Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Notices 18149

concerning state plan disapproval. The

Office contributes to the development of

national policy based on regional

perspectives on all ACF programs. It

oversees ACF operations, the

management of ACF regional staff;

coordinates activities across regional

programs; and assures that goals and

objectives are met and departmental and

agency initiatives are carried out. The

Office alerts the Assistant Secretary for

Children and Families to problems and

issues that may have significant regional

or national impact. The Office

represents ACF at the regional level in

executive communications within ACF,

with the HHS Regional Director, other

HHS operating divisions, other federal

agencies, and public or private local

organizations representing children and

families.

Within the Office of the Regional Hub

Director, the Program Coordination and

Planning Unit (PCPU), headed by the

Executive Officer and consisting of

administrative staff, assists the Regional

Hub Director in providing day-to-day

support for regional administrative

functions, including budget, internal

systems, employee relations and human

resource development activities. The

PCPU develops and implements the

regional planning process. Tracking,

monitoring and reporting on regional

progress in the attainment of ACF

national goals and objectives are carried

out. The PCPU coordinates public

awareness activities, information

dissemination and education campaigns

in accordance with the ACF Office of

Public Affairs and in conjunction with

the HHS Regional Director. The unit

also assists the Regional Hub Director in

management of cross-cutting initiatives

and activities among the regional

components, and ensures effective and

efficient management of internal

automation processes.

For Regions 4 and 9, delete paragraph

A and replace with the following:

KD.20 Functions. A. The Office of the

Regional Hub Director is headed by a

Director, who reports to the Assistant

Secretary for Children and Families

through the Director, Office of Regional

Operations and State Systems. The

Office is responsible for the

Administration for Children and

Families’ key national goals and

priorities. It represents ACF’s regional

interests, concerns, and relationships

within the Department and among other

Federal agencies and focuses on State

agency culture change, more effective

partnerships, and improved customer

service. It provides executive leadership

and direction to state, county, city,

territorial and tribal governments, as

well as public and private local grantees

to ensure effective and efficient program

and financial management. The Office

ensures that these entities conform to

federal laws, regulations, policies and

procedures governing the programs, and

exercises all delegated authorities and

responsibilities for oversight of the

programs. The Office takes action to

approve state plans and submits

recommendations to the Assistant

Secretary for Children and Families

concerning state plan disapproval. The

Office contributes to the development of

national policy based on regional

perspectives on all ACF programs. It

oversees ACF operations, the

management of ACF regional staff;

coordinates activities across regional

programs; and assures that goals and

objectives are met and departmental and

agency initiatives are carried out. The

Office alerts the Assistant Secretary for

Children and Families to problems and

issues that may have significant regional

or national impact. It represents ACF at

the regional level in executive

communications within ACF, with the

HHS Regional Director, other HHS

operating divisions, other federal

agencies, and public or private local

organizations representing children and

families.

Within the Office of the Regional Hub

Director, an administrative staff assists

the Regional Hub Director in providing

day-to-day support for regional

administrative functions, including

budget, internal systems, employee

relations, and human resource

development activities. The Staff

develops and implements the regional

planning process. It tracks, monitors

and reports on regional progress in the

attainment of ACF national goals and

objectives. The Staff coordinates public

awareness activities, information

dissemination and education campaigns

in accordance with the ACF Office of

Public Affairs and in conjunction with

the HHS Regional Director. It assists the

Regional Hub Director in management

of cross-cutting initiatives and activities

among the regional components, and

ensures effective and efficient

management of internal automation

processes.

IV. Within Chapter KD, replace the

term ‘‘Regional Administrator’’ with

‘‘Regional Hub Director’’ in Regions 2, 4,

5, 6 and 9.

Dated: April 17, 1996.

Mary Jo Bane,

Assistant Secretary for Children and Families.

[FR Doc. 96–10008 Filed 4–23–96; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 96N–0015]

Personal Blood Storage of Memphis,

Inc.; Opportunity for Hearing on a

Proposal to Revoke U.S. License No.

1131

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. 1131) and the product

licenses issued to Personal Blood

Storage of Memphis, Inc., for the

manufacture of Whole Blood, Red Blood

Cells, Plasma, and Platelets. The

proposed revocation is based on the

establishment’s discontinuing of

manufacturing of products to the extent

that a meaningful inspection or

evaluation cannot be made.

DATES: The firm may submit a written

request for a hearing to the Dockets

Management Branch by May 24, 1996,

and any data and information justifying

a hearing by June 24, 1996. Other

interested persons may submit written

comments on the proposed revocation

by June 24, 1996.

ADDRESSES: Submit written requests for

a hearing, any data and information

justifying a hearing, and 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:

Gloria J. Hicks, 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.

1131) and product licenses issued to

Personal Blood Storage of Memphis,

Inc., formerly located at 5182 East

Raines Rd., Memphis, TN 38118, for the

manufacture of Whole Blood, Red Blood

Cells, Plasma, and Platelets. 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 May 23, 1995, an FDA investigator

attempted to conduct an inspection of

Personal Blood Storage of Memphis,

Inc., and found that the facility was

vacant. Communication with the person

listed as the responsible head indicated

that all of the firm’s employees were
18150 Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Notices

dismissed on March 3, 1995. During a

June 1, 1995, telephone conversation

with FDA staff at the Center for

Biologics Evaluation and Research

(CBER), one of the owners of the firm

stated that the firm ceased operations in

December 1994. FDA explained that it

could move to revoke the license if the

firm remained inoperative. FDA

requested a written response within 30

days regarding whether the owners

intended to reopen the establishment.

As of July 24, 1995, none of the owners

had contacted FDA regarding the firm’s

intentions. In addition, messages left by

FDA staff on one owner’s telephone

answering machine were not answered.

An FDA investigator, from the Nashville

District Office, was permitted to visit

the unoccupied facility by the property

owner on August 3, 1995. The

investigator documented that the office

space and two walk-in freezers were

empty and that there was no electrical

or water service at the facility. The U.S.

Postal Service supplied FDA with the

firm’s forwarding address, and FDA sent

a certified letter, dated September 8,

1995, to the firm’s responsible head.

The certified letter stated that, under 21

CFR 601.5(b), a license may be revoked

if the Commissioner finds that after

reasonable efforts authorized FDA

employees have been unable to gain

access to an establishment for the

purposes of conducting an inspection,

or that the manufacturing of a product

has been discontinued to an extent that

a meaningful inspection cannot be

made. The letter also stated that

following repeated attempts to conduct

an inspection, FDA had determined that

a meaningful inspection could not be

made. The letter provided the firm’s

responsible head notice of FDA’s intent

to revoke U.S. License No. 1131 and

announced FDA’s intent to offer an

opportunity for a hearing. The

responsible head responded by

telephone on September 12, 1995, and

said that she was no longer employed by

Personal Blood Storage of Memphis, Inc.

She also sent a copy of a March 3, 1995,

letter to CBER in which she had stated

that she was no longer the Technical

Director or responsible head for

Personal Blood Storage of Memphis, Inc.

A copy of FDA’s letter of intent to

revoke U.S. License No. 1131 was also

sent to one owner’s address in Texas

and was returned by the U.S. Postal

Service as unclaimed.

Because FDA made reasonable efforts

to notify the firm of the proposed

revocation and no response was

received from the firm, FDA is

proceeding pursuant to 21 CFR 12.21(b)

and publishing this notice of an

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

license 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) Record of teleconference dated June

1, 1995; (2) letter to FDA from

responsible head dated March 3, 1995;

(3) Summary of Findings dated August

3, 1995, (Endorsement-Form FDA 481);

(4) FDA certified letter to responsible

head dated September 8, 1995; (5) copy

of information returned from the U.S.

Postal Service showing that the copy of

FDA certified letter of September 8,

1995, sent to one owner’s Texas address,

was unclaimed; and (6) record of

teleconference dated September 12,

1995. These documents are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Personal Blood Storage of Memphis,

Inc., may submit a written request for a

hearing to the Dockets Management

Branch by May 24, 1996, and any data

and information justifying a hearing

must be submitted by June 24, 1996.

Other interested persons may submit

comments on the proposed revocation

by June 24, 1996. 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, grant or denial of

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 with the required analyses, the

Commissioner of Food and Drugs 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 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 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: April 12, 1996.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 96–10025 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

Grassroots Regulatory Partnership

Meeting; Southeast Region, Atlanta

District Office; Turkey/Broiler Industry

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) (Office of

External Affairs, Office of Regulatory

Affairs, Office of the Southeast Region,

and Center for Veterinary Medicine) is

announcing a free public meeting.

FDA’s Atlanta District Office (Southeast

Region) and the Center for Veterinary

Medicine will meet with interested

persons in the Southeast Region to

address specific issues related to the

turkey/broiler industry. The agency is

holding this meeting to promote the

President’s initiative for a partnership

approach with front-line regulators and

the people affected by the work of the

agency, and to create local partnerships.

DATES: The public meeting will be held

on Tuesday, May 14, 1996, from 8 a.m.

to 5 p.m.

ADDRESSES: The public meeting will be

held at the Sheraton Inn—Raleigh at

Crabtree Valley, 4501 Creedmoor Rd.,

Raleigh, NC 27812. Attendees requiring

overnight accommodations may contact

the hotel at 919–787–7111.

FOR FURTHER INFORMATION CONTACT:

JoAnn M. Pittman, FDA Atlanta District,

60 Eighth St. NE., Atlanta, GA 30309,

404–347–7355, or FAX 404–347–1912.