[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Notices]
[Pages 76344-76347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0202]


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 January 
19, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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--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 to 1.282 of FDA's regulations (21 CFR 1.278 to 
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 Bureau of 
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 already counted in the 
importer's entry notice information collection, 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) to 1.282(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 under

[[Page 76345]]

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 the Federal Register of May 31, 2006 (71 FR 30940), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received two timely letters in response, 
each containing one or more comments. To the extent that the comments 
suggest changes to the requirements of the prior notice interim final 
rule (21 CFR Part 1, subpart I), such a request is outside the scope of 
the four collection of information topics on which the notice solicits 
comments and, thus, will not be addressed here. The interim final rule 
established a 75-day comment period. In order to ensure that those 
commenting on the interim final rule had the benefit of FDA's outreach 
and educational efforts and had experience with the systems, 
timeframes, and data elements of the prior notice system, FDA reopened 
the comment period for 30 days on April 14, 2004 (69 FR 19763), and for 
an additional 60 days on May 18, 2004 (69 FR 28060), for a total of 165 
days. The prior notice final rule currently is being developed and will 
publish in the near future. The agency's responses to the comments 
received in response to the 60-day notice published May 31, 2006, 
reference provisions found in the prior notice interim final rule and 
will not address any changes being considered for the final rule.
    (Comment) One comment stated that prior notice information provided 
to FDA has no practical utility for goods transshipped through the 
United States, from one point in Canada to another point in Canada, 
when the goods are shipped by a Customs-Trade Partnership Against 
Terrorism (C-TPAT) or Partners In Protection (PIP) certified exporter, 
and carried by a C-TPAT certified carrier, with a C-TPAT approved bolt 
seal on the container. The comment argued that because these goods do 
not enter U.S. commerce and the parties responsible for the goods (the 
exporter and carrier) are classified as ``low risk,'' the shipments 
have already been determined to be ``low risk,'' and thus, prior notice 
review by FDA is not necessary and the prior notice information 
provided to FDA has no practical utility. The comment also noted that 
Free and Secure Trade (FAST) approved drivers are now accepted by the 
U.S. Department of Homeland Security for the transportation of 
dangerous goods (including explosives) into and through the United 
States and argued that FAST approved drivers for shipments of food 
products transshipped through the United States should make it 
unnecessary to provide prior notice information for the shipment.
    (Response) FDA does not agree that obtaining prior notice 
information is unnecessary if shipments can be characterized as ``low 
risk.'' Prior notice is a statutory requirement under section 801(m) of 
the act. As explained in the prior notice interim final rule, section 
801(m) of the act applies to all food imported or offered for import 
into the United States except as outlined in 21 CFR 1.277(b) (68 FR 
58974 at 58993), including ``low-risk'' shipments.
    (Comment) Another comment asserted that transhipments, including 
both those originating in Canada and entering the United States for 
purposes of export to a third country, as well as Canadian shipments 
routed through the United States and returned to Canada, are 
transported under bond and information about the transshipments is 
entered in ABI/ACS. This comment further asserted that ABI/ACS captures 
the information necessary to identify transhipments that may pose a 
risk as defined by FDA. The comment suggested that it would minimize 
the burden of the collection of information if exporters of 
transhipments through the United States would be required to provide 
only the information originally required in ABI/ACS and not be required 
to enter additional information for FDA prior notice purposes.
    (Response) FDA disagrees. ABI/ACS information submitted during 
entry cannot substitute for the submission of prior notice because it 
does not meet the requirements of the Bioterrorism Act, such as 
providing FDA with certain specified information before the food 
arrives in the United States. As we explained in the prior notice 
interim final rule, entry may be made up to 15 days after a food 
arrives in the United States and does not contain all of the 
information required in a prior notice, such as the country from which 
the article is shipped (68 FR 58974 at 58975-58976). The information in 
a prior notice is necessary for FDA to determine whether it should 
examine the food at the U.S. port of arrival. Moreover, the comment 
implies that these shipments should be exempt from prior notice 
requirements because the shipments are under strict CBP control and are 
secured by a bond, i.e., that these shipments are low-risk. As we 
explained previously, section 801(m) of the act requires prior notice 
for all food imported or offered for import into the United States 
except as outlined in 21 CFR 1.277(b). FDA notes, however, the policy 
established in the March 2005 revision to the prior notice interim 
final rule CPG, which addresses imported food arriving from and exiting 
to the same country. It describes the situations and conditions under 
which FDA and CBP should typically consider not taking regulatory 
action despite the fact that prior notice is not submitted.
    (Comment) One comment noted that ``Standard Manifest'' data 
elements must be transmitted to CBP prior to arrival in order to clear 
a regular shipment, and the ``Preferred Manifest'' data elements must 
be transmitted to CBP in order to clear a low risk FAST/C-TPAT 
shipment. In addition to these CBP transmissions, a separate prior 
notice transmission to FDA, with a different data set, is required to 
meet the prior notice requirements. The comment suggested that, to 
minimize the burden of the collection of information on respondents, 
FDA and CBP should work together to develop integrated data elements 
for both regular and FAST/C-TPAT shipments which would meet both FDA 
and CBP requirements, and the information required should be submitted 
once and then transferred to the other agency as required.
    (Response) FDA disagrees. FDA's Bioterrorism Act and CBP's Trade 
Act of 2002 have different statutory requirements. For example under 
section 801(m) of the act, FDA, not CBP, must receive prior notice. In 
implementing these laws, the agencies require different information and 
use different targeting and screening tools. FDA and CBP have discussed 
interfacing with the Automated Manifest System (AMS) (the module of ACS 
through which carriers, port authorities, or service bureaus transmit 
electronically the cargo declaration portion of the inward foreign 
manifest to CBP) for manifest data and determined that the general 
cargo data in AMS are not suitable to accommodate the detailed 
information requirements of section 801(m) of the act. For example, AMS 
does not collect the country of origin. In addition, its collection of 
the identities of the article of food and its manufacturer differs from 
the way those are collected under the prior notice interim final and 
final rules in such a way that the data would not meet our needs in 
carrying out the purpose of section 801(m) of the act. Therefore, the 
information collection burden may not necessarily be reduced as the 
comment suggests because manifest data could

[[Page 76346]]

not substitute for certain prior notice requirements.
    (Comment) Another comment suggested that both the FDA and CBP 
systems be simplified to more efficiently enter data that are common to 
all products in the shipment. For instance, information such as 
importer and shipper, which is common to all products in a shipment, 
should only need to be entered once.
    (Response) The Bioterrorism Act requires notice for each article of 
food and requires in that notice, for each article of food, certain 
information. As stated in the interim final rule, an ``article'' refers 
to a single food that is associated with the same complete FDA Product 
Code, the same package size, and the same manufacturer or grower (68 FR 
58974 at 59003). This is consistent with how entry is filed with CBP. 
An article of food is a unique item related to a specific manufacturer 
or grower and a specific process or size. All of these pieces of 
information are critical for a risk-based assessment of the food. The 
ABI/ACS system provides the capability to submit information for 
multiple food items as lines in a single entry, when entry level 
information is consistent for a number of articles in a shipment. For 
example, shipment level information, such as estimated time of arrival, 
can be captured once for all articles within a shipment. The ability to 
minimize data entry by copying specific information from one article, 
or line, to another depends upon the sophistication of the software 
being used by the submitter to create the submission to CBP. The FDA PN 
System Interface allows for simplified submission of similar articles 
of food by allowing the submitter to easily repeat common information 
(e.g., FDA product code, manufacturer, etc.) while entering different 
quantities (e.g., amount and package size). Both systems thus 
significantly reduce the amount of repetitive entry.
    FDA estimates the burden for 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 Respondent        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 to 1.281                                                None           6,500                949.50       6,171,750           0.167    1,030,682\2\
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Prior Notice submitted through PN System Interface
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1.280 to 1.281                                         FDA 3540\3\         214,400                  8.33       1,785,952           0.384         685,806
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New Prior Notice Submissions Subtotal                                                                                                          1,716,488
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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                  3.34          21,710            0.25           5,428
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Prior Notice cancelled through PN System Interface
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1.282 and 1.283(a)(5)                                     FDA 3540         214,400                  0.31          66,464            0.25          16,616
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Prior Notice Cancellations Subtotal                                                                                                               22,044
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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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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                                                                                                                           1,738,541
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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.
    FDA received 282,244 prior notices through ABI/ACS during December 
2003; 6,865,722 during 2004; and 6,171,939 during 2005. Based on this 
experience, FDA estimates that approximately 6,500 users of ABI/ACS 
will submit an average of 949.5 prior notices annually, for a total of 
6,171,750 prior notices received annually through ABI/ACS. FDA 
estimates the reporting burden for a prior notice submitted through 
ABI/ACS to be 10 minutes, or 0.167 hours, per notice, for a total 
burden of 1,030,682 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 35,308 prior notices through the PN System Interface 
during December 2003; 1,425,825 during 2004; and 1,786,896 during 2005. 
Based on this experience, FDA estimates that

[[Page 76347]]

approximately 214,400 registered users of the PN System Interface will 
submit an average of 8.33 prior notices annually, for a total of 
1,785,952 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 23 minutes, or 0.384 
hours, per notice, for a total burden of 685,806 hours.
    FDA received no cancellations of prior notices through ABI/ACS 
during December 2003; 16,624 during 2004; and 21,720 during 2005. Based 
on this experience, FDA estimates that approximately 6,500 users of 
ABI/ACS will submit an average of 3.34 cancellations annually, for a 
total of 21,710 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 5,428 hours.
    FDA received 1,539 cancellations of prior notices through the PN 
System Interface during December 2003; 64,918 during 2004; and 65,491 
during 2005. Based on this experience, FDA estimates that approximately 
214,400 registered users of the PN System Interface will submit an 
average of 0.31 cancellations annually, for a total of 66,464 
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 16,616 hours.
    FDA has not received any requests for review under Sec. Sec.  
1.283(d) or 1.285(j) in the last 3 years (December 2003 through 2005); 
therefore, the agency estimates no more than one request 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 (December 2003 through 2005); therefore, the agency 
estimates no more than one post-hold submission 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.
    In cases where a regulation implements a statutory information 
collection requirement, only the additional burden attributable to the 
regulation, if any, has been included in FDA's burden estimate.

    Dated: December 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21737 Filed 12-19-06; 8:45 am]
BILLING CODE 4160-01-S