Submission for OMB Review; Comment Request, 27802-27803 [E9-13728]
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27802
Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: June 8, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–13684 Filed 6–10–09; 8:45 am]
BILLING CODE 4184–01–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
[Docket No. FDA–2008–N–0572]
Implementation of the Animal Generic
Drug User Fee Act of 2008; User Fee
Cover Sheet Form FDA 3728—21 U.S.C.
379j-21 (OMB Control Number 0910–
0632)—Extension
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Implementation of
the Animal Generic Drug User Fee Act
of 2008; User Fee Cover Sheet Form
FDA 3728
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
(the PRA).
DATES: Fax written comments on the
collection of information by July 13,
2009.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0632. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
This collection of information is
currently approved under the
emergency processing provisions of the
PRA for 180 days. FDA is now seeking
a 3-year clearance.
Section 741 of the act (21 U.S.C. 379j21), establishes three different kinds of
user fees: (1) Fees for certain types of
abbreviated applications for generic new
animal drugs, (2) annual fees for certain
generic new animal drug products, and
(3) annual fees for certain sponsors of
abbreviated applications for generic new
animal drugs and/or investigational
submissions for generic new animal
drugs. Because the submission of user
fees concurrently with applications is
required, the review of an application
cannot begin until the fee is submitted.
Form FDA 3728, the Animal Generic
Drug User Fee Cover Sheet, is designed
to provide the minimum necessary
information in order to do the following:
(1) Determine whether a fee is required
for review of an application, (2)
determine the amount of fee required,
and (3) account for and track user fees.
In the Federal Register of March 11,
2009 (74 FR 10596), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 U.S.C.
379j-21
Form FDA
3728
jlentini on PROD1PC65 with NOTICES
1 There
Annual Frequency per
Response
No. of Respondents
20
Total Annual Responses
2
Hours per Response
40
Total Hours
.08
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are generic animal drug
applicants. Based on FDA’s database
system, there are an estimated 20
sponsors of new animal drugs
potentially subject to the Animal
Generic Drug User Fee Act of 2008.
Dated: June 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–13716 Filed 6–10–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
Submission for OMB Review;
Comment Request
Administration for Children and
Families
Title: Performance Progress Report.
OMB No.: 0970–0334.
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16:37 Jun 10, 2009
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27803
Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
Description: The Performance
Progress Report (SF–PPR) is a set of
uniform reporting formats used for
standard reporting on performance
under grants and cooperative
agreements.
In addition to allowing for uniformity
of information collection, these formats
will support systematic electronic
collection and submission of
information. These formats will provide
interim and final performance progress
information as required by OMB
Circulars A–102 and 2 CFR part 215.
The SF–PPR consists of a cover page
and six optional formats. The cover page
contains identifying data elements and
a section for a performance narrative.
Use of the cover page is required, and
programs may require their respondents
to submit only this page and/or attach
a performance narrative. Alternatively,
programs may opt to require the cover
page and one or more of the six optional
formats: Performance Measures,
Program Indicators, Benchmark
Evaluations, Table of Activity Results,
Activity-Based Expenditures, and
Program/Project Management
The SF–PPR has been successfully
piloted at the Administration for
Children and Families (ACF). All
discretionary programs (starting with
FY09 awards) are to submit the SF–PPR
to the ACF Office of Grants
Management. Program offices with
expiring data collections are required to
migrate to the SF–PPR format.
Additionally, a number of program
offices have voluntarily migrated their
collections to the SF–PPR format in
anticipation of government-wide
standardization. ACF, with its Online
Data Collection tool (OLDC), has
provided program offices with the
capability to collect SF–PPR data
electronically.
ACF and the Grants Center of
Excellence (CoE) is sponsoring this
collection on behalf of the Grants Policy
Committee, other Federal grant-making
agencies, and the CoE partners.
CoE Partners are defined as:
Corporation for National and
Community Service,
Denali Commission,
Department of State,
DHHS/Administration on Aging,
DHHS/Centers for Medicare Services,
DHHS/Health Research and Services
Administration,
DHHS/Indian Health Services,
DHHS/Office of Public Health Services,
DOT/Federal Air Administration,
DOT/Federal Highway Administration,
DOT/Federal Motor Carrier Safety
Administration,
DOT/Federal Railroad Administration,
DOT/Federal Transport Administration,
DOT/Pipeline and Hazardous Materials
Safety Administration,
Environmental Protection Agency,
Institute of Museum and Library
Services,
Social Security Administration,
Department of Treasury,
USDA/Food Safety and Inspection
Service,
Veterans Administration.
The revised burden estimates are
based on grant projects and awards for
ACF and its CoE partners for FY2008 as
reported by internal ACF reporting
systems and USASpending.gov.
Respondents: Federal government
grantees
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
jlentini on PROD1PC65 with NOTICES
Performance Progress Report (SF–PPR) .....................................................
Cover Page Continuation (SF–PPR–2) .........................................................
Performance Measures (SF–PPR–A) ............................................................
Program Indicators (SF–PPR–B) ..................................................................
Benchmark Evaluations (SF–PPR–C) ...........................................................
Table of Activity Results (SF–PPR–D) ..........................................................
Activity Based Expenditures (SF–PPR–E) ....................................................
Program/Project Management (SF–PPR–F) .................................................
Estimated Total Annual Burden
Hours: 86,808.18
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
VerDate Nov<24>2008
16:37 Jun 10, 2009
Jkt 217001
Dated: June 8, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–13728 Filed 6–10–09; 8:45 am]
PO 00000
Average burden
hours per
response
1
1
1
1
1
1
1
1
0.42
0.33
0.75
3
1.50
0.75
0.33
0.50
131,281
86
430
8,961
248
4,238
2,616
45
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7245,
Attn: Desk Officer for the
Administration for Children and
Families.
BILLING CODE 4184–01–P
Number of
responses per
respondent
Total burden
hours
55,138.02
28.38
322.50
26,883
372
3,178.50
863.28
22.50
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0260]
Draft Guidance for Industry: Questions
and Answers Regarding the
Reportable Food Registry as
Established by the Food and Drug
Administration Amendments Act of
2007; Availability; Announcement of
Further Delay in Implementation of the
Food and Drug Administration
Amendments Act of 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Guidance for Industry: Questions and
Frm 00037
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Agencies
[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27802-27803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13728]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Performance Progress Report.
OMB No.: 0970-0334.
[[Page 27803]]
Description: The Performance Progress Report (SF-PPR) is a set of
uniform reporting formats used for standard reporting on performance
under grants and cooperative agreements.
In addition to allowing for uniformity of information collection,
these formats will support systematic electronic collection and
submission of information. These formats will provide interim and final
performance progress information as required by OMB Circulars A-102 and
2 CFR part 215.
The SF-PPR consists of a cover page and six optional formats. The
cover page contains identifying data elements and a section for a
performance narrative. Use of the cover page is required, and programs
may require their respondents to submit only this page and/or attach a
performance narrative. Alternatively, programs may opt to require the
cover page and one or more of the six optional formats: Performance
Measures, Program Indicators, Benchmark Evaluations, Table of Activity
Results, Activity-Based Expenditures, and Program/Project Management
The SF-PPR has been successfully piloted at the Administration for
Children and Families (ACF). All discretionary programs (starting with
FY09 awards) are to submit the SF-PPR to the ACF Office of Grants
Management. Program offices with expiring data collections are required
to migrate to the SF-PPR format. Additionally, a number of program
offices have voluntarily migrated their collections to the SF-PPR
format in anticipation of government-wide standardization. ACF, with
its Online Data Collection tool (OLDC), has provided program offices
with the capability to collect SF-PPR data electronically.
ACF and the Grants Center of Excellence (CoE) is sponsoring this
collection on behalf of the Grants Policy Committee, other Federal
grant-making agencies, and the CoE partners.
CoE Partners are defined as:
Corporation for National and Community Service,
Denali Commission,
Department of State,
DHHS/Administration on Aging,
DHHS/Centers for Medicare Services,
DHHS/Health Research and Services Administration,
DHHS/Indian Health Services,
DHHS/Office of Public Health Services,
DOT/Federal Air Administration,
DOT/Federal Highway Administration,
DOT/Federal Motor Carrier Safety Administration,
DOT/Federal Railroad Administration,
DOT/Federal Transport Administration,
DOT/Pipeline and Hazardous Materials Safety Administration,
Environmental Protection Agency,
Institute of Museum and Library Services,
Social Security Administration,
Department of Treasury,
USDA/Food Safety and Inspection Service,
Veterans Administration.
The revised burden estimates are based on grant projects and awards
for ACF and its CoE partners for FY2008 as reported by internal ACF
reporting systems and USASpending.gov.
Respondents: Federal government grantees
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Performance Progress Report (SF-PPR)............ 131,281 1 0.42 55,138.02
Cover Page Continuation (SF-PPR-2).............. 86 1 0.33 28.38
Performance Measures (SF-PPR-A)................. 430 1 0.75 322.50
Program Indicators (SF-PPR-B)................... 8,961 1 3 26,883
Benchmark Evaluations (SF-PPR-C)................ 248 1 1.50 372
Table of Activity Results (SF-PPR-D)............ 4,238 1 0.75 3,178.50
Activity Based Expenditures (SF-PPR-E).......... 2,616 1 0.33 863.28
Program/Project Management (SF-PPR-F)........... 45 1 0.50 22.50
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 86,808.18
Additional Information:
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Administration,
Office of Information Services, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests
should be identified by the title of the information collection. E-mail
address: infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Fax: 202-395-7245,
Attn: Desk Officer for the Administration for Children and Families.
Dated: June 8, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9-13728 Filed 6-10-09; 8:45 am]
BILLING CODE 4184-01-P