[Federal Register Volume 80, Number 4 (Wednesday, January 7, 2015)]
[Notices]
[Pages 920-921]
[FR Doc No: 2014-30546]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Actions on Special Permit Applications

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration (PHMSA), DOT.

ACTION: Notice of actions on special permit applications.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given of the actions on special permits
applications in (October to October 2014). The mode of transportation
involved are identified by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft. Application numbers prefixed by the letters EE represent
applications for Emergency Special Permits. It should be noted that
some of the sections cited were those in effect at the time certain
special permits were issued.

    Issued in Washington, DC, on December 8, 2014.
Donald Burger,
Chief, Special Permits and Approval Branch.

------------------------------------------------------------------------
                                                      Nature of special
    S.P. No.         Applicant      Regulation(s)      permit thereof
------------------------------------------------------------------------
                   MODIFICATION SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
11150-M.........  Maine State      49 CFR 172.101   To modify the
                   Ferry Service    and 172.301(c).  special permit to
                   Augusta, ME.                      authorize cylinders
                                                     having a water
                                                     capacity exceeding
                                                     100 pounds.
9610-M..........  Alliant          49 CFR           To modify the
                   Techsystems      172.201(c),      special permit to
                   Operations LLC   Subpart F of     authorize Class I
                   Eden Prairie,    Part 172,        smokeless powder
                   MN.              172.301(c),      UN0161 in
                                    172.203(a),      combination
                                    174.59, and      packaging.
                                    174.61(a).
14506-M.........  SLR              49 CFR           To modify the
                   International    173.4(a)(1)(i)   special permit to
                   Corporation      , 173.4a(c)      authorize inner
                   Bothell, WA.     and (d).         packagings without
                                                     the removable
                                                     closure secured in
                                                     place, and all
                                                     shipments not
                                                     necessarily be
                                                     packaged
                                                     identically but
                                                     similarly.
15448-M.........  U.S. Department  49 CFR 172.320,  To modify the
                   of Defense       173.51,          special permit to
                   Scott AFB, IL.   173.56, 173.57   authorize
                                    and 173.58.      packagings that
                                                     have not been
                                                     specifically
                                                     approved.
14919-M.........  TK Holdings      49 CFR           To modify the
                   Inc. Armada,     173.301(a),      special permit to
                   MI.              173.302a, and    remove the
                                    178.65(f)(2).    specifications for
                                                     cylinder sizes and
                                                     water capacities.
14447-M.........  Taminco US Inc   49 CPR           To modify the
                   Allentown, PA.   177.834(i),      special permit to
                                    172.203(a),      authorize the
                                    and 172.302(c).  addition of
                                                     Division 2.1, new
                                                     Division 6.1, and
                                                     new Class 3 and 8
                                                     materials.
------------------------------------------------------------------------
                       NEW SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
16218-N.........  Mountain Blade   49 CFR 172.101,  To authorize the
                   Runner, LLC      Column (9B),     transportation in
                   Montrose, CO.    172.204(c)(3),   commerce of certain
                                    173.27(6)(2),    hazardous materials
                                    175.30(a)(1)     by 14 CFR part 133.
                                    172.200,         Rotorcraft External
                                    172.301(c),      Load Operations
                                    Part 178 and     transporting
                                    175.75.          hazardous materials
                                                     attached to or
                                                     suspended from an
                                                     aircraft, in remote
                                                     areas of the US
                                                     only, without being
                                                     subject to hazard
                                                     communication
                                                     requirements,
                                                     quantity
                                                     limitations and
                                                     certain loading and
                                                     stowage
                                                     requirements. (mode
                                                     4).
16267-N.........  Korean Air Los   49 CFR 172.101   To authorize the one-
                   Angeles, CA.     Column (9B),     time transportation
                                    172.204(c)(3),   in commerce of
                                    173.27, and      certain explosives
                                    175.30(a)(1).    that are forbidden
                                                     for transportation
                                                     by cargo only
                                                     aircraft. (mode 4).
15955-N.........  Thompson Tank,   49 CFR 173.315.  To authorize the
                   Inc. Lakewood,                    manufacture,
                   CA.                               marking, sale and
                                                     use of non-DOT
                                                     specification cargo
                                                     tanks manufactured
                                                     to ASME Section XII
                                                     stamped with a
                                                     ``T'' Stamp instead
                                                     of the ``U'' stamp.
                                                     (mode 1).
1597I-N.........  National         49 CFR           To authorize the
                   Aeronautics      173.301(a)(1),   transportation in
                   and Space        173.301(a)(2),   commerce of non-DOT
                   Administration   173.301(0(1,     specification
                   (NASA)           173.302(a) and   pressure
                   Houston, TX.     173.302a(a).     receptacles
                                                     containing
                                                     nitrogen,
                                                     compressed. (modes
                                                     1, 2, 3, 4).
15973-N.........  Codman &         49 CFR parts     To authorize the
                   Shurtleff,       171-180.         transportation in
                   Inc. Raynham,                     commerce of small
                   MA.                               amounts of butane
                                                     contained within a
                                                     Medstream Pump as
                                                     unregulated. (modes
                                                     4, 5).

16022-N.........  Zhejiang Juhua    49 CFR          To authorize the
                   Equipment        178.274(b),      manufacture,
                   Manufacturing    178.276(6)(1)    marking, sale and
                   Co., Ltd.        and              use of non-DOT
                   Quzhou,          178.276(a)(2).   specification
                   Zhejiang.                         portable tanks
                                                     mounted within an
                                                     ISO frame that have
                                                     been designed,
                                                     constructed and
                                                     stamped in
                                                     accordance with
                                                     Section VIII,
                                                     Division 2 of the
                                                     ASME Code. (modes
                                                     1, 2, 3).
16103-N.........  Insituform       49 CFR 173.203   To authorize the
                   Technologies,    and 173.242.     transportation in
                   LLC                               commerce of resin-
                   Chesterfield,                     impregnated, coated
                   MO.                               polyester felt
                                                     tubing used as a
                                                     means of restoring
                                                     structural
                                                     integrity to aging
                                                     or damaged
                                                     wastewater, potable
                                                     water and
                                                     industrial
                                                     pipelines through
                                                     use of a
                                                     trenchless, cured-
                                                     in-place pipe
                                                     (``CIPP'')
                                                     technology. (mode
                                                     1).
16142-N.........  Nantong CIMC     49 CFR           To authorize the
                   Tank Equipment   178.274(6) and   manufacture,
                   Co. Ltd.         178.276(6)(1).   marking, sale and
                   Jiangsu,                          use of UN T75 Code
                   Province.                         portable tanks that
                                                     are designed,
                                                     constructed,
                                                     certified and
                                                     stamped in
                                                     accordance with
                                                     Section VIII
                                                     Division 1, latest
                                                     edition of the ASME
                                                     Code. (modes 1, 2,
                                                     3).
16163-N.........  The Dow          49 CFR           To authorize that
                   Chemical         180.605(h)(3).   the required 5 year
                   Company                           periodic pressure
                   Midland, MI.                      test on UN portable
                                                     tanks used in the
                                                     transport of a
                                                     Division 4.3
                                                     material be
                                                     performed
                                                     pneumatically (with
                                                     nitrogen) rather
                                                     than with water.
                                                     (modes 1, 2, 3, 4).
16172-N.........  Entegris, Inc.   49 CFR           To authorize the
                   Danbury, CT.     173.301(f).      transportation in
                                                     commerce of a Zone
                                                     B toxic by
                                                     inhalation gas in a
                                                     DOT3AA cylinder
                                                     that is fitted with
                                                     an alternative
                                                     pressure relief
                                                     device. (modes 1,
                                                     3).
16178-N.........  National         49 CFR 173.302a  To authorize the
                   Aeronautics                       transportation in
                   and Space                         commerce of
                   Administration                    compressed gases in
                   (NASA)                            non-DOT
                   Washington, DC.                   specification
                                                     cylinders. (modes
                                                     1, 3).
------------------------------------------------------------------------
                    EMERGENCY SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
16108-M.........  Carleton         49 CFR           To modify the
                   Technologies     173.302a,        special permit to
                   Inc.             173.304a and     bring it in line
                   Westminster,     180.205.         with SIO 11119-2
                   MD.                               and DOT-SP 14756.
                                                     (modes 1, 2, 3, 4,
                                                     5).
15999-M.........  National         49 CFR parts     To modify the
                   Aeronautics      172 and 173.     special permit by
                   and Space                         adding a Division
                   Administration                    1.4S material
                   (NASA)                            (modes 1, 3).
                   Washington, DC.
16263-M.........  Kalitta Air,     49 CFR 172.101   (mode 4).
                   LLC Ypsilanti,   Column (9B),
                   MI.              172.204(c)(3),
                                    173.27(b)(2)
                                    and (3) and
                                    175.30(a)(1).
16263-M.........  Kalitta Air,     49 CFR 172.101   (mode 4).
                   LLC Ypsilanti,   Column (9B),
                   MI.              172.204(c)(3),
                                    173.27(b)(2)
                                    and (3) and
                                    175.30(a)(1).
16219-N.........  Structural       49 CFR 173.302a  To authorize the
                   Composites       and 173.304a.    manufacture,
                   Industries                        marking, sale and
                   (SCI) Pomona,                     use of aluminum-
                   CA.                               lined carbon-fiber
                                                     composite cylinders
                                                     for use in
                                                     transporting
                                                     certain Division
                                                     2.1 and 2.2
                                                     hazardous
                                                     materials. (modes
                                                     1, 2, 3, 4).
16311-N.........  Raytheon         49 CFR 172.101   To authorize the
                   Missile          Column (9B),     offering in air
                   Systems          172.204(c)(3),   transportation of
                   Tucson, AR.      173.27(b)(2)     certain Class I
                                    and (3).         explosives which
                                                     are forbidden or
                                                     exceed the quantity
                                                     limitations
                                                     authorized for
                                                     transportation by
                                                     cargo aircraft.
                                                     (mode 4).
16170-N.........  Hydro Stat LLC   49 CFR           To authorize the
                   Holly, MI.       180.213(b)(2).   removal of certain
                                                     requalification
                                                     markings from DOT-
                                                     3AL cylinders that
                                                     have previously
                                                     been retested in
                                                     accordance with DOT-
                                                     SP 14546 or DOT-SP
                                                     14854, to allow
                                                     them to be returned
                                                     to a 5 year
                                                     hydrostatic retest
                                                     schedule and
                                                     eliminate the need
                                                     for quality control
                                                     for the gases to be
                                                     used. (modes 1, 2,
                                                     3, 4, 5).
------------------------------------------------------------------------

------------------------------------------------------------------------

------------------------------------------------------------------------
                                 DENIED
------------------------------------------------------------------------
16289-N................................  Request by NYS Department of
                                          Environmental Conservation
                                          Albany, NY November 21, 2014.
                                          To authorize the
                                          transportation in commerce of
                                          ebola contaminated waste in
                                          alternative packaging.
------------------------------------------------------------------------

[FR Doc. 2014-30546 Filed 1-6-15; 8:45 am]
BILLING CODE 4910-60-M


[Federal Register: October 31, 2008 (Volume 73, Number 212)]
[Notices]
[Page 64943]
[DOCID:fr31oc08-65]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8735-3]

California State Nonroad Engine Pollution Control Standards;
California Nonroad Compression Ignition Engines; Within-the-Scope
Request; Opportunity for Public Hearing; Correction of Docket Number

AGENCY: Environmental Protection Agency.

ACTION: Notice; correction.

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SUMMARY: On October 7, 2008, the U.S. Environmental Protection Agency's
(EPA's) Office of Air and Radiation announced an opportunity for public
hearing and written comment. The notice concerns the California Air
Resources Board's request seeking EPA's confirmation that its
amendments affecting emission standards for three broad categories of
new compression ignition engines are within the scope of previous
authorizations issued by EPA. Please be advised the docket number for
that notice was incorrect.

FOR FURTHER INFORMATION CONTACT: David Dickinson, Compliance and
Innovative Strategies Division (6405J), U.S. Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Telephone:
(202) 343-9256, Fax:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
Correction

    In the Federal Register at 73 FR 58583 (October 7, 2008), on page
58583 (2nd column), correct the docket ID number to read EPA-HQ-OAR-
2008-0670. This previous Federal Register notice provided instructions
for submitting comments and such instructions should continue to be
followed with the docket number provided by this notice.

    Dated: October 22, 2008.
Robert J. Meyer,
Principal Deputy Assistant Administrator, Office of Air and Radiation.
[FR Doc. E8-25793 Filed 10-30-08; 8:45 am]

BILLING CODE 6560-50-M


[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Rules and Regulations]
[Pages 53816-53817]
[FR Doc No: 2011-22105]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2011-N-0002]

Advisory Committee; Change of Name and Function; Technical
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the
standing advisory committees' regulations to change the name and
function of the Anesthetic and Life Support Drugs Advisory Committee.
This action is being taken to reflect changes made to the charter for
this advisory committee.

DATES: Effective September 6, 2011.

FOR FURTHER INFORMATION CONTACT: Philip Bautista, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001.

SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the
Anesthetic and Life Support Drugs Advisory Committee, which was
established on May 1, 1978, has been changed. The Agency decided that
the name ``Anesthetic and Analgesic Drug Products Advisory Committee''
would more accurately describe the subject areas for which the
committee is responsible. The mandate of the committee is being
expanded to include analgesics, e.g., abuse-deterrent opioids, novel
analgesics, and opioid abuse.
    The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products including analgesics, e.g., abuse-deterrent opioids, novel
analgesics, and issues related to opioid abuse, and those for use in
anesthesiology.
    The Anesthetic and Life Support Drugs Advisory Committee name was
changed and its functions expanded in the charter renewal dated June 9,
2011. FDA is hereby revising 21 CFR 14.100 (c)(1) to reflect these
changes.
    Publication of this final rule constitutes a final action on this
change under the Administrative Procedure Act. Under 5 U.S.C.
553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good
cause to dispense with notice and public procedure and to proceed to an
immediately effective regulation. Such notice and procedures are
unnecessary and are not in the public interest, because the final rule
is merely codifying the new name and the expanded function of the
advisory committee to reflect the current committee charter.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.

    Therefore, under the Federal Food and Drug, and Cosmetic Act and
under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as
follows:

    Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109, Pub. L. 108-155.

0
2. Section 14.100 is amended by revising the heading of paragraph
(c)(1) and paragraph (c)(1)(ii) to read as follows:

Sec.  14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (1) Anesthetic and Analgesic Drug Products Advisory Committee.
* * * * *
    (ii) Function: Reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products
including analgesics, e.g., abuse-deterrent opioids, novel analgesics,
and issues related to opioid abuse, and those for use in
anesthesiology.
* * * * *

    Dated: August 25, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-22105 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62112-62116]
[FR Doc No: 2016-21567]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC16-11-000]

Commission Information Collection Activities (FERC Forms 6 and
580); Comment Request

AGENCY: Federal Energy Regulatory Commission.

ACTION: Comment request.

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SUMMARY: The Commission previously issued a Notice in the Federal
Register (81 FR 38169, 6/13/2016) requesting public comments on FERC
Forms 6, 580, 1, 1-F, and 3-Q. The Commission received no comments
regarding FERC Forms 6 and 580. This 30-day notice only solicits
comments on FERC Forms 6 and 580. FERC received comments regarding FERC
Forms 1, 1-F, and 3-Q and will address those comments in a subsequent
notice also in Docket No. IC16-11-000.

    In compliance with the requirements of the Paperwork Reduction Act
of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory
Commission (Commission or FERC) is submitting these information
collections (FERC Form 6 [Annual Report of Oil Pipeline Companies] and
FERC Form 580 [Interrogatory on Fuel and Energy Purchase Practices]) to
the Office of Management and Budget (OMB) for review of the information
collection requirements. Any interested person may file comments
directly with OMB and should address a copy of those comments to the
Commission as explained below.

DATES: Comments on the FERC Forms 6 and 580 are due by October 11,
2016.

ADDRESSES: Comments filed with OMB, identified by the OMB Control Nos.
1902-0022 (FERC Form 6) or 1902-0137 (FERC-580) should be sent via
email to the Office of Information and Regulatory Affairs:
<EMAIL_ADDRESS>Attention: Federal Energy Regulatory
Commission Desk Officer.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC16-11-000, by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Type of Request: Three-year extension of the information collection
requirements for all collections described below with no changes to the
current reporting requirements. There are some non-substantive
corrections being made to the instructions (such as reflecting the
current estimated burden hours and updating addresses). Please note
that each collection is distinct from the next.
    Comments: Comments are invited on: (1) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information will have
practical utility; (2) the accuracy of the agency's estimates of the
burden and cost of the collections of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility and clarity of the information collections; and
(4) ways to minimize the burden of the collections of information on
those who are to respond, including the use of automated collection
techniques or other forms of information technology.

FERC Form No. 6, Annual Report of Oil Pipeline Companies \1\
---------------------------------------------------------------------------

    \1\ The renewal request for the FERC Form No. 6 in Docket No.
IC16-11 is for the current form, with no change to the reporting
requirements. None of the comments received in Docket No. IC16-11
pertained to FERC Form 6. The FERC Form No. 6 is also part of the
Forms Refresh effort (Docket No. AD15-11), which is a separate
activity and not addressed in this Notice. In addition, there is a
pending Docket No. RM15-19 which is a separate activity and is not
addressed in this Notice.
---------------------------------------------------------------------------

    OMB Control No.: 1902-0022.
    Abstract: Under the Interstate Commerce Act (ICA), (Section 20, 54
Stat. 916), the Interstate Commerce Commission (ICC) was authorized and
empowered to make investigations and to collect and record data to the
extent considered necessary or useful for the purpose of carrying out
the provisions of the ICA.
    In 1977, the Department of Energy Organization Act transferred to
the Commission from the ICC the responsibility to regulate oil pipeline
companies. In accordance with the transfer of authority, the Commission
was delegated the responsibility to require oil pipelines to file
annual reports of information necessary for the Commission to exercise
its statutory responsibilities.\2\ The transfer included the Form P,
the predecessor to the FERC Form No. 6, Annual Report of Oil Pipeline
Companies (Form 6).\3\
---------------------------------------------------------------------------

    \2\ Section 402(b) of the Department of Energy Organization Act
(DOE Act), 42 U.S.C. 7172 provides that; ``[t]here are hereby
transferred to, and vested in, the Commission all functions and
authority of the Interstate Commerce Commission or any officer or
component of such Commission where the regulatory function
establishes rates or charges for the transportation of oil by
pipeline or established the valuation of any such pipeline.''
    \3\ The ICC developed the Form P to collect information on an
annual basis to enable it to carry out its regulation of oil
pipeline companies under the Interstate Commerce Act. A
comprehensive review of the reporting requirements for oil pipeline
companies was performed on September 21, 1982, when the Commission
issued Order 260 revising the former ICC Form P, ``Annual Report of
Carriers by Pipeline'' and re-designating it as FERC Form No. 6,
``Annual Report of Oil Pipeline Companies''.
---------------------------------------------------------------------------

    To reduce burden on industry, the FERC Form No. 6 has three tiers
of reporting requirements:
    1. Each oil pipeline carrier whose annual jurisdictional operating
revenues has been $500,000 or more for each of the three previous
calendar years must file FERC Form No. 6. Oil pipeline carriers
submitting a complete FERC Form No. 6 must submit FERC Form 6-Q.\4\
Newly established entities must use projected data to determine whether
FERC Form No. 6 must be filed.
---------------------------------------------------------------------------

    \4\ FERC Form 6-Q is covered separately and is approved by OMB
under OMB Control No. 1902-0206. It is not a subject of this Notice;
FERC Form 6-Q is being addressed separately in Docket No. IC16-7-
000.
---------------------------------------------------------------------------

    2. Oil pipeline carriers exempt from filing FERC Form No. 6 whose
annual jurisdictional operating revenues have been more than $350,000
but less than $500,000 for each of the three previous calendar years
must prepare and file page 301, ``Operating Revenue Accounts (Account
600), and page 700, ``Annual cost of Service Based Analysis Schedule,''
of FERC Form No. 6. When submitting pages 301 and 700, each exempt oil
pipeline carrier must include page 1 of the FERC Form No. 6, the
Identification and Attestation schedules.
    3. Oil pipeline carriers exempt from filing FERC Form No. 6 and
page 301 and whose annual jurisdictional operating revenues were
$350,000 or less for each of the three previous calendar years must
prepare and file page 700, ``Annual Cost of Service Based Analysis
Schedule,'' of FERC Form No. 6.
    The Commission uses the FERC Form No. 6 information in:
     Implementation of its financial audits and programs, the
continuous review of the financial condition of regulated companies,
and the assessment of energy markets
     various rate proceedings and economic analyses
     background research for use in litigation
     programs relating to the administration of the ICA
     computation of annual charges, which are required by
Section 3401 of the Omnibus Budget Reconciliation Act of 1986.
    Type of Respondent: Oil Pipelines.
    Estimate of Annual Burden: The Commission estimates the annual
public

reporting burden \5\ and cost \6\ for the FERC Form No. 6 information
collection as follows.
---------------------------------------------------------------------------

    \5\ The burden associated with the one-time re-filing of Page
700 data for Years 2009-2011 has been completed and is not included.
    \6\ The cost is based on FERC's 2016 average cost (salary plus
benefits) of $74.50/hour. The Commission staff believes that the
industry's level and skill set is comparable to FERC.

                                                FERC Form No. 6, Annual Report of Oil Pipeline Companies
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Annual number
     Number of respondents \7\        of responses    Total number       Average burden & cost per         Total annual burden hours &       Cost per
                                     per respondent   of responses                response                      total annual cost         respondent ($)
(1)                                             (2)     (1) * (2) =  (4)..............................  (3) * (4) = (5).................       (5) / (1)
                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
198................................               1             198  161 hrs.;........................  31,878 hrs.;....................         $11,995
                                                                     $11,995..........................  $2,375,010......................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The reporting requirements are not changing. However we are making
non-substantive corrections to update the number of burden hours and
addresses in the instructions, as detailed in Attachment A.
---------------------------------------------------------------------------

    \7\ The number of respondents (and responses) is subject to
change because of normal fluctuations in the industry (e.g.,
companies merging, splitting, entering into and exiting the
industry).
---------------------------------------------------------------------------

FERC Form No. 580, Interrogatory on Fuel and Energy Purchase Practices

    OMB Control No.: 1902-0137.
    Abstract: FERC Form No. 580 is collected in even numbered years.
The Public Utility Regulatory Policies Act (PURPA) \8\ amended the
Federal Power Act (FPA) and directed the Commission to make
comprehensive biennial reviews of certain matters related to automatic
adjustment clauses (AACs) in wholesale rate schedules used by public
utilities subject to the Commission's jurisdiction. Specifically, the
Commission is required to examine whether the clauses effectively
provide the incentives for efficient use of resources and whether the
clauses reflect only those costs that are either ``subject to periodic
fluctuations'' or ``not susceptible to precise determinations'' in rate
cases prior to the time the costs are incurred.
---------------------------------------------------------------------------

    \8\ Enacted November 8, 1978.
---------------------------------------------------------------------------

    The Commission is also required to review the practices of each
public utility under AACs ``to insure efficient use of resources under
such clauses.'' \9\ In response to the PURPA directive, the Commission
(Docket Number IN79-6-000) established an investigation. Beginning in
1982, the Commission collected ``Interrogatory on Fuel and Energy
Purchase Practices'' data every other year.
---------------------------------------------------------------------------

    \9\ The review requirement is set forth in two paragraphs of
Section 208 of PURPA, 49 Stat. 851; 16 U.S.C. 824d.
---------------------------------------------------------------------------

    Based on filer comments in response to the new electronic form used
in the 2014 collections, FERC recommends the following changes to the
instructions. FERC is not changing the requirements of the information
collection.

Question 2a

--Revise Question 2a columns as follows:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
Docket number under which rate schedule  Docket number under which rate
 containing AAC through which costs       schedule containing AAC
 were passed during 2012 and/or 2013      through which costs were
 was accepted for filing by FERC. Was     passed during 2014 and/or 2015
 rate schedule superseded or abandoned    was accepted for filing by
 during 2012-2013? If so, provide dates.  FERC. Was rate schedule
                                          superseded or abandoned during
                                          2014-2015? If so, provide
                                          dates.
------------------------------------------------------------------------

Question 2b

--Revise the paragraph under Question 2b to read:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
If any of the Utility's wholesale rate   If any of the Utility's
 and/or service agreements containing     wholesale rate and/or service
 an AAC listed in Question 2a, that was   agreements containing an AAC
 used during 2012 and/or 2013, was        listed in Question 2a, that
 filed with the Commission before         was used during 2014 and/or
 January 1, 1990, attach an electronic    2015, was filed with the
 copy of it with this filing. List the    Commission before January 1,
 documents you are submitting below.      1990, attach an electronic
 Note: Once this information is           copy of it with this filing.
 submitted electronically in a text-      List the documents you are
 searchable format it will not be         submitting below. Note: Once
 necessary to submit it in future Form    this information is submitted
 580 filings. See: http://www.ferc.gov/   electronically in a text-
 docs-filing/elibrary/accept-file-        searchable format it will not
 formats.asp for listing of Commission    be necessary to submit it in
 accepted document types.                 future Form 580 filings. See:
                                          http://www.ferc.gov/docs-filing/elibrary/accept-file-formats.asp for listing of
                                          Commission accepted document
                                          types.
------------------------------------------------------------------------

Question 3

--Revise the paragraph under Question 3 to read:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
If during the 2012-2013 period, the      If during the 2014-2015 period,
 Utility had any contracts or             the Utility had any contracts
 agreements for the purchase of either    or agreements for the purchase
 energy or capacity under which all or    of either energy or capacity
 any portion of the purchase costs were   under which all or any portion
 passed through a fuel adjustment         of the purchase costs were
 clause (FAC), for each purchase from a   passed through a fuel
 PURPA Qualifying Facility (QF) or        adjustment clause (FAC), for
 Independent Power Producer (IPP)         each purchase from a PURPA
 provide the information requested in     Qualifying Facility (QF) or
 the non-shaded columns of the table      Independent Power Producer
 below. Provide the information           (IPP) provide the information
 separately for each reporting year       requested in the non-shaded
 2012 and 2013. Do not report purchased   columns of the table below.
 power where none of the costs were       Provide the information
 recovered through an FAC. For each       separately for each reporting
 purchase where costs were flowed         year 2014 and 2015. Do not
 through an FAC, fill-in the non-shaded   report purchased power where
 columns and either ``Only energy         none of the costs were
 charges'' or ``The total cost of the     recovered through an FAC. For
 purchase of economic power'' columns,    each purchase where costs were
 whichever apply.                         flowed through an FAC, fill-in
                                          the non-shaded columns and
                                          either ``Only energy charges''
                                          or ``The total cost of the
                                          purchase of economic power''
                                          columns, whichever apply.
------------------------------------------------------------------------

Question 4a

--Revise Question 4a columns as follows:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
If emission allowance costs were         If emission allowance costs
 incurred by the Utility in 2012 and/or   were incurred by the Utility
 2013 and were recovered through a FAC,   in 2014 and/or 2015 and were
 provide the following information.       recovered through a FAC,
                                          provide the following
                                          information.
Dollar value of emission allowance cost  Dollar value of emission
 passed through a FAC: 2012[verbar]2013.  allowance cost passed through
                                          a FAC: 2014[verbar]2015.
------------------------------------------------------------------------

Question 5

--Revise the paragraph under Question 5 as follows:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
Provide the information requested below  Provide the information
 regarding the Utility's fuel             requested below regarding the
 procurement policies and practices in    Utility's fuel procurement
 place during 2012 and/or 2013 for        policies and practices in
 fuels whose costs were subject to 18     place during 2014 and/or 2015
 CFR 35.14. Note: Responses to this       for fuels whose costs were
 question may be filed as Privileged.     subject to 18 CFR 35.14. Note:
 To do so, skip this question now and     Responses to this question may
 answer it via the Fuel Procurement       be filed as Privileged. To do
 Policies and Practices Privileged        so, skip this question now and
 Addendum provided. Otherwise, answer     answer it via the Fuel
 it here and your responses will be       Procurement Policies and
 made public.                             Practices Privileged Addendum
                                          provided. Otherwise, answer it
                                          here and your responses will
                                          be made public.
------------------------------------------------------------------------

Question 6

--Revise the paragraph under Question 6 as follows:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
For each fuel supply contract, of        For each fuel supply contract,
 longer than one year in duration, in     of longer than one year in
 force at any time during 2012 and/or     duration, in force at any time
 2013, where costs were subject to 18     during 2014 and/or 2015, where
 CFR 35.14, (including informal           costs were subject to 18 CFR
 agreements with associated companies),   35.14, (including informal
 provide the requested information.       agreements with associated
 Report the information individually      companies), provide the
 for each contract, for each calendar     requested information. Report
 year. [No response to any part of        the information individually
 Question 6 for fuel oil no. 2 is         for each contract, for each
 necessary.] Report all fuels consumed    calendar year. [No response to
 for electric power generation and        any part of Question 6 for
 thermal energy associated with the       fuel oil no. 2 is necessary.]
 production of electricity. Information   Report all fuels consumed for
 for only coal, natural gas, and oil      electric power generation and
 should be reported.                      thermal energy associated with
                                          the production of electricity.
                                          Information for only coal,
                                          natural gas, and oil should be
                                          reported.
------------------------------------------------------------------------

Question 7

--Revise the paragraph under Question 6 as follows:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
For each fuel supply contract,           For each fuel supply contract,
 including informal agreements with       including informal agreements
 associated or affiliated companies in    with associated or affiliated
 force at any time during 2012 or 2013    companies in force at any time
 WHERE CONTRACT SHORTFALL COSTS WERE      during 2014 or 2015 WHERE
 PASSED THROUGH an FAC subject to 18      CONTRACT SHORTFALL COSTS WERE
 CFR 35.14, provide for each contract     PASSED THROUGH an FAC subject
 separately the information requested     to 18 CFR 35.14, provide for
 below. Only report the information       each contract separately the
 requested for shortfalls that occurred   information requested below.
 under your contracts during reporting    Only report the information
 years 2012 or 2013 and that are not      requested for shortfalls that
 under dispute i.e., parties agree        occurred under your contracts
 there was indeed a shortfall.            during reporting years 2014 or
                                          2015 and that are not under
                                          dispute i.e., parties agree
                                          there was indeed a shortfall.
------------------------------------------------------------------------

Question 8

--Revise the paragraph under Question 8 as follows:

------------------------------------------------------------------------
                  From                                  To
------------------------------------------------------------------------
For each fuel supply contract that was   For each fuel supply contract
 bought-out or bought-down, including     that was bought-out or bought-
 informal agreements with associated or   down, including informal
 affiliated companies in force at any     agreements with associated or
 time during 2012 or 2013 WHERE           affiliated companies in force
 CONTRACT BUY-OUT AND/OR BUY-DOWN COSTS   at any time during 2014 or
 WERE PASSED THROUGH an FAC subject to    2015 WHERE CONTRACT BUY-OUT
 18 CFR 35.14, provide for each           AND/OR BUY-DOWN COSTS WERE
 contract separately the information      PASSED THROUGH an FAC subject
 requested below. Only report the         to 18 CFR 35.14, provide for
 information requested for contract buy-  each contract separately the
 downs and buy-outs that occurred under   information requested below.
 your contracts during reporting years    Only report the information
 2012 or 2013 and that are not under      requested for contract buy-
 dispute i.e., parties agree there was    downs and buy-outs that
 indeed a shortfall.                      occurred under your contracts
                                          during reporting years 2014 or
                                          2015 and that are not under
                                          dispute i.e., parties agree
                                          there was indeed a shortfall.
------------------------------------------------------------------------

    Access to the Revised Materials: A copy of the revised form (which
includes instructions and glossary) and desk reference will be
publically available in Docket No. IC16-11-000, but they will not be
published in the Federal Register.\10\ Interested parties can see these
materials electronically as part of this notice in FERC's eLibrary
(http://www.ferc.gov/docs-filing/elibrary.asp) by searching Docket No.
IC16-11-000.
---------------------------------------------------------------------------

    \10\ The revised form is intended to illustrate superficial
changes only and does not include all the interactive features of
the actual form.
---------------------------------------------------------------------------

    Type of Respondent: Large electric public utilities within FERC
jurisdiction.
    Estimate of Annual Burden: \11\ The Commission estimates the annual
\12\ public reporting burden for the information collection as:
---------------------------------------------------------------------------

    \11\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.
    \12\ The FERC Form 580 data is collected on a biennial basis. In
order to represent the burden appropriately, the ``Annual Number of
Responses per Respondent'' is assigned a figure of 0.5. This figure
means that one response per respondent is received on average for
each two year period. The ``Total Annual Burden Hours & Total Annual
Cost'' figures are all annual figures based on the biennial
frequency assumption.
    \13\ The estimates for cost per response are derived using the
2016 FERC average salary plus benefits of $154,647/year (or $74.50/
hour). Commission staff finds that the work done for this
information collection is typically done by wage categories similar
to those at FERC.

                                                                      FERC Form 580
                                                  [Interrogatory on fuel and energy purchase practices]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Annual number                                              Total annual  burden     Annual cost
                                          Number of     of responses    Total number     Average burden & cost    hours  & total  annual  per respondent
                                         respondents   per respondent   of responses      per  response \13\               cost                 ($)
                                                  (1)             (2)     (1) * (2) =  (4).....................  (3) * (4) = (5)........       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Respondents with FACs................              37             0.5            18.5  103 hrs.; $7,673.50.....  1,905.5 hrs.;                  3,836.75
                                                                                $141,959.75.
Respondents with AACs, but no FACs...              10             0.5               5  20 hrs.; $1,490.........  100 hrs.; $7,450.......             745
Respondents with no AACs nor FACs....              35             0.5            17.5  2 hrs.; $149............  35 hrs.; $2,607.50.....           74.50
                                      ------------------------------------------------------------------------------------------------------------------
    Total............................  ..............  ..............              41  ........................  2,040.5 hrs.;            ..............
                                                                                $152,017.25.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: September 1, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-21567 Filed 9-7-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Proposed Rules]
[Page 23678]
[DOCID:fr20my09-27]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2008-0786; FRL-8907-4]

Approval and Promulgation of Air Quality Implementation Plans;
Minnesota

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to approve a request submitted by the
Minnesota Pollution Control Agency (MPCA) on October 9, 2008, to revise
the Minnesota State Implementation Plan (SIP) for particulate matter
less than 10 microns (PM10). The proposed approval revises
the Minnesota SIP by updating information regarding the steel mini-mill
facility located at 1678 Red Rock Road, St. Paul, Minnesota. It
acknowledges the change of ownership and operation of the source from
North Star Steel Company to Gerdau Ameristeel US, Inc. The revision
also amends the SIP by removing the Administrative Order issued to
North Star Steel Company, and replacing the SIP conditions from the
Administrative Order and placing those SIP requirements in a joint
Title I/Title V document for Gerdau Ameristeel US, Inc. These revisions
will not result in an increase in PM10 emissions because no
emission limits were increased.

DATES: Comments must be received on or before June 19, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2008-0786, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: John M. Mooney, Chief, Criteria Pollutant Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: John M. Mooney, Chief, Criteria Pollutant
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal
holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental
Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J),
U.S. Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because EPA views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule.
    EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: May 5, 2009.
Walter W. Kovalick, Jr.,
Acting Regional Administrator, Region 5.
[FR Doc. E9-11636 Filed 5-19-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: December 18, 2008 (Volume 73, Number 244)]
[Notices]
[Page 77082]
[DOCID:fr18de08-120]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Form N-54A, SEC File No. 270-182, OMB Control No. 3235-
0237.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
     Form N-54A (17 CFR 274.53) under the Investment Company
Act of 1940 (15 U.S.C. 80a-1 et seq.) (the ``Act''); Notification of
Election to be Subject to Sections 55 through 65 of the Investment
Company Act of 1940 (15 U.S.C. 80a-54 through 64) Filed Pursuant to
Section 54(a) of the Act (15 U.S.C. 80a-53(a)).
    Form N-54A is the notification to the Commission of election to be
regulated as a business development company. A company making such an
election only has to file a Form N-54A once.
    It is estimated that approximately 6 respondents per year file with
the Commission a Form N-54A. Form N-54A requires approximately 0.5
burden hours per response resulting from creating and filing the
information required by the Form. The total burden hours for Form N-54A
would be 3.0 hours per year in the aggregate. The estimated annual
burden of 3.0 hours represents a decrease of 20.0 hours over the prior
estimate of 23.0 hours. The decrease in burden hours is attributable to
a decrease in the number of respondents from 46 to 6.
    The estimate of average burden hours for Form N-54A is made solely
for the purposes of the PRA and is not derived from a comprehensive or
even representative survey or study of the cost of Commission rules and
forms.
    The collection of information under Form N-54A is mandatory. The
information provided by the Form is not kept confidential. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid
control number.
    Please direct general comments regarding the above information to
the following persons: (i) Desk Officer for the Securities and Exchange
Commission, Office of Management and Budget, Room 10102, New Executive
Office Building, Washington, DC 20503 or e-mail to:
<EMAIL_ADDRESS>and (ii) Lewis W. Walker, Acting Director/CIO,
Securities and Exchange Commission, c/o Shirley Martinson, 6432 General
Green Way, Alexandria, VA 22312; or send an e-mail to: PRA_
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: December 10, 2008.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-29969 Filed 12-17-08; 8:45 am]

BILLING CODE 8011-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, Office of Water, Office of Wastewater Management 2. X OMB control number b. None 2040 0086 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes x No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. x Three years from approval date b. G Other Specify: / /___

7. Title Applications for NPDES Discharge Permits and the Sewage Sludge Management Permits 8. Agency form number( s) ( If applicable) EPA ICR # 0226.17, EPA Form Numbers: 3510 1; 3510 2A; 3510 2B; 3510 2C; 3510 2D; 3510 2E; 3510 2F; 3510 2S; 3510 6; 3510 7; 7550 22; 7550 22A 9. Keywords NPDES, Sewage Sludge, Applications, Permits 10. Abstract The Clean Water Act ( CWA) authorizes the EPA to issue permits for the discharge of pollutants into waters of the United States. The Act also authorizes EPA to issue permits for the use and disposal of sewage sludge. The ICR includes all the reporting requirements relating to facilities applying for NPDES permits to discharge wastewater and to facilitate disposing or applying sewage sludge ( biosolids).

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. X Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 291,898 b. Total annual responses 291,898 1. Percentage of these responses collected electronically 0 % c. Total hours requested 1,398,737 d. Current OMB inventory 2,038,694 e. Difference  639,957 f. Explanation of difference 1. Program Change 0 2. Adjustment  639,957 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 0 c. Total annualized cost requested $ 0 d. Current OMB inventory $ 1,005 e. Difference $ 1,005 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 1,005 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. X Program planning or management b. X_ Program evaluation f. __ Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Jack Faulk Phone: 202 564 0768 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official James A. Hanlon, Director Office of Wastewater Management / s/ Office of Water Date Signature of Senior Official or designee Date OMB 83 I 10/ 95


[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37622-37625]
[FR Doc No: 2015-16129]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0742]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of
Producers of Drugs and Listing of Drugs in Commercial Distribution

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
31, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0045.
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--21 CFR Part 207

OMB Control Number 0910-0045--Extension

    Requirements for drug establishment registration and drug listing
are set forth in section 510 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360), section 351 of the Public Health
Service Act (42 U.S.C. 262), and part 207 (21 CFR part 207).
Fundamental to FDA's mission to protect the public health is the
collection of this information, which is used for important activities
such as postmarket surveillance for serious adverse drug reactions,
inspection of drug manufacturing and processing facilities, and
monitoring of drug products imported into the United States.
Comprehensive, accurate, and up to date information is critical to
conducting these activities with efficiency and effectiveness.
    Under section 510 of the FD&C Act, FDA is authorized to establish a
system for registration of producers of drugs and for listing of drugs
in commercial distribution. To implement section 510 of the FD&C Act,
FDA issued part 207. Under current Sec.  207.20, manufacturers,
repackers, and relabelers that engage in the manufacture, preparation,
propagation, compounding, or processing of human or veterinary drugs
and biological products, including bulk drug substances and bulk drug
substances for prescription compounding, and drug premixes as well as
finished dosage forms, whether prescription or over-the-counter, are
required to register their establishment. In addition, manufacturers,
repackers, and relabelers are required to submit a listing of every
drug or biological product in commercial distribution. Owners or
operators of establishments that distribute under their own label or
trade name a drug product manufactured by a registered establishment
are not required either to register or list. However, distributors may
elect to submit drug listing information in lieu of the registered

establishment that manufactures the drug product. Foreign drug
establishments must also comply with the establishment registration and
product listing requirements if they import or offer for import their
products into the United States.
    Under current Sec.  207.21, establishments, both domestic and
foreign, must register with FDA within 5 days after beginning the
manufacture of drugs or biologicals, or within 5 days after the
submission of a drug application or biological license application. In
addition, establishments must register annually. Changes in individual
ownership, corporate or partnership structure, location, or drug
handling activity must be submitted as amendments to registration under
current Sec.  207.26 within 5 days of such changes. Under Sec.
207.20(b), private label distributors may request their own labeler
code and elect to submit drug listing information to FDA. In such
instances, at the time of submitting or updating drug listing
information, private label distributors must certify to the registered
establishment that manufactured, prepared, propagated, compounded, or
processed (which includes, among other things, repackaging and
relabeling) the listed drug that the drug listing submission was made.
Establishments must, within 5 days of beginning the manufacture of
drugs or biologicals, submit to FDA a listing for every drug or
biological product in commercial distribution at that time. Private
label distributors may elect to submit to FDA a listing of every drug
product they place in commercial distribution. Registered
establishments must submit to FDA drug product listing for those
private label distributors who do not elect to submit listing
information.
    Under Sec.  207.25, product listing information submitted to FDA by
domestic and foreign manufacturers must, depending on the type of
product being listed, include any new drug application number or
biological establishment license number, copies of current labeling and
a sampling of advertisements, a quantitative listing of the active
ingredient for each drug or biological product not subject to an
approved application or license, the national drug code (NDC) number,
and any drug imprinting information.
    In addition to the product listing information required, FDA may
also require, under Sec.  207.31, a copy of all advertisements and a
quantitative listing of all ingredients for each listed drug or
biological product not subject to an approved application or license;
the basis for a determination, by the establishment, that a listed drug
or biological product is not subject to marketing or licensing approval
requirements; and a list of certain drugs or biological products
containing a particular ingredient. FDA may also request, but not
require, the submission of a qualitative listing of the inactive
ingredients for all listed drugs or biological products, and a
quantitative listing of the active ingredients for all listed drugs or
biological products subject to an approved application or license.
    Under Sec.  207.30, establishments must update their product
listing information every June and December or, at the discretion of
the establishment, when any change occurs. These updates must include
the following information: (1) A listing of all drug or biological
products introduced for commercial distribution that have not been
included in any previously submitted list; (2) all drug or biological
products formerly listed for which commercial distribution has been
discontinued; (3) all drug or biological products for which a notice of
discontinuance was submitted and for which commercial distribution has
been resumed; and (4) any material change in any information previously
submitted. No update is required if no changes have occurred since the
previously submitted list.
    Historically, drug establishment registration and drug listing
information have been submitted in paper form using Form FDA 2656
(Registration of Drug Establishment/Labeler Code Assignment), Form FDA
2657 (Drug Product Listing), and Form FDA 2658 (Registered
Establishments' Report of Private Label Distributors) (collectively
referred to as FDA Forms). Changes in the FD&C Act resulting from
enactment of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) (FDAAA) require that drug establishment registration
and drug listing information be submitted electronically unless a
waiver is granted. Before the enactment of FDAAA, section 510(p) of the
FD&C Act expressly provided for electronic submission of drug
establishment registration information upon a finding that electronic
receipt was feasible, and section 510(j) of the FD&C Act provided that
drug listing information be submitted in the form and manner prescribed
by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C
Act, now expressly, requires electronic drug listing in addition to
drug establishment registration. In certain cases, if it is
unreasonable to expect a person to submit registration and listing
information electronically, FDA may grant a waiver from the electronic
format requirement.
    In the Federal Register of June 1, 2009 (74 FR 26248), FDA
announced the availability of a guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing'' (the 2009 guidance). The
document provides guidance to industry on the statutory requirement to
submit electronically drug establishment registration and drug listing
information. The guidance describes the types of information to include
for purposes of drug establishment registration and drug listing and
how to prepare and submit the information in an electronic format
(Structured Product Labeling (SPL) files) that FDA can process, review,
and archive. In addition to the information that previously was
collected on the FDA Forms, the guidance addresses electronic
submission of other required information as follows:
     For registered foreign drug establishments, the name,
address, and telephone number of its U.S. agent (Sec.  207.40(c));
     the name of each importer that is known to the
establishment (the U.S. company or individual in the United States that
is an owner, consignee, or recipient of the foreign establishment's
drug that is imported into the United States. An importer does not
include the consumer or patient who ultimately purchases, receives, or
is administered the drug, unless the foreign establishment ships the
drug directly to the consumer or the patient) (section 510(i)(1)(A) of
the FD&C Act); and
     the name of each person who imports or offers for import
(the name of each agent, broker, or other entity, other than a carrier,
that the foreign drug establishment uses to facilitate the import of
their drug into the United States) (section 510(i)(1)(A) of the FD&C
Act).
    FDA also recommends the voluntary submission of the following
additional information, when applicable:
     To facilitate correspondence between foreign
establishments and FDA, the email address for the U.S. agent, and the
telephone number(s) and email address for the importer and person who
imports or offers for import their drug;
     a site-specific Data Universal Numbering System number for
each entity (e.g., the registrant, establishments, U.S. agent,
importer);
     the NDC product code for the source drug that is repacked
or relabeled;

     distinctive characteristics of certain listed drugs, i.e.,
the flavor, the color, and image of the actual solid dosage form; and
     registrants may indicate that they view as confidential
the registrant's business relationship with an establishment, or an
inactive ingredient.
    In addition to this collection of information, there is an
additional burden for the following activities:
     preparing a standard operating procedure (SOP) for the
electronic submission of drug establishment registration and drug
listing information;
     creating the SPL file, including accessing and reviewing
the technical specifications and instructional documents provided by
FDA (accessible at http://www.fda.gov/oc/datacouncil/spl.html);
     reviewing and selecting appropriate terms and codes used
to create the SPL file (accessible at http://www.fda.gov/oc/datacouncil/spl.html);
     obtaining the digital certificate used with FDA's
electronic submission gateway and uploading the SPL file for submission
(accessible at http://www.fda.gov/esg/default.htm); and
     requests for waivers from the electronic submission
process as described in the draft guidance.
    When FDA published the 2009 guidance on submitting establishment
registration and drug listing information in electronic format, the
Agency also amended its burden estimates for OMB control number 0910-
0045 to include the additional burden for the collection of information
that had not been submitted using the FDA forms, and to create and
upload the SPL file. The amended burden estimates included the one-time
preparation of an SOP for creating and uploading the SPL file. Although
most firms will already have prepared an SOP for the electronic
submission of drug establishment registration and drug listing
information, each year additional firms will need to create an SOP. As
provided in Table 2, FDA estimates that approximately 1,000 firms will
have to expend a one-time burden to prepare, review, and approve an
SOP, and the Agency estimates that it will take 40 hours per
recordkeeper to create 1,000 new SOPs for a total of 40,000 hours.
    In the Federal Register of March 23, 2015 (80 FR 15214), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
    The comment noted that under Sec.  207.20(a), manufacturers,
repackers, and relabelers are required to register their establishment
and submit a listing of every drug or biological product in commercial
distribution. Under Sec.  207.20(b), owners or operators of
establishments that distribute under their own label or trade name a
drug product manufactured by a registered establishment are not
required either to register or list but may elect to submit drug
listing information in lieu of the registered establishment that
manufactures the drug product. The comment said that although the
burden of listing private label drugs rests on the manufacturer, the
standard industry practice has been to submit two separate listings
under different marketing categories. The comment said that these
listings are submitted either by the private label distributor or by
the manufacturer and ``in order for the necessary information to be
provided to FDA (all Offices and Centers) both listings are
necessary.'' The comment also recommended that all drug listings should
include the marketing category of the drug.
    FDA Response: Under section 510 of the FD&C Act and part 207,
contract manufacturers (registered establishments) are required to list
their products with FDA under their own labeler code. To properly
identify such a listing, contract manufacturers should list products
manufactured for a private label distributor by using one of following
marketing categories: (1) Approved Drug Product Manufactured
Exclusively For Private Label Distributor; (2) OTC Monograph Drug
Product Manufactured Exclusively For Private Label Distributor; (3)
Unapproved Drug Product Manufactured Exclusively For Private Label
Distributor. Contract manufacturers may also include the private label
distributor's labeling with the listing submission.
    Additionally, Sec.  207.20(b) requires that the private label
distributor have its product listed under its own labeler code (using
whatever marketing category is appropriate to the finished product
(e.g., NDA, OTC Monograph, Unapproved Drug)). The private label
distributor may elect to do this on its own. If the private label
distributor elects not to do this, then the responsibility for
submitting the additional listing falls on the registered establishment
(the contract manufacturer).
    In Tables 1 and 2, the information collection requirements of the
drug establishment registration and drug listing requirements have been
grouped according to the information collection areas of the
requirements.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        Activity                             Number of         responses per       Total annual    Average burden per     Total hours
                                                            respondents         respondent          responses           response
--------------------------------------------------------------------------------------------------------------------------------------------------------
New registrations, including new labeler codes requests              1,400                2                 2,800                4.5              12,600
Annual updates of registration information.............             10,000                1                10,000                4.5              45,000
New drug listings......................................              1,567                7                11,000                4.5              49,500
New listings for private label distributor.............                146               10.06              1,469                4.5               6,611
June and December updates of all drug listing                        5,300               20               106,000                4.5             477,000
 information...........................................
Waiver requests........................................                  1                1                     1                1                     1
                                                        ------------------------------------------------------------------------------------------------
    Total..............................................  .................  ..................  .................  ..................            590,712
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                    Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Activity resulting from Section 510(p) of the FD&C Act as      Number of      Number of records     Total annual      Average burden
                     amended by FDAAA                        recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-time preparation of SOP..............................              1,000                  1              1,000                 40             40,000
SOP maintenance..........................................              3,295                  1              3,295                  1              3,295
    Total................................................             43,295
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.

    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16129 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18351-18352]
[FR Doc No: 2013-06823]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0032]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling;
Notification Procedures for Statements on Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April
25, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0331.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food Labeling; Notification Procedures for Statements on Dietary
Supplements--21 CFR 101.93 (OMB Control Number 0910-0331)--Extension

    Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) requires
that FDA be notified by manufacturers, packers, and distributors of
dietary supplements that they are marketing a dietary supplement
product that bears on its label or in its labeling a statement provided
for in section 403(r)(6). Section 403(r)(6) of the FD&C Act requires
that FDA be notified, with a submission about such statements, no later
than 30 days after the first marketing of the dietary supplement.
Information that is required in the submission includes: (1) The name
and address of the manufacturer, packer, or distributor of the dietary
supplement product; (2) the text of the statement that is being made;
(3) the name of the dietary ingredient or supplement that is the
subject of the statement; (4) the name of the dietary supplement
(including the brand name); and (5) a signature of a responsible
individual who can certify the accuracy of the information presented,
and who must certify that the information contained in the notice is
complete and accurate, and that the notifying firm has substantiation
that the statement is truthful and not misleading.
    The procedural regulation for this program is codified at 21 CFR
101.93. Section 101.93 provides submission procedures and identifies
the information that must be included in order to meet the requirements
of section 403 of the FD&C Act.
    Description of Respondents: Respondents to this collection of
information include manufacturers, packers, or distributors of dietary
supplements that bear section 403(r)(6) of the FD&C Act statements on
their labels or labeling.
    In the Federal Register of January 18, 2013 (78 FR 4153), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one letter in response to the
notice. One comment in the letter suggested that electronic submission
could potentially decrease the reporting burden. FDA agrees and is in
the process of developing a method of receiving submissions
electronically.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                          Number of
  21 CFR section       Number of        responses per       Total annual      Average burden      Total hours
                      respondents         respondent         responses         per response
----------------------------------------------------------------------------------------------------------------
         101.93              2,200                  1              2,200               0.75              1,650
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We believe that there will be minimal burden on the industry to
generate information to meet the requirements of section 403 of the
FD&C Act in submitting information regarding section 403(r)(6)
statements on labels or in labeling of dietary supplements. We are
requesting only information that is immediately available to the
manufacturer, packer, or distributor of the dietary supplement that
bears such a statement on its label or in its labeling. We estimate
that, each year, approximately 2,200 firms will submit the information
required by section 403 of the FD&C Act. We estimate that a firm will
require 0.75 hours to gather the information needed and prepare a
submission, for a total of 1,650 hours (2,200 x 0.75). This estimate is
based on the average number of notification submissions received by us
in the preceding 3 years.

    Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06823 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P