Agency Information Collection Request; 60-Day Public Comment Request, 79489-79490 [E8-30743]
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Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices
divested, or that the manner of the
divestitures is not acceptable, the
parties must unwind the sale and divest
the assets within six months of the date
the Order becomes final to another
Commission-approved acquirer. If the
parties fail to divest within six months,
the Commission may appoint a trustee
to divest the Products.
The proposed remedy contains
several provisions to ensure that the
divestitures are successful. The Order
requires Teva and Barr to provide
transitional services to enable the
Commission-approved acquirers to
obtain all of the necessary approvals
from the FDA. These transitional
services include technology transfer
assistance to manufacture the Products
in substantially the same manner and
quality employed or achieved by Teva
or Barr. Most of the oral contraceptive
products had been divested to Teva
pursuant to a Commission Order in the
matter of Watson Pharmaceuticals, Inc./
Andrx Corporation, Docket No. C-4172
(October 31, 2006). This proposed D&O
does not relieve Watson of any of its
obligations pursuant to the Commission
Order issued in the above referenced
Watson/Andrx matter.
The Commission has appointed
William Rahe of Quantic Regulatory
Services, LLC (‘‘Quantic’’) to oversee the
asset transfer and to ensure Teva’s and
Barr’s compliance with all of the
provisions of the proposed Consent
Agreement. Mr. Rahe is a senior
consultant at Quantic and has several
years of experience in the
pharmaceutical industry. He is a highlyqualified expert on FDA regulatory
matters and currently advises Quantic
clients on achieving satisfactory
regulatory compliance and interfacing
with the FDA. In order to ensure that
the Commission remains informed
about the status of the proposed
divestitures and the transfers of assets,
the proposed Consent Agreement
requires Teva and Barr to file reports
with the Commission periodically until
the divestitures and transfers are
accomplished.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above e-mail address within 60
days.
Proposed Project: Ensuring That
Department of Health and Human
Services Funds Do Not Support
Coercive or Discriminatory Policies or
Practices in Violation of Federal Law—
OMB No. 0990–NEW—Office of the
Secretary.
Abstract: The proposed information
collection is contained in the Final Rule
entitled, ‘‘Ensuring That Department of
Health and Human Services Funds Do
Not Support Coercive or Discriminatory
Policies or Practices in Violation of
Federal Law.’’ The purpose of this
collection is to ensure, by requiring
written certification of compliance
similar to other, existing certifications
currently made by funding recipients
and applicants, that recipients of
Department funds are aware of and
comply with the legal obligations
imposed on them by the Church
Amendments (42 U.S.C. 300a–7), Public
Health Service Act section 245 (42
U.S.C. 238n) and the Weldon
Amendment (Consolidated
Appropriations Act, 2008, Pub. L. 110–
161 Div. G section 508(d), 121 Stat.
1844, 2209). We estimate the universe
and number of entities that would be
required to certify to be 571,947. The act
of certification consists of reviewing the
certification language, reviewing
relevant entity policies and procedures,
and reviewing files before signing.
Although some entities may need to
sign a certification statement more than
once, we assume that the entity will
only carefully review the language,
procedures and their files before signing
the initial statement each year.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E8–30831 Filed 12–24–08: 8:45 am]
BILLING CODE 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
AGENCY:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
dwashington3 on PROD1PC60 with NOTICES
Type of respondent
Hospitals (less than 100 beds) ........................................................................
Hospitals (less than 100 beds) ........................................................................
Hospitals (200–500 beds) ................................................................................
Hospitals (more than 500 beds) ......................................................................
Nursing Homes (less than 50 beds) ................................................................
Nursing Homes (50–99 beds) .........................................................................
Nursing Homes (99—199 beds) ......................................................................
Nursing Homes (more than 200 beds) ............................................................
Physicians Offices ...........................................................................................
Offices of Other Health Care Practitioners ......................................................
Outpatient Care Centers ..................................................................................
VerDate Aug<31>2005
15:57 Dec 24, 2008
Jkt 217001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
2403
1129
1160
244
2388
5819
6877
1037
234200
115378
26901
E:\FR\FM\29DEN1.SGM
1
1
1
1
1
1
1
1
1
1
1
29DEN1
Average
burden hours
per response
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
Total burden
hours
1202
565
580
122
1194
2910
3439
519
117100
57689
13451
79490
Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Number of
respondents
Type of respondent
Medical and Diagnostics Laboratories .............................................................
Home Health Care Services ............................................................................
Pharmacies (chain and independent) ..............................................................
Dental Schools .................................................................................................
Medical Schools (Allopathic) ............................................................................
Medical Schools (Osteopathic) ........................................................................
Nursing Schools (Licensed practical) ..............................................................
Nursing Schools (Baccalaureate) ....................................................................
Nursing Schools (Associate Degree) ...............................................................
Nursing Schools (Diploma) ..............................................................................
Occupational Therapy Schools ........................................................................
Optometry Schools ..........................................................................................
Pharmacy Schools ...........................................................................................
Podiatry Schools ..............................................................................................
Public Health Schools ......................................................................................
Residency Programs (accredited) ...................................................................
Health Insurance Carriers and 3rd party Administrators .................................
Grant awards ...................................................................................................
Contractors ......................................................................................................
State and territorial governments ....................................................................
Totals ........................................................................................................
Seleda M. Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E8–30743 Filed 12–24–08; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–09–09AI]
dwashington3 on PROD1PC60 with NOTICES
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to Maryam I. Daneshvar, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS D–74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
Comments are invited 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
VerDate Aug<31>2005
13:19 Dec 24, 2008
Jkt 217001
11856
20184
58109
56
125
20
1138
550
885
78
142
17
92
7
37
8494
4578
63741
4245
57
571947
proposed collection of information; (c)
ways to enhance 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Evaluation of the Action Plan for the
National Public Health Initiative on
Diabetes and Women’s Health—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Approximately 24 million Americans
have diabetes, and more than 9 million
of these individuals are women. It is
projected that from 2000 to 2025,
women will represent more than half of
all cases of diabetes in the United
States.
Diabetes can have unique and
profound effects on women’s lives and
health. For instance, diabetes is a more
common cause of coronary heart disease
among women than men. In addition,
among people with diabetes, the
prognosis of heart disease is worse for
women than men, with women having
poorer quality of life and lower survival
rates. The burden of diabetes for women
is also unique because the disease can
affect mothers and their unborn
children. After pregnancy, as many as
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
........................
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
........................
Total burden
hours
5928
10092
29055
28
63
10
569
275
443
39
71
9
46
4
19
4247
2289
31871
2123
29
285981
10–50% of women with gestational
diabetes mellitus (GDM) are diagnosed
with type 2 diabetes within five years of
delivery. The offspring of women with
a history of gestational diabetes are also
at risk for becoming obese during
childhood or adolescence, which may
increase their risk of developing type 2
diabetes later in life.
To address the burden of diabetes on
women’s health, the National Public
Health Initiative on Diabetes and
Women’s Health (‘‘The Initiative’’) was
established to provide support and
resources for the creation and
implementation of a national public
health Action Plan. The Initiative is cosponsored by the American Diabetes
Association (ADA), the American
Association of Diabetes Educators
(AADE), the American Public Health
Association (APHA), the Association of
State and Territorial Health Officials
(ASTHO), and the Centers for Disease
Control and Prevention (CDC). CDC’s
Division of Diabetes Translation is
dedicated to the prevention and control
of diabetes, and to reducing or
eliminating health disparities through
targeted research, programs, and
partnerships.
The Initiative’s Action Plan identifies
gaps in diabetes-related research and
programmatic activities, and strategic
objectives, within the areas of: (1)
Community health; (2) diabetes state
programs; (3) education and community
outreach; (4) quality of care; (5)
research; and (6) surveillance. Cosponsors of the Initiative and other
partner organizations have been
encouraged to act on the deficiencies
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Notices]
[Pages 79489-79490]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30743]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed information collection request for public
comment. Interested persons are invited to send comments regarding this
burden estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above e-mail
address within 60 days.
Proposed Project: Ensuring That Department of Health and Human
Services Funds Do Not Support Coercive or Discriminatory Policies or
Practices in Violation of Federal Law--OMB No. 0990-NEW--Office of the
Secretary.
Abstract: The proposed information collection is contained in the
Final Rule entitled, ``Ensuring That Department of Health and Human
Services Funds Do Not Support Coercive or Discriminatory Policies or
Practices in Violation of Federal Law.'' The purpose of this collection
is to ensure, by requiring written certification of compliance similar
to other, existing certifications currently made by funding recipients
and applicants, that recipients of Department funds are aware of and
comply with the legal obligations imposed on them by the Church
Amendments (42 U.S.C. 300a-7), Public Health Service Act section 245
(42 U.S.C. 238n) and the Weldon Amendment (Consolidated Appropriations
Act, 2008, Pub. L. 110-161 Div. G section 508(d), 121 Stat. 1844,
2209). We estimate the universe and number of entities that would be
required to certify to be 571,947. The act of certification consists of
reviewing the certification language, reviewing relevant entity
policies and procedures, and reviewing files before signing. Although
some entities may need to sign a certification statement more than
once, we assume that the entity will only carefully review the
language, procedures and their files before signing the initial
statement each year.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average
Type of respondent Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Hospitals (less than 100 beds).................. 2403 1 30/60 1202
Hospitals (less than 100 beds).................. 1129 1 30/60 565
Hospitals (200-500 beds)........................ 1160 1 30/60 580
Hospitals (more than 500 beds).................. 244 1 30/60 122
Nursing Homes (less than 50 beds)............... 2388 1 30/60 1194
Nursing Homes (50-99 beds)...................... 5819 1 30/60 2910
Nursing Homes (99--199 beds).................... 6877 1 30/60 3439
Nursing Homes (more than 200 beds).............. 1037 1 30/60 519
Physicians Offices.............................. 234200 1 30/60 117100
Offices of Other Health Care Practitioners...... 115378 1 30/60 57689
Outpatient Care Centers......................... 26901 1 30/60 13451
[[Page 79490]]
Medical and Diagnostics Laboratories............ 11856 1 30/60 5928
Home Health Care Services....................... 20184 1 30/60 10092
Pharmacies (chain and independent).............. 58109 1 30/60 29055
Dental Schools.................................. 56 1 30/60 28
Medical Schools (Allopathic).................... 125 1 30/60 63
Medical Schools (Osteopathic)................... 20 1 30/60 10
Nursing Schools (Licensed practical)............ 1138 1 30/60 569
Nursing Schools (Baccalaureate)................. 550 1 30/60 275
Nursing Schools (Associate Degree).............. 885 1 30/60 443
Nursing Schools (Diploma)....................... 78 1 30/60 39
Occupational Therapy Schools.................... 142 1 30/60 71
Optometry Schools............................... 17 1 30/60 9
Pharmacy Schools................................ 92 1 30/60 46
Podiatry Schools................................ 7 1 30/60 4
Public Health Schools........................... 37 1 30/60 19
Residency Programs (accredited)................. 8494 1 30/60 4247
Health Insurance Carriers and 3rd party 4578 1 30/60 2289
Administrators.................................
Grant awards.................................... 63741 1 30/60 31871
Contractors..................................... 4245 1 30/60 2123
State and territorial governments............... 57 1 30/60 29
Totals...................................... 571947 .............. .............. 285981
----------------------------------------------------------------------------------------------------------------
Seleda M. Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. E8-30743 Filed 12-24-08; 8:45 am]
BILLING CODE 4150-28-P
