated by large entities, e.g.,
contract laboratories, sponsors of FDA-regulated products,
universities, or government agencies. Failure to include the
information in a filing to FDA would mean that Agency scientific
experts could not make a valid determination of product safety. FDA
receives, reviews, and approves hundreds of new product applications
each year based on information received. The recordkeeping requirements
are necessary to document the proper conduct of a safety study, to
assure the quality and integrity of the resulting final report, and to
provide adequate proof of the safety of regulated products. FDA
conducts onsite audits of records and reports during its inspections of
testing laboratories to verify reliability of results submitted in
applications.
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 Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.35(b)(7)........................................................ 300 60.25 18,075 1 18,075
58.185............................................................. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b)........................................................... 300 20 6,000 0.21 1,260
58.35(b)(1)-(b)(6) and (c)......................................... 300 270.76 81,228 3.36 272,926
58.63(b) and (c)................................................... 300 60 18,000 0.09 1,620
58.81(a)-(c)....................................................... 300 301.8 90,540 0.14 12,676
58.90(c) and (g)................................................... 300 62.7 18,810 0.13 2,445
58.105(a) and (b).................................................. 300 5 1,500 11.8 17,700
58.107(d).......................................................... 300 1 300 4.25 1,275
58.113(a).......................................................... 300 15.33 4,599 6.8 31,273
58.120............................................................. 300 15.38 4,614 32.7 150,878
58.195............................................................. 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.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a
Governmentwide, electronic docket management system. Electronic
submissions will be accepted by FDA through FDMS only.
Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3464 Filed 2-15-11; 8:45 am]
BILLING CODE 4160-01-P
