[Federal Register: November 9, 2004 (Volume 69, Number 216)]
[Notices]               
[Page 64957]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no04-71]                         

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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.

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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 the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, 7519 Standish Pl., Rockville, MD 20855, 301-827-2945, 
abeaulie@cvm.fda.gov. Alternatively, you may contact Margaret Oeller, 
Office of Minor Use and Minor Species Animal Drug Development, Center 
for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 301-
827-3067, 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.

    Dated: November 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24880 Filed 11-8-04; 8:45 am]

BILLING CODE 4160-01-S