Announcement of Supplemental Funding for Cooperative Agreements to the New Mexico Department of Health, Office of Border Health; Arizona Department of Health Services, Office of Border Health; California Department of Public Health, Office of Binational Border Health; Texas Department of State Health Services, Office of Border Health to Improve the Health of Persons and Communities Along the U.S.-Mexico Border, 59402-59403 [2012-23722]
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59402
Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden hours
per response
Total burden
hours
Forms
Type of respondent
Civil Rights Complaint Form .......
3,493
1
45/60
2,620
Health Information Privacy Complaint Form.
Individuals or households, Not-for-profit
institutions.
Individuals or households, Not-for-profit
institutions.
10,286
1
45/60
7,715
Total .....................................
.................................................................
........................
........................
........................
10,335
Keith A. Tucker,
Information Collection Clearance Officer,
Department of Health and Human Services.
[FR Doc. 2012–23776 Filed 9–26–12; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Supplemental
Funding for Cooperative Agreements
to the New Mexico Department of
Health, Office of Border Health;
Arizona Department of Health
Services, Office of Border Health;
California Department of Public Health,
Office of Binational Border Health;
Texas Department of State Health
Services, Office of Border Health to
Improve the Health of Persons and
Communities Along the U.S.-Mexico
Border
Office of Global Affairs, Office
of the Secretary, DHHS.
Announcement Type: Cooperative
Agreement—FY 2012 Supplemental
Funding Announcement. Noncompetitive.
Catalog of Federal Domestic
Assistance: 93.018.
Projects Period: September 30, 2012—
August 31, 2013.
SUMMARY: The Office of Global Affairs
(OGA) announces that up to
$150,000.00 ($37,500.00 to each State)
in fiscal year (FY) 2012 funds are being
awarded for supplemental funding to
existing cooperative agreements to the
Department of Health Services of the
states of New Mexico, Arizona, Texas
and California, whom will work through
the U.S.–Mexico Border Health
Commission, to improve the health of
persons and communities along the
U.S.-Mexico border. This initiative
addresses Border Binational Health
Week; Prevention and Health Promotion
among Vulnerable Populations on the
U.S.-Mexico Border; U.S.-Mexico Border
Tuberculosis Consortium and Legal
Issues Forum; Border Binational Obesity
Prevention Summit; Border Health
Research Forum, Work Group and
Expert Panel Meeting; Healthy Border
erowe on DSK2VPTVN1PROD with
AGENCY:
VerDate Mar<15>2010
17:39 Sep 26, 2012
Jkt 226001
2010/2020 Strategic Plan; the Outreach
Office Planning Meeting, and
programmatic and administrative
support to the members and staff of the
U.S.-Mexico Border Health
Commissions. The budget period will be
one year with a project period of five
years for a total of $150,000.00
(including indirect costs).
I. Funding Opportunity Description
Under the authority of 22 U.S.C. 290n,
OGA announces the allocation of fiscal
year (FY) 2012 funds as supplemental
funding to already existing cooperative
agreements to the New Mexico
Department of Health, Office of Border
Health; Arizona Department of Health
Services, Office of Border Health;
California Department of Public Health,
Office of Binational Border Health;
Texas Department of State Health
Services, Office of Border Health to
strengthen the binational public health
projects and programs along the U.S.Mexico border. Activities to be
addressed through the cooperative
agreement will relate to the following
topic areas: (1) Border Binational Health
Week; (2) Prevention and Health
Promotion among Vulnerable
Populations on the U.S.-Mexico Border;
(3) U.S.-Mexico Border Tuberculosis
Consortium and Legal Issues Forum; (4)
Border Binational Obesity Prevention
Summit; (5) Border Health Research
Forum, Work Group and Expert Panel
Meeting; (6) Healthy Border 2010/2020
Strategic Plan; and (7) the Outreach
Office Planning Meeting.
This assistance will support current,
on-going and proposed public health
initiatives in this border region, under
ongoing, cooperative agreements already
awarded to the border health offices in
the States of California, Arizona, New
Mexico, and Texas. that support the
goals and objectives of the U.S.-Mexico
Border Health Commission, serve to
strengthen access to health care, disease
prevention, and public health along the
U.S.-Mexico border.
Background: The U.S.-Mexico Border
Health Commission (USMBHC), in
collaboration with the U.S. Department
of Health and Human Services, works
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
toward creating awareness about the
U.S.-Mexico border, its people, and its
environment. It educates others about
the unique challenges at the border
through outreach efforts, data collection
and analysis, and joint collaborative
efforts with public and private partners
in the border health community. The
USMBHC serves as a rallying point for
shared concerns about the U.S.-Mexico
border and as a catalyst for action to
develop plans directed toward solving
specific health related problems.
Outreach offices of the USMBHC work
with the border states to address public
health concerns and needs affecting the
border region. The Department of Health
Services of the states of New Mexico,
Arizona, Texas and California will work
with their Mexican counterparts to
promote and strengthen binational
health initiatives along the U.S.-Mexico
border.
Purpose: The overall objective of the
five-year cooperative agreements with
the Offices of Border Health in
California, Arizona, New Mexico and
Texas, initiated in 2011, is to support
and coordinate the USMBHC’s
objectives and the development of the
outreach health activities along the U.S.
and Mexico border. The cooperative
agreements focus on time-limited,
product-oriented, and measurable
outputs that may contribute to and help
to inform the binational dialogue at
local, state, and federal levels, regarding
mutual challenges in border health,
including tuberculosis; obesity/diabetes;
infectious disease and public health
emergencies; strategic planning; access
to care; and research, data collection,
and academic alliances.
Activities: Each state will use these
supplemental funds in support of the
goals of the Commission, to expand and
enhance ongoing activities. Specifically:
• Arizona will expand participation
in the Leaders Across Borders Program,
which addresses major public health
problems along the border through
developing leadership skills and
facilitating collaborative partnerships
among U.S. and Mexico health officials.
E:\FR\FM\27SEN1.SGM
27SEN1
Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Notices
• California will increase the number
of participants attending the Border
Health Research Forum and will host a
stakeholders meeting in support of the
Prevention and Health Promotion
among Vulnerable Populations on the
U.S.-Mexico Border Initiative.
• Texas will increase the number of
participants attending the Border
Binational Obesity Prevention Summit,
to share knowledge and best practices
regarding a critical problem affecting
border populations.
• New Mexico will plan, coordinate,
and execute Phase IV of the Healthy
Border 2010/2020 Strategic Plan, and
will increase the number of regional
activities of the Prevention and Health
Promotion among Vulnerable
Populations on the U.S.-Mexico Border
Initiative, to improve health outcomes
of vulnerable populations living on the
U.S.-Mexico Border.
II. Award Information
The administrative and funding
instrument to be used for this program
will be cooperative agreements in which
substantial OGA/HHS scientific and/or
programmatic involvement is
anticipated during the performance of
these projects. Under the cooperative
agreements, OGA/HHS will support
and/or stimulate awardees activities by
working with them in a non-directive
partnership role. Awardees will also be
expected to work directly with and in
support of the U.S.-Mexico Border
Health Commission and its stated goals
and initiatives as outlined in the
submitted work plan.
Approximately $150,000.00
($37,500.00 to each State) in fiscal year
(FY) 2012 funds are available as
supplemental funding to the already
existing agreements. The anticipated
start date is September 30, 2012 through
August 31, 2013. There will only be four
awards made from this announcement.
erowe on DSK2VPTVN1PROD with
III. Justification for the Exception to
Competition
15:00 Sep 26, 2012
Jkt 226001
IV. Agency Contacts
For programmatic requirements,
please contact: Craig Shapiro MD, Office
of Global Affairs, DHHS, Mary E.
Switzer Building, 330 C Street, SW.,
Washington, DC 20201, Phone: (202)
260–0399.
For administrative requirements
please contact: Alice Bettencourt,
Director, Office of Grants Management,
Office of the Assistant Secretary for
Health, 1101 Wotton Parkway, Suite
550, Rockville, MD 20852, Telephone:
(240) 453–8822.
Dated: September 20, 2012.
Jimmy Kolker,
Principal Deputy Director.
[FR Doc. 2012–23722 Filed 9–26–12; 8:45 am]
BILLING CODE 4150–38–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0190]
Determination That ENDURON
(methyclothiazide) Tablets and Six
Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the seven drug products listed in
this document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
The supplemental funding is for
ongoing, cooperative agreements already
awarded to the border health offices in
the States of California, Arizona, New
Mexico, and Texas. The purpose of the
activities of the cooperative agreements
is to accomplish the goals and objectives
of the US-Mexico Border Health
Commission. State border health offices
have both extensive experience working
with the Border Health Commission,
and have existing relationships and
ongoing initiatives with Mexican border
states. This experience and
relationships make the offices unique in
helping the Commission carry out its
VerDate Mar<15>2010
binational health initiatives and
activities along the border.
The supplemental funds are to
provide additional support for several
key activities of the cooperative
agreements. Because the activities are
ongoing, and being planned and carried
out by the State border health offices,
awarding the funds to the border health
offices is the only practicable way to
accomplish the objectives of enhancing
and extending the activities.
FOR FURTHER INFORMATION CONTACT:
Mark Geanacopoulos, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
59403
Hampshire Ave., Bldg. 51, rm. 6206,
Silver Spring, MD 20993–0002, 301–
796–6925.
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 approved
under an ANDA procedure. ANDA
sponsors 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. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn 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).
Under 314.161(a) (21 CFR 314.161(a)),
the Agency must determine whether a
listed drug was withdrawn from sale for
reasons of safety or effectiveness: (1)
Before an ANDA that refers to that listed
drug may be approved, (2) whenever a
listed drug is voluntarily withdrawn
from sale and ANDAs that refer to the
listed drug have been approved, and (3)
when a person petitions for such a
determination under 21 CFR 10.25(a)
and 10.30. Section 314.161(d) provides
that if FDA determines that a listed drug
was removed from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
As requested by the applicants, FDA
withdrew approval of NDA 012524 for
Enduron (methyclothiazide) Tablets and
NDA 017577 for Ditropan (oxybutynin
chloride) Tablets in the Federal Register
of March 19, 2012 (77 FR 16039). In
addition, FDA has become aware that
E:\FR\FM\27SEN1.SGM
27SEN1
]]>Agencies
[Federal Register Volume 77, Number 188 (Thursday, September 27, 2012)]
[Notices]
[Pages 59402-59403]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23722]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Announcement of Supplemental Funding for Cooperative Agreements
to the New Mexico Department of Health, Office of Border Health;
Arizona Department of Health Services, Office of Border Health;
California Department of Public Health, Office of Binational Border
Health; Texas Department of State Health Services, Office of Border
Health to Improve the Health of Persons and Communities Along the U.S.-
Mexico Border
AGENCY: Office of Global Affairs, Office of the Secretary, DHHS.
Announcement Type: Cooperative Agreement--FY 2012 Supplemental
Funding Announcement. Non-competitive.
Catalog of Federal Domestic Assistance: 93.018.
Projects Period: September 30, 2012--August 31, 2013.
SUMMARY: The Office of Global Affairs (OGA) announces that up to
$150,000.00 ($37,500.00 to each State) in fiscal year (FY) 2012 funds
are being awarded for supplemental funding to existing cooperative
agreements to the Department of Health Services of the states of New
Mexico, Arizona, Texas and California, whom will work through the U.S.-
Mexico Border Health Commission, to improve the health of persons and
communities along the U.S.-Mexico border. This initiative addresses
Border Binational Health Week; Prevention and Health Promotion among
Vulnerable Populations on the U.S.-Mexico Border; U.S.-Mexico Border
Tuberculosis Consortium and Legal Issues Forum; Border Binational
Obesity Prevention Summit; Border Health Research Forum, Work Group and
Expert Panel Meeting; Healthy Border 2010/2020 Strategic Plan; the
Outreach Office Planning Meeting, and programmatic and administrative
support to the members and staff of the U.S.-Mexico Border Health
Commissions. The budget period will be one year with a project period
of five years for a total of $150,000.00 (including indirect costs).
I. Funding Opportunity Description
Under the authority of 22 U.S.C. 290n, OGA announces the allocation
of fiscal year (FY) 2012 funds as supplemental funding to already
existing cooperative agreements to the New Mexico Department of Health,
Office of Border Health; Arizona Department of Health Services, Office
of Border Health; California Department of Public Health, Office of
Binational Border Health; Texas Department of State Health Services,
Office of Border Health to strengthen the binational public health
projects and programs along the U.S.-Mexico border. Activities to be
addressed through the cooperative agreement will relate to the
following topic areas: (1) Border Binational Health Week; (2)
Prevention and Health Promotion among Vulnerable Populations on the
U.S.-Mexico Border; (3) U.S.-Mexico Border Tuberculosis Consortium and
Legal Issues Forum; (4) Border Binational Obesity Prevention Summit;
(5) Border Health Research Forum, Work Group and Expert Panel Meeting;
(6) Healthy Border 2010/2020 Strategic Plan; and (7) the Outreach
Office Planning Meeting.
This assistance will support current, on-going and proposed public
health initiatives in this border region, under ongoing, cooperative
agreements already awarded to the border health offices in the States
of California, Arizona, New Mexico, and Texas. that support the goals
and objectives of the U.S.-Mexico Border Health Commission, serve to
strengthen access to health care, disease prevention, and public health
along the U.S.-Mexico border.
Background: The U.S.-Mexico Border Health Commission (USMBHC), in
collaboration with the U.S. Department of Health and Human Services,
works toward creating awareness about the U.S.-Mexico border, its
people, and its environment. It educates others about the unique
challenges at the border through outreach efforts, data collection and
analysis, and joint collaborative efforts with public and private
partners in the border health community. The USMBHC serves as a
rallying point for shared concerns about the U.S.-Mexico border and as
a catalyst for action to develop plans directed toward solving specific
health related problems. Outreach offices of the USMBHC work with the
border states to address public health concerns and needs affecting the
border region. The Department of Health Services of the states of New
Mexico, Arizona, Texas and California will work with their Mexican
counterparts to promote and strengthen binational health initiatives
along the U.S.-Mexico border.
Purpose: The overall objective of the five-year cooperative
agreements with the Offices of Border Health in California, Arizona,
New Mexico and Texas, initiated in 2011, is to support and coordinate
the USMBHC's objectives and the development of the outreach health
activities along the U.S. and Mexico border. The cooperative agreements
focus on time-limited, product-oriented, and measurable outputs that
may contribute to and help to inform the binational dialogue at local,
state, and federal levels, regarding mutual challenges in border
health, including tuberculosis; obesity/diabetes; infectious disease
and public health emergencies; strategic planning; access to care; and
research, data collection, and academic alliances.
Activities: Each state will use these supplemental funds in support
of the goals of the Commission, to expand and enhance ongoing
activities. Specifically:
Arizona will expand participation in the Leaders Across
Borders Program, which addresses major public health problems along the
border through developing leadership skills and facilitating
collaborative partnerships among U.S. and Mexico health officials.
[[Page 59403]]
California will increase the number of participants
attending the Border Health Research Forum and will host a stakeholders
meeting in support of the Prevention and Health Promotion among
Vulnerable Populations on the U.S.-Mexico Border Initiative.
Texas will increase the number of participants attending
the Border Binational Obesity Prevention Summit, to share knowledge and
best practices regarding a critical problem affecting border
populations.
New Mexico will plan, coordinate, and execute Phase IV of
the Healthy Border 2010/2020 Strategic Plan, and will increase the
number of regional activities of the Prevention and Health Promotion
among Vulnerable Populations on the U.S.-Mexico Border Initiative, to
improve health outcomes of vulnerable populations living on the U.S.-
Mexico Border.
II. Award Information
The administrative and funding instrument to be used for this
program will be cooperative agreements in which substantial OGA/HHS
scientific and/or programmatic involvement is anticipated during the
performance of these projects. Under the cooperative agreements, OGA/
HHS will support and/or stimulate awardees activities by working with
them in a non-directive partnership role. Awardees will also be
expected to work directly with and in support of the U.S.-Mexico Border
Health Commission and its stated goals and initiatives as outlined in
the submitted work plan.
Approximately $150,000.00 ($37,500.00 to each State) in fiscal year
(FY) 2012 funds are available as supplemental funding to the already
existing agreements. The anticipated start date is September 30, 2012
through August 31, 2013. There will only be four awards made from this
announcement.
III. Justification for the Exception to Competition
The supplemental funding is for ongoing, cooperative agreements
already awarded to the border health offices in the States of
California, Arizona, New Mexico, and Texas. The purpose of the
activities of the cooperative agreements is to accomplish the goals and
objectives of the US-Mexico Border Health Commission. State border
health offices have both extensive experience working with the Border
Health Commission, and have existing relationships and ongoing
initiatives with Mexican border states. This experience and
relationships make the offices unique in helping the Commission carry
out its binational health initiatives and activities along the border.
The supplemental funds are to provide additional support for
several key activities of the cooperative agreements. Because the
activities are ongoing, and being planned and carried out by the State
border health offices, awarding the funds to the border health offices
is the only practicable way to accomplish the objectives of enhancing
and extending the activities.
IV. Agency Contacts
For programmatic requirements, please contact: Craig Shapiro MD,
Office of Global Affairs, DHHS, Mary E. Switzer Building, 330 C Street,
SW., Washington, DC 20201, Phone: (202) 260-0399.
For administrative requirements please contact: Alice Bettencourt,
Director, Office of Grants Management, Office of the Assistant
Secretary for Health, 1101 Wotton Parkway, Suite 550, Rockville, MD
20852, Telephone: (240) 453-8822.
Dated: September 20, 2012.
Jimmy Kolker,
Principal Deputy Director.
[FR Doc. 2012-23722 Filed 9-26-12; 8:45 am]
BILLING CODE 4150-38-P
