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, 45660-45661 [2015-18796]
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45660
Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices
Rockville, MD 20855, 240–402–0670,
mai.huynh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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.
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 selfaddressed 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 https://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.,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:44 Jul 30, 2015
Jkt 235001
An IFAH representative also
participates in the VICH Steering
Committee meetings.
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).
II. Guidance on Bracketing and
Matrixing Designs for Stability Testing
of New Veterinary Drug Substances and
Medicinal Products
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\31JYN1.SGM
31JYN1
Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices
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 https://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 https://
www.regulations.gov.
VI. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/cvm or https://
www.regulations.gov.
Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18796 Filed 7–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1051]
Modified Risk Tobacco Product
Applications: Applications for 10
Products Submitted by Swedish Match
North America Inc.; Reopening of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
period for public comment on modified
risk tobacco product applications
(MRTPAs) submitted by Swedish Match
North America Inc. for 10 tobacco
products and announcing the
availability for public comment of
amendments to the MRTPAs. The notice
of availability for the originally-filed
applications appeared in the Federal
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:44 Jul 30, 2015
Jkt 235001
Register of August 27, 2014 (79 FR
51183). In that notice, FDA requested
comments on the 10 originally-filed
MRTPAs that are posted on https://
www.regulations.gov and FDA’s Web
site. The comment period on these
originally-filed applications closed on
February 23, 2015. FDA is reopening the
comment period to seek comment
specifically on amendments made to the
originally-filed MRTPAs submitted by
Swedish Match North America Inc.
DATES: Submit either electronic or
written comments on the amendments
by August 31, 2015.
ADDRESSES: Submit electronic
comments to https://
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. Identify
comments with Docket Number FDA–
2014–N–1051.
FOR FURTHER INFORMATION CONTACT:
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 1–877–287–1373, AskCTP@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 27,
2014 (79 FR 51183), FDA published a
notice of availability of MRTPAs
submitted by Swedish Match North
America Inc. for 10 tobacco products
and gave the public 180 days to
comment on the applications.
FDA is required by section 911(e) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 387k(e))
to make an MRTPA available to the
public (except for matters in the
application that are trade secrets or
otherwise confidential commercial
information) and to request comments
by interested persons on the information
contained in the application and on the
label, labeling, and advertising
accompanying the application. The
determination of whether an order is
appropriate under section 911 of the
FD&C Act is based on the scientific
information submitted by the applicant
as well as the scientific evidence and
other information that is made available
to the Agency, including through public
comments.
FDA has received and accepted a
number of amendments to Swedish
Match North America Inc.’s 10
originally-filed MRTPAs and is making
these amendments available (except for
matters in the amendments that are
trade secrets or otherwise confidential
commercial information) for public
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
45661
comment. FDA is reopening the period
for public comment so that the public
has the opportunity to review and
comment on these amendments.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
Persons with access to the Internet
may obtain the document at either
https://www.accessdata.fda.gov/Static/
widgets/tobacco/SMNA_MRTPA_FDA2014-N-1051.html or https://
www.regulations.gov.
Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18782 Filed 7–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
David Anderson, University of
Oregon, Eugene: Based on an
assessment conducted by the University
of Oregon, Eugene (UOE), the
Respondent’s admission, and analysis
conducted by ORI, ORI and UOE found
that Mr. David Anderson, Graduate
Student, UOE, engaged in research
misconduct in research supported by
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH), grants R01 MH087214, R01
MH077105, and TA MH020002.
ORI found that Respondent engaged
in research misconduct by falsifying
and/or fabricating data in the following
four (4) publications:
• Journal of Neuroscience
31(3):1128–38, 2011 (hereafter referred
to as ‘‘Paper 1’’).
Journal of Experimental Psychology:
Human Perception and Performance
SUMMARY:
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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, mai.huynh@fda.hhs.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 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.
[[Page 45661]]
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 https://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 https://www.regulations.gov.
VI. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/cvm or https://www.regulations.gov.
Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18796 Filed 7-30-15; 8:45 am]
BILLING CODE 4164-01-P
