9706 Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices

from the National Information Center

website at www.ffiec.gov/nic/.

Unless otherwise noted, comments

regarding each of these applications

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than March 8, 2001.

A. Federal Reserve Bank of

Richmond (A. Linwood Gill, III, Vice

President) 701 East Byrd Street,

Richmond, Virginia 23261–4528:

1. BB&T Corporation, Winston-Salem,

North Carolina; to merge with Century

South Banks, Inc., Alpharetta, Georgia,

and Independent Bancorp, Inc., Oxford,

Alabama, and thereby indirectly acquire

Century South Bank of Alabama,

Oxford, Alabama; Century South Bank

of Central Georgia, National

Association, Macon, Georgia; Century

South Bank of Dahlonega, Dahlonega,

Georgia; Century South Bank of

Danielsville, Danielsville, Georgia;

Century South Bank of Dawsonville,

Dawsonville, Georgia; Century South

Bank of Ellijay, Ellijay, Georgia; Century

South Bank of Fannin County, National

Association, Blue Ridge, Georgia;

Century South Bank of Lavonia,

Lavonia, Georgia; Century South Bank

of Northeast Georgia, National

Association; Gainesville, Georgia;

Century South Bank of Polk County,

Copperhill, Tennessee; and Century

South Bank of the Coastal Region,

National Association, Savannah,

Georgia.

In connection with this application,

Applicant also has applied to acquire

HBI Acquisition Corp., Waynesboro,

North Carolina, and thereby indirectly

acquire Century South Bank of the

Carolinas, FSB, Waynesville, North

Carolina, and thereby engage in

operating a savings association,

pursuant to § 225.28(b)(4)(ii) of

Regulation Y.

B. Federal Reserve Bank of

Minneapolis (JoAnne F. Lewellen,

Assistant Vice President), 90 Hennepin

Avenue, Minneapolis, Minnesota

55480–0291:

1. Native American Bancorporation,

Co., Denver, Colorado; to become a bank

holding company by acquiring 100

percent of the voting shares of Blackfeet

National Bank, Browning, Montana.

C. Federal Reserve Bank of Kansas

City (D. Michael Manies, Assistant Vice

President), 925 Grand Avenue, Kansas

City, Missouri 64198–0001:

1. American State Bancshares, Inc.,

Great Bend, Kansas; to become a bank

holding company by acquiring 100

percent of the voting shares of American

State Bank & Trust Company, NA, Great

Bend, Kansas.

Board of Governors of the Federal Reserve

System, February 6, 2001.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 01–3393 Filed 2–8–01; 8:45 am]

BILLING CODE 6210–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0048]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Current Good

Manufacturing Practice Regulations for

Type A Medicated Articles

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

(PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the recordkeeping requirements for

manufacturers of Type A medicated

articles.

DATES: Submit written or electronic

comments on the collection of

information by April 10, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

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 set forth in this document.

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.

Current Good Manufacturing Practice

Regulations for Type A Medicated

Articles—21 CFR 226 (OMB Control No.

0910–0154)—Extension

Under section 501 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 351), FDA has the statutory

authority to issue current good

manufacturing practice (CGMP)

regulations for drugs, including Type A

medicated articles. A Type A medicated

article is a feed product containing a

concentrated drug diluted with a feed

carrier substance. A Type A medicated

article is intended solely for use in the

manufacture of another Type A

medicated article or a Type B or Type

C medicated feed. Medicated feeds are

administered to animals for the

prevention, cure, mitigation, or

treatment of disease or for growth

promotion and feed efficiency.

Statutory requirements for CGMP’s for

Type A medicated articles have been

codified in part 226 (21 CFR part 226).

Type A medicated articles that are not

manufactured in accordance with these

regulations are considered adulterated

under section 501(a)(2)(B) of the act.

Under part 226, a manufacturer is

Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices 9707

required to establish, maintain, and

retain records for Type A medicated

articles, including records to document

procedures required under the

manufacturing process to assure that

proper quality control is maintained.

Such records would, for example,

contain information concerning receipt

and inventory of drug components,

batch production, laboratory assay

results (i.e., batch and stability testing),

and product distribution. This

information is needed so that FDA can

monitor drug usage and possible

misformulation of Type A medicated

articles. The information could also

prove useful to FDA in investigating

product defects when a drug is recalled.

In addition, FDA will use the CGMP

criteria in part 226 to determine

whether or not the systems used by

manufacturers of Type A medicated

articles are adequate to assure that their

medicated articles meet the

requirements of the act as to safety and

also meet the articles, claimed identity,

strength, quality, and purity, as required

by section 501(a)(2)(B) of the act as to

safety and also meet the articles,

claimed identity, strength, quality, and

purity, as required by section

501(a)(2)(B) of the act.

The respondents for Type A

medicated articles are pharmaceutical

firms that manufacture both human and

veterinary drugs, those firms that

produce only veterinary drugs and

commercial feed mills.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.42 115 260 29,900 0.75 22,425

226.58 115 260 29,900 1.75 52,325

226.80 115 260 29,900 0.75 52,325

226.102 115 260 29,900 1.75 52,325

226.110 115 260 29,900 0.25 7,475

226.115 115 10 1,150 0.5 575

Total 187,450

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the time required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

manufacturing sites, number of Type A

medicated articles being manufactured,

etc.) are derived from agency records

and experience.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3348 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0046]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Current Good

Manufacturing Practice Regulations for

Medicated Feeds

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

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the recordkeeping requirements for

manufacturers of medicated animal

feeds.

DATES: Submit written or electronic

comments on the collection of

information by April 10, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1462.

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 set forth in this document.

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.