Federal Register / Vol. 62, No. 197 / Friday, October 10, 1997 / Notices 53011

Dated: October 3, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–26984 Filed 10–9–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0115]

SEF, P.A.; Revocation of U.S. License

No. 1166

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of 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 (RBC’s). SEF, P.A., did

not respond to a notice of opportunity

for a hearing on a proposal to revoke its

licenses.

DATES: The revocation of the

establishment license (U.S. License No.

1166) and the product licenses is

effective October 10, 1997.

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

revoking 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 RBC’s including frozen,

deglycerolized, frozen rejuvenated, and

rejuvenated deglycerolized RBC’s.

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. On February 28, 1996,

the owner of SEF, P.A., stated that all

the firm’s equipment was stored in a

warehouse in Miami, FL. The owner

also indicated that he would voluntarily

surrender the firm’s license because

SEF, P.A. was no longer in operation

and there were no plans to resume

operations. On June 17, 1996, FDA

successfully contacted the owner by

telephone and he 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.

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 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.

Under 21 CFR 12.21(b), FDA

published in the Federal Register of

April 9, 1997 (62 FR 17193), a notice of

opportunity for a hearing on a proposal

to revoke the licenses of SEF, P.A. In the

notice, FDA explained that the proposed

license revocation was based on the

inability of FDA employees to conduct

a meaningful inspection of the facility

because it was no longer in operation

and noted that documentation in

support of the license revocation had

been placed on file for public

examination with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. The notice provided the firm 30

days to submit a written request for a

hearing and 60 days to submit any data

and information justifying a hearing.

The notice provided other interested

persons with 60 days to submit

comments on the proposed revocation.

The firm did not respond within the 30-

day time period with a written request

for a hearing. The 30-day time period,

prescribed in the notice of opportunity

for a hearing and in the regulation, may

not be extended. No comments were

received from any other parties.

Accordingly, under 21 CFR 12.38,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), the establishment license

(U.S. License No. 1166) and the product

licenses issued to SEF, P.A. are revoked,

effective October 10, 1997.

Dated: September 25, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 97–26987 Filed 10–9–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Closed Meetings

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

National Center for Research Resources

Special Emphasis Panel (SEP) meetings:

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 3, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.

Contact Person: Dr. D.G. Patel, Scientific

Review Administrator, 6705 Rockledge Drive,

MSC 7965, Room 6018, Bethesda 20892–

7965, (301) 435–0820.

Purpose/Agenda: To evaluate and review

grant applications.

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 4, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.

Contact Person: Dr. D.G. Patel, Scientific

Review Administrator, 6705 Rockledge Drive,

MSC 7965, Room 6018, Bethesda 20892–

7965, (301) 435–0820.

Purpose/Agenda: To evaluate and review

grant applications.

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 5, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.

Contact Person: Dr. D.G. Patel, Scientific

Review Administrator, 6705 Rockledge Drive,

MSC 7965, Room 6018, Bethesda 20892–

7965, (301) 435–0820.

Purpose/Agenda: To evaluate and review

grant applications.

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 7, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.
53012 Federal Register / Vol. 62, No. 197 / Friday, October 10, 1997 / Notices

Contact Person: Dr. D.G. Patel, Scientific

Review Administrator, 6705 Rockledge Drive,

MSC 7965, Room 6018, Bethesda 20892–

7965, (301) 435–0820.

Purpose/Agenda: To evaluate and review

grant applications.

These meetings will be closed in

accordance with the provisions set forth in

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

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

application and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.371, Biomedical Research

Technology, National Institutes of Health,

HHS)

Dated: October 3, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–26886 Filed 10–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Meeting of the Sickle Cell

Disease Advisory Committee

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

Sickle Cell Disease Advisory

Committee, National heart, Lung, and

Blood Institute, November 14, 1997. The

meeting will be held at the National

Institutes of Health, Rockledge II,

Conference Room 9104, 6701 Rockledge

Drive, Bethesda, Maryland 20892.

The entire meeting will be open to the

public from 9:00 a.m. to adjournment, to

discuss recommendations on the

implementation and evaluation of the

Sickle Cell Disease Program. Attendance

by the public will be limited to space

available.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact the Executive Secretary in

advance of the meeting.

Dr. Clairce D. Reid, Executive

Secretary, Sickle Cell Disease Advisory

Committee, Division of Blood Diseases

and Resource, NHLBI, Two Rockledge

Center, Suite 10160, 6701 Rockledge

Drive, Bethesda, Maryland 20892, (301)

435–0080, will furnish substantive

program information, a summary of the

meeting, and a roster of the committee

members.

(Catalog of Federal Domestic Assistance

Program No. 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: October 3, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–26888 Filed 10–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; 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

National Institute of Child Health and

Human Development Special Emphasis

Panel (SEP) meeting:

Name of SEP: NICHD Training Grant

Review.

Date: October 22–23, 1997.

Time: October 22–8:00 a.m.–5:00 p.m.;

October 23–8:00 a.m.–adjournment.

Place: Holiday Inn—Silver Spring, 8777

Georgia Avenue, Silver Spring, Maryland

20910.

Contact Person: Gopal M. Bhatnagar, Ph.D.,

Scientific Review Administrator, DSR, 6100

Executive Boulevard, Room 5E01, Bethesda,

Maryland 20892. Telephone: 301–496–1485.

Purpose/Agenda: To evaluate and review

research grant applications.

This meeting will be closed in accordance

with the provisions set forth in sections

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

discussion of these applications could reveal

confidential trade secrets of commercial

property such as patentable material and

personal information concerning individuals

associated with the applications, the

disclosure of which would constitute a

clearly unwarranted invasion of personal

privacy.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Nos. [93.864, Population Research

and No. 93.865, Research for Mothers and

Children], National Institutes of Health, HHS)

Dated: October 3, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–26881 Filed 10–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Arthritis and

Musculoskeletal and Skin Diseases,

Closed Meeting

Purusant 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

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

Special Emphasis Panel (SEP) meeting:

Name of SEP: NIAMS SEP SCOR Review.

Date: November 17–18, 1997.

Time: November 17—8:00 a.m.–5:00 p.m.;

November 18—8:00 a.m.—adjournment.

Place: Holiday Inn Chevy Chase, 5520

Wisconsin Avenue, Bethesda, Maryland

20815.

Contact Person: Aftab A. Ansari, Ph.D.,

Scientific Review Administrator, Natcher

Building, 45 Center Drive, Rm 5AS25U,

Bethesda, Maryland 20892–6500, Telephone:

301–594–4952.

Purpose/Agenda: To evaluate and review

research grant applications.

This meeting will be closed in accordance

with the provisions set forth in sections

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

discussion of these applications could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the applications, the

disclosure of which would constitute a

clearly unwarranted invasion of personal

privacy.

(Catalog of Federal Domestic Assistance

Program Nos. [93.846, Project Grants in

Arthritis, Musculoskeletal and Skin Diseases

Research], National Institutes of Health,

HHS)

Dated: October 3, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–26882 Filed 10–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Neurological

Disorders and Stroke; Division of

Extramural Activities; 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:

Name of Committee: National Institute of

Neurological Disorders and Stroke Special

Emphasis Panel.

Date: December 4, 1997.

Time: 10:00 a.m.