[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12549-12552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5655]
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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.
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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 http://www.regulations.gov. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 http://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
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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\
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Prior Notice submitted through PN System Interface
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1.280, 1.281 FDA 3540\3\ 21,500 73 1,569,500 0.37 580,715\2\
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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
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1.282, 1.283(a)(5) FDA 3540 21,500 3 64,500 0.25 16,125
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Prior Notice Cancellations Subtotal 21,000
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Prior Notice Requests for Review and Post-hold Submissions
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1.283(d), 1.285(j) None 1 1 1 8 8
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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 http://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]
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