Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices 58091

SUMMARY: Notice is hereby given that

ACYF will award grant funds without

competition to the National Adoption

Center, Inc. (NAC), Philadelphia,

Pennsylvania. This grant is a sole source

award which will support the operation

of the National Adoption Information

Exchange and the continued

development, expansion and

implementation of a national Internetbased photo-listing activity. This award

is made noncompetitively after our

review of a proposal submitted by the

NAC.

Background

In 1983, the National Adoption Center

(then doing business as the Adoption

Center of Delaware Valley) received a

competitive grant award for a fieldinitiated proposal to develop a

computerized database of children freed

for adoption and waiting placement

from state child welfare agencies. This

database activity became known as the

National Adoption Exchange and had

been authorized in law in 1978 with the

passage of the Adoption Opportunities

Act. Currently, children are entered into

the database by caseworkers from 44

States, though all 50 States are members

of the exchange system and may enter

information on adoptable children into

the database. Subsequent to the

development of the database/exchange

in the mid-1990s, NAC developed a

small internet-based listing, with

accompanying photographs, of some of

the children, using privately generated

funds and in-kind expert services from

computer software corporations.

Currently, this photo listing has

expanded to include children from 43

State child welfare agencies.

In 1998, President Clinton announced

an initiative to mount a national

internet-based photo listing of children

adoptable from public child welfare

agencies. In FY 2000, the Congressional

Conference Report Language included a

reference to NAC by saying, ‘‘The

conference agreement includes $400,000

for the National Adoption Center to

develop a national adoption photo

listing service on the Internet.’’ The

Senate Report Language also referenced

NAC by saying ‘‘The Committee

recognizes that, under the Adoption and

Safe Families Act, States are required to

use all available resources to find homes

for children. The Committee is aware

that the National Adoption Center

operates a multi-state, technology-based

adoption clearinghouse to facilitate

placement of needy children with

adoptive parents. The Committee

understands that the Department plans

to implement a national adoption photo

listing service on the Internet to help

increase the number of adoptions. The

Committee supports the idea that a

national web site could include all

youngsters available in public adoptions

and will increase the likelihood that

children will find loving, stable homes.

The National Adoption Center has been

at the forefront of developing and

implementing technology-based

resources to help facilitate adoptions

and could be instrumental in creating a

national adoption web site.’’

Following our review of the proposal

submitted by the NAC for these

activities, this award is made

noncompetively. The NAC proposal

presents a unique opportunity to

produce important progress on a set of

tasks of significant interest to the

Department.

The project period will be for 24

months, beginning September 29, 2000

and ending September 30, 2001. The

grantee will be awarded $900,000

during the first twelve months of the

project period. The grantee may, in the

second twelve months of the project

period, be awarded additional

noncompetitive continuation funding of

up to $1.6 million, depending on the

availability of funds, satisfactory

performance by the grantee, and a

determination that such continued

funding would be in the best interest of

the government.

Authority: This award will be made

pursuant to the Adoption Opportunities:

Title II of the Child Abuse Prevention and

Treatment and Adoption Reform Act of 1978,

as amended [42 U.S.C. 5111]. (CFDA 93.652).

FOR FURTHER INFORMATION CONTACT:

Sally Flanzer, Children’s Bureau,

Administration on Children, Youth and

Families, 330 C Street, SW, Room 2429,

Washington, D.C. 20447; Telephone:

(202) 205–8914.

Dated: September 20, 2000.

Patricia Montoya,

Commissioner, Administration on Children,

Youth and Families.

[FR Doc. 00–24717 Filed 9–26–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00F–0812]

Bayer Co.; Filing of Food Additive

Petition; Amendment; Withdrawal in

Part

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

filing notice for a food additive petition

filed by Bayer Co. to clarify that the

petitioner’s request to amend the food

additive regulations to provide for a

more descriptive term in place of

‘‘inhibitor of yeast,’’ for the safe use of

dimethyl dicarbonate (DMDC) will also

involve adding related limitations to 21

CFR 172.133. The agency is also

announcing the withdrawal of the

petitioner’s additional request to amend

the food additive regulations to provide

for the safe use of DMDC in

noncarbonated juice beverages

containing up to and including 100

percent juice.

FOR FURTHER INFORMATION CONTACT:

Martha D. Peiperl, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3077.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 7, 2000 (65 FR 12014), FDA

announced that a food additive petition

(FAP 0A4718) had been filed by Bayer

Co., c/o McKenna & Cuneo LLP, 1900 K

St. NW., Washington, DC 20006–1108.

The petition proposed to amend the

food additive regulations in § 172.133

Dimethyl dicarbonate (21 CFR 172.133)

both to provide for the safe use of

DMDC in noncarbonated juice beverages

containing up to and including 100

percent juice and to provide for a more

descriptive term in place of ‘‘inhibitor of

yeast,’’ for the safe use of DMDC.

Upon further review of the petition,

FDA determined that, if granted, the

requested amendment of § 172.133 to

provide for a more descriptive term in

place of ‘‘inhibitor of yeast’’ for the safe

use of DMDC will also require adding

related limitations to this regulation.

Therefore, FDA is amending the filing

notice of March 7, 2000, to indicate that

this proposed amendment will involve

adding related limitations to § 172.133.

The petitioner’s additional request, to

amend the food additive regulations to

provide for the safe use of DMDC in

noncarbonated juice beverages

containing up to and including 100

percent juice, was converted to a food

contact substance notice (FCN 0035), 21

U.S.C. 348(h)(5). This request to amend

the food additive regulations was

withdrawn from the petition as of the

effective date of FCN 0035 (June 9,

2000).

The agency has determined under 21

CFR 25.30(I) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

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.