The Food and Drug Administration (FDA) of the U. S. Health and Human Services (DHHS) has announced the establishment of a new Office of Minor Use and Minor Species (MUMS) Animal Drug Development and is requesting comments on the implementation of the newly-enacted MUMS Animal Health Act.  The solicitation appeared in the Federal Register (69 FR 64957, November 9, 2004).

The text of the FDA announcement follows this note.

The deadline for submitting comments is JANUARY 10, 2005.   All questions about this solicitation should be directed to the point of contact listed in the FDA announcement.

Federal Register
November 9, 2004 (Volume 69, Number 216)
[Notices]
[Page 64957]
From the Federal Register Online via GPO Access

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0480]

The Minor Use and Minor Species Animal Health Act; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

Summary
The Food and Drug Administration (FDA) is announcing the establishment of a new Office of Minor Use and Minor Species (MUMS) Animal Drug Development and is requesting comments on the implementation of the newly enacted MUMS Animal Health Act. This notice is intended to provide the public with contact information for the new MUMS office as well as to provide a venue for public comment.

Dates: Submit written or electronic comments by January 10, 2005.

Addresses: Submit written comments to: 
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
Submit electronic comments to http://www.fda.gov/dockets/ecomments

For Further Information Contact: 
Andrew Beaulieu
Office of Minor Use and Minor Species Animal Drug Development
Center for Veterinary Medicine
7519Standish Pl.
Rockville, MD 20855, 
Telephone: 301-827-2945
Email: abeaulie@cvm.fda.gov

Alternatively, Contact:
Margaret Oeller
Office of Minor Use and Minor Species Animal Drug Development
Center for Veterinary Medicine
7519 Standish Pl.
Rockville, MD 20855
Telephone: 301- 827-3067
Email: moeller@cvm.fda.gov 

Supplementary Information:
I. Background
The MUMS Animal Health Act became law on August 2, 2004 (Public Law 108-282). Several elements of the law became immediately effective on that date. These include the provisions for designation of MUMS drugs under section 573 and for conditional approval of MUMS drugs under section 571.  The indexing provisions under section 572 of the law will only become effective upon publication of final implementing regulations. As mandated by the MUMS law, FDA has established the new Office of MUMS Animal Drug Development in the Center for Veterinary Medicine (CVM). FDA is requesting comments on any aspect of implementation of the MUMS legislation (see section II of this document). Requests for further information should be directed to the Office of MUMS Animal Drug Development (see FOR FURTHER INFORMATION CONTACT).

II. Comments
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments. 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.  Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Source: AASRP ListServe
November 9, 2004

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