7564 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0056] (formerly 

Docket No. 2007N–0444) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recordkeeping 

and Records Access Requirements for 

Food Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 10, 

2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0560. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Recordkeeping and Records Access 

Requirements for Food Facilities—21 

CFR 1.337, 1.345, and 1.352 (OMB 

Control Number 0910–0560)—Extension 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 414 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 350c), which requires that 

persons who manufacture, process, 

pack, hold, receive, distribute, transport, 

or import food in the United States 

establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food. Sections 1.326 

through 1.363 (21 CFR 1.326 through 

1.363) of FDA’s regulations set forth the 

requirements for recordkeeping and 

records access. The requirement to 

establish and maintain records improves 

FDA’s ability to respond to, and further 

contain, threats of serious adverse 

health consequences or death to humans 

or animals from accidental or deliberate 

contamination of food. 

Description of Respondents: Persons 

that manufacture, process, pack, hold, 

receive, distribute, transport, or import 

food in the United States are required to 

establish and maintain records, 

including persons that engage in both 

interstate and intrastate commerce. 

FDA’s regulations require that records 

for non-transporters include the name 

and full contact information of sources, 

recipients, and transporters, an adequate 

description of the food including the 

quantity and packaging, and the receipt 

and shipping dates §§ 1.337 and 1.345). 

Required records for transporters 

include the names of consignor and 

consignee, points of origin and 

destination, date of shipment, number 

of packages, description of freight, route 

of movement and name of each carrier 

participating in the transportation, and 

transfer points through which shipment 

moved (§ 1.352). Existing records may 

be used if they contain all of the 

required information and are retained 

for the required time period. 

In the Federal Register of November 

19, 2007 (72 FR 65033), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1.337, 1.345, and 1.352 (records 

maintenance) 379,493 1 379,493 13.228 5,020,000 

1.337, 1.345, and 1.352 (learning for 

new firms) 18,975 1 18,975 4.790 90,890 

Total 5,110,890 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

This estimate is based on FDA’s 

estimate of the number of facilities 

affected by the final rule entitled 

‘‘Establishment and Maintenance of 

Records Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002,’’ published 

in the Federal Register of December 9, 

2004 (69 FR 71562 at 71630). With 

regard to records maintenance, FDA 

estimates that approximately 379,493 

facilities will spend 13.228 hours 

collecting, recording, and checking for 

accuracy of the limited amount of 

additional information required by the 

regulations, for a total of 5,020,000 

hours annually. In addition, FDA 

estimates that new firms entering the 

affected businesses will incur a burden 

from learning the regulatory 

requirements and understanding the 

records required for compliance. In this 

regard, the agency estimates the number 

of new firms entering the affected 

businesses to be 5 percent (5%) of 

379,493, or 18,975 firms. Thus, FDA 

estimates that approximately 18,975 

facilities will spend 4.790 hours 

learning about the recordkeeping and 

records access requirements, for a total 

of 90,890 hours annually. Therefore, the 

total annual recordkeeping burden is 

estimated to be 5,110,890 hours. 

Dated: January 30, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–2324 Filed 2–7–08; 8:45 am] 

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