80 FR 27322 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL23(R)); Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing; Revised Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 92 (May 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 92 (May 13, 2015)
| Page Range | 27322-27323 | |
| FR Document | 2015-11527 |
[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)] [Notices] [Pages 27322-27323] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11527] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0598 (Formerly 2000D-1631)] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL23(R)); Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing; Revised Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised guidance for industry (GFI) #116 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In this VICH guidance, the recommendation for a second test to evaluate the potential of a chemical to produce chromosomal effects is revised. The revised guidance indicates that the potential of a chemical to produce chromosomal effects can be evaluated using one of the following three tests: (1) An in vitro chromosomal aberrations test using metaphase analysis, which detects both clastogenicity and aneugenicity; (2) an in vitro mammalian cell micronucleus test, which detects the activity of clastogenicity and aneugenicity; or (3) a mouse lymphoma test, which, with modification, can detect both gene mutation and chromosomal damage. This revised VICH guidance document is intended to facilitate the mutual acceptance of safety data necessary for the establishment of acceptable daily intakes for veterinary drug residues in human food by the relevant regulatory authorities. DATES: Submit either electronic or written comments on Agency guidance at any time. ADDRESSES: Submit written requests for single copies of the revised 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 revised guidance document. Submit electronic comments on the revised 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: Tong Zhou, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0826, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the [[Page 27323]] 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 (ICH) 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. In the Federal Register of March 5, 2013 (78 FR 14306), FDA published a notice of availability for a draft revised guidance document entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)) giving interested persons until May 6, 2013, to comment on the draft revised guidance. FDA received one comment on the draft revised guidance, and that comment, as well as those received by other VICH member regulatory agencies, were considered as the guidance was finalized. The guidance announced in this document finalizes the draft revised guidance dated March 5, 2013. The revised guidance is a product of the Safety Expert Working Group of the VICH. This revised VICH guidance document recommends a second test to evaluate the potential of a chemical to produce chromosomal effects. The revised VICH guidance indicates that the potential of a chemical to produce chromosomal effects can be evaluated using one of the following three tests: (1) An in vitro chromosomal aberrations test using metaphase analysis, which detects both clastogenicity and aneugenicity; (2) an in vitro mammalian cell micronucleus test, which detects the activity of clastogenicity and aneugenicity; or (3) a mouse lymphoma test, which, with modification, can detect both gene mutation and chromosomal damage. This revised VICH guidance is intended to facilitate the mutual acceptance of safety data necessary for the establishment of acceptable daily intakes for veterinary drug residues in human food by the relevant regulatory authorities. The objective of this revised VICH guidance is to ensure international harmonization of genotoxicity testing. II. Significance of Guidance This guidance, developed under the VICH process, is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on this topic. 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 the applicable statutes and regulations. III. 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. IV. 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 revised guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: May 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-11527 Filed 5-12-15; 8:45 am] BILLING CODE 4164-01-P
![27322 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
• Exclusivity will be posted to the docket at http:// entitled ‘‘Studies to Evaluate the Safety
The Q&A format is intended to promote www.regulations.gov. of Residues of Veterinary Drugs in
transparency and facilitate development Human Food: Genotoxicity Testing’’
III. The Paperwork Reduction Act of
programs for proposed biosimilar (VICH GL23(R)). This revised guidance
1995
products by addressing questions that has been developed for veterinary use
may arise in the early stages of This draft guidance refers to by the International Cooperation on
development. In addition, these Q&As information collection provisions that Harmonisation of Technical
respond to questions the Agency has are subject to review by the Office of Requirements for Registration of
received from prospective BLA and new Management and Budget (OMB) under Veterinary Medicinal Products (VICH).
drug application (NDA) applicants the Paperwork Reduction Act of 1995 In this VICH guidance, the
regarding the appropriate statutory (the PRA) (44 U.S.C. 3501–3520). The recommendation for a second test to
authority under which certain products submission of an investigational new evaluate the potential of a chemical to
will be regulated. drug application is covered under 21 produce chromosomal effects is revised.
CFR part 312 and approved under OMB The revised guidance indicates that the
In the Federal Register of February
Control No. 0910–0014. The submission potential of a chemical to produce
15, 2012 (77 FR 8885), FDA published
of an NDA is covered under 21 CFR chromosomal effects can be evaluated
a notice announcing the availability of
314.50 and approved under OMB using one of the following three tests:
a draft guidance entitled ‘‘Biosimilars:
Control No. 0910–0001. The submission (1) An in vitro chromosomal aberrations
Questions and Answers Regarding
of a BLA under section 351(a) of the test using metaphase analysis, which
Implementation of the Biologics Price
PHS Act is covered under part 601 (21 detects both clastogenicity and
Competition and Innovation Act of
CFR part 601) and approved under OMB aneugenicity; (2) an in vitro mammalian
2009.’’ Although interested parties can
Control No. 0910–0338. The submission cell micronucleus test, which detects
comment on any guidance at any time,
of a BLA under section 351(k) of the the activity of clastogenicity and
to ensure that the Agency considered
PHS Act is covered under part 601 and aneugenicity; or (3) a mouse lymphoma
comments on the draft guidance before
approved under OMB control number test, which, with modification, can
beginning work on the final version of
0910–0719. detect both gene mutation and
the guidance, FDA requested that
interested parties submit comments by IV. Electronic Access chromosomal damage. This revised
April 16, 2012. FDA’s consideration of VICH guidance document is intended to
Persons with access to the Internet facilitate the mutual acceptance of
these comments, among other things, is may obtain the document at http://
reflected in this revised draft guidance safety data necessary for the
www.fda.gov/Drugs/Guidance establishment of acceptable daily
(which provides new and revised Q&As) ComplianceRegulatoryInformation/
and the final guidance. This revised intakes for veterinary drug residues in
Guidances/default.htm, http:// human food by the relevant regulatory
draft guidance describes the status of www.fda.gov/BiologicsBloodVaccines/
the draft guidance Q&As provided in authorities.
GuidanceComplianceRegulatory
this revised draft guidance and the DATES: Submit either electronic or
Information/default.htm, or http://www.
status of the final guidance Q&As that written comments on Agency guidance
regulations.gov.
are included in the guidance entitled at any time.
‘‘Biosimilars: Questions and Answers Dated: May 7, 2015. ADDRESSES: Submit written requests for
Regarding Implementation of the Leslie Kux, single copies of the revised guidance to
Biologics Price Competition and Associate Commissioner for Policy. the Policy and Regulations Staff (HFV–
Innovation Act of 2009.’’ FDA intends to [FR Doc. 2015–11528 Filed 5–12–15; 8:45 am] 6), Center for Veterinary Medicine, Food
update these guidances to include BILLING CODE 4164–01–P and Drug Administration, 7519 Standish
additional Q&As as appropriate. Pl., Rockville, MD 20855. Send one self-
This draft guidance is being issued addressed adhesive label to assist that
consistent with FDA’s good guidance DEPARTMENT OF HEALTH AND office in processing your request. See
practices regulation (21 CFR 10.115). HUMAN SERVICES the SUPPLEMENTARY INFORMATION section
The draft guidance, when finalized, will for electronic access to the revised
Food and Drug Administration guidance document.
represent the current thinking of FDA
on this topic. It does not establish any [Docket No. FDA–2000–D–0598 (Formerly Submit electronic comments on the
rights for any person and is not binding 2000D–1631)] revised guidance to http://
on FDA or the public. You can use an www.regulations.gov. Submit written
alternative approach if it satisfies the International Cooperation on comments to the Division of Dockets
requirements of the applicable statutes Harmonisation of Technical Management (HFA–305), Food and Drug
and regulations. Requirements for Registration of Administration, 5630 Fishers Lane, Rm.
Veterinary Medicinal Products (VICH 1061, Rockville, MD 20852.
II. Comments GL23(R)); Studies To Evaluate the FOR FURTHER INFORMATION CONTACT:
Interested persons may submit either Safety of Residues of Veterinary Drugs Tong Zhou, Center for Veterinary
electronic comments regarding this in Human Food: Genotoxicity Testing; Medicine (HFV–153), Food and Drug
document to http://www.regulations.gov Revised Guidance for Industry; Administration, 7500 Standish Place,
or written comments to the Division of Availability Rockville, MD 20855, 240–402–0826,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Dockets Management (see ADDRESSES). It AGENCY: Food and Drug Administration, Tong.Zhou@fda.hhs.gov.
is only necessary to send one set of HHS. SUPPLEMENTARY INFORMATION:
comments. Identify comments with the ACTION: Notice.
docket number found in brackets in the I. Background
heading of this document. Received SUMMARY: The Food and Drug In recent years, many important
comments may be seen in the Division Administration (FDA or Agency) is initiatives have been undertaken by
of Dockets Management between 9 a.m. announcing the availability of a revised regulatory authorities and industry
and 4 p.m., Monday through Friday, and guidance for industry (GFI) #116 associations to promote the
VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1](https://thefederalregister.org/doc/80_FR_27414/page/1.svg)
![Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27323
international harmonization of Genotoxicity Testing’’ (VICH GL23(R)) IV. Comments
regulatory requirements. FDA has giving interested persons until May 6, Interested persons may submit either
participated in efforts to enhance 2013, to comment on the draft revised electronic comments regarding this
harmonization and has expressed its guidance. FDA received one comment document to http://www.regulations.gov
commitment to seek scientifically based, on the draft revised guidance, and that or written comments to the Division of
harmonized technical procedures for the comment, as well as those received by Dockets Management (see ADDRESSES). It
development of pharmaceutical other VICH member regulatory agencies, is only necessary to send one set of
products. One of the goals of were considered as the guidance was comments. Identify comments with the
harmonization is to identify, and then finalized. The guidance announced in docket number found in brackets in the
reduce, differences in technical this document finalizes the draft revised heading of this document. Received
requirements for drug development guidance dated March 5, 2013. The comments may be seen in the Division
among regulatory agencies in different revised guidance is a product of the of Dockets Management between 9 a.m.
countries.
FDA has actively participated in the Safety Expert Working Group of the and 4 p.m., Monday through Friday, and
International Conference on VICH. will be posted to the docket at http://
Harmonisation of Technical This revised VICH guidance www.regulations.gov.
Requirements for Registration of document recommends a second test to VI. Electronic Access
Pharmaceuticals for Human Use (ICH) evaluate the potential of a chemical to
Persons with access to the Internet
for several years to develop harmonized produce chromosomal effects. The
technical requirements for the approval may obtain the revised guidance at
revised VICH guidance indicates that
of human pharmaceutical and biological either http://www.fda.gov/
the potential of a chemical to produce
products among the European Union, AnimalVeterinary/
chromosomal effects can be evaluated
Japan, and the United States. The VICH GuidanceComplianceEnforcement/
using one of the following three tests:
is a parallel initiative for veterinary GuidanceforIndustry/default.htm or
(1) An in vitro chromosomal aberrations http://www.regulations.gov.
medicinal products. The VICH is test using metaphase analysis, which
concerned with developing harmonized detects both clastogenicity and Dated: May 7, 2015.
technical requirements for the approval aneugenicity; (2) an in vitro mammalian Leslie Kux,
of veterinary medicinal products in the cell micronucleus test, which detects Associate Commissioner for Policy.
European Union, Japan, and the United the activity of clastogenicity and [FR Doc. 2015–11527 Filed 5–12–15; 8:45 am]
States, and includes input from both aneugenicity; or (3) a mouse lymphoma BILLING CODE 4164–01–P
regulatory and industry representatives. test, which, with modification, can
The VICH Steering Committee is
detect both gene mutation and
composed of member representatives DEPARTMENT OF HEALTH AND
chromosomal damage. This revised
from the European Commission, HUMAN SERVICES
VICH guidance is intended to facilitate
European Medicines Evaluation Agency,
European Federation of Animal Health, the mutual acceptance of safety data
Food and Drug Administration
Committee on Veterinary Medicinal necessary for the establishment of
Products, FDA, the U.S. Department of acceptable daily intakes for veterinary
drug residues in human food by the [Docket No. FDA–2010–N–0128]
Agriculture, the Animal Health
Institute, the Japanese Veterinary relevant regulatory authorities. The
Prescription Drug User Fee Act; Public
Pharmaceutical Association, the objective of this revised VICH guidance
Meeting; Request for Comments
Japanese Association of Veterinary is to ensure international harmonization
Biologics, and the Japanese Ministry of of genotoxicity testing. AGENCY: Food and Drug Administration,
Agriculture, Forestry, and Fisheries. HHS.
II. Significance of Guidance
Six observers are eligible to ACTION: Notice of public meeting;
participate in the VICH Steering This guidance, developed under the request for comments
Committee: One representative from the VICH process, is being issued consistent
government of Australia/New Zealand, with FDA’s good guidance practices SUMMARY: The Food and Drug
one representative from the industry in regulation (21 CFR 10.115). This Administration (FDA or Agency) is
Australia/New Zealand, one guidance represents the current thinking announcing a public meeting on the
representative from the government of of FDA on this topic. It does not reauthorization of the Prescription Drug
Canada, one representative from the establish any rights for any person and User Fee Act (PDUFA) for fiscal years
industry of Canada, one representative is not binding on FDA or the public. (FYs) 2018 through 2022. PDUFA
from the government of South Africa, authorizes FDA to collect user fees for
You can use an alternative approach if
and one representative from the the process for the review of human
it satisfies the requirements of the
industry of South Africa. The VICH drugs. The current legislative authority
applicable statutes and regulations.
Secretariat, which coordinates the for PDUFA expires in September 2017.
preparation of documentation, is III. Paperwork Reduction Act of 1995 At that time, new legislation will be
provided by the International required for FDA to continue collecting
Federation for Animal Health (IFAH). This guidance refers to previously user fees in future fiscal years. The
An IFAH representative also approved collections of information Federal Food, Drug, and Cosmetic Act
asabaliauskas on DSK5VPTVN1PROD with NOTICES
participates in the VICH Steering found in FDA regulations. These (FD&C Act) requires that FDA begin the
Committee meetings. collections of information are subject to PDUFA reauthorization process by
In the Federal Register of March 5, review by the Office of Management and publishing a notice in the Federal
2013 (78 FR 14306), FDA published a Budget (OMB) under the Paperwork Register requesting public input and
notice of availability for a draft revised Reduction Act of 1995 (44 U.S.C. 3501– holding a public meeting where the
guidance document entitled ‘‘Studies to 3520). The collections of information in public may present its views on the
Evaluate the Safety of Residues of 21 CFR part 514 have been approved reauthorization. FDA invites public
Veterinary Drugs in Human Food: under OMB control number 0910–0032. comment as the Agency begins the
VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1](https://thefederalregister.org/doc/80_FR_27414/page/2.svg)
Document Created: 2015-12-16 07:47:15
Document Modified: 2015-12-16 07:47:15
| 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 guidance at any time. | |
| Contact | Tong Zhou, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0826, [email protected] | |
| FR Citation | 80 FR 27322 |
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