[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Notices]
[Pages 15774-15775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7923]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0463]
Foods--Adulteration Involving Hard or Sharp Foreign Objects;
Compliance Policy Guide; 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 compliance policy guide (CPG) entitled ``Foods--
Adulteration Involving Hard or Sharp Foreign Objects.'' This CPG is
intended to help FDA components and industry comply with FDA's internal
enforcement process concerning foods that contain hard or sharp foreign
objects.
DATES: Written comments on this CPG may be submitted at any time.
ADDRESSES: Submit written requests for single copies of Compliance
Policy Guide (CPG) Sec. 555.425 ``Foods--Adulteration Involving Hard or
Sharp Foreign Objects'' to the Director, Division of Compliance Policy
(HFC-230), Office of Enforcement, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-827-0482. Copies of the CPG may also be downloaded to a
personal computer with access to the World Wide Web (WWW). The Office
of Regulatory Affairs (ORA) home page includes the CPG and may be
accessed at ``http://www.fda.gov/ora''. The CPG will be available on
the Compliance References page for ORA.
Submit comments to MaryLynn A. Datoc, the second contact person
listed in this document in the ``FOR FURTHER INFORMATION CONTACT''
section.
FOR FURTHER INFORMATION CONTACT:
Technical Questions Concerning Foreign Objects in Foods: Alan R.
Olsen, Microanalytical Branch (HFS-315), Office of Plant, Dairy Foods,
and Beverages, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4438,
FAX 202-205-4091.
Questions Concerning Regulatory Actions and All Comments: MaryLynn
A. Datoc, Division of Compliance Policy (HFC-230), Office of
Enforcement, Office of Regulatory Affairs, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0413,
FAX 301-827-0482.
SUPPLEMENTARY INFORMATION: FDA has developed a CPG to provide guidance
on FDA's internal enforcement process concerning foods that contain
hard or sharp foreign objects. This guidance synthesizes FDA's case-by-
case responses to the problem of hard or sharp foreign objects in food.
The CPG is intended to provide clear policy and regulatory guidelines
to FDA's field and headquarters staff with regard to such foods. It
also contains information that may be useful to the regulated industry
and to the public.
Therefore, FDA has prepared a CPG to describe its internal
enforcement process. The CPG is being issued as a guidance document and
represents the agency's current thinking on the subject. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public.
The agency has adopted good guidance practices (GGP's) that set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This CPG is being issued as a level 2 guidance consistent with
GGP's.
Interested persons may submit to the second contact person listed
in this document written comments regarding the CPG entitled ``Foods--
Adulteration Involving Hard or Sharp Foreign Objects.'' Two copies of
any comments
[[Page 15775]]
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 CPG and received
comments may be seen in the office above between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: March 23, 1999.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 99-7923 Filed 3-31-99; 8:45 am]
BILLING CODE 4160-01-F