Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 13240-13242 [E8-4903]
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Federal Register / Vol. 73, No. 49 / Wednesday, March 12, 2008 / Notices
specific injury research that focuses on
prevention and control.
Matters To Be Discussed: The meeting
will include the review, discussion, and
evaluation of individual research grant
and cooperative agreement applications
submitted in response to the Fiscal Year
2008 Funding Opportunity
Announcement (FOA) CE08–001: Youth
Violence Prevention Through
Community-Level Change.
Agenda items are subject to change as
priorities dictate.
FOR FURTHER INFORMATION CONTACT: J.
Felix Rogers, Ph.D., M.P.H., Telephone
(770) 488–4334, NCIPC/ERPO, CDC,
4770 Buford Highway, NE., M/S F62,
Atlanta, GA 30341.
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 CDC and
the Agency for Toxic Substances and
Disease Registry.
Dated: March 6, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–4945 Filed 3–11–08; 8:45 am]
BILLING CODE 4163–18–P
Matters To Be Discussed: The meeting
will include the review, discussion, and
evaluation of ‘‘NIOSH Education and
Research Center, PAR 06–485.’’
NIOSH determines that agency
business requires its consideration of
this matter on less than 15 days notice
to the public and that no earlier notice
of this meeting was possible.
FOR FURTHER INFORMATION CONTACT: M.
Chris Langub, PhD., Scientific Review
Officer, NIOSH, CDC, 2400 Century
Parkway, NE., Atlanta, GA 30345,
Telephone (404) 498–2543.
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 CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: March 6, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–4906 Filed 3–11–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2008–N–0154]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Good Laboratory
Practice Regulations for Nonclinical
Studies
Centers for Disease Control and
Prevention
pwalker on PROD1PC71 with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): National
Institute for Occupational Safety and
Health (NIOSH) Education and
Research Center, Program
Announcement for Research (PAR)
PAR06–485
AGENCY:
ACTION:
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: 1 p.m.–2 p.m., March
17, 2008 (Closed).
Place: NIOSH, 2400 Century Parkway,
NE., Atlanta, GA 30345, Telephone
(866) 649–6988.
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.
VerDate Aug<31>2005
19:30 Mar 11, 2008
Jkt 214001
Food and Drug Administration,
HHS.
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.
Submit written or electronic
comments on the collection of
information by May 12, 2008.
DATES:
PO 00000
Frm 00051
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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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12MRN1.SGM
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Federal Register / Vol. 73, No. 49 / Wednesday, March 12, 2008 / Notices
Good Laboratory Practice (GLP)
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 statues 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 humans 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 the 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 the
following information: (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 BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
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
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
300
58.35(b)(1) to (b)(6) and (c)
300
58.63(b) and (c)
300
58.81(a) to (c)
20
Total Annual
Records
Hours per
Record
Total Hours
6,000
.21
1,260
81,228
3.36
272,926
60
18,000
.09
1,620
300
301.8
90,540
.14
12,676
58.90(c) and (g)
300
62.7
18,810
.13
2,445
58.105(a) and (b)
300
5
1,500
58.107(d)
300
1
300
58.113(a)
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58.29(b)
Annual Frequency
per Recordkeeping
300
15.33
58.120
300
15.38
58.195
300
270.76
251.5
11.8
4.25
1,275
4,599
6.8
31,273
4,614
32.7
150,878
75,450
3.9
294,255
Total
1There
17,700
786,308
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 73, No. 49 / Wednesday, March 12, 2008 / Notices
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: March 6, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–4903 Filed 3–11–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
pwalker on PROD1PC71 with NOTICES
Proposed Collection: Comment
Request; Revision of OMB No. 0925–
0002, exp. 10/31/08, ‘‘Ruth L.
Kirschstein NRSA Individual
Fellowship Application and Related
Forms’’
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Office of Extramural Research, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Ruth L.
Kirschstein NRSA Individual
Fellowship Application and Related
Forms. Type of Information Collection
Request: Revision of a currently
approved collection, OMB 0925–0002,
Expiration Date 10/31/08. Form
Numbers: PHS 416–1, 416–9, 416–5,
416–7, 6031, 6031–1. Need and Use of
Information Collection: The PHS 416–1
and 416–9 are used by individuals to
apply for direct research training
support. Awards are made to individual
applicants for specified training
proposals in biomedical and behavioral
research, selected as a result of a
national competition. The other related
forms (PHS 416–5, 416–7, 6031, 6031–
1) are used by these individuals to
activate, terminate, and provide for
payback of a National Research Service
Award. Frequency of response:
Applicants may submit applications for
published receipt dates. If awarded,
annual progress is reported and trainees
may be appointed or reappointed.
Affected Public: Individuals or
households; businesses or other forprofit; not-for-profit institutions; Federal
Government; and State, Local or Tribal
Governments. Type of Respondents:
Adult scientific trainees and
VerDate Aug<31>2005
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Jkt 214001
professionals. The annual reporting
burden is as follows: Estimated Number
of Respondents: 34,454; Estimated
Number of Responses per Respondent:
1; Average Burden Hours Per Response:
4.1; and Estimated Total Annual Burden
Hours Requested: 142,301. The
annualized cost to respondents is
estimated at: $4,980,535. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
For Further Information Contact: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Ms. Mikia Currie,
Division of Grants Policy, Office of
Policy for Extramural Research
Administration, NIH, Rockledge 1
Building, Room 3505, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number 301–435–
0941, or e-mail your request, including
your address to: curriem@od.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: March 3, 2008.
George Gardner,
Assistant Grants Policy Officer, OPERA, OER,
National Institutes of Health.
[FR Doc. E8–4871 Filed 3–11–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, AIDS SBIR
Biological Sciences.
Date: March 19–21, 2008.
Time: 6 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting)
Contact Person: Kenneth A. Roebuck, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Molecular
Mechanisms of Neuronal Development and
Regeneration.
Date: March 21, 2008.
Time: 4 p.m. to 7 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Lawrence Baizer, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152,
MSC 7850, Bethesda, MD 20892, (301) 435–
1257, baizerl@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel.
Member Conflicts: Cell Biology.
Date: April 8–9, 2008.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 73, Number 49 (Wednesday, March 12, 2008)]
[Notices]
[Pages 13240-13242]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0154]
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 written or electronic comments on the collection of
information by May 12, 2008.
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: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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 13241]]
Good Laboratory Practice (GLP) 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 statues
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 humans 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 the 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 the
following information: (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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.29(b) 300 20 6,000 .21 1,260
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 .09 1,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.81(a) to (c) 300 301.8 90,540 .14 12,676
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.90(c) and (g) 300 62.7 18,810 .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.
[[Page 13242]]
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: March 6, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4903 Filed 3-11-08; 8:45 am]
BILLING CODE 4160-01-S
