[Federal Register Volume 66, Number 47 (Friday, March 9, 2001)]
[Notices]
[Page 14155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5952]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0107]


 Guidance for Industry: Expedited Review for New Animal Drug 
Applications for Human Pathogen Reduction Claims; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry (#121) entitled ``Expedited 
Review for New Animal Drug Applications for Human Pathogen Reduction 
Claims.'' The guidance provides advice to industry about the process 
that the Center for Veterinary Medicine (CVM) plans to use to grant 
expedited review status (ERS) for applications for new animal drugs 
intended to reduce human pathogens in food-producing animals.

DATES:  Submit written comments on the guidance at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the guidance and the docket number found in brackets in the heading 
of this document. Submit written requests for single copies of the 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7580, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Expedited Review for New Animal Drug Applications for Human 
Pathogen Reduction Claims.'' The guidance advises industry about the 
process that CVM intends to use to grant expedited review status for 
applications for new animal drugs designed to reduce human pathogens in 
food-producing animals and to thereby potentially decrease the 
incidence of human illness. Specifically, it provides procedures for 
requesting and criteria for granting expedited review status for new 
animal drug applications and investigational new animal drug 
applications for new animal drugs that will have human pathogen 
reduction claims on their labels. The guidance reflects the agency's 
current thinking on these procedures and criteria.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). FDA has determined that obtaining public participation prior 
to issuance of this guidance is not appropriate. The goal of this 
guidance is to allow products to be approved more quickly if they 
potentially offer important advances in reducing human pathogens in 
food animals, and thereby may result in a decrease of the incidence of 
human illness, and are supported by appropriate data. Implementing the 
guidance immediately, prior to receiving public comment, will further 
advance this goal. The concern for public health is supported by 
Congress. The committee reports for the fiscal year 2001 agriculture 
appropriations bills (H. Rept. 106-619 and S. Rept. 106-288) state 
that: ``In view of the significant public health benefits of 
competitive exclusion products, the FDA should review new animal drug 
applications for these products on an expedited basis.''
    While FDA will immediately implement this guidance, the agency is 
inviting public comment and will revise the document as appropriate. 
The guidance represents the agency's current thinking on the procedures 
for requesting and criteria for granting ERS for applications for new 
animal drugs designed to reduce human pathogens in food-producing 
animals. 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 and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the guidance at any time. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. A copy of the 
guidance and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

III. Electronic Access

     Copies of this guidance document may be obtained on the Internet 
from the CVM home page at http://www.fda.gov/cvm/.

    Dated: March 6, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-5952 Filed 3-6-01; 4:25 pm]
BILLING CODE 4160-01-S