Federal Register / Vol. 62, No. 150 / Tuesday, August 5, 1997 / Notices 42133

establishments. There are an estimated

3,021 FDA registered blood collection

facilities in the United States that

annually collect an estimated

23,500,000 units of whole blood and

source plasma. Of the 3,021 registered

establishments, 1,799 establishments

perform pheresis collections and 278

establishments perform transfusions.

There are also an estimated 4,500 Health

Care Financing Administration

registered transfusion services. The

recordkeeping chart reflects the estimate

that 95 percent of the recordkeepers

which collect 98 percent of the blood

supply had developed SOP’s as part of

their normal business practice.

Establishments may minimize burdens

associated with the CGMP and related

regulations by using model SOP’s

developed by blood organizations.

These blood organizations represent

almost all of the registered

establishments.

FDA estimates the burden of this

information collection as follows:

ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

606.170(b) 42 1 42 8 336

There are no capital costs or operating and maintenance costs associated with this information collection.

ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

606.100(b) 151 1 151 24 3,624

606.100(c) 151 3.6 550 3.6 550

606.110(a) 90 5 450 2.5 225

606.151(e) 239 12 2,868 1 239

606.160 151 3,112 470,000 1,556 234,956

606.165 151 3,112 470,000 258 38,958

606.170(a) 376 12 4,512 12 4,512

There are no capital costs or operating and maintenance costs associated with this information collection.

Dated: July 28, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20495 Filed 8-4-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0155]

Bio-Components, Inc.; Revocation of

U.S. License No. 1160

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of U.S. License No. 1160,

which includes the establishment

license and the product licenses for the

manufacture of Source Plasma and

Source Leukocytes, issued to BioComponents, Inc. (BCI). BCI did not

respond to a notice of opportunity for a

hearing on a proposal to revoke its

licenses.

DATES: The revocation of U.S. License

No. 1160 is effective August 5, 1997.

FOR FURTHER INFORMATION CONTACT:

Annette A. Ragosta, 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. 1160) and the product

licenses issued to Bio-Components, Inc.,

440 North Beach St., Daytona Beach, FL

32114, for the manufacture of Source

Plasma and Source Leukocytes. The

revocation is based on the failure of BCI,

and its responsible management to

conform to the applicable standards

established in the license and to the

applicable Federal regulations designed

to ensure the continued safety, purity,

and potency of the manufactured

product (see § 601.5(b)(4) (21 CFR

601.5(b)(4))).

In a letter dated May 13, 1994, FDA

informed BCI of the agency’s intent to

revoke the firm’s license and its intent

to issue an opportunity for a hearing on

the proposed revocation. In the Federal

Register of January 30, 1996 (61 FR

3040), FDA published a notice of

opportunity for a hearing on the

proposed revocation of the license

under § 12.21(b) (21 CFR 12.21(b)), as

provided in § 601.5(b). As described in

the notice of opportunity for a hearing,

the grounds for the proposed license

revocation were based on the results of

an FDA inspection of BCI conducted

between January 21, 1993, and February

12, 1993. FDA determined that the

deviations documented during the

January and February 1993 inspection

constituted a danger to the public health

and accordingly suspended BCI’s

license in a letter dated March 19, 1993.

FDA subsequently determined that BCI

demonstrated careless disregard for the

applicable regulations and the

applicable standards in its license due

to, among other things, the firm’s past

history of noncompliance and the firm’s

failure to submit an adequate corrective

action plan. Due to this evidence of

willfulness, FDA did not provide BCI

with further opportunity to demonstrate

or achieve compliance. Documentation

in support of the proposed 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 of opportunity for a

hearing provided BCI with 30 days to

submit a written request for a hearing,

as specified in § 12.21(b), and 60 days

to submit any data or information

justifying a hearing. The notice

provided other interested persons with

60 days to submit written comments on
42134 Federal Register / Vol. 62, No. 150 / Tuesday, August 5, 1997 / Notices

the proposed revocation action. BCI did

not submit, within the 30-day time

period, a written request for a hearing

on the proposed revocation of its

license. The 30-day time period,

prescribed in the notice of opportunity

for a hearing and in the regulations, may

not be extended. No other written

comments on the proposed revocation

were received within the prescribed 60

days specified in the notice of

opportunity for a hearing.

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 5.67), U.S. License No. 1160, issued

to Bio-Components, Inc., is revoked

effective August 5, 1997.

This notice is issued and published

under 21 CFR 601.8.

Dated: July 28, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20496 Filed 8-4-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0015]

Personal Blood Storage of Memphis,

Inc.; Revocation of U.S. License No.

1131

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. 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. Personal

Blood Storage of Memphis, Inc., 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.

1131) and the product licenses is

effective August 5, 1997.

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

revoking the establishment license (U.S.

License No. 1131) and the 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.

An attempted onsite inspection by

FDA on May 23, 1995, revealed that the

facility was no longer in operation at the

location listed on the license. An FDA

investigator, from the Nashville District

Office, was permitted to visit the

unoccupied facility on August 3, 1995.

The investigator documented that the

office space and two walk-in freezers

were empty and there was no electrical

or water service at the facility. Based on

the inability of authorized FDA

employees to conduct a meaningful

inspection of the facility, FDA initiated

proceedings for the revocation of the

licenses under 21 CFR 601.5(b)(1) and

(b)(2). 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 providing notice of

FDA’s intent to revoke the licenses and

its intent to offer an opportunity for a

hearing on the proposed revocation. 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 the Center for Biologics

Evaluation and Research (CBER), in

which she 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 this letter was returned by

the U.S. Postal Service as unclaimed.

Under § 12.21(b) (21 CFR 12.21(b)),

FDA published in the Federal Register

of April 24, 1996 (61 FR 18149), a notice

of opportunity for a hearing on a

proposal to revoke the licenses of

Personal Blood Storage of Memphis, Inc.

In the notice, FDA explained that the

proposed license revocation was based

on the inability of authorized 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 written

comments on the proposed revocation.

The firm did not respond within the 30-

day time period with a written request

for a hearing. Under § 12.21(b), the 30-

day time period, prescribed in the

notice of opportunity for a hearing and

in the regulations, may not be extended.

No other interested persons submitted

written comments on the proposed

revocation within the 60-day time

period.

Accordingly, under 21 CFR

12.38(a)(1), 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, CBER (21 CFR 5.67), the

establishment license (U.S. License No.

1131), and the product licenses issued

to Personal Blood Storage of Memphis,

Inc., are revoked, effective August 5,

1997.

This notice is issued and published

under 21 CFR 601.8.

Dated: July 28, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20494 Filed 8-4-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institutes of Allergy and

Infectious Diseases; Notice of 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 Allergy and

Infectious Diseases Special Emphasis

Panel (SEP) meeting:

Name of SEP: To evaluate research grant

R03 AI41597–01 (Telephone Conference

Call).

Date: August 11, 1997.

Time: 1:00 p.m. to Adjournment.

Place: Teleconference, 6003 Executive

Boulevard, Solar Bldg., Room 4C01,

Bethesda, MD 20892, (301) 496–2550.

Contact Person: Dr. Kevin Callahan,

Scientific Review Adm., 6003 Executive

Boulevard, Solar Bldg., Room 4C20,

Bethesda, Md 20892, (301) 496–8424.

Purpose/Agenda: To evaluate a grant

application.

This meeting will be closed in accordance

with the provisions set forth in sections

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

Applications and/or proposals and the