44972 Federal Register / Vol. 75, No. 146 / Friday, July 30, 2010 / Notices 

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 

Section 401(a) of the Children’s 

Health Insurance Program 

Reauthorization Act of 2009 (Pub. L. 

111–3) (CHIPRA), added section 1139A 

to the Social Security Act (the Act). 

Section 1139A(a)(6), as added by section 

(401)(a), requires the Secretary to report 

to the Congress by January 1, 2011, and 

every 3 years thereafter, on the status of 

the following factors that influence the 

quality of care given to children under 

the Medicaid and Children’s Health 

Insurance Program. 

• The duration and stability of health 

insurance coverage for children under 

titles XIX and XXI of the Social Security 

Act. 

• The quality of care provided under 

titles XIX and XXI for: 

+ Preventive health care services. 

+ Health care for acute conditions. 

+ Chronic health care. 

+ Health services to ameliorate the 

effects of physical and mental 

conditions and to aid in the growth 

and development of infants, young 

children, school-age children, and 

adolescents with special health care 

needs. 

• The quality of children’s health care 

under titles XIX and XXI, across the 

various domains of quality, including: 

+ Clinical quality. 

+ Health care safety. 

+ Family experience with health care. 

+ Health care in the most integrated 

setting. 

+ Elimination of racial, ethnic, and 

socio-economic disparities in health 

and health care. 

• The status of voluntary reporting by 

States under titles XIX and XXI, 

utilizing the initial core quality 

measurement set. Based on the 

assessment of these factors affecting the 

quality of care given to children under 

titles XIX and XXI, the Secretary is also 

required to make any recommendations 

for legislative changes that are needed to 

improve the quality of care provided to 

children under titles XIX and XXI, 

including recommendations for quality 

reporting by the States. 

II. Solicitation of Comments 

We request public comments for 

consideration in the formulation of 

legislative changes to be recommended 

by the Secretary, including 

requirements for the process and 

content of quality reporting by the 

States. We request that these suggestions 

address the dimensions of quality and 

the subject areas listed above. 

III. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

Dated: July 19, 2010. 

Marilyn Tavenner, 

Principal Deputy Administrator, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2010–18140 Filed 7–29–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1579–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application From 

a Hospital Seeking To Enter Into an 

Agreement With a Different Organ 

Procurement Organization 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: A hospital that had 

previously been granted a waiver under 

section 1138(a)(2) of the Social Security 

Act (the Act), has requested to enter into 

an agreement with a different Organ 

Procurement Organization (OPO). This 

notice requests comments from 

hospitals, OPOs, and the general public 

for our consideration in determining 

whether we should grant the request. 

We are particularly interested in 

information and material that will help 

determine whether the change is likely 

to increase organ donation and will 

ensure equitable treatment for patients 

in both affected OPO service areas. 

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 

September 28, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–1579–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 ‘‘Submit a comment’’ instructions. 

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–1579–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–1579–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 FURTHER INFORMATION CONTACT: 

Mark A. Horney, (410) 786–4554. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 146 / Friday, July 30, 2010 / Notices 44973 

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 § 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 comment 

period beginning on the publication 

date of the notice in the Federal 

Register. 

On June 11, 2010, we published a 

Federal Register notice (75 FR 33313) 

that established a public process for 

hospitals that had previously been 

granted a waiver under section 

1138(a)(2) of the Act. Under the notice, 

a hospital may request approval to work 

with a different OPO. 

II. Procedures for Requesting a Change 

in OPOs 

For hospitals that had previously been 

granted a waiver request under section 

1138(a)(2) of the Act but are now 

seeking to enter into an agreement with 

a different OPO, the hospital may file a 

request, by letter, to CMS containing the 

information set forth in the June 11, 

2010 notice (75 FR 33313). Upon receipt 

of a request, we publish a Federal 

Register notice to solicit public 

comments, modeled after 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 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 request to 

change the OPO and notify the hospital 

and the OPOs involved. 

III. Hospital Requests To Change OPOs 

As permitted by the June 11, 2010 

notice (75 FR 33313), the following 

hospital has requested to work with an 

OPO other than the OPO it had been 

designated to work through based on a 

previous waiver request: 

OSF St. Anthony Medical Center of 

Rockford, Illinois, Provider Number 14– 

0233, is requesting to work with: Gift of 

Hope Organ & Tissue Donor Network, 

425 Spring Lake Drive, Itasca, IL 60143. 

OSF St. Anthony Medical Center has 

an existing waiver to work with: UW 

Health Organ Procurement 

Organization, 450 Science Drive, Suite 

220, Madison, WI 53711. 

(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: July 21, 2010. 

Marilyn Tavenner 

Principal Deputy Administrator and Chief 

Operating Officer, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–18370 Filed 7–29–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0260] 

Report: A New Approach to Targeting 

Inspection Resources and Identifying 

Patterns of Adulteration: The 

Reportable Food Registry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a report entitled ‘‘A New 

Approach to Targeting Inspection 

Resources and Identifying Patterns of 

Adulteration: The Reportable Food 

Registry.’’ The report presents FDA’s 

experience with the Reportable Food 

Registry (RFR or the Registry) from the 

opening of the Reportable Food 

electronic portal on September 8, 2009, 

until March 31, 2010. 

ADDRESSES: Submit written requests for 

single copies of the report to the Office 

of Food Defense, Communication and 

Emergency Response (HFS–005), Center 

for Food Safety and Applied Nutrition, 


srobinson on DSKHWCL6B1PROD with NOTICES