82 FR 1342 - Draft Guidance for Industry: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 3 (January 5, 2017)

Page Range		1342-1343
FR Document		2016-31998

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #243 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56). 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 document is intended to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists. Use of veterinary drug products in honeybee production is considered as a minor use in minor species in most jurisdictions.

Federal Register, Volume 82 Issue 3 (Thursday, January 5, 2017)

[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1342-1343]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31998]



[[Page 1342]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4461]


Draft Guidance for Industry: Study Design Recommendations for 
Residue Studies in Honey for Establishing Maximum Residue Limits and 
Withdrawal Periods; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry (GFI) #243 entitled 
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 
Drugs in Food-Producing Species: Study Design Recommendations for 
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' 
(VICH GL56). 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 document is intended to provide study design recommendations 
which will facilitate the universal acceptance of the generated residue 
depletion data to fulfill the national/regional requirements in order 
to establish appropriate Maximum Residue Limits (MRLs) or other safe 
limits in honey following the treatment of honeybees with veterinary 
drug products, or to justify withdrawal periods in honey for 
registration purposes when an MRL already exists. Use of veterinary 
drug products in honeybee production is considered as a minor use in 
minor species in most jurisdictions.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-4461 for ``Studies to Evaluate the Metabolism and Residue 
Kinetics of Veterinary Drugs in Food-Producing Species: Study Design 
Recommendations for Residue Studies in Honey for Establishing MRLs and 
Withdrawal Periods'' (VICH GL56). Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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 requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

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

    FDA is announcing the availability of a draft GFI #243 entitled 
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 
Drugs in Food-Producing Species: Study Design Recommendations for 
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' 
(VICH GL56). In recent years, many important initiatives have been 
undertaken by regulatory authorities and industry associations to 
promote the international harmonization of regulatory

[[Page 1343]]

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 Council for 
Harmonisation of Technical Requirements for 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 and European Medicines Agency, 
International Federation for Animal Health--Europe, FDA, the U.S. 
Department of Agriculture, the U.S. Animal Health Institute, the 
Japanese Ministry of Agriculture, Forestry, and Fisheries, and the 
Japanese Veterinary Products Association.
    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.

II. Draft Guidance on Studies To Evaluate the Metabolism and Residue 
Kinetics of Veterinary Drugs in Food-Producing Species: Study Design 
Recommendations for Residue Studies in Honey for Establishing MRLs and 
Withdrawal Periods

    The VICH Steering Committee held a meeting in June 2016 and agreed 
that the draft guidance document entitled ``Studies to Evaluate the 
Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing 
Species: Study Design Recommendations for Residue Studies in Honey for 
Establishing MRLs and Withdrawal Periods'' (VICH GL56) should be made 
available for public comment. This draft VICH guidance document is 
intended to provide study design recommendations which will facilitate 
the universal acceptance of the generated residue depletion data to 
fulfill the national/regional requirements in order to establish 
appropriate MRLs or other safe limits in honey following the treatment 
of honeybees with veterinary drug products, or to justify withdrawal 
periods in honey for registration purposes when an MRL already exists. 
Use of veterinary drug products in honeybee production is considered as 
a minor use in minor species in most jurisdictions.
    FDA and the VICH Expert Working Group will consider comments about 
the draft guidance document.

III. Significance of Guidance

    This level 1 draft guidance, developed under the VICH process, has 
been revised to conform to FDA's good guidance practices regulation (21 
CFR 10.115). For example, the document has been designated ``guidance'' 
rather than ``guideline.'' In addition, guidance documents do not 
include mandatory language such as ``shall,'' ``must,'' ``require,'' or 
``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent 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.

IV. Paperwork Reduction Act of 1995

    This draft 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 Action 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. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31998 Filed 1-4-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1343

requirements. FDA has participated in Drugs in Food-Producing Species: Study Dated: December 30, 2016.
efforts to enhance harmonization and Design Recommendations for Residue Leslie Kux,
has expressed its commitment to seek Studies in Honey for Establishing MRLs Associate Commissioner for Policy.
scientifically based, harmonized and Withdrawal Periods’’ (VICH GL56) [FR Doc. 2016–31998 Filed 1–4–17; 8:45 am]
technical procedures for the should be made available for public BILLING CODE 4164–01–P
development of pharmaceutical comment. This draft VICH guidance
products. One of the goals of document is intended to provide study
harmonization is to identify, and then design recommendations which will DEPARTMENT OF HEALTH AND
reduce, differences in technical facilitate the universal acceptance of the HUMAN SERVICES
requirements for drug development generated residue depletion data to
among regulatory agencies in different fulfill the national/regional Food and Drug Administration
countries. requirements in order to establish [Docket No. FDA–2016–N–4531]
FDA has actively participated in the appropriate MRLs or other safe limits in
International Council for Harmonisation honey following the treatment of Emerging Tick-Borne Diseases and
of Technical Requirements for honeybees with veterinary drug Blood Safety; Public Workshop
Pharmaceuticals for Human Use for products, or to justify withdrawal
several years to develop harmonized periods in honey for registration AGENCY: Food and Drug Administration,
technical requirements for the approval purposes when an MRL already exists. HHS.
of human pharmaceutical and biological Use of veterinary drug products in ACTION: Notice of public workshop.
products among the European Union, honeybee production is considered as a
Japan, and the United States. The VICH minor use in minor species in most SUMMARY: The Food and Drug
is a parallel initiative for veterinary jurisdictions. Administration (FDA) is announcing a
medicinal products. The VICH is public workshop entitled ‘‘Emerging
FDA and the VICH Expert Working
concerned with developing harmonized Tick-Borne Diseases and Blood Safety.’’
Group will consider comments about
technical requirements for the approval The purpose of the public workshop is
the draft guidance document.
of veterinary medicinal products in the to discuss tick-borne pathogens that
European Union, Japan, and the United III. Significance of Guidance continue to emerge as threats to blood
States, and includes input from both safety, the effectiveness of current and
This level 1 draft guidance, developed
regulatory and industry representatives. potential mitigation strategies, and the
under the VICH process, has been
The VICH Steering Committee is general approach to decision making on
revised to conform to FDA’s good
composed of member representatives blood safety interventions. The
guidance practices regulation (21 CFR
from the European Commission and workshop has been planned in
European Medicines Agency, 10.115). For example, the document has
partnership with AABB; America’s
International Federation for Animal been designated ‘‘guidance’’ rather than
Blood Centers; National Heart, Lung,
Health—Europe, FDA, the U.S. ‘‘guideline.’’ In addition, guidance
and Blood Institute, National Institutes
Department of Agriculture, the U.S. documents do not include mandatory
of Health (NIH); the U.S. Department of
Animal Health Institute, the Japanese language such as ‘‘shall,’’ ‘‘must,’’
Defense; and the U.S. Department of
Ministry of Agriculture, Forestry, and ‘‘require,’’ or ‘‘requirement,’’ unless
Health and Human Services. The
Fisheries, and the Japanese Veterinary FDA is using these words to describe a
workshop will include presentations
Products Association. statutory or regulatory requirement.
and panel discussions by experts from
Six observers are eligible to The draft guidance, when finalized, academic institutions, industry, and
participate in the VICH Steering will represent the current thinking of government agencies.
Committee: One representative from the FDA on this topic. It does not establish
DATES: The public workshop will be
government of Australia/New Zealand, any rights for any person and is not
held on April 6, 2017, from 8 a.m. to
one representative from the industry in binding on FDA or the public. You can
5:30 p.m. See the SUPPLEMENTARY
Australia/New Zealand, one use an alternative approach if it satisfies
INFORMATION section for registration date
representative from the government of the requirements of the applicable
and information.
Canada, one representative from the statutes and regulations.
ADDRESSES: The public workshop will
industry of Canada, one representative IV. Paperwork Reduction Act of 1995 be held at the Natcher Auditorium,
from the government of South Africa,
This draft guidance refers to Natcher Conference Center, Bldg. 45,
and one representative from the
previously approved collections of National Institutes of Health Campus,
industry of South Africa. The VICH
information found in FDA regulations. 9000 Rockville Pike, Bethesda, MD
Secretariat, which coordinates the
These collections of information are 20892. Entrance for the public
preparation of documentation, is
subject to review by the Office of workshop participants (non-NIH
provided by the International
Management and Budget (OMB) under employees) is through the NIH Gateway
Federation for Animal Health.
the Paperwork Reduction Action of Center located adjacent to the Medical
II. Draft Guidance on Studies To 1995 (44 U.S.C. 3501–3520). The Center Metro, where routine security
Evaluate the Metabolism and Residue collections of information in 21 CFR check procedures will be performed.
Kinetics of Veterinary Drugs in Food- part 514 have been approved under Please visit the following Web site for
Producing Species: Study Design OMB control number 0910–0032. NIH campus location, parking, security,
Recommendations for Residue Studies and travel information http://
mstockstill on DSK3G9T082PROD with NOTICES

in Honey for Establishing MRLs and V. Electronic Access www.nih.gov/about/visitor/index.htm.
Withdrawal Periods Persons with access to the Internet Please visit the following Web site for
The VICH Steering Committee held a may obtain the draft guidance at either information on the Natcher Conference
meeting in June 2016 and agreed that http://www.fda.gov/AnimalVeterinary/ Center: http://www.genome.gov/
the draft guidance document entitled GuidanceComplianceEnforcement/ 11007522.
‘‘Studies to Evaluate the Metabolism GuidanceforIndustry/default.htm or FOR FURTHER INFORMATION CONTACT:
and Residue Kinetics of Veterinary http://www.regulations.gov. Kimberly Jones or Pauline Cottrell,

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Document Created: 2018-02-01 14:51:13
Document Modified: 2018-02-01 14:51:13

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 of availability.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 6, 2017.
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		82 FR 1342

82 FR 1342 - Draft Guidance for Industry: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 3 (January 5, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration