58092 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: September 14, 2000.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 00–24843 Filed 9–26–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1145–NC]

Medicare and Medicaid Programs;

Announcement of Additional

Applications From Hospitals

Requesting Waivers for Organ

Procurement Service Areas

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice with comment period.

SUMMARY: This notice announces two

additional applications that we have

received from hospitals requesting

waivers from entering into agreements

with their designated organ

procurement organizations (OPOs) in

accordance with section 1138(a)(2) of

the Social Security Act. This notice

requests comments from OPOs and the

general public for our consideration in

determining whether we should grant

these waivers.

DATES: We will consider comments if

we receive them at the appropriate

address, as provided below, no later

than 5 p.m. on November 27, 2000.

ADDRESSES: Mail written comments (1

original and 3 copies) to the following

address: Health Care Financing

Administration, Department of Health

and Human Services, Attention: HCFA–

1145–NC, P.O. Box 8016, Baltimore, MD

21244–8016.

To ensure that mailed comments are

received in time for us to consider them,

please allow for possible delays in

delivering them.

If you prefer, you may deliver your

written comments (1 original and 3

copies) to one of the following

addresses: Room 443–G, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201, or

Room C5–16–03, 7500 Security

Boulevard, Baltimore, MD 21244–1850.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

HCFA–1145–NC. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 3

weeks after publication of a document,

in Room 443–G of the Department’s

offices at 200 Independence Avenue,

SW., Washington, DC, on Monday

through Friday of each week from 8:30

a.m. to 5 p.m. (phone: (202) 690–7890).

FOR FURTHER INFORMATION CONTACT:

Mark A. Horney, (410) 786–4554.

SUPPLEMENTARY INFORMATION:

I. Background

Section 1138(a)(1)(A)(iii) of the Social

Security Act (the Act) provides that a

hospital must notify the designated OPO

(for the service area in which it is

located), as defined under section

1138(a)(3)(B) of the Act, of potential

organ donors. Under section

1138(a)(1)(C) of the Act, the hospital

must have an agreement to identify

potential donors only with that

designated OPO.

Section 1138(a)(2) of the Act provides

that the hospital may obtain a waiver

from the Secretary of these

requirements. A waiver allows the

hospital to have an agreement with an

OPO, other than the designated OPO, if

the hospital meets 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 a

hospital’s waiver.

Section 1138(a)(2)(A) further 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 service area

due to the changes made in definitions

for metropolitan statistical areas

(MSAs); 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 within 30 days of

receiving the application and offer

interested parties an opportunity to

comment in writing within 60 days of

the published notice.

The regulations at 42 CFR 486.316(d)

provide that if we change the OPO

designated for an area, hospitals located

in that area must enter into agreements

with the newly designated OPO or

submit a request for a waiver within 30

days of notice of the change in

designation. 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 §§ 486.316(e) and (f).

Section 486.316(g) further specifies that

a hospital may continue to operate

under its existing agreement with a now

out-of-area OPO while we are

processing the waiver request submitted

in accordance with § 486.316(d).

II. Waiver Request Procedures

In October 1995, we issued a Program

Memorandum (Transmittal No. A–95–

11) that has been supplied to each

hospital. This Program Memorandum

detailed the waiver process and

discussed the information that hospitals

must provide in requesting a waiver. We

indicated that upon receipt of the

waiver requests, we would publish a

Federal Register notice to solicit public

comments, as required by section

1138(a)(2)(D) of the Act.

We will review the requests and

comments received. During the review

process, we may consult on an asneeded basis with the Public Health

Service’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 requests

and notify the affected hospitals and

OPOs.

III. Additional Hospital Waiver

Requests

As allowed under § 486.316(e), each

of the following two hospitals has

requested a waiver to have an agreement

with an alternative, out-of-area OPO.

The listing includes the name of the

facility, the city and State of the facility,

the requested OPO, and the currently

designated area OPO. This request is not

a result of a governmental change;

therefore, the exception under

§ 486.316(g) does not apply to these two

hospitals. Moreover, these hospitals

may not work with the requested OPOs

rather than the designated OPOs until

the completion of our review.

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices 58093

Name of facility City State Requested OPO Designated

OPO

Copley Hospital ................................................................. Morrisville ............................ VI NYAP MAOB

Mercy Memorial Hospital .................................................. Urbana ................................. OH OHLC OHLP

IV. Keys to the OPO Codes

The keys to the acronyms used in the

listings to identify OPOs and their

addresses are as follows:

MAOB ........... New England Organ Bank,

One Gateway Center,

Newton, MA 02158.

NYAP ............ Center for Donation and

Transplant, 218 Great

Oaks Blvd, Albany, NY

12203.

OHLC ............ Life Connection of Ohio,

1545 Holland Road, Suite

C, Maumee, OH 43537–

1694.

OHLP ............ Lifeline of Ohio, 770

Kinnear Road, Suite 200,

Columbus, OH 43212.

V. Collection of Information

Requirements

Under the Paperwork Reduction Act

of 1995, we are required to provide 60-

day notice in the Federal Register and

solicit public comment before a

collection of information requirement is

submitted to the Office of Management

and Budget (OMB) for review and

approval. In order to fairly evaluate

whether an information collection

requirement should be approved by

OMB, section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995

requires that we solicit comment on the

following issues:

• The need for the information

collection and its usefulness in carrying

out the proper functions of our agency.

• The accuracy of our estimate of the

information collection burden.

• The quality, utility, and clarity of

the information to be collected.

• Recommendations to minimize the

information collection burden on the

affected public, through the use of

automated collection techniques or

other forms of information technology.

Section 486.316 states the

requirements for a Medicare or

Medicaid participating hospital to

request a waiver permitting the hospital

to have an agreement with an OPO other

than the OPO designated for the service

area in which the hospital is located.

The burden associated with these

requirements are currently approved

under OMB 0938–0688, HCFA–R–13,

Conditions of Coverage for Organ

Procurement Organizations, with an

expiration date of November 30, 2001.

Authority: Section 1138 of the Social

Security Act (42 U.S.C. 1320b–8).

(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: August 31, 2000.

Robert A. Berenson,

Director, Center for Health Plans and

Providers, Health Care Financing

Administration.

[FR Doc. 00–24820 Filed 9–26–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

White House Initiative on Asian

Americans and Pacific Islanders,

President’s Advisory Commission;

Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to conduct a

public meeting by teleconference during

the month October 2000.

Name: President’s Advisory Commission

on Asian Americans and Pacific Islanders

(AAPIs).

Date and Time: October 11, 2000; 5 p.m.–

7 p.m. EST.

The President’s Advisory Commission on

AAPIs will conduct a public meeting by

teleconference on October 11, from 5 p.m. to

7 p.m. EST inclusive. The meeting is open to

the public; however, teleconference lines are

limited. Please call Mr. Tyson Nakashima,

(301) 443–2492, if you are interested in

participating in the call and to obtain the

dial-in number. Agenda items will include,

but will not be limited to: Approval of

September Commission meeting minutes;

reports from subcommittees; administrative

tasks; and deadlines.

The purpose of the Commission is to

advise the President on the issues facing

Asian Americans and Pacific Islanders

(AAPIs). Requests to address the Commission

should be made in writing and should

include the name, address, telephone number

and business or professional affiliation of the

interested party. Individuals or groups

addressing similar issues are encouraged to

combine comments and present through a

single representative. The allocation of time

for remarks may be adjusted to accommodate

the level of expressed interest. Written

requests should be faxed to (301) 443–0259.

Anyone who has interest in joining any

portion of the meeting or who requires

additional information about the Commission

should contact: Mr. Tyson Nakashima, Office

of the White House Initiative on AAPIs,

Parklawn Building, Room 10–42, 5600

Fishers Lane, Rockville, MD, 20857,

Telephone (301) 443–2492. Anyone who

requires special assistance, such as sign

language interpretation or other reasonable

accommodations, should contact Mr.

Nakashima no later than October 4, 2000.

Dated: September 21, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–24845 Filed 9–26–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute Special Emphasis Panel, Shared

Pathology Informatics Network.

Date: October 30–31, 2000.

Time: 7 pm to 5 pm.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn Bethesda, 8120

Wisconsin Ave, Bethesda, MD 20814.

Contact Person: Kenneth L. Bielat,

Scientific Review Administrator, Division of

Extramural Activities, National Cancer

Institute, National Institutes of Health, 6116

Executive Boulevard, Room 8043, Bethesda,

MD 20892, (301) 496–7576.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and