ADAA Minor Use/Minor Species Working Group Reports

• Working Group Report: Proposals to Increase the The Legal Availability of Animal Drugs for Minor Species and Minor Uses (Aug. 19, 1998) [html] [pdf] Note: pdf file is better for printing.

• Cover Letter: CVM Seeks Comments on a Discussion Draft: "Proposals to Increase the Availability of Approved Animal Drugs for Minor Species and Minor Uses" (Dec. 19, 1997)

Meetings

• International Workshop on Minor Use and Minor Species (MUMS): A Global Perspective, October 7 & 8, 2004 - DoubleTree Hotel, Rockville, MD

CVM Updates

• New Legislation To Help Make Animal Drugs Available For Limited Uses, Minor Species
  August 3, 2004

• FDA Holding Workshop on Minor Use and Minor Species Drugs , June 22, 2004

• CPG on Extra-Label Use of Medicated Feeds for Minor Species Available, April 24, 2001

• Sheep Reclassified as Minor Species For All Data Collection Purposes, August 4, 2000

• FDA Holding Meeting on Establishing Resistance and Monitoring Thresholds, August 1, 2000

• Draft CPG On Use Of Medicated Feeds For Minor Species Available, August 26, 1999

• Finalized Minor Uses/Minor Species Guidance Available February 11, 1999

• FDA Seeking Comments on a Discussion Draft of MUMS Proposals (Dec. 23, 1997)

• Minor Uses/Minor Species Draft Guidance Published
  (Oct. 6, 1997)

• Request for Comments on Minor Species and Minor Uses Approval Options (June 26, 1997)

Federal Register Notices

• New Animal Drug Applications; Sheep as a Minor Species
  [text ] [ pdf ] July 26, 1999

• Proposals to Increase the Legal Availability of Animal Drugs for Minor Species and Minor Uses
  ( text ) ( pdf)
  October 29, 1998 (posted 10/30/98)

• FDA Approval of Animal Drugs for Minor Uses and Minor Species; Draft Guidance Document; Availability; Request for Comments 62 Fed. Reg. 50,952 (Sept. 29, 1997)

• Request for Comments on Development of Options to Encourage Animal Drug Approvals for Minor Species and for Minor Uses text version (June 23, 1997)

Guidance Documents - Draft and/or Final

• Compliance Policy Guide - Section 615.115 - Extra Label Use of Medicated Feeds for Minor Species (3/2001)

• Guidance for Industry: FDA Approval of Animal Drugs for Minor Uses and for Minor Species (4/1999)

Additional Information

• FDA News - FDA Commends Passage by the House of Representatives of S. 741, a Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development, July 21, 2004

• FDA News - FDA Commends Senate Passage of Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development, March 8, 2004

Links to Other Minor Use Minor Species Sites

• NRSP-7 Minor Use Animal Drug Page - NRSP-7 is a cooperative effort for approval of minor use animal drugs

• MUMsRx - an on-line database of FDA approved drugs for minor species