[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 [email protected]. 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\
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Annual Frequency Total Annual Hours per
21 CFR Section FDA Form No. No. of Respondents per Response Responses Response Total Hours
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New Facilities
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Domestic
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1.230-1.233 FDA 3537\2\ 13,560 1 13,560 2.5 33,900
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Foreign
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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
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1.235 FDA 3537a 6,390 1 6,390 1 6,390
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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