Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Notices 21337 

that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has federalism implications. 

Since this regulation does not impose 

any costs on State or local governments, 

the requirements of Executive Order 

13132 are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

Dated: December 17, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: January 22, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–8498 Filed 4–13–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1343–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. 

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 

June 22, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–1343–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 http://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–1343–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: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–1343–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: http:// 

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. 

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 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

21338 Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Notices 

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 

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 an OPO other than the 

OPO designated for the service area in 

which the hospital is located: 

Jennie Stuart Medical Center 

(Medicare provider number 18–0051) of 

Hopkinsville, Kentucky, is requesting a 

waiver to work with: Kentucky Organ 

Donor Affiliates, 106 E. Broadway, 

Louisville, Kentucky 40202. 

The Hospital’s Designated OPO is: 

Tennessee Donor Services, 7015 

Middlebrook Pike, Knoxville, Tennessee 

37909. 

(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: April 15, 2010. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2010–9504 Filed 4–22–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Subcommittee for Dose 

Reconstruction Reviews (SDRR), 

Advisory Board on Radiation and 

Worker Health (ABRWH), National 

Institute for Occupational Safety and 

Health (NIOSH) 

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 following meeting for the 

aforementioned subcommittee: 

Time and Date: 3 p.m.–5 p.m., May 

10, 2010. 

Teleconference: Audio Conference 

Call via FTS Conferencing. The USA toll 

free dial in number is 1–866–659–0537 

with a pass code of 9933701. 

Status: Open to the public, but 

without a public comment period. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 to advise the 

President on a variety of policy and 

technical functions required to 

implement and effectively manage the 

new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines that 

have been promulgated by the 

Department of Health and Human 

Services (HHS) as a final rule; advice on 

methods of dose reconstruction which 

have also been promulgated by HHS as 

a final rule; advice on the scientific 

validity and quality of dose estimation 

and reconstruction efforts being 

performed for purposes of the 

compensation program; and advice on 

petitions to add classes of workers to the 

Special Exposure Cohort (SEC). 

In December 2000, the President 

delegated responsibility for funding, 

staffing, and operating the Advisory 

Board to HHS, which subsequently 

delegated this authority to CDC. NIOSH 

implements this responsibility for CDC. 

The charter was issued on August 3, 

2001, renewed at appropriate intervals, 

and will expire on August 3, 2011. 

Purpose: The Advisory Board is 

charged with (a) Providing advice to the 

Secretary, HHS, on the development of 

guidelines under Executive Order 

13179; (b) providing advice to the 

Secretary, HHS, on the scientific 

validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advise the Secretary on 

whether there is a class of employees at 

any Department of Energy facility who 

were exposed to radiation but for whom 

it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such 

radiation doses may have endangered 

the health of members of this class. The 

Subcommittee for Dose Reconstruction 

Reviews was established to aid the 

Advisory Board in carrying out its duty 

to advise the Secretary, HHS, on dose 

reconstruction. 

Matters to be Discussed: The agenda 

for the Subcommittee meeting includes: 

selection of individual radiation dose 

reconstruction cases to be considered 

for review by the Advisory Board. 

The agenda is subject to change as 

priorities dictate. 

In the event an individual cannot 

attend, written comments may be 

submitted. Any written comments 

received will be provided at the meeting 

and should be submitted to the contact 

person below well in advance of the 

meeting. 

Contact Person for More Information: 

Theodore Katz, Executive Secretary, 

NIOSH, CDC, 1600 Clifton Road, 

Mailstop E–20, Atlanta GA 30333, 

Telephone (513) 533–6800, Toll Free 1 

(800)CDC–INFO, E-mail ocas@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES