CVM Seeks Comments on a Discussion Draft:
"Proposals to Increase the Availability of Approved Animal Drugs for Minor Species and Minor Uses"
December 19, 1997
Center for Veterinary Medicine
D.H.H.S. Pub. No. (FDA) 95-6001
U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
7500 Standish Place, HFV-12, Rockville, Maryland 20855
The Center for Veterinary Medicine seeks comments on a Discussion Draft: "PROPOSALS TO INCREASE THE AVAILABILITY OF APPROVED ANIMAL DRUGS FOR MINOR SPECIES AND MINOR USES." [ pdf version or text version--ed. ] The discussion draft is a working document being made available through the Internet on the CVM World Wide Web site.
Internet publication of this discussion draft is part of an on-going process expected to lead to the announcement of recommendations for legislative or regulatory changes to the procedure for approval of animal drugs intended for use in minor species or for minor uses. The on-going process and this discussion draft are responses to section 2(f) of the Animal Drug Availability Act of 1996 (ADAA), which requires the Secretary of Health and Human Services to consider and announce such recommendations. The working document includes a discussion of several options and possible changes.
The public is encouraged to comment on these concepts and related concerns. In particular, comments are sought about a number of questions in the discussion draft that focus on specific issues. The deadline for comments is January 19, 1998.
The Center will accept e-mail comments, which should be identified with the docket number (Docket No. 97N-0217) and addressed to gmitchel@bangate.fda.gov. Paper comments should be sent to
FDA's Dockets Management Branch (HFA-305)
12420 Parklawn Dr.
Rm. 1-23
Rockville, MD 20857
with the docket number placed at the top of each comment. CVM will send paper copies of e-mail comments to the Dockets Management Branch, where they will be placed in the public docket along with any paper comments. Copies of all comments will be available for viewing between 9 a.m. and 4 p.m., Monday through Friday in the Public Reading Room in the Dockets Management Branch (address above). In addition, all comments will be posted on CVM's web site, where they will be available after the January 19, 1998, deadline for submission.
The comments will be considered in finalizing the legislative and regulatory changes that FDA plans to announce, in accordance with the ADAA, no later than April 9, 1998. Enactment of the ADAA (Pub. L. 104-250) reflected Congress's concerns about a general problem regarding animal drug availability. Among other things, the legislation recognized particular problems relating to the availability of approved new animal drugs for minor uses and for use in minor species.
On June 23, 1997, FDA published a notice in the Federal Register requesting comments and suggestions on this issue. In that notice, FDA sought comments on the scope of the definition of minor species or minor use, the creation of additional statutory authority, potential administrative and regulatory changes, the creation of incentives, and the extension of existing legal authority under the Animal Medicinal Drug Use Clarification Act (AMDUCA) on subjects such as medicated feeds and reproductive hormones. Thirty-five comments were received in response to this notice.
The discussion draft describes a range of legislative and regulatory changes intended to facilitate minor use and minor species drug approvals. Preliminary proposals appearing in the discussion draft include:
Creating incentives and removing disincentives for pursuing minor use/minor species drug approvals,
Enhancing existing programs for data development,
Developing a system for sharing data from major species applications,
Modifying the extralabel provisions of the Federal Food, Drug, and Cosmetic Act,
Creating an "orphan animal drug program,"
Establishing conditional drug approvals for nonfood minor uses,
Providing for expert review panels or other alternative approval standards for nonfood minor uses, and
Promoting the international harmonization of drug approvals for minor use/minor species.
Paper copies of the discussion draft are available from the Communications Staff, FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, telephone: 301-594-1755. Questions about section 2(f) of the ADAA and this request for comments should be directed to Dr. Bert Mitchell, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, telephone: 301-827-5587, fax: 301-594-1807, e-mail: gmitchel@bangate.fda.gov. Questions about the proposed changes to the approval process may be directed to the leader of the Minor Use/Minor Species Working Group, Dr. Linda Wilmot, Center for Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, telephone: 301-594-0614, fax: 301-594-2297, e-mail: lwilmot@bangate.fda.gov.
|
||||||
|
||||||
|
||||||