Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices 20497

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: April 20, 1995.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 95–10197 Filed 4–25–95; 8:45 am]

BILLING CODE 4163–19–P

National Committee on Vital and Health

Statistics (NCVHS) Executive

Subcommittee: Meeting

Pursuant to Pub. L. 92–463, the

National Center for Health Statistics

(NCHS), Centers for Disease Control and

Prevention (CDC), announces the

following committee meeting.

Name: NCVHS Executive Subcommittee.

Time and Date: 8:30 a.m.–5 p.m., May 24,

1995.

Place: Suite 200 East, Conference Room

002–003, 1100 New York Avenue, NW.,

Washington, DC 20005.

Status: Open.

Purpose: The purpose of this meeting is for

the Executive Subcommittee to review

accomplishments, logistics, needs and work

plans of NCVHS and individual

subcommittees.

Contact Person for More Information:

Substantive program information as well as

summaries of the meeting and a roster of

committee members may be obtained from

Gail F. Fisher, Ph.D., Executive Secretary,

NCVHS, NCHS, CDC, Room 1100,

Presidential Building, 6525 Belcrest Road,

Hyattsville, Maryland 20782, telephone 301/

436–7050.

Dated: April 20, 1995.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–10198 Filed 4–25–95; 8:45 am]

BILLING CODE 4163–18–M

Food and Drug Administration

[Docket No. 95N–0013]

Benton County Ag Center, Inc.;

Proposal to Withdraw Approval of

Applications for Medicated Animal

Feeds; Opportunity for a Hearing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Center for Veterinary

Medicine (CVM), Food and Drug

Administration (FDA), is providing an

opportunity for a hearing on a proposal

to withdraw approval of certain

medicated feed applications (MFA’s)

held by Benton County Ag Center, Inc.,

for animal feeds bearing or containing

new animal drugs (NAD’s). This action

is based on new information showing

the firm’s methods and controls used for

manufacturing, processing, and packing

of the medicated feeds are inadequate to

assure and preserve the identity,

strength, quality, and purity of the

NAD’s therein, and they were not made

adequate within a reasonable time after

receipt of written notice from FDA.

DATES: Requests for a hearing and data

and information in support of the

hearing request are due by May 26,

1995.

ADDRESSES: Requests for a hearing in

response to this notice should be

identified with Docket No. 95N–0013

and sent to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Karen A. Kandra, Center for Veterinary

Medicine (HFV–246), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1765.

SUPPLEMENTARY INFORMATION: CVM is

providing an opportunity for a hearing

on a proposal to withdraw approval of

11 MFA’s held by the firm doing

business as Benton County Ag Center,

Inc., 312 Railroad St., P.O. Box 308,

Keystone, IA 52249–0308, for the

manufacture of animal feeds bearing or

containing Category II NAD’s. Benton

County Ag Center, Inc., is a feed mill

that manufactures both medicated and

nonmedicated animal feeds. The 11

MFA’s, held by Benton County Ag

Center, Inc., were approved under

section 512(m) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360b(m)) and are identified as

follows:

MFA

Number

Drug/Combination Species

1. F 93–

642.

Carbadox ........... Swine

2. F 127–

333.

Tylosin/

Sulfamethazine.

Swine

3. F 131–

878.

Carbadox ........... Swine

4. F 139–

280.

Levamisole Hydrochloride.Cattle and

swine

5. F 141–

603.

Carbadox/

Pyrantel tartrate.

Swine

6. F 141–

604.

Pyrantel tartrate Swine

MFA

Number

Drug/Combination Species

7. F 141–

757.

Lincomycin/

Pyrantel tartrate.

Swine

8. F 144–

054.

Sulfamethazine/

Chlortetracycline (CTC)/Penicillin.

Swine

9. F 147–

607.

Sulfamethazine/

CTC.

Cattle

10. F

147–

617.

Arsanilic acid ..... Chickens, turkeys, and

swine

11. F

147–

641.

Oxytetracycline/

Neomycin.

Chickens, turkeys, swine,

cattle, and

mink

To manufacture a Type B or C animal

feed bearing or containing a Category II

NAD (i.e., Type A medicated article) a

firm must file an MFA (Form FDA 1900)

with FDA and obtain its approval. FDA

does not approve such an application

unless, among other things, the firm

agrees to comply with the agency’s

regulations for current good

manufacturing practice (CGMP) for

medicated feeds (21 CFR part 225),

which are intended to help assure that

feed bearing or containing an NAD

meets the requirements of the act

pertaining to identity, strength, quality,

and purity. The agency determines

whether the firm’s manufacture of

medicated feed is in compliance with

the CGMP regulations by inspecting the

facilities and controls used for, and the

methods used in, the manufacture,

processing, and packing of the feed by

the firm.

On December 22, 1992, the Iowa

Department of Agriculture (Medicated

Feed Bureau), under contract with FDA

pursuant to section 702(a) of the act (21

U.S.C. 372(a)), inspected Benton County

Ag Center, Inc. The inspection revealed

significant deviations from the CGMP’s

for medicated feeds. The investigator

noted the deviations on an inspectional

observations form (Form FDA 483) (Ref.

1), issued a copy to the firm’s General

Manager, and discussed in detail the

deviations with him. The deviations

included the following:

1. Production records did not show

when flushing of equipment was

performed or the final disposition of

flush materials, as required by 21 CFR

225.102(b)(4).

2. Production records did not show

the actual quantity of medicated feed

produced, as required by 21 CFR

225.102(b)(2)(iv).

3. Production records were not

checked by a responsible person to

determine if all required production

steps had been performed, as required

by 21 CFR 225.102(b)(4).