[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56854-56856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24762]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Study 
Design Recommendations for Residue Studies in Honey for Establishing 
Maximum Residue Levels and Withdrawal Periods; Guidance for Industry; 
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 final 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 
that 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 or approval purposes, as applicable, when an MRL already 
exists.

DATES: The announcement of the guidance is published in the Federal 
Register on November 14, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 Dockets Management Staff 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 Dockets Management Staff. If you do not wish 
your name and

[[Page 56855]]

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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 7500 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 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 final 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 requirements. FDA 
has participated in efforts to enhance harmonization and is committed 
to seeking scientifically based harmonized technical procedures for 
pharmaceutical development. 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, with input from both regulatory and 
industry representatives, harmonized technical requirements for the 
registration or approval of pharmaceutical products for human use 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 in Canada, 
one representative from the government of South Africa, and one 
representative from the industry in South Africa. The World 
Organisation for Animal Health, the Associate Member, has one delegate. 
The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by HealthforAnimals.
    In the Federal Register of January 5, 2017 (82 FR 1342), FDA 
published the notice of availability for a draft guidance 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), giving interested persons until March 6, 2017, to comment 
on the draft guidance. FDA received two comments on the draft guidance, 
and those comments, as well as those received by other VICH member 
regulatory agencies, were considered as the guidance was finalized. The 
guidance announced in this notice finalizes the draft guidance dated 
January 2017. The final guidance is a product of the Metabolism and 
Residue Kinetics Expert Working Group of the VICH.
    This VICH guidance document 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 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 or approval purposes, as applicable, when an MRL already 
exists.

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). 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.
    The guidance represents the current thinking of FDA 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'' (VICH 
GL56). 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. 
This guidance is not subject to Executive Order 12866.

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. Electronic Access

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


[[Page 56856]]


    Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24762 Filed 11-13-18; 8:45 am]
 BILLING CODE 4164-01-P