80 FR 45660 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 147 (July 31, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 147 (July 31, 2015)
| Page Range | 45660-45661 | |
| FR Document | 2015-18796 |
[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)] [Notices] [Pages 45660-45661] From the Federal Register Online [www.thefederalregister.org] [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 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. [[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 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] BILLING CODE 4164-01-P
![45660 Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices
DEPARTMENT OF HEALTH AND Rockville, MD 20855, 240–402–0670, An IFAH representative also
HUMAN SERVICES mai.huynh@fda.hhs.gov. participates in the VICH Steering
SUPPLEMENTARY INFORMATION: Committee meetings.
Food and Drug Administration
I. Background II. Guidance on Bracketing and
[Docket No. FDA–2009–D–0309] Matrixing Designs for Stability Testing
In recent years, many important
initiatives have been undertaken by of New Veterinary Drug Substances and
International Cooperation on Medicinal Products
Harmonisation of Technical regulatory authorities and industry
Requirements for Registration of associations to promote the In the Federal Register of July 21,
Veterinary Medicinal Products; international harmonization of 2009 (74 FR 35875), FDA published a
Bracketing and Matrixing Designs for regulatory requirements. FDA has notice of availability for a draft guidance
Stability Testing of New Veterinary participated in efforts to enhance entitled ‘‘Bracketing and Matrixing
Drug Substances and Medicinal harmonization and has expressed its Designs for Stability Testing of New
Products; Guidance for Industry; commitment to seek scientifically based Veterinary Drug Substances and
Availability harmonized technical procedures for the Medicinal Products’’ (VICH GL45)
development of pharmaceutical giving interested persons until August
AGENCY: Food and Drug Administration, products. One of the goals of 20, 2009, to comment on the draft
HHS. harmonization is to identify and then guidance. FDA did not receive
ACTION: Notice. reduce differences in technical comments on the draft guidance.
requirements for drug development Comments received by other VICH
SUMMARY: The Food and Drug among regulatory agencies in different member regulatory agencies were
Administration (FDA) is announcing the countries. considered as the guidance was
availability of a guidance for industry FDA has actively participated in the finalized. The guidance announced in
(GFI) #198 entitled ‘‘Bracketing and International Conference on this notice finalizes the draft guidance
Matrixing Designs for Stability Testing Harmonisation of Technical dated July 20, 2009. The final guidance
of New Veterinary Drug Substances and Requirements for Registration of is a product of the Expert Quality
Medicinal Products’’ (VICH GL45). This Pharmaceuticals for Human Use for Working Group of the VICH.
guidance has been developed for several years to develop harmonized
technical requirements for the approval This VICH guidance document
veterinary use by the International
of human pharmaceutical and biological provides guidance on bracketing and
Cooperation on Harmonisation of
products among the European Union, matrixing study designs. Specific
Technical Requirements for Registration
Japan, and the United States. The VICH principles are defined in this guidance
of Veterinary Medicinal Products
is a parallel initiative for veterinary for situations in which bracketing or
(VICH). This VICH guidance is an annex
medicinal products. The VICH is matrixing can be applied. This VICH
to a VICH guidance GFI #73 entitled
concerned with developing harmonized guidance document is intended to
‘‘Stability Testing of New Veterinary
technical requirements for the approval address recommendations on the
Drug Substances and Medicinal
of veterinary medicinal products in the application of bracketing and matrixing
Products (Revision)’’ VICH GL3(R). This
European Union, Japan, and the United to stability studies conducted in
VICH guidance document is intended to
States, and includes input from both accordance with principles outlined in
provide guidance on the application of
regulatory and industry representatives. the VICH guidance GFI #73 entitled
reduced designs (i.e., bracketing and
The VICH Steering Committee is ‘‘Stability Testing of New Veterinary
matrixing) for stability studies
composed of member representatives Drug Substances and Medicinal
conducted in accordance with the
from the European Commission; Products (Revision) VICH GL3(R)’’ that
principles outlined in VICH GL3(R).
European Medicines Evaluation Agency; published in the Federal Register of
DATES: Submit either electronic or November 23, 2007 (72 FR 65751).
European Federation of Animal Health;
written comments on Agency guidances
Committee on Veterinary Medicinal III. Significance of Guidance
at any time.
Products; FDA; the U.S. Department of
ADDRESSES: Submit written requests for Agriculture; the Animal Health This guidance, developed under the
single copies of this guidance to the Institute; the Japanese Veterinary VICH process, has been revised to
Policy and Regulations Staff (HFV–6), Pharmaceutical Association; the conform with FDA’s good guidance
Center for Veterinary Medicine, Food Japanese Association of Veterinary practices regulation (21 CFR 10.115).
and Drug Administration, 7519 Standish Biologics; and the Japanese Ministry of For example, the document has been
Pl., Rockville, MD 20855. Send one self- Agriculture, Forestry, and Fisheries. designated ‘‘guidance’’ rather
addressed adhesive label to assist that Six observers are eligible to ‘‘guideline.’’ In addition, guidance
office in processing your request. See participate in the VICH Steering documents must not include mandatory
the SUPPLEMENTARY INFORMATION section Committee: One representative from the language such as ‘‘shall,’’ ‘‘must,’’
for electronic access to the guidance government of Australia/New Zealand, ‘‘require,’’ or ‘‘requirements,’’ unless
document. one representative from the industry in FDA is using these words to describe a
Submit electronic comments on the Australia/New Zealand, one statutory or regulatory requirement. The
guidance to http://www.regulations.gov. representative from the government of guidance represents the current thinking
Submit written comments to the Canada, one representative from the of FDA on Bracketing and Matrixing
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Division of Dockets Management (HFA– industry of Canada, one representative Designs for Stability Testing of New
305), Food and Drug Administration, from the government of South Africa, Veterinary Drug Substances and
5630 Fishers Lane, Rm. 1061, Rockville, and one representative from the Medicinal Products. It does not
MD 20852. industry of South Africa. The VICH establish any rights for any person and
FOR FURTHER INFORMATION CONTACT: Mai Secretariat, which coordinates the is not binding on FDA or the public.
Huynh, Center for Veterinary Medicine preparation of documentation, is You can use an alternative approach if
(HFV–142), Food and Drug provided by the International it satisfies the requirements of
Administration, 7500 Standish Pl., Federation for Animal Health (IFAH). applicable statutes and regulations.
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![Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices 45661
IV. Paperwork Reduction Act of 1995 Register of August 27, 2014 (79 FR comment. FDA is reopening the period
This guidance refers to previously 51183). In that notice, FDA requested for public comment so that the public
approved collections of information comments on the 10 originally-filed has the opportunity to review and
found in FDA regulations. These MRTPAs that are posted on http:// comment on these amendments.
collections of information are subject to www.regulations.gov and FDA’s Web
II. Comments
review by the Office of Management and site. The comment period on these
originally-filed applications closed on Interested persons may submit either
Budget (OMB) under the Paperwork
February 23, 2015. FDA is reopening the electronic comments regarding this
Reduction Act of 1995 (44 U.S.C. 3501–
comment period to seek comment document to http://www.regulations.gov
3520). The collections of information in
specifically on amendments made to the or written comments to the Division of
21 CFR part 514 have been approved
originally-filed MRTPAs submitted by Dockets Management (see ADDRESSES). It
under OMB control number 0910–0032.
Swedish Match North America Inc. is only necessary to send one set of
V. Comments DATES: Submit either electronic or comments. Identify comments with the
Interested persons may submit either written comments on the amendments docket number found in brackets in the
electronic comments regarding this by August 31, 2015. heading of this document. Received
document to http://www.regulations.gov ADDRESSES: Submit electronic comments may be seen in the Division
or written comments to the Division of comments to http:// of Dockets Management between 9 a.m.
Dockets Management (see ADDRESSES). It www.regulations.gov. Submit written and 4 p.m., Monday through Friday, and
is only necessary to send one set of comments to the Division of Dockets will be posted to the docket at http://
comments. Identify comments with the Management (HFA–305), Food and Drug www.regulations.gov.
docket number found in brackets in the Administration, 5630 Fishers Lane, Rm. Persons with access to the Internet
heading of this document. Received 1061, Rockville, MD 20852. Identify may obtain the document at either
comments may be seen in the Division comments with Docket Number FDA– http://www.accessdata.fda.gov/Static/
of Dockets Management between 9 a.m. 2014–N–1051. widgets/tobacco/SMNA_MRTPA_FDA-
and 4 p.m., Monday through Friday, and FOR FURTHER INFORMATION CONTACT:
2014-N-1051.html or http://
will be posted to the docket at http:// Center for Tobacco Products, Food and www.regulations.gov.
www.regulations.gov. Drug Administration, 10903 New Dated: July 27, 2015.
Hampshire Ave., Silver Spring, MD Leslie Kux,
VI. Electronic Access
20993, 1–877–287–1373, AskCTP@ Associate Commissioner for Policy.
Persons with access to the Internet fda.hhs.gov. [FR Doc. 2015–18782 Filed 7–30–15; 8:45 am]
may obtain the guidance at either SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P
http://www.fda.gov/cvm or http://
www.regulations.gov. I. Background
Dated: July 27, 2015. In the Federal Register of August 27, DEPARTMENT OF HEALTH AND
Leslie Kux, 2014 (79 FR 51183), FDA published a HUMAN SERVICES
Associate Commissioner for Policy. notice of availability of MRTPAs
submitted by Swedish Match North Office of the Secretary
[FR Doc. 2015–18796 Filed 7–30–15; 8:45 am]
America Inc. for 10 tobacco products
BILLING CODE 4164–01–P
and gave the public 180 days to Findings of Research Misconduct
comment on the applications. AGENCY: Office of the Secretary, HHS.
DEPARTMENT OF HEALTH AND FDA is required by section 911(e) of ACTION: Notice.
HUMAN SERVICES the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 387k(e)) SUMMARY: Notice is hereby given that
Food and Drug Administration to make an MRTPA available to the the Office of Research Integrity (ORI)
public (except for matters in the has taken final action in the following
[Docket No. FDA–2014–N–1051] application that are trade secrets or case:
Modified Risk Tobacco Product otherwise confidential commercial David Anderson, University of
Applications: Applications for 10 information) and to request comments Oregon, Eugene: Based on an
Products Submitted by Swedish Match by interested persons on the information assessment conducted by the University
North America Inc.; Reopening of contained in the application and on the of Oregon, Eugene (UOE), the
Comment Period label, labeling, and advertising Respondent’s admission, and analysis
accompanying the application. The conducted by ORI, ORI and UOE found
AGENCY: Food and Drug Administration, determination of whether an order is that Mr. David Anderson, Graduate
HHS. appropriate under section 911 of the Student, UOE, engaged in research
Notice; reopening of the
ACTION: FD&C Act is based on the scientific misconduct in research supported by
comment period. information submitted by the applicant National Institute of Mental Health
as well as the scientific evidence and (NIMH), National Institutes of Health
SUMMARY: The Food and Drug other information that is made available (NIH), grants R01 MH087214, R01
Administration (FDA) is reopening the to the Agency, including through public MH077105, and TA MH020002.
period for public comment on modified comments. ORI found that Respondent engaged
asabaliauskas on DSK5VPTVN1PROD with NOTICES
risk tobacco product applications FDA has received and accepted a in research misconduct by falsifying
(MRTPAs) submitted by Swedish Match number of amendments to Swedish and/or fabricating data in the following
North America Inc. for 10 tobacco Match North America Inc.’s 10 four (4) publications:
products and announcing the originally-filed MRTPAs and is making • Journal of Neuroscience
availability for public comment of these amendments available (except for 31(3):1128–38, 2011 (hereafter referred
amendments to the MRTPAs. The notice matters in the amendments that are to as ‘‘Paper 1’’).
of availability for the originally-filed trade secrets or otherwise confidential Journal of Experimental Psychology:
applications appeared in the Federal commercial information) for public Human Perception and Performance
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Document Created: 2015-12-15 12:59:58
Document Modified: 2015-12-15 12:59:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Mai Huynh, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0670, [email protected] | |
| FR Citation | 80 FR 45660 |
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