Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (
You may submit written comments at any time.
You may submit written requests for a single copy of the final guidance entitled “Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients” (VICH GL18) to the Communications Staff (HFV–12), 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
You may submit written comments on the guidance to the Dockets Management Branch (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Kevin J. Greenlees (HFV–150), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6977, e-mail, kgreenle@cvm.fda.gov.
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
FDA has actively participated in the ICH 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; 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.
Two observers are eligible to participate in the VICH Steering Committee: One representative from the Government of Australia/New Zealand, and one representative from the industry in Australia/New Zealand. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the Confédération Mondiale de L’Industrie de la Santé Animale (COMISA). A COMISA representative also participates in the VICH Steering Committee meetings.
In the
This guidance is intended to recommend acceptable amounts of residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in the final guidance) for the safety of the target animal as well as for the safety of human consumers of products derived from treated food-producing animals. The guidance is intended to assist in developing new animal drug applications (referred to as marketing applications in the final guidance) submitted to the European Union, Japan, and the United States.
This final level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (65 FR 56468, September 19, 2000). 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. Information collected is covered under OMB control number 0910–0032.
Persons with access to the Internet may obtain the document at http://www.fda.gov/cvm.
As with all of FDA’s guidances, the public is encouraged to submit written comments with new data or other new information pertinent to this guidance. FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance. The agency will notify the public of any such amendments through a notice in the
Interested persons may, at any time, submit written or electronic comments regarding this guidance. Written comments should be submitted to the Dockets Management Branch (address above). Two copies of any comments are to be submitted, except individuals may submit one copy. Comments should be identified with the docket number found in the brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Comments may also be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select “99D–4071 Impurities: Residual Solvents in New Veterinary Medicinal Products” and follow the directions.