Federal Register / Vol. 66, No. 25 / Tuesday, February 6, 2001 / Notices 9087

206), Food and Drug Administration,

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

202–418–3032.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 1M4727) has been filed by

the National Fisheries Institute, 1901

North Fort Myer Dr., Arlington, VA

22209. The petition proposes to amend

the food additive regulations in Part 179

Irradiation in the Production, Processing

and Handling of Food (21 CFR part 179)

to provide for the safe use of ionizing

radiation for control of foodborne

pathogens in raw-, frozen-, cooked-,

partially cooked-, shelled-, or driedcrustaceans, or cooked- or ready-to-cook

crustaceans processed with batter,

breading, spices, or small amounts of

other food ingredients.

The agency has determined under 21

CFR 25.32(j) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: January 11, 2001.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 01–3095 Filed 2–5–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1672]

Ashford Blood Bank, Inc.; Opportunity

for Hearing on a Proposal to Revoke

U.S. License No. 0740–001

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for a hearing on a proposal

to revoke the establishment license (U.S.

License No. 0740–001) and product

licenses issued to Ashford Blood Bank,

Inc., for the manufacture of Whole

Blood and Red Blood Cells. The

proposed revocation is based on the fact

that authorized FDA employees have

been unable to gain access to either of

the establishment’s locations for the

purpose of carrying out a required

inspection of the facility and that the

manufacturing of products has been

discontinued to an extent that a

meaningful inspection or evaluation

cannot be made.

DATES: The firm may submit written

requests for a hearing by March 8, 2001,

and any data and information justifying

a hearing by April 9, 2001. Other

interested persons may submit written

comments on the proposed revocation

by April 9, 2001.

ADDRESSES: Submit written requests for

a hearing, any data and information

justifying a hearing, and any written

comments on the proposed revocation

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Joseph L. Okrasinski, Center for

Biologics Evaluation and Research

(HFM–17), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6210.

SUPPLEMENTARY INFORMATION: FDA is

initiating proceedings to revoke the

establishment license (U.S. License No.

0740–001) and product licenses issued

to Ashford Blood Bank, Inc., Ashford

Medical Center, suite 401–402,

Santurce, PR 00907, for the manufacture

of Whole Blood and Red Blood Cells.

Proceedings to revoke the licenses are

being initiated because: (1) Authorized

FDA employees have been unable to

gain access to either of the

establishment’s locations for the

purpose of carrying out a required

inspection of the facility, and (2)

manufacturing of products has been

discontinued to an extent that a

meaningful inspection or evaluation

cannot be made.

In a certified return-receipt letter

dated October 28, 1997, FDA notified an

authorized official of the firm that FDA

had suspended the firm’s establishment

and product licenses for the

manufacture of Whole Blood and Red

Blood Cells at its facilities at Santurce,

PR, and Bayamon, PR. This action was

based on the fact that significant

deviations from the regulations were

noted by FDA’s San Juan district office

during inspections of the facilities

conducted August 19, 1997, through

September 17, 1997, and September 9,

1997, through September 17, 1997,

respectively. FDA’s San Juan district

office attempted to conduct additional

inspections of the two Ashford facilities.

On May 1, 1998, FDA investigators

attempted to inspect the satellite

collection facility at Bayamon, PR, but

found that the facility was no longer in

operation, and the manufacturing of

Whole Blood and Red Blood Cells had

been discontinued. On November 23,

1999, FDA investigators attempted to

inspect the main facility in Santurce,

PR, but found that the facility was no

longer in operation and the

manufacturing of Whole Blood and Red

Blood Cells had been discontinued.

In certified, return-receipt letters

dated April 13, 2000, sent to the firm’s

facility at Santurce, PR, and also to the

Ashford Blood Bank, Inc., P.O. Box

195034, San Juan, PR, 00919, FDA

notified an authorized official of the

firm that FDA’s attempts to conduct

inspections of the two facilities at

Santurce, PR and Bayamon, PR were

unsuccessful because the facilities were

no longer in operation and the

manufacture of Whole Blood and Red

Blood Cells had been discontinued. The

letter also advised the authorized

official that, under 21 CFR 601.5(b)(1)

and (b)(2) (now codified as 21 CFR

601.5(b)(1)(i) and (b)(1)(ii)), when FDA

finds that authorized employees have

been unable to gain access to an

establishment for the purpose of

carrying out an inspection under 21 CFR

600.21, or the manufacturing of

products or of a product has been

discontinued to an extent that a

meaningful inspection cannot be made,

the Commissioner of Food and Drugs

(the Commissioner) shall institute

proceedings for license revocation. In

the same letter, FDA stated that a

meaningful inspection could not be

made at the establishment and notified

the firm of FDA’s intent to revoke U.S.

License No. 0740–001 and its intent to

offer an opportunity for a hearing.

Because FDA has made reasonable

efforts to notify the firm of the proposed

revocation and has not received any

response from the firm to the revocation

letter, FDA is proceeding under 21 CFR

12.21(b) and publishing this notice of

opportunity for a hearing on a proposal

to revoke the licenses of the previously

mentioned firm.

FDA has placed copies of the

documents relevant to the proposed

revocation on file with the Dockets

Management Branch (address above)

under the docket number found in

brackets in the heading of this notice.

These documents include: (1) Summary

of Findings, May 1, 1998; (2)

memorandum regarding FDA visit to

Santurce location, November 23, 1999;

and (3) FDA letters to the authorized

official dated October 28, 1997, and

April 13, 2000. These documents are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Ashford Blood Bank, Inc., may submit

a written request for a hearing to the

Dockets Management Branch by March

9088 Federal Register / Vol. 66, No. 25 / Tuesday, February 6, 2001 / Notices

8, 2001, and any data and information

justifying a hearing must be submitted

by April 9, 2001. Other interested

persons may submit written comments

on the proposed license revocation to

the Dockets Management Branch by

April 9, 2001. The failure of the licensee

to file a timely written request for a

hearing constitutes an election by the

licensee not to avail itself of the

opportunity for a hearing concerning the

proposed license revocation.

FDA’s procedures and requirements

governing a notice of opportunity for a

hearing, notice of appearance and

request for a hearing, grant or denial of

a hearing, and submission of data to

justify a hearing on proposed revocation

of a license are contained in 21 CFR

parts 12 and 601. A request for a hearing

may not rest upon mere allegations or

denials but must set forth a genuine and

substantial issue of fact. If the

Commissioner determines upon review

of any objections or requests for a

hearing that a hearing is not justified, in

whole or in part, or if a request for a

hearing is not made within the required

time with the required format or

required analyses, the Commissioner

will deny the hearing request, with an

explanation for the denial.

Two copies of any submissions are to

be provided to FDA, except that

individuals may submit one copy.

Submissions are to be identified with

the docket number found in brackets in

the heading of this document. Such

submissions, except for data and

information prohibited from public

disclosure under 21 CFR 10.20(j)(2)(i),

21 U.S.C. 331(j), or 18 U.S.C. 1905, may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

This notice is issued under section

351 of the Public Health Service Act (42

U.S.C. 262) and sections 201, 501, 502,

505, and 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 351,

352, 355, and 371), and under the

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Director of the Center

for Biologics Evaluation and Research

(21 CFR 5.67).

Dated: January 24, 2001.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 01–3094 Filed 2–5–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Notice of Hearing: Reconsideration of

Disapproval of Missouri State Plan

Amendment (SPA) 99–29

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of hearing.

SUMMARY: This notice announces an

administrative hearing on March 8,

2001, at 10:00 a.m., Plaza Room 664,

Richard Bolling Federal Building, 601 E.

Twelfth Street, Kansas City, Missouri

64106, to reconsider our decision to

disapprove Missouri SPA 99–29.

CLOSING DATE: Requests to participate in

the hearing as a party must be received

by the presiding officer by February 21,

2001.

FOR FURTHER INFORMATION CONTACT:

Kathleen Scully-Hayes, Presiding

Officer, HCFA, C1–09–13, 7500 Security

Boulevard, Baltimore, MD 21244,

Telephone: (410) 786–2055.

SUPPLEMENTARY INFORMATION: This

notice announces an administrative

hearing to reconsider HCFA’s decision

to disapprove Missouri’s SPA 99–29.

Missouri submitted SPA 99–29 on

December 29, 1999, which proposed to

pay for school-based assessment

services described in an individualized

education plan pursuant to the

Individuals with Disabilities Education

Act (IDEA) using a bundled rate

methodology. One rate would be paid

for a variable package of assessment

services, regardless of the number of

assessment services provided to a

particular child. As explained below,

HCFA disapproved Missouri SPA 99–29

after consulting with the Secretary on

October 31, 2000.

Section 1116 of the Social Security

Act (the Act) and 42 CFR part 430,

establish Department procedures that

provide an administrative hearing for

reconsideration of a disapproval of a

State plan or plan amendment. HCFA is

required to publish a copy of the notice

to a State Medicaid agency that informs

said agency of the time and place of the

hearing and the issues to be considered.

If the agency is subsequently notified of

additional issues that will be considered

at the hearing, that notice will also be

published.

In accordance with the requirements

contained at 42 CFR 430.76(b)(2), any

individual or group that wants to

participate in the hearing as a party

must petition the presiding officer

within 15 days after publication of this

notice. Any interested person or

organization that wants to participate as

amicus curiae must petition the

presiding officer before the hearing

begins in accordance with the

requirements contained at 42 CFR

430.76(c). If the hearing is later

rescheduled, the presiding officer will

notify all participants.

The first issue is whether payment for

Medicaid services using a bundled rate

methodology, under which payment is

made at a single rate for one or more in

a group of different services furnished to

an eligible individual over a fixed

period of time, meets the conditions set

forth in section 1902(a)(30) of the Act.

Section 1902(a)(30)(A) provides that

Medicaid State plans must provide for

such methods and procedures relating

to the payment for care and services

available under the plan as may be

necessary to ensure that payments are

consistent with efficiency, economy,

and quality of care. The amendment

proposed to pay for school-based

assessment services furnished pursuant

to the IDEA using a bundled rate

methodology. Under the proposed

payment methodology, one rate would

be paid for a variable package of

assessment services, regardless of the

number of assessment services provided

to a particular child. As explained

below, HCFA was unable to approve

Missouri SPA 99–29 because the

proposed payment methodology was not

in compliance with section

1902(a)(30)(A) of the statute, and could

not generate sufficient documentation to

establish such compliance.

On May 21, 1999, HCFA issued a

letter to all State Medicaid directors

indicating that it would no longer

approve State plan amendments

proposing reimbursement for schoolbased health services using a bundled

rate. That letter described a bundled rate

as a single rate for one or more in a

group of different services furnished to

an eligible individual during a fixed

period of time. In the May 21 letter,

HCFA explained that such rates do not

ensure accurate and reasonable

payments consistent with efficiency,

economy, and quality of care.

Specifically, HCFA stated that the

bundled rate is inconsistent with

economy since the rate is not designed

to accurately reflect true costs or

reasonable fee-for-service rates. The

bundled rate is also inconsistent with

efficiency since it requires substantially

more Federal oversight resources to

establish the accuracy and

reasonableness of State expenditures. In

sum, HCFA concluded that, with a

bundled rate, there is no reliable basis

for determining that the payments