Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Notices 40721

Manufacturers’’ (CP 7382.830). This

draft document provides guidance to the

FDA field staff for the enforcement of

the quality system regulation (part 820

(21 CFR part 820)). This draft is a

revision to the document first made

available in May 1995, in accordance

with the amendments to part 820,

effective June 1, 1997.

This guidance document represents

the agency’s current thinking on

inspection of medical device

manufacturers. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

applicable statute, regulations, or both.

The agency has adopted Good

Guidance Practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This draft guidance document is

issued as a Level 1 guidance consistent

with GGP’s.

II. Electronic Access

In order to receive the ‘‘Draft

Compliance Program Guidance Manual:

Inspection of Medical Device

Manufacturers’’ (CP 7382.830) via your

fax machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (487) followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the World Wide Web (WWW).

CDRH maintains an entry on the WWW

for easy access to information including

text, graphics, and files that may be

downloaded to a personal computer

with access to the Web. Updated on a

regular basis, the CDRH home page

includes the ‘‘Draft Compliance Program

Guidance Manual: Inspection of

Medical Device Manufacturers’’ (CP

7382.830), device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at ‘‘http://www.fda.gov/cdrh’’. The

‘‘Draft Compliance Program Guidance

Manual: Inspection of Medical Device

Manufacturers’’ (CP 7382.830) will be

available at ‘‘http://www.fda.gov/cdrh/

ochome.html’’.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

II. Comments

This draft document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to Dockets Management Branch

(address above) written comments

regarding this draft guidance document.

Written comments may be submitted at

any time, however, comments should be

submitted by October 28, 1998, to

ensure adequate consideration in

preparation of the final document. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the document and

received comments are available for

examination in the the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: July 17, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–20305 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0566]

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH);

Draft Guidance on Stability Testing of

New Animal Drug Substances and

Products (#73), Stability Testing for

New Dosage Forms of New Animal

Drugs (#74), and Stability Testing:

Photostability Testing of New Animal

Drug Substances and Products (#75);

Availability; Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment of three draft

guidance for industry documents

entitled ‘‘Stability Testing of New

Animal Drug Substances and Products,’’

‘‘Stability Testing for New Drug Dosage

Forms of New Animal Drugs,’’and

‘‘Stability Testing: Photostability

Testing of New Animal Drug Substances

and Products.’’ These related draft

guidance documents have been adapted

for veterinary use by the International

Cooperation on Harmonisation of

Technical Requirements for Registration

of Veterinary Medicinal Products

(VICH) from guidelines that were

adopted by the International Conference

on Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH).

The draft guidance is intended to

provide guidance on stability testing of

new drug substances and products and

new dosage forms included as part of

registration applications for approval of

veterinary medicinal products

submitted to the European Union,

Japan, and the United States.

DATES: Written comments should be

submitted by August 31, 1998.

Note: FDA will accept comments after the

deadline, but to assure consideration at the

next VICH Committee meeting, we must

receive them by August 31, 1998.

ADDRESSES: Submit written requests for

single copies of these draft guidance

documents to the Communications Staff

(HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments to the

Dockets Management Branch (HFA–
40722 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Notices

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments should be

identified with the full title of the draft

guidance document and the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section of

this document for electronic access to

the draft guidance documents.

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance documents:

William G. Marnane, Center for

Veterinary Medicine (HFV–140),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–594–0678, e-mail

‘‘wmarnane@bangate.fda.gov’’.

Regarding VICH: Sharon Thompson,

Center for Veterinary Medicine

(HFV–3), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–

1798, e-mail

‘‘sthompso@bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

regulatory authorities, industry

associations, and individual sponsors to

promote the international

harmonization of regulatory

requirements. FDA has participated in

efforts to enhance harmonization and

has expressed its commitment to

seeking scientifically based harmonized

technical requirements for the

development of pharmaceutical

products. One of the goals of

harmonization is to identify and reduce

the differences in technical

requirements for drug development

among regulatory agencies in different

countries.

FDA has actively participated in the

ICH for several years to develop

harmonized technical requirements for

the registration of human

pharmaceutical products among the

European Union, Japan, and the United

States. The VICH is a parallel initiative

for veterinary medicinal products. The

VICH is concerned with developing

harmonized technical requirements for

the registration of veterinary medicinal

products in the European Union, Japan,

and the United States, and it includes

input from both regulatory and industry

representatives.

The VICH meetings are held under the

auspices of the Office International des

E ́pizooties (OIE). The VICH Steering

Committee is composed of member

representatives from the European

Commission, the European Medicines

Evaluation Agency, the European

Federation of Animal Health, the U.S.

Food and Drug Administration, the U.S.

Department of Agriculture, the Animal

Health Institute, the Japanese Veterinary

Pharmaceutical Association, and the

Japanese Ministry of Agriculture,

Forestry and Fisheries.

Four observers are eligible to

participate in the VICH Steering

Committee: One representative from the

government of Australia/New Zealand,

one representative from the industry in

Australia/New Zealand, one

representative from MERCOSUR

(Argentina, Brazil, Uruguay, and

Paraguay), and one representative from

Federacion Latino-Americana de la

Industria para la Salud Animal. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confe ́de ́ration

Mondiale de L’Industrie de la Sante ́

Animale (COMISA). A COMISA

representative participates in the VICH

Steering Committee meetings.

At a meeting held on February 26 and

27, l998, the VICH Steering Committee

agreed that the draft guidance

documents entitled ‘‘Stability Testing of

New Animal Drug Substances and

Products,’’ ‘‘Stability Testing for New

Dosage Forms of New Animal Drugs,’’

and ‘‘Stability Testing: Photostability

Testing of New Animal Drug Substances

and Products’’ should be made available

for public comment. These draft

guidance documents were prepared by

the VICH Quality Working Group and

are based on ICH Guidelines that have

already been adopted by FDA for human

pharmaceuticals.

The draft guidance entitled ‘‘Stability

Testing of New Animal Drug Substances

and Products’’ addresses the generation

of stability information that should be

included in submissions for

applications for registration or approval

of new molecular entities and associated

drug products in the European Union,

Japan, and the United States. In this

guidance’s discussion of ‘‘stress testing’’

for both new drug substances and drug

products, the comment states that ‘‘light

testing’’ should be an integral part of

stress testing and will be considered in

a separate annexed VICH document.

That separate draft document is entitled

‘‘Stability Testing: Photostability

Testing of New Animal Drug Substances

and Products,’’ and sets out a basic

testing protocol for photostability. The

third draft guidance entitled ‘‘Stability

Testing for New Dosage Forms of New

Animal Drugs’’ is also an annex to

‘‘Stability Testing of New Animal Drug

Substances and Products.’’ It addresses

the generation of stability information

for new dosage forms for submission by

the owner of the original application for

registration, after the original

application for new drug substances and

products has been submitted. Comments

about these draft guidance documents

will be considered by FDA and the

VICH Quality Working Group.

Ultimately, FDA intends to adopt the

VICH Steering Committee’s final

guidance and to publish as future

guidance documents.

These draft guidance documents,

developed under the VICH process,

have been revised to conform to FDA’s

Good Guidance Practices (62 FR 8961,

February 27, l997) . For example, the

documents have been designated

‘‘guidance’’ rather than ‘‘guideline.’’

Since guidance documents are not

binding, mandatory words such as

‘‘must,’’ ‘‘shall,’’ and ‘‘will’’ in the

original VICH documents have been

substituted with ‘‘should.’’

These draft guidance documents

represent current FDA thinking on

stability testing of new animal drug

substances and products and new

dosage forms of new animal drugs. The

documents do not create or confer any

rights for or on any person and will not

operate to bind FDA or the public.

Alternate approaches may be used if

they satisfy the requirements of

applicable statutes, regulations, or both.

II. Comments

Interested persons may, on or before

August 31, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding the

guidance documents. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

guidance documents and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the guidance documents

using the World Wide Web (WWW). For

WWW access, connect to CVM at ‘‘http:/

/www.fda.gov/cvm’’.

Dated: July 23, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20310 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F