[Federal Register Volume 71, Number 241 (Friday, December 15, 2006)]
[Notices]
[Pages 75555-75557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0197]


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 January 
16, 2007.

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.

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.

Registration of Food Facilities Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.230 
through 1.235 (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 (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

[[Page 75556]]

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, 
365 days a year. 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 June 2, 2006 (71 FR 32103), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. We received no comments.
    FDA estimates the burden of complying with the information 
collection provisions of the agency's regulations for food facility 
registration as follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                    FDA  Form       No. of       Annual Frequency   Total Annual     Hours per
 21 CFR Section        No.        Respondents     per Respondent      Responses       Response      Total Hours
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New Facilities
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  Domestic
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  1.230 through   FDA 3537\2\           13,650                  1          13,650            2.5          34,125
   1.233
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  Foreign
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  1.230 through   FDA 3537              29,200                  1          29,200            8.5         248,200
   1.233
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  New Facility Registration Subtotal                                                                     282,325
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a)
----------------------------------------------------------------------------------------------------------------
  1.234           FDA 3537              92,850                  1          92,850            1            92,850
----------------------------------------------------------------------------------------------------------------
  1.235           FDA 3537a              1,300                  1           1,300            1             1,300
----------------------------------------------------------------------------------------------------------------
  Updates or Cancellations to Existing Registration Subtotal                                              94,150
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Total Hours Annually                                                                                     376,475
----------------------------------------------------------------------------------------------------------------
\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 82,485 new domestic facility 
registrations during 2003; 32,099 during 2004; and 13,652 during 2005. 
Based on this experience, FDA estimates the annual number of new 
domestic facility registrations will be 13,650. 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 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

[[Page 75557]]

estimated to be 34,125 hours (13,650 x 2.5 hours).
    FDA received 89,990 new foreign facility registrations during 2003; 
49,574 during 2004; and 29,193 during 2005. Based on this experience, 
FDA estimates the annual number of new foreign facility registrations 
will be 29,200. 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 
248,200 hours (29,200 x 8.5 hours).
    FDA received 131,354 updates to facility registrations during 2003; 
137,384 during 2004; and 92,835 during 2005. Based on this experience, 
FDA estimates that it will receive 92,850 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 92,850 hours.
    FDA received 12,556 cancellations of facility registrations during 
2003; 7,467 during 2004; and 1,280 during 2005. Based on this 
experience, FDA estimates the annual number of cancellations will be 
1,300. 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 1,300 hours.
    In cases where a regulation implements a statutory information 
collection requirement, only the additional burden attributable to the 
regulation, if any, has been included in FDA's burden estimate.

    Dated: December 11, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21375 Filed 12-14-06; 8:45 am]
BILLING CODE 4160-01-S