International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products; Request for Comments; Availability, 30763-30764 [05-10625]

Download as PDF Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices Dated: May 23, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–10624 Filed 5–24–05; 11:50 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0200] International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products; Request for Comments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document for industry (#177) entitled ‘‘Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products’’ (VICH GL40). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide general principles through recommendations on the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications. Submit written or electronic comments on the draft guidance by June 27, 2005, to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. DATES: VerDate jul<14>2003 16:42 May 26, 2005 Jkt 205001 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. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Comments should be identified with the full title of the draft guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary Medicine (HFV–143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6956, email: dbensley@cvm.fda.gov. SUPPLEMENTARY INFORMATION: 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; 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. PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 30763 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 Biotechnological/ Biological Veterinary Medicinal Products The VICH Steering Committee held a meeting in August 2004 and agreed that the draft guidance document entitled ‘‘Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products,’’ (VICH GL40) should be made available for public comment. This draft VICH guidance document provides general principles through recommendations on the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications. The recommendations in this document apply to products composed of wellcharacterized proteins and polypeptides, and their derivatives which are isolated from tissues, body fluids, cell cultures, or produced using recombinant deoxyribonucleic acid (rDNA) technology. Thus, the document covers the generation and submission of specifications for products such as cytokines, growth hormones and growth factors, insulins, and monoclonal antibodies. This document does not cover antibiotics, heparins, vitamins, cell metabolites, DNA products, allergenic extracts, vaccines, cells, whole blood, and cellular blood components. FDA and the VICH Safety Working Group will consider comments about the draft guidance document. Information collection is covered under OMB control number 0910–0032. III. Significance of Guidance The draft guidance document, 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.’’ Because guidance documents are not binding, mandatory E:\FR\FM\27MYN1.SGM 27MYN1 30764 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices words such as ‘‘must,’’ ‘‘shall,’’ and ‘‘will’’ in the original VICH document have been substituted with ‘‘should.’’ Similarly, words such as ‘‘require’’ or ‘‘requirement’’ have been replaced by ‘‘recommend’’ or ‘‘recommendation’’ as appropriate to the context. The draft VICH guidance (#177) is consistent with the agency’s current thinking on the subject matter. This guidance does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative method may be used as long as it satisfies the requirements of applicable statutes and regulations. IV. Comments This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this draft guidance document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Electronic comments may also be submitted via the Internet at https:// www.fda.gov/dockets/ecomments. Once on this Internet site, select Docket No. 2005D–0200 entitled ‘‘Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products’’ (VICH GL40) and follow the directions. Copies of the draft guidance document entitled ‘‘Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products’’ (VICH GL40) may be obtained on the Internet from the Center for Veterinary Medicine home page at https://www.fda.gov/cvm. Dated: May 23, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–10625 Filed 5–24–05; 11:50 am] 16:42 May 26, 2005 Effective Date for Calendar Year 2005 Rates Indian Health Service Consistent with previous annual rate revisions, the Calendar Year 2005 rates will be effective for services provided on/or after January 1, 2005 to the extent consistent with payment authorities including the applicable Medicaid State plan. Reimbursement Rates for Calendar Year 2005 Indian Health Service, HHS. Notice. AGENCY: ACTION: SUMMARY: Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83–568 (42 U.S.C. 2001(a)) and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2005 for Medicare and Medicaid Beneficiaries and Beneficiaries of other Federal Agencies. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements. Public Law 106–554, dated December 21, 2000, authorized IHS facilities to file Medicare Part B claims with the carrier for payment for physician and certain other practitioner services provided on or after July 1, 2001. Inpatient Hospital Per Diem Rate (Excludes Physician/Practitioner Services) Calendar Year 2005 Lower 48 States—$1,542 Alaska—$2,032 Outpatient Per Visit Rate (Excluding Medicare) Calendar Year 2005 Lower 48 States—$223 Alaska—$391 Outpatient Per Visit Rate (Medicare) Calendar Year 2005 Lower 48 States—$181 Alaska—$371 Medicare Part B Inpatient Ancillary Per Diem Rate Calendar Year 2005 Lower 48 States—$312 Alaska—$635 Outpatient Surgery Rate (Medicare) Established Medicare rates for freestanding Ambulatory Surgery Centers. BILLING CODE 4160–01–S VerDate jul<14>2003 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 205001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 Dated: May 20, 2005 Charles W. Grimm, Assistant Surgeon General, Director, Indian Health Service. [FR Doc. 05–10650 Filed 5–26–05; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2005–21202] Collection of Information Under Review by Office of Management and Budget (OMB): OMB Control Number: 1625–0018 Coast Guard, DHS. Request for comments. AGENCY: ACTION: SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the Coast Guard intends to seek the approval of OMB for the renewal of one Information Collection Request (ICR). The ICR comprises (1) 1625–0018, Official Logbook. Before submitting the ICR to OMB, the Coast Guard is inviting comments on it as described below. DATES: Comments must reach the Coast Guard on or before July 26, 2005. ADDRESSES: To make sure that your comments and related material do not enter the docket [USCG–2005–21202] more than once, please submit them by only one of the following means: (1) By mail to the Docket Management Facility, U.S. Department of Transportation (DOT), room PL–401, 400 Seventh Street, SW., Washington, DC 20590–0001. (2) By delivery to room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366– 9329. (3) By fax to the Docket Management Facility at 202–493–2251. (4) Electronically through the Web site for the Docket Management System at https://dms.dot.gov. The Docket Management Facility maintains the public docket for this notice. Comments and material received E:\FR\FM\27MYN1.SGM 27MYN1

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[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Notices]
[Pages 30763-30764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10625]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0200]


International Cooperation on Harmonization of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on Specifications: Test Procedures and 
Acceptance Criteria for New Biotechnological/Biological Veterinary 
Medicinal Products; Request for Comments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document for industry (177) 
entitled ``Specifications: Test Procedures and Acceptance Criteria for 
New Biotechnological/Biological Veterinary Medicinal Products'' (VICH 
GL40). This draft guidance has been developed for veterinary use by the 
International Cooperation on Harmonization of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
VICH guidance document is intended to provide general principles 
through recommendations on the setting and justification, to the extent 
possible, of a uniform set of international specifications for 
biotechnological and biological products to support new marketing 
applications.

DATES: Submit written or electronic comments on the draft guidance by 
June 27, 2005, to ensure their adequate consideration in preparation of 
the final document. General comments on agency guidance documents are 
welcome at any time.

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 requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    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. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments. Comments should be identified 
with the full title of the draft guidance and the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary 
Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6956, e-mail: dbensley@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

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; 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 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 Biotechnological/Biological Veterinary Medicinal 
Products

    The VICH Steering Committee held a meeting in August 2004 and 
agreed that the draft guidance document entitled ``Specifications: Test 
Procedures and Acceptance Criteria for New Biotechnological/Biological 
Veterinary Medicinal Products,'' (VICH GL40) should be made available 
for public comment. This draft VICH guidance document provides general 
principles through recommendations on the setting and justification, to 
the extent possible, of a uniform set of international specifications 
for biotechnological and biological products to support new marketing 
applications. The recommendations in this document apply to products 
composed of well-characterized proteins and polypeptides, and their 
derivatives which are isolated from tissues, body fluids, cell 
cultures, or produced using recombinant deoxyribonucleic acid (r-DNA) 
technology. Thus, the document covers the generation and submission of 
specifications for products such as cytokines, growth hormones and 
growth factors, insulins, and monoclonal antibodies. This document does 
not cover antibiotics, heparins, vitamins, cell metabolites, DNA 
products, allergenic extracts, vaccines, cells, whole blood, and 
cellular blood components.
    FDA and the VICH Safety Working Group will consider comments about 
the draft guidance document. Information collection is covered under 
OMB control number 0910-0032.

III. Significance of Guidance

    The draft guidance document, 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.'' Because guidance documents are not binding, 
mandatory

[[Page 30764]]

words such as ``must,'' ``shall,'' and ``will'' in the original VICH 
document have been substituted with ``should.'' Similarly, words such 
as ``require'' or ``requirement'' have been replaced by ``recommend'' 
or ``recommendation'' as appropriate to the context.
    The draft VICH guidance (177) is consistent with the 
agency's current thinking on the subject matter. This guidance does not 
create or confer any rights for or on any person and will not operate 
to bind FDA or the public. An alternative method may be used as long as 
it satisfies the requirements of applicable statutes and regulations.

IV. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this draft 
guidance document. Submit a single copy of electronic comments or two 
paper copies of any mailed comments, except that individuals may submit 
one paper copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. A copy of the draft 
guidance and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Electronic comments may also be submitted via the Internet at 
https://www.fda.gov/dockets/ecomments. Once on this Internet site, 
select Docket No. 2005D-0200 entitled ``Specifications: Test Procedures 
and Acceptance Criteria for New Biotechnological/Biological Veterinary 
Medicinal Products'' (VICH GL40) and follow the directions.
    Copies of the draft guidance document entitled ``Specifications: 
Test Procedures and Acceptance Criteria for New Biotechnological/
Biological Veterinary Medicinal Products'' (VICH GL40) may be obtained 
on the Internet from the Center for Veterinary Medicine home page at 
https://www.fda.gov/cvm.

    Dated: May 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10625 Filed 5-24-05; 11:50 am]
BILLING CODE 4160-01-S

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