[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Pages 45660-45661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18796]
[[Page 45660]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0309]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Bracketing and Matrixing Designs for Stability Testing of New
Veterinary Drug Substances and Medicinal Products; Guidance for
Industry; 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 a guidance for industry (GFI) #198 entitled
``Bracketing and Matrixing Designs for Stability Testing of New
Veterinary Drug Substances and Medicinal Products'' (VICH GL45). 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 is an annex
to a VICH guidance GFI #73 entitled ``Stability Testing of New
Veterinary Drug Substances and Medicinal Products (Revision)'' VICH
GL3(R). This VICH guidance document is intended to provide guidance on
the application of reduced designs (i.e., bracketing and matrixing) for
stability studies conducted in accordance with the principles outlined
in VICH GL3(R).
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Policy and Regulations Staff (HFV-6), 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 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, 240-402-0670, [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 Registration 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.
Six 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, one representative
from the industry of Canada, one representative from the government of
South Africa, and one representative from the industry of South Africa.
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 Bracketing and Matrixing Designs for Stability Testing
of New Veterinary Drug Substances and Medicinal Products
In the Federal Register of July 21, 2009 (74 FR 35875), FDA
published a notice of availability for a draft guidance entitled
``Bracketing and Matrixing Designs for Stability Testing of New
Veterinary Drug Substances and Medicinal Products'' (VICH GL45) giving
interested persons until August 20, 2009, to comment on the draft
guidance. FDA did not receive comments on the draft guidance. Comments
received by other VICH member regulatory agencies were considered as
the guidance was finalized. The guidance announced in this notice
finalizes the draft guidance dated July 20, 2009. The final guidance is
a product of the Expert Quality Working Group of the VICH.
This VICH guidance document provides guidance on bracketing and
matrixing study designs. Specific principles are defined in this
guidance for situations in which bracketing or matrixing can be
applied. This VICH guidance document is intended to address
recommendations on the application of bracketing and matrixing to
stability studies conducted in accordance with principles outlined in
the VICH guidance GFI #73 entitled ``Stability Testing of New
Veterinary Drug Substances and Medicinal Products (Revision) VICH
GL3(R)'' that published in the Federal Register of November 23, 2007
(72 FR 65751).
III. Significance of Guidance
This guidance, developed under the VICH process, has been revised
to conform with FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather ``guideline.'' In addition, guidance documents must not include
mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirements,'' unless FDA is using these words to describe a
statutory or regulatory requirement. The guidance represents the
current thinking of FDA on Bracketing and Matrixing Designs for
Stability Testing of New Veterinary Drug Substances and Medicinal
Products. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of applicable statutes and regulations.
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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 21 CFR part 514 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/cvm or http://www.regulations.gov.
Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18796 Filed 7-30-15; 8:45 am]
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