[Federal Register: October 29, 2004 (Volume 69, Number 209)]
[Notices]
[Page 63158-63159]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc04-73]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0453]
Draft Revised Compliance Policy Guide ``Sec. 560.400--Imported
Milk and Cream--Federal Import Milk Act (CPG 7119.05);'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft revision of the compliance policy guide (CPG)
entitled ``Sec. 560.400--Imported Milk and Cream--Federal Import Milk
Act.'' The draft CPG provides guidance on the
[[Page 63159]]
applicability of the Federal Import Milk Act (FIMA) to imported milk
and cream.
DATES: Submit written or electronic comments on the draft revised CPG
by November 29, 2004. General comments on agency guidance documents are
welcome any time.
ADDRESSES: Submit written requests for single copies of the draft
revision of the CPG entitled ``Sec. 560.400--Imported Milk and Cream--
Federal Import Milk Act'' to the 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
240-632-6861. See the SUPPLEMENTARY INFORMATION section for electronic
access to the document.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Esther Lazar, Center for Food Safety
and Applied Nutrition (HFS-306), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1485, FAX:
301-436-2632.
SUPPLEMENTARY INFORMATION:
I. Background
The FIMA (21 U.S.C. 141 et seq.) prohibits the importation into the
United States of milk and cream without a valid permit from the
Secretary of Health and Human Services. FDA is revising the CPG to
clarify and update its policy regarding which dairy products require
permits under the FIMA. As explained in the draft CPG, FDA intends to
consider the following dairy products to be subject to the FIMA's
permit requirement for importation into the United States:
Milk, lowfat milk, skim milk, fortified milk, flavored
milk, concentrated milk, evaporated milk, sweetened condensed milk,
ultra filtered milk.
Cream, half-and-half, heavy cream, light cream, and light
whipping cream.
FDA does not intend to require a FIMA permit for the following
dairy products:
Sour cream, cultured milk, acidified milk, yogurt, cheese,
ice cream, and eggnog.
Dried milk, nonfat dry milk, nonfat dry milk fortified
with vitamins A and D, and other dehydrated milk products.
Any dairy product for which a permit is otherwise
required, if it has been processed and packaged in hermetically sealed
containers so as to be commercially sterile in accordance with the
requirements of 21 CFR 108.35 and 21 CFR part 113.
FDA has adopted good guidance practices (GGPs) that set forth the
agency's policies and procedures for the development, issuance, and use
of guidance documents (21 CFR 10.115). The draft guidance is being
issued as a level 1 draft guidance consistent with GGPs. The draft
revised CPG represents the agency's current thinking on the
applicability of the FIMA to imported milk and cream. 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 statues and
regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4.p.m., Monday
through Friday.
III. Electronic Access
A copy of the draft revised CPG may be downloaded to a personal
computer with access to the Internet. The Office of Regulatory Affairs
home page includes the draft revised CPG and may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora
under ``Compliance Reference.''
Dated: October 22, 2004.
John Marzilli,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-24153 Filed 10-28-04; 8:45 am]
BILLING CODE 4160-01-S