Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 12549-12552 [2010-5655]
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12549
Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR
Section
FDA Form No.
No. of
Respondents
Annual Frequency
per Respondent
Total Annual
Responses
Hours
per Response
Total Hours
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
1 There
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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
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
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0118]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prior Notice of
Imported Food 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
FDA’s regulations requiring that the
agency receive prior notice before food
is imported or offered for import into
the United States.
DATES: Submit written or electronic
comments on the collection of
information by May 17, 2010.
ADDRESSES: Submit electronic
comments on the collection of
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information to https://
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.
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.
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SUPPLEMENTARY INFORMATION:
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Prior Notice of Imported Food Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.278 to
1.285 (OMB Control Number 0910–
0520)—Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 801(m) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 381(m)), which
requires that FDA receive prior notice
for food, including food for animals,
that is imported or offered for import
into the United States. Sections 1.278,
1.279, 1.280, 1.281, and 1.282 of FDA’s
regulations (21 CFR 1.278, 1.279, 1.280,
1.281, 1.282) set forth the requirements
for submitting prior notice; §§ 1.283(d)
and 1.285(j) (21 CFR 1.283(d) and
1.285(j)) set forth the procedure for
requesting FDA review after an article of
food has been refused admission under
section 801(m)(1) of the act or placed on
hold under section 801(l) of the act; and
§ 1.285(i) (21 CFR 1.285(i)) sets forth the
procedure for post-hold submissions.
Advance notice of imported food allows
FDA, with the support of the U.S.
Customs and Border Protection (CBP), to
target import inspections more
effectively and help protect the nation’s
food supply against terrorist acts and
other public health emergencies. Any
person with knowledge of the required
information may submit prior notice for
an article of food. Thus, the respondents
to this information collection may
include importers, owners, ultimate
consignees, shippers, and carriers.
FDA’s regulations require that prior
notice of imported food be submitted
electronically using CBP’s Automated
Broker Interface of the Automated
Commercial System (ABI/ACS)
(§ 1.280(a)(1)) or the FDA Prior Notice
(PN) System Interface (Form FDA 3540).
The term ‘‘Form FDA 3540’’ refers to the
electronic system known as the FDA PN
System Interface, which is available at
https://www.access.fda.gov. Prior notice
must be submitted electronically using
either ABI/ACS or the FDA PN System
Interface. Information collected by FDA
in the prior notice submission includes:
The submitter and transmitter (if
different from the submitter); entry type
and CBP identifier; the article of food,
including complete FDA product code;
the manufacturer, for an article of food
no longer in its natural state; the grower,
if known, for an article of food that is
in its natural state; the FDA Country of
Production; the shipper, except for food
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imported by international mail; the
country from which the article of food
is shipped or, if the food is imported by
international mail, the anticipated date
of mailing and country from which the
food is mailed; the anticipated arrival
information or, if the food is imported
by international mail, the U.S. recipient;
the importer, owner, and ultimate
consignee, except for food imported by
international mail or transshipped
through the United States; the carrier
and mode of transportation, except for
food imported by international mail;
and planned shipment information,
except for food imported by
international mail (§ 1.281).
Much of the information collected for
prior notice is identical to the
information collected for FDA’s
importer’s entry notice, which has been
approved under OMB control number
0910–0046. The information in FDA’s
importer’s entry notice is collected
electronically via CBP’s ABI/ACS at the
same time the respondent files an entry
for import with CBP. To avoid doublecounting the burden hours are already
accounted for in the importer’s entry
notice information collection, and the
burden hour analysis in table 1 of this
document reflects the reduced burden
for prior notice submitted through ABI/
ACS in the column labeled ‘‘Hours per
Response.’’
In addition to submitting a prior
notice, a submitter should cancel a prior
notice and must resubmit the
information if information changes after
FDA has confirmed a prior notice
submission for review (e.g., if the
identity of the manufacturer changes)
(§ 1.282). However, changes in the
estimated quantity, anticipated arrival
information, or planned shipment
information do not require resubmission
of prior notice after FDA has confirmed
a prior notice submission for review
(§ 1.282(a)(1)(i), (a)(1)(ii), and (a)(1)(iii)).
In the event that an article of food has
been refused admission under section
801(m)(1) of the act or placed on hold
under section 801(l), §§ 1.283(d) and
1.285(j) set forth the procedure for
requesting FDA review and the
information required to be included in
a request for review. In the event that an
article of food has been placed under
hold under section 801(l) of the act,
§ 1.285(i) sets forth the procedure for
and the information to be included in a
post-hold submission.
FDA estimates the burden of this
collection of information as follows:
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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
Prior Notice Submissions
Prior Notice submitted through ABI/ACS
1.280, 1.281
6,500
1,290
8,385,000
0.15
1,257,7502
21,500
None
73
1,569,500
0.37
580,7152
Prior Notice submitted through PN System Interface
FDA 35403
1.280, 1.281
New Prior Notice Submissions Subtotal
1,838,465
Prior Notice Cancellations
Prior Notice cancelled through ABI/ACS
1.282
FDA 3540
6,500
3
19,500
0.25
4,875
21,500
3
64,500
0.25
16,125
Prior Notice cancelled through PN System Interface
1.282,
1.283(a)(5)
FDA 3540
Prior Notice Cancellations Subtotal
21,000
Prior Notice Requests for Review and Post-hold Submissions
1.283(d),
1.285(j)
None
1
1
1
8
8
1.285(i)
None
1
1
1
1
1
Prior Notice Requests for Review and Post-hold Submissions Subtotal
9
Total Hours Annually
1,859,474
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer’s Entry Notice information collection approved under OMB Control No. 0910–0046 are not included in this total.
3 The term ‘‘Form FDA 3540’’ refers to the electronic system known as the FDA PN System Interface, which is available at https://
www.access.fda.gov.
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2 To
This estimate is based on FDA’s
experience and the average number of
prior notice submissions, cancellations,
and requests for review received in the
past 3 years.
In the Federal Register of November
7, 2008 (73 FR 66294), FDA and CBP
issued the prior notice final rule, which
finalized the prior notice interim final
rule (IFR) (October 10, 2003, 68 FR
58974)). From the IFR to the final rule,
FDA removed a few of the required
prior notice data elements. Specifically,
submitters no longer need to include the
fax number of the submitter and
transmitter, the anticipated border
crossing, the country of the carrier, or
the 6-digit HTS code in their prior
notices. Other changes include the
addition of the registration number of
the transshipper for articles of food for
transshipment, storage and export, or
manipulation and export; flexibility in
submitting the registration number and
the city and country of the manufacturer
and shipper instead of full addresses of
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these entities; and the option of
submitting the tracking number for
articles of food arriving by express
consignment instead of anticipated
arrival information when the prior
notice is submitted through the PN
System Interface (73 FR 66294 at
66402). Accordingly, FDA has reduced
its estimate of the hours per response for
prior notices received through ABI/ACS
from 10 minutes, or 0.167 hours, per
notice, to 9 minutes, or 0.15 hours, per
notice. FDA has also reduced its
estimate of the hours per response for
prior notices received through the PN
System Interface from 23 minutes, or
0.384 hours, per notice, to 22 minutes,
or 0.366 hours (rounded to 0.37 hours),
per notice.
FDA received 8,144,419 prior notices
through ABI/ACS during 2007;
8,266,200 during 2008; and 5,221,549 as
of August 26, 2009. Based on this
experience, FDA estimates that
approximately 6,500 users of ABI/ACS
will submit an average of 1,290 prior
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notices annually, for a total of 8,385,000
prior notices received annually through
ABI/ACS. FDA estimates the reporting
burden for a prior notice submitted
through ABI/ACS to be 9 minutes, or
0.15 hours, per notice, for a total burden
of 1,257,750 hours. This estimate takes
into consideration the burden hours
already counted in the information
collection approval for FDA’s importer’s
entry notice, as previously discussed in
this document.
FDA received 1,744,287 prior notices
through the PN System Interface during
2007; 1,662,033 during 2008; and
989,708 as of August 26, 2009. Based on
this experience, FDA estimates that
approximately 21,500 registered users of
the PN System Interface will submit an
average of 73 prior notices annually, for
a total of 1,569,500 prior notices
received annually through the PN
System Interface. FDA estimates the
reporting burden for a prior notice
submitted through the PN System
Interface to be 22 minutes, or 0.366
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sroberts on DSKD5P82C1PROD with NOTICES
hours (rounded to 0.37 hours), per
notice 22 minutes, or 0.366 hours
(rounded to 0.37 hours), per notice, for
a total burden of 580,715 hours.
FDA received 16,215 cancellations of
prior notices through ABI/ACS during
2007; 16,673 during 2008; and 16,045 as
of August 26, 2009. Based on this
experience, FDA estimates that
approximately 6,500 users of ABI/ACS
will submit an average of 2.64 (rounded
to 3) cancellations annually, for a total
of 19,500 cancellations received
annually through ABI/ACS. FDA
estimates the reporting burden for a
cancellation submitted through ABI/
ACS to be 15 minutes, or 0.25 hours, per
cancellation, for a total burden of 4,875
hours.
FDA received 58,345 cancellations of
prior notices through the PN System
Interface during 2007; 63,779 during
2008; and 55,019 as of August 26, 2009.
Based on this experience, FDA estimates
that approximately 21,500 registered
users of the PN System Interface will
submit an average of 3.24 (rounded to 3)
cancellations annually, for a total of
64,500 cancellations received annually
through the PN System Interface. FDA
estimates the reporting burden for a
cancellation submitted through the PN
System Interface to be 15 minutes, or
0.25 hours, per cancellation, for a total
burden of 16,125 hours.
FDA has not received any requests for
review under §§ 1.283(d) or 1.285(j) in
the last 3 years (2007 through August
26, 2009); therefore, the agency
estimates that one or fewer requests for
review will be submitted annually. FDA
estimates that it will take a requestor
about 8 hours to prepare the factual and
legal information necessary to prepare a
request for review. Thus, FDA has
estimated a total reporting burden of 8
hours.
FDA has not received any post-hold
submissions under § 1.285(i) in the last
3 years (2007 through August 26, 2009);
therefore, the agency estimates that one
or fewer post-hold submissions will be
submitted annually. FDA estimates that
it will take about 1 hour to prepare the
written notification described in
§ 1.285(i)(2)(i). Thus, FDA has estimated
a total reporting burden of 1 hour.
Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–5655 Filed 3–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0124]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Requirements
Under the Comprehensive Smokeless
Tobacco Health Education Act of 1986,
as amended by the Family Smoking
Prevention and Tobacco Control Act
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information pertaining
to the submission of smokeless tobacco
rotational warning plans under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986 (the
Smokeless Tobacco Act), as amended by
the Family Smoking Prevention and
Tobacco Control Act (the Tobacco
Control Act).
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 https://
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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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
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.
Requirements under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
amended by the Family Smoking
Prevention and Tobacco Control Act
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Smokeless
Tobacco Act (15 U.S.C. 4402), as
amended by section 204 of the Tobacco
Control Act, requires that
manufacturers, packagers, importers,
distributors, and retailers (in limited
circumstances) of smokeless tobacco
products include one of four specified
health warning label statements on
product packages and in
advertisements.1 The Smokeless
Tobacco Act, as amended, also requires
smokeless tobacco product
manufacturers, importers, distributors,
and certain retailers to submit a plan to
FDA specifying the method to rotate,
display, and distribute the specified
health warning label statements
1 The warnings themselves disclose information
completely supplied by the Federal Government. As
such, the disclosure does not constitute a
‘‘collection of information’’ as it is defined in the
regulations implementing the PRA, nor, by
extension, do the financial resources expended in
relation to it constitute paperwork ‘‘burden.’’ See 5
CFR 1320.3(c)(2).
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[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12549-12552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5655]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0118]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prior Notice of Imported Food 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 FDA's regulations requiring that the agency receive prior
notice before food is imported or offered for import into the United
States.
DATES: Submit written or electronic comments on the collection of
information by May 17, 2010.
ADDRESSES: Submit electronic comments on the collection of
[[Page 12550]]
information to https://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.
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.278 to
1.285 (OMB Control Number 0910-0520)--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) added section 801(m) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(m)),
which requires that FDA receive prior notice for food, including food
for animals, that is imported or offered for import into the United
States. Sections 1.278, 1.279, 1.280, 1.281, and 1.282 of FDA's
regulations (21 CFR 1.278, 1.279, 1.280, 1.281, 1.282) set forth the
requirements for submitting prior notice; Sec. Sec. 1.283(d) and
1.285(j) (21 CFR 1.283(d) and 1.285(j)) set forth the procedure for
requesting FDA review after an article of food has been refused
admission under section 801(m)(1) of the act or placed on hold under
section 801(l) of the act; and Sec. 1.285(i) (21 CFR 1.285(i)) sets
forth the procedure for post-hold submissions. Advance notice of
imported food allows FDA, with the support of the U.S. Customs and
Border Protection (CBP), to target import inspections more effectively
and help protect the nation's food supply against terrorist acts and
other public health emergencies. Any person with knowledge of the
required information may submit prior notice for an article of food.
Thus, the respondents to this information collection may include
importers, owners, ultimate consignees, shippers, and carriers.
FDA's regulations require that prior notice of imported food be
submitted electronically using CBP's Automated Broker Interface of the
Automated Commercial System (ABI/ACS) (Sec. 1.280(a)(1)) or the FDA
Prior Notice (PN) System Interface (Form FDA 3540). The term ``Form FDA
3540'' refers to the electronic system known as the FDA PN System
Interface, which is available at https://www.access.fda.gov. Prior
notice must be submitted electronically using either ABI/ACS or the FDA
PN System Interface. Information collected by FDA in the prior notice
submission includes: The submitter and transmitter (if different from
the submitter); entry type and CBP identifier; the article of food,
including complete FDA product code; the manufacturer, for an article
of food no longer in its natural state; the grower, if known, for an
article of food that is in its natural state; the FDA Country of
Production; the shipper, except for food imported by international
mail; the country from which the article of food is shipped or, if the
food is imported by international mail, the anticipated date of mailing
and country from which the food is mailed; the anticipated arrival
information or, if the food is imported by international mail, the U.S.
recipient; the importer, owner, and ultimate consignee, except for food
imported by international mail or transshipped through the United
States; the carrier and mode of transportation, except for food
imported by international mail; and planned shipment information,
except for food imported by international mail (Sec. 1.281).
Much of the information collected for prior notice is identical to
the information collected for FDA's importer's entry notice, which has
been approved under OMB control number 0910-0046. The information in
FDA's importer's entry notice is collected electronically via CBP's
ABI/ACS at the same time the respondent files an entry for import with
CBP. To avoid double-counting the burden hours are already accounted
for in the importer's entry notice information collection, and the
burden hour analysis in table 1 of this document reflects the reduced
burden for prior notice submitted through ABI/ACS in the column labeled
``Hours per Response.''
In addition to submitting a prior notice, a submitter should cancel
a prior notice and must resubmit the information if information changes
after FDA has confirmed a prior notice submission for review (e.g., if
the identity of the manufacturer changes) (Sec. 1.282). However,
changes in the estimated quantity, anticipated arrival information, or
planned shipment information do not require resubmission of prior
notice after FDA has confirmed a prior notice submission for review
(Sec. 1.282(a)(1)(i), (a)(1)(ii), and (a)(1)(iii)). In the event that
an article of food has been refused admission under section 801(m)(1)
of the act or placed on hold under section 801(l), Sec. Sec. 1.283(d)
and 1.285(j) set forth the procedure for requesting FDA review and the
information required to be included in a request for review. In the
event that an article of food has been placed under hold under section
801(l) of the act, Sec. 1.285(i) sets forth the procedure for and the
information to be included in a post-hold submission.
FDA estimates the burden of this collection of information as
follows:
[[Page 12551]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submissions
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Prior Notice submitted through ABI/ACS
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1.280, 1.281 None 6,500 1,290 8,385,000 0.15 1,257,750\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice submitted through PN System Interface
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280, 1.281 FDA 3540\3\ 21,500 73 1,569,500 0.37 580,715\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Prior Notice Submissions Subtotal 1,838,465
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Prior Notice Cancellations
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Prior Notice cancelled through ABI/ACS
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1.282 FDA 3540 6,500 3 19,500 0.25 4,875
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Prior Notice cancelled through PN System Interface
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282, 1.283(a)(5) FDA 3540 21,500 3 64,500 0.25 16,125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancellations Subtotal 21,000
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Prior Notice Requests for Review and Post-hold Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.283(d), 1.285(j) None 1 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.285(i) None 1 1 1 1 1
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Prior Notice Requests for Review and Post-hold Submissions Subtotal 9
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Total Hours Annually 1,859,474
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer's Entry Notice information collection approved
under OMB Control No. 0910-0046 are not included in this total.
\3\ The term ``Form FDA 3540'' refers to the electronic system known as the FDA PN System Interface, which is available at https://www.access.fda.gov.
This estimate is based on FDA's experience and the average number
of prior notice submissions, cancellations, and requests for review
received in the past 3 years.
In the Federal Register of November 7, 2008 (73 FR 66294), FDA and
CBP issued the prior notice final rule, which finalized the prior
notice interim final rule (IFR) (October 10, 2003, 68 FR 58974)). From
the IFR to the final rule, FDA removed a few of the required prior
notice data elements. Specifically, submitters no longer need to
include the fax number of the submitter and transmitter, the
anticipated border crossing, the country of the carrier, or the 6-digit
HTS code in their prior notices. Other changes include the addition of
the registration number of the transshipper for articles of food for
transshipment, storage and export, or manipulation and export;
flexibility in submitting the registration number and the city and
country of the manufacturer and shipper instead of full addresses of
these entities; and the option of submitting the tracking number for
articles of food arriving by express consignment instead of anticipated
arrival information when the prior notice is submitted through the PN
System Interface (73 FR 66294 at 66402). Accordingly, FDA has reduced
its estimate of the hours per response for prior notices received
through ABI/ACS from 10 minutes, or 0.167 hours, per notice, to 9
minutes, or 0.15 hours, per notice. FDA has also reduced its estimate
of the hours per response for prior notices received through the PN
System Interface from 23 minutes, or 0.384 hours, per notice, to 22
minutes, or 0.366 hours (rounded to 0.37 hours), per notice.
FDA received 8,144,419 prior notices through ABI/ACS during 2007;
8,266,200 during 2008; and 5,221,549 as of August 26, 2009. Based on
this experience, FDA estimates that approximately 6,500 users of ABI/
ACS will submit an average of 1,290 prior notices annually, for a total
of 8,385,000 prior notices received annually through ABI/ACS. FDA
estimates the reporting burden for a prior notice submitted through
ABI/ACS to be 9 minutes, or 0.15 hours, per notice, for a total burden
of 1,257,750 hours. This estimate takes into consideration the burden
hours already counted in the information collection approval for FDA's
importer's entry notice, as previously discussed in this document.
FDA received 1,744,287 prior notices through the PN System
Interface during 2007; 1,662,033 during 2008; and 989,708 as of August
26, 2009. Based on this experience, FDA estimates that approximately
21,500 registered users of the PN System Interface will submit an
average of 73 prior notices annually, for a total of 1,569,500 prior
notices received annually through the PN System Interface. FDA
estimates the reporting burden for a prior notice submitted through the
PN System Interface to be 22 minutes, or 0.366
[[Page 12552]]
hours (rounded to 0.37 hours), per notice 22 minutes, or 0.366 hours
(rounded to 0.37 hours), per notice, for a total burden of 580,715
hours.
FDA received 16,215 cancellations of prior notices through ABI/ACS
during 2007; 16,673 during 2008; and 16,045 as of August 26, 2009.
Based on this experience, FDA estimates that approximately 6,500 users
of ABI/ACS will submit an average of 2.64 (rounded to 3) cancellations
annually, for a total of 19,500 cancellations received annually through
ABI/ACS. FDA estimates the reporting burden for a cancellation
submitted through ABI/ACS to be 15 minutes, or 0.25 hours, per
cancellation, for a total burden of 4,875 hours.
FDA received 58,345 cancellations of prior notices through the PN
System Interface during 2007; 63,779 during 2008; and 55,019 as of
August 26, 2009. Based on this experience, FDA estimates that
approximately 21,500 registered users of the PN System Interface will
submit an average of 3.24 (rounded to 3) cancellations annually, for a
total of 64,500 cancellations received annually through the PN System
Interface. FDA estimates the reporting burden for a cancellation
submitted through the PN System Interface to be 15 minutes, or 0.25
hours, per cancellation, for a total burden of 16,125 hours.
FDA has not received any requests for review under Sec. Sec.
1.283(d) or 1.285(j) in the last 3 years (2007 through August 26,
2009); therefore, the agency estimates that one or fewer requests for
review will be submitted annually. FDA estimates that it will take a
requestor about 8 hours to prepare the factual and legal information
necessary to prepare a request for review. Thus, FDA has estimated a
total reporting burden of 8 hours.
FDA has not received any post-hold submissions under Sec. 1.285(i)
in the last 3 years (2007 through August 26, 2009); therefore, the
agency estimates that one or fewer post-hold submissions will be
submitted annually. FDA estimates that it will take about 1 hour to
prepare the written notification described in Sec. 1.285(i)(2)(i).
Thus, FDA has estimated a total reporting burden of 1 hour.
Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5655 Filed 3-15-10; 8:45 am]
BILLING CODE 4160-01-S
