[Federal Register: March 24, 2006 (Volume 71, Number 57)]
[Notices]
[Page 14874]
[DOCID:fr24mr06-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-86-000]

CenterPoint Energy Gas Transmission Company; Notice of Request
Under Blanket Authorization

March 16, 2006.

    Take notice that on March 10, 2006, CenterPoint Energy Gas
Transmission Company (CEGT), 1111 Louisiana Street, Houston, Texas
77002-5231, filed in Docket No. CP06-86-000, a request pursuant to
Sections 157.205 and 157.216 of the Commission's Regulations under the
Natural Gas Act (18 CFR Sections 157.205 and 157.216) for authorization
to abandon certain facilities in the State of Louisiana, under CEGT's
blanket certificate issued in Docket Nos. CP82-384-000 and 001 pursuant
to section 7(c) of the Natural Gas Act, all as more fully set forth in
the application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the Web at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,

(202) 502-8659.
    CEGT proposes to abandon, by sale and transfer, certain above-
ground facilities that are currently a part of various CEGT delivery
point facilities in the State of Louisiana as described more fully in
the request. CEGT further proposes to sell and transfer these
facilities to CenterPoint Energy Louisiana Gas, a distribution division
of CenterPoint Energy Gas Resources Corp, d/b/a, at the estimated net
book value, which as of December 31, 2005 is $14,895.43. CEGT states
that no services would be abandoned as a result of the proposed sale
and transfer. Louisiana Gas, it is said, would own and operate these
facilities as part of its distribution system.
    Any person or the Commission's Staff may, within 45 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to Section 157.205 of
the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR
157.205) a protest to the request. If no protest is filed within the
time allowed therefore, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request shall be treated as
an application for authorization pursuant to Section 7 of the NGA.
    Any questions regarding this application should be directed to
Lawrence O. Thomas, Director--Rates & Regulatory, CenterPoint Energy
Gas Transmission Company, P.O. Box 21734, Shreveport, Louisiana 71151,
or call<PHONE_NUMBER> or fax<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
[FR Doc. E6-4249 Filed 3-23-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 9, 2007 (Volume 72, Number 46)]
[Notices]
[Page 10795-10796]
[DOCID:fr09mr07-134]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55381; File No. SR-CBOE-2007-18]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Request Permanent Approval of a Pilot Program Relating
to Market-Makers Quoting Remotely

March 1, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 22, 2007, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Exchange filed the proposal as a ``non-controversial''
proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
\3\ and Rule 19b-4(f)(6) thereunder.\4\ The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to amend CBOE Rule 8.3 to request permanent approval
of a pilot program relating to Market-Makers quoting away from CBOE's
trading floor. The text of the proposed rule change is available on
CBOE's Web site (http://www.cboe.org/Legal), at the CBOE's Office of

the Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to request permanent
approval of an existing Pilot Program that allows a CBOE Market-Maker
to submit electronic quotations away from CBOE's trading floor in his/
her appointed Hybrid Classes and Hybrid 2.0 Classes. In March 2005,
CBOE amended its rules relating to Market-Maker appointments and
quoting obligations.\5\ Among other changes, CBOE amended Rule 8.3 to
provide that a Market-Maker may submit electronic quotations from a
location outside of his/her appointed trading station.\6\ Previously,
Market-Makers were only permitted to stream electronic quotations in
their appointed Hybrid and Hybrid 2.0 classes when they were physically
present in the trading crowd. In making this change, CBOE determined to
request that it only be approved on a pilot basis to give CBOE the
ability to evaluate the effectiveness of allowing Market-Makers to
quote remotely. CBOE extended the Pilot Program for an additional year
last March 2006.\7\ The current Pilot Program is scheduled to expire on
March 24, 2007.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 51429 (March 24,
2005), 70 FR 16536 (March 31, 2005) (approving SR-CBOE-2004-58).
    \6\ Last year, CBOE amended its rules to allow Market-Makers to
create a ``Virtual Trading Crowd'' appointment, and also modified
the language in Rule 8.3(c) such that it states a Market-Maker can
quote electronically away from CBOE's trading floor pursuant to the
Pilot Program. (See Securities Exchange Act Release No. 54182 (July
20, 2006), 71 FR 42692 (July 20, 2006) (approving SR-CBOE-2006-51).)
    \7\ See Securities Exchange Act Release No. 53410 (March 3,
2006), 71 FR 12747 (March 13, 2006) (granting immediate
effectiveness to SR-CBOE-2006-24).
---------------------------------------------------------------------------

    CBOE believes that the Pilot Program has been successful, in that
it allows Market-Makers to choose how they would like to participate in
CBOE's Hybrid Trading System, i.e., electronically, in open outcry, or
both. Although not all Market-Makers have chosen to quote
electronically away from CBOE's trading floor in their appointed Hybrid
Classes and Hybrid 2.0 Classes, those Market-Makers that have availed
themselves of this Pilot Program continue to provide liquidity and
increased competition in their appointed option classes when they quote
remotely. CBOE has not experienced any negative effects of allowing
Market-Makers to quote from a location away from CBOE's trading floor.
Thus, CBOE believes it would be appropriate and beneficial to
permanently approve the Pilot Program, and permit Market-Makers to
continue to have the option to quote electronically away from CBOE's
trading floor.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\8\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) of the
Act,\9\ which requires that the rules of an exchange be designed to
promote just and equitable principles of trade, to prevent fraudulent
and manipulative acts and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(iii) of the Act \10\ and subparagraph (f)(6) of Rule 19b-4
\11\

thereunder because it does not: (i) Significantly affect the protection
of investors or the public interest; (ii) impose any significant burden
on competition; (iii) become operative for 30 days from the date on
which it was filed, or such shorter time as the Commission may
designate; and the Exchange has given the Commission written notice of
its intention to file the proposed rule change at least five business
days prior to filing.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-18 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2007-18. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of the CBOE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2007-18 and should be
submitted on or before March 30, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-4191 Filed 3-8-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Rules and Regulations]
[Pages 2449-2453]
[FR Doc No: 2019-00713]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2018-0530; FRL-9987-96-Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
State of Colorado; Motor Vehicle Inspection and Maintenance Program and
Associated Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving two
State Implementation Plan (SIP) revisions submitted by the State of
Colorado. The revisions involve amendments to Colorado's Regulation
Number 11, ``Motor Vehicle Emissions Inspection Program.'' The
revisions enhance the use of Regulation Number 11's Clean Screen
Program, allow self-inspecting vehicle fleets to use the On-Board
Diagnostics (OBD) testing procedure, provide corrections to the Low
Emitter Index (LEI) component of the Clean Screen Program, clarify
existing provisions, correct administrative errors, delete obsolete
language, establish inspection procedures for when emission control
equipment tampering is detected, and make several other minor
associated revisions. These actions are being taken under section 110
of the Clean Air Act (CAA).

DATES: This final rule is effective on March 11, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-OAR-2018-0530. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available (e.g.,
Confidential Business Information) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material,

is not placed on the internet and will be publicly available only in
hard copy form. Publicly available docket materials are available
through www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Tim Russ, Air Program, U.S.
Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In a rulemaking published on August 17, 2018 (83 FR 41035), the EPA
proposed approval of various revisions to Colorado's Regulation Number
11 that the State submitted to the EPA on February 20, 2015, and on May
14, 2018. Most of the revisions involve minor updates to several
sections of Regulation Number 11 and the deletion of obsolete language.
The August 17, 2018 notice gives a detailed description of each
revision.
    In this rulemaking the EPA is taking final action to approve the
proposed revisions, which are listed in section III below. The reasons
for our approval are provided in the proposed rule.

II. Response to Public Comments

    The EPA received one anonymous comment on the proposed SIP
amendments to Colorado's Regulation Number 11. After reviewing the
comment, the EPA has determined that the comment is outside the scope
of our proposed action. We note the EPA is not removing or relaxing any
emissions standards in this action. The comment that we received on
this action is available for review in the docket for this rulemaking.
This rule will be finalized as proposed without revisions.

III. Final Action

    For the reasons expressed in the proposed rule, the EPA is
approving the two SIP submittals to Regulation Number 11 as submitted
by the State of Colorado on February 20, 2015, and on May 14, 2018.
These revisions were discussed in our August 17, 2018 proposed rule and
are as follows:
    a. Addition of a definition of ``Tampering'' to Part A.II.
    b. Revisions to Part B.IV.B to require span gases to be labelled in
accordance with Attachment VI of Appendix A.
    c. Revisions to Part A.II.16 and Part C.XII. (A.3 and C.2) to
increase clean screening efficiency by removing the requirement that
two qualifying clean screen observations must be made on different days
or at different locations.
    d. Revisions to Part C.II.B.4 to remove incomplete and obsolescent
qualifying criteria for certain vehicles that are unable to be tested
on the IM240 chassis dynamometer.
    e. Revisions to Part C.II.C to allow self-inspecting gasoline
vehicle fleets to utilize the more effective and more convenient OBDII
testing procedure on all 1996 model year and newer vehicles.
    f. Revisions to Part C.II.C.3 regarding acceptable readiness
criteria for OBD sensors and monitors.
    g. Revisions to Part C.II.C.9 and C.10 regarding I/M240 tests and
tampering associated with OBD tests.
    h. Revisions to Part C.VIII and IX to clarify and modernize
provisions for issuance of emissions repair, diagnostic and economic
hardship waivers.
    i. Revisions to Part D.I.B. 5, 6, and 7 to remove obsolete language
regarding dwell meters, timing lights, and idle adjustment.
    j. Revisions to Part F.VI.B, the roadside remote sensing clean
screen LEI, to allow for greater utilization of this component of the
I/M program.
    k. Revisions to Part F.VII regarding OBD testing criteria.
    l. Revisions to Appendix A, Technical Specifications; Introduction,
Section 2.11; Attachment IV, Section 2.0; Attachment V; Attachment VI,
and the deletion of Appendix B in its entirety to remove obsolete
specifications and procedures for vehicle inspection analyzer
calibration gasses.
    m. Corrections of typographical, grammatical, and formatting errors
throughout Regulation Number 11.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of
Colorado's Regulation Number 11 described in the amendments set forth
to 40 CFR part 52, below. The EPA has made, and will continue to make,
these materials generally available through www.regulations.gov and at
the EPA Region 8 office (please contact the person identified in the
FOR FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by the EPA
for inclusion in the SIP, have been incorporated by reference by the
EPA into that plan, are fully federally enforceable under sections 110
and 113 of the CAA as of the effective date of the final rulemaking of
the EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Statutory and Executive Orders Review

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
final action merely approves some state law as meeting federal
requirements; this final action does not impose additional requirements
beyond those imposed by state law. For that reason, this final action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, Oct. 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, Feb. 2, 2017)
regulatory action because actions such as approving SIPs are exempted
under Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, Aug. 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible

methods, under Executive Order 12898 (59 FR 7629, Feb. 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 8, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: December 20, 2018.
Douglas Benevento,
Regional Administrator, Region 8.

    40 CFR part 52 is amended to read as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart G--Colorado

0
2. In Sec.  52.320, the table in paragraph (c) is amended by:
0
a. Revising the entry for ``II. Definitions.'' under the centered
heading ``5 CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions
Inspection Program--Part A, General Provisions, Area of Applicability,
Schedules for Obtaining Certification of Emissions Control,
Definitions, Exemptions, and Clean Screening/Remote Sensing'';
0
b. Revising the entry for ``IV. Span Gases For Use With Colo `94 Test
Analyzer Systems.'' under the centered heading ``5 CCR 1001-13,
Regulation Number 11, Motor Vehicle Emissions Inspection Program--Part
B, Standards and Procedures for the Approval, Operation, Gas Span
Adjustment, Calibration and Certification of the Division Approved Test
Analyzer Systems for Use in the Basic and Enhanced Areas and Test
Analyzer Systems for Licensed Dealers in the Enhanced Area'';
0
c. Revising the entries for ``II. Exhaust Emissions Inspection
Procedures'' and ``VIII. Certification of Emissions Control'', by
removing and reserving the entry for ``IX. Adjustment Procedures'' and
by revising the entries for ``X. Emissions Related Repairs'' and ``XII.
Clean Screen Inspection Program Procedures'' under the centered heading
``5 CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions
Inspection Program--Part C, Inspection Procedures and Requirements for
Exhaust Emissions, Fuel Evaporation Control, Visible Smoke Emissions,
Emissions Control Systems, On-Board Diagnostics (OBD); and Practices to
Ensure Proper Emissions Related Adjustments and Repairs'';
0
d. Revising the entry for ``I. Licensing of Emissions Inspection and
Readjustment Stations, Inspection-Only Stations, Inspection-Only
Facilities, Enhanced Inspection Centers, Fleet Inspection Stations and
Motor Vehicle Dealer Test Facilities'' under the centered heading ``5
CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions Inspection
Program--Part D, Qualification and Licensing of Emissions Mechanics,
Emissions Inspectors and Clean Screen Inspectors; Licensing of
Emissions Inspection and Readjustment Stations, Inspection-Only
Stations, Inspection-Only Facilities, Fleets, Motor Vehicle Dealer Test
Facilities and Enhanced Inspection Centers; Qualification of Clean
Screen Inspection Sites; and Registration of Emissions Related Repair
Facilities and Technicians'';
0
e. Revising the entries for ``VI. Clean Screen Program Maximum
Allowable Emissions Limits'' and ``VII. On-Board Diagnostic Inspection
Passing Criteria'' under the centered heading ``5 CCR 1001-13,
Regulation Number 11, Motor Vehicle Emissions Inspection Program--Part
F, Maximum Allowable Emissions Limits for Motor Vehicle Exhaust,
Evaporative and Visible Emissions for Light-Duty and Heavy-Duty
Vehicles'';
0
f. Revising the entry for ``Appendix A, Technical Specifications''
under the centered heading ``5 CCR 1001-13, Regulation Number 11,
Appendices''; and
0
g. Removing the entry for ``Appendix B, Standards and Specifications
for the Suppliers of Span and Calibration Gases'' under the centered
heading ``5 CCR 1001-13, Regulation Number 11, Appendices.''
    The revisions read as follows:

Sec.  52.320  Identification of plan.

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                          State       EPA effective   Final Rule citation/
               Title                 effective date       date                date                 Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
  5 CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions Inspection Program--Part A, General Provisions,
 Area of Applicability, Schedules for Obtaining Certification of Emissions Control, Definitions, Exemptions, and
                                         Clean Screening/Remote Sensing
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
II. Definitions....................      11/30/2014       3/11/2019  [Insert Federal         ...................
                                                                      Register citation]. 2/
                                                                      7/2019.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
     5 CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions Inspection Program--Part B, Standards and
   Procedures for the Approval, Operation, Gas Span Adjustment, Calibration and Certification of the Division
  Approved Test Analyzer Systems for Use in the Basic and Enhanced Areas and Test Analyzer Systems for Licensed
                                          Dealers in the Enhanced Area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
IV. Span Gases For Use With              11/30/2014       3/11/2019  [Insert Federal         ...................
 Colorado 94 and Colorado 97 Test                                     Register citation]. 2/
 Analyzer Systems.                                                    7/2019.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
 5 CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions Inspection Program--Part C, Inspection Procedures
  and Requirements for Exhaust Emissions, Fuel Evaporation Control, Visible Smoke Emissions, Emissions Control
  Systems, On-Board Diagnostics (OBD); and Practices To Ensure Proper Emissions Related Adjustments and Repairs
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
II. Exhaust Emissions Inspection     11/30/2014, 9/       3/11/2019  [Insert Federal         .
 Procedures.                                30/2017                   Register citation]. 2/
                                                                      7/2019.

                                                  * * * * * * *
VIII. Certification of Emissions         11/30/2014       3/11/2019  [Insert Federal         ...................
 Control.                                                             Register citation]. 2/
                                                                      7/2019.

                                                  * * * * * * *
X. Emissions Related Repairs.......      11/30/2014       3/11/2019  [Insert Federal         ...................
                                                                      Register citation]. 2/
                                                                      7/2019.

                                                  * * * * * * *
XII. Clean Screen Inspection             11/30/2014       3/11/2019  [Insert Federal         ...................
 Program Procedures.                                                  Register citation]. 2/
                                                                      7/2019.
----------------------------------------------------------------------------------------------------------------
   5 CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions Inspection Program--Part D, Qualification and
   Licensing of Emissions Mechanics, Emissions Inspectors and Clean Screen Inspectors; Licensing of Emissions
    Inspection and Readjustment Stations, Inspection-Only Stations, Inspection-Only Facilities, Fleets, Motor
 Vehicle Dealer Test Facilities and Enhanced Inspection Centers; Qualification of Clean Screen Inspection Sites;
                     and Registration of Emissions Related Repair Facilities and Technicians
----------------------------------------------------------------------------------------------------------------
I. Licensing of Emissions                 9/30/2017       3/11/2019  [Insert Federal         ...................
 Inspection and Readjustment                                          Register citation]. 2/
 Stations, Inspection-Only                                            7/2019.
 Stations, Inspection-Only
 Facilities, Enhanced Inspection
 Centers, Fleet Inspection Stations
 and Motor Vehicle Dealer Test
 Facilities.

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   5 CCR 1001-13, Regulation Number 11, Motor Vehicle Emissions Inspection Program--Part F, Maximum Allowable
   Emissions Limits for Motor Vehicle Exhaust, Evaporative and Visible Emissions for Light-Duty and Heavy-Duty
                                                    Vehicles
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
VI. Clean Screen Program Maximum          9/30/2017       3/11/2019  [Insert Federal         ...................
 Allowable Emissions Limits.                                          Register citation]. 2/
                                                                      7/2019.
VII. On-Board Diagnostic Inspection       9/30/2017       3/11/2019  [Insert Federal         ...................
 Passing Criteria.                                                    Register citation]. 2/
                                                                      7/2019.

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                                 5 CCR 1001-13, Regulation Number 11, Appendices
----------------------------------------------------------------------------------------------------------------
Appendix A, Technical                11/30/2014, 9/       3/11/2019  [Insert Federal         ...................
 Specifications.                            30/2017                   Register citation]. 2/
                                                                      7/2019.

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* * * * *
[FR Doc. 2019-00713 Filed 2-6-19; 8:45 am]
 BILLING CODE 6560-50-P


NOTE:  This draft supporting statement for the First Federal Register
Notice (December 2008) uses the estimates for the current approved
Information Collection (EPA ICR Number 0138.08).  EPA will revise the
estimates prior to OMB submission with the Second Federal Register
Notice. The public will have a second opportunity to comment at that
time.

THE INFORMATION COLLECTION REQUEST (ICR)

SUPPORTING STATEMENT

FOR THE 301(h) PROGRAM

Modification of Secondary Treatment Requirements for Discharges Into
Marine Waters, EPA ICR Number 0138.0809, OMB Control Number 2040-0088

April 2005December 2008

A.	JUSTIFICATION

1.	Need for Information Collection

As described below in more detail, the 301(h) program involves
collecting information from two sources: 1) the municipal wastewater
treatment facility, commonly called a publicly owned treatment works
(POTW) and 2) the State in which the POTW is located.  The POTW seeking
to obtain a 301(h) waiver provides application, monitoring, and toxic
control program information.  The State provides State determination and
State certification information.  The statutory and regulatory
authorities for these two aspects of the section 301(h) program are
discussed in the following sections.

Statutory Authority

The Clean Water Act (CWA) requires that POTWs achieve compliance with
uniform technology-based standards of secondary treatment.  These
standards describe the minimum level of effluent quality attainable by
secondary treatment.  Section 301(h) of the CWA provides that POTWs that
discharge into certain marine waters specified in the section may apply
for and obtain a waiver from secondary treatment requirements for
conventional pollutants (Biochemical oxygen demand(BOD, Suspended
solids(SS, pH(a measure of acidity or alkalinity) if particular
regulatory criteria are met.  According to this section, such a waiver
must be issued by the Administrator of the U.S. Environmental Protection
Agency (EPA) with the concurrence of the State.  The section also
established an application deadline of December 31, 1982, for eligible
POTWs choosing to apply.  The POTW receiving a 301(h) waiver benefits
since it reduces costs of construction as well as operation and
maintenance.  The Ocean Pollution Reduction Act of 1994 provided an
opportunity for one additional POTW to reapply for a 301(h) waiver by
April 1995.

Section 301(h) lists nine criteria that an applicant must satisfy to
ensure that any proposed less-than-secondary discharge does not
adversely affect the marine receiving water(s ecosystem or beneficial
uses.  To obtain a section 301(h) waiver, a POTW must demonstrate that
it meets the following criteria:

1)	An applicable water quality standard exists for the pollutant for
which the modification is requested.

2)	The modified discharge, alone or in combination with pollutants from
other sources, will not interfere with attaining or maintaining water
quality that protects water supplies, biota, and recreational uses.

3)	The POTW has a monitoring program to measure the discharge(s effects
on the receiving waters and biota.

4)	The modified discharge will not result in additional requirements on
any other point or nonpoint sources.

5)	All pretreatment requirements will be enforced.

6)	Special requirements for pollutants for which no pretreatment
standards exist will be met.

7)	A program to eliminate the entrance of toxic pollutants from
nonindustrial sources will be established.

8)	There will be no new or increased discharges during the term of the
permit.

9)	The discharge has received at least primary or equivalent treatment
and meets water quality criteria established under section 304(a)(1) of
the CWA.

Once a 301(h) permit is issued, the POTW must monitor the effects of its
discharge and establish both a monitoring program and a toxics control
program for nonindustrial and industrial sources as specified in Numbers
3, 5, 6, and 7 above.

Numbers 6 and 9 of the above criteria were added to the original
provisions of section 301(h).  They correspond to sections 303(c) and
(d), respectively, of the Water Quality Act (WQA) and amend section
301(h) of the CWA.  The WQA (Public Law 100-4) was passed February 4,
1987.  WQA section 303(c) requires each 301(h) waiver applicant serving
a population of over 50,000 to make two demonstrations: 1) to
demonstrate that, with respect to any toxic pollutant introduced from an
industrial source for which there is an applicable pretreatment
requirement in effect, sources introducing waste into the POTW are in
compliance with all applicable pretreatment requirements; and 2) to
demonstrate that the POTW has in effect a pretreatment program which, in
combination with the  treatment processes, removes the same amount of
such pollutant as if the POTW has secondary treatment and no
pretreatment program exists for such pollutant.  Section 303(d) of the
WQA states that, at the time the waiver becomes effective, 301(h) waiver
applicants must be discharging effluent that has received at
least-primary or equivalent treatment and meets water quality criteria
after initial mixing.

The State in which the discharge originates is responsible for
determining compliance with two of the nine criteria listed above(Number
1, which states that an applicable water quality standard must exist,
and Number 4, which states that the discharge must not result in
additional requirements for any other point or nonpoint sources.  The
State is the best entity to evaluate these criteria because compliance
with state law and impacts on other State sources are matters of State
responsibility.  In addition, section 301(h) provides that EPA may not
approve a 301(h) modification if the State does not concur with the
modification.

Another section of the CWA also relates to State activities.  Section
401(a)(1) of the Act requires that States certify that all EPA-issued
permits meet all State laws, including State water quality standards.
This certification is relevant to 301(h) modified permits because the
authority to make 301(h) decisions has not been delegated to the states.
 Every permit with 301(h) modification is issued either by EPA alone or
jointly by the State and EPA, in the case of States delegated authority
to implement the National Pollutant Discharge Elimination System (NPDES)
program.  If the State does not concur with a 301(h) waiver, or if the
State denies certification under section 401 of the CWA, EPA may not
issue a permit.  Concurrence with a 301(h) decision takes the form of
the 401(a)(1) certification.  Combining these two requirements ensures
that any effort expended in concurring with a 301(h) requirement will
not be repeated in preparing a 401(a)(1) certification.

Regulatory Authority

Regulations implementing section 301(h) of the CWA were originally
promulgated by EPA on June 15, 1979, and revised on June 8, 1982, and
November 26, 1982.  Revisions to these 1982 regulations were published
on August 9, 1994, to respond to changes required by the WQA.  This
supporting statement incorporates the requirements of these revisions to
the 301(h) regulations.

The 301(h) regulations, 40 CFR Part 125, Subpart G, incorporate the nine
301(h) criteria listed previously and specify the way in which a POTW
that wants to obtain a variance from secondary treatment requirements
can demonstrate that its less-than-secondary discharge complies with
these criteria.  The regulations establish requirements for
applications, for monitoring and toxics control programs, and for State
determinations of compliance with the two criteria of the CWA discussed
in the previous section.  The regulations mandating collection of State
certification information are contained in 40 CFR 124.53 and 124.54.

Program Status and Information Needs

As indicated above, the application deadline for 301(h) waivers has
passed; EPA received 208 applications by the 1982 deadline.  The
application received pursuant to the Ocean Pollution Reduction Act of
1994 is for a POTW that previously withdrew from the 301(h) program.
Table 1 lists the POTWs that currently have waivers or have decisions
pending.

	TABLE 1.  STATUS OF POTWs AS OF AUGUST 2005

Current 301(h) Waiver Recipients

Name

State

EPA REGION I

Bayville Village

Boothbay Harbor

Bucksport

Eastport

Eastport/Quoddy

Jonesport

Lubec

Milbridge

Newton Highlands (Squirrel Is)

North Haven

Northport Village (Belfast)

Searsport

Winterport

Gloucester

Gosnold

Portsmouth

EPA REGION II

Aguadilla

Arecibo

Bayamon/Puerto Nuevo

Carolina

EPA REGION IX

Tafuna (Pago Pago)

Utulei

Goleta

Morro Bay

San Diego (Pt. Loma)*

Honouliuli (Honolulu)

Sand Island (Honolulu)

Agana

Agat

Northern District (Dededo)

EPA REGION X

Anchorage

Haines

Ketchikan

Pelican

Petersburg

Sitka

Skagway

Whittier

Wrangell

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

MA

MA

NH

PR

PR

PR

PR

AS

AS

CA

CA

CA

HI

HI

GU

GU

GU

AK

AK

AK

AK

AK

AK

AK

AK

AK

Total = 39

*San Diego reapplied for a 301(h) waiver in April 1995, pursuant to
Ocean Pollution Reduction Act of 1994.  San Diego (Pt. Loma) was in the
original universe of 208 applicants for a 301(h) waiver, and withdrew
its application.  It is listed here to reflect its current status.

	TABLE 1 (continued)

301(h) Applications Pending Final Decision

Name

State

EPA REGION I

Stonington

EPA REGION II

Ponce

ME

PR

Total = 2

At this time in the 301(h) program evolution, EPA has obtained most of
the information it needs from POTWs to make decisions on waiver
applications.  However, application information from POTWs is still
needed in two situations: 1) when that POTW elects to submit a revised
application and 2) when a 301(h) permit is nearing its expiration date
and the permittee desires to renew its permit.  EPA also needs two types
of information from the States for these revised and renewed 301(h)
permit applications: 1) determinations on whether a proposed 301(h)
discharge meets State water quality standards and whether the discharge
will result in additional treatment requirements for another point
source and 2) a 401(a)(1) certification before EPA can issue a draft
modified NPDES permit under the 301(h) program.

Based on the status of the program and the associated statutory and
regulatory requirements, EPA needs six types of information to conduct
the 301(h) program during the 3-year term of the Information Collection
Request (ICR): 1) application revision information; 2) permit reissuance
information; 3) monitoring program information; 4) toxics control
program information; 5) State determination information; and 6) State
certification information.  Table 2 summarizes information needs of the
301(h) program and the regulatory requirements that mandate the
collection of this information.

TABLE 2.  INFORMATION COLLECTION ACTIVITIES FOR THE 301(h) PROGRAM

	Activity

	Regulatory Authority

Application Revision

40 CFR 125.59(d), (f) and (g)

Permit Reissuance

40 CFR 125.59 (c), (f) and (g)

Monitoring Program

40 CFR 125.68(c) and (d)

40 CFR 125.63(b), (c), and (d)

Toxics Control Program

40 CFR 125.66

State Determination

40 CFR 125.61(b)(2) and 125.64(b)

State Certification

40 CFR 124.53 and 124.54

The status of the 301(h) program drives the relative emphases on types
and amounts of information needed by the EPA from the POTWs and States.
Much of the information EPA needs at this time is ongoing information
about the monitoring and toxics control programs from all 301(h)
permittees.  The Agency(s need for application revision information will
be reduced as decisions are made on the pending and tentative decision
applications, while the need for updated information for permit renewals
will continue to have importance as the 301(h) permits reach their
expiration dates.

EPA(s need for the six types of information is explained in more detail
below.

Application Revision Information

Section 125.59(d) of 40 CFR allows a POTW to revise its application one
time only, following a tentative decision by EPA to deny the waiver
request.  In its application revision, the POTW usually corrects
deficiencies and changes proposed treatment levels as well as outfall
and diffuser locations.  The application revision is a voluntary
submission for the applicant.  In addition, 40 CFR Section 125.59(g)
allows applicants that are authorized or requested to submit additional
information to submit a revised application where the information
supports changes in proposed treatment levels and/or outfall location
and diffuser design.  EPA needs this information to evaluate revised
applications and to determine whether the modified discharge will ensure
receiving water quality, biological habitats, and beneficial uses of the
receiving waters.

Permit Reissuance Information

When permits with 301(h) waivers reach their expiration dates, EPA must
have updated information on the discharge to determine whether the
301(h) criteria are still being met and whether the 301(h) variance
should be reissued.  Under 40 CFR 125.59(f), each 301(h) permittee is
required to submit an application for a new section 301(h) modified
permit within 180 days of the existing permit(s expiration date; 40 CFR
Part 125.59(c) lists the information required for a modified permit.
The information that EPA needs to determine whether the POTW(s
reapplication meets the section 301(h) criteria previously listed is
outlined in the questionnaire attached to 40 CFR Part 125, Subpart G.
The questionnaire is similar to the two used by POTWs for their original
applications.

The revisions to 40 CFR Part 125 covered by this supporting statement
include revisions to the two questionnaires.  The main change is that
originally two questionnaires were used(one for small POTWs
(contributing population less than 50,000 people and average dry weather
flows less than 5 million gallons per day [mgd]) and the other
questionnaire for large POTWs (contributing populations more than 50,000
people and average dry weather flows greater than 5 mgd). The current
regulations now contain one questionnaire.  The breakdown of information
required of small and large POTWs is the same in the merged
questionnaire as in the previous separate questionnaire for small and
large POTWs.  Although the two questionnaires have been merged, small
POTWs are not required to submit all the information required of large
POTWs.

Monitoring and Toxics Control Program Information

Once a waiver has been granted, EPA must continue to assess whether the
discharge is meeting the criteria listed on pages 2 and 3 and that the
receiving water quality, biological habitats, and beneficial uses are
protected.  To do this, EPA needs monitoring information furnished by
the permittee.  According to 40 CFR 125.68(d), any permit issued with a
301(h) variance must contain the monitoring requirements of 40 CFR
125.63(b), (c), and (d) for biomonitoring, water quality criteria and
standards monitoring, and effluent monitoring, respectively.  Section
125.68(d) also requires reporting at the frequency specified in the
monitoring program.  In addition to monitoring information, EPA needs
information on the toxics control program to ensure that the permittee
is minimizing industrial and nonindustrial toxic pollutant and pesticide
discharges into the treatment works (40 CFR 125.66).

State Determination Information

For revised or renewed 301(h) permit applications, EPA also needs a
State determination.  The State determines whether all State laws
(including water quality standards) are met to ensure that receiving
water quality, biological habitats, and beneficial uses of the receiving
waters are protected.  Additionally, the State must determine if the
applicant(s discharge will result in additional treatment, pollution
control, or any other requirement for any other point or nonpoint
sources.  This process allows the State(s views to be taken into account
when EPA reviews the 301(h) application and develops permit conditions.
As mentioned previously, the State is the best source for this
information because it is aware of State laws and on combined effects of
discharges in the State.

State Certification Information

For revised and renewed 301(h) permit applications, EPA also needs the
401(a)(1) information to ensure that all State laws are met by any
permit it issues with a 301(h) modification and that the State accepts
all the permit conditions.  This information is the vehicle by which the
State can exercise its authority to concur with or deny a 301(h)
decision made by the EPA Regional Office.

2.  Description and Practical Utility of the Information Collection
Activity

EPA Headquarters and the EPA Regional Offices use the information
collected under this information collection request to conduct various
activities in the 301(h) program.  The six collection activities covered
by this ICR are listed in Table 3 along with a description of the
respondents and the frequency of the collection.  The following
describes each of the six information collection activities and
highlights:

Respondents;

Processes and techniques used to obtain the information;

How and by whom the information is used; and

Flow of the information(where it is submitted, filed, etc.

Permit Reissuance Information

The first two types of information collection covered by this ICR are
used in the application process.  Permit reissuance information is
submitted by 301(h) permittees nearing the expiration date of their
permits.  The permittee must submit an application for a renewed section
301(h) permit 180 days prior to the expiration of its existing permit.
Each POTW must submit a new application questionnaire (which may
reference previous submittals to the extent they are relevant and not
out of date), along with any other NPDES permit application information
required by the Region.  The data requested by the questionnaire consist
of general information on the treatment system, the effluent, the
receiving water characteristics, the biological conditions in the
receiving waters, and the State and Federal laws that affect the
discharge.  The questionnaire also provides a framework to assess the
effects of the discharge and requests appropriate data for these
analyses.  In addition, data are requested on physical characteristics
of the discharge, compliance with applicable water quality standards,
existence of pretreatment standards or secondary or equivalent levels of
treatment for toxic pollutants from industrial sources, impact on public
water supplies, biological impact of the discharge, effects on other
point and nonpoint sources, and the proposed monitoring and toxics
control programs.

	TABLE 3.  301(h) PROGRAM INFORMATION COLLECTION ACTIVITIES, RESPONDENT
DESCRIPTIONS, AND FREQUENCY

	Activity

	Respondents

	Frequency

Permit Reissuance

Any 301(h) permittee nearing expiration date of permit.

Once every 5 years beginning with permit issuance.

Application Revision

Original 301(h) waiver applicants that have not yet received a final
decision.

One time.

Monitoring Program

All 301(h) permittees.

Varies case-by-case as individual permit specifies.

Toxics Control Program

All 301(h) permittees.

Varies case-by-case.

State Determination

States in which POTWs with draft 301(h) permits are located.

Once every 5 years beginning with permit issuance.

State Certification

States in which POTWs with draft 301(h) permits are located.

Same as above regarding permit reissuance.

Many of the required data are available to the POTW from the studies and
monitoring performed during the life of the permit, from implementation
of toxics control and pretreatment programs, and from initial studies
performed for the original waiver application.  To obtain reapplication
information, the POTW can review existing data on monitoring, treatment
plant operation, and pretreatment and toxics control, and, if necessary,
conduct new studies of the receiving waters, the discharge, and the
impacts of the discharge on receiving waters.

EPA uses the information to determine whether the criteria of section
301(h) (as amended by WQA Section 303) are being met and whether the
receiving water quality, biological habitats, and beneficial uses will
be protected.  For the initial waiver applications, EPA conducted very
involved technical evaluations.  The Agency expects that similar but
reduced effort will be required to evaluate the permit reissuance
information.  Once EPA makes a decision regarding the reapplication for
a waiver, it uses the data provided by the POTW to develop permit
conditions and specify the monitoring program that will be incorporated
in the NPDES permit.  EPA specifies the parameters to be measured,
techniques to be used, and frequency of

monitoring.  In addition, EPA uses the data to make recommendations for
the toxics control and pretreatment programs.

Permit reissuance information is submitted to the appropriate EPA
Regional Offices, where it is evaluated.  These data are then filed at
the Regional Office and can be retrieved as required.

Application Revision Information

The second type of information used in the application process is the
application revision information.  These data are submitted once by any
original applicant for a 301(h) waiver that has received a tentative
decision when the applicant desires to revise its original application.
Revisions of the proposed treatment levels and/or outfall and diffuser
location and design, and data to correct any deficiencies can be
included in the revised application.  This one-time-opportunity is
generally used by POTWs that have received tentative denials of the
301(h) waiver.  Two POTWs currently have applications with pending
waiver decisions.  Applicants authorized or asked to submit additional
information under 40 CFR 125.59(g) may also submit a revised application
where that information supports changes in proposed treatment levels
and/or outfall location and diffuser design.

As with the first type of information, these data are used by the EPA
Regional Office to determine whether the revised proposed discharge
meets the criteria specified under section 301(h).  If the criteria are
met, EPA may issue a decision to approve the waiver.  The application
revision information is also used to make decisions on the monitoring
and toxics programs requirements and is then filed and retained by the
EPA Regional Office.

Monitoring and Toxics Control Program Information

The next two information collection elements(monitoring and toxics
control program data(are used by EPA in the ongoing administration of
the 301(h) program.  The type and frequency of information submitted
varies among the POTWs, depending on their particular circumstances.
POTWs may be required to conduct biological, water quality, and effluent
monitoring.  Certain small POTWs may be required to conduct only
periodic surveys of the biological communities most likely to be
affected by the discharge and may not need to provide the
bioaccumulation, sediment sampling, and fisheries data required of
larger POTWs.  Monitoring data are used by the EPA Region to evaluate
the continuing impact of the modified discharge on the marine biota, to
evaluate continuing compliance with applicable water quality standards
and/or criteria, to measure the toxic substances and pesticides in the
effluent, and to assess compliance with permit requirements.  These data
are also used to evaluate the continued effectiveness of the toxics
control program.

All monitoring data are submitted by the POTW to the EPA Regional
Office.  These data are stored in the Ocean Data Evaluation System
(ODES), described in section 3, and can be easily retrieved, or stored
in the new STORET Office of Water Storage and Retrieval System or an
equivalent database, and analyzed, as determined by the EPA Regional
Office.

The toxics control program information includes any information EPA can
use to determine whether the POTW is implementing effective industrial
and nonindustrial toxics control programs.  POTWs must develop a public
education program for nonindustrial source control and submit this
program to EPA within 18 months of the modification approval.
Additional and continued information associated with this program may
also be required.

State Determination Information

The final two types of information collection covered by this ICR, State
determinations and State certifications, are collected and submitted by
States, not POTWs as in the first four activities.  The State
determination is used in the application process.  Applicants for 301(h)
waivers must submit with their application revision or reapplication two
determinations signed by the appropriate State or interstate agency of
the State where the discharge originates: 1) a determination that the
modified discharge will comply with State law including water quality
standards and 2) a determination indicating whether the applicant(s
discharge will result in additional treatment, pollution control, or
other requirements for any other point or nonpoint sources.  Both
determinations must outline the reasons for the conclusions reached in
the State determination.  Therefore, the respondents of this information
collection are the States in which a proposed 301(h) discharge
originates.

The appropriate State agency or department has the background
information available to make these determinations.  For the first
determination, the State needs to identify and interpret the applicable
State requirements and then evaluate the application data as they relate
to these standards, using applicable analytical techniques.  For the
second determination, the State must review information contained in
State files or databases and employ appropriate technical evaluations to
determine the effects of the proposed discharge on other sources.

The State submits this determination information to the applicant,
which, in turn, submits the information to the Regional Administrator.
The information is reviewed and filed at the Region along with other
301(h) application information.  The State determinations must be
received by the EPA Regional Office no later than 90 days after the
application, reapplication, or application revision is submitted to EPA.
 EPA will not begin review of a 301(h) application revision unless it
has received favorable determinations from the State.  If the State
submits an unfavorable determination, the State is deemed not to concur
with the proposed variance.  Consequently, if the State provides an
unfavorable determination, EPA must deny the application without further
review.  If the determination is favorable, EPA uses the information to
assess the State(s position on these issues and to incorporate the
State(s views when deciding on both a variance application and a draft
permit.  In addition, EPA uses this information to explain the State(s
reasoning to any applicants that challenge the State(s position.

State Certification Information

The last type of information under this ICR, the 401(a) certification,
is used after the 301(h) application process is complete, during the
permit issuance process.  Certification information is submitted only if
EPA tentatively approves the 301(h) waiver application and has prepared
a draft permit incorporating a 301(h) waiver.  The certification is
required for both the original draft permit with a 301(h) variance and
each subsequent, or reissued, permit containing such a variance.  When
an EPA Regional Administrator issues a tentative approval on a 301(h)
variance, he or she forwards the decision to the State and specifies a
reasonable time (not more than 60 days) for the State to submit the
certification.  If the State does not submit the certification by this
time, the State is deemed to have concurred with the variance.

The State certification must contain the following information:

Any additional or more stringent conditions than the draft permit
necessary to ensure compliance with applicable CWA sections 208(e), 301,
302, 303, 306, and 307 and with appropriate requirements of State law.
If the State finds that more stringent conditions are necessary, it must
cite the CWA or State law references on which the condition is based.

  A statement of the extent to which each condition of the draft permit
can be made less stringent without violating the requirements of State
law, including water quality standards.

The State must review the appropriate State laws and CWA sections in
reference to the particular conditions in the draft permit.  To obtain
the information for the certification, the State uses the information it
derived from preparing its determination of compliance with State laws
and water quality standards.  It uses appropriate technical evaluations
to obtain the other information required for the certification.  The
background data that the State needs to prepare the certification should
be available in State files, and the State should be familiar with the
analytical techniques it must use.  In addition, the State has available
all background information and calculations that EPA used to make the
301(h) waiver decision and to establish permit conditions.  This
information is particularly useful to the State in reviewing very
complex permits and in assessing aspects of the draft permit and the
301(h) modification for which it does not have extensive experience.  In
these situations, the State has the benefit of EPA(s expertise and
technical evaluation.

The EPA Regional Office uses the information contained in the State
certification to ensure that the State concurs with any 301(h)
modifications it has approved and to ensure that the conditions in the
draft and final permits meet, and will continue to meet, all State laws
and water quality standards.  The certification is also used by EPA to
ensure a State is fully aware of all permit conditions imposed on a
discharger in that State and that all permit conditions are workable for
the State.  In addition, EPA uses the information to make any necessary
revisions to the draft permit before issuing a final permit.

The 401(a)(1) certification is submitted to the EPA Regional Office
within the time specified by EPA.  The information is used by EPA in
developing the final permit and is filed at the Regional Office with all
the permit application data for that POTW.

3.	Use of Improved Information Technology to Minimize Burden

EPA has developed a user-friendly computer system for the 301(h)
program, the Ocean Data Evaluation System (ODES).  It has been used by
both POTWs and EPA to store and analyze marine environmental data.  EPA
has recently developed a new user-friendly STORET (STOrage and
RETrieval) system for water quality data. STORET is the standard data
storage system within EPA(s Office of Water.  The new STORET system
provides access for POTWs to submit data directly to the STORET system.
Regional Offices have developed equivalent databases. A POTW can use
ODES to prepare information that EPA requires for the 301(h) program
such as impact assessment and evaluation, monitoring program designs,
and statistical analysis and modeling of marine and estuarine data.  EPA
can use ODES to store data, primarily monitoring data, provided under
the 301(h) program by POTWs; for national environmental assessments,
impact assessments, and evaluations; and for permit compliance
determinations.  There are other statistical analytical packages
available that can be used for data analysis as determined by the EPA
Regional Office.  Improvements in monitoring technology also afford
advantages to acquire measurements of important environmental parameters
electronically.  These data are more easily collected, managed and can
be imported with fewer errors, and with less time and effort for
storage, retrieval, analysis and reporting.

The State determinations and State certifications, however, must be made
on a case-by-case basis.  No particular format for the response is
required, and the response does not involve repetitive reporting or
frequent updating.

4.	Nonduplication

Section 301(h) requires a case-by-case demonstration of compliance with
criteria in that section, thereby minimizing the potential for
duplication of information collection.  EPA has taken additional
precautions.  As described below, the regulations are designed so that
applicants can use available information to the maximum extent.  Also,
EPA is coordinating information requests among related programs.  For
example, the Ocean Discharge Criteria, 40 CFR Part 125, Subpart M,
promulgated under the authority of CWA section 403(c), presume that
section 301(h) permittees comply with the criteria for ocean dischargers
(i.e., do not cause unreasonable degradation to the marine environment)
for those pollutants to which the waiver applies.  In addition, section
301(h) applicants who are also grantees in EPA(s construction grants
program provide information under the construction program regulations
(40 CFR Part 35), rather than under the Section 301(h) regulations.

In terms of the State(s Nonduplication effort, determination
information is requested from the State because it is the best and only
source of such information.  This type of information is not requested
by other Federal agencies or EPA offices because it relates specifically
to the 301(h) program.  The office preparing the ICR, the Office of
Wetlands, Oceans and Watersheds (OWOW), is the only EPA office involved
in the 301(h) program.

5.	Consideration of Alternatives

The criteria and legislative history of section 301(h) clearly indicate
that variance applications must be based on site-specific information
regarding the treatment system discharge characteristics, receiving
water quality and biological habitats, beneficial uses, oceanographic
characteristics, pretreatment program and standards, and impacts of the
modified discharges on water quality, biota, and beneficial uses.  EPA
has considered carefully the possible availability of information
collected for other purposes (e.g., water quality management planning,
permitting, pretreatment enforcement and research).  However, none of
these other sources, individually, is sufficient to enable EPA to
determine compliance with section 301(h) criteria for permit reissuance
applications, and revised applications.  Collectively, these sources may
be sufficient for many POTWs preparing reapplications when organized in
response to the application questionnaire.  In fact, EPA believes most
small applicants are able to complete the application questionnaire
using information from a variety of existing sources.  Still, it is
expected that some small applicants and most large applicants will need
to collect more data to demonstrate compliance with certain statutory
criteria for reapplications, and revised applications.

In such cases, the regulations encourage applicants to submit plans of
study to EPA for consultation before collecting additional field data.
This kind of structured communication ensures that available information
is used to the maximum relevant extent and additional data needs, if
any, are provided in a cost-effective and timely way.  The project plan
approach is intended to ensure that an applicant’s(s limited time and
resources will be used only for additional data collection that is
essential for making a decision on its application revision and permit
reissuance applications.

The State(s decision must be made on a case-by-case basis in order to
consider the particular circumstances of each 301(h) application and
draft permit.  The State is the best and only source for the
determinations because it is most familiar with the information and is
most likely to have the information available to submit to EPA.

6.	Minimizing the Burden for Small Applicants

The section 301(h) regulations and application questionnaire (40 CFR
Part 125, Subpart G) are designed to simplify application requirements
for all applicants and to reduce the cost burden for small applicants.
Small applicants are defined in the regulations as municipalities having
POTW service populations of less than 50,000 or discharge design flows
of less than 5 mgd.  EPA(s evaluation of applications showed that most
small applicants are able to complete the application questionnaire
using available information on their wastewater treatment system,
outfall configuration, discharge characteristics, receiving water
quality, biological habitats, oceanographic characteristics, and
beneficial uses.  Hence, for most small applicants, the cost of permit
reissuance application and application revision is minimized.  Also,
small applicants have the flexibility to design ongoing biological,
water quality, and discharge monitoring programs that are cost-effective
for their individual circumstances.  Finally, small applicants do not
have the burden of substantial elements of the requirements for
development and implementation of toxics control programs if they
certify that there are no known or suspected sources of toxics or
associated water quality or biological problems.  Therefore, EPA
believes that the costs to small section 301(h) applicants and small
section 301(h) permittees are minimized by the regulations and
questionnaire while compliance with section 301(h) criteria is ensured.

7.	Consideration of Less Frequent Collection

Application revision information is submitted once and is submitted only
if the POTW elects to revise its original application.  Reapplication
information is submitted every 5 years as the permit expires.
Similarly, the State determination information and State certification
information is submitted one time for each revised or renewed permit
application, and draft permit.  Therefore, frequency of collection is
not an issue for these four categories of information collection.

The frequency of collection for monitoring and toxics program
information is determined on a case-by-case basis.  The information is
collected as frequently as is necessary to conduct the 301(h) program;
frequency can be minimized because the requirement is developed for each
respondent based on its particular circumstances.

8.	General Requirements

This ICR meets the requirements contained in 5 CFR 1320.5(d)(2).

9.	Consultations

Lines of communication with the respondents are kept open, and
respondents have numerous opportunities to comment to EPA, States, or
EPA(s contractor(s) concerning the information collection activities of
the 301(h) program.  EPA generally has a contractor prepare the
Technical Review Reports for 301(h) applications.

In addition, comments were formally requested in the Federal Register
(56 FR 2814, January 24, 1991) on the proposed revised 301(h)
regulations that included the information collection requirements
covered by a previous ICR, and again upon publication of the revised
regulations on August 9, 1994 (59 FR 40642), covered in the February
1996 ICR.  No comments were received.

In addition, as part of the process to prepare and submit the previous
and this current information collection request to OMB, EPA solicited
comments on the information request, required by 5 CFR 1320.8(d) (63 FR
71112, December 23, 1998; 67 FR 71245 January 3, 2002; and 70 FR 35082
June 16, 2005).  EPA received no comments.

10.  Confidentiality

The information covered by this ICR involves treatment plant operating
data, effects of POTWs( discharges on marine environments, and States(
viewpoints on issues concerning effects of POTWs( discharges on marine
environments.  None of this information is confidential; thus
confidentiality is not an issue.

11.  Sensitive Questions

No information of a sensitive nature is requested by this ICR.

12.  Cost to the Government and to the Respondents

The review costs to the Federal government and preparation costs to the
respondents (both POTWs and States) for the six information collection
activities covered under this ICR are summarized in Tables A-1 and A-2
of the appendix.  For respondents, the labor hour burden used in these
cost estimates is derived under the next item, Section 13.  For the
Federal government burden hour estimates used in computing the estimated
costs in Table A-1 are summarized in Table A-3 of the appendix.  These
burden hour estimates for the Federal government address decisions on
applications, review of State determinations and State certifications,
and evaluating the adequacy of permittee monitoring and toxics control
programs.

13.  Estimation of Respondent Burden

This section describes how the burden to respondents of the six 301(h)
information collection activities is estimated.  The burden is divided
into two categories: 1) POTW respondent burden and 2) State respondent
burden.  For the six information collection activities, the burden
estimate is dependent upon the size of the POTW applying for a section
301(h) variance.  Small POTWs, defined by EPA as those with flows of
less than 5 mgd and/or those that serve a population of less than 50,000
people, have reduced burdens in responding to each information
requirement. Correspondingly, it is less burdensome for States to make
determinations and certifications for these small POTWs than for large
POTWs with flows greater than 5 mgd and serving populations larger than
50,000 people.  The burden to POTWs is also not evenly distributed over
the years covered by this ICR because of changes in the program status
and associated information needs.

Annual, total, and average burdens and number of respondents for each
of the six information activities are compiled on Table A-4 of the
appendix.  Individual tables for each of the six information collection
activities are summarized on Tables A-6, A-7, A-8, A-10 and A-11 of the
appendix.  POTW respondents to these activities must complete five
general tasks:

1)	Read instructions supplied by EPA and contained in the regulations.

2)	Plan activities(determine what data are required and what must be
done to obtain the data.

3)	Create information using field surveys and other techniques.

4)	Gather information through literature searches, interviews, and
analyses of field survey and monitoring data.

5)	Complete permit reissuance application and transmit to EPA.

The effort required to complete these activities for permit
reapplication and application revision is estimated in Table A-5 of the
appendix.  The estimates in this table are based on EPA(s experience in
evaluating numerous original applications and application revisions.  It
is assumed that preparation of reapplications will require less effort
than preparation of original applications.  In addition, in breaking
down the estimates of effort for small and large applicants, it is
assumed that little or no field work is performed by small POTWs and
that a field study is conducted by each large POTW.

For application revision and reapplication, the number of respondents
and total burden hours for the 3 years covered by this ICR are presented
in Tables A-6 and A-7 of the appendix, respectively.  The number of POTW
respondents for each year varies depending on the program status and the
associated information needs, such as how many 301(h) permits are
nearing their expiration dates.  These numbers are projected by EPA
based on applicable program data and program experience.

The burden estimates for the monitoring program and for the toxics
control program are presented in Table A-8 of the appendix.  The
monitoring program effort estimates are for typical small and large
permittees and include the design and execution of necessary field
studies plus analyses and report writing.  EPA has estimated the burden
based on experience plus estimates from consulting firms contacted for
this purpose.  The toxics control program estimates are also for typical
small and large permittees and include estimates for developing and
implementing nonindustrial source control programs.

The burdens for State determinations and State certifications
activities are summarized in Tables A-9, A-10, and A-11 of the appendix.
 Respondents to these activities must complete four general tasks: 1)
identify applicable State requirements; 2) analyze material; 3) review
accuracy; and 4) report information.  For example, in deciding whether
the discharge will comply with State law, the State needs to identify
and interpret applicable State requirements.  The State would then
review the application data, which contain information on effluent and
ambient water quality characteristics, in order to consider the validity
of the data and select appropriate data points and conditions under
which compliance will be determined.  In addition, the State may wish to
review information contained in State files in order to check or verify
the applicant(s data.  Following this, the State would select the
technical evaluations it wishes to employ and apply them to the data
selected.  Finally, the State would check the accuracy of its approach
and calculations, and submit its determinations.

EPA realizes that the State burden will vary, depending on the
complexity of the issues raised by a particular application.  A State
determination and certification of an applicant with a large discharge
from multiple pollutant sources may take more time to review than an
application from a small POTW.  EPA(s past experiences have involved a
wide range of extremes from relatively simple to complex applications,
and this experience has been considered in developing typical burdens.
In addition, EPA has not specified in detail the nature of the States(
submissions, nor has EPA required the States to follow certain review
procedures.  As a result, the burden will also vary depending on the
level of effort and review procedures that the State chooses to adopt in
reaching its concurrence decision.  The burden in providing 401
certification under 40 CFR Part 124 similarly draws on Agency experience
and reflects the fact that the work done by the State in making its
determinations under 40 CFR Part 125 will not be duplicated at the 401
certification stage.  The effort required to complete these activities
is estimated in Table A-9 of the appendix.  The numbers of respondents
and burden hours for State determinations and State certifications for
the 3 years covered by this ICR are presented in Tables A-10 and A-11 of
the appendix.  The average annual burdens for all six information
collection activities are summarized in Table A-12 of the appendix.

14.  Reasons for Change in Burden

Since the last ICR was submitted, the universe of POTWs in the 301(h)
program and subject to the 301(h) information requirements has
decreased.  This is because a POTW has withdrawn from the program.
There are also changes in the distribution of the burden over the 3
years covered by this ICR because of changes in program status and
information needs.  As a result, information requirements and the total
burden hours in the current ICR are reduced.  Table A-13 of the appendix
explains the reasons for the changes.  The average annual burden
estimate for this ICR is 61377 hours.

15.  Scheduling

This information collection activity does not involve a survey.

16.  Standard Industrial Classification (SIC)

The SIC number for POTWs (sewerage systems) is 4952, and the SIC number
for State governments is 9511.

17.  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 652 hours per response for POTWs
and 86 hours per response for States.  Burden means 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.  This includes the time needed to review instructions; develop,
acquire, install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.  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 OMB control number.  The OMB control numbers for EPA's
regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including through the use of automated collection
techniques to the Director, Office of Information Collection, Collection
Strategies Division (2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW, Washington, D.C. 20460; and to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA.
Include the EPA ICR number and OMB control number in any correspondence.

B.  COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

This information collection activity does not employ statistical
methods.

	APPENDIX

See docket attachment 1--ICRtables_301h clean final 2005f for Draft
Supporting Statement tables

Draft for public review with First federal Register Notice—Has not
been submitted to OMB December 2008 Submitted to OMB with Second Federal
Register Notice

Draft for public review with First federal Register Notice—Has not
been submitted to OMB December 2008

Submitted to OMB with Second Federal Register Notice

 PAGE  21

Draft for public review with First federal Register Notice—Has not
been submitted to OMB December 2008

Submitted to OMB with Second Federal Register NoticeDraft for public
review with First Federal Register Notice(Has not been submitted to OMB
April 2005


[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Pages 71446-71447]
[FR Doc No: 2010-29520]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0554]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reports of Corrections and Removals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements for reports of corrections and removal.

DATES: Submit either electronic or written comments on the collection
of information by January 24, 2011.

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

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Reports of Corrections and Removals--21 CFR Part 806 (OMB Control
Number 0910-0359)--Extension

    The collection of information required under the reports of
corrections and removals, part 806 (21 CFR part 806), implements
section 519(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360i(g)), as amended by the Food and Drug
Administration Modernization Act (FDAMA) of 1997 (21 U.S.C. 301) (Pub.
L. 105-115). Each device manufacturer or importer under Sec.  806.10
shall submit a written report to FDA of any action initiated to correct
or remove a device to reduce a risk to health posed by the device, or
to remedy a violation of the FD&C Act caused by the device that may
present a risk to health, within 10 working days of initiating such
correction or removal. Each device manufacturer or importer of a device
who initiates a correction or removal of a device that is not required
to be reported to FDA under Sec.  806.20 shall keep a record of such
correction or removal.
    The information collected in the reports of corrections and
removals will be used by FDA to identify marketed devices that have
serious problems and to ensure that defective devices are removed from
the market. This will assure that FDA has current and complete
information regarding these corrections and removals and to determine
whether recall action is adequate.

    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                           21 CFR section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
806.10.............................................................             666                1              666               10            6,660
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 2--Estimated Average Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                           21 CFR Section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                      recordkeepers    recordkeeping       records           record
--------------------------------------------------------------------------------------------------------------------------------------------------------
806.20.............................................................              90                1               90               10              900
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are manufacturers and
importers of medical devices. FDA reviewed reports of device
corrections and removals submitted to the Agency for the previous 3
years as part of responding to the current request for approval of the
information collection requirements for Sec. Sec.  806.10 and 806.20.
This information was obtained through the Agency's voluntary recall
provisions (i.e., 21 CFR part 7). The specific information requested
was the total number of class I, II, and III recalls for the last 3
years. This information was obtained from the Agency's Recall
Enterprise System--a database of all recalls submitted to the Agency.
    This information is relevant since a Sec.  806.10 report is
required for all class I and II recalls. Although class III recalls are
not required to be submitted to FDA (by Sec.  806.10) a record must be
kept in the firm's Sec.  806.20 file. Therefore, the number of class I
and II recalls can be used to estimate the maximum number of reports
that are required to be submitted under Sec.   806.10. Also, the
recordkeeping burden can be estimated based upon the number of class
III recalls, which are not required to be reported but must be retained
in a Sec.  806.20 file.
    FDA has determined that estimates of the reporting burden for Sec.
806.10 should be revised to reflect a projected 7.3 percent increase
(from the last PRA numbers) in reports submitted to FDA as class I and
II. FDA also estimates the recordkeeping burden in Sec.  806.20 should
be revised to reflect a reduction of 6.8 percent (from the last PRA
numbers) in records filed and maintained under this section. The
estimates of time needed to collect part 806 information have not
changed.

    Dated: November 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29520 Filed 11-22-10; 8:45 am]
BILLING CODE 4160-01-P