International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on “Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological Acceptable Daily Intake (ADI)” (VICH GL36(R)); Availability, 14308-14309 [2013-05016]

Download as PDF 14308 Federal Register / Vol. 78, No. 43 / Tuesday, March 5, 2013 / Notices such approach satisfies the requirements of the applicable statutes and regulations. V. Comments Interested persons may submit either electronic comments regarding this document to http://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 draft revised guidance at either http://www.fda.gov/ AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: February 27, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–05014 Filed 3–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2003–D–0433] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on ‘‘Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological Acceptable Daily Intake (ADI)’’ (VICH GL36(R)); Availability AGENCY: Food and Drug Administration, HHS. emcdonald on DSK67QTVN1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI #159) entitled ‘‘Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI),’’ (VICH GL36(R)). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical VerDate Mar<15>2010 15:14 Mar 04, 2013 Jkt 229001 Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora. 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 selfaddressed 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 guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Silvia A. Pineiro, Center for Veterinary Medicine (HFV–157), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8227, Silvia.Pineiro@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a revised guidance for industry (GFI #159) entitled ‘‘Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI),’’ (VICH GL36(R)). 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 scientificallybased, 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 Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Four observers are eligible to participate in the VICH Steering Committee: One representative from the governments of Australia/New Zealand, one representative from industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. 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 Microbiological ADI In the Federal Register of June 3, 2011 (76 FR 32218), FDA published a notice of availability for a draft revised guidance entitled ‘‘Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI’’ (VICH GL36(R)). Interested persons were given until August 2, 2011, to comment on the draft revised guidance. FDA received two comments on the draft, and those comments, as well as those received by other VICH member regulatory agencies, were considered as the guidance was finalized. No substantive changes were made in finalizing this guidance document. The revised guidance announced in this document finalizes the draft revised guidance dated June 2, 2011. The final revised guidance is a product of the Microbiological ADI Expert Working Group of the VICH. This document provides guidance for assessing the human food safety of E:\FR\FM\05MRN1.SGM 05MRN1 Federal Register / Vol. 78, No. 43 / Tuesday, March 5, 2013 / Notices residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora. The objectives of this guidance are to: (1) Outline the steps in determining the need for establishing a microbiological acceptable daily intake (ADI); (2) recommend test systems and methods for determining no-observable adverse effect concentrations (NOAECs) and noobservable adverse effect levels (NOAELs) for the endpoints of health concern; and (3) recommend a procedure to derive a microbiological ADI. It is recognized that different tests may be useful. The experience gained with the recommended tests may result in future modifications to this guidance and its recommendations. III. Significance of Guidance This 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 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 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 the applicable statutes and regulations. 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 Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in this guidance have been approved under OMB control number 0910–0032. emcdonald on DSK67QTVN1PROD with NOTICES V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. 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. VerDate Mar<15>2010 15:14 Mar 04, 2013 Jkt 229001 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: February 27, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–05016 Filed 3–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and for Information AGENCY: Food and Drug Administration, HHS. Notice; request for comments and information. ACTION: SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ‘‘Pilot Projects for Improving Product Tracing along the Food Supply System.’’ FDA is announcing the opening of a docket to provide stakeholders and other interested parties an opportunity to submit comments and information that will help the Agency as it forms its own recommendations, to be contained in the Agency’s report to Congress, and as it implements the FSMA provisions relating to the tracking and tracing of food. DATES: Submit electronic or written comments and information by April 4, 2013. ADDRESSES: You may submit comments and information, identified by Docket No.FDA–2012–N–2012–N–1153, by any of the following methods: Electronic Submissions Submit electronic comments and information in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments and information. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 14309 Written Submissions Submit written submissions in the following way: • Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2012–N–1153 for this notice. All comments and information received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments and information, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments and information received, go to http://www.regulations.gov and insert the docket number(s), 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 (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sherri A. McGarry, Office of Foods, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1212, Silver Spring, MD 20903, 301– 796–3851. SUPPLEMENTARY INFORMATION: I. Background A. FSMA Provisions Regarding Enhanced Tracking and Tracing of Food and Recordkeeping On January 4, 2011, the President signed FSMA (Pub. L. 111–353) into law. Section 204 of FSMA, 21 U.S.C. 2223, relates to enhanced tracking and tracing of food and recordkeeping. As part of this provision, FDA must, among other things, complete the following: 1. Establish pilot projects in coordination with the food industry to explore and evaluate methods for rapid and effective tracking and tracing of foods. FDA is required to submit a report to Congress on the findings of the pilot projects together with FDA’s recommendations for improving tracking and tracing of food; 2. Assess the costs and benefits associated with the adoption and use of several product tracing technologies and the feasibility of such technologies for different sectors of the food industry (including small businesses); 3. To the extent practicable in assessing the costs, benefits, and E:\FR\FM\05MRN1.SGM 05MRN1

Agencies

[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14308-14309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05016]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0433]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Revised 
Guidance for Industry on ``Studies To Evaluate the Safety of Residues 
of Veterinary Drugs in Human Food: General Approach To Establish a 
Microbiological Acceptable Daily Intake (ADI)'' (VICH GL36(R)); 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry (GFI 159) 
entitled ``Studies to Evaluate the Safety of Residues of Veterinary 
Drugs in Human Food: General Approach to Establish a Microbiological 
Acceptable Daily Intake (ADI),'' (VICH GL36(R)). 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 guidance for assessing the human food safety of residues from 
veterinary antimicrobial drugs with regard to effects on the human 
intestinal flora.

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 guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Silvia A. Pineiro, Center for 
Veterinary Medicine (HFV-157), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8227, 
Silvia.Pineiro@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
revised guidance for industry (GFI 159) entitled ``Studies to 
Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
General Approach to Establish a Microbiological Acceptable Daily Intake 
(ADI),'' (VICH GL36(R)).

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.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Approval 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, the U.S. FDA, the U.S. Department of Agriculture, the Animal 
Health Institute, the Japanese Veterinary Pharmaceutical Association, 
the Japanese Association of Veterinary Biologics, and the Japanese 
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering 
Committee: One representative from the governments of Australia/New 
Zealand, one representative from industry in Australia/New Zealand, one 
representative from the government of Canada, and one representative 
from the industry of Canada. 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 Microbiological ADI

    In the Federal Register of June 3, 2011 (76 FR 32218), FDA 
published a notice of availability for a draft revised guidance 
entitled ``Studies to Evaluate the Safety of Residues of Veterinary 
Drugs in Human Food: General Approach to Establish a Microbiological 
ADI'' (VICH GL36(R)). Interested persons were given until August 2, 
2011, to comment on the draft revised guidance. FDA received two 
comments on the draft, and those comments, as well as those received by 
other VICH member regulatory agencies, were considered as the guidance 
was finalized. No substantive changes were made in finalizing this 
guidance document. The revised guidance announced in this document 
finalizes the draft revised guidance dated June 2, 2011. The final 
revised guidance is a product of the Microbiological ADI Expert Working 
Group of the VICH.
    This document provides guidance for assessing the human food safety 
of

[[Page 14309]]

residues from veterinary antimicrobial drugs with regard to effects on 
the human intestinal flora. The objectives of this guidance are to: (1) 
Outline the steps in determining the need for establishing a 
microbiological acceptable daily intake (ADI); (2) recommend test 
systems and methods for determining no-observable adverse effect 
concentrations (NOAECs) and no-observable adverse effect levels 
(NOAELs) for the endpoints of health concern; and (3) recommend a 
procedure to derive a microbiological ADI. It is recognized that 
different tests may be useful. The experience gained with the 
recommended tests may result in future modifications to this guidance 
and its recommendations.

III. Significance of Guidance

    This 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 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 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 the applicable 
statutes and regulations.

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 Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance have been approved under 
OMB control number 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

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: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05016 Filed 3-4-13; 8:45 am]
BILLING CODE 4160-01-P