
[Federal Register: March 16, 2010 (Volume 75, Number 50)]
[Notices]               
[Page 12549-12552]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr10-62]                         

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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]
BILLING CODE 4160-01-S

