Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions, 75175-75176 [2010-30264]
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75175
Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices
defined by Section 510(b) of the Social
Security Act (42 U.S.C. 710(b)) with a
focus on those groups that are most
likely to bear children out-of-wedlock,
such as youth in or aging out of foster
care.
States are encouraged to develop
flexible, medically accurate and
effective abstinence-based plans
responsive to their specific needs. These
plans must provide abstinence
education, and at the option of the State,
where appropriate, mentoring,
counseling, and adult supervision to
promote abstinence from sexual activity,
with a focus on those groups which are
most likely to bear children out-ofwedlock. An expected outcome for all
programs is to promote abstinence from
sexual activity.
OMB approval is requested to solicit
comments from the public on
paperwork reduction as it relates to
ACYF’s receipt of the following
documents from applicants and
awardees:
Application for Mandatory Formula
Grant
State Plan
Performance Progress Report
Respondents: 50 States and 9
Territories, to include, District of
Columbia, Puerto Rico, Virgin Islands,
Guam, American Samoa, Northern
Mariana Islands, the Federated States of
Micronesia, the Marshall Islands and
Palau.
ANNUAL BURDEN ESTIMATES
Application, to include program narrative ................................
Post-Award State Plan ............................................................
Performance Progress Reports ...............................................
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Estimated Total Annual Burden
Hours: 7,316
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: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–30272 Filed 12–1–10; 8:45 am]
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Number of
responses per
respondent
Number of
respondents
Instrument
59
59
59
1
1
2
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0182]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUMMARY:
In the
Federal Register of June 18, 2010 (75 FR
34746), the Agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
SUPPLEMENTARY INFORMATION:
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Average burden
hours
per response
Total burden
hours
24
40
30
1,416
2,360
3,540
OMB control number 0910–0354. The
approval expires on November 30, 2013.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: November 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30277 Filed 12–1–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0603]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fees and Fee Waivers and Reductions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
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 reporting requirements for the
SUMMARY:
E:\FR\FM\02DEN1.SGM
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75176
Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices
animal drug user fees and fee waivers
and reductions.
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 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:
Johnny 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: 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.
Animal Drug User Fees and Fee
Waivers and Reductions—(OMB
Control Number 0910–0540—Extension)
Enacted on November 18, 2003, the
Animal Drug User Fee Act (ADUFA)
(Pub. L. 108–130) amended the Federal
Food, Drug, and Cosmetic Act and
requires FDA to assess and collect user
fees for certain applications, products,
establishments, and sponsors. It also
requires the Agency to grant a waiver
from, or a reduction of those fees in
certain circumstances. Thus, to
implement this statutory provision of
ADUFA, FDA developed a guidance
entitled ‘‘Guidance for Industry: Animal
Drug User Fees and Fee Waivers and
Reductions.’’ It provides guidance on the
types of fees FDA is authorized to
collect under ADUFA, and on how to
request waivers and reductions from
FDA’s animal drug user fees. The
guidance also describes the types of fees
and fee waivers and reductions, the
information FDA recommends
respondents submit in support of a
request for a fee waiver or reduction,
how respondents may submit such a
request, and FDA’s process for
reviewing requests.
Respondents to this collection of
information are new animal drug
sponsors. Requests for waivers or
reductions may be submitted by a
person paying any of the animal drug
user fees assessed—application fees,
product fees, establishment fees, or
sponsor fees.
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
740(d)(1)(A) Significant barrier to innovation ......................
740(d)(1)(B) Fees exceed cost ...........................................
740(d)(1)(C) Free choice feeds ..........................................
740(d)(1)(D) Minor use or minor species ...........................
740(d)(1)(E) Small business ...............................................
Request for reconsideration of a decision ...........................
Request for review—(user fee appeal officer) .....................
22
0
2
52
0
5
2
1
1
1
1
1
1
1
22
0
2
52
0
5
2
2
2
2
2
0
2
2
44
0
4
104
0
10
4
Total ..............................................................................
........................
........................
........................
........................
166
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system,
there are an estimated 250 sponsors of
products subject to ADUFA. However,
not all sponsors will have any
submissions in a given year and some
may have multiple submissions. The
total number of waiver requests is based
on the number of submission types
received by FDA in fiscal year 2008.
Dated: November 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30264 Filed 12–1–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
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Gastrointestinal Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
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]]>Agencies
[Federal Register Volume 75, Number 231 (Thursday, December 2, 2010)]
[Notices]
[Pages 75175-75176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0603]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Drug User Fees and Fee Waivers and Reductions
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 reporting requirements for
the
[[Page 75176]]
animal drug user fees and fee waivers and reductions.
DATES: Submit either electronic or written comments on the collection
of information by January 31, 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: Johnny 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: 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.
Animal Drug User Fees and Fee Waivers and Reductions--(OMB Control
Number 0910-0540--Extension)
Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA)
(Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act and
requires FDA to assess and collect user fees for certain applications,
products, establishments, and sponsors. It also requires the Agency to
grant a waiver from, or a reduction of those fees in certain
circumstances. Thus, to implement this statutory provision of ADUFA,
FDA developed a guidance entitled ``Guidance for Industry: Animal Drug
User Fees and Fee Waivers and Reductions.'' It provides guidance on the
types of fees FDA is authorized to collect under ADUFA, and on how to
request waivers and reductions from FDA's animal drug user fees. The
guidance also describes the types of fees and fee waivers and
reductions, the information FDA recommends respondents submit in
support of a request for a fee waiver or reduction, how respondents may
submit such a request, and FDA's process for reviewing requests.
Respondents to this collection of information are new animal drug
sponsors. Requests for waivers or reductions may be submitted by a
person paying any of the animal drug user fees assessed--application
fees, product fees, establishment fees, or sponsor fees.
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
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A) Significant barrier 22 1 22 2 44
to innovation..................
740(d)(1)(B) Fees exceed cost... 0 1 0 2 0
740(d)(1)(C) Free choice feeds.. 2 1 2 2 4
740(d)(1)(D) Minor use or minor 52 1 52 2 104
species........................
740(d)(1)(E) Small business..... 0 1 0 0 0
Request for reconsideration of a 5 1 5 2 10
decision.......................
Request for review--(user fee 2 1 2 2 4
appeal officer)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 166
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on FDA's database system, there are an estimated 250 sponsors
of products subject to ADUFA. However, not all sponsors will have any
submissions in a given year and some may have multiple submissions. The
total number of waiver requests is based on the number of submission
types received by FDA in fiscal year 2008.
Dated: November 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30264 Filed 12-1-10; 8:45 am]
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