Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 41503-41504 [2011-17736]
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41503
Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
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, 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. 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,
[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.
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.
DATES: Fax written comments on the
collection of information by August 15,
2011.
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 e-mailed to
oira_submission@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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUMMARY:
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.
In the Federal Register of February
16, 2011 (76 FR 9025), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
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
wreier-aviles on DSKGBLS3C1PROD with NOTICES
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
58.29(b) ........................................................
VerDate Mar<15>2010
14:55 Jul 13, 2011
Jkt 223001
PO 00000
Number of records
per recordkeeper
300
Frm 00056
20
Fmt 4703
Sfmt 4703
Total annual
records
Average burden
per recordkeeping
6,000
E:\FR\FM\14JYN1.SGM
0.21
14JYN1
Total hours
1,260
41504
Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR Section
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
58.35(b)(1) to (b)(6) and (c) .........................
58.63(b) and (c) ...........................................
58.81(a) to (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
270.76
60
301.8
62.7
5
1
15.33
15.38
251.5
81,228
18,000
90,540
18,810
1,500
300
4,599
4,614
75,450
3.36
0.09
0.14
0.13
11.8
4.25
6.8
32.7
3.9
272,926
1,620
12,676
2,445
17,700
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.
Dated: July 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
[FR Doc. 2011–17736 Filed 7–13–11; 8:45 am]
BILLING CODE 4160–01–P
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Adverse Experience Reporting For
Licensed Biological Products; and
General Records—21 CFR Part 600
(OMB Control Number 0910–0308)—
Extension
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
AGENCY:
Food and Drug Administration,
HHS.
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.
DATES: Fax written comments on the
collection of information by August 15,
2011.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0308. Also
include the FDA docket number found
in brackets in the heading of this
document.
wreier-aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
VerDate Mar<15>2010
14:55 Jul 13, 2011
Jkt 223001
Under the Public Health Service Act
(42 U.S.C. 262), FDA may only approve
a biologics license application for a
biological product that is safe, pure, and
potent. When a biological product is
approved and enters the market, the
product is introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to insure its safe use. FDA
issued the Adverse Experience
Reporting (AER) requirements in part
600 (21 CFR part 600) to enable FDA to
take actions necessary for the protection
of the public health in response to
reports of adverse experiences related to
licensed biological products. The
primary purpose of FDA’s AER system
is to identify potentially serious safety
problems with licensed biological
products. Although premarket testing
discloses a general safety profile of a
biological product’s comparatively
common adverse effects, the larger and
more diverse patient populations
exposed to the licensed biological
product provides the opportunity to
collect information on rare, latent, and
long-term effects. In addition,
production and/or distribution
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
problems have contaminated biological
products in the past. AER reports are
obtained from a variety of sources,
including manufacturers, patients,
physicians, foreign regulatory Agencies,
and clinical investigators. Identification
of new and unexpected safety issues
through the analysis of the data in the
AER system contributes directly to
increased public health protection. For
example, evaluation of these safety
issues enables FDA to take focused
regulatory action. Such action may
include, but is not limited to, important
changes to the product’s labeling (such
as adding a new warning), coordination
with manufacturers to ensure adequate
corrective action is taken, and removal
of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed
manufacturers or any person whose
name appears on the label of a licensed
biological product to report each
adverse experience that is both serious
and unexpected, whether foreign or
domestic, as soon as possible but in no
case later than 15 calendar days of
initial receipt of the information by the
licensed manufacturer. These reports
are known as postmarketing 15-day alert
reports. This section also requires
licensed manufacturers to submit any
followup reports within 15 calendar
days of receipt of new information or as
requested by FDA, and if additional
information is not obtainable to
maintain records of the unsuccessful
steps taken to seek additional
information. In addition, this section
requires a person who submits an
adverse action report to the licensed
manufacturer rather than FDA to
maintain a record of this action. Section
600.80(e) requires licensed
manufacturers to submit a 15-day alert
report for an adverse experience
obtained from a postmarketing clinical
study only if the licensed manufacturer
concludes that there is a reasonable
possibility that the product caused the
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41503-41504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17736]
[[Page 41503]]
-----------------------------------------------------------------------
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.
DATES: Fax written comments on the collection of information by August
15, 2011.
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 e-mailed to oira_submission@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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
Juanmanuel.vilela@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, 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. 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.
In the Federal Register of February 16, 2011 (76 FR 9025), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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)................................................. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
21 CFR Section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b).................................................... 300 20 6,000 0.21 1,260
[[Page 41504]]
58.35(b)(1) to (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) to (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.
Dated: July 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17736 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P
