[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Pages 40010-40011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17872]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1804]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Studies 
To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
General Approach To Establish an Acute Reference Dose; 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 guidance for industry (GFI) #232 entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: General Approach to Establish an Acute Reference Dose'' 
(VICH GL54). 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 address the nature and types of data 
that can be useful in determining a toxicological acute reference dose 
(ARfD) for residues of veterinary drugs, the studies that may generate 
such data, and how the ARfD may be calculated based on these data.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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): 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-2015-D-1804 for ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: General Approach to Establish an Acute 
Reference Dose.'' 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 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.
    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: Tong Zhou, Center for Veterinary 
Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0826, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of GFI #232 entitled ``Studies 
to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
General Approach to Establish an Acute Reference Dose'' (VICH GL54). 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

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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 VICH Secretariat, which coordinates the preparation of 
documentation, is provided by HealthforAnimals.

II. Guidance for Industry on Studies To Evaluate the Safety of Residues 
of Veterinary Drugs in Human Food: General Approach To Establish an 
Acute Reference Dose

    In the Federal Register of June 1, 2015 (80 FR 31041), FDA 
published the notice of availability for a draft guidance entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: General Approach to Establish an Acute Reference Dose'' 
(VICH GL54) giving interested persons until July 31, 2015, 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 
June 1, 2015. The final guidance is a product of the Safety Expert 
Working Group of the VICH.
    This VICH guidance document is intended to address the nature and 
types of data that can be useful in determining a toxicological ARfD 
for residues of veterinary drugs, the studies that may generate such 
data, and how the ARfD may be calculated based on these data.

III. 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 Safety of Residues of Veterinary Drugs in Human Food: 
General Approach to Establish an Acute Reference Dose.'' 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 is not a 
significant regulatory action subject to Executive Order 12866.

IV. 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 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 guidance at 
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17872 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P