[Federal Register: December 15, 2006 (Volume 71, Number 241)]
[Notices]
[Page 75555-75557]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de06-85]
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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
いいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいい
Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a)
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1.234 FDA 3537 92,850 1 92,850 1 92,850
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1.235 FDA 3537a 1,300 1 1,300 1 1,300
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Updates or Cancellations to Existing Registration Subtotal 94,150
いいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいい
Total Hours Annually 376,475
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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 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