[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Notices]
[Pages 19489-19490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0453]


Compliance Policy Guide Sec. 560.400--Imported Milk and Cream--
Federal Import Milk Act (Compliance Policy Guide 7119.05); 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 ``Sec. 
560.400--Imported Milk and Cream--Federal Import Milk Act (CPG 
7119.05).'' The CPG provides guidance on the applicability of the 
Federal Import Milk Act (FIMA) to imported milk and cream. This 
document updates the existing CPG.

DATES: Submit written or electronic comments concerning the CPG or the 
supporting document at any time.

ADDRESSES: Submit written requests for single copies of the CPG 
entitled ``Sec. 560.400--Imported Milk and Cream--Federal Import Milk 
Act (CPG 7119.05)'' to the Division of Compliance Policy (HFC-230), 
Office of Enforcement, Office of Regulatory Affairs, 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 on the revised CPG 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://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

    In the Federal Register of October 29, 2004 (69 FR 63158), FDA 
announced the availability of a draft CPG entitled ``Sec. 560.400--
Imported Milk and Cream--Federal Import Milk Act (CPG 7119.05).'' After 
considering comments received, FDA has finalized the CPG. The CPG 
updates and replaces ``CPG Sec. 560.400--Imported Milk and

[[Page 19490]]

Cream--Import Milk Act (CPG 7119.05).''
    FDA received 10 comments on the draft CPG. The comments represented 
the views of individual consumers, industry, and industry trade 
representatives. One comment requested clarification on whether 
sweetened condensed milk was subject to a FIMA permit. Nine comments 
were outside the scope of the draft CPG. After considering carefully 
the relevant comment received, FDA revised its intended treatment of 
sweetened condensed milk and evaporated milk under the FIMA. 
Accordingly, under Section III.B. of the CPG, ``Application of the 
FIMA:,'' the following changes were made:
     In paragraph 1.i. of the CPG, we removed ``Sweetened 
Condensed Milk'' and ``Evaporated Milk'' from the list of products that 
FDA intends to consider as subject to the FIMA's permit requirements 
for importation; and
     In paragraph 2.ii. of the CPG, we added ``Sweetened 
Condensed Milk'' and ``Evaporated Milk'' to the list of products that 
FDA intends to consider as not subject to the FIMA's permit 
requirements for importation.
    We also edited the CPG to clarify the following:
     In section II of the CPG, regulations under the FIMA are 
found in 21 CFR part 1210;
     In section II of the CPG, FDA intends to consider 
sweetened condensed milk and evaporated milk as not subject to the 
provisions of the FIMA. Sweetened condensed milk is required by Sec.  
131.120 (21 CFR 131.120) to contain a quantity of nutritive 
carbohydrate sweetener sufficient to prevent spoilage, and evaporated 
milk is required by Sec.  131.130 to be sealed in a container and so 
processed by heat as to prevent spoilage;
     In section III of the CPG, FDA intends to consider 
``Nonfat Milk'' as subject to the FIMA's permit requirement for 
importation; and
     In section V of the CPG, the specimen charge should be 
worded, ``The article of [milk] [cream] is not accompanied by a valid 
import milk permit, as required by the Federal Import Milk Act (21 
U.S.C. 141-149).''
    The CPG is being issued as level 1 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The CPG represents 
the agency's current thinking on its enforcement process concerning the 
FIMA. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public.

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

    An electronic version of the revised CPG is available on the 
Internet at http://www.fda.gov/ora under ``Compliance References.''

    Dated: March 30, 2005.
John R. Marzilli,
Deputy Associate Commissioner for Regulatory Affairs.
[FR Doc. 05-7343 Filed 4-12-05; 8:45 am]
BILLING CODE 4160-01-S