[Federal Register Volume 70, Number 35 (Wednesday, February 23, 2005)]
[Rules and Regulations]
[Pages 8726-8727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3424]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N-0277]


Establishment and Maintenance of Records Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
regulation that appeared in the Federal Register of December 9, 2004 
(69 FR 71562). The document issued a final regulation that requires the 
establishment and maintenance of records by persons who manufacture, 
process, pack, transport, distribute, receive, hold, or import food in 
the United States. Such records allow for the identification of the 
immediate previous sources and immediate subsequent recipients of food. 
The document was published with some errors. This document corrects 
those errors.

DATES: This rule is effective February 7, 2005.

FOR FURTHER INFORMATION CONTACT: Nega Beru, Center for Food Safety and 
Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-1400.

SUPPLEMENTARY INFORMATION: In FR Doc. 04-26929, appearing on page 71562 
in the Federal Register of Thursday, December 9, 2004, the following 
corrections are made to the SUPPLEMENTARY INFORMATION:
    1. On page 71562, in the first column, under DATES after 
``Compliance Dates'' the phrase ``except that for small businesses 
employing fewer than 500, but more than 10 full-time equivalent 
employees, the compliance date is June 9, 2005;'' is corrected to read 
``except that for small businesses employing fewer than 500, but more 
than 10 full-time equivalent employees, the compliance date is June 9, 
2006;''.
    2. On page 71564, in the second column, the sixth bullet, beginning 
in the 4\th\ line, the phrase ``except that the compliance date for 
small businesses employing fewer that 500, but more than 10 full-time 
equivalent employees is June 9, 2005,'' is corrected to read ``except 
that the compliance date for small businesses employing fewer than 500, 
but more than 10 full-time equivalent employees is June 9, 2006,''.
    3. On page 71565, in the second column, the last bullet, second 
sentence, the sentence ``Small businesses have June 9, 2005, of this 
final rule to come into compliance with these regulations, and very 
small businesses have December 11, 2006, of this final rule to come 
into compliance with these regulations.'' is corrected to read ``Small 
businesses have until June 9, 2006, to come into compliance with these 
regulations, and very small businesses have until December 11, 2006, to 
come into compliance with these regulations.''
    4. On page 71609, in the third column, in the 1\st\ complete 
paragraph, the sentences ``Section 1.368 of the final rule requires 
large businesses (500 or more full-time equivalent employees) to be in 
compliance within December 9, 2005. Small businesses (those with fewer 
than 500, but more than 10 full-time equivalent employees) must be in 
compliance within June 9, 2005, and very small businesses that employ 
10 or fewer full-time equivalent employees must be in compliance within 
December 11, 2006.'' are corrected to read ``Section 1.368 of the final 
rule requires large businesses (500 or more full-time equivalent 
employees) to be in compliance by December 9, 2005. Small businesses 
(those with fewer than 500, but more than 10 full-time equivalent 
employees) must be in compliance by June 9, 2006, and very small 
businesses that employ 10 or fewer full-time equivalent employees must 
be in compliance by December 11, 2006.''
    5. On page 71627, in the third column, beginning in the 12\th\ line 
from the bottom, the sentence ``For example, from CA, LA, and TX alone, 
DOT reports over 12 percent of intrastate truck tonnage is from FDA-
regulated products (ref. 18).'' is corrected to read ``For example, for 
California in 1997, DOT reports 12.8 percent of revenue from 
specialized freight transportation is for intrastate traffic in 
agricultural products (ref. 18).''
    6. On page 71651, in the first column, in Reference 18, the phrase 
``U.S. Department of Transportation, available at http://www.transtats.bts.gov, accessed on April 6, 2004.'' is corrected to 
read ``1997 Economic Census, Transportation and Warehousing, Geographic 
Area Series, California 1997, issued January 2000, U.S. Department of 
Commerce.''

List of Subjects in 21 CFR Part 1

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

0
Therefore, 21 CFR part 1 is corrected by making the following 
correcting amendments:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
7. The authority citation for 21 CFR 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, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 
264.

0
8. In Sec.  1.363, revise paragraph (b) to read as follows:


Sec.  1.363   What are the consequences of failing to establish or 
maintain records or make them available to FDA as required by this 
subpart?

* * * * *
    (b) The failure of a nontransporter immediate previous source or a 
nontransporter immediate subsequent recipient who enters an agreement 
under Sec.  1.352(e) to establish, maintain, or establish and maintain, 
records required under Sec.  1.352(a), (b), (c), or (d), or the refusal 
to permit access to or

[[Page 8727]]

verification or copying of any such required record, is a prohibited 
act under section 301 of the act.
* * * * *

0
9. In Sec.  1.368, revise paragraph (a) to read as follows:


Sec.  1.368  What are the compliance dates for this subpart?

* * * * *
    (a) The compliance date for the requirements in this subpart is 
June 9,2006, for small businesses employing fewer that 500, but more 
than 10 full-time equivalent employees.
* * * * *

    Dated: February 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3424 Filed 2-22-05; 8:45 am]
BILLING CODE 4160-01-S