80 FR 12501 - 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: Marker Residue Depletion Studies To Establish Product Withdrawal Periods; 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		12501-12502
FR Document		2015-05345

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI #207) entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods'' (VICH GL48(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 (2011 guidance), 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 is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.

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

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12501-12502]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0166]


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: Marker Residue Depletion Studies To Establish 
Product Withdrawal Periods; Revised Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry (GFI #207) entitled 
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 
Drugs in Food-Producing Animals: Marker Residue Depletion Studies to 
Establish Product Withdrawal Periods'' (VICH GL48(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 (2011 guidance), 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 is intended to provide 
study design recommendations that will facilitate the universal 
acceptance of the generated residue depletion data to fulfill the 
national/regional requirements.

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 on the guidance 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.

[[Page 12502]]

    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, 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: Marker Residue 
Depletion Studies To Establish Product Withdrawal Periods

    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: Marker 
Residue Depletion Studies to Establish Product Withdrawal Periods'' 
(VICH GL48(R)) should be made available to the public. The 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 includes minor 
changes that clarify recommendations for conducting a single timepoint 
study for products proposed for a 0-day withdrawal period or a 0-day 
milk discard time. In addition, the design for a 0-day milk discard 
timestudy was described, and a definition for preruminant was added. 
This revised guidance is a product of the Metabolism and Residue 
Kinetics Expert Working Group of the VICH.
    As part of the approval process for veterinary medicinal products 
in food-producing animals, national/regional regulatory authorities 
require data from marker residue depletion studies in order to 
establish appropriate withdrawal periods in edible tissues, including 
meat, milk, and eggs. The objective of this guidance is to provide 
study design recommendations that will facilitate the universal 
acceptance of the generated residue depletion data to fulfill the 
national/regional requirements.

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. 2015-05345 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12501

shall provide such person a written related to substantial equivalence or 513(g) Requests for Information’’ assists
statement of the classification (if any) of safety and effectiveness in a 513(g) FDA staff and regulated industry by
such device and the requirements of the request for information. FDA’s describing the user fees associated with
FD&C Act applicable to the device. responses to 513(g) requests for 513(g) requests. The Medical Device
The guidance document entitled information are not device classification User Fee Cover Sheet (Form FDA 3601),
‘‘Guidance for Industry and Food and decisions and do not constitute FDA which accompanies the supplemental
Drug Administration Staff; FDA and clearance or approval for marketing. material described in this information
Industry Procedures for Section 513(g) Classification decisions and clearance or collection, is approved under OMB
Requests for Information Under the approval for marketing require control number 0910–0511 and expires
Federal Food, Drug, and Cosmetic Act’’ submissions under different sections of April 30, 2016.
establishes procedures for submitting, the FD&C Act. Additionally, the FD&C In the Federal Register of July 22,
reviewing, and responding to requests Act, as amended by the FDA 2014 (79 FR 42517), FDA published a
for information respecting the class in Amendments Act of 2007 (Public Law 60-day notice requesting public
which a device has been classified or 110–85), requires FDA to collect user comment on the proposed collection of
the requirements applicable to a device fees for 513(g) requests for information. information. No comments were
under the FD&C Act that are submitted The guidance document entitled received.
in accordance with section 513(g) of the ‘‘Guidance for Industry and Food and FDA estimates the burden of this
FD&C Act. FDA does not review data Drug Administration Staff; User Fees for collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Center for Devices and Radiological Health 513(g) requests ............. 114 1 114 12 1,368
Center for Biologics Evaluation and Research 513(g) requests ......... 4 1 4 12 48

Total .............................................................................................. .................... ........................ .................... .................... 1,416
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Respondents to this collection of SUMMARY: The Food and Drug for electronic access to the guidance
information are mostly device Administration (FDA) is announcing the document.
manufacturers; however, anyone may availability of a revised guidance for Submit electronic comments on the
submit a 513(g) request for information. industry (GFI #207) entitled ‘‘Studies to revised guidance to http://
The total number of annual responses is Evaluate the Metabolism and Residue www.regulations.gov. Submit written
based on the average number of 513(g) Kinetics of Veterinary Drugs in Food- comments on the guidance to the
requests received each year by the Producing Animals: Marker Residue Division of Dockets Management (HFA–
Agency. Depletion Studies to Establish Product 305), Food and Drug Administration,
Dated: March 2, 2015. Withdrawal Periods’’ (VICH GL48(R)). 5630 Fishers Lane, Rm. 1061, Rockville,
Leslie Kux,
This revised guidance, which provides MD 20852.
minor updates to a final guidance on the
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Julia
same topic for which a notice of
[FR Doc. 2015–05358 Filed 3–6–15; 8:45 am]
availability was published in the Oriani, Center for Veterinary Medicine
BILLING CODE 4164–01–P Federal Register of September 15, 2011 (HFV–151), Food and Drug
(2011 guidance), has been developed for Administration, 7500 Standish Pl.,
veterinary use by the International Rockville, MD 20855, 240–402–0788,
DEPARTMENT OF HEALTH AND julia.oriani@fda.hhs.gov.
Cooperation on Harmonisation of
HUMAN SERVICES
Technical Requirements for Registration SUPPLEMENTARY INFORMATION:
Food and Drug Administration of Veterinary Medicinal Products
(VICH). This revised VICH guidance is I. Background
[Docket No. FDA–2010–D–0166] intended to provide study design In recent years, many important
recommendations that will facilitate the initiatives have been undertaken by
International Cooperation on universal acceptance of the generated regulatory authorities and industry
Harmonisation of Technical residue depletion data to fulfill the associations to promote the
Requirements for Registration of national/regional requirements. international harmonization of
Veterinary Medicinal Products; Studies DATES: Submit either electronic or regulatory requirements. FDA has
To Evaluate the Metabolism and written comments on Agency guidances participated in efforts to enhance
Residue Kinetics of Veterinary Drugs at any time. harmonization and has expressed its
in Food-Producing Animals: Marker ADDRESSES: Submit written requests for commitment to seek scientifically based
Residue Depletion Studies To
mstockstill on DSK4VPTVN1PROD with NOTICES

single copies of the guidance to the harmonized technical procedures for the
Establish Product Withdrawal Periods; Communications Staff (HFV–12), Center development of pharmaceutical
Revised Guidance for Industry; for Veterinary Medicine, Food and Drug products. One of the goals of
Availability Administration, 7519 Standish Pl., harmonization is to identify, and then
AGENCY: Food and Drug Administration, Rockville, MD 20855. Send one self- reduce, differences in technical
HHS. addressed adhesive label to assist that requirements for drug development
office in processing your request. See among regulatory agencies in different
ACTION: Notice.
the SUPPLEMENTARY INFORMATION section countries.

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12502 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices

FDA has actively participated in the published in the Federal Register of V. Comments
International Conference on September 15, 2011 (76 FR 57056). The Interested persons may submit either
Harmonisation of Technical revised guidance includes minor electronic comments regarding this
Requirements for Registration of changes that clarify recommendations document to www.regulations.gov or
Pharmaceuticals for Human Use for for conducting a single timepoint study written comments to the Division of
several years to develop harmonized for products proposed for a 0-day Dockets Management (see ADDRESSES). It
technical requirements for the approval withdrawal period or a 0-day milk is only necessary to send one set of
of human pharmaceutical and biological discard time. In addition, the design for comments. Identify comments with the
products among the European Union, a 0-day milk discard timestudy was docket number found in brackets in the
Japan, and the United States. The VICH described, and a definition for heading of this document. Received
is a parallel initiative for veterinary preruminant was added. This revised comments may be seen in the Division
medicinal products. The VICH is guidance is a product of the Metabolism of Dockets Management between 9 a.m.
concerned with developing harmonized and Residue Kinetics Expert Working and 4 p.m., Monday through Friday, and
technical requirements for the approval Group of the VICH. will be posted to the docket at http://
of veterinary medicinal products in the As part of the approval process for www.regulations.gov.
European Union, Japan, and the United veterinary medicinal products in food-
States, and includes input from both producing animals, national/regional VI. Electronic Access
regulatory and industry representatives. regulatory authorities require data from Persons with access to the Internet
The VICH Steering Committee is marker residue depletion studies in may obtain the guidance at either
composed of member representatives order to establish appropriate http://www.fda.gov/AnimalVeterinary/
from the European Commission, withdrawal periods in edible tissues, GuidanceComplianceEnforcement/
European Medicines Evaluation Agency, including meat, milk, and eggs. The GuidanceforIndustry/default.htm or
European Federation of Animal Health, objective of this guidance is to provide http://www.regulations.gov.
Committee on Veterinary Medicinal study design recommendations that will
Products, FDA, U.S. Department of Dated: March 3, 2015.
facilitate the universal acceptance of the
Agriculture, the Animal Health Leslie Kux,
generated residue depletion data to
Institute, Japanese Veterinary fulfill the national/regional Associate Commissioner for Policy.
Pharmaceutical Association, Japanese requirements. [FR Doc. 2015–05345 Filed 3–6–15; 8:45 am]
Association of Veterinary Biologics, and BILLING CODE 4164–01–P
Japanese Ministry of Agriculture, III. Significance of Guidance
Forestry, and Fisheries.
As a result of Level 2 revisions, this
Six observers are eligible to DEPARTMENT OF HEALTH AND
participate in the VICH Steering VICH revised guidance is being issued
in final, consistent with FDA’s good HUMAN SERVICES
Committee: One representative from the
government of Australia/New Zealand, guidance practice (GGP) regulations at Food and Drug Administration
one representative from the industry in 21 CFR 10.115(g)(4). This guidance,
developed under the VICH process, has [Docket No. FDA–2007–D–0369]
Australia/New Zealand, one
representative from the government of been revised to conform to FDA’s GGP
regulation (21 CFR 10.115). For Product-Specific Bioequivalence
Canada, one representative from the Recommendations; Draft and Revised
industry of Canada, one representative example, the document has been
designated ‘‘guidance’’ rather than Draft Guidances for Industry;
from the government of South Africa, Availability
and one representative from the ‘‘guideline.’’ In addition, guidance
industry of South Africa. The VICH documents must not include mandatory AGENCY: Food and Drug Administration,
Secretariat, which coordinates the language such as ‘‘shall,’’ ‘‘must,’’ HHS.
preparation of documentation, is ‘‘require,’’ or ‘‘requirement,’’ unless ACTION: Notice.
provided by the International FDA is using these words to describe a
Federation for Animal Health (IFAH). statutory or regulatory requirement. SUMMARY: The Food and Drug
An IFAH representative also This VICH guidance represents the Administration (FDA or the Agency) is
participates in the VICH Steering Agency’s current thinking on this topic. announcing the availability of
Committee meetings. It does not create or confer any rights for additional draft and revised draft
or on any person and does not operate product-specific bioequivalence (BE)
II. Revised Guidance on Studies To to bind FDA or the public. An recommendations. The
Evaluate the Metabolism and Residue alternative approach may be used if recommendations provide product-
Kinetics of Veterinary Drugs in Food- such approach satisfies the specific guidance on the design of BE
Producing Animals: Marker Residue requirements of applicable statutes and studies to support abbreviated new drug
Depletion Studies To Establish Product regulations. applications (ANDAs). In the Federal
Withdrawal Periods Register of June 11, 2010, FDA
IV. Paperwork Reduction Act of 1995 announced the availability of a guidance
In June 2014, the VICH Steering
Committee agreed that a revised This revised guidance refers to for industry entitled ‘‘Bioequivalence
guidance document entitled ‘‘Studies to previously approved collections of Recommendations for Specific
Evaluate the Metabolism and Residue information found in FDA regulations. Products,’’ which explained the process
that would be used to make product-
mstockstill on DSK4VPTVN1PROD with NOTICES

Kinetics of Veterinary Drugs in Food- These collections of information are
Producing Animals: Marker Residue subject to review by the Office of specific BE recommendations available
Depletion Studies to Establish Product Management and Budget (OMB) under to the public on FDA’s Web site. The BE
Withdrawal Periods’’ (VICH GL48(R)) the Paperwork Reduction Act of 1995 recommendations identified in this
should be made available to the public. (44 U.S.C. 3501–3520). The collections notice were developed using the process
The revised guidance is a revision of a of information in 21 CFR part 514 have described in that guidance.
final guidance on the same topic for been approved under OMB control DATES: Although you can comment on
which a notice of availability was number 0910–0032. any guidance at any time (see 21 CFR

VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

Document Created: 2015-12-18 12:05:08
Document Modified: 2015-12-18 12:05:08

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 12501

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