Proposed Information Collection Activity; Comment Request, 1694-1695 [2012-262]
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1694
ACTION:
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices
Notice
The Administration on Aging
(AoA) 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 information
collection requirements relating to State
Annual Long-Term Care Ombudsman
Report and Instructions for Older
Americans Act Title VII.
DATES: Submit written or electronic
comments on the collection of
information by March 12, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to:
louise.ryan@aoa.hhs.gov.
Submit written comments on the
collection of information to: U.S.
Department of Health and Human
Services: Administration on Aging,
Washington, DC 20201. Attention:
Louise Ryan.
FOR FURTHER INFORMATION CONTACT:
Louise Ryan by telephone: (202) 357–
3503 or by email:
louise.ryan@aoa.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, AoA is publishing notice
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, AoA invites comments
on: (1) Whether the proposed collection
of information is necessary for the
proper performance of AoA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
AoA’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.
Under section 712(c), and section
712(h) (1)-(3) of the Older Americans
Act, as amended, states are required to
provide information on ombudsmen
activities to AoA, which AoA is then
required to present to Congress. The
reporting system, the National
Ombudsman Reporting System (NORS),
was developed in response to these
directives and other needs pertaining to
the Long Term Care Ombudsman
Program and approved by the Office of
Management and Budget for use for the
first time in FY 1995–96; it was
extended a second time with slight
modifications for use in FY 1997–2001
and extended for the third time with no
change for use from FY 2002–2006. It
was extended, with modifications, a
fourth time for use from FY 2007–2008.
It was extended a fifth time with no
modifications. This current (sixth)
request is to extend, with no
modifications, use of the existing State
Annual Long-Term Care Ombudsman
Report (and Instructions) for use from
FY 2012–2014. The current form and
instructions are posted on the AoA Web
site at: https://www.aoa.gov/AoARoot/
AoA_Programs/Elder_Rights/
Ombudsman/index.aspx. AoA estimates
the burden of this collection of
information as follows: Approximately
one and one-half hour per respondent,
with 52 State Agencies on Aging
responding annually for a total of 78
hours.
Dated: January 6, 2012.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2012–323 Filed 1–10–12; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Head Start Health Managers
Descriptive Study.
OMB No.: New Collection.
Description
The Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing a data collection activity that
will provide descriptive data about the
Head Start Health Component. The
goals of the Head Start Health Manager
Descriptive Study are (1) to describe the
characteristics of Health Managers and
related staff in Head Start (HS) and
Early Head Start (EHS) programs; (2) to
identify the current landscape of health
programs and services being offered to
children and families; (3) to determine
how health initiatives are prioritized,
implemented, and sustained; and (4) to
identify the programmatic features and
policy levers that exist to support health
services including staffing,
environment, and community
collaboration. These objectives will be
accomplished through an online survey
of all HS/EHS Health Managers,
including American Indian/Alaskan
Native and Migrant and Seasonal Head
Start grantees. The survey responses
will be further informed by semistructured interviews conducted with a
subsample of Head Start Health
Managers, teachers, and family service
workers.
Respondents
The target respondents for this data
collection are Head Start Health
Managers at the grantee and delegate
level; however data will also be
collected from Head Start Directors,
Teachers, and Family Service Workers.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Head Start Health Managers Survey ...............................................................
Head Start Director Survey .............................................................................
VerDate Mar<15>2010
15:02 Jan 10, 2012
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Number of
responses per
respondent
2,879
2,879
E:\FR\FM\11JAN1.SGM
1
1
11JAN1
Average
burden
hours per
response
1.25
.25
Total
annual
burden
hours
3,599
720
1695
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Annual
number of
respondents
Instrument
Semi-structured interviews Head Start Health Managers ...............................
Semi-structured interviews Head Start Teachers and Family Service Workers ................................................................................................................
Estimated Total Annual Burden
Hours: 4394.
In compliance with the requirements
of Section 3506(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 Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@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: January 4, 2012.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012–262 Filed 1–10–12; 8:45 am]
pmangrum on DSK3VPTVN1PROD with NOTICES
BILLING CODE 4184–22–M
VerDate Mar<15>2010
15:02 Jan 10, 2012
Jkt 226001
.75
30
60
1
.75
45
[Docket Nos. FDA–2011–P–0743 and FDA–
2011–P–0822]
Determination That AVALIDE
(Hydrochlorothiazide and Irbesartan),
Oral Tablets, 25 Milligrams/300
Milligrams and 12.5 Milligrams/75
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
that AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 milligrams
(mg)/300 mg and 12.5 mg/75 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
hydrochlorothiazide and irbesartan, oral
tablets, 25 mg/300 mg and 12.5 mg/75
mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Jane
Inglese, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6210, Silver Spring,
MD 20993–0002, (301) 796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Total
annual
burden
hours
1
Food and Drug Administration
ACTION:
Average
burden
hours per
response
40
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg, are the subject of
NDA 20–758, held by Sanofi-Aventis,
and initially approved on September 30,
1997. AVALIDE is indicated for
treatment of hypertension in patients
whose blood pressure is not adequately
controlled on monotherapy. AVALIDE
is also indicated for initial therapy for
hypertension in patients who are likely
to need multiple drugs to achieve their
blood pressure goals.
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg are currently listed
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
EAS Consulting Group, LLC on behalf
of Aurobindo Pharmaceuticals, Ltd.
submitted a citizen petition dated
October 11, 2011 (Docket No. FDA–
2011–P–0743), under § 10.30 (21 CFR
10.30), requesting that the Agency
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Pages 1694-1695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-262]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Head Start Health Managers Descriptive Study.
OMB No.: New Collection.
Description
The Administration for Children and Families (ACF), U.S. Department
of Health and Human Services (HHS), is proposing a data collection
activity that will provide descriptive data about the Head Start Health
Component. The goals of the Head Start Health Manager Descriptive Study
are (1) to describe the characteristics of Health Managers and related
staff in Head Start (HS) and Early Head Start (EHS) programs; (2) to
identify the current landscape of health programs and services being
offered to children and families; (3) to determine how health
initiatives are prioritized, implemented, and sustained; and (4) to
identify the programmatic features and policy levers that exist to
support health services including staffing, environment, and community
collaboration. These objectives will be accomplished through an online
survey of all HS/EHS Health Managers, including American Indian/Alaskan
Native and Migrant and Seasonal Head Start grantees. The survey
responses will be further informed by semi-structured interviews
conducted with a subsample of Head Start Health Managers, teachers, and
family service workers.
Respondents
The target respondents for this data collection are Head Start
Health Managers at the grantee and delegate level; however data will
also be collected from Head Start Directors, Teachers, and Family
Service Workers.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Annual number responses per hours per Total annual
of respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Head Start Health Managers Survey............... 2,879 1 1.25 3,599
Head Start Director Survey...................... 2,879 1 .25 720
[[Page 1695]]
Semi-structured interviews Head Start Health 40 1 .75 30
Managers.......................................
Semi-structured interviews Head Start Teachers 60 1 .75 45
and Family Service Workers.....................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 4394.
In compliance with the requirements of Section 3506(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
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email
address: OPREinfocollection@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: January 4, 2012.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012-262 Filed 1-10-12; 8:45 am]
BILLING CODE 4184-22-M
