Federal Register / Vol. 66, No. 94 / Tuesday, May 15, 2001 / Notices 26867

are to be submitted except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: March 7, 2001.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug

Evaluation and Research.

[FR Doc. 01–12093 Filed 5–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0192]

Draft Guidance for Industry on Forms

for Registration of Producers of Drugs

and Listing of Drugs in Commercial

Distribution; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Forms for

Registration of Producers of Drugs and

Listing of Drugs in Commercial

Distribution.’’ The draft guidance is

intended to assist establishments that

are required to register (‘‘registrants’’)

and submit listing information for drugs

and biological products in obtaining and

submitting the necessary forms to meet

registration and listing requirements;

this draft guidance will also assist those

private label distributors that are not

required to register, but elect to submit

designated information directly to FDA.

FDA proposes to make available through

the Internet, rather than through

conventional mail, the following

registration and listing forms: Form FDA

2656 (Registration of Drug

Establishment), Form FDA 2656e

(Annual Update of Drug Establishment),

Form FDA 2657 (Drug Product Listing),

and Form FDA 2658 (Registered

Establishments’ Report of Private Label

Distributors).

DATES: Submit written comments on

this draft guidance document by July 16,

2001. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Submit written requests for

single copies of this draft guidance to

the Division of Drug Information (HFD–

240), Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT:

For human drugs: Kathy Smith,

Center for Drug Evaluation and

Research (HFD–90), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

1086.

For biological drugs: Robert A. Yetter,

Center for Biologics Evaluation and

Research (HFM–10), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–

827–0373, yetter@cber.fda.gov.

For veterinary drugs: Lowell Fried,

Center for Veterinary Medicine

(HFV–212), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–

0165, lfried@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Under part 207 (21 CFR part 207), as

authorized and required by section 510

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360) and

sections 351 and 361 of the Public

Health Service Act (PHS Act) (42 U.S.C.

262 amd 264), establishments (e.g.

manufacturers, repackers, and

relabelers) engaged in the manufacture,

preparation, propagation, compounding,

or processing of human drugs,

veterinary drugs, and biological

products, with certain exceptions, are

required to register and submit listing

information.

Under part 207, these ‘‘registrants’’

use Form FDA 2656 to submit

establishment registration information

and to submit annual re-registration

information (FDA had also used Form

FDA 2656e for annual re-registration,

but this form will no longer be

necessary); private label distributors use

Form FDA 2656 to obtain a labeler code;

registrants and, in some cases, private

label distributors use Form FDA 2657 to

submit listing information for drugs and

biological products and to update listing

information; and registrants use Form

FDA 2658 to submit listing information

for private label distributors (FDA has

also used the compliance verification

report for updating listing information).

Registrants will use new Form FDA

3356 to submit establishment and listing

information for those human cells,

tissues, and cellular and tissue-based

products regulated as drugs and/or

biological products under the act and

section 351 of the PHS Act beginning

January 21, 2003.

If a registrant or private label

distributor prefers to receive any of

these forms through conventional mail,

they may direct such requests to the

designated agency contacts. Under the

draft guidance, information previously

submitted on Form FDA 2656e would

be submitted on Form FDA 2656.

Distribution of these forms through the

Internet will reduce administrative costs

to the agency. The draft guidance also

contains registration information

applicable to human cells, tissue, and

cellular and tissue-based product

establishments.

The draft guidance explains that,

unless specifically requested otherwise,

FDA is discontinuing the conventional

mailing of these forms to registrants and

private label distributors. These forms

are available on the Internet.

Registrants, and if appropriate, private

label distributors must continue to

submit completed forms to FDA in

accordance with the registration and

listing requirements in part 207. The

draft guidance explains where to obtain

the forms on the Internet, how to make

changes to information, and where to

submit completed forms.

Internet availability of these forms

(instead of availability by conventional

mail) is part of an agency initiative to

use modern technology to facilitate the

submission of establishment registration

and listing information. FDA is

developing software to make possible

the electronic submission of the

requisite registration and listing

information for drugs and biological

products. The agency plans to propose

rulemaking that would revise the

requirements for registration and listing

and would require registrants to submit

this information electronically.

This Level 1 draft guidance is being

issued consistent with FDA’s good

guidance practices regulation (21 CFR

10.115; 65 FR 56468, September 19,

2000). This draft guidance represents

the agency’s current thinking on this

topic. 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

requirements of the applicable statutes

and regulations.

26868 Federal Register / Vol. 66, No. 94 / Tuesday, May 15, 2001 / Notices

II. Comments

Interested persons may, at any time,

submit written or electronic comments

regarding the draft guidance. Written

comments should be submitted to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. The draft guidance 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

Comments may also be submitted

electronically on the Internet at http://

www.fda.gov/dockets/ecomments. Once

on this Internet site, select the relevant

‘‘docket number’’ and follow the

directions. Copies of this draft guidance

for industry are available on the Internet

at http://www.fda.gov/cder/guidance/

index.htm.

Dated: May 7, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12179 Filed 5–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–2406]

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH);

Final Guidance for Industry entitled

‘‘Good Clinical Practice’’ (VICH GL9);

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a final guidance for

industry (No. 85) entitled ‘‘Good

Clinical Practice’’ (VICH GL9). This

guidance document has been developed

for veterinary use by the International

Cooperation on Harmonisation of

Technical Requirements for Registration

of Veterinary Medicinal Products

(VICH). The final VICH guidance is

intended to provide a unified standard

for designing, conducting, monitoring,

recording, and reporting studies used in

registration applications for approval of

veterinary products submitted to the

European Union, Japan, and the United

States.

DATES: Submit written comments at any

time. This guidance will be

implemented July 1, 2001.

ADDRESSES: Submit written requests for

a single copy of the final guidance 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. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the final

guidance document.

Submit written comments at any time

on the final guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852,—

e-mail: fdadockets@oc.fda.gov.

FOR FURTHER INFORMATION CONTACT:

Herman M. Schoenemann (HFV–120),

Center for Veterinary Medicine, Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0220, e-mail: 3hschoene@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote the

international harmonization of

regulatory recommendations. FDA has

participated in efforts to enhance

harmonization and has expressed its

commitment to seek scientifically based

harmonized technical recommendations

for the development of pharmaceutical

products. One of the goals of

harmonization is to identify and then

reduce the differences in technical

recommendations for drug development

among regulatory agencies in different

countries.

FDA has actively participated in the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use for

several years to develop harmonized

technical recommendations for the

approval of human pharmaceutical and

biological 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 recommendations

for the approval of veterinary medicinal

products in the European Union, Japan,

and the United States, and includes

input from both regulatory and industry

representatives.

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. FDA; the U.S.

Department of Agriculture; the Animal

Health Institute; the Japanese Veterinary

Pharmaceutical Association; the

Japanese Association of Veterinary

Biologics; and the Japanese Ministry of

Agriculture, Forestry and Fisheries.

Two observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/New Zealand

and one representative from the

industry in Australia/New Zealand. 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 also participates in the

VICH Steering Committee meetings.

II. Guidance on Good Clinical Practice

In the Federal Register of August 3,

1999 (64 FR 42135), FDA published the

notice of availability of the draft

guidance entitled ‘‘Good Clinical

Practices’’ (VICH GL9), giving interested

persons until September 2, 1999 to

submit comments. After considering the

comments received, FDA made

principally editorial changes. The final

guidance was submitted to the VICH

Steering Committee. At a meeting held

on June 14 through 16, 2000, the VICH

Steering Committee endorsed the final

guidance for industry, VICH GL9.

The guidance is intended to be an

international ethical and scientific

quality standard for designing,

conducting, monitoring, recording,

auditing, analyzing, and reporting

clinical studies evaluating veterinary

products. This final guidance document

is intended to be consistent with the

laws of the European Union, Japan, and

the United States.

VICH GL9 is a revision of and will

replace CVM guidance No. 58 entitled

‘‘Good Target Animal Studies Practices:

Investigators and Monitors.’’ In

addition, there are some minor conflicts

between this guidance and recent CVM

guidance No. 56 entitled ‘‘Protocol

Development Guideline for Clinical

Effectiveness and Target Animal Safety

Trials,’’ and No. 104 entitled ‘‘Guidance

for Industry: Content and Format of

Effectiveness and Target Animal Safety

Technical Sections and Final Study

Reports for Submission to the Division

of Therapeutic Drugs for Non-Food

Animals.’’ Until the center revises these

guidances, sponsors should follow the