International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability, 57060-57061 [2011-23605]

Download as PDF 57060 Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices 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. It is no longer necessary to send two copies of mailed 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 https://www.regulations.gov. Dated: September 8, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–23492 Filed 9–14–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0588] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#214) entitled ‘‘Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data’’ (VICH GL35). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommended standards to construct a single electronic message to transmit data wreier-aviles on DSKGBLS3C1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:38 Sep 14, 2011 Jkt 223001 elements for submission of adverse event reports (AERs) to all member regions. 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 written or electronic comments on the draft guidance by November 14, 2011. ADDRESSES: Submit written requests for single copies of the draft 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 draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary Medicine (HFV–240), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240–276–9048, e-mail: margarita.brown@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry (#214) entitled ‘‘Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data (VICH GL35).’’ 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 PO 00000 Frm 00044 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, U.S. FDA, 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 government of Australia/New Zealand, one representative from the 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. Draft Guidance on Electronic Standards for Transfer of Data The VICH Steering Committee held a meeting in June 2010, and agreed that the draft guidance document entitled ‘‘Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data’’ (VICH GL35) should be made available for public comment. This draft VICH guidance document is intended to provide recommended standards to construct a single electronic message to transmit data elements for submission of AERs to all member regions. The need to transfer and disseminate information quickly, accurately and easily between Regulatory Authorities (RA) and Marketing Authorization Holders (MAH) on a worldwide scope is especially pertinent to the notification and assimilation of information for pharmacovigilance. Whereas the recommended definition of the pharmacovigilance information has E:\FR\FM\15SEN1.SGM 15SEN1 Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices been set forth within the draft guidances entitled, ‘‘Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER’s)’’ (VICH GL24), ‘‘Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of Terms’’ (VICH GL30) and ‘‘Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports’’ (VICH GL42), this draft guidance defines recommended electronic standards for transfer of data. In order to allow for electronic exchange of this information between stakeholders, further specification of the field descriptors and their relationships, including agreement on format of the electronic message is essential. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. III. 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 Act of 1995 (44 U.S.C. 3501–3520). The collections of information in this guidance have been approved under OMB Control No. 0910–0284. wreier-aviles on DSKGBLS3C1PROD with NOTICES IV. Significance of Guidance This 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 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 draft guidance, when finalized, will represent 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 applicable statutes and regulations. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket VerDate Mar<15>2010 15:07 Sep 14, 2011 Jkt 223001 57061 Dated: September 9, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. 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. [FR Doc. 2011–23650 Filed 9–14–11; 8:45 am] VI. Electronic Access BILLING CODE 4140–01–P Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: September 9, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–23605 Filed 9–14–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel, Review Conference Grant Application (R13). Date: October 12, 2011. Time: 11 a.m. to 12 p.m. Agenda: To review and evaluate grant applications, Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Mary Kelly, Scientific Review Officer, Scientific Review Branch, National Inst of Dental & Craniofacial Research, NIH 6701 Democracy Blvd, room 672, MSC 4878, Bethesda, MD 20892–4878, 301–594–4809, mary_kelly@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Sickle Cell Disease Advisory Committee. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Sickle Cell Disease Advisory Committee. Date: October 3, 2011. Time: 8:30 a.m. to 4 p.m. Agenda: Discussion of Programs and Issues. Place: National Institutes of Health, 6701 Rockledge Drive, Conference Rooms 9100/ 9104, Bethesda, MD 20892. Contact Person: W. Keith Hoots, MD, Director, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Suite 9030, Bethesda, MD 20892, 301–435–0080, hootswk@nhlbi.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// www.nhlbi.nih.gov/meetings/index.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 9, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–23654 Filed 9–14–11; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57060-57061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23605]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0588]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Guidance for Industry on Pharmacovigilance of Veterinary Medicinal
Products: Electronic Standards for Transfer of Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (214) entitled
``Draft Guidance for Industry, Pharmacovigilance of Veterinary
Medicinal Products: Electronic Standards for Transfer of Data'' (VICH
GL35). This draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
VICH guidance document is intended to provide recommended standards to
construct a single electronic message to transmit data elements for
submission of adverse event reports (AERs) to all member regions.

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 written or electronic comments on the draft guidance
by November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft
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 draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary
Medicine (HFV-240), Food and Drug Administration, 7519 Standish Place,
Rockville, MD 20855, 240-276-9048, e-mail: margarita.brown@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
(214) entitled ``Draft Guidance for Industry,
Pharmacovigilance of Veterinary Medicinal Products: Electronic
Standards for Transfer of Data (VICH GL35).'' 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, U.S. FDA, 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 government of Australia/New
Zealand, one representative from the 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. Draft Guidance on Electronic Standards for Transfer of Data

The VICH Steering Committee held a meeting in June 2010, and agreed
that the draft guidance document entitled ``Draft Guidance for Industry
on Pharmacovigilance of Veterinary Medicinal Products: Electronic
Standards for Transfer of Data'' (VICH GL35) should be made available
for public comment. This draft VICH guidance document is intended to
provide recommended standards to construct a single electronic message
to transmit data elements for submission of AERs to all member regions.
The need to transfer and disseminate information quickly,
accurately and easily between Regulatory Authorities (RA) and Marketing
Authorization Holders (MAH) on a worldwide scope is especially
pertinent to the notification and assimilation of information for
pharmacovigilance. Whereas the recommended definition of the
pharmacovigilance information has

[[Page 57061]]

been set forth within the draft guidances entitled, ``Pharmacovigilance
of Veterinary Medicinal Products: Management of Adverse Event Reports
(AER's)'' (VICH GL24), ``Pharmacovigilance of Veterinary Medicinal
Products: Controlled Lists of Terms'' (VICH GL30) and
``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for
Submission of Adverse Event Reports'' (VICH GL42), this draft guidance
defines recommended electronic standards for transfer of data.
In order to allow for electronic exchange of this information
between stakeholders, further specification of the field descriptors
and their relationships, including agreement on format of the
electronic message is essential.
FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. 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 Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB Control No. 0910-0284.

IV. Significance of Guidance

This 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 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 draft guidance, when finalized, will represent 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 applicable statutes and regulations.

V. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
It is only necessary to send one set of comments. It is no longer
necessary to send two copies of mailed 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 draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

Dated: September 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23605 Filed 9-14-11; 8:45 am]
BILLING CODE 4160-01-P

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