Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Notices 17193

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Health Care Policy and

Research

Notice of Health Care Policy and

Research Special Emphasis Panel

Meeting

In accordance with section 10(a) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2), announcement is

made of the following special emphasis

panel scheduled to meet during the

month of April 1997:

Name: Health Care Policy and Research

Special Emphasis Panel.

Date and Time: April 28, 1997, 11 a.m.

Place; Agency for Health care Policy and

Research, 2101 E. Jefferson Street, Suite 400,

Rockville, MD 20852.

Open April 28, 1997, 11 a.m. to 11:10 a.m.

Closed for remainder of meeting.

Purpose: This Panel is charged with

conducting the initial review of grant

applications proposing analytical and

theoretical research on costs, quality, access,

and efficiency of the delivery of health

services for the research grant program

administered by the Agency for Health Care

Policy and Research (AHCPR).

Agenda: The open session of the meeting

on April 28, from 11 a.m. to 11:10 a.m., will

be devoted to a business meeting covering

administrative matters. During the closed

session, the panel will be reviewing and

discussing grant applications dealing with

health services research issues. In accordance

with the Federal Advisory Committee Act,

section 10(d) of 5 U.S.C., Appendix 2 and 5

U.S.C. 552b(c)(6), the Acting Administrator,

AHCPR, has made a formal determination

that this letter session will be closed because

the discussions are likely to reveal personal

information concerning individuals

associated with the grant applications. This

information is exempt from mandatory

disclosure.

Anyone wishing to obtain a roster of

members or other relevant information

should contact Carmen Johnson, Agency for

Health Care Policy and Research, Suite 400,

2101 East Jefferson Street, Rockville,

Maryland 20852, Telephone (301) 594–1449

x1613.

Agenda items for this meeting are subject

to change as priorities dictate.

Dated: March 31, 1997.

Lisa A. Simpson,

Acting Administrator.

[FR Doc. 97–9051 Filed 4–8–97; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Toxic Substances and

Disease Registry

Board of Scientific Counselors,

Agency for Toxic Substances and

Disease Registry: Meeting

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

the Federal Advisory Committee Act

(Pub. L. 92–463), the Agency for Toxic

Substances and Disease Registry

(ATSDR) announces the following

committee meeting.

Name: Board of Scientific Counselors,

Agency for Toxic Substances and Disease

Registry (BSC, ATSDR).

Times and Dates: 8:30 a.m.–5 p.m., April

28, 1997; 9 a.m.–3 p.m., April 29, 1997.

Place: The Chattanooga Choo-Choo

Holiday Inn, 400 Market Street, Chattanooga,

Tennessee 37402.

Status: Open to the public, limited by the

available space.

Purpose: The Board of Scientific

Counselors, ATSDR, advises the Secretary;

the Assistant Secretary for Health; and the

Administrator, ATSDR, on ATSDR programs

to ensure scientific quality, timeliness,

utility, and dissemination of results.

Specifically, the Board advises on the

adequacy of the science in ATSDR-supported

research, emerging problems that require

scientific investigation, accuracy and

currency of the science in ATSDR reports,

and program areas to emphasize and/or to deemphasize. In addition, the Board

recommends research programs and

conference support for which the Agency

seeks to make grants to universities, colleges,

research institutions, hospitals, and other

public and private organizations.

Matters to be Discussed: Agenda items will

include a visit to a hazardous waste site; an

update on the ATSDR Child Health Initiative

Work Group recommendations; a discussion

on the Brownfields Initiative; the ATSDR

response to the Community/Tribal Forum

recommendations; an overview on

environmental medicine and health

promotion, partners in 3 health promotion,

and medical monitoring criteria for the

Hanford Nuclear Reservation; and a

discussion on placing a site on inactive

status.

Written comments are welcome and should

be received by the contact person listed

below prior to the opening of the meeting.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Charles Xintaras, Sc.D., Executive Secretary,

BSC, ATSDR, M/S E–28, 1600 Clifton Road,

NE, Atlanta, Georgia 30333, telephone 404/

639–0708.

Dated: April 3, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–9067 Filed 4–8–97; 8:45 am]

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Board of Scientific Counselors,

National Institute for Occupational

Safety and Health: Charter Renewal

This gives notice under the Federal

Advisory Committee Act (Pub. L. 92–

463) of October 6, 1972, that the Board

of Scientific Counselors, National

Institute for Occupational Safety and

Health (BSC, NIOSH), Centers for

Disease Control and Prevention (CDC),

Department of Health and Human

Services, has been renewed for a 2-year

period beginning February 3, 1997,

through February 3, 1999.

For further information, contact Bryan

D. Hardin, Ph.D., Executive Secretary,

BSC, NIOSH, CDC, 200 Independence

Avenue, SW., Washington, DC. 20201,

telephone 202/401–0721 or fax 202/

260–4464.

Dated: April 3, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–9043 Filed 4–8–97; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0115]

SEF, P.A.; Opportunity for Hearing on

a Proposal to Revoke U.S. License No.

1166

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. 1166) and the product

licenses issued to SEF, P.A., doing

business as National Health Guard, Inc.,

for the manufacture of Whole Blood and

Red Blood Cells. The proposed

revocation is based on the

establishment’s discontinuance of

product manufacturing to the extent that

a meaningful inspection cannot be

made.

DATES: The firm may submit a written

request for a hearing to the Dockets

Management Branch by May 9, 1997
17194 Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Notices

and any data and information justifying

a hearing by June 9, 1997. Other

interested persons may submit written

comments on the proposed revocation

by June 9, 1997.

ADDRESSES: Submit written requests for

a hearing, and any data and information

that would justify a hearing, including

any comments on the proposed

revocation to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

initiating proceedings to revoke the

establishment license (U.S. License No.

1166) and product licenses issued to

SEF, P.A., doing business as National

Health Guard, Inc., 1885 West

Commercial Blvd., suite 140, Fort

Lauderdale, FL 33309, for the

manufacture of Whole Blood (CPDA–1)

and Red Blood Cells (RBC) including

frozen, deglycerolized, frozen

rejuvenated, and rejuvenated

deglycerolized RBC’s. Proceedings to

revoke the licenses are being initiated

because an inspection of the facility by

FDA revealed that the firm was no

longer in operation.

On February 13, 1996, FDA attempted

to inspect the SEF, P.A., facility located

at 1820 North University Dr., Plantation,

FL. The facility was found to be vacant.

A visit that same day to the firm’s

previous business address, 1885 West

Commercial Blvd., suite 140, Fort

Lauderdale, FL, found that location to

be vacant as well. Later that same day,

February 13, 1996, FDA contacted by

telephone the person on file with the

agency as being the responsible head of

SEF, P.A. The individual informed FDA

that he had resigned from the firm on

July 12, 1995, because he lacked

sufficient authority to bring the firm

into compliance with FDA regulations.

The individual also informed FDA that

the person succeeding him as the

responsible head had resigned in

December 1995, and that the firm had

ceased operations in January or

February of 1996.

In a telephone conversation between

FDA and the owner of SEF, P.A., on

February 28, 1996, the owner stated that

all the firm’s equipment was stored in

a Miami, FL, warehouse. During this

conversation the owner indicated that

he would voluntarily surrender the

firm’s license since SEF, P.A., was no

longer in operation and there were no

plans to resume operations. After this

telephone conversation, FDA made

several attempts to obtain the voluntary

revocation of the firm’s license. This

effort included telephone calls on

March 21 and 27, 1996, and April 9,

1996. On each occasion, a secretary or

receptionist took a message from FDA

requesting the owner to return FDA’s

calls. On April 15, 1996, FDA was

contacted by the owner who verified

that the firm was out of business and

that a letter from him requesting the

voluntary revocation of U.S. License No.

1166 would be forthcoming. On June 17,

1996, FDA successfully contacted the

owner who indicated that he no longer

desired to relinquish the license.

Further attempts to contact the owner

on July 2 and 29, 1996, were

unsuccessful. On both occasions,

messages were left with the answering

party that were never replied to by the

owner. On August 1, 1996, the last two

known locations of the SEF, P.A., were

visited again by FDA investigators who

determined that both locations were

vacant and displayed no evidence of

recent business activity. On October 10,

1996, FDA contacted the State of

Florida, Agency for Health Care

Administration, which reported that

Florida License No. 800001631 held by

SEF, P.A., had been terminated on July

2, 1996.

FDA sent a certified, return-receipt

letter dated November 1, 1996, to the

firm’s owner. The letter stated that

under 21 CFR 601.5(b) a license may be

revoked when the Commissioner of

Food and Drugs (the Commissioner)

finds that: (1) Authorized FDA

employees after reasonable efforts have

been unable to gain access to an

establishment or a location for the

purposes of carrying out an inspection,

or (2) manufacturing of products or of a

product has been discontinued to an

extent that a meaningful inspection or

evaluation cannot be made. The letter

provided the firm’s owner notice of

FDA’s intent to revoke U.S. License No.

1166 and announced FDA’s intent to

offer an opportunity for a hearing.

Because SEF, P.A., is no longer in

operation and is not manufacturing any

products, a meaningful inspection

required under 21 CFR 600.21 cannot be

conducted. Furthermore, FDA made

reasonable efforts to obtain the

voluntary revocation of the firm’s

licenses. Therefore, FDA is proceeding

under to 21 CFR 12.21(b) and

publishing this notice of opportunity for

a hearing on a proposal to revoke the

licenses of the above establishment.

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 the following:

(1) Intention to revoke license letter

dated November 1, 1996; (2)

memorandum of investigation

inspection March 5, 1996. These

documents are available for public

examination in the Dockets

Management Branch (address above)

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

through Friday.

SEF, P.A., may submit a written

request for a hearing to the Dockets

Management Branch by May 9, 1997

and any data and information justifying

a hearing must be submitted by June 9,

1997. Other interested persons may

submit written comments on the

proposed revocation by June 9, 1997.

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 procedures and requirements

governing a notice of opportunity for a

hearing, notice of appearance and

request for a hearing, and submission of

data and information to justify a hearing

on a 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 that requires a hearing. If

it conclusively appears from the face of

the data, information, and factual

analyses submitted in support of the

request for a hearing that there is no

genuine and substantial issue of fact for

resolution at a hearing, or if a request for

a hearing is not made within the

requested time, or in the required format

or is not accompanied by the required

analyses, the Commissioner will deny

the hearing request, making available

the findings and conclusions that justify

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. The

public availability of information in

submissions is governed by 21 CFR

10.20(j)(2)(i). Publicly available

submissions 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
Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Notices 17195

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Director of CBER (21

CFR 5.67).

Dated: March 27, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 97–8987 Filed 4–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Statement of Organization, Functions,

and Delegations of Authority

Part D, Chapter DB (Office of

Operations) of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (35 FR 3685, February 25,

1970, and 60 FR 56605, November 9,

1995, and in pertinent part at 56 FR

50126, October 3, 1991) is amended to

reflect the reorganization of the Center

for Veterinary Medicine (CVM), Office

of Operations, in the Food and Drug

Administration (FDA).

The Center for Veterinary Medicine

will continue to develop and

recommend the veterinary medical

policy of the Agency with respect to the

safety and effectiveness of animal drugs,

feeds, feed additives, veterinary medical

devices (medical devices for animal

use), and other veterinary medical

products. The restructuring of the

Center is proposed to strengthen the

delivery of services to our constituents

and customer groups by streamlining

the organization through delayering

lines of authority and responsibility,

and improving channels of

communications at all levels within the

Center.

1. Delete Office of the Center Director

(HFV1), Center for Veterinary Medicine

(HFV), in its entirety and replace with

the following:

Office of the Center Director (DBVA).

Directs overall Center activities and

coordinates and establishes Center

policy in the areas of research,

management, scientific evaluation,

compliance and surveillance.

Approves new animal drug

applications and issues notices of

withdrawal of new animal drug

approvals when the opportunity for a

hearing has been waived.

Authorizes for use as edible products

animals treated with investigational

drugs and terminates exemptions for

investigational trials. In conjunction

with appropriate agency officials in the

foods area, provides FDA policy

development and direction on

environmental impact matters.

Serves as focal point for operational

review and compliance activity policy

and legislative matters; serves as focal

point for international harmonization

and trade issues related to animal drugs

and feeds; leads and provides oversight

of research animal issues for FDA.

Plans, develops and implements the

Center’s Equal Employment

Opportunity and Affirmative Action

Program.

Develops, reviews, and coordinates all

Federal Register publications pertaining

to Center functions and coordinates

requests and activities pertaining to the

Regulatory Flexibility Act, Executive

Orders on Regulations, Paperwork

Reduction Act, and regulations planning

and implementation.

2. Delete the Office of Management

(HFV1A), Center for Veterinary

Medicine (HFV), in its entirety and

replace with the following:

Office of Management and

Communications (DBVB). Provides

guidance and leadership in the analysis,

planning, coordination and evaluation

of administrative management activities

including: personnel; employee

orientation and development;

procurement; travel; facilities; property;

security; records management;

performance management; awards;

budget formulation and execution;

information resources management;

program analysis; and management

analysis. Provides administrative

assistance and support to the Veterinary

Medicine Advisory Committee (VMAC)

Executive Secretary.

Plans, develops, and implements

Center management policies. Provides

leadership and direction for the

management and administrative

interface with the Agency, the

Department and other Federal agencies.

Serves as Center interface with the

Agency and Department on budget issue

resolutions.

Performs analysis, program

assessments, or special studies of key

issues relative to policy review and

oversight. Directs a variety of shortrange and long-range special projects or

assignments of substantial significant to

the Center.

Implements Internal Control Reviews

in accordance with the Office of

Management and Budget, Department

and Agency guidelines. Provides

direction in the preparation of responses

to the Office of Inspector General and

the General Accounting Office regarding

audits and investigation.

Directs the Center’s outreach efforts to

consumers, professionals and the

industry in communicating the program

goals and priorities of the Center.

Maintains the CVM Home Page on the

World Wide Web. Provides automated

scientific literature searches and

retrieval support. Supports public and

consumer affairs, including freedom of

information.

Directs the Center’s Strategic Plan and

the efforts of Strategic Implementation

Groups (SIG) to effectively accomplish

Center goals and objectives. Facilitates

implementation of SIG

recommendations.

3. Insert Administrative Staff (DBVB–

1), under the Office of Management and

Communications (DBVB), reading as

follows:

Administrative Staff (DBVB–1). Serves

as the focal point in the Center for

administrative management activities.

Coordinates the administrative

management activities in the Offices

with designated Administrative

Officers, i.e., personnel management,

property acquisition and surplus,

inventory, procurement, travel services,

security procedures, records

management, performance management,

conflict of interest, special government

employees, and telecommunications.

Safeguards the administrative

management services against waste,

fraud and abuse.

Manages the Center’s award systems

through the Strategic Plan Awards

Committee and the CVM Incentive

Awards Committee. Manages CVM’s

participation in the Agency’s Honor

Award process, including the first and

second tier ceremonies.

Provides budget execution and fiscal

accounting services for the Center.

Monitors and provides officials with

continual awareness of obligated

commitments and status of funds.

Directs, develops and implements the

Center’s overall professional, scientific,

technical, clerical, and management

training programs; formal career

development programs and New

Employee Orientation Program.

Coordinates all Special training

programs from the Agency and

Department.

4. Insert Communications Staff

(DBVB–2), under the Office of

Management and Communications

(DBVB), reading as follows:

Communications Staff (DBVB–2).

Plans, produces, and publishes a

bimonthly subscription newsletter

entitled the FDA VETERINARIAN and

other publications such as CVM

UPDATES and consumer fliers.

Supports FDA public affairs/

consumer affairs initiatives, including