[Federal Register Volume 69, Number 100 (Monday, May 24, 2004)]
[Rules and Regulations]
[Page 29428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11598]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N-0276]
RIN 0910-AC40


Registration of Food Facilities Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) published an interim 
final rule in the Federal Register of October 10, 2003 (68 FR 58894). 
The interim final rule requires domestic and foreign facilities that 
manufacture/process, pack, or hold food for human or animal consumption 
in the United States, to register with FDA by December 12, 2003. Due to 
several errors in Sec. Sec.  1.231 and 1.232 (21 CFR 1.231 and 1.232), 
the interim final rule contains some incorrect information. This 
document corrects those errors.

DATES: Effective May 24, 2004.

FOR FURTHER INFORMATION CONTACT: Melissa S. Scales, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1720.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 10, 2003 
(68 FR 58894), FDA published an interim final rule on Registration of 
Food Facilities under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002. Since that time, FDA has 
discovered that the interim final rule contains several errors.
    First, FDA is correcting the phone number to which registration 
form requests and other technical questions should be directed. The 
appropriate phone numbers are 1-800-216-7331 or 301-575-0156.
    Second, Sec.  1.232 of the interim final rule contains several 
editorial errors. Section 1.232(d) currently states that each foreign 
facility must submit ``the name, address, phone number, and emergency 
contact phone number of its U.S. agent (if there is no other emergency 
contact designated under Sec.  1.233(c)).'' To improve the clarity of 
this provision, FDA is also revising Sec.  1.232(d). The reference to 
Sec.  1.233(c) in this sentence is incorrect; the proper reference is 
to Sec.  1.233(e). Also, the reference in Sec.  1.232(g) to Sec.  
1.233(e) is incorrect; the proper reference is to Sec.  1.233(j).

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 334, 343, 350c, 350d, 352, 355, 360b, 362, 371, 
374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.

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2. Section 1.231 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  1.231  How and where do you register?

* * * * *
    (b) * * *
    (1) You must register using Form 3537. You may obtain a copy of 
this form by writing to the U.S. Food and Drug Administration (HFS-
681), 5600 Fishers Lane, Rockville, MD 20857 or by requesting a copy of 
this form by phone at 1-800-216-7331 or 301-575-0156.
* * * * *

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3. Section 1.232 is amended by revising paragraphs (d) and (g) to read 
as follows:


Sec.  1.232  What information is required in the registration?

* * * * *
    (d) For a foreign facility, the name, address, phone number, and, 
if no emergency contact is designated under Sec.  1.233(e), the 
emergency contact phone number of the foreign facility's U.S. agent;
* * * * *
    (g) Applicable food product categories as identified in Sec.  170.3 
of this chapter, unless you check either ``most/all human food product 
categories,'' according to Sec.  1.233(j), or ``none of the above 
mandatory categories'' because your facility manufactures/processes, 
packs, or holds a food that is not identified in Sec.  170.3 of this 
chapter;
* * * * *

    Dated: May 10, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11598 Filed 5-21-04; 8:45 am]
BILLING CODE 4160-01-S