[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27312-27313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10952]


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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 
GL51); Guidance for Industry on Statistical Evaluation of Stability 
Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of guidance for industry (GFI 219) entitled 
``Guidance for Industry on Statistical Evaluation of Stability Data, 
VICH GL51.'' This guidance has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This 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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the 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 Pl., 
Rockville, MD 20855, 240-402-0669, [email protected].

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 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, European Medicines Evaluation Agency, 
European Federation of Animal Health, 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 governments 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. Guidance on Statistical Evaluation of Stability Data

    In the Federal Register of April 4, 2012 (77 FR 20406), FDA 
published a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry on Statistical Evaluation of Stability 
Data, VICH GL51.'' Interested persons were given until June 4, 2012, to 
comment on the draft guidance. FDA received several comments on the 
draft, and those comments, as well as those received by other VICH 
member regulatory agencies, were considered as the guidance was 
finalized. No substantive changes were made in finalizing this guidance 
document. The guidance announced in this document finalizes the draft 
guidance dated January 10, 2012. The final guidance is a product of the 
Quality Expert Working Group of the VICH.
    This VICH guidance document provides 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 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 guidance addresses the evaluation of stability data that 
should be submitted in registration applications for new molecular 
entities and associated veterinary medicinal products. The guidance 
provides recommendations on establishing retest periods and shelf lives 
for drug

[[Page 27313]]

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.

III. Significance of Guidance

    This 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.
    This 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.

IV. Paperwork Reduction Act of 1995

    This 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 guidance have been approved under 
OMB control number 0910-0032.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

VI. Electronic Access

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

    Dated: May 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10952 Filed 5-12-14; 8:45 am]
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