[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65670-65672]
[FR Doc No: 2013-25974]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0179]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 our regulations requiring that the Agency receive 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 December 31, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
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, we are publishing this notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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 we 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 our 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 our review after we have 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.'' In the Federal
Register of May 5, 2011 (76 FR 25542), we issued an interim final rule
(IFR) entitled ``Information Required in Prior Notice of Imported
Food'' (2011 IFR) that implemented section 304 of FSMA and requested
public comments. OMB approved the collection of information
requirements of the 2011 IFR under OMB control number 0910-0683. On May
30, 2013 (78 FR 32359), we published a final rule that adopts, without
change, the regulatory requirements established in the 2011 IFR,
specifically that a person submitting prior notice of imported food,
including food for animals, must report the name of any country that
has refused entry of that product. In this request for extension of OMB
approval under the PRA, we are combining the burden hours associated
with OMB control number 0910-0683 (collection entitled ``Information
Required in Prior Notice of Imported Food'') with the burden hours
approved under OMB control number 0910-0520 (collection entitled
``Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002''). If approved, we
will discontinue the information collection in OMB control number 0910-
0683, having incorporated the burden into OMB control number 0910-0520.
    Advance notice of imported food allows us, 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,
we may better identify imported food shipments that may pose safety and
security risks to U.S. consumers. This additional knowledge can further
help us 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.
    Our 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 http://www.access.fda.gov/. Information we
collect 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 name of any country
that has refused entry of the article of food; 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 our 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 of this document reflects our estimate of the
reduced burden for prior 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 us if information
changes after we have 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 we have confirmed a prior notice
submission for review (Sec.  1.282(a)(1)(i) to (a)(1)(iii)). In the
event that we refuse admission to an article of food under section
801(m)(1) of the FD&C Act or we place it under hold under section
801(l), Sec. Sec.  1.283(d) and 1.285(j) set forth the procedure for
requesting our review and the information required in a request for
review. In the event that we place an article of food under hold under
section 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.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                    FDA                      Number of
                         21 CFR Section                            Form      Number of     responses per   Total annual   Average burden    Total hours
                                                                    No.     respondents     respondent       responses     per response
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                                                                Prior Notice Submissions
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Prior Notice submitted through ABI/ACS:
    1.280, 1.281................................................   (\4\)          15,000             608       9,120,000           0.167   \2\ 1,523,040
Prior Notice submitted through PNSI:
    1.280, 1.281................................................     \3\          26,667              58       1,546,686           0.384         593,927
                                                                    3540
                                                                 ---------------------------------------------------------------------------------------
        New Prior Notice Submissions Subtotal...................  ......  ..............  ..............  ..............  ..............       2,116,967
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                               Prior Notice Cancellations
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Prior Notice cancelled through ABI/ACS:
    1.282.......................................................    3540           4,098               1           4,098           0.25            1,025
Prior Notice cancelled through PNSI:
    1.282, 1.283(a)(5)..........................................    3540          33,096               1          33,096           0.25            8,274
                                                                 ---------------------------------------------------------------------------------------
        Prior Notice Cancellations Subtotal.....................  ......  ..............  ..............  ..............  ..............           9,299
Prior Notice Requests for Review and Post-hold Submissions:
    1.283(d), 1.285(j)..........................................   (\4\)               1               1               1           8                   8
    1.285(i)....................................................   (\4\)               1               1               1           1                   1
                                                                 ---------------------------------------------------------------------------------------
        Prior Notice Requests for Review and Post-hold            ......  ..............  ..............  ..............  ..............               9
         Submissions Subtotal...................................
                                                                 ---------------------------------------------------------------------------------------
            Total Hours Annually................................  ......  ..............  ..............  ..............  ..............       2,126,275
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer's Entry Notice information collection approved
  under OMB Control No. 0910-0046 are not included in this total.
\3\ The term ``Form FDA 3540'' refers to the electronic submission system known as the Prior Notice System Interface (PNSI), which is available at http://www.access.fda.gov.
\4\ None.

    This estimate is based on our experience and the average number of
prior notice submissions, cancellations, and requests for review
received in the past 3 years.
    As discussed, on May 30, 2013, we published a final rule that
adopts, without change, the regulatory requirements established in the
2011 IFR, specifically that a person submitting prior notice of
imported food, including food for animals, must report the name of any
country that has refused entry of that product. We estimate that it
would take on average about one additional minute (0.016 hours) per
entry for each respondent to submit prior notice with this additional
piece of information. Accordingly, we have increased our estimate of
the hours per response for prior notices received through ABI/ACS from
9 minutes, or 0.15 hours, per notice, to 10 minutes, or 0.167 hours,
per notice. We have also increased our estimate of the hours per
response for prior notices received through PNSI from 22 minutes, or
0.366 hours (rounded to 0.37 hours), per notice, to 23 minutes, or
0.384 hours, per notice.
    We received 8,570,504 prior notices through ABI/ACS during 2010;
9,054,187 during 2011; and 9,716,147 during 2012. Based on this
experience, we estimate that approximately 15,000 users of ABI/ACS will
submit an average of 608 prior notices annually, for a total of
9,120,000 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 1,523,040 hours. This estimate takes into consideration the
burden hours already counted in the information collection approval for
our importer's entry notice (OMB Control No. 0910-0683), as previously
discussed in this document.
    We received 1,566,029 prior notices through PNSI during 2010;
1,498,609 during 2011; and 1,524,901 during 2012. Based on this
experience, we estimate that approximately 26,667 registered users of
PNSI will submit an average of 58 prior notices annually, for a total
of 1,546,686 prior notices received annually. We estimate the reporting
burden for a prior notice submitted through PNSI to be 23 minutes, or
0.384 hours, per notice, for a total burden of 593,927 hours.
    We received 4,488 cancellations of prior notices through ABI/ACS
during 2010; 3,993 during 2011; and 3,812 during 2012. Based on this
experience, we estimate that approximately 4,098 users of ABI/ACS will
submit an average of 1 cancellation annually, for a total of 4,098
cancellations received annually through ABI/ACS. We estimate 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 1,024.5
hours, rounded to 1,025 hours.
    We received 33,353 cancellations of prior notices through PNSI
during 2010; 33,343 during 2011; and 32,592 during 2012. Based on this
experience, we estimate that approximately 33,096 registered users of
PNSI will submit an average of 1 cancellation annually, for a total of
33,096 cancellations received annually. We estimate the reporting
burden for a cancellation submitted through PNSI to be 15 minutes, or
0.25 hours, per cancellation, for a total burden of 8,274 hours.
    We have not received any requests for review under Sec.  1.283(d)
or Sec.  1.285(j) in the last 3 years (2010, 2011, and 2012);
therefore, we estimate that one or fewer requests for review will be
submitted annually. We estimate that it will take a requestor about 8
hours to prepare the factual and legal information necessary to prepare
a request for review. Thus, we have estimated a total reporting burden
of 8 hours.
    We have not received any post-hold submissions under Sec.  1.285(i)
in the last 3 years (2010, 2011, and 2012); therefore, we estimate that
one or fewer post-hold submissions will be submitted annually. We
estimate that it will take about 1 hour to prepare the written
notification described in Sec.  1.285(i)(2)(i). Thus, we have estimated
a total reporting burden of 1 hour.

    Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25974 Filed 10-31-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Pages 75118-75119]
[FR Doc No: 2022-26547]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2022-0193]

Agency Information Collection Activities: Requests for Comments;
Clearance of New Approval of Information Collection: ICAO CO2
Certification Database

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
The initial Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on April 26, 2022. The collection involves the possibility
for airplane manufacturers, for which a newly built airplane is subject
to the applicability of Annex 16, Volume III of the Convention on Civil
Aviation (hereinafter the ``Chicago Convention''), to submit an
electronic datasheet to the FAA for posting to the CO2
Certification Database (CO2DB). The information to be
collected will be necessary because of FAA's commitment to help (a)
provide publicly available data on the CO2 Metric Value (MV)
which represents a measure of fuel burn performance of airplane types
against CO2 technology/design standards, (b) track and
communicate the improvement in airplane CO2 MVs over time
and (c) provide an incentive to improve the CO2 MV of
airplane types.

DATES: Written comments should be submitted by January 6, 2023.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Laszlo Windhoffer by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Supporting Statement A
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information.
    OMB Control Number: 2120-XXXX.
    Title: ICAO CO2 Certification Database
(CO2DB).
    Form Numbers: FAA Form 1240-6.
    Type of Review: Clearance of a new information collection.
    Background: The initial Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on April 26, 2022 (87 FR 24606).
    In March 2017, the International Civil Aviation Organization (ICAO)
Council adopted the Volume III of Annex 16 of the Chicago Convention
(Environmental Protection) for the implementation of a new airplane
CO2 emissions standard. The Standard will apply to new
airplane type designs from 2020, and to airplane type designs already
in-production as of 2023. Those in-production airplane which by 2028 do
not meet the standard will no longer be able to be produced unless
their designs are sufficiently modified to comply with the in-
production standard.
    To support the implementation of Annex 16 Volume III, ICAO agreed
that, similar to noise and engine emissions, an ICAO CO2
Certification Database (CO2DB) should be developed and
continuously maintained in a publicly accessible manner. The U.S.
Federal Aviation Administration will host the new database on behalf of
ICAO.
    The aim of the CO2DB is to (a) Provide publicly
available data on the CO2 Metric Value (MV) which represents
a measure of fuel burn performance of airplane types against
CO2 technology/design standards, (b) Track and communicate
the improvement in airplane CO2 MVs over time and (c)
Provide an incentive to improve the CO2 MV of airplane
types.
    The collection of data towards the CO2DB is expected to
leverage the Airplane Airworthiness Certification process, which
includes; airplane performance measurement, computation of relevant
metrics (e.g., CO2 MV) and submission of the information to
the Certificating Authority (CA) of the State of Design. As part of the
airworthiness certification process, the data/information is reviewed
by the CA and approved. Given that the submission of information into
the CO2DB is voluntary, it is expected that the applicant
(e.g., airplane manufacturer) will decide to submit a CO2DB
Datasheet to its CA and ultimately to the U.S. FAA. If the applicant
decides to submit information to the CO2DB, the applicant
will prepare a CO2DB Datasheet by using the CO2DB
Datasheet Template that will be publicly available via the CO2DB web
page expected to be hosted on the FAA Office of Environment and Energy
website. Once the U.S. FAA collects the CO2DB Datasheets it
may conduct an information check to identify any gross errors or
mistakes. Similar to other ICAO environment databases, the entity
submitting the information (in this case the applicant) will be solely
responsible for the accuracy of the information. If there are any
questions about submissions, the U.S. FAA will communicate with the
applicant to attempt to address any issues.
    CO2DB Datasheets will then be integrated into the
CO2DB and the records of changes will be updated. It is
expected that the database will be available for download in a common
table format (e.g., Microsoft Excel file) as well as a collection of
the submitted CO2DB Datasheets. Additional background and
supporting information will also be available on the CO2DB
website along with a Support Function communication mechanism (e.g.,
email address).
    Respondents: Respondents will be airplane manufacturers (or
``applicants'') subject to the applicability of Annex 16, Volume III of
the Chicago Convention. From the outset, FAA expects about 3 U.S.
airplane applicants to submit CO2DB

Datasheets for their certified airplanes. It should be noted that
additional respondents from outside the United States (i.e., Airplane
Manufacturers for which the Certificating Authority is another ICAO
Member State than the United States) are expected to submit
CO2DB Datasheets to the CO2DB for their certified
airplane. These non-US applicants were assumed to be outside the scope
of the burden analysis contained in Supporting Statement A and were
therefore not included as respondents.
    Frequency: If they decide to submit information to the
CO2DB, the manufacturers will submit data after the
certification of an airplane. It is expected that manufacturers would
submit one CO2DB Datasheet for each airplane model. As
described in Supporting Statement A and based on historical frequency
of airplane certification, each U.S. manufacturer could be expected to
certificate up to two new models every three years. Thus, in
mathematical terms, the FAA would expect to receive an average of two
thirds of one datasheet per year and per respondent.
    Estimated Average Burden per Response: It is expected that filling
and submitting a CO2DB Datasheet could take approximately
2.5 hours.
    Estimated Total Annual Burden: Based on the above, FAA expects that
the annual submission of CO2DB Datasheet by U.S. airplane manufacturers
could take approximately 5 hours for an average of 2 submissions per
year ($368 in filing and submission costs). This is estimated for all 3
U.S. airplane manufacturers.

    Issued in Washington, DC, on December 1, 2022.
Kevin Welsh,
Executive Director, Office of Environment and Energy, Federal Aviation
Administration.
[FR Doc. 2022-26547 Filed 12-6-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58298-58299]
[FR Doc No: 2013-22938]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2712-001.
    Applicants: Cargill Power Markets, LLC.
    Description: Response to FERC letter dated September 5, 2013. Data
Request of Cargill Power Markets, LLC.
    Filed Date: 9/12/13.
    Accession Number: 20130912-5062.
    Comments Due: 5 p.m. ET 10/3/13.

    Docket Numbers: ER13-2371-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Queue Position Y1-044; First Revised Service Agreement
No. 3384 to be effective 8/12/2013.
    Filed Date: 9/11/13.
    Accession Number: 20130911-5075.
    Comments Due: 5 p.m. ET 10/2/13.

    Docket Numbers: ER13-2372-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Queue Position X1-045; Original Service Agreement No.
3641 to be effective 8/12/2013.
    Filed Date: 9/11/13.
    Accession Number: 20130911-5090.
    Comments Due: 5 p.m. ET 10/2/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 12, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-22938 Filed 9-20-13; 8:45 am]
BILLING CODE 6717-01-P