[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Notices]
[Pages 517-518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-70]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1164]


Food Additive Petition Expedited Review--Guidance for Industry 
and Center for Food Safety and Applied Nutrition Staff; 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 guidance document entitled ``Food Additive Petition 
Expedited Review--Guidance for Industry and Center for Food Safety and 
Applied Nutrition Staff.'' FDA believes it is in the interest of 
enhanced food safety to review petitions for certain food additives in 
an expedited manner. Expedited review will be considered when an 
additive is intended to decrease incidences of foodborne illnesses 
through its antimicrobial actions against human pathogens that might be 
present in food.

DATES: Written comments concerning this guidance may be submitted at 
any time.

ADDRESSES: Written comments concerning this guidance may be submitted 
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 docket number found in brackets 
in the heading of this document. Submit written requests for single 
copies of the guidance to the Office of Premarket Approval (HFS-200), 
Food and Drug Administration, 200 C St. SW., Washington DC 20204, or by 
telephone to the Office of Premarket Approval at 202-418-3100 (voice), 
or FAX 202-418-3131. All requests should identify the guidance by its 
title of ``Food Additive Petition Expedited Review--Guidance for 
Industry and Center for Food Safety and Applied Nutrition Staff.'' See 
the Supplementary Information section for electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington DC 20204-0001, 202-418-3074.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.) provides for the approval of the use of food additives that 
are shown to be safe for their intended use. Section 409 of the act (21 
U.S.C. 348) provides for the filing of petitions to request such 
approval, and also authorizes FDA (by delegation) to initiate the 
approval process. The agency receives food additive petitions for a 
broad range of proposed uses, including petitions proposing the 
approval of a substance for use in reducing the number of pathogens in 
or on food.
    FDA believes it is in the interest of enhanced food safety to 
review petitions for certain food additives in an expedited manner. 
Expedited review will generally be considered when an additive is 
intended to decrease the incidence of foodborne illness through its 
antimicrobial action against human pathogens that might be present in 
food.

[[Page 518]]

    Designating a food additive petition for expedited review means 
that the food additive petition would be reviewed ahead of other 
pending food additive petitions, i.e., the petition will be placed at 
the beginning of the appropriate review queues. All other aspects of 
the review process (e.g., data requirements for the petition, 
procedures for evaluating petitions and communicating with petitioners) 
will be the same for an expedited review petition as for all other food 
additive petitions.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the procedures to be followed for expedited review of food additive 
petitions. 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.
    The guidance document entitled ``Food Additive Petition Expedited 
Review--Guidance for Industry and Center for Food Safety and Applied 
Nutrition Staff'' is a Level 1 guidance under the agency's Good 
Guidance Practices (62 FR 8961, February 27, 1997). Level 1 guidance 
documents are generally subject to public comment prior to 
implementation. However, public comment prior to implementation of this 
guidance document is not required because there is a public health 
justification for immediate implementation.

III. Comments

    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding the 
guidance document. 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. The guidance document and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday. 
Such comments will be considered when determining whether to amend the 
guidance.

IV. Electronic Access

    The guidance may also be accessed at the Center for Food Safety and 
Applied Nutrition home page on the World Wide Web at ``http://
www.fda.gov/cfsan''.

    Dated: December 15, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-70 Filed 1-4-99; 8:45 am]
BILLING CODE 4160-01-F