International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on ``Quality of Biotechnological Products in the Veterinary Field: Stability Testing of Biotechnological/Biological Products'' (VICH GL17); Availability; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-4070]

International Cooperation on Harmonisation of Technical

Requirements for Registration of Veterinary Medicinal Products (VICH);

Draft Guidance on ``Quality of Biotechnological Products in the

Veterinary Field: Stability Testing of Biotechnological/Biological

Products'' (VICH GL17); Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability for comment on the draft guidance for industry entitled

``Quality of Biotechnological Products in the Veterinary Field:

Stability Testing of Biotechnological/Biological Products'' (VICH

GL17). This guidance has been adapted for veterinary use by the

International Cooperation on Harmonisation of Technical Requirements

for Registration of Veterinary Medicinal Products (VICH) from a

guidance regarding pharmaceuticals for human use which was adopted by

the International Conference on Harmonisation of Technical Requirements

for Registration of Pharmaceuticals for Human Use (ICH). This draft

VICH document is intended to provide guidance to applicants regarding

the stability studies that should be conducted and the stability data

that should be provided in support of new animal drug applications

(NADA's) (referred to as marketing applications in the draft guidance)

for veterinary biotechnological/biological products that are regulated

by FDA.

DATES: Submit written comments by November 12, 1999.

ADDRESSES: Send written comments to the Dockets Management Branch (HFA-

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of the draft guidance document and the docket number found in the

heading of this document.

Copies of the draft guidance document entitled ``Quality of

Biotechnological Products in the Veterinary Field: Stability Testing of

Biotechnological/Biological Products'' (VICH GL17) may be obtained on

the

[[Page 55295]]

Internet from the CVM home page at ``http://www.fda.gov/cvm/fda/TOCs/

guideline.html''. Persons without Internet access may submit written

requests for single copies of the draft guidance to the Communications

Staff (HFV-12), Center for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-

addressed adhesive label to assist that office in processing your

requests.

FOR FURTHER INFORMATION CONTACT:

Regarding VICH: Sharon R. Thompson, Center for Veterinary Medicine

(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD

20855, 301-594-1798, e-mail ``[email protected]'', or

Robert C. Livingston, Center for Veterinary Medicine (HFV-1), Food

and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-

594-5903, e mail ``[email protected]''.

Regarding the guidance document: William G. Marnane, Center for

Veterinary Medicine (HFV-140), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-827-6966, e-mail

``[email protected]''.

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 seek 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 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 requirements 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 meetings are held under the auspices of the Office

International des Epizooties (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; Committee on Veterinary Medicinal Products; 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 Confederation Mondiale de L'Industrie

de la Sante Animale (COMISA). A COMISA representative participates in

the VICH Steering Committee meetings.

II. Guidance on Stability Testing of Biotechnological/Biological

Products

This draft guidance entitled ``Quality of Biotechnological Products

in the Veterinary Field: Stability Testing of Biotechnological/

Biological Products'' (VICH GL17), has been adapted for veterinary use

by the VICH from a guidance regarding pharmaceuticals for human use

which was adopted by the ICH and published in the Federal Register of

July 10, 1996 (61 FR 36466). At a meeting held on May 18 through 20,

1999, the VICH Steering Committee agreed that VICH GL17 should be made

available for public comment.

This draft guidance document is intended to provide guidance to

applicants regarding the stability studies that should be conducted and

the stability data that should be provided in support of NADA's for

veterinary biotechnological/biological products that are regulated by

FDA. It is intended to supplement the tripartite VICH GL3 guidance

entitled ``Stability Testing of New Veterinary Drug Substances and

Medicinal Products.'' Biotechnological/biological products have

distinguishing characteristics to which consideration should be given

in any well-defined testing program designed to confirm their stability

during the intended storage period. For such products, in which the

active components are typically proteins and/or polypeptides,

maintenance of molecular conformation and biological activity is

dependent on noncovalent as well as covalent forces. The products are

particularly sensitive to environmental factors such as temperature

changes, oxidation, light, ionic content, and shear. In order to ensure

maintenance of biological activity and to avoid degradation, stringent

conditions for their storage are usually necessary.

Comments about this draft guidance document will be considered by

the FDA and the VICH Quality Working Group. Ultimately, FDA intends to

adopt the VICH Steering Committee's final guidance and publish it as

future guidance.

This draft guidance document has been revised to conform to FDA's

good guidance practices (62 FR 8961, February 27, l997) . For example,

the document has been designated ``guidance'' rather than

``guideline.'' Because guidance documents are not binding, mandatory

words such as ``must,'' ``shall,'' and ``will'' in the original VICH

documents have been substituted with ``should.''

This draft guidance represents the agency's current thinking on

stability testing of veterinary biotechnological/biological products.

The document does not create or confer any rights for or on any person

and will not operate to bind FDA or the public. You may use alternate

methods as long as they satisfy the requirements of the applicable

statute and regulation.

III. Comments

General comments are welcome at any time, however, in order to

ensure consideration at the next meeting, interested persons should

submit written comments on or before November 12, 1999, to the Dockets

Management Branch (address above) regarding this draft guidance

document. 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 draft guidance document and received comments are available for

public examination in the Dockets Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: September 30, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 99-26502 Filed 10-8-99; 8:45 am]

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