
[Federal Register: May 28, 2010 (Volume 75, Number 103)]
[Notices]               
[Page 30036-30038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my10-94]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0118]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 0910-0520. 
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.

Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002--(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 through 1.282 of FDA's regulations (21 CFR 1.278 
through 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 
under 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.

[[Page 30037]]

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) (Sec.  1.280(a)(2)). 
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) through (a)(1)(iii)). In the event that an 
article of food has been refused admission under section 801(m)(1) or 
placed under hold under section 801(l) of the act, 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.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of 
March 16, 2010 (75 FR 12549), 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 this notice. 
These comments were outside the scope of the four collection of 
information topics on which the notice solicits public comment and, 
thus, will not be addressed here.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
       21 CFR  Section No.              FDA  Form No.         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 through 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 through 1.281              FDA 3540\3\                        21,500                 73          1,569,500               0.37            580,715
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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 and 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) and 1.285(j)            None                                    1                  1                  1               8                     8
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[[Page 30038]]


  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 number 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.
    On November 7, 2008, FDA and CBP issued the prior notice final rule 
(73 FR 66294), which finalized the prior notice interim final rule 
(IFR) (68 FR 58894, October 10, 2003). 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 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 
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 has also reduced its estimate of the hours per response for 
prior notices received through the PN System Interface from 23 minutes 
to 22 minutes. 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 
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: May 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12866 Filed 5-27-10; 8:45 am]
BILLING CODE 4160-01-S

