Document ID: FDA-2010-N-0119-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act (of 2002)
Posted Date: 2010-03-16T04:00Z

[Federal Register: March 16, 2010 (Volume 75, Number 50)]
[Notices]               
[Page 12547-12549]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr10-61]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of the agency's regulations that require registration for 
domestic and foreign facilities that manufacture, process, pack, or 
hold food for human or animal consumption in the United States.

[[Page 12548]]

DATES: Submit written or electronic comments on the collection of 
information by May 17, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Registration of Food Facilities Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.230-1.235 
(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 1.230-1.235 of FDA's regulations (21 CFR 
1.230-1.235) 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).
    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Annual Frequency     Total Annual        Hours  per
          21 CFR  Section               FDA Form No.     No. of  Respondents    per Respondent       Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12549]]

Domestic
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.230-1.233                                FDA 3537\2\                13,560                  1             13,560                2.5             33,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.230-1.233                                   FDA 3537                23,370                  1             23,370                8.5            198,645
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Facility Registration Subtotal                                                                                                               232,545
--------------------------------------------------------------------------------------------------------------------------------------
Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------
Total Hours Annually                                                                                                                             357,465
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5656 Filed 3-15-10; 8:45 am]
BILLING CODE 4160-01-S