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, 1349-1352 [2016-32030]
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Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
Consultation Policy issued in February
2016.
For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
ADDRESSES:
II. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/tribal or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
document.
Dated: December 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31951 Filed 1–4–17; 8:45 am]
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FOR FURTHER INFORMATION CONTACT:
Sarah Walinsky, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, (240)
402–4075.
SUPPLEMENTARY INFORMATION:
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Under Executive Order 13175 of
November 6, 2000, executive
departments and Agencies are charged
with engaging in regular and meaningful
consultation and collaboration with
Indian tribal governments in the
development of Federal policies that
have tribal implications and are
responsible for strengthening the
government-to-government relationship
between the United States and Indian
Tribes. The HHS Tribal Consultation
Policy, revised on December 14, 2010,
further clarifies that each HHS
Operating and Staff Division must have
an accountable consultation process to
ensure meaningful and timely input by
tribal officials in the development of
policies that have tribal implications.
The FDA Tribal Consultation Policy,
which finalizes the draft FDA Tribal
Consultation Policy issued in February
2016, is based on the HHS Tribal
Consultation Policy and includes
Agency-specific consultation guidelines
that complement the Department-wide
efforts.
The purpose of the FDA Tribal
Consultation Policy is to further the
government-to-government relationship
between FDA and Indian Tribes and
facilitate tribal consultation with FDA.
The policy provides background on
FDA’s mission and organizational
structure and elaborates on the
principles and guidelines in the HHS
Tribal Consultation Policy. We
consulted with Indian Tribes on the
FDA Tribal Consultation Policy, which
is intended to serve as a platform for the
Agency to create consistent and
meaningful tribal consultation across
FDA Centers and Offices. A copy of the
final policy has also been shared with
Indian Tribes in a letter to tribal leaders.
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Food and Drug Administration
[Docket No. FDA–2010–N–0118]
I. Background
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
The Food and Drug
Administration (FDA or the Agency) 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 regulations
requiring that the Agency receives prior
notice before food is imported or offered
for import into the United States.
DATES: Submit either electronic or
written comments on the collection of
information by March 6, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
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1349
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0118 for ‘‘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.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
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
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of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Prior Notice of Imported Food Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.278 to
1.285
OMB Control Number 0910–0520—
Revision
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
(FD&C Act) (21 U.S.C. 381(m)), which
requires that FDA receives 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 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
the Agency review after FDA has
refused admission of an article of food
under section 801(m)(1) of the FD&C
Act or placed an article of food under
hold under section 801(l) of the FD&C
Act; and § 1.285(i) sets forth the
procedure for post-hold submissions.
Section 304 of the FDA Food Safety
Modernization Act (FSMA) (Pub. L.
111–353) amended section 801(m) of the
FD&C Act to require a person submitting
prior notice of imported food, including
food for animals, to report, in addition
to other information already required,
‘‘any country to which the article has
been refused entry.’’
Advance notice of imported food
allows FDA, with the support of the
U.S. Customs and Border Protection
(CBP), to target import inspections more
effectively and help protect the nation’s
food supply against terrorist acts and
other public health emergencies. By
requiring that a prior notice contain
additional information that indicates
prior refusals by any country and also
identifies the country or countries, the
Agency may better identify imported
food shipments that may pose safety
and security risks to U.S. consumers.
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This additional knowledge can further
help FDA to make better informed
decisions in managing the potential
risks of imported food shipments into
the United States.
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 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
System Interface (PNSI) (Form FDA
3540) (§ 1.280(a)(2)). PNSI is an
electronic submission system available
on the FDA Industry Systems page at
https://www.access.fda.gov/. Information
the Agency collects in the prior notice
submission includes: (1) The submitter
and transmitter (if different from the
submitter); (2) entry type and CBP
identifier; (3) the article of food,
including complete FDA product code;
(4) the manufacturer, for an article of
food no longer in its natural state; (5)
the grower, if known, for an article of
food that is in its natural state; (6) the
FDA Country of Production; (7) the
name of any country that has refused
entry of the article of food; (8) the
shipper, except for food imported by
international mail; (9) 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;
(10) the anticipated arrival information
or, if the food is imported by
international mail, the U.S. recipient;
(11) the importer, owner, and ultimate
consignee, except for food imported by
international mail or transshipped
through the United States; (12) the
carrier and mode of transportation,
except for food imported by
international mail; and (13) 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
importer’s entry notice, which has been
approved under OMB control number
0910–0046. The information in an
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 reflects FDA’s
estimate of the reduced burden for prior
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the estimated quantity, anticipated
arrival information, or planned
shipment information do not require
resubmission of prior notice after the
Agency has confirmed a prior notice
submission for review (§ 1.282(a)(1)(i) to
(iii)). In the event that FDA refuses
admission to an article of food under
section 801(m)(1) or the Agency places
it under hold under section 801(l) of the
FD&C Act, §§ 1.283(d) and 1.285(j) (21
notice submitted through ABI/ACS in
column 6, entitled ‘‘Average Burden per
Response.’’
In addition to submitting a prior
notice, a submitter should cancel a prior
notice and must resubmit the
information to FDA if information
changes after the Agency has confirmed
a prior notice submission for review
(e.g., if the identity of the manufacturer
changes) (§ 1.282). However, changes in
1351
CFR 1.283(d) and 1.285(j)) set forth the
procedure for requesting FDA’s review
and the information required in a
request for review. In the event that the
Agency places an article of food under
hold under § 801(l) of the FD&C Act,
§ 1.285(i) sets forth the procedure for,
and the information to be included in,
a post-hold submission.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section No.
FDA Form No.
Number of
responses per
respondent
Number of
respondents
Average burden per
response
(hours)
Total annual
responses
Total hours
Prior Notice Submissions
Prior Notice Submitted Through ABI/ACS
1.280–1.281 .................................
None
1,700
7647
12,999,900
0.167 (10 minutes) ....
2 2,170,983
Prior Notice Submitted Through PNSI
1.280–1.281 .................................
3 3540
27,000
70
1,890,000
0.384 (23 minutes) ....
725,760
New Prior Notice Submissions Subtotal.
........................
........................
........................
........................
....................................
2,896,743
7,040
0.25 (15 minutes) ......
1760
Prior Notice Cancellations
Prior Notice Cancelled Through ABI/ACS
1.282 ............................................
3540
7,040
1
Prior Notice Cancelled Through PNSI
1.282, 1.283(a)(5) ........................
Prior Notice
Subtotal.
Cancellations
3540
35,208
1
35,208
0.25 (15 minutes) ......
8,802
........................
........................
........................
........................
....................................
10,562
Prior Notice Requests for Review and Post-Hold Submissions
1.283(d), 1.285(j), ........................
None
1
1
1
8 ................................
8
1.285(i) .........................................
None
263
1
263
1 ................................
263
Prior Notice Requests for
Review and Post-Hold
Submissions Subtotal.
........................
........................
........................
........................
....................................
271
Total ..............................................................................................................................................................................................
2,907,576
1 There
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.
3 The term ‘‘Form FDA 3540’’ refers to the electronic submission system known as PNSI, which is available at https://www.access.fda.gov.
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2 To
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 10,450,824 prior notices
through ABI/ACS during 2014;
11,282,015 during 2015; and 12,153,880
during 2016. Based on this experience,
the Agency estimates that
approximately 1,700 users of ABI/ACS
will submit an average of 7,647 prior
notices annually, for a total of
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12,999,900 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 hour, per
notice, for a total burden of 2,170,983
hours. This estimate takes into
consideration the burden hours already
counted in the information collection
approval for FDA importer’s entry
notice (OMB control number 0910–
0046), as previously discussed.
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FDA received 1,529,110 prior notices
through PNSI during 2014; 1,633,567
during 2015; and 1,768,790 during 2016.
Based on this experience, the Agency
estimates that approximately 27,000
registered users of PNSI will submit an
average of 70 prior notices annually, for
a total of 1,890,000 prior notices
received annually. FDA estimates the
reporting burden for a prior notice
submitted through PNSI to be 23
minutes, or 0.384 hour, per notice, for
a total burden of 725,760 hours.
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FDA received 7,265 cancellations of
prior notices through ABI/ACS during
2014; 7,910 during 2015; and 5,948
during 2016. Based on this experience,
the Agency estimates that
approximately 7,040 users of ABI/ACS
will submit an average of 1 cancellation
annually, for a total of 7,040
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 hour, per cancellation, for a total
burden of 1,760 hours.
FDA received 36,324 cancellations of
prior notices through PNSI during 2014;
39,553 during 2015; and 29,743 during
2016. Based on this experience, the
Agency estimates that approximately
35,208 registered users of PNSI will
submit an average of 1 cancellation
annually, for a total of 35,208
cancellations received annually. FDA
estimates the reporting burden for a
cancellation submitted through PNSI to
be 15 minutes, or 0.25 hour, per
cancellation, for a total burden of 8,802
hours.
FDA has not received any requests for
review under § 1.283(d) or § 1.285(j) in
the last 3 years; 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, the Agency
has estimated a total reporting burden of
8 hours.
FDA received 235 post-hold
submissions under § 1.285(i) during
2014; 218 during 2015; and 337 during
2016. Based on this experience, the
Agency estimates that 263 post-hold
submissions under § 1.285(i) 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, the Agency
estimates a total reporting burden of 263
hours.
Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; The National Health Service
Corps Loan Repayment Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA has
submitted an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than February 6, 2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The National Health Service Corps Loan
Repayment Program.
OMB No. 0915–0127 Revision.
Abstract: The National Health Service
Corps (NHSC) Loan Repayment Program
(LRP) was established to assure an
adequate supply of trained primary care
health professionals to provide services
in the neediest Health Professional
Shortage Areas (HPSAs) of the United
States. Under this program, the
Department of Health and Human
Services agrees to repay the qualifying
educational loans of selected primary
care health professionals. In return, the
health professionals agree to serve for a
specified period of time in an NHSCapproved site located in a federallydesignated HPSA approved by the
Secretary for LRP participants. The
forms used by the LRP include the
SUMMARY:
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following: The NHSC LRP Application,
the Authorization for Disclosure of Loan
Information form, the Privacy Act
Release Authorization form, and if
applicable, the Verification of
Disadvantaged Background form and the
Private Practice Option form. The first
four of the aforementioned NHSC LRP
forms collect information that is needed
for selecting participants and repaying
qualifying educational loans. The last
referenced form, the Private Practice
Option Form, is needed to collect
information for all participants who
have applied for that service option.
NHSC-approved sites are health care
facilities that provide comprehensive
outpatient, ambulatory, primary health
care services to populations residing in
HPSAs. Related in-patient services may
be provided by NHSC-approved Critical
Access Hospitals (CAHs). To become an
NHSC-approved site, new sites must
submit a Site Application for review
and approval. Existing NHSC-approved
sites are required to complete a Site
Recertification Application to maintain
their NHSC-approved status. Both the
NHSC Site Application and Site
Recertification Application request
information on the clinical service site,
sponsoring agency, recruitment contact,
staffing levels, service users, charges for
services, employment policies, and
fiscal management capabilities.
Assistance in completing these
applications may be obtained through
the appropriate State Primary Care
Offices and HRSA’s NHSC program
office. The information collected on the
applications is used for determining the
eligibility of sites for the assignment of
NHSC health professionals and to verify
the need for NHSC clinicians. NHSC
service site approval is valid for 3 years.
Sites wishing to remain eligible for the
assignment of NHSC providers must
submit a Site Recertification
Application every 3 years.
The proposed ICR is a revision to
OMB control number 0915–0127 (NHSC
LRP) by combining previously approved
OMB number 0915–0230 (NHSC Site
Application and Site Recertification
Application forms) and adding a new
form to the ICR called the NHSC
Comprehensive Behavioral Health
Services Checklist.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to obtain
information that is used to assess an
LRP applicant’s eligibility and
qualifications for the LRP and obtain
information for NHSC site applicants.
Clinicians interested in participating in
the NHSC LRP must submit an
application to the NHSC to participate
in the program, and health care facilities
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]]>Agencies
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1349-1352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-32030]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0118]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) 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 regulations requiring that the
Agency receives prior notice before food is imported or offered for
import into the United States.
DATES: Submit either electronic or written comments on the collection
of information by March 6, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-N-0118 for ``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.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
[[Page 1350]]
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.278 to
1.285
OMB Control Number 0910-0520--Revision
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 (FD&C Act) (21 U.S.C. 381(m)),
which requires that FDA receives 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 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 the Agency review after FDA has
refused admission of an article of food under section 801(m)(1) of the
FD&C Act or placed an article of food under hold under section 801(l)
of the FD&C Act; and Sec. 1.285(i) sets forth the procedure for post-
hold submissions.
Section 304 of the FDA Food Safety Modernization Act (FSMA) (Pub.
L. 111-353) amended section 801(m) of the FD&C Act to require a person
submitting prior notice of imported food, including food for animals,
to report, in addition to other information already required, ``any
country to which the article has been refused entry.''
Advance notice of imported food allows FDA, with the support of the
U.S. Customs and Border Protection (CBP), to target import inspections
more effectively and help protect the nation's food supply against
terrorist acts and other public health emergencies. By requiring that a
prior notice contain additional information that indicates prior
refusals by any country and also identifies the country or countries,
the Agency may better identify imported food shipments that may pose
safety and security risks to U.S. consumers. This additional knowledge
can further help FDA to make better informed decisions in managing the
potential risks of imported food shipments into the United States.
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 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 System Interface (PNSI) (Form FDA 3540) (Sec.
1.280(a)(2)). PNSI is an electronic submission system available on the
FDA Industry Systems page at https://www.access.fda.gov/. Information
the Agency collects in the prior notice submission includes: (1) The
submitter and transmitter (if different from the submitter); (2) entry
type and CBP identifier; (3) the article of food, including complete
FDA product code; (4) the manufacturer, for an article of food no
longer in its natural state; (5) the grower, if known, for an article
of food that is in its natural state; (6) the FDA Country of
Production; (7) the name of any country that has refused entry of the
article of food; (8) the shipper, except for food imported by
international mail; (9) 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;
(10) the anticipated arrival information or, if the food is imported by
international mail, the U.S. recipient; (11) the importer, owner, and
ultimate consignee, except for food imported by international mail or
transshipped through the United States; (12) the carrier and mode of
transportation, except for food imported by international mail; and
(13) 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 importer's entry notice, which has
been approved under OMB control number 0910-0046. The information in an
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 reflects FDA's estimate of the reduced burden for
prior
[[Page 1351]]
notice submitted through ABI/ACS in column 6, entitled ``Average Burden
per Response.''
In addition to submitting a prior notice, a submitter should cancel
a prior notice and must resubmit the information to FDA if information
changes after the Agency 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 the Agency has confirmed a prior
notice submission for review (Sec. 1.282(a)(1)(i) to (iii)). In the
event that FDA refuses admission to an article of food under section
801(m)(1) or the Agency places it under hold under section 801(l) of
the FD&C Act, 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's review and the
information required in a request for review. In the event that the
Agency places an article of food under hold under Sec. 801(l) of the
FD&C Act, Sec. 1.285(i) sets forth the procedure for, and the
information to be included in, a post-hold submission.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section No. FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submitted Through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280-1.281......................... None 1,700 7647 12,999,900 0.167 (10 minutes)................ \2\ 2,170,983
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submitted Through PNSI
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280-1.281......................... \3\ 3540 27,000 70 1,890,000 0.384 (23 minutes)................ 725,760
---------------------------------------------------------------- ---------------
New Prior Notice Submissions .............. .............. .............. .............. .................................. 2,896,743
Subtotal.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancellations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancelled Through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282............................... 3540 7,040 1 7,040 0.25 (15 minutes)................. 1760
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancelled Through PNSI
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282, 1.283(a)(5).................. 3540 35,208 1 35,208 0.25 (15 minutes)................. 8,802
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancellations .............. .............. .............. .............. .................................. 10,562
Subtotal.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Requests for Review and Post-Hold Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.283(d), 1.285(j),................. None 1 1 1 8................................. 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.285(i)............................ None 263 1 263 1................................. 263
---------------------------------------------------------------- ---------------
Prior Notice Requests for Review .............. .............. .............. .............. .................................. 271
and Post-Hold Submissions
Subtotal.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total............................................................................................................................... 2,907,576
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 submission system known as PNSI, 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 10,450,824 prior notices through ABI/ACS during 2014;
11,282,015 during 2015; and 12,153,880 during 2016. Based on this
experience, the Agency estimates that approximately 1,700 users of ABI/
ACS will submit an average of 7,647 prior notices annually, for a total
of 12,999,900 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 hour, per notice, for a total burden
of 2,170,983 hours. This estimate takes into consideration the burden
hours already counted in the information collection approval for FDA
importer's entry notice (OMB control number 0910-0046), as previously
discussed.
FDA received 1,529,110 prior notices through PNSI during 2014;
1,633,567 during 2015; and 1,768,790 during 2016. Based on this
experience, the Agency estimates that approximately 27,000 registered
users of PNSI will submit an average of 70 prior notices annually, for
a total of 1,890,000 prior notices received annually. FDA estimates the
reporting burden for a prior notice submitted through PNSI to be 23
minutes, or 0.384 hour, per notice, for a total burden of 725,760
hours.
[[Page 1352]]
FDA received 7,265 cancellations of prior notices through ABI/ACS
during 2014; 7,910 during 2015; and 5,948 during 2016. Based on this
experience, the Agency estimates that approximately 7,040 users of ABI/
ACS will submit an average of 1 cancellation annually, for a total of
7,040 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 hour, per cancellation, for a total burden of 1,760
hours.
FDA received 36,324 cancellations of prior notices through PNSI
during 2014; 39,553 during 2015; and 29,743 during 2016. Based on this
experience, the Agency estimates that approximately 35,208 registered
users of PNSI will submit an average of 1 cancellation annually, for a
total of 35,208 cancellations received annually. FDA estimates the
reporting burden for a cancellation submitted through PNSI to be 15
minutes, or 0.25 hour, per cancellation, for a total burden of 8,802
hours.
FDA has not received any requests for review under Sec. 1.283(d)
or Sec. 1.285(j) in the last 3 years; 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, the Agency has estimated a total reporting burden of 8
hours.
FDA received 235 post-hold submissions under Sec. 1.285(i) during
2014; 218 during 2015; and 337 during 2016. Based on this experience,
the Agency estimates that 263 post-hold submissions under Sec.
1.285(i) 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, the Agency estimates a total reporting burden of
263 hours.
Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-32030 Filed 1-4-17; 8:45 am]
BILLING CODE 4164-01-P
