80 FR 12490 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies; Revised Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 45 (March 9, 2015)

Page Range		12490-12491
FR Document		2015-05346

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI #208) entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies'' (VICH GL49(R)). This revised guidance, which provides minor updates to a final guidance on the same topic for which a notice of availability was published in the Federal Register of September 15, 2011, has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised VICH guidance document is intended to provide a general description of the criteria that have been found by the European Union, Japan, United States, Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies.

Federal Register, Volume 80 Issue 45 (Monday, March 9, 2015)

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12490-12491]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05346]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0165]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Studies 
To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in 
Food-Producing Animals: Validation of Analytical Methods Used in 
Residue Depletion Studies; Revised 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 revised guidance for industry (GFI #208) entitled 
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 
Drugs in Food-Producing Animals: Validation of Analytical Methods Used 
in Residue Depletion Studies'' (VICH GL49(R)). This revised guidance, 
which provides minor updates to a final guidance on the same topic for 
which a notice of availability was published in the Federal Register of 
September 15, 2011, has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This revised 
VICH guidance document is intended to provide a general description of 
the criteria that have been found by the European Union, Japan, United 
States, Australia, New Zealand, and Canada to be suitable for the 
validation of analytical methods used in veterinary drug residue 
depletion studies.

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 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: Julia Oriani, Center for Veterinary 
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0788, [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

[[Page 12491]]

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, U.S. Department of Agriculture, the Animal Health 
Institute, Japanese Veterinary Pharmaceutical Association, Japanese 
Association of Veterinary Biologics, and 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. Revised Guidance on Studies To Evaluate the Metabolism and Residue 
Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of 
Analytical Methods Used in Residue Depletion Studies

    In June 2014, the VICH Steering Committee agreed that a revised 
guidance document entitled ``Studies to Evaluate the Metabolism and 
Residue Kinetics of Veterinary Drugs in Food-Producing Animals: 
Validation of Analytical Methods Used in Residue Depletion Studies'' 
(VICH GL49(R)) should be made available to the public. This revised 
guidance is a revision of a final guidance on the same topic for which 
a notice of availability was published in the Federal Register of 
September 15, 2011 (76 FR 57056). The revised guidance makes minor 
changes such as correcting a typographical error in table 2 (Annex 3). 
Also, the explanatory text for table 2 (Annex 3) was revised to correct 
a description of the statistical model and to provide an explanation of 
the procedure used to generate the data in the table. This revised 
guidance is a product of the Metabolism and Residue Kinetics Expert 
Working Group of the VICH.
    During the veterinary drug development process, residue depletion 
studies are conducted to determine the concentration of the residue or 
residues present in the edible products (tissues, milk, eggs, or honey) 
of animals treated with veterinary drugs. This information is used in 
regulatory submissions around the world. Submission of regulatory 
methods (i.e., postapproval control methods) and the validation 
requirements of the regulatory methods are usually well defined by 
various regulatory agencies worldwide and might even be defined by 
national or regional law. However, the residue depletion studies are 
generally conducted before the regulatory methods have been completed. 
Oftentimes the in-house validated residue methods provide the framework 
for the methods submitted for regulatory monitoring. Harmonization of 
the validation requirements for methodology used during residue 
depletion studies and submitted to the regulatory agencies in support 
of the maximum residue limits and withdrawal periods should be 
achievable. It is the intent of this document to describe a validation 
procedure that is acceptable to the regulatory bodies of the VICH 
regions for use in the residue depletion studies. This validated method 
could continue on to become the ``regulatory method'' but that phase of 
the process will not be addressed in any detail in this guidance. For 
purposes of this guidance, the term ``acceptable'' refers to the 
scientific evaluation of the analytical method in terms of the 
described validation criteria, not to acceptance of the analytical 
method as satisfying the applicable national/regional laws and 
regulations of any of the relevant regulatory bodies.

III. Significance of Guidance

    As a result of Level 2 revisions, this VICH revised guidance is 
being issued in final, consistent with FDA's good guidance practice 
(GGP) regulations at 21 CFR 10.115(g)(4). This guidance, developed 
under the VICH process, has been revised to conform to FDA's GGP 
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 VICH 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 applicable 
statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This revised 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 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: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05346 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P

12490 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices

Agenda: To review and evaluate Place: National Institutes of Health, Two and Canada to be suitable for the
cooperative agreement applications. Democracy Plaza, 6707 Democracy validation of analytical methods used in
Place: National Institutes of Health, Two Boulevard, Bethesda, MD 20892 (Telephone veterinary drug residue depletion
Democracy Plaza, 6707 Democracy Conference Call).
Boulevard, Bethesda, MD 20892, (Telephone Contact Person: Robert Wellner, Ph.D.,
studies.
Conference Call). Scientific Review Officer, Review Branch, DATES: Submit either electronic or
Contact Person: Ann A. Jerkins, Ph.D., DEA, NIDDK, National Institutes of Health, written comments on Agency guidances
Scientific Review Officer, Review Branch, Room 706, 6707 Democracy Boulevard, at any time.
DEA, NIDDK, National Institutes of Health, Bethesda, MD 20892–5452, 301–594–4721
Room 759, 6707 Democracy Boulevard, rw175w@nih.gov. ADDRESSES: Submit written requests for
Bethesda, MD 20892–5452, 301–594–2242, (Catalogue of Federal Domestic Assistance single copies of the guidance to the
jerkinsa@niddk.nih.gov. Program Nos. 93.847, Diabetes, Communications Staff (HFV–12), Center
This notice is being published less than 15 Endocrinology and Metabolic Research; for Veterinary Medicine, Food and Drug
days prior to the meeting due to the timing 93.848, Digestive Diseases and Nutrition Administration, 7519 Standish Pl.,
limitations imposed by the review and Research; 93.849, Kidney Diseases, Urology
funding cycle.
Rockville, MD 20855. Send one self-
and Hematology Research, National Institutes addressed adhesive label to assist that
Name of Committee: National Institute of of Health, HHS)
Diabetes and Digestive and Kidney Diseases office in processing your request. See
Special Emphasis Panel; HIV-Associated Dated: March 3, 2015. the SUPPLEMENTARY INFORMATION section
Nephropathy Program Project. David Clary, for electronic access to the guidance
Date: March 30, 2015. Program Analyst, Office of Federal Advisory document.
Time: 10:00 a.m. to 1:00 p.m. Committee Policy. Submit electronic comments on the
Agenda: To review and evaluate grant revised guidance to http://
[FR Doc. 2015–05306 Filed 3–6–15; 8:45 am]
applications. www.regulations.gov. Submit written
Place: National Institutes of Health, Two BILLING CODE 4140–01–P
Democracy Plaza, 6707 Democracy comments to the Division of Dockets
Boulevard, Bethesda, MD 20892 (Telephone Management (HFA–305), Food and Drug
Conference Call). DEPARTMENT OF HEALTH AND Administration, 5630 Fishers Lane, Rm.
Contact Person: Michele L. Barnard, Ph.D., HUMAN SERVICES 1061, Rockville, MD 20852.
Scientific Review Officer, Review Branch, FOR FURTHER INFORMATION CONTACT: Julia
DEA, NIDDK, National Institutes of Health, Food and Drug Administration Oriani, Center for Veterinary Medicine
Room 753, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898, [Docket No. FDA–2010–D–0165] (HFV–151), Food and Drug
barnardm@extra.niddk.nih.gov. Administration, 7500 Standish Pl.,
Name of Committee: National Institute of International Cooperation on Rockville, MD 20855, 240–402–0788,
Diabetes and Digestive and Kidney Diseases Harmonisation of Technical julia.oriani@fda.hhs.gov.
Special Emphasis Panel; NIDDK R24 Review. Requirements for Registration of SUPPLEMENTARY INFORMATION:
Date: March 30, 2015. Veterinary Medicinal Products; Studies
Time: 2:00 p.m. to 4:00 p.m. To Evaluate the Metabolism and I. Background
Agenda: To review and evaluate grant Residue Kinetics of Veterinary Drugs In recent years, many important
applications. in Food-Producing Animals: Validation
Place: National Institutes of Health, Two initiatives have been undertaken by
of Analytical Methods Used in Residue regulatory authorities and industry
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Depletion Studies; Revised Guidance associations to promote the
Conference Call). for Industry; Availability international harmonization of
Contact Person: Robert Wellner, Ph.D., AGENCY: Food and Drug Administration, regulatory requirements. FDA has
Scientific Review Officer, Review Branch, participated in efforts to enhance
DEA, NIDDK, National Institutes of Health,
HHS.
ACTION: Notice. harmonization and has expressed its
Room 706, 6707 Democracy Boulevard, commitment to seek scientifically based
Bethesda, MD 20892–5452, 301–594–4721,
rw175w@nih.gov. SUMMARY: The Food and Drug harmonized technical procedures for the
Administration (FDA) is announcing the development of pharmaceutical
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases availability of a revised guidance for products. One of the goals of
Special Emphasis Panel; Building a Kidney: industry (GFI #208) entitled ‘‘Studies to harmonization is to identify, and then
Cells to Organ. Evaluate the Metabolism and Residue reduce, differences in technical
Date: April 7, 2015. Kinetics of Veterinary Drugs in Food- requirements for drug development
Time: 8:00 a.m. to 5:00 p.m. Producing Animals: Validation of among regulatory agencies in different
Agenda: To review and evaluate grant Analytical Methods Used in Residue countries.
applications. Depletion Studies’’ (VICH GL49(R)). FDA has actively participated in the
Place: Washington Marriott at Metro
Center, 775 12th St. NW., Washington, DC
This revised guidance, which provides International Conference on
20005. minor updates to a final guidance on the Harmonisation of Technical
Contact Person: Paul A. Rushing, Ph.D., same topic for which a notice of Requirements for Registration of
Scientific Review Officer, Review Branch, availability was published in the Pharmaceuticals for Human Use for
DEA, NIDDK, National Institutes of Health, Federal Register of September 15, 2011, several years to develop harmonized
Room 747, 6707 Democracy Boulevard, has been developed for veterinary use technical requirements for the approval
Bethesda, MD 20892–5452, (301) 594–8895, by the International Cooperation on of human pharmaceutical and biological
rushingp@extra.niddk.nih.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES

Harmonisation of Technical products among the European Union,
Name of Committee: National Institute of Requirements for Registration of Japan, and the United States. The VICH
Diabetes and Digestive and Kidney Diseases Veterinary Medicinal Products (VICH). is a parallel initiative for veterinary
Special Emphasis Panel; NIDDK R24 Grant
Review.
This revised VICH guidance document medicinal products. The VICH is
Date: April 8, 2015. is intended to provide a general concerned with developing harmonized
Time: 12:00 p.m. to 2:00 p.m. description of the criteria that have been technical requirements for the approval
Agenda: To review and evaluate grant found by the European Union, Japan, of veterinary medicinal products in the
applications. United States, Australia, New Zealand, European Union, Japan, and the United

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Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12491

States, and includes input from both concentration of the residue or residues requirements of applicable statutes and
regulatory and industry representatives. present in the edible products (tissues, regulations.
The VICH Steering Committee is milk, eggs, or honey) of animals treated
composed of member representatives IV. Paperwork Reduction Act of 1995
with veterinary drugs. This information
from the European Commission, is used in regulatory submissions This revised guidance refers to
European Medicines Evaluation Agency, around the world. Submission of previously approved collections of
European Federation of Animal Health, regulatory methods (i.e., postapproval information found in FDA regulations.
Committee on Veterinary Medicinal control methods) and the validation These collections of information are
Products, FDA, U.S. Department of requirements of the regulatory methods subject to review by the Office of
Agriculture, the Animal Health are usually well defined by various Management and Budget (OMB) under
Institute, Japanese Veterinary regulatory agencies worldwide and the Paperwork Reduction Act of 1995
Pharmaceutical Association, Japanese might even be defined by national or (44 U.S.C. 3501–3520). The collections
Association of Veterinary Biologics, and regional law. However, the residue of information in 21 CFR part 514 have
Japanese Ministry of Agriculture, depletion studies are generally been approved under OMB control
Forestry, and Fisheries. conducted before the regulatory number 0910–0032.
Six observers are eligible to methods have been completed.
participate in the VICH Steering V. Comments
Oftentimes the in-house validated
Committee: One representative from the residue methods provide the framework Interested persons may submit either
government of Australia/New Zealand, for the methods submitted for regulatory electronic comments regarding this
one representative from the industry in monitoring. Harmonization of the document to www.regulations.gov or
Australia/New Zealand, one validation requirements for written comments to the Division of
representative from the government of methodology used during residue Dockets Management (see ADDRESSES).
Canada, one representative from the depletion studies and submitted to the It is only necessary to send one set of
industry of Canada, one representative regulatory agencies in support of the comments. Identify comments with the
from the government of South Africa, maximum residue limits and docket number found in brackets in the
and one representative from the withdrawal periods should be heading of this document. Received
industry of South Africa. The VICH achievable. It is the intent of this comments may be seen in the Division
Secretariat, which coordinates the document to describe a validation of Dockets Management between 9 a.m.
preparation of documentation, is procedure that is acceptable to the and 4 p.m., Monday through Friday, and
provided by the International regulatory bodies of the VICH regions will be posted to the docket at http://
Federation for Animal Health (IFAH). for use in the residue depletion studies. www.regulations.gov.
An IFAH representative also This validated method could continue
participates in the VICH Steering VI. Electronic Access
on to become the ‘‘regulatory method’’
Committee meetings. but that phase of the process will not be Persons with access to the Internet
addressed in any detail in this guidance. may obtain the guidance at either
II. Revised Guidance on Studies To http://www.fda.gov/AnimalVeterinary/
Evaluate the Metabolism and Residue For purposes of this guidance, the term
‘‘acceptable’’ refers to the scientific GuidanceComplianceEnforcement/
Kinetics of Veterinary Drugs in Food- GuidanceforIndustry/default.htm or
Producing Animals: Validation of evaluation of the analytical method in
terms of the described validation http://www.regulations.gov.
Analytical Methods Used in Residue
Depletion Studies criteria, not to acceptance of the Dated: March 3, 2015.
analytical method as satisfying the Leslie Kux,
In June 2014, the VICH Steering applicable national/regional laws and
Committee agreed that a revised Associate Commissioner for Policy.
regulations of any of the relevant [FR Doc. 2015–05346 Filed 3–6–15; 8:45 am]
guidance document entitled ‘‘Studies to regulatory bodies.
Evaluate the Metabolism and Residue BILLING CODE 4164–01–P
Kinetics of Veterinary Drugs in Food- III. Significance of Guidance
Producing Animals: Validation of As a result of Level 2 revisions, this
Analytical Methods Used in Residue DEPARTMENT OF HEALTH AND
VICH revised guidance is being issued
Depletion Studies’’ (VICH GL49(R)) in final, consistent with FDA’s good HUMAN SERVICES
should be made available to the public. guidance practice (GGP) regulations at Food and Drug Administration
This revised guidance is a revision of a 21 CFR 10.115(g)(4). This guidance,
final guidance on the same topic for developed under the VICH process, has [Docket No. FDA–2013–N–1152]
which a notice of availability was been revised to conform to FDA’s GGP
published in the Federal Register of regulation (21 CFR 10.115). For Agency Information Collection
September 15, 2011 (76 FR 57056). The example, the document has been Activities; Proposed Collection;
revised guidance makes minor changes designated ‘‘guidance’’ rather than Comment Request; Petition To
such as correcting a typographical error ‘‘guideline.’’ In addition, guidance Request an Exemption From 100
in table 2 (Annex 3). Also, the documents must not include mandatory Percent Identity Testing of Dietary
explanatory text for table 2 (Annex 3) language such as ‘‘shall,’’ ‘‘must,’’ Ingredients: Current Good
was revised to correct a description of ‘‘require,’’ or ‘‘requirement,’’ unless Manufacturing Practice in
the statistical model and to provide an FDA is using these words to describe a Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
mstockstill on DSK4VPTVN1PROD with NOTICES

explanation of the procedure used to statutory or regulatory requirement.
generate the data in the table. This This VICH guidance represents the Supplements
revised guidance is a product of the Agency’s current thinking on this topic. AGENCY: Food and Drug Administration,
Metabolism and Residue Kinetics Expert It does not create or confer any rights for HHS.
Working Group of the VICH. or on any person and does not operate ACTION: Notice.
During the veterinary drug to bind FDA or the public. An
development process, residue depletion alternative approach may be used if SUMMARY: The Food and Drug
studies are conducted to determine the such approach satisfies the Administration (FDA) is announcing an

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Document Created: 2015-12-18 12:05:19
Document Modified: 2015-12-18 12:05:19

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		Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0788, [email protected]
FR Citation		80 FR 12490

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 45 (March 9, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration