Medicare and Medicaid Programs; Procedure for Hospitals Seeking To Enter Into an Agreement With a Different Organ Procurement Organization Following an 1138(a)(2) Waiver, 33313-33315 [2010-14098]
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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
approval process, FDA identifies the
established pharmacologic class for each
approved medical product if
appropriate. An established
pharmacologic class is one that FDA has
determined is scientifically valid and
clinically meaningful according to the
principles outlined in the guidance for
industry and review staff ‘‘Labeling for
Human Prescription Drugs and
Biological Products—Determining
Established Pharmacologic Class for Use
in the Highlights of Prescribing
Information,’’ published in October
2009.
For SPL indexing, the established
pharmacologic class is represented by
an established pharmacologic class term
or phrase. FDA also uses the
Department of Veterans Affairs National
Drug File Reference Terminology to
identify other scientifically valid and
clinically meaningful SPL indexing
terms for each active ingredient that are
representative of mechanism of action,
physiologic effect, and chemical
structure.
On the FDA Data Standards Council
Web site, FDA has posted a Microsoft
Excel spreadsheet containing a list of
proposed established pharmacologic
classes and indexing concepts
completed to date for each active
ingredient associated with approved
human prescription drug and biological
products.1
III. Indexing Indications Information
FDA has determined that another high
priority for indexing of product labeling
information, as resources permit, is the
medical product indications category.
With indexing of indications, the goal
is to determine terms or phrases that
represent the recognized disease or
condition, manifestation of a recognized
disease or condition, or symptoms
associated with a recognized disease or
condition that accurately capture the
approved indication appearing in the
Indications section of labeling. The
current intent is to index the basic
indication concepts without the more
specific usage and limitations of use
information. Criteria are under
development to determine the
appropriate level of granularity and
consistency in the choice of concepts
indexed.
After consideration of existing
alternatives including the National
Library of Medicine’s Clinical
Observations Recording and Encoding
(CORE) subset of Systematized
Nomenclature of Medicine Clinical
1 See
https://www.fda.gov/ForIndustry/Data
Standards/StructuredProductfxsp0;Labeling/
ucm162549.htm.
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15:04 Jun 10, 2010
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Terms (SNOMED CT), FDA chose the
Veterans Health Administration and
Kaiser Permanente (VA/KP) Problem
List subset of SNOMED CT as the
terminology for SPL indexing of product
labeling information on indication.2
SNOMED CT is a comprehensive
clinical terminology that includes
expressions for body structures, clinical
findings, procedures, and hundreds of
thousands of other clinical concepts.
More information on SNOMED CT is
available at https://www.nlm.nih.gov/
research/umls/Snomed/
snomed_main.html.
IV. Request for Comments
FDA is establishing an open docket
for comments to obtain public input on
the indexing process. Representatives of
the human prescription drug and
biological product industries, health
care providers, and other health care
professionals are particularly
encouraged to participate and submit
comments.
FDA is asking for comment on all
aspects of indexing the content of
labeling. In particular, FDA is asking for
comments on the following:
1. FDA is currently indexing
pharmacologic class and indications.
When indexing of these categories is
complete, FDA plans to index
additional labeling information
categories. For example, warnings and
precautions, other adverse reactions,
drug interactions, pediatric, or
pregnancy information may be useful
categories of information for future
indexing. Other categories may also be
identified. Please comment on the
subsequent labeling categories that
should be indexed by FDA as well as
the priority order for indexing these
categories.
2. For each indexing category, FDA
will develop a series of principles to
ensure the consistent assignment of
indexing concepts. Please comment on
the type of principles that may be useful
for this task.
3. FDA chose the VA/KP Problem List
subset of SNOMED CT as the indexing
terminology for indications for the
following reasons:
• The VA/KP Problem List is the
named SPL data standard terminology
for indexing the medical condition.3
• The subset represents conditions at
a level of discreteness that are clinically
relevant.
2 FDA News: https://www.fda.gov/NewsEvents/
Newsroom/PressAnnouncements/2006/
ucm108642.htm
3 SNOMED CT VA/KP subset: https://
www.nlm.nih.gov/research/umls/Snomed/snomed_
problem_list.html
PO 00000
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33313
Please comment on the use of the VA/
KP Problem List for the indexing of
indications.
4. For indications, the degree of
complexity indexed is limited by FDA’s
intention to first capture the main focus
of the indication as a single existing
concept using the 01312010 version of
the SNOMED CT VA/KP Problem List
subset. Additional indication modifiers
found in approved product labeling
such as disease severity or chronicity
will not always be indexed. Please
comment on this approach.
5. FDA will use the SPL standard to
disseminate indexing information. Once
entered into the SPL file, the indexed
elements will be available for uploading
into computer systems for sorting and
other data manipulations. We believe
this approach is more user friendly than
the Microsoft Excel spreadsheet format
we are currently using to showcase
pharmacologic class on the Data
Standards Web site. Please comment on
this approach to make SPL indexing
information available to interested
parties.
V. 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.
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–14047 Filed 6–10–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1576–N]
Medicare and Medicaid Programs;
Procedure for Hospitals Seeking To
Enter Into an Agreement With a
Different Organ Procurement
Organization Following an 1138(a)(2)
Waiver
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
E:\FR\FM\11JNN1.SGM
11JNN1
33314
Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY: This notice announces the
procedures that will be used when a
hospital, that has previously been
granted a waiver under sections
1138(a)(2) of the Social Security Act (the
Act), seeks to enter into an agreement
with a different Organ Procurement
Organization (OPO). The procedures are
modeled after the public process
required by 1138(a)(2) of the Act. The
process affords the public an
opportunity to comment on the
proposed change and to submit
information and material with respect to
whether the change is likely to increase
organ donation and will assure
equitable treatment for patients in both
affected OPO service areas.
DATES: Effective Date: This notice is
effective June 11, 2010.
FOR FURTHER INFORMATION CONTACT:
Mark A. Horney, (410) 786–4554.
SUPPLEMENTARY INFORMATION:
I. Background
Organ Procurement Organizations
(OPOs) are not-for-profit organizations
that are responsible for the
procurement, preservation, and
transport of transplantable organs to
transplant centers throughout the
country. Qualified OPOs are designated
by the Centers for Medicare & Medicaid
Services (CMS) to recover or procure
organs in CMS-defined exclusive
geographic service areas, pursuant to
section 371(b)(1) of the Public Health
Service Act (42 U.S.C. 273(b)(1)) and
our regulations at 42 CFR 486.306. Once
an OPO has been designated for an area,
hospitals in that area that participate in
Medicare and Medicaid are required to
work with that OPO in providing organs
for transplant, pursuant to section
1138(a)(1)(C) of the Social Security Act
(the Act), and our regulations at
§ 482.45.
Section 1138(a)(1)(A)(iii) of the Act
provides that a hospital must notify the
designated OPO (for the service area in
which it is located) of potential organ
donors. Under section 1138(a)(1)(C) of
the Act, every participating hospital
must have an agreement to identify
potential donors only with its
designated OPO.
However, section 1138(a)(2)(A) of the
Act provides that a hospital may obtain
a waiver of the above requirements from
the Secretary under certain specified
conditions. A waiver allows the hospital
to have an agreement with an OPO other
than the one initially designated by
CMS, if the hospital meets certain
conditions specified in section
1138(a)(2)(A) of the Act. In addition, the
Secretary may review additional criteria
described in section 1138(a)(2)(B) of the
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Act to evaluate the hospital’s request for
a waiver.
Section 1138(a)(2)(A) of the Act states
that in granting a waiver, the Secretary
must determine that the waiver: (1) Is
expected to increase organ donations;
and (2) will ensure equitable treatment
of patients referred for transplants
within the service area served by the
designated OPO and within the service
area served by the OPO with which the
hospital seeks to enter into an
agreement under the waiver. In making
a waiver determination, section
1138(a)(2)(B) of the Act provides that
the Secretary may consider, among
other factors: (1) Cost-effectiveness; (2)
improvements in quality; (3) whether
there has been any change in a
hospital’s designated OPO due to the
changes made in definitions for
metropolitan statistical areas; and (4)
the length and continuity of a hospital’s
relationship with an OPO other than the
hospital’s designated OPO. Under
section 1138(a)(2)(D) of the Act, the
Secretary is required to publish a notice
of any waiver application received from
a hospital within 30 days of receiving
the application, and to offer interested
parties an opportunity to comment in
writing during the 60-day period
beginning on the publication date in the
Federal Register.
Several hospitals have asked for and
been granted waivers to work with a
hospital other than the designated OPO.
The statute does not expressly establish
procedures for the situation where a
hospital that had previously been
granted a waiver, desires to enter into an
agreement with a different OPO or
return to work with the OPO that has
been designated for the relevant
geographic area. Given the importance
of the hospital-OPO relationship for all
potential transplant patients in the
affected service areas, we are
establishing an open and transparent
process for addressing these situations.
Specifically, using the same framework
provided in section 1138(a)(2), the
Secretary will enable hospitals that had
been granted a waiver to apply to enter
into an agreement with a different OPO.
A specific notice will be published in
the Federal Register within 30 days of
the agency’s receipt of such a request.
We will provide the public an
opportunity to submit information and
material with respect to whether the
proposed change would be expected to
increase organ donation and would
ensure the equitable treatment for
transplant patients in both of the
affected OPO service areas.
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
II. Request Procedures
A hospital that has previously been
granted a waiver under section
1138(a)(2) but desiring to enter into an
agreement with a different OPO, may
file a request by submitting it to CMS at
the following address: Director, Centers
for Medicare and Medicaid Services,
Division of Technical Payment Policy,
7500 Security Blvd, C4–25–02,
Baltimore, MD 21244–1850.
The letter should supply sufficient
information and data to address how
changing OPOs:
1. Is expected to increase organ
donation; and
2. Will assure equitable treatment of
patients referred for transplant within
the existing OPO service area, within
the service area of the OPO with which
the hospital wishes to enter an
agreement.
In making a change in OPO
determination, the Secretary may
consider, among other factors:
1. Cost effectiveness;
2. Improvements in quality;
3. Whether there has been a change in
a hospital’s service due to a change in
definition of metropolitan statistical
area (MSA); and
4. The length and continuity of a
hospital relationship with the OPO with
which the hospital wants to align.
Upon receipt of such a request, we
would publish a Federal Register notice
to solicit public comments, consistent
with the procedures set forth in section
1138(a)(2)(D) of the Act.
Under these procedures, we will
review the request and comments
received. During the review process, we
may consult on an as-needed basis with
the Health Resources Services
Administration’s Division of
Transplantation, the United Network for
Organ Sharing, and our regional offices.
If necessary, we may request additional
clarifying information from the applying
hospital or others. We will then make a
final determination on the request and
notify the hospital and the designated
and requested OPOs.
By providing an open and transparent
public process with an opportunity to
consider public comments, information
and materials, the Secretary will be able
to make better decisions concerning
whether the proposed change in the
OPO will be expected to increase organ
donation and will assure equitable
treatment for patients in both affected
OPO service areas.
III. Collection of Information
Requirements
We anticipate receiving less than 10
hospital requests in a 12-month period.
E:\FR\FM\11JNN1.SGM
11JNN1
Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
Therefore, in accordance with 5 CFR
1320.3(c), the reporting requirements in
this notice are not defined as
information collection requirements.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; Program No. 93.774, Medicare—
Supplementary Medical Insurance, and
Program No. 93.778, Medical Assistance
Program)
Dated: June 3, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating
Officer, Centers for Medicare & Medicaid
Services.
[FR Doc. 2010–14098 Filed 6–10–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Date: July 2, 2010. (Open on July 2
from 8 a.m. to 8:15 a.m. and closed for
the remainder of the meeting.)
Place: Hyatt Regency Bethesda Hotel,
7400 Wisconsin Avenue, 1 Bethesda
Metro Center, Conference Room TBD,
Bethesda, MD 20814.
Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the non-confidential portions
of this meeting should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Room 2038, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for this meeting are
subject to change as priorities dictate.
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: May 27, 2010.
Carolyn M. Clancy,
Director.
Dental Products Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
Dated: June 4, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–14074 Filed 6–10–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0268]
[FR Doc. 2010–13982 Filed 6–10–10; 8:45 am]
AGENCY:
BILLING CODE 4160–90–M
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Notice of Meeting
ACTION:
In accordance with section 10(d) of
the Federal Advisory Committee Act (5
U.S.C., Appendix 2), announcement is
made of a Health Care Policy and
Research Special Emphasis Panel (SEP)
meeting.
A Special Emphasis Panel is a group
of experts in fields related to health care
research who are invited by the Agency
for Healthcare Research and Quality
(AF[RQ), and agree to be available, to
conduct on an as needed basis,
scientific reviews of applications for
AHRQ support. Individual members of
the Panel do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
Substantial segments of the upcoming
SEP meeting listed below will be closed
to the public in accordance with the
Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b(c)(6). Grant
applications for the OS ARRA:
Clinically-Enhanced State Data for
Analysis for CE Impact (R01)
applications are to be reviewed and
discussed at this meeting. These
discussions are likely to reveal personal
information concerning individuals
associated with the applications. This
information is exempt from mandatory
disclosure under the above-cited
statutes.
SEP Meeting on: OS ARRA:
Clinically-Enhanced State Data for
Analysis for CE Impact (R01).
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15:04 Jun 10, 2010
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33315
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Research 2
Practice and Construction Research
Application, Request for Application
(RFA) OH09–001, Initial Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the aforementioned meeting:
Time and Date: 3 a.m.–5 p.m., July 7, 2010
(Closed).
Place: National Institute for Occupational
Safety and Health (NIOSH), 2400 Century
Parkway, NE., Fourth Floor, Atlanta, Georgia
30345, Telephone: (404) 498–2530.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5,
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Section 10(d) of Public Law
92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Research 2 Practice and
Construction Research Application, RFA
OH09–001’’.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Chris
Langub, PhD, Scientific Review Officer,
NIOSH, CDC, 2400 Century Center, Atlanta,
GA 30333, Telephone: (404) 498–2543.
The Director, Management Analysis and
Services Office has been delegated the
PO 00000
Frm 00078
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Food and Drug Administration,
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dental Products
Panel of the Medical Devices Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 14 and 15, 2010, from
8 a.m. to 6 p.m.
Location: Holiday Inn-Gaithersburg,
Main Ballroom, 2 Montgomery Village
Ave., Gaithersburg, MD 20879.
Contact Person: Olga I. Claudio, Food
and Drug Administration, Center for
Devices and Radiological Health, WO
66, rm. 1553, Silver Spring, MD 20993–
0002, 301–796–7608 or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code 301–451–
2518. Please call the Information Line
for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Comments: FDA is opening a docket
for public comment on this document.
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33313-33315]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1576-N]
Medicare and Medicaid Programs; Procedure for Hospitals Seeking
To Enter Into an Agreement With a Different Organ Procurement
Organization Following an 1138(a)(2) Waiver
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 33314]]
SUMMARY: This notice announces the procedures that will be used when a
hospital, that has previously been granted a waiver under sections
1138(a)(2) of the Social Security Act (the Act), seeks to enter into an
agreement with a different Organ Procurement Organization (OPO). The
procedures are modeled after the public process required by 1138(a)(2)
of the Act. The process affords the public an opportunity to comment on
the proposed change and to submit information and material with respect
to whether the change is likely to increase organ donation and will
assure equitable treatment for patients in both affected OPO service
areas.
DATES: Effective Date: This notice is effective June 11, 2010.
FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.
SUPPLEMENTARY INFORMATION:
I. Background
Organ Procurement Organizations (OPOs) are not-for-profit
organizations that are responsible for the procurement, preservation,
and transport of transplantable organs to transplant centers throughout
the country. Qualified OPOs are designated by the Centers for Medicare
& Medicaid Services (CMS) to recover or procure organs in CMS-defined
exclusive geographic service areas, pursuant to section 371(b)(1) of
the Public Health Service Act (42 U.S.C. 273(b)(1)) and our regulations
at 42 CFR 486.306. Once an OPO has been designated for an area,
hospitals in that area that participate in Medicare and Medicaid are
required to work with that OPO in providing organs for transplant,
pursuant to section 1138(a)(1)(C) of the Social Security Act (the Act),
and our regulations at Sec. 482.45.
Section 1138(a)(1)(A)(iii) of the Act provides that a hospital must
notify the designated OPO (for the service area in which it is located)
of potential organ donors. Under section 1138(a)(1)(C) of the Act,
every participating hospital must have an agreement to identify
potential donors only with its designated OPO.
However, section 1138(a)(2)(A) of the Act provides that a hospital
may obtain a waiver of the above requirements from the Secretary under
certain specified conditions. A waiver allows the hospital to have an
agreement with an OPO other than the one initially designated by CMS,
if the hospital meets certain conditions specified in section
1138(a)(2)(A) of the Act. In addition, the Secretary may review
additional criteria described in section 1138(a)(2)(B) of the Act to
evaluate the hospital's request for a waiver.
Section 1138(a)(2)(A) of the Act states that in granting a waiver,
the Secretary must determine that the waiver: (1) Is expected to
increase organ donations; and (2) will ensure equitable treatment of
patients referred for transplants within the service area served by the
designated OPO and within the service area served by the OPO with which
the hospital seeks to enter into an agreement under the waiver. In
making a waiver determination, section 1138(a)(2)(B) of the Act
provides that the Secretary may consider, among other factors: (1)
Cost-effectiveness; (2) improvements in quality; (3) whether there has
been any change in a hospital's designated OPO due to the changes made
in definitions for metropolitan statistical areas; and (4) the length
and continuity of a hospital's relationship with an OPO other than the
hospital's designated OPO. Under section 1138(a)(2)(D) of the Act, the
Secretary is required to publish a notice of any waiver application
received from a hospital within 30 days of receiving the application,
and to offer interested parties an opportunity to comment in writing
during the 60-day period beginning on the publication date in the
Federal Register.
Several hospitals have asked for and been granted waivers to work
with a hospital other than the designated OPO. The statute does not
expressly establish procedures for the situation where a hospital that
had previously been granted a waiver, desires to enter into an
agreement with a different OPO or return to work with the OPO that has
been designated for the relevant geographic area. Given the importance
of the hospital-OPO relationship for all potential transplant patients
in the affected service areas, we are establishing an open and
transparent process for addressing these situations. Specifically,
using the same framework provided in section 1138(a)(2), the Secretary
will enable hospitals that had been granted a waiver to apply to enter
into an agreement with a different OPO. A specific notice will be
published in the Federal Register within 30 days of the agency's
receipt of such a request. We will provide the public an opportunity to
submit information and material with respect to whether the proposed
change would be expected to increase organ donation and would ensure
the equitable treatment for transplant patients in both of the affected
OPO service areas.
II. Request Procedures
A hospital that has previously been granted a waiver under section
1138(a)(2) but desiring to enter into an agreement with a different
OPO, may file a request by submitting it to CMS at the following
address: Director, Centers for Medicare and Medicaid Services, Division
of Technical Payment Policy, 7500 Security Blvd, C4-25-02, Baltimore,
MD 21244-1850.
The letter should supply sufficient information and data to address
how changing OPOs:
1. Is expected to increase organ donation; and
2. Will assure equitable treatment of patients referred for
transplant within the existing OPO service area, within the service
area of the OPO with which the hospital wishes to enter an agreement.
In making a change in OPO determination, the Secretary may
consider, among other factors:
1. Cost effectiveness;
2. Improvements in quality;
3. Whether there has been a change in a hospital's service due to a
change in definition of metropolitan statistical area (MSA); and
4. The length and continuity of a hospital relationship with the
OPO with which the hospital wants to align.
Upon receipt of such a request, we would publish a Federal Register
notice to solicit public comments, consistent with the procedures set
forth in section 1138(a)(2)(D) of the Act.
Under these procedures, we will review the request and comments
received. During the review process, we may consult on an as-needed
basis with the Health Resources Services Administration's Division of
Transplantation, the United Network for Organ Sharing, and our regional
offices. If necessary, we may request additional clarifying information
from the applying hospital or others. We will then make a final
determination on the request and notify the hospital and the designated
and requested OPOs.
By providing an open and transparent public process with an
opportunity to consider public comments, information and materials, the
Secretary will be able to make better decisions concerning whether the
proposed change in the OPO will be expected to increase organ donation
and will assure equitable treatment for patients in both affected OPO
service areas.
III. Collection of Information Requirements
We anticipate receiving less than 10 hospital requests in a 12-
month period.
[[Page 33315]]
Therefore, in accordance with 5 CFR 1320.3(c), the reporting
requirements in this notice are not defined as information collection
requirements.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance, and Program No. 93.778, Medical
Assistance Program)
Dated: June 3, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare
& Medicaid Services.
[FR Doc. 2010-14098 Filed 6-10-10; 8:45 am]
BILLING CODE 4120-01-P
