64450 Federal Register / Vol. 66, No. 240 / Thursday, December 13, 2001 / Notices
DEPARTMENT OF HEALTH AND Dated: November 16, 2001. Branch (HFA–305), Food and Drug HUMAN SERVICES L. Robert Lake, Administration, 5630 Fishers Lane, rm. Director of Regulations and Policy, Center 1061, Rockville, MD 20852. Submit Food and Drug Administration for Food Safety and Applied Nutrition. electronic comments to http:// [FR Doc. 01–30765 Filed 12–12–01; 8:45 am] www.fda.gov/dockets/ecomments. [Docket No. 99F–2535] BILLING CODE 4160–01–S Comments should be identified with the full title of the draft guidance and the Ciba Specialty Chemicals Corp; docket number found in brackets in the Withdrawal of Food Additive Petition DEPARTMENT OF HEALTH AND heading of this document. HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: AGENCY: Food and Drug Administration, William C. Keller, Center for Veterinary Food and Drug Administration HHS. Medicine (HFV–210), Food and Drug [Docket No. 01D–0501] Administration, 7500 Standish Pl., ACTION: Notice. Rockville, MD 20855, 301–827–6642, e- International Cooperation on mail: [email protected]. SUMMARY: The Food and Drug Harmonisation of Technical SUPPLEMENTARY INFORMATION: Administration (FDA) is announcing the Requirements for Approval of withdrawal, without prejudice to a Veterinary Medicinal Products (VICH); I. Background future filing, of a food additive petition Draft Guidance for Industry on In recent years, many important (FAP 9B4680) proposing that the food ‘‘Pharmacovigilance of Veterinary initiatives have been undertaken by additive regulations be amended to Medicinal Products: Management of regulatory authorities and industry provide for the expanded safe use of 5,7- Periodic Summary Update Reports associations to promote the bis(1,1-dimethylethyl)-3-hydroxy-2(3H)- (PSUs)’’ (VICH GL29); Request for international harmonization of benzofuranone, reaction products with Comments; Availability regulatory requirements. FDA has o-xylene as an antioxidant and/or AGENCY: Food and Drug Administration, participated in efforts to enhance stabilizer in olefin polymers, adhesives, HHS. harmonization and has expressed its pressure-sensitive adhesives, and ACTION: Notice. commitment to seek scientifically based ethylene-vinyl acetate copolymers harmonized technical procedures for the intended for use in contact with food. SUMMARY: The Food and Drug development of pharmaceutical Administration (FDA) is announcing the products. One of the goals of FOR FURTHER INFORMATION CONTACT: availability of a draft guidance for harmonization is to identify and then Anna P. Shanklin, Center for Food industry (#142) entitled reduce differences in technical Safety and Applied Nutrition (HFS– ‘‘Pharmacovigilance of Veterinary requirements for drug development 215), Food and Drug Administration, Medicinal Products: Management of among regulatory agencies in different 200 C St. SW., Washington, DC 20204, Periodic Summary Update Reports countries. 202–418–3093. (PSUs)’’ (VICH GL29). This draft FDA has actively participated in the (After December 14, 2001, the Center guidance has been developed by the International Conference on for Food Safety and Applied Nutrition’s International Cooperation on Harmonisation of Technical address will be: 5100 Paint Branch Harmonisation of Technical Requirements for Approval of Pkwy., College Park, MD 20740.) Requirements for Registration of Pharmaceuticals for Human Use for Veterinary Medicinal Products (VICH). several years to develop harmonized SUPPLEMENTARY INFORMATION: In a notice This draft guidance is intended to technical requirements for the approval published in the Federal Register of describe the reporting system for of human pharmaceutical and biological August 6, 1999 (64 FR 42950), FDA identification of possible adverse events products among the European Union, announced that a food additive petition following the use of marketed veterinary Japan, and the United States. The VICH (FAP 9B4680) had been filed by Ciba medicinal products submitted to the is a parallel initiative for veterinary Specialty Chemicals Corp., 540 White European Union, Japan, and the United medicinal products. The VICH is Plains Rd., Tarrytown, NY 10591–9005. States. concerned with developing harmonized The petition proposed to amend the DATES: Submit written or electronic technical requirements for the approval food additive regulations in § 178.2010 comments on the draft guidance by of veterinary medicinal products in the Antioxidants and/or stabilizers for January 14, 2002, to ensure their European Union, Japan, and the United polymers (21 CFR 178.2010) to provide adequate consideration in preparation of States, and includes input from both for the expanded safe use of 5,7-bis(1,1- the final document. General comments regulatory and industry representatives. dimethylethyl)-3-hydroxy-2(3H)- on agency guidance documents are The VICH Steering Committee is benzofuranone, reaction products with welcome at any time. composed of member representatives o-xylene as an antioxidant and/or ADDRESSES: Submit written requests for from the European Commission, stabilizer for olefin polymers complying single copies of the draft guidance to the European Medicines Evaluation Agency; with 21 CFR 177.1520, adhesives Communications Staff (HFV–12), Center European Federation of Animal Health; Committee on Veterinary Medicinal complying with 21 CFR 175.105, for Veterinary Medicine (CVM), Food Products; FDA; the U.S. Department of pressure-sensitive adhesives complying and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self- Agriculture; the Animal Health with 21 CFR 175.125, and ethylene- addressed adhesive label to assist that Institute; the Japanese Veterinary vinyl acetate copolymers complying office in processing your requests. See Pharmaceutical Association; the with 21 CFR 177.1350 intended for use the SUPPLEMENTARY INFORMATION section Japanese Association of Veterinary in contact with food. Ciba Specialty for electronic access to the draft Biologics; and the Japanese Ministry of Chemicals Corp. has now withdrawn guidance document. Agriculture, Forestry, and Fisheries. the petition without prejudice to a Submit written comments on the draft Two observers are eligible to future filing (21 CFR 171.7). guidance to the Dockets Management participate in the VICH Steering
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Committee: One representative from the ‘‘must,’’ ‘‘shall,’’ and ‘‘will’’ in the DEPARTMENT OF THE INTERIOR Government of Australia/New Zealand original VICH documents have been and one representative from the substituted with ‘‘should.’’ Similarly, Fish and Wildlife Service industry in Australia/New Zealand. The words such as ‘‘require’’ or VICH Secretariat, which coordinates the ‘‘requirement’’ have been replaced by Notice of Availability of a Draft preparation of documentation, is ‘‘recommendation’’ or ‘‘recommended’’ Addendum to the Recovery Plan for provided by the Confe´de´ration as appropriate to the context. the Multi-Island Plants for Public Review and Comment Mondiale de L’Industrie de la Sante´ The draft guidance represents the Animale (COMISA). A COMISA agency’s current thinking on AGENCY: Fish and Wildlife Service, representative also participates in the management of PSUs of approved new Interior. VICH Steering Committee meetings. animal drugs. This guidance does not ACTION: Notice of document availability. II. Draft Guidance on Management of create or confer any rights for or on any Periodic Summary Update Reports person and will not operate to bind FDA SUMMARY: We, the U.S. Fish and The VICH Steering Committee held a or the public. An alternative method Wildlife Service, announce the meeting on June 28, 2001, and agreed may be used as long as it satisfies the availability for public review of a draft that the draft guidance document requirements of applicable statutes and Addendum to the Recovery Plan for the entitled ‘‘Pharmacovigilance of regulations. Multi-Island Plants. There are 10 plant taxa included in this plan, all of which Veterinary Medicinal Products: IV. Comments Management of Periodic Summary are listed as endangered. All 10 taxa are Update Reports (PSUs)’’ should be made This draft guidance document is being endemic to the Maui Nui group of available for public comment. distributed for comment purposes only islands in the Hawaiian Islands. This draft guidance should be read in and is not intended for implementation DATE: We will consider comments on conjunction with the VICH guidance at this time. Interested persons may the draft addendum received by document entitled ‘‘Pharmacovigilance submit written or electronic comments February 11, 2002. of Veterinary Medicinal Products: regarding this draft guidance document. ADDRESSES: Copies of the draft recovery Management of Adverse Event Reports Written or electronic comments should plan addendum are available for (AERs)’’ (VICH GL24) that defines the be submitted to the Dockets inspection, by appointment, during PSU. Management Branch (address above). normal business hours at the following The draft guidance describes Submit written or electronic comments locations: U.S. Fish and Wildlife harmonized submission timing and by January 14, 2002, to ensure adequate Service, Pacific Islands Fish and submission content for PSU reports. consideration in preparation of the final Wildlife Office, 300 Ala Moana Harmonization of those elements guidance. Two copies of any comments Boulevard, Room 3–122, Box 50088, between the VICH regions facilitates the are to be submitted, except that Honolulu, Hawaii 96850 (phone 808/ reporting responsibilities for the individuals may submit one copy. 541–3441) and Hawaii State Library 478 marketing authorities or drug sponsors, Comments are to be identified with the S. King Street, Honolulu, Hawaii 96813. many with worldwide activities. More docket number found in brackets in the Requests for copies of the draft specifically, the draft guidance presents heading of this document. A copy of the addendum and written comments and the terms and definitions intended to draft guidance and received comments materials regarding this plan should be harmonize other previously used terms are available for public examination in addressed to Paul Henson, Field referring to similar pharmacovigilance the Dockets Management Branch Supervisor, Ecological Services, at the concepts. The draft guidance describes between 9 a.m. and 4 p.m., Monday above U.S. Fish and Wildlife Service the various components of information through Friday. Honolulu address. flow within the pharmacovigilance V. Electronic Access FOR FURTHER INFORMATION CONTACT: system. Finally, the draft guidance Christa Russell, Plant Conservation defines data elements that are Electronic comments may be Program Coordinator, at the above U.S. sufficiently comprehensive to cover submitted electronically on the Internet Fish and Wildlife Service Honolulu complex reports from most sources for at http://www.fda.gov/dockets/ address. the purpose of electronic transmission. ecomments. Once on this Internet site, FDA and the VICH Safety Working SUPPLEMENTARY INFORMATION: select [Docket No. 01D–0501] Group will consider comments about ‘‘Pharmacovigilance of Veterinary Background the draft guidance document. Medicinal Products: Management of Ultimately, FDA intends to adopt the Restoring endangered or threatened Periodic Summary Update Reports VICH Steering Committee’s final animals and plants to the point where (PSUs)’’ (VICH GL29) and follow the guidance and publish it as a final they are again secure, self-sustaining directions. guidance. (Information collection is members of their ecosystems is a covered under OMB control number Copies of the draft guidance entitled primary goal of the U.S. Fish and 0910– 0012.) ‘‘Pharmacovigilance of Veterinary Wildlife Service’s endangered species Medicinal Products: Management of program. To help guide the recovery III. Significance of Guidance Periodic Summary Update Reports effort, we are working to prepare This draft document, developed (PSUs)’’ (VICH GL29) may be obtained recovery plans for most of the listed under the VICH process, has been on the Internet from the CVM home species native to the United States. revised to be consistent with FDA’s page at http://www.fda.gov/cvm. Recovery plans describe actions good guidance practices regulation (21 Dated: December 3, 2001. considered necessary for the CFR 10.115). For example, the conservation of the species, establish document has been designated Margaret M. Dotzel, criteria for downlisting or delisting ‘‘guidance’’ rather than ‘‘guideline.’’ Associate Commissioner for Policy. listed species, and estimate time and Because guidance documents are not [FR Doc. 01–30766 Filed 12–12–01; 8:45 am] cost for implementing the recovery binding, mandatory words such as BILLING CODE 4160–01–S measures needed.
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