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, 30033-30035 [2010-13003]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices
Number of
respondents
Form
Total ..............................................................................
463
Responses
per
respondents
........................
Total
responses
522,815
Hours per
response
........................
30033
Total burden
hours
278,765.95
* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data system.
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: May 25, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–12964 Filed 5–27–10; 8:45 am]
BILLING CODE 4165–15–P
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Notice.
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
oira_submission@omb.eop.gov. 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
VerDate Mar<15>2010
17:43 May 27, 2010
Jkt 220001
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 (§ 1.231). The term ‘‘Form
FDA 3537’’ refers to both the paper
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
version of the form and the electronic
system known as the Food Facility
Registration Module, which is available
at https://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 § 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 § 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 (§ 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 (§ 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
E:\FR\FM\28MYN1.SGM
28MYN1
30034
Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices
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 BURDEN1
21 CFR
Section
FDA Form No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours
per Response
Total Hours
New Facilities
Domestic
FDA 35372
13,560
1
13,560
2.5
33,900
FDA 3537
1.230–1.233
23,370
1
23,370
8.5
198,645
Foreign
1.230–1.233
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
jlentini on DSKJ8SOYB1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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 https://www.access.fda.gov.
2 The
This estimate is based on FDA’s
experience and the average number of
new facility registrations, updates and
cancellations received in the past 3
VerDate Mar<15>2010
17:43 May 27, 2010
Jkt 220001
years. FDA received 12,681 new
domestic facility registrations during
2006; 14,629 during 2007; and 13,378
during 2008. Based on this experience,
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
FDA estimates the annual number of
new domestic facility registrations will
be 13,560. FDA estimates that listing the
information required by the
E:\FR\FM\28MYN1.SGM
28MYN1
30035
Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices
jlentini on DSKJ8SOYB1PROD with NOTICES
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0120]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Cosmetic Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
DATES: Fax written comments on the
collection of information by June 28,
2010..
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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0599. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
collection of information to OMB for
review and clearance.
Cosmetic Labeling Regulations—(OMB
Control Number 0910–0599)—Extension
The Federal Food, Drug, and Cosmetic
Act (the act) and the Fair Packaging and
Labeling Act (the FPLA) require that
cosmetic manufacturers, packers, and
distributors disclose information about
themselves or their products on the
labels or labeling of their products.
Sections 201, 502, 601, 602, 603, 701,
and 704 of the act (21 U.S.C. 321, 352,
361, 362, 363, 371, and 374) and
sections 4 and 5 of the FPLA (15 U.S.C.
1453 and 1454) provide authority to
FDA to regulate the labeling of cosmetic
products. Failure to comply with the
requirements for cosmetic labeling may
render a cosmetic adulterated under
section 601 of the act or misbranded
under section 602 of the act.
FDA’s cosmetic labeling regulations
are published in part 701 (21 CFR part
701). Four of the cosmetic labeling
regulations have information collection
provisions. Section 701.3 requires the
label of a cosmetic product to bear a
declaration of the ingredients in
descending order of predominance.
Section 701.11 requires the principal
display panel of a cosmetic product to
bear a statement of the identity of the
product. Section 701.12 requires the
label of a cosmetic product to specify
the name and place of business of the
manufacturer, packer, or distributor.
Section 701.13 requires the label of a
cosmetic product to declare the net
quantity of contents of the product.
FDA’s cosmetic labeling regulations
remain unchanged by this notice. FDA
is publishing this notice in compliance
with the PRA. This notice does not
represent any new regulatory initiative.
In the Federal Register of March 16,
2010 (75 FR 12546), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one letter,
containing multiple comments, in
response to the notice. One comment
expressed strong support for the
labeling of cosmetics. Additional
comments were outside the scope of the
four collection of information topics on
which the notice solicits comments and,
thus, will not be addressed here.
FDA estimates the annual burden of
this collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1
21 CFR Section
No. of
Respondents
701.3
VerDate Mar<15>2010
Annual Frequency
of Disclosure
1,518
17:43 May 27, 2010
Jkt 220001
PO 00000
Frm 00069
21
Fmt 4703
Sfmt 4703
Total Annual
Disclosures
Hours per
Disclosure
31,878
E:\FR\FM\28MYN1.SGM
Total Hours
1
28MYN1
31,878
]]>Agencies
[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30033-30035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13003]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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 https://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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 https://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
