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, 76344-76347 [E6-21737]
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76344
Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of Respondents
Part 3
43
1There
BILLING CODE 4160–01–S
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.
Notice.
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.
Fax written comments on the
collection of information by January 19,
2007.
DATES:
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.
ADDRESSES:
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.
sroberts on PROD1PC70 with NOTICES
Total Annual Responses
1
Hours per Response
43
24
Total Hours
1,032
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21636 Filed 12–19–06; 8:45 am]
ACTION:
Annual Frequency per
Response
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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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; §§ 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 § 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)
(§ 1.280(a)(1)) or the FDA Prior Notice
(PN) System Interface (Form FDA 3540)
(§ 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 https://
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
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Fmt 4703
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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 (§ 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 doublecounting 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)
(§ 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
(§ 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
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hold under section 801(l) of the act,
§§ 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, § 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 75day 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
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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
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76345
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/CTPAT 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
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Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices
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 BURDEN1
21 CFR Section No.
FDA Form No.
No. of
Respondents
Annual Frequency
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
Prior Notice Submissions
Prior Notice submitted through ABI/ACS
1.280 to 1.281
None
6,500
949.50
6,171,750
0.167
1,030,6822
214,400
8.33
1,785,952
0.384
685,806
Prior Notice submitted through PN System Interface
FDA 35403
1.280 to 1.281
New Prior Notice Submissions Subtotal
1,716,488
Prior Notice Cancellations
Prior Notice cancelled through ABI/ACS
1.282
FDA 3540
6,500
3.34
21,710
0.25
5,428
214,400
0.31
66,464
0.25
16,616
Prior Notice cancelled through PN System Interface
1.282 and 1.283(a)(5)
FDA 3540
Prior Notice Cancellations Subtotal
22,044
Prior Notice Requests for Review and Post-hold Submissions
1.283(d) and 1.285(j),
None
1
1
1
8
8
1.285(i)
None
1
1
1
1
1
Prior Notice Requests for Review and Post-hold Submissions Subtotal
9
Total Hours Annually
1,738,541
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
3The term ‘‘Form FDA 3540’’ refers to the electronic system known as the FDA PN System Interface, which is available at https://
www.access.fda.gov.
sroberts on PROD1PC70 with NOTICES
2To
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
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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
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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
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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 §§ 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 § 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
§ 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.
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76347
Dated: December 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21737 Filed 12–19–06; 8:45 am]
Because of a greater than anticipated
response for attending the public
workshop, FDA is announcing in this
notice a new location and time.
BILLING CODE 4160–01–S
II. New Location and Time for the
Public Workshop
The new location will be the
Universities at Shady Grove, Conference
Center Auditorium (see ADDRESSES).
Directions and information on parking,
hotels, and transportation options can
be found at https://
www.shadygrove.umd.edu/conference.
The new time will be 8:30 a.m. to 4:30
p.m.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D–0478]
Marketed Unapproved Drugs; Public
Workshop; Change of Meeting
Location and Time
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
change of location and time for the
upcoming public workshop on marketed
unapproved drugs. Registration for the
public workshop is closed. A new
address and time are given for those
persons who have previously registered
with FDA.
DATES: The public workshop will be
held on January 9, 2007, from 8:30 a.m.
to 4:30 p.m.
ADDRESSES: The public workshop will
be held in the Universities at Shady
Grove, Conference Center Auditorium,
bldg. 1, 9640 Gudelsky Dr., Rockville,
MD. Directions and information on
parking, hotels, and transportation
options can be found at https://
www.shadygrove.umd.edu/conference.
The agenda for the workshop will be
posted at https://www.fda.gov/cder/drug/
unapproved_drugs.
FOR FURTHER INFORMATION CONTACT:
Karen Kirchberg, Center for Drug
Evaluation and Research (HFD–330),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–8916, e-mail:
Karen.Kirchberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November
1, 2006 (71 FR 64284), FDA issued a
notice announcing a public workshop
on issues related to the application
process for seeking approval for
marketed unapproved drugs. The
November 1, 2006, notice invited
individuals interested in attending the
workshop to register and submit topics
for discussion by November 15, 2006.
Registration for the workshop is closed.
Attendance at the workshop is limited
to those persons who have previously
registered with FDA.
PO 00000
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Dated: December 14, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21738 Filed 12–19–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Production, Recovery and Purification
Process for Plasmid DNA Clinical
Manufacturing
Description of Technology: Available
for licensing from NIH is a method for
large scale production, recovery, and
purification process for plasmid DNA
manufacturing meeting human clinical
trial requirements. DNA plasmid
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]]>Agencies
[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Notices]
[Pages 76344-76347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21737]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section No. FDA Form No. Respondents per Respondent Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice submitted through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280 to 1.281 None 6,500 949.50 6,171,750 0.167 1,030,682\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice submitted through PN System Interface
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280 to 1.281 FDA 3540\3\ 214,400 8.33 1,785,952 0.384 685,806
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Prior Notice Submissions Subtotal 1,716,488
-----------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancellations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice cancelled through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282 FDA 3540 6,500 3.34 21,710 0.25 5,428
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice cancelled through PN System Interface
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282 and 1.283(a)(5) FDA 3540 214,400 0.31 66,464 0.25 16,616
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancellations Subtotal 22,044
-----------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Requests for Review and Post-hold Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.283(d) and 1.285(j), None 1 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.285(i) None 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Requests for Review and Post-hold Submissions Subtotal 9
-----------------------------------------------------------------------------------------------------------------------------------------
Total Hours Annually 1,738,541
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://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
