13160 Federal Register / Vol. 60, No. 47 / Friday, March 10, 1995 / Notices

The Federal Register Online Via GPO

Access; Public Meeting for Federal,

State and Local Agencies, and Others

Interested in a Demonstration of GPO

Access, the Online Service Providing

the Federal Register and Other Federal

Databases

The Superintendent of Documents

will hold a public meeting for Federal,

state, and local government agencies,

and others interested in an overview

and demonstration of the Government

Printing Office’s online service GPO

Access, provided under the Government

Printing Office Electronic Information

Access Enhancement Act of 1993

(Public Law 103–40).

The session is available on

Wednesday, April 5, 1995, from 1 p.m.

to 2:30 p.m. The training session will be

held at the Dallas Public Library,

Library Auditorium, 1515 Young Street,

Dallas, Texas 75201.

The online Federal Register Service

offers access to the daily issues of the

Federal Register by 6 a.m. on the day

of publication. All notices, rules and

proposed rules, Presidential documents,

executive orders, separate parts, and

reader aids are included in the database

as ASCII text files, with graphics

provided in TIFF format. The online

Federal Register is available via the

Internet or as a dial-in service.

Historical data is available from January

1994 forward.

Other databases currently available

online through GPO Access include the

Congressional Record; Congressional

Record Index, including the History of

Bills; Congressional Bills; Public Laws;

and U.S. Code.

Individuals interested in attending the

training session should contact the

GPO’s Office of Electronic Information

Dissemination Services, John Berger,

Product Manager, on 202–512–1525;

(FAX) 202–512–1262; or by Internet email at help@eids05.eids.gpo.gov.

Seating reservations will be accepted

through Friday, March 31, 1995.

Michael F. DiMario,

Public Printer.

[FR Doc. 95–5940 Filed 3–9–95; 8:45 am]

BILLING CODE 1505–02–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 92D–0039]

Animal Drug Manufacturing; Revised

Guideline; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the revised four-part

guideline entitled, ‘‘Animal Drug

Manufacturing Guidelines, 1994’’

prepared by the Center for Veterinary

Medicine (CVM). These guidelines

describe the data and information for

the manufacturing portions of

abbreviated new animal drug

applications, new animal drug

applications, and supplements for

pharmaceutical dosage forms.

DATES: Written comments on these

guidelines may be submitted at any

time.

ADDRESSES: Submit written requests for

single copies of the revised guidelines

entitled, ‘‘Animal Drug Manufacturing

Guidelines, 1994: I. Pilot Batch

Manufacture, II. Tentative Expiration

Dates, III. Manufacturing Sites, and IV.

New Animal Drug Substance Sources’’

to the Communications and Education

Branch (HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1755.

Send two self-addressed adhesive labels

to assist that office in processing your

requests. Submit written comments on

the revised guidelines to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. Requests and comments should

be identified with the docket number

found in brackets in the heading of this

document. A copy of the revised

guidelines and received comments may

be seen at the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

William G. Marnane, Center for

Veterinary Medicine (HFV–143), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

0678.

SUPPLEMENTARY INFORMATION: The Food

and Drug Administration (FDA) is

announcing the availability of the

revised four-part guideline entitled,

‘‘Animal Drug Manufacturing

Guidelines, 1994: I. Pilot Batch

Manufacture, II. Tentative Expiration

Dates, III. Manufacturing Sites, and IV.

New Animal Drug Substance Sources’’

prepared by CVM. These guidelines are

intended to be used by both pioneer and

generic manufacturers of veterinary

drug products so that they are informed

of the type of information that FDA

believes will provide an acceptable

submission to support the

manufacturing requirements for new

animal drug applications, abbreviated

new animal drug applications, and

supplemental applications for

pharmaceutical dosage forms. In the

Federal Register of August 21, 1992 (57

FR 37979), FDA issued a notice of

availability of the four CVM guidelines

entitled, ‘‘Animal Drug Manufacturing

Guidelines, 1992.’’ Comments by the

public were requested to be submitted at

any time so that future revisions of the

guidelines could be developed in

consideration of the remarks.

The agency received three comments

on the 1992 guidelines. The comments

came from two drug manufacturers and

one trade association. The 1992

guidelines have been revised as a result

of these comments and from internal

discussions within CVM.

Many editorial comments were made

about all four guidelines. The editorial

comments were adopted in the revised

guidelines when the agency deemed

that they were appropriate and provided

clarification. Technical comments about

‘‘Guideline I. Pilot Batch Manufacture’’

focused on the CVM recommendations

for the size of the test batch and the type

of equipment or production facility that

is appropriate for manufacturing test

lots. A suggestion was made to allow

bridging data in cases where the

recommendations for batch size,

production facility, equipment, and

standard operating procedures are not

practicable. Technical comments about

‘‘Guideline II. Tentative Expiration

Dates’’ centered on a clarification of the

definition of exaggerated storage

conditions for different dosage forms

and the application of expiration dating

to all manufacturing sites for one drug

product. Technical comments about

‘‘Guideline III. Manufacturing Sites’’

included criticisms of the definitions of

the different types of manufacturing

sites, the option for the agency to

request bioequivalence data, and the

appropriate location of sterile process

validation data in the drug application.

Technical comments about ‘‘Guideline

IV. New Animal Drug Substance

Sources’’ were made regarding the

definitions of primary and alternate

sources of the new animal drug

substance, test batch and stability data

for supplemental applications, and

bioequivalence data requirements for

mastitis products. All of these

comments were considered in the

revision of the manufacturing

guidelines.

One of the most significant changes to

the 1992 guidelines is to allow bridging

data to be submitted when the

recommendations for batch size,

production facility, equipment, and

standard operating procedures for pilot