[Federal Register: October 29, 2004 (Volume 69, Number 209)]
[Page 63158-63159]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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: 


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 

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]