Federal Register / Vol. 62, No. 150 / Tuesday, August 5, 1997 / Notices 42131

dealing in, to a limited extent, all types

of debt and equity securities, other than

interests in open end investment

companies; See J.P. Morgan & Co., Inc.,

et al., 75 Fed. Res. Bull. 192 (1989) and

Citicorp, et al., 73 Fed. Res. Bull. 473

(1987); underwriting and dealing in

bank-eligible securities, pursuant to §

225.28(b)(8) of the Board’s Regulation Y;

providing securities brokerage services

on either a stand-alone or full-service

basis, pursuant to § 225.28(b)(7) of the

Board’s Regulation Y; acting as agent for

issuers and holders in the private

placement of various types of securities

with financially sophisticated

counterparties in a non-public offering,

pursuant to § 225.28(b)(7) of the Board’s

Regulation Y; buying and selling on the

order of investors as a riskless principal,

pursuant to § 225.28(b)(7) of the Board’s

Regulation Y; making, acquiring or

servicing loans or other extensions of

credit, including purchasing and selling

such loans and extensions of credit in

the secondary market, and engaging in

mortgage banking activities, pursuant to

§ 225.28(b)(1) of the Board’s Regulation

Y; acting as an investment or financial

advisor to the extent of (i) serving as the

advisory company for a mortgage or real

estate investment trust; (ii) serving as an

investment adviser to an investment

company registered under the 1940 Act,

including sponsoring, organizing and

managing a closed-end investment

company; (iii) providing portfolio

investment advice; (iv) furnishing

general economic information and

advice, general economic statistical

forecasting services and industry

studies; and/or (v) providing financial

advice to state and local governments,

such as with respect to the issuance of

their securities, pursuant to §

225.28(b)(6) of the Board’s Regulation Y;

providing advice and acting as arranger

in connection with merger, acquisition,

divestiture and financial transactions,

including public and private financings,

loan syndications, interest rate and

currency swaps, interest rate caps and

similar transactions and/or furnishing

evaluation and fairness opinions in

connection with merger, acquisition,

and similar transactions, pursuant to §§

225.28(b)(6) and (b)(7) of the Board’s

Regulation Y; acting as agent or broker

with respect to interests in loan

syndications, interest rate and currency

swaps, interest rate caps, floors and

collars, and options on such

instruments, pursuant to § 225.28(b)(7)

of the Board’s Regulation Y; leasing

personal or real property or acting as

agent, broker or adviser in leasing such

property, pursuant to § 225.28(b)(3) of

the Board’s Regulation Y; providing

management consulting advice to nonaffiliated depository institutions,

pursuant to § 225.28(b)(9) of the Board’s

Regulation Y; engaging in futures,

forward and option contracts on bankeligible securities for hedging purposes,

pursuant to § 225.28(b)(8) of the Board’s

Regulation Y; engaging in securities

credit activities, pursuant to the Federal

Reserve’s Regulation T (covering credit

by brokers and dealers), including

acting as a ‘‘conduit’’ or ‘‘intermediary’’

in securities borrowing and lending,

pursuant to § 225.28(b)(7) of the Board’s

Regulation Y; and serving as the general

partner of and holding equity interests

in certain limited partnerships that

would be exempt from registration

under the 1940 Act, See Meridian

Bancorp, Inc., 80 Fed. Res. Bull. 736

(1994).

B. Federal Reserve Bank of Atlanta

(Lois Berthaume, Vice President) 104

Marietta Street, N.W., Atlanta, Georgia

30303-2713:

1. C B & T, Inc., McMinnville,

Tennessee; to acquire CBT Insurance,

Inc., Smithville, Tennessee, and thereby

continue to engage in insurance

activities, pursuant to § 225.28(b)(11) of

the Board’s Regulation Y. The proposed

activity will be conducted throughout

the state of Tennessee.

Board of Governors of the Federal Reserve

System, July 31, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–20584 Filed 8-4-97; 8:45 am]

BILLING CODE 6210-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Agency Information Collection

Activities: Proposed Collections;

Comment Request

The Department of Health and Human

Services, Office of the Secretary will

periodically publish summaries of

proposed information collections

projects and solicit public comments in

compliance with the requirements of

Section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995. To request more

information on the project or to obtain

a copy of the information collection

plans and instruments, call the OS

Reports Clearance Officer on (202) 690–

6207.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Projects 1. Voluntary

Industry ‘‘Partner’’ Survey to Implement

Executive Order 12862—The

Department of Health and Human

Services plans to conduct mail surveys

of its contractors in each agency to

obtain feedback for improving

acquisition products and services—

Respondents: Contractors of the

Department; Annual Responses: 2400;

Average Burden per Response: 12

minutes; Total Annual Burden: 480

hours

Send comments to Cynthia Agens

Bauer, OS Reports Clearance Officer,

Room 503H, Humphrey Building, 200

Independence Avenue, S.W.,

Washington, DC, 20201. Written

comments should be received within 60

days of this notice.

Dated: July 30, 1997.

Dennis P. Williams,

Deputy Assistant Secretary, Budget.

[FR Doc. 97–20569 Filed 8–4–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0311]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

reinstatement of an existing collection

of information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection provisions

relating to the regulation of FDA’s

current good manufacturing practice
42132 Federal Register / Vol. 62, No. 150 / Tuesday, August 5, 1997 / Notices

(CGMP) and related regulations for

blood and blood components.

DATES: Submit written comments on the

collection of information by October 6,

1997.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed reinstatement

of an existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

CGMP and Related Regulations for

Blood and Blood Components—Parts

606 and 640 (21 CFR Parts 606 and

640)—(OMB Control Number 0910–

0116)—Reinstatement

Under the statutory requirements

contained in the Public Health Service

Act (42 U.S.C. 262), no blood, blood

component, or derivative may move in

interstate commerce unless: (1) It is

propagated or manufactured and

prepared at an establishment holding an

unsuspended and unrevoked license; (2)

the product complies with regulatory

standards designed to ensure safety,

purity, and potency; and (3) it bears a

label plainly marked with the product’s

proper name, its manufacturer, and

expiration date.

The CGMP and related regulations

implement FDA’s statutory authority to

ensure the safety, purity, and potency of

blood and blood components. The

information collection requirements in

the CGMP regulations provide FDA with

the necessary information to perform its

duty to ensure the safety, purity, and

potency of blood and blood

components. These requirements

establish accountability and traceability

in the processing and handling of blood

and blood components and enable FDA

to perform meaningful inspections. The

recordkeeping requirements serve

preventative and remedial purposes.

The disclosure requirements identify

the various blood and blood

components and important properties of

the product, demonstrate that the CGMP

requirements have been met, and

facilitate the tracing of a product back

to its original source. The reporting

requirements inform FDA of any

deviations that occur and that may

require immediate corrective action.

Section 606.100(b) requires that

written standard operating procedures

(SOP’s) be maintained for the collection,

processing, compatibility testing,

storage and distribution of blood and

blood components used for transfusion

and manufacturing purposes. Section

606.100(c) requires the review of all

pertinent records to a lot or unit of

blood prior to release of the lot or unit.

Any unexplained discrepancy or failure

of a lot or unit of final product to meet

any of its specifications must be

thoroughly investigated, and the

investigation, including conclusions

and followup, must be recorded. Section

606.110(a) requires a physician to

certify in writing that the donor’s health

permits plateletpheresis or

leukapheresis if a variance from

additional regulatory standards for a

specific product is used when obtaining

the product from a specific donor for a

specific recipient. Section 606.151(e)

requires that records of expedited

transfusions in life-threatening

emergencies be maintained. So that all

steps in the collection, processing,

compatibility testing, storage and

distribution, quality control, and

transfusion reaction reports and

complaints for each unit of blood and

blood components can be clearly traced,

§ 606.160 requires that legible and

indelible contemporaneous records of

each significant step be made and

maintained for no less than 5 years.

Section 606.165 requires that

distribution and receipt records be

maintained to facilitate recalls, if

necessary. Section 606.170(a) requires

records to be maintained of any reports

of complaints of adverse reactions as a

result of blood collection or transfusion.

Each such report must be thoroughly

investigated, and a written report,

including conclusions and followup,

must be prepared and maintained.

Section 606.170(b) requires that fatal

complications of blood collections and

transfusions be reported to FDA as soon

as possible and that a written report

shall be submitted within 7 days. In

addition to the CGMP’s in part 606,

there are regulations in part 640 that

require additional standards for blood

and blood components: §§ 640.3(a) and

(f), 640.4(a), 640.25(b)(4) and (c)(1),

640.27(b), 640.31(b), 640.33(b),

640.51(b), 640.53(c), 640.56(b) and (d),

640.61, 640.63(b)(3), (e)(1) and (e)(3),

640.65(b)(2), 640.66, 640.71(b)(1),

640.72, 640.73, and 640.76(a) and (b).

The information collection requirements

and estimated burdens for these

regulations are included in the part 606

burden estimates, as described below.

The recordkeeping requirements for

§§ 640.3(a)(1), 640.4(a)(1), and 640.66,

which address the maintenance of

SOP’s, are included in the estimate for

§ 606.100(b); the recordkeeping

requirements for § 640.27(b), which

addresses the maintenance of donor

health records for plateletpheresis, is

included in the estimate for

§ 606.110(a); and the recordkeeping

requirements for §§ 640.3(a)(2), 640.3(f),

640.4(a)(2), 640.25(b)(4) and (c)(1),

640.31(b), 640.33(b), 640.51(b),

640.53(c), 640.56(b) and (d), 640.61,

640.63(b)(3), (e)(1), and (e)(3),

640.65(b)(2), 640.71(b)(1), 640.72, and

640.76(a) and (b), which address the

maintenance of various records, are

included in the estimate for § 606.160.

The reporting requirement in § 640.73,

which addresses the reporting of fatal

donor reactions, is included in the

estimate for § 606.170(b).

Respondents to this collection of

information are registered blood
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