[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30033-30035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0119]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Registration of Food 
Facilities Under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 June 
28, 2010.

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: 202-395-7285, or e-mailed to <a href="/cdn-cgi/l/email-protection#1e71776c7f416d6b7c73776d6d7771705e71737c307b716e30797168"><span class="__cf_email__" data-cfemail="0c63657e6d537f796e61657f7f6563624c63616e2269637c226b637a">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0502. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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.

Registration of Food Facilities Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002-- (OMB Control 
Number 0910-0502)--Extension

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) added section 415 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350d), which 
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. Sections 1.230 through 1.235 of FDA's regulations 
(21 CFR 1.230 through 1.235) set forth the procedures for registration 
of food facilities. Information provided to FDA under these regulations 
will help the agency to notify quickly the facilities that might be 
affected by a deliberate or accidental contamination of the food 
supply.
    Description of Respondents: The respondents to this information 
collection include owners, operators, or agents in charge of domestic 
or foreign facilities that manufacture/process, pack, or hold food for 
human or animal consumption in the United States. Domestic facilities 
are required to register whether or not food from the facility enters 
interstate commerce. Foreign facilities that manufacture/process, pack, 
or hold food also are required to register unless food from that 
facility undergoes further processing (including packaging) by another 
foreign facility before the food is exported to the United States. 
However, if the subsequent foreign facility performs only a minimal 
activity, such as putting on a label, both facilities are required to 
register.
    FDA's regulations require that each facility that manufactures, 
processes, packs, or holds food for human or animal consumption in the 
United States register with FDA using Form FDA 3537 (Sec.  1.231). The 
term ``Form FDA 3537'' refers to both the paper version of the form and 
the electronic system known as the Food Facility Registration Module, 
which is available at http://www.access.fda.gov. The agency strongly 
encourages electronic registration because it is faster and more 
convenient. The system the agency has developed can accept electronic 
registrations from anywhere in the world 24 hours a day, 7 days a week. 
A registering facility will receive confirmation of electronic 
registration and its registration number instantaneously once all the 
required fields on the registration screen are filled in. However, 
paper registrations will be accepted. Form FDA 3537 is available for 
download for registration by mail, fax, or CD-ROM. Registration by mail 
may take several weeks to several months, depending on the speed of the 
mail system and the number of paper registrations that FDA will have to 
enter manually.
    Information FDA requires on the registration form includes the name 
and full address of the facility; emergency contact information; all 
trade names the facility uses; applicable food product categories 
identified in Sec.  170.3 (21 CFR 170.3), unless ``most/all'' human 
food categories ``or none of the above mandatory categories'' is 
selected as a response; and a certification statement that includes the 
name of the individual authorized to submit the registration form. 
Additionally, facilities are encouraged to submit their preferred 
mailing address; type of activity conducted at the facility; food 
categories not included under Sec.  170.3, but which are helpful to FDA 
for responding to an incident; type of storage, if the facility is 
primarily a holding facility; and approximate dates of operation if the 
facility's business is seasonal.
    In addition to registering, a facility is required to submit timely 
updates within 60 days of a change to any required information on its 
registration form, using Form FDA 3537 (Sec.  1.234), and to cancel its 
registration when the facility ceases to operate or is sold to new 
owners or ceases to manufacture/process, pack, or hold food for 
consumption in the United States, using Form FDA 3537a (Sec.  1.235).
    In the Federal Register of March 16, 2010 (75 FR 12547), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 30034]]

information. FDA received one letter, containing multiple comments, in 
response to the notice.
    (Comment 1) One comment contended that it was unnecessary for 
companies to have to register their facilities with FDA.
    (Response) FDA disagrees. In the Preliminary Regulatory Impact 
Analysis (PRIA) for the proposed rule (see the Federal Register of 
Feburary 3, 2003 (68 FR 5378 at 5387 to 5413)), FDA asserted that 
requiring registration of manufacturers/ processors, packers, and 
holders of food would aid in deterring and limiting the effects of 
foodborne outbreaks in four ways. One, by requiring registration, 
persons who might intentionally contaminate the food supply would be 
deterred from entering the food production chain. Two, if FDA is aware 
of a specific food threat, a registration database would make FDA 
better able to inform the facilities potentially affected by the 
threat. Three, FDA would be able to deploy more efficiently its 
domestic compliance and regulatory resources. Four, FDA inspectors, 
using prior notice and registration, would be better able to identify 
shipments offered for import for inspection.
    Registering with FDA creates a paper trail, which would, even if 
the information in the registration were falsified, provide evidence 
that could link the registration to the false registrant. Persons who 
might attempt to intentionally contaminate the U.S. food supply would 
be deterred, by the creation of additional evidence that might be used 
against them, from starting a business in the food supply chain. 
Persons who might intentionally contaminate the food supply but refuse 
to register would be subject to criminal and civil sanctions and, if 
foreign, would risk having their product held at a U.S. port. With 
emergency contact information and product categories, FDA can quickly 
call or e-mail the emergency contact at both domestic and foreign 
facilities that may be targeted by a specific food threat. If FDA 
suspects a particular product is at risk, the agency can quickly 
identify which facilities to contact. This rapid communication ability 
will allow facilities to respond quickly to a threat and possibly limit 
the effect of a deliberate strike on the food supply, as well as public 
health emergencies due to accidental contamination of food.
    (Comment 2) One comment stated that facilities that hold food 
should not be required to register.
    (Response) FDA disagrees with the suggested change to its 
regulations. The agency's regulations implement the food facility 
registration requirements in section 305 of the Bioterrorism Act, which 
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.
    (Comment 3) One comment stated that, to lessen the burden of the 
regulation, FDA should not require firms to update their registration 
information, but only to cancel their registration when the facility 
stops holding food.
    (Response) FDA disagrees with the suggested change to its 
regulations. Requiring registrants to update the registration 
information for their facilities will directly enhance FDA's ability to 
satisfy the agency's obligation to maintain an up-to-date list of 
registered facilities, as required by section 415(a)(4) of the act. FDA 
has balanced the greater efficiency of the agency's having specific 
information regarding food manufactured/processed, packed, or held at 
each facility against the burden on facilities to submit initially and 
update this information as circumstances change. Without updated 
emergency contact information and product categories, the agency's 
ability to quickly call or e-mail the emergency contact at facilities 
that may be targeted by a specific food threat would be negatively 
impacted.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Annual Frequency     Total Annual        Hours  per
          21 CFR  Section               FDA Form No.     No. of  Respondents     per Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.230-1.233                                FDA 3537\2\                13,560                  1             13,560                2.5             33,900
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Foreign
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.230-1.233                                   FDA 3537                23,370                  1             23,370                8.5            198,645
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New Facility Registration Subtotal                                                                                                               232,545
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Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a)
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1.234                                         FDA 3537               118,530                  1            118,530                  1            118,530
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.235                                        FDA 3537a                 6,390                  1              6,390                  1              6,390
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updates or Cancellations to Existing Registration Subtotal                                                                                       124,920
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Total Hours Annually                                                                                                                             357,465
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3537'' refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module,
  which is available at http://www.access.fda.gov.

    This estimate is based on FDA's experience and the average number 
of new facility registrations, updates and cancellations received in 
the past 3 years. FDA received 12,681 new domestic facility 
registrations during 2006; 14,629 during 2007; and 13,378 during 2008. 
Based on this experience, FDA estimates the annual number of new 
domestic facility registrations will be 13,560. FDA estimates that 
listing the information required by the

[[Page 30035]]

Bioterrorism Act and presenting it in a format that will meet the 
agency's registration regulations will require a burden of 
approximately 2.5 hours per average domestic facility registration. The 
average domestic facility burden hour estimate of 2.5 hours takes into 
account that some respondents completing the registration may not have 
readily available Internet access. Thus, the total annual burden for 
new domestic facility registrations is estimated to be 33,900 hours 
(13,560 x 2.5 hours).
    FDA received 25,513 new foreign facility registrations during 2006; 
23,302 during 2007; and 21,281 during 2008. Based on this experience, 
FDA estimates the annual number of new foreign facility registrations 
will be 23,370. FDA estimates that listing the information required by 
the Bioterrorism Act and presenting it in a format that will meet the 
agency's registration regulations will require a burden of 
approximately 8.5 hours per average foreign facility registration. The 
average foreign facility burden hour estimate of 8.5 hours includes an 
estimate of the additional burden on a foreign facility to obtain a 
U.S. agent, and takes into account that for some foreign facilities the 
respondent completing the registration may not be fluent in English 
and/or not have readily available Internet access. Thus, the total 
annual burden for new foreign facility registrations is estimated to be 
198,645 hours (23,370 x 8.5 hours).
    FDA received 114,199 updates to facility registrations during 2006; 
128,070 during 2007; and 113,318 during 2008. Based on this experience, 
FDA estimates that it will receive 118,530 updates annually. FDA also 
estimates that updating a registration will, on average, require a 
burden of approximately 1 hour, taking into account fluency in English 
and Internet access. Thus, the total annual burden for updating all 
registrations is estimated to be 118,530 hours.
    FDA received 5,703 cancellations of facility registrations during 
2006; 5,578 during 2007; and 7,888 during 2008. Based on this 
experience, FDA estimates the annual number of cancellations will be 
6,390. FDA also estimates that cancelling a registration will, on 
average, require a burden of approximately 1 hour, taking into account 
fluency in English and Internet access. Thus, the total annual burden 
for cancelling registrations is estimated to be 6,390 hours.

    Dated: May 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13003 Filed 5-27-10; 8:45 am]
BILLING CODE 4160-01-S


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