[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1342-1343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31998]



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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Draft Guidance for Industry: Study Design Recommendations for 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.

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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the availability of a draft guidance for industry (GFI) #243 entitled 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 6, 2017.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

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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