
[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Notices]
[Pages 20406-20407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8039]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0288]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on Statistical Evaluation of Stability 
Data, VICH GL51; 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availability of a draft guidance for industry (219) entitled 
``Draft Guidance for Industry on Statistical Evaluation of Stability 
Data, VICH GL51.''
    This draft guidance has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
VICH guidance document is intended to provide recommendations on how to 
use stability data generated in accordance with the principles detailed 
in the VICH guidance entitled ``Stability Testing of New Veterinary 
Drug Substances and Medicinal Products, GL3(R)'' to propose a retest 
period or shelf life in a registration application.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 4, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Mai Huynh, Center for Veterinary 
Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855, 240-276-8273, Mai.huynh@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(219) entitled, ``Draft Guidance for Industry on Statistical 
Evaluation of Stability Data, VICH GL51.'' In recent years, many 
important initiatives have been undertaken by regulatory authorities 
and industry associations 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 procedures for the development of 
pharmaceutical products. One of the goals of harmonization is to 
identify and then reduce differences in technical requirements for drug 
development among regulatory agencies in different countries.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use 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 Steering Committee is composed of member representatives 
from the European Commission, the European Medicines Evaluation Agency, 
the European Federation of Animal Health, the Committee on Veterinary 
Medicinal Products, 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.
    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 the government of Canada, and one 
representative from the industry of Canada. The VICH Secretariat, which 
coordinates the preparation of documentation, is provided by the 
International Federation for Animal Health (IFAH). An IFAH 
representative also participates in the VICH Steering Committee 
meetings.

II. Draft Guidance on Statistical Evaluation of Stability Data

    The VICH Steering Committee held a meeting on November 14, 2011, 
and agreed that the draft guidance document entitled ``Draft Guidance 
for Industry on Statistical Evaluation of Stability Data, VICH GL51'' 
should be made available for public comment. This draft VICH guidance 
document is intended to provide recommendations on how to use stability 
data generated in accordance with the principles detailed in the VICH 
guidance entitled, ``Stability Testing of New Veterinary Drug 
Substances and Medicinal Products, GL3(R)'' to propose a retest period 
or shelf life in a registration application. This draft guidance 
describes when and how extrapolation can be considered when proposing a 
retest period for a drug substance or a shelf life for a veterinary 
medicinal product that extends beyond the period covered by available 
data from the stability study under the long-term storage condition.
    This draft guidance addresses the evaluation of stability data that 
should be submitted in registration applications for new molecular 
entities and associated veterinary medicinal products. The draft 
guidance provides recommendations on establishing retest periods and 
shelf lives for drug substances and veterinary medicinal products 
intended for storage at or below ``room temperature.'' It covers 
stability studies using single- or multi-factor designs and full or 
reduced designs.
    FDA and the VICH Expert Working Group will consider comments about 
the draft guidance document.

[[Page 20407]]

III. Significance of Guidance

    This draft guidance, developed under the VICH process, has been 
revised to conform to FDA's good guidance practices regulation (21 CFR 
10.115). For example, the document has been designated ``guidance'' 
rather than ``guideline.'' In addition, guidance documents must not 
include mandatory language such as ``shall,'' ``must,'' ``require,'' or 
``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent 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 applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this draft guidance have been approved 
under OMB control number 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
It is only necessary to send one set of comments. Identify comments 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-8039 Filed 4-3-12; 8:45 am]
BILLING CODE 4160-01-P


