[Federal Register Volume 71, Number 104 (Wednesday, May 31, 2006)]
[Notices]
[Pages 30940-30942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0202]


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 July 31, 2006.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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 Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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

[[Page 30941]]

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 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) 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.
    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 PNSI
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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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[[Page 30942]]

 
Prior notice cancelled through PNSI
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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 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 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 (December 2003 through 2005); 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.
    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: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8311 Filed 5-30-06; 8:45 am]
BILLING CODE 4160-01-S