[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1349-1352]
[FR Doc No: 2016-32030]

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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.

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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

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: http://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<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, 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 http://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

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\
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                                                                         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)
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                                                                Prior Notice Submissions
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                                                         Prior Notice Submitted Through ABI/ACS
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1.280-1.281.........................            None           1,700            7647      12,999,900  0.167 (10 minutes)................   \2\ 2,170,983
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                                                           Prior Notice Submitted Through PNSI
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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.
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                                                               Prior Notice Cancellations
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                                                         Prior Notice Cancelled Through ABI/ACS
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1.282...............................            3540           7,040               1           7,040  0.25 (15 minutes).................            1760
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                                                           Prior Notice Cancelled Through PNSI
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1.282, 1.283(a)(5)..................            3540          35,208               1          35,208  0.25 (15 minutes).................           8,802
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    Prior Notice Cancellations        ..............  ..............  ..............  ..............  ..................................          10,562
     Subtotal.
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                                               Prior Notice Requests for Review and Post-Hold Submissions
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1.283(d), 1.285(j),.................            None               1               1               1  8.................................               8
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1.285(i)............................            None             263               1             263  1.................................             263
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    Prior Notice Requests for Review  ..............  ..............  ..............  ..............  ..................................             271
     and Post-Hold Submissions
     Subtotal.
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    Total...............................................................................................................................       2,907,576
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer's Entry Notice information collection approved
  under OMB control number 0910-0046 are not included in this total.
\3\ The term ``Form FDA 3540'' refers to the electronic submission system known as PNSI, which is available at http://www.access.fda.gov.

    This estimate is based on FDA's experience and the average number
of prior notice submissions, cancellations, and requests for review
received in the past 3 years.
    FDA received 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.

    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


[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Notices]
[Page 69615]
[FR Doc No: 2020-24272]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2266-102]

Nevada Irrigation District; Notice of Designation of Certain
Commission Personnel as Non-Decisional

    Commission staff members Rachael Warden (Office of the General
Counsel<PHONE_NUMBER><EMAIL_ADDRESS>and Elizabeth Molloy
(Office of the General Counsel;<PHONE_NUMBER>;
<EMAIL_ADDRESS>are assigned to help resolve issues related
to the Yuba-Bear Hydroelectric Project No. 2266.
    As ``non-decisional'' staff, Ms. Warden and Ms. Molloy will not
participate in an advisory capacity in any matters related to the Yuba-
Bear Hydroelectric Project No. 2266.

    Dated: October 27, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-24272 Filed 11-2-20; 8:45 am]
BILLING CODE 6717-01-P


Indiana's Data Management Systems Presented at Intergovernmental Meeting on Coal Combustion Materials Golden, Colorado April 15  16, 2002 CCW Disposal In Indiana

Currently, there are 15 surface mines approved for CCW disposal

2 additional permits are presently in technical review

Of the 15 mines, only 8 have had CCW disposed

Presently, 4 mines are actively disposing CCW Disposal In Indiana

Memorandum 92 1 Policy providing requirements for CCW disposal through existing authority of IC 14 34 & 312 IAC 25

New or significant revision to an existing permit requiring public notice, opportunity for comments and appeals

Approval by landowners where disposal is to take place

Disposal limited to CCW generated in Indiana or from the burning of Indiana coal ° Extensive geologic and hydrogeologic characterization Coal Mined and CCW Disposed at Mines in Indiana Since 1991 322,335,538 3,361,579 0 50,000,000 100,000,000 150,000,000 200,000,000 250,000,000 300,000,000 350,000,000 Net Tonnage TONS Coal Mined CCW Disposed ( 1.04% of total) Coal Production and Coal Mine CCW Disposal 0 5,000,000 10,000,000 15,000,000 20,000,000 25,000,000 30,000,000 35,000,000 40,000,000 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001*

Tons Coal Production CCW Disposed * 3 Qtrs Only Surface CCW Shale Spoil CCW Subsoil Highwall Spoil Mine Advance Indiana's CCW Database Indiana's CCW Database

Initial bulk, 18 hr and 30 day leachate analyses are entered into the database once the CCW permit is approved

During disposal bulk, 18 hr and 30 day leachate analyses submitted in the quarterly reports are entered into the database CCW Disposal In Indiana

CCW characterization for each waste stream/ type ° Bulk analysis:

Al Mn F pH As Hg Fe Pb Ba Ni Na Cl

Cd Se SO4  2 TDS K Zn SO3  2 V Cr Ag B potential acidity Cu Mo Mg TOC MPC calculation Net neutralization potential Neutralization potential CCW Disposal In Indiana Al Mn F pH As Hg Fe Pb Ba Ni Na Cl

Cd Se SO4  2 TDS K Zn SO 3  2 V Cr Ag B TOC Cu Mo Mg MPC calculation ASTM Method D3987 85 Shake Extraction of Solid Waste ° 18 hr and 30 day leachate analyses: CCW Disposal In Indiana CCW leaching elements at concentrations exceeding ¼ RCRA standards cannot be disposed CCW Disposal In Indiana

Baseline ( minimum of 6 months)

Al Mn F pH ( field)

As Hg Fe pH ( lab)

Ba Ni Na Sp. Conductivity Cd Se SO4  2 TDS Ca Zn SO3  2 Alkalinity Cr Ag B Acidity Cu Mo Mg TOC Pb Cl SWE Cat/ Anion Balance Hardness Temperature ° Ground Water CCW Disposal In Indiana Al Mn F pH ( field)

As Hg Fe pH ( lab)

Ba Ni Na Sp. Conductivity Cd Se SO4  2 TDS Ca Zn SO3  2 Alkalinity Cr Ag B Acidity Cu Mo Mg TOC Pb Cl TSS Cat/ An Balance Temperature Discharge rate ° Surface Water Ash Database S 321 Pride Mine  ( Selenium)

Quarters 1  4, 2000 30 Day Leachate 0.025 0.075 0.125 0.175 0.225 0.275 189 1/ 31/ 2000 284 4/ 19/ 2000 830 7/ 14/ 2000 1114 10/ 23/ 2000 mg/

l Selenium 1/ 4 RCRA Indiana's CCW Database

Data in the CCW Database are tracked by:

° Facility / Generator ° Waste type ( flyash, bottom ash, etc.)

° Analysis type ( bulk, 18 hr, 30 day)

° Analysis date ° Permit number Indiana's CCW Database

Future features of the CCW Database:

° Electronic transfer of data from labs via permittee ° Selection of up to 10 parameter queries ° Unsurpassed graphing and statistical capabilities Indiana's CCW Database R: Base Geographic Information Systems Geographic Information Systems

Current GIS work:

Transferring pertinent permit data ( monitoring and residential wells, surface water monitoring points, bond release info, etc.) into system

Transferring coal mine permit boundaries onto topo maps and/ or aerial photos

Depicting CCW disposal locations within the mined areas

Application development ( making system user friendly)

Linking location data to database and spreadsheet info Geographic Information Systems

Future GIS considerations:

GIS and spreadsheet charting working in tandem

Hydrology parameter contouring using additional GIS tools

Modeling with GIS and/ or specialized hydrology software Indiana's Water Database Indiana's Water Database

Future features of the Water Database:

More statistical analyses

Addition of Indiana's Ground Water Quality Standards

Improved graphing capabilities

Add programming to capture and report on missing samples based on monthly, quarterly or annual frequencies