Proposed Information Collection Activity; Comment Request, 15735-15736 [E9-7705]
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15735
Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
Dated: April 1, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–7779 Filed 4–6–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Building Strong Families (BSF)
Demonstration and Evaluation Impact
Study Second Follow-up.
OMB No.: 0970–0304.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), anticipates continuing
data collection for the 15-month followup surveys of the Building Strong
Families (BSF) Demonstration and
Evaluation. Data collection will
continue for an additional 6 months
beyond the current date of expiration
(July 31, 2009).
BILLING CODE 4162–20–P
This data collection is a part of the
BSF evaluation, which is an important
opportunity to learn if well-designed
interventions can help low-income
couples develop the knowledge and
relationship skills that research has
shown are associated with healthy
marriages. The BSF evaluation uses an
experimental design that randomly
assigns couples who volunteer to
participate in BSF programs to a
program or control group.
Materials for the original 15-month
data collection effort, previously
submitted to OMB, covered impact and
implementation data collections. Data
collection for the impact study is
complete. ACF anticipates collecting
data for an additional 6 months in order
to complete data collection for the entire
sample of participants.
Respondents: Couples enrolled in the
BSF evaluation, including program and
control groups.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
15-month telephone survey (female partner) ..................................................
15-month telephone survey (male partner) .....................................................
Total Burden Hours: 2,495.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@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
Number of
responses per
respondent
1,434
1,434
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: March 30, 2009.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E9–7501 Filed 4–6–09; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
1
1
Average
burden hours
per response
.91
.83
Estimated
annual burden
hours
1,305
1,190
Title: Head Start Grant Application
and Budget Instruments.
OMB No.: 0970–0207.
Description: The Office of Head Start
is proposing to renew, without changes,
the Head Start Grant Application and
Budget Instrument, which standardizes
the grant application information that is
requested from all Head Start and Early
Head Start grantees applying for
continuation grants. The application
and budget forms are available in a
password-protected, Web-based system.
Completed applications can be
transmitted electronically to Regional
and Central Offices. The Administration
for Children and Families believes that
this application form makes the process
of applying for Head Start program
grants more efficient for applicants.
Respondents: Head Start and Early
Head Start grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
HS grant and budget instrument .....................................................................
Estimated Total Annual Burden Hours: ....................................................
1,600
........................
1
........................
33
........................
52,800
52,800
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15736
Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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. 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: April 1, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–7705 Filed 4–6–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
Food and Drug Administration
[Docket No. FDA–2009–N–0148]
Generic New Animal Drug User Fee
Rates and Payment Procedures for
Fiscal Year 2009
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2009 generic new animal drug
user fees. The Federal Food, Drug, and
Cosmetic Act (the act), as amended by
the Animal Generic Drug User Fee Act
of 2008 (AGDUFA), authorizes FDA to
collect user fees for certain abbreviated
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applications for a generic new animal
drug, on certain generic new animal
drug products, and on certain sponsors
of such abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs. This notice
establishes the fee rates for FY 2009.
For FY 2009, the generic new animal
drug user fee rates are: $41,400 for each
abbreviated application for a generic
new animal drug; $3,005 for each
generic new animal drug product;
$56,350 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $42,265 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $28,175
for a generic new animal drug sponsor
paying 50 percent of the sponsor fee.
AGDUFA required FDA to issue
invoices for FY 2009 product and
sponsor fees by December 31, 2008, or
within 30 days of enactment of an
appropriation for these fees, whichever
is later. The appropriations were
enacted on March 11, 2009. These fees
will be due and payable within 30 days
of the issuance of the invoices. The
application fee rates are effective for all
abbreviated applications for generic new
animal drugs submitted on or after July
1, 2008, and will remain in effect
through September 30, 2009.
FOR FURTHER INFORMATION CONTACT: Visit
the FDA Web site at https://www.fda.gov/
oc/adufa/agdufamain.html or contact
Bryan Walsh, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7529 Standish Pl.,
Rockville, MD 20855, 240–276–9730.
For general questions, you may also email the Center for Veterinary Medicine
(CVM) at: cvmagdufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Section 741 of the act (21 U.S.C. 379j–
21) 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 (21 U.S.C. 379j–21(a)). When
certain conditions are met, FDA will
waive or reduce fees for generic new
animal drugs intended solely to provide
for a minor use or minor species
indication (21 U.S.C. 379j–21(d)).
For FY 2009 through FY 2013, the act
establishes aggregate yearly base
revenue amounts for each of these fee
categories. Base revenue amounts
established for years after FY 2009 are
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subject to adjustment for workload. Fees
for applications, products, and sponsors
are to be established each year by FDA
so that the revenue for each fee category
will approximate the level established
in the statute, after the level has been
adjusted for workload.
II. Revenue Amount for FY 2009
A. Statutory Fee Revenue Amounts
AGDUFA (Title II of Public Law 110–
316, signed by the President on August
14, 2008) specifies that the aggregate
revenue amount for FY 2009 for
abbreviated application fees is
$1,449,000 and the other two generic
new animal drug user fee categories,
annual product fees and annual sponsor
fees, are $1,691,000 each, before any
adjustment for workload is made (see 21
U.S.C. 379j–21(b)).
B. Inflation Adjustment to Fee Revenue
Amount
The amounts established in AGDUFA
for each year for FY 2009 through FY
2013 include an inflation adjustment, so
no further inflation adjustment is
required.
C. Workload Adjustment Fee Revenue
Amount
For each FY beginning after FY 2009,
AGDUFA provides that statutory fee
revenue amounts shall be further
adjusted to reflect changes in review
workload (21 U.S.C. 379j–21(c)(1)). No
workload adjustment is to be made in
fee revenue amounts for FY 2009.
III. Abbreviated Application Fee
Calculations for FY 2009
The term ‘‘abbreviated application for
a generic new animal drug’’ is defined
in 21 U.S.C. 379j–21(k)(1).
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
The application fee must be paid for
abbreviated applications for generic new
animal drugs that are subject to fees
under AGDUFA and that are submitted
on or after July 1, 2008. The application
fees are to be set so that they will
generate $1,449,000 in fee revenue for
FY 2009. This is the amount set out in
the statute and no adjustments to it are
required for FY 2009.
To set fees for abbreviated
applications for generic new animal
drugs to realize $1,449,000, FDA must
first make some assumptions about the
number of fee-paying abbreviated
applications it will receive over the 15
months from July 1, 2008, through
September 30, 2009.
The agency knows the number of such
applications that have been submitted
in previous years. That number
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[Federal Register Volume 74, Number 65 (Tuesday, April 7, 2009)]
[Notices]
[Pages 15735-15736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7705]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Head Start Grant Application and Budget Instruments.
OMB No.: 0970-0207.
Description: The Office of Head Start is proposing to renew,
without changes, the Head Start Grant Application and Budget
Instrument, which standardizes the grant application information that
is requested from all Head Start and Early Head Start grantees applying
for continuation grants. The application and budget forms are available
in a password-protected, Web-based system. Completed applications can
be transmitted electronically to Regional and Central Offices. The
Administration for Children and Families believes that this application
form makes the process of applying for Head Start program grants more
efficient for applicants.
Respondents: Head Start and Early Head Start grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
HS grant and budget instrument.............. 1,600 1 33 52,800
Estimated Total Annual Burden Hours:.... ............... ............... ............... 52,800
----------------------------------------------------------------------------------------------------------------
[[Page 15736]]
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
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. 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: April 1, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9-7705 Filed 4-6-09; 8:45 am]
BILLING CODE 4184-01-P
