Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices 66631

List of Subjects

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements.

Dated: December 17, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

[FR Doc. 97–33329 Filed 12–18–97; 8:45 am]

BILLING CODE 6065–50–F

FEDERAL MARITIME COMMISSION

Ocean Freight Forwarder License

Applicants

Notice is hereby given that the

following applicants have filed with the

Federal Maritime Commission

applications for licenses as ocean freight

forwarders pursuant to section 19 of the

Shipping Act of 1984 (46 U.S.C. app.

1718 and 46 CFR 510).

Persons knowing of any reason why

any of the following applicants should

not receive a license are requested to

contact the Office of Freight Forwarders,

Federal Maritime Commission,

Washington, D.C. 20573.

Prem International, Inc., 7225 N.W. 25th

Street, Suite 203, Miami, FL 33122,

Officers: Hugo Pedro Kelly, President,

Sergio Barci, Vice President

UT Freight Forwarders Ltd., 161–15

Rockaway Blvd., Jamaica, NY 11434,

Officers: John Hwang, President, Lisa

Cho, Secretary

Triton Forwarding, Inc., 3080 Bristol

Street, Suite 610, Costa Mesa, CA

92626, Officers: Anthony G. Khamis,

Director, Leonard Yanovsky, Director

Interamericas Consulting Import Export

Inc., 22716 SW 65 Way, Boca Raton,

FL 33428, Officer: Iracema V.S.

Heidal, President.

Dated: December 15, 1997.

Ronald D. Murphy,

Assistant Secretary.

[FR Doc. 97–33121 Filed 12–18–97; 8:45 am]

BILLING CODE 6730–01–M

FEDERAL RESERVE SYSTEM

Formations of, Acquisitions by, and

Mergers of Bank Holding Companies

The companies listed in this notice

have applied to the Board for approval,

pursuant to the Bank Holding Company

Act of 1956 (12 U.S.C. 1841 et seq.)

(BHC Act), Regulation Y (12 CFR Part

225), and all other applicable statutes

and regulations to become a bank

holding company and/or to acquire the

assets or the ownership of, control of, or

the power to vote shares of a bank or

bank holding company and all of the

banks and nonbanking companies

owned by the bank holding company,

including the companies listed below.

The applications listed below, as well

as other related filings required by the

Board, are available for immediate

inspection at the Federal Reserve Bank

indicated. The application also will be

available for inspection at the offices of

the Board of Governors. Interested

persons may express their views in

writing on the standards enumerated in

the BHC Act (12 U.S.C. 1842(c)). If the

proposal also involves the acquisition of

a nonbanking company, the review also

includes whether the acquisition of the

nonbanking company complies with the

standards in section 4 of the BHC Act.

Unless otherwise noted, nonbanking

activities will be conducted throughout

the United States.

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 January 15,

1998.

A. Federal Reserve Bank of Dallas

(Genie D. Short, Vice President) 2200

North Pearl Street, Dallas, Texas 75201-

2272:

1. Industry Bancshares, Inc., Industry,

Texas; to acquire 100 percent of the

voting shares of Citizens State Bank,

Buffalo, Texas.

B. Federal Reserve Bank of San

Francisco (Pat Marshall, Manager of

Analytical Support, Consumer

Regulation Group) 101 Market Street,

San Francisco, California 94105-1579:

1. New Century Financial

Corporation, Spokane, Washington; to

become a bank holding company by

acquiring 100 percent of the voting

shares of New Century Bank (in

organization), Spokane, Washington.

Board of Governors of the Federal Reserve

System, December 16, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–33201 Filed 12–18–97; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee Information Line

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has changed its

procedure for accessing the Advisory

Committee Information Line (the

information line) concerning those

advisory committees under the purview

of the Center for Biologics Evaluation

and Research (CBER). CBER has

assigned a separate 5-digit code to each

of its advisory committees.

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee

Management Office (HFA–306), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4820.

SUPPLEMENTARY INFORMATION: The

information line provides the public

with access to the most current

information available on upcoming FDA

advisory committee meetings, guidance

for making an oral presentation during

the open public hearing portion of an

advisory committee meeting, and

procedures for obtaining copies of

transcripts of advisory committee

meetings. The information line can be

accessed by dialing 1–800–741–8138 or

301–443–0572. Each advisory

committee has been assigned a 5-digit

code on the information line that

enables the public to obtain information

about a particular advisory committee

by using that code. This 5-digit code

appears in each individual notice of a

meeting. Information provided is

preliminary and may change before a

meeting is held. The information line

will be updated when such changes are

made. The following is a list of CBER’s

advisory committees and the 5-digit

code assigned to each advisory

committee:

Committee name Code

Allergenic Products Advisory Committee ........................................................................................................ 12388

Biological Response Modifiers Advisory Committee ....................................................................................... 12389

Blood Products Advisory Committee ............................................................................................................... 19516
66632 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices

Committee name Code

Vaccines and Related Biological Products Advisory Committee .................................................................... 12391

Transmissible Spongiform Encephalopathies Advisory Committee ................................................................ 12392

Dated: December 11, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–33097 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0503]

Agency Information Collection

Activities: Proposed Collection

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

requirements for submission of a new

animal drug application (NADA).

DATES: Submit written comments on the

collection of information by February

17, 1998.

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:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1686.

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.

New Animal Drug Application (NADA),

Form FDA 356 V, 21 CFR Part 514,

(OMB Control number 0910–0032—

Reinstatement)

Description: FDA has the

responsibility under the Federal Food,

Drug, and Cosmetic Act (the act), for the

approval of new animal drugs that are

safe and effective. Section 512(b) of the

act (21 U.S.C. 360b(b)) requires that a

sponsor submit and receive approval of

a NADA, before interstate marketing is

allowed. The regulations implementing

statutory requirements for NADA

approval have been codified under 21

CFR part 514. NADA applicants

generally use a single form, FDA 356 V.

The NADA must contain, among other

things, safety and effectiveness data for

the drug, labeling, a list of components,

manufacturing and controls

information, and complete information

on any methods used to determine

residues of drug chemicals in edible

tissues. While the NADA is pending, an

amended application may be submitted

for proposed changes. After an NADA

has been approved, a supplemental

application must be submitted for

certain proposed changes, including

changes beyond the variations provided

for in the NADA and other labeling

changes. An amended application and a

supplemental application may omit

statements concerning which no change

is proposed. This information is

reviewed by FDA scientific personnel to

ensure that the intended use of an

animal drug, whether as a

pharmaceutical dosage form, in drinking

water, or in medicated feed, is safe and

effective. The respondents are

pharmaceutical firms that produce

veterinary products and commercial

feed mills.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. 21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 356 V 514.1 and 514.6 190 6.76 1,824 211.6 271,694

514.8 and 514.9 30 8,520

514.11 1 1,824

Total burden hours 282,038

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