[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