[Federal Register Volume 64, Number 93 (Friday, May 14, 1999)]
[Notices]
[Page 26424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0389]


Final Guidance on FDA Approval of New Animal Drugs for Minor Uses 
and for Minor Species; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance document entitled ``Guidance for 
Industry: FDA Approval of New Animal Drugs for Minor Uses and for Minor 
Species.'' This guidance document is intended to provide specific 
guidance on the means for generating effectiveness and safety data to 
support the approval of new animal drugs for minor uses and minor 
species.

DATES: Written comments may be provided at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry: FDA Approval of New Animal 
Drugs for Minor Uses and for Minor Species'' to the Communications 
Staff (HFV-12), Center for Veterinary Medicine (CVM), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-
addressed adhesive label to assist that office in processing your 
request. Copies of this guidance document may also be obtained from the 
CVM home page at ``http://www.fda.gov/cvm''. Submit written comments on 
the guidance document to the Policy and Regulations Team (HFV-6), 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT: Margaret R. Oeller, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7581, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The major purpose of this guidance document 
is to suggest means of generating effectiveness and safety data to 
support the approval of minor use new animal drugs. Minor use of a new 
animal drug is defined as use in a minor species or use in any animal 
species for a condition that is rare or that occurs in limited 
geographic areas. Minor species are defined by exclusion, as any 
species other than major species. Major species are defined as cattle, 
swine, chickens, turkeys, horses, dogs, and cats. According to current 
regulations, sheep are a minor species except with respect to human 
food safety data collection requirements, for which sheep are 
considered major species.
     The guidance document, as applied to minor use new animal drugs, 
does not lessen the legal requirements for demonstrating the safety and 
effectiveness of a new animal drug. Instead, the guidance document 
suggests possible means of generating safety and effectiveness data to 
satisfy these requirements.
     In the Federal Register of September 29, 1997 (62 FR 50952), FDA 
published a notice of availability of a draft guidance on this subject. 
The notice gave interested persons an opportunity to submit comments by 
December 29, 1997. Seven comments were received by industry and trade 
associations. FDA considered these comments and revised the draft 
guidance document where appropriate.
     This guidance document is intended to reflect the current way that 
animal drugs are approved for minor species and minor uses. The Animal 
Drug Availability Act of 1996 required CVM to examine the way that 
these products are approved and to propose means to facilitate such 
approvals. In the Federal Register of October 29, 1998 (63 FR 58056), 
CVM published a notice of the availability of its report proposing 
several options to encourage animal drug approvals for minor species 
and for minor uses. It is very likely that additional policies and 
programs will be implemented over the next few years to accomplish this 
goal. Because policies and programs may change, sponsors are encouraged 
to contact CVM early in project development to determine the most 
efficient path to approval of their products. If any program and policy 
changes affect the policies in this guidance, CVM will revise this 
final guidance.
     The final guidance represents the agency's current thinking on the 
means of generating efficacy and safety data to support approval of new 
animal drug applications for minor use new animal drugs. 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 the applicable statute, 
regulations, or both. 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. CVM will periodically review 
the comments concerning the document and, when appropriate, amend the 
guidance.

    Dated: May 5, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-12179 Filed 5-13-99; 8:45 am]
BILLING CODE 4160-01-F