[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
