Medicare and Medicaid Programs; Announcement of an Application from a Hospital Requesting Waiver for Organ Procurement Service Area, 59272-59274 [2010-24100]
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59272
Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices
recommendations in the draft guidance,
these establishments could submit a
single process form that covers all
container sizes of a product. Thus, the
estimated number of annual voluntary
process filings is 2,725 process filings
(2,251 products/892 establishments x
540 establishments x 2 = 2,725.4 process
filings, rounded to 2,725). On average,
we calculate that the annual frequency
of reporting would be 5 process filings
(2,725 process filings/540
establishments = 5.04, rounded to 5).
For the purpose of this analysis, we use
the rounded number of process filings
(i.e., 5) and, thus, calculate that the
estimated recurring reporting burden for
acidified foods and voluntarily register
their establishments will submit a total
of 30,000 process filings in the first
year—i.e., twice as many process filings
as would be submitted, on average, by
any given establishment on an annual
basis (2 x 5 process filings/
establishment on an annual basis x
3,000 establishments = 30,000 process
filings), resulting in a one-time reporting
burden of 9,900 hours (30,000 process
filings x 0.33 hours/establishment =
9,900 hours). Table 2 of this document
includes the estimated one-time
reporting burden for establishments that
voluntarily submit process filings for
fermented foods and/or acid foods.
submission of Form 2541a is 2,700
process filings rather than 2,725 process
filings (540 establishments x 5 process
filings per establishment = 2,700
process filings), resulting in an annual
reporting burden of 891 hours (2,700
process filings x 0.33 hours/process
filing = 891 hours). Table 2 of this
document includes the estimated onetime and recurring reporting burden for
establishments that voluntarily submit
process filings for foods that they
conclude are acid foods or fermented
foods that are not also acidified foods.
We also estimate that all 3,000
establishments that process foods that
they conclude are acid foods or
fermented foods that are not also
TABLE 2.—ESTIMATED ONE-TIME AND RECURRING REPORTING BURDEN1
Activity
No. of
Reporters
Registration (Form FDA 2541)2
Annual Frequency
per Reporter
Total Annual
Records
Hours per
Record
Total Hours
2,250
1
2,250
0.17
383
180
1
180
0.17
31
Process filing (Form FDA
2541a)2
3,000
10
30,000
0.33
9,900
Process filing (Form FDA
2541a)
540
5
2,700
0.33
891
Registration (Form FDA 2541)
Total one-time burden
10,283
Total recurring burden
922
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
reporting burden.
2 One-time
III. 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.
IV. Electronic Access
changes to Web site after this document
publishes in the Federal Register.)
1. Codex Alimentarius Commission,
Recommended International Code of
Hygienic Practice for Low and Acidified Low
Acid Canned Foods CAC/RCP 23–1979, Rev.
2 (1993), Available at https://www.codex
alimentarius.net/download/standards/24/
CXP_023e.pdf, Accessed and printed on June
17, 2008.
Dated: September 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24089 Filed 9–24–10; 8:45 am]
BILLING CODE 4160–01–S
srobinson on DSKHWCL6B1PROD with NOTICES
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov or at https://
www.fda.gov/FoodGuidances.
Jkt 220001
[CMS–1820–NC]
Medicare and Medicaid Programs;
Announcement of an Application from
a Hospital Requesting Waiver for
Organ Procurement Service Area
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
A hospital has requested a
waiver of statutory requirements that
would otherwise require the hospital to
enter into an agreement with its
designated Organ Procurement
Organization (OPO). The request was
made in accordance with section
1138(a)(2) of the Social Security Act (the
Act). This notice requests comments
from OPOs and the general public for
our consideration in determining
whether we should grant the requested
waiver.
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen between 9 a.m. and 4
p.m., Monday through Friday. (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
17:01 Sep 24, 2010
Centers for Medicare & Medicaid
Services
SUMMARY:
V. References
VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
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Fmt 4703
Sfmt 4703
E:\FR\FM\27SEN1.SGM
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Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices
Comment Date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
November 26, 2010.
ADDRESSES: In commenting, please refer
to file code CMS–1820–NC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the instructions under the ‘‘More Search
Options’’ tab.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1820–NC, P.O. Box 8010,
Baltimore, MD 21244–1850.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Department of
Health and Human Services, Attention:
CMS–1820–NC, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
srobinson on DSKHWCL6B1PROD with NOTICES
DATES:
VerDate Mar<15>2010
17:01 Sep 24, 2010
Jkt 220001
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Mark A. Horney, (410) 786–4554.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
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 42 CFR
§ 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.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
59273
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.
The criteria that the Secretary uses to
evaluate the waiver in these cases are
the same as those described above under
sections 1138(a)(2)(A) and (B) of the Act
and have been incorporated into the
regulations at § 486.308(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program
Memorandum (Transmittal No. A–95–
11) detailing the waiver process and
discussing the information hospitals
must provide in requesting a waiver. We
indicated that upon receipt of a waiver
request, we would publish a Federal
Register notice to solicit public
comments, as required by section
1138(a)(2)(D) of the Act.
According to these requirements, we
will review the request and comments
received. During the review process, we
may consult on an as-needed basis with
the Health Resources and Services
E:\FR\FM\27SEN1.SGM
27SEN1
59274
Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices
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 waiver
request and notify the hospital and the
designated and requested OPOs.
III. Hospital Waiver Requests
As permitted by § 486.308(e), the
following hospital has requested a
waiver in order to enter into an
agreement with a designated OPO other
than the OPO designated for the service
area in which the hospital is located:
War Memorial Hospital (Medicare
provider number 51–1309), of Berkeley
Springs, West Virginia, is requesting a
waiver to work with:
LifeNet Health, 1864 Concert Drive,
Virginia Beach, VA 23453.
The Hospital’s Designated OPO is:
Center for Organ Recovery and
Education, RIDC Park, 204 Sigma
Drive, Pittsburgh, PA 15238.
IV. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
(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: September 21, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–24100 Filed 9–24–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
srobinson on DSKHWCL6B1PROD with NOTICES
[CMS–1825–NC]
Medicare and Medicaid Programs;
Announcement of Application from
Hospital Requesting Waiver for Organ
Procurement Service Area
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
VerDate Mar<15>2010
17:01 Sep 24, 2010
Jkt 220001
A hospital has requested a
waiver of statutory requirements that
would otherwise require the hospital to
enter into an agreement with its
designated Organ Procurement
Organization (OPO). The request was
made in accordance with section
1138(a)(2) of the Social Security Act (the
Act). This notice requests comments
from OPOs and the general public for
our consideration in determining
whether we should grant the requested
waiver.
DATES: Comment Date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
November 26, 2010.
ADDRESSES: In commenting, please refer
to file code CMS–1825–NC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the instructions under the ‘‘More Search
Options’’ tab.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1825–NC, P.O. Box 8010,
Baltimore, MD 21244–1850.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Department of
Health and Human Services, Attention:
CMS–1825–NC, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to one of
the following addresses prior to the
close of the comment period:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
SUMMARY:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Mark A. Horney, (410) 786–4554.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
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
E:\FR\FM\27SEN1.SGM
27SEN1
]]>Agencies
[Federal Register Volume 75, Number 186 (Monday, September 27, 2010)]
[Notices]
[Pages 59272-59274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1820-NC]
Medicare and Medicaid Programs; Announcement of an Application
from a Hospital Requesting Waiver for Organ Procurement Service Area
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: A hospital has requested a waiver of statutory requirements
that would otherwise require the hospital to enter into an agreement
with its designated Organ Procurement Organization (OPO). The request
was made in accordance with section 1138(a)(2) of the Social Security
Act (the Act). This notice requests comments from OPOs and the general
public for our consideration in determining whether we should grant the
requested waiver.
[[Page 59273]]
DATES: Comment Date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on November 26, 2010.
ADDRESSES: In commenting, please refer to file code CMS-1820-NC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the instructions under
the ``More Search Options'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1820-NC, P.O. Box 8010,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Department of Health and Human Services,
Attention: CMS-1820-NC, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
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 42 CFR 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.
The criteria that the Secretary uses to evaluate the waiver in
these cases are the same as those described above under sections
1138(a)(2)(A) and (B) of the Act and have been incorporated into the
regulations at Sec. 486.308(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program Memorandum (Transmittal No. A-
95-11) detailing the waiver process and discussing the information
hospitals must provide in requesting a waiver. We indicated that upon
receipt of a waiver request, we would publish a Federal Register notice
to solicit public comments, as required by section 1138(a)(2)(D) of the
Act.
According to these requirements, we will review the request and
comments received. During the review process, we may consult on an as-
needed basis with the Health Resources and Services
[[Page 59274]]
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 waiver request and
notify the hospital and the designated and requested OPOs.
III. Hospital Waiver Requests
As permitted by Sec. 486.308(e), the following hospital has
requested a waiver in order to enter into an agreement with a
designated OPO other than the OPO designated for the service area in
which the hospital is located: War Memorial Hospital (Medicare provider
number 51-1309), of Berkeley Springs, West Virginia, is requesting a
waiver to work with:
LifeNet Health, 1864 Concert Drive, Virginia Beach, VA 23453.
The Hospital's Designated OPO is:
Center for Organ Recovery and Education, RIDC Park, 204 Sigma Drive,
Pittsburgh, PA 15238.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
(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: September 21, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-24100 Filed 9-24-10; 8:45 am]
BILLING CODE 4120-01-P
