Cooperative Agreement With the World Health Organization Department of Food Safety and Zoonoses in Support of Strategies That Address Food Safety Problems That Align Domestically and Globally (U01); Correction, 44592-44593 [2011-18881]
Download as PDF
<![CDATA[
sroberts on DSK5SPTVN1PROD with NOTICES
44592
Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Notices
was submitted on May 15, 2011, and
disapproved on June 1, 2011. The SPA
proposed to prohibit the State Medicaid
agency from entering into a contract or
grant with providers that perform
abortions or maintain or operate
facilities where abortions are performed,
except for hospitals or ambulatory
surgical centers.
CMS based the disapproval on a
determination that SPA 11–011 would
not comply with the requirements of
section 1902(a)(23) of the Social
Security Act (the Act). Whether SPA
11–011 complies with section
1902(a)(23) of the Act is the only issue
in this reconsideration. Section
1902(a)(23) of the Act provides that
beneficiaries may obtain covered
services from any qualified provider
that undertakes to provide such
services. Contrary to that requirement,
this SPA would eliminate the ability of
Medicaid beneficiaries to receive
services from specific providers for
reasons unrelated to their qualifications
to provide such services. It is not
consistent with section 1902(a)(23) for
Medicaid programs to exclude qualified
health care providers from providing
services that are funded under the
program because of a provider’s scope of
practice. Such a restriction would have
a particular effect on beneficiaries’
ability to access family planning
providers. It is important to note that
access to family planning providers is
an important statutory priority, as
evidenced by the additional protections
for beneficiary choice of family
planning providers under section
1902(a)(23)(B) of the Act for managed
care enrollees. It is also important to
note that neither SPA 11–011 nor the
disapproval affect the applicable
restrictions on Federal funding of
abortion services.
Section 1116 of the Act and Federal
regulations at 42 CFR part 430, establish
Department procedures that provide an
administrative hearing for
reconsideration of a disapproval of a
State plan or plan amendment. CMS is
required to publish a copy of the notice
to a State Medicaid agency that informs
the agency of the time and place of the
hearing, and the issues to be considered.
If we subsequently notify the agency of
additional issues that will be considered
at the hearing, we will also publish that
notice.
Any individual or group that wants to
participate in the hearing as a party
must petition the presiding officer
within 15 days after publication of this
notice, in accordance with the
requirements contained at 42 CFR
430.76(b)(2). Any interested person or
organization that wants to participate as
VerDate Mar<15>2010
16:12 Jul 25, 2011
Jkt 223001
amicus curiae must petition the
presiding officer before the hearing
begins in accordance with the
requirements contained at 42 CFR
430.76(c). If the hearing is later
rescheduled, the presiding officer will
notify all participants.
The notice to Indiana announcing an
administrative hearing to reconsider the
disapproval of its SPA reads as follows:
Ms. Patricia Casanova,
Director, MS 07, 402 W. Washington Street,
Room W382, Indianapolis, IND 46204–
2739.
Dear Ms.Casanova:
I am responding to your request for
reconsideration of the decision to disapprove
the Indiana State Plan Amendment (SPA) 11–
011 which was submitted on May 15, 2011,
and disapproved on June 1, 2011. The SPA
proposed to prohibit the State Medicaid
agency from entering into a contract or grant
with providers that perform abortions or
maintain or operate facilities where abortions
are performed, except for hospitals or
ambulatory surgical centers.
Whether SPA 11–011 complies with
section 1902(a)(23) of the Act is the only
issue in this reconsideration.
Section 1902(a)(23) of the Act provides that
beneficiaries may obtain covered services
from any qualified provider that undertakes
to provide such services. Contrary to that
requirement, this SPA would eliminate the
ability of Medicaid beneficiaries to receive
services from specific providers for reasons
unrelated to their qualifications to provide
such services. It is not consistent with
section 1902(a)(23) for Medicaid programs to
exclude qualified health care providers from
providing services that are funded under the
program because of a provider’s scope of
practice. Such a restriction would have a
particular effect on beneficiaries’ ability to
access family planning providers. It is
important to note that access to family
planning providers is an important statutory
priority, as evidenced by the additional
protections for beneficiary choice of family
planning providers under section
1902(a)(23)(B) of the Act for managed care
enrollees. It is also important to note that
neither SPA 11–011 nor the disapproval
affect the applicable restrictions on Federal
funding of abortion services.
I am scheduling a hearing on your request
for reconsideration to be held on September
13, 2011, at the CMS Chicago Regional
Office, 233 N. Michigan Avenue, Suite 600,
Chicago, IL 60601, in order to reconsider the
decision to disapprove SPA 11–011.
If this date is not acceptable, we would be
glad to set another date that is mutually
agreeable to the parties. The hearing will be
governed by the procedures prescribed by
Federal regulations at 42 CFR Part 430.
I am designating Mr. Benjamin Cohen as
the presiding officer. If these arrangements
present any problems, please contact the
presiding officer at (410) 786–3169. In order
to facilitate any communication which may
be necessary between the parties to the
hearing, please notify the presiding officer to
indicate acceptability of the hearing date that
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
has been scheduled and provide names of the
individuals who will represent the State at
the hearing. As you requested, I will also
provide this response to Indiana Solicitor
General Thomas M. Fisher.
Sincerely,
Donald M. Berwick, M.D.
Section 1116 of the Social Security
Act (42 U.S.C. 1316; 42 CFR 430.18).
(Catalog of Federal Domestic Assistance
program No. 13.714, Medicaid Assistance
Program.)
Dated: July 20, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–18831 Filed 7–25–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0010]
Cooperative Agreement With the World
Health Organization Department of
Food Safety and Zoonoses in Support
of Strategies That Address Food
Safety Problems That Align
Domestically and Globally (U01);
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 28, 2011 (76 FR 37817).
The document announced the
availability of funds for the support of
a sole source cooperative agreement
with the World Health Organization.
The document published stating that the
total funding available was up to
$260,000 (total costs including indirect
costs) in fiscal year 2011 in support of
this project. This document corrects that
error.
SUMMARY:
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
For Programmatic Questions and
Concerns Contact
Katherine Bond, Office of
International Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–8318, e-mail:
Katherine.bond@fda.hhs.gov.
For Financial and Administrative
Questions and Concerns Contact
Gladys Melendez, Office of
Acquisition and Grant Services (HFA–
E:\FR\FM\26JYN1.SGM
26JYN1
Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Notices
500), Food and Drug Administration,
5630 Fishers Lane, rm. 1078, Rockville,
MD 20857, 301–827–7175, e-mail:
gladys.Melendez-bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–16120, appearing on page 37817,
in the Federal Register of Tuesday, June
28, 2011, the following correction is
made:
1. On page 37819, in third column,
section A. Award Amount is corrected
to read as follows:
The total funding available is up to
$360,000 (total costs including indirect
costs) in fiscal year 2011 in support of
this project. One award will be made.
Funding will be provided for one year,
with the possibility of up to four
additional years of support, contingent
upon successful performance and
available funding.
Dated: July 21, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–18881 Filed 7–25–11; 8:45 am]
BILLING CODE 4160–01–P
Submit written requests for
single copies of this report to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft report.
Submit electronic comments on the
draft report to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ruth Barratt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 4540,
Silver Spring, MD 20993–0002, 301–
796–2600.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0239]
Identifying the Center for Drug
Evaluation and Research’s Science
and Research Needs; Availability of a
Draft Report; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft report entitled
‘‘Identifying CDER’s Science and
Research Needs.’’ This document
identifies current priorities in regulatory
science related to the mission of the
Center for Drug Evaluation and Research
(CDER), and will guide strategic
planning of internal research efforts.
Through external communication of the
science and research needs outlined in
the report, CDER hopes to stimulate
research and foster collaborations with
external partners and stakeholders to
address these priorities.
DATES: Although you can comment on
the report at any time, to ensure that the
Agency considers your comment on this
report before it begins work on the final
version of the report, submit either
electronic or written comments on the
report by September 26, 2011.
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:12 Jul 25, 2011
Jkt 223001
FDA is announcing the availability of
a draft report entitled ‘‘Identifying
CDER’s Science and Research Needs.’’
This report is the result of an effort to
identify regulatory science needs that, if
addressed, would enhance CDER’s
ability to fulfill its regulatory mission. A
publication entitled ‘‘FDA Critical Path
Opportunities Report and Critical Path
Opportunities List’’ was published in
March 2006. That report focused on the
scientific challenges underlying medical
product development and served as a
catalyst for CDER to launch an effort to
identify specific areas that would
benefit from additional regulatory
science efforts. More recently, FDA
released, ‘‘Advancing Regulatory
Science for Public Health’’, which
incorporates the Critical Path objectives
into a broad framework for advancing
regulatory science. In support of these
initiatives, this report delineates major
areas of scientific need that can
contribute to the development of a
strategic science and research agenda.
To begin an assessment of these
needs, more than 200 representatives
from CDER’s offices were asked to
identify: (1) Scientific challenges
currently addressed on a case-by-case
basis that might benefit from the
development of a systematized
approach; (2) recurrent science issues
across teams, divisions, or offices; and
(3) emerging scientific challenges. A
comprehensive set of science and
research needs was compiled from these
discussions. Senior management from
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
44593
CDER offices reviewed and prioritized
topics from their offices. These science
and research needs were ultimately
grouped into seven categories that were
reviewed and endorsed by the CDER
Science Prioritization and Review
Committee and CDER senior
management.
Seven major categories that crossed
multiple disciplines were identified: (1)
Improve access to postmarket data
sources and explore feasibility of their
use in different types of analyses; (2)
improve risk assessment and
management strategies to reinforce the
safe use of drugs; (3) evaluate the
effectiveness and impact of different
types of regulatory communications to
the public and other stakeholders; (4)
evaluate the links among product
quality attributes, manufacturing
processes, and product performance; (5)
develop and improve predictive models
of safety and efficacy in humans; (6)
improve clinical trial design, analysis,
and conduct; and (7) enhance
individualization of patient treatment.
The draft report is not intended to
address the need to maintain a robust
scientific readiness to respond rapidly
to regulatory crises, but by
communicating CDER’s current science
and research needs, CDER hopes to
stimulate research and foster
collaborations with external partners
and stakeholders. CDER is
disseminating this document externally
and soliciting input on: (1) Research and
initiatives that may be ongoing; and (2)
opportunities to collaborate with
external partners and stakeholders to
maximize resources to address the areas
for development discussed previously.
The input will be reviewed and
incorporated as appropriate into plans
for collaborations and potential external
partners will be contacted for further
discussion.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov.
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44592-44593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18881]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0010]
Cooperative Agreement With the World Health Organization
Department of Food Safety and Zoonoses in Support of Strategies That
Address Food Safety Problems That Align Domestically and Globally
(U01); Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of June 28, 2011 (76 FR 37817).
The document announced the availability of funds for the support of a
sole source cooperative agreement with the World Health Organization.
The document published stating that the total funding available was up
to $260,000 (total costs including indirect costs) in fiscal year 2011
in support of this project. This document corrects that error.
FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
For Programmatic Questions and Concerns Contact
Katherine Bond, Office of International Programs, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-8318, e-mail: Katherine.bond@fda.hhs.gov.
For Financial and Administrative Questions and Concerns Contact
Gladys Melendez, Office of Acquisition and Grant Services (HFA-
[[Page 44593]]
500), Food and Drug Administration, 5630 Fishers Lane, rm. 1078,
Rockville, MD 20857, 301-827-7175, e-mail: gladys.Melendez-bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. 2011-16120, appearing on page
37817, in the Federal Register of Tuesday, June 28, 2011, the following
correction is made:
1. On page 37819, in third column, section A. Award Amount is
corrected to read as follows:
The total funding available is up to $360,000 (total costs
including indirect costs) in fiscal year 2011 in support of this
project. One award will be made. Funding will be provided for one year,
with the possibility of up to four additional years of support,
contingent upon successful performance and available funding.
Dated: July 21, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18881 Filed 7-25-11; 8:45 am]
BILLING CODE 4160-01-P
