[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Rules and Regulations]
[Page 65879]
[FR Doc No: 2014-26341]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-0894; Special Conditions No. 25-532-SC]

Special Conditions: Airbus A350-900 Series Airplane; Interaction
of Systems and Structures

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions, request for comments; correction.

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SUMMARY: This document corrects errors that appeared in final special
conditions docket no. FAA-2013-0894, which was published in the Federal
Register on December 20, 2013 (78 FR 76980). The errors are in the
document's special conditions stage (notice vs. final) and special
conditions number.

DATES: This action is effective November 6, 2014.

FOR FURTHER INFORMATION CONTACT: Todd Martin, FAA, Airframe/Cabin
Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification
Service, 1601 Lind Avenue SW., Renton, Washington, 98057-3356;
telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The final special conditions document
designated as ``Docket No. FAA-2013-0894; Notice No. 25-13-16-SC'' was
published in the Federal Register on December 20, 2013 (78 FR 76980).
The document issued special conditions pertaining to interaction of
systems and structures on Airbus A350-900 series airplanes.
    As published, the document contained two errors: One referring to
the document's special conditions stage, ``Notice no.,'' instead of
``Special Conditions No.;'' and one in the special conditions number
itself, 25-13-16-SC (a notice number), instead of 25-532-SC (the
assigned final special conditions number).
    Because this error and correction do not affect the regulatory
content of the special conditions, the special conditions are not being
re-published.

Correction

    In the final special conditions, request for comments document [FR
Doc. 2013-30235, Filed 12-19-13; 8:45 a.m.] published on December 20,
2013 (78 FR 76980), make the following correction:
    On page 76980, in the first column, in the heading, correct
``Notice No. 25-13-16-SC'' to read ``Special Conditions No. 25-532-
SC''.

    Issued in Renton, Washington, on October 31, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-26341 Filed 11-5-14; 8:45 am]
BILLING CODE 4910-13-P


subpart; OR for each          63.2292).             NCASI Method IM/CAN/
 process unit used in                                WP-99.02 (IBR, see
 calculation of an emissions                         Sec.   63.14); OR
 average under Sec.                                  the NCASI Method
 63.2240(c).                                         ISS/FP-A105.01
                                                     (IBR, see Sec.
                                                     63.14); OR ASTM
                                                     D6348-03 (IBR, see
                                                     Sec.   63.14)
                                                     provided that
                                                     percent R as
                                                     determined in Annex
                                                     A5 of ASTM D6348-03
                                                     is equal or greater
                                                     than 70 percent and
                                                     less than or equal
                                                     to 130 percent.

(7) each process unit         measure emissions of  Method 308 in
 subject to a compliance       methanol.             appendix A to 40
 option in table 1B to this                          CFR part 63; OR
 subpart for which you                               Method 320 in
 choose to demonstrate                               appendix A to 40
 compliance using a methanol                         CFR part 63; OR the
 compliance option.                                  NCASI Method CI/WP-
                                                     98.01 (IBR, see
                                                     Sec.   63.14); OR
                                                     the NCASI Method IM/
                                                     CAN/WP-99.02 (IBR,
                                                     see Sec.   63.14);
                                                     OR the NCASI Method
                                                     ISS/FP-A105.01
                                                     (IBR, see Sec.
                                                     63.14).
(8) each process unit         measure emissions of  Method 316 in
 subject to a compliance       formaldehyde.         appendix A to 40
 option in table 1B to this                          CFR part 63; OR
 subpart for which you                               Method 320 in
 choose to demonstrate                               appendix A to 40
 compliance using a                                  CFR part 63; OR
 formaldehyde compliance                             Method 0011 in
 option.                                             ``Test Methods for
                                                     Evaluating Solid
                                                     Waste, Physical/
                                                     Chemical Methods''
                                                     (EPA Publication
                                                     No. SW-846) for
                                                     formaldehyde (IBR,
                                                     see Sec.   63.14);
                                                     OR the NCASI Method
                                                     CI/WP-98.01 (IBR,
                                                     see Sec.   63.14);
                                                     OR the NCASI Method
                                                     IM/CAN/WP-99.02
                                                     (IBR, see Sec.
                                                     63.14); OR the
                                                     NCASI Method ISS/FP-
                                                     A105.01 (IBR, see
                                                     Sec.   63.14).
(9) each reconstituted wood   meet the design       Methods 204 and 204A
 product press at a new or     specifications        through 204F of 40
 existing affected source or   included in the       CFR part 51,
 reconstituted wood product    definition of wood    appendix M, to
 board cooler at a new         products enclosure    determine capture
 affected source subject to    in Sec.   63.2292;    efficiency (except
 a compliance option in        or determine the      for wood products
 table 1B to this subpart or   percent capture       enclosures as
 used in calculation of an     efficiency of the     defined in Sec.
 emissions average under       enclosure directing   63.2292).
 Sec.   63.2240(c).            emissions to an add-  Enclosures that
                               on control device.    meet the definition
                                                     of wood products
                                                     enclosure or that
                                                     meet Method 204
                                                     requirements for a
                                                     permanent total
                                                     enclosure (PTE) are
                                                     assumed to have a
                                                     capture efficiency
                                                     of 100 percent.
                                                     Enclosures that do
                                                     not meet either the
                                                     PTE requirements or
                                                     design criteria for
                                                     a wood products
                                                     enclosure must
                                                     determine the
                                                     capture efficiency
                                                     by constructing a
                                                     TTE according to
                                                     the requirements of
                                                     Method 204 and
                                                     applying Methods
                                                     204A through 204F
                                                     (as appropriate).
                                                     As an alternative
                                                     to Methods 204 and
                                                     204A through 204F,
                                                     you may use the
                                                     tracer gas method
                                                     contained in
                                                     appendix A to this
                                                     subpart.
(10) each reconstituted wood  determine the         a TTE and Methods
 product press at a new or     percent capture       204 and 204A
 existing affected source or   efficiency.           through 204F (as
 reconstituted wood product                          appropriate) of 40
 board cooler at a new                               CFR part 51,
 affected source subject to                          appendix M. As an
 a compliance option in                              alternative to
 table 1A to this subpart.                           installing a TTE
                                                     and using Methods
                                                     204 and 204A
                                                     through 204F, you
                                                     may use the tracer
                                                     gas method
                                                     contained in
                                                     appendix A to this
                                                     subpart. Enclosures
                                                     that meet the
                                                     design criteria (1)
                                                     through (4) in the
                                                     definition of wood
                                                     products enclosure,
                                                     or that meet Method
                                                     204 requirements
                                                     for a PTE (except
                                                     for the criteria
                                                     specified in
                                                     section 6.2 of
                                                     Method 204) are
                                                     assumed to have a
                                                     capture efficiency
                                                     of 100 percent.
                                                     Measured emissions
                                                     divided by the
                                                     capture efficiency
                                                     provides the
                                                     emission rate.
(11) each process unit        establish the site-   data from the
 subject to a compliance       specific operating    parameter
 option in tables 1A and 1B    requirements          monitoring system
 to this subpart or used in    (including the        or THC CEMS and the
 calculation of an emissions   parameter limits or   applicable
 average under Sec.            THC concentration     performance test
 63.2240(c).                   limits) in Table 2    method(s).
                               to this subpart.
------------------------------------------------------------------------

0
20. Table 7 to Subpart DDDD is revised to read as follows:

   Table 7 to Subpart DDDD of Part 63--Continuous Compliance With the
              Compliance Options and Operating Requirements
------------------------------------------------------------------------
                                For the following   You must demonstrate
                               compliance options        continuous
          For . . .               and operating      compliance by . . .
                               requirements . . .
------------------------------------------------------------------------
(1) Each process unit listed  Compliance options    Collecting and
 in Table 1B to this subpart   in Table 1B to this   recording the
 or used in calculation of     subpart or the        operating parameter
 an emissions average under    emissions averaging   monitoring system
 Sec.   63.2240(c).            compliance option     data listed in
                               in Sec.               Table 2 to this
                               63.2240(c) and the    subpart for the
                               operating             process unit
                               requirements in       according to Sec.
                               Table 2 to this       63.2269(a) through
                               subpart based on      (b) and Sec.
                               monitoring of         63.2270; AND
                               operating             reducing the
                               parameters.           operating parameter
                                                     monitoring system
                                                     data to the
                                                     specified averages
                                                     in units of the
                                                     applicable
                                                     requirement
                                                     according to
                                                     calculations in
                                                     Sec.   63.2270; AND
                                                     maintaining the
                                                     average operating
                                                     parameter at or
                                                     above the minimum,
                                                     at or below the
                                                     maximum, or within
                                                     the range
                                                     (whichever applies)
                                                     established
                                                     according to Sec.
                                                     63.2262.
(2) Each process unit listed  Compliance options    Collecting and
 in Tables 1A and 1B to this   in Tables 1A and 1B   recording the THC
 subpart or used in            to this subpart or    monitoring data
 calculation of an emissions   the emissions         listed in Table 2
 average under Sec.            averaging             to this subpart for
 63.2240(c).                   compliance option     the process unit
                               in Sec.               according to Sec.
                               63.2240(c) and the    63.2269(d); AND
                               operating             reducing the CEMS
                               requirements in       data to 3-hour
                               Table 2 of this       block averages
                               subpart based on      according to
                               THC CEMS data.        calculations in
                                                     Sec.   63.2269(d);
                                                     AND maintaining the
                                                     3-hour block
                                                     average THC
                                                     concentration in
                                                     the exhaust gases
                                                     less than or equal
                                                     to the THC
                                                     concentration
                                                     established
                                                     according to Sec.
                                                     63.2262.
(3) Each process unit using   Compliance options    Conducting a repeat
 a biofilter.                  in Tables 1B to       performance test
                               this subpart or the   using the
                               emissions averaging   applicable
                               compliance option     method(s) specified
                               in Sec.               in Table 4 to this
                               63.2240(c).           subpart within 2
                                                     years following the
                                                     previous
                                                     performance test
                                                     and within 180 days
                                                     after each
                                                     replacement of any
                                                     portion of the
                                                     biofilter bed media
                                                     with a different
                                                     type of media or
                                                     each replacement of
                                                     more than 50
                                                     percent (by volume)
                                                     of the biofilter
                                                     bed media with the
                                                     same type of media.
(4) Each process unit using   Compliance options    Checking the
 a catalytic oxidizer.         in Table 1B to this   activity level of a
                               subpart or the        representative
                               emissions averaging   sample of the
                               compliance option     catalyst at least
                               in Sec.               every 12 months and
                               63.2240(c).           taking any
                                                     necessary
                                                     corrective action
                                                     to ensure that the
                                                     catalyst is
                                                     performing within
                                                     its design range.
(5) Each process unit listed  Compliance options    Collecting and
 in Table 1A to this           in Table 1A to this   recording on a
 subpart, or each process      subpart or the        daily basis process
 unit without a control        emissions averaging   unit controlling
 device used in calculation    compliance option     operating parameter
 of an emissions averaging     in Sec.               data; AND
 debit under Sec.              63.2240(c) and the    maintaining the
 63.2240(c).                   operating             operating parameter
                               requirements in       at or above the
                               Table 2 to this       minimum, at or
                               subpart based on      below the maximum,
                               monitoring of         or within the range
                               process unit          (whichever applies)
                               controlling           established
                               operating             according to Sec.
                               parameters.           63.2262.
(6) Each Process unit listed  Compliance options    Implementing your
 in Table 1B to this subpart   in Table 1B to this   plan to address how
 using a wet control device    subpart or the        organic HAP
 as the sole means of          emissions averaging   captured in the
 reducing HAP emissions.       compliance option     wastewater from the
                               in Sec.               wet control device
                               63.2240(c).           is contained or
                                                     destroyed to
                                                     minimize re-release
                                                     to the atmosphere.
(7) Each process unit listed  Compliance options    Conducting a repeat
 in Table 1B to this subpart   in Tables 1B to       performance test
 using a control device        this subpart.         using the
 other than a biofilter.                             applicable
                                                     method(s) specified
                                                     in Table 4 to this
                                                     subpart by [DATE 3
                                                     YEARS AFTER DATE OF
                                                     PUBLICATION OF
                                                     FINAL RULE IN THE
                                                     FEDERAL REGISTER]
                                                     or within 60 months
                                                     following the
                                                     previous
                                                     performance test,
                                                     whichever is later,
                                                     and thereafter
                                                     within 60 months
                                                     following the
                                                     previous
                                                     performance test.
------------------------------------------------------------------------

0
21. Table 9 to Subpart DDDD is revised to read as follows:

      Table 9 to Subpart DDDD of Part 63--Requirements for Reports
------------------------------------------------------------------------
                                 The report must     You must submit the
 You must submit a(n) . . .       contain . . .         report . . .
------------------------------------------------------------------------
(1) Compliance report.......  The information in    Semiannually
                               Sec.   63.2281(c)     according to the
                               through (g).          requirements in
                                                     Sec.   63.2281(b).
(2) immediate startup,        (i) Actions taken     By fax or telephone
 shutdown, and malfunction     for the event.        within 2 working
 report if you had a                                 days after starting
 startup, shutdown, or                               actions
 malfunction during the                              inconsistent with
 reporting period that is                            the plan.
 not consistent with your
 SSMP before [DATE 181 DAYS
 AFTER DATE OF PUBLICATION
 OF FINAL RULE IN THE
 Federal Register]a.
                              (ii) The information  By letter within 7
                               in Sec.               working days after
                               63.10(d)(5)(ii).      the end of the
                                                     event unless you
                                                     have made
                                                     alternative
                                                     arrangements with
                                                     the permitting
                                                     authority.
(3) Performance test report.  The information       According to the
                               required in Sec.      requirements of
                               63.7(g).              Sec.   63.2281(i).
(4) CMS performance           The information       According to the
 evaluation.                   required in Sec.      requirements of
                               63.7(g).              Sec.   63.2281(j).
------------------------------------------------------------------------
a The requirement for the SSM report in row 2 of this table does not
  apply for new or reconstructed affected sources that commenced
  construction or reconstruction after September 6, 2019.

0
22. Table 10 to Subpart DDDD is revised to read as follows:

                                Table 10 to Subpart DDDD of Part 63--Applicability of General Provisions to Subpart DDDD
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Applies to subpart DDDD before  Applies to subpart DDDD on and
                                                                                [DATE 181 DAYS AFTER DATE OF     after [DATE 181 DAYS AFTER
                                                                                PUBLICATION OF FINAL RULE IN    DATE OF PUBLICATION OF FINAL
              Citation                       Subject              Brief description        THE Federal Register] except    RULE IN THE Federal Register]
                                                                                as noted in footnote ``a'' to    except as noted in footnote
                                                                                this table                  ``a'' to this table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   63.1........................  Applicability.........  Initial applicability        Yes...........................  Yes.
                                                              determination;
                                                              applicability after
                                                              standard established;
                                                              permit requirements;
                                                              extensions, notifications.
Sec.   63.2........................  Definitions...........  Definitions for part 63      Yes...........................  Yes.
                                                              standards.
Sec.   63.3........................  Units and               Units and abbreviations for  Yes...........................  Yes.
                                      Abbreviations.          part 63 standards.
Sec.   63.4........................  Prohibited Activities   Prohibited activities;       Yes...........................  Yes.
                                      and Circumvention.      compliance date;
                                                              circumvention,
                                                              fragmentation.
Sec.   63.5........................  Preconstruction Review  Preconstruction review       Yes...........................  Yes.
                                      and Notification        requirements of section
                                      Requirements.           112(i)(1).
Sec.   63.6(a).....................  Applicability.........  GP apply unless compliance   Yes...........................  Yes.
                                                              extension; GP apply to
                                                              area sources that become
                                                              major.
Sec.   63.6(b)(1)-(4)..............  Compliance Dates for    Standards apply at           Yes...........................  Yes.
                                      New and Reconstructed   effective date; 3 years
                                      Sources.                after effective date; upon
                                                              startup; 10 years after
                                                              construction or
                                                              reconstruction commences
                                                              for section 112(f).
Sec.   63.6(b)(5)..................  Notification..........  Must notify if commenced     Yes...........................  Yes.
                                                              construction or
                                                              reconstruction after
                                                              proposal.
Sec.   63.6(b)(6)..................  [Reserved]............
Sec.   63.6(b)(7)..................  Compliance Dates for    Area sources that become     Yes...........................  Yes.
                                      New and Reconstructed   major must comply with
                                      Area Sources that       major source standards
                                      Become Major.           immediately upon becoming
                                                              major, regardless of
                                                              whether required to comply
                                                              when they were an area
                                                              source.
Sec.   63.6(c)(1)-(2)..............  Compliance Dates for    Comply according to date in  Yes...........................  Yes.
                                      Existing Sources.       subpart, which must be no
                                                              later than 3 years after
                                                              effective date; for
                                                              section 112(f) standards,
                                                              comply within 90 days of
                                                              effective date unless
                                                              compliance extension.
Sec.   63.6(c)(3)-(4)..............  [Reserved]............
Sec.   63.6(c)(5)..................  Compliance Dates for    Area sources that become     Yes...........................  Yes.
                                      Existing Area Sources   major must comply with
                                      that Become Major.      major source standards by
                                                              date indicated in subpart
                                                              or by equivalent time
                                                              period (e.g., 3 years).
Sec.   63.6(d).....................  [Reserved]............
Sec.   63.6(e)(1)(i)...............  General Duty to         You must operate and         Yes...........................  No, see Sec.   63.2250 for
                                      Minimize Emissions..    maintain affected source                                     general duty requirement.
                                                              in a manner consistent
                                                              with safety and good air
                                                              pollution control
                                                              practices for minimizing
                                                              emissions.
Sec.   63.6(e)(1)(ii)..............  Requirement to Correct  You must correct             Yes...........................  No.
                                      Malfunctions ASAP.      malfunctions as soon as
                                                              practicable after their
                                                              occurrence.
Sec.   63.6(e)(1)(iii).............  Operation and           Operation and maintenance    Yes...........................  Yes.
                                      Maintenance             requirements are
                                      Requirements.           enforceable independent of
                                                              emissions limitations or
                                                              other requirements in
                                                              relevant standards.
Sec.   63.6(e)(2)..................  [Reserved]............
Sec.   63.6(e)(3)..................  Startup, Shutdown, and  Requirement for SSM and      Yes...........................  No.
                                      Malfunction Plan        SSMP; content of SSMP.
                                      (SSMP).
Sec.   63.6(f)(1)..................  SSM Exemption.........  You must comply with         Yes...........................  No.
                                                              emission standards at all
                                                              times except during SSM.
Sec.   63.6(f)(2)-(3)..............  Methods for             Compliance based on          Yes...........................  Yes.
                                      Determining             performance test,
                                      Compliance/Finding of   operation and maintenance
                                      Compliance.             plans, records, inspection.
Sec.   63.6(g)(1)-(3)..............  Alternative Standard..  Procedures for getting an    Yes...........................  Yes.
                                                              alternative standard.
Sec.   63.6(h)(1)..................  SSM Exemption.........  You must comply with         NA............................  No.
                                                              opacity and visible
                                                              emission standards at all
                                                              times except during SSM.
Sec.   63.6(h)(2)-(9)..............  Opacity/Visible         Requirements for opacity     NA............................  NA.
                                      Emission (VE)           and visible emission
                                      Standards.              standards.
Sec.   63.6(i)(1)-(14).............  Compliance Extension..  Procedures and criteria for  Yes...........................  Yes.
                                                              Administrator to grant
                                                              compliance extension.
Sec.   63.6(i)(15).................  [Reserved]............
Sec.   63.6(i)(16).................  Compliance Extension..  Compliance extension and     Yes...........................  Yes.
                                                              Administrator's authority.
Sec.   63.6(j).....................  Presidential            President may exempt source  Yes...........................  Yes.
                                      Compliance Exemption.   category from requirement
                                                              to comply with rule.

Sec.   63.7(a)(1)-(2)..............  Performance Test Dates  Dates for conducting         Yes...........................  Yes.
                                                              initial performance
                                                              testing and other
                                                              compliance demonstrations;
                                                              must conduct 180 days
                                                              after first subject to
                                                              rule.
Sec.   63.7(a)(3)..................  Section 114 Authority.  Administrator may require a  Yes...........................  Yes.
                                                              performance test under CAA
                                                              section 114 at any time.
Sec.   63.7(b)(1)..................  Notification of         Must notify Administrator    Yes...........................  Yes.
                                      Performance Test.       60 days before the test.
Sec.   63.7(b)(2)..................  Notification of         If have to reschedule        Yes...........................  Yes.
                                      Rescheduling.           performance test, must
                                                              notify Administrator as
                                                              soon as practicable.
Sec.   63.7(c).....................  Quality Assurance/Test  Requirement to submit site-  Yes...........................  Yes.
                                      Plan.                   specific test plan 60 days
                                                              before the test or on date
                                                              Administrator agrees with;
                                                              test plan approval
                                                              procedures; performance
                                                              audit requirements;
                                                              internal and external QA
                                                              procedures for testing.
Sec.   63.7(d).....................  Testing Facilities....  Requirements for testing     Yes...........................  Yes.
                                                              facilities.
Sec.   63.7(e)(1)..................  Performance Testing...  Performance tests must be    Yes...........................  No, see Sec.   63.2262(a)-(b).
                                                              conducted under
                                                              representative conditions;
                                                              cannot conduct performance
                                                              tests during SSM; not a
                                                              violation to exceed
                                                              standard during SSM.
Sec.   63.7(e)(2)..................  Conditions for          Must conduct according to    Yes...........................  Yes.
                                      Conducting              rule and EPA test methods
                                      Performance Tests.      unless Administrator
                                                              approves alternative.
Sec.   63.7(e)(3)..................  Test Run Duration.....  Must have three test runs    Yes...........................  Yes.
                                                              for at least the time
                                                              specified in the relevant
                                                              standard; compliance is
                                                              based on arithmetic mean
                                                              of three runs; specifies
                                                              conditions when data from
                                                              an additional test run can
                                                              be used.
Sec.   63.7(f).....................  Alternative Test        Procedures by which          Yes...........................  Yes.
                                      Method.                 Administrator can grant
                                                              approval to use an
                                                              alternative test method.
Sec.   63.7(g).....................  Performance Test Data   Must include raw data in     Yes...........................  Yes.
                                      Analysis.               performance test report;
                                                              must submit performance
                                                              test data 60 days after
                                                              end of test with the
                                                              notification of compliance
                                                              status; keep data for 5
                                                              years.
Sec.   63.7(h).....................  Waiver of Tests.......  Procedures for               Yes...........................  Yes.
                                                              Administrator to waive
                                                              performance test.
Sec.   63.8(a)(1)..................  Applicability of        Subject to all monitoring    Yes...........................  Yes.
                                      Monitoring              requirements in standard.
                                      Requirements.
Sec.   63.8(a)(2)..................  Performance             Performance specifications   Yes...........................  Yes.
                                      Specifications.         in appendix B of part 60
                                                              apply.
Sec.   63.8(a)(3)..................  [Reserved]............
Sec.   63.8(a)(4)..................  Monitoring with Flares  Requirements for flares in   NA............................  NA.
                                                              Sec.   63.11 apply.
Sec.   63.8(b)(1)..................  Monitoring............  Must conduct monitoring      Yes...........................  Yes.
                                                              according to standard
                                                              unless Administrator
                                                              approves alternative.
Sec.   63.8(b)(2)-(3)..............  Multiple Effluents and  Specific requirements for    Yes...........................  Yes.
                                      Multiple Monitoring     installing monitoring
                                      Systems.                systems; must install on
                                                              each effluent before it is
                                                              combined and before it is
                                                              released to the atmosphere
                                                              unless Administrator
                                                              approves otherwise; if
                                                              more than one monitoring
                                                              system on an emission
                                                              point, must report all
                                                              monitoring system results,
                                                              unless one monitoring
                                                              system is a backup.
Sec.   63.8(c)(1)..................  Monitoring System       Maintain monitoring system   Yes...........................  Yes.
                                      Operation and           in a manner consistent
                                      Maintenance.            with and good air
                                                              pollution control
                                                              practices.
Sec.   63.8(c)(1)(i)...............  Operation and           Must maintain and operate    Yes...........................  No.
                                      Maintenance of CMS.     CMS in accordance with
                                                              Sec.   63.6(e)(1).
Sec.   63.8(c)(1)(ii)..............  Spare Parts for CMS...  Must maintain spare parts    Yes...........................  Yes.
                                                              for routine CMS repairs.
Sec.   63.8(c)(1)(iii).............  Requirements to         Must develop and implement   Yes...........................  No.
                                      Develop SSMP for CMS.   SSMP for CMS.
Sec.   63.8(c)(2)-(3)..............  Monitoring System       Must install to get          Yes...........................  Yes.
                                      Installation.           representative emission of
                                                              parameter measurements;
                                                              must verify operational
                                                              status before or at
                                                              performance test.
Sec.   63.8(c)(4)..................  Continuous Monitoring   CMS must be operating        Yes...........................  Yes.
                                      System (CMS)            except during breakdown,
                                      Requirements.           out-of-control, repair,
                                                              maintenance, and high-
                                                              level calibration drifts;
                                                              COMS must have a minimum
                                                              of one cycle of sampling
                                                              and analysis for each
                                                              successive 10-second
                                                              period and one cycle of
                                                              data recording for each
                                                              successive 6-minute
                                                              period; CEMS must have a
                                                              minimum of one cycle of
                                                              operation for each
                                                              successive 15-minute
                                                              period.
Sec.   63.8(c)(5)..................  Continuous Opacity      COMS minimum procedures....  NA............................  NA.
                                      Monitoring System
                                      (COMS) Minimum
                                      Procedures.
Sec.   63.8(c)(6)-(8)..............  CMS Requirements......  Zero and high-level          Yes...........................  Yes.
                                                              calibration check
                                                              requirements; out-of-
                                                              control periods.
Sec.   63.8(d)(1)-(2)..............  CMS Quality Control...  Requirements for CMS         Yes...........................  Yes.
                                                              quality control, including
                                                              calibration, etc..
Sec.   63.8(d)(3)..................  Written Procedures for  Must keep quality control    Yes...........................  No, see Sec.   63.2282(f).
                                      CMS.                    plan on record for 5
                                                              years. Keep old versions
                                                              for 5 years after
                                                              revisions. May incorporate
                                                              as part of SSMP to avoid
                                                              duplication..
Sec.   63.8(e).....................  CMS Performance         Notification, performance    Yes...........................  Yes.
                                      Evaluation.             evaluation test plan,
                                                              reports.
Sec.   63.8(f)(1)-(5)..............  Alternative Monitoring  Procedures for               Yes...........................  Yes.
                                      Method.                 Administrator to approve
                                                              alternative monitoring.
Sec.   63.8(f)(6)..................  Alternative to          Procedures for               Yes...........................  Yes.
                                      Relative Accuracy       Administrator to approve
                                      Test.                   alternative relative
                                                              accuracy tests for CEMS.
Sec.   63.8(g).....................  Data Reduction........  COMS 6-minute averages       Yes...........................  Yes.
                                                              calculated over at least
                                                              36 evenly spaced data
                                                              points; CEMS 1 hour
                                                              averages computed over at
                                                              least 4 equally spaced
                                                              data points; data that
                                                              can't be used in average;
                                                              rounding of data.
Sec.   63.9(a).....................  Notification            Applicability and State      Yes...........................  Yes.
                                      Requirements.           delegation.
Sec.   63.9(b)(1)-(2)..............  Initial Notifications.  Submit notification 120      Yes...........................  Yes.
                                                              days after effective date;
                                                              contents of notification.
Sec.   63.9(b)(3)..................  [Reserved]............
Sec.   63.9(b)(4)-(5)..............  Initial Notifications.  Submit notification 120      Yes...........................  Yes.
                                                              days after effective date;
                                                              notification of intent to
                                                              construct/reconstruct;
                                                              notification of
                                                              commencement of construct/
                                                              reconstruct; notification
                                                              of startup; contents of
                                                              each.
Sec.   63.9(c).....................  Request for Compliance  Can request if cannot        Yes...........................  Yes.
                                      Extension.              comply by date or if
                                                              installed best available
                                                              control technology/lowest
                                                              achievable emission rate.
Sec.   63.9(d).....................  Notification of         For sources that commence    Yes...........................  Yes.
                                      Special Compliance      construction between
                                      Requirements for New    proposal and promulgation
                                      Source.                 and want to comply 3 years
                                                              after effective date.
Sec.   63.9(e).....................  Notification of         Notify EPA Administrator 60  Yes...........................  Yes.
                                      Performance Test.       days prior.
Sec.   63.9(f).....................  Notification of         Notify EPA Administrator 30  No............................  No.
                                      Visible Emissions/      days prior.
                                      Opacity Test.
Sec.   63.9(g).....................  Additional              Notification of performance  Yes...........................  Yes.
                                      Notifications When      evaluation; notification
                                      Using CMS.              using COMS data;
                                                              notification that exceeded
                                                              criterion for relative
                                                              accuracy.

Sec.   63.9(h)(1)-(6)..............  Notification of         Contents; due 60 days after  Yes...........................  Yes.
                                      Compliance Status.      end of performance test or
                                                              other compliance
                                                              demonstration, except for
                                                              opacity/VE, which are due
                                                              30 days after; when to
                                                              submit to Federal vs.
                                                              State authority.
Sec.   63.9(i).....................  Adjustment of           Procedures for               Yes...........................  Yes.
                                      Submittal Deadlines.    Administrator to approve
                                                              change in when
                                                              notifications must be
                                                              submitted.
Sec.   63.9(j).....................  Change in Previous      Must submit within 15 days   Yes...........................  Yes.
                                      Information.            after the change.
Sec.   63.10(a)....................  Recordkeeping/          Applies to all, unless       Yes...........................  Yes.
                                      Reporting.              compliance extension; when
                                                              to submit to Federal vs.
                                                              State authority;
                                                              procedures for owners of
                                                              more than one source.
Sec.   63.10(b)(1).................  Recordkeeping/          General Requirements; keep   Yes...........................  Yes.
                                      Reporting.              all records readily
                                                              available; keep for 5
                                                              years.
Sec.   63.10(b)(2)(i)..............  Recordkeeping of        Records of occurrence and    Yes...........................  No, see Sec.   63.2282(a).
                                      Occurrence and          duration of each startup
                                      Duration of Startups    or shutdown that causes
                                      and Shutdowns.          source to exceed emission
                                                              limitation.
Sec.   63.10(b)(2)(ii).............  Recordkeeping of        Records of occurrence and    Yes...........................  No, see Sec.   63.2282(a) for
                                      Failures to Meet a      duration of each                                             recordkeeping of (1) date,
                                      Standard.               malfunction of operation                                     time and duration; (2)
                                                              or air pollution control                                     listing of affected source or
                                                              and monitoring equipment.                                    equipment, and an estimate of
                                                                                the quantity of each
                                                                                regulated pollutant emitted
                                                                                over the standard; and (3)
                                                                                actions to minimize emissions
                                                                                and correct the failure.
Sec.   63.10(b)(2)(iii)............  Maintenance Records...  Records of maintenance       Yes...........................  Yes.
                                                              performed on air pollution
                                                              control and monitoring
                                                              equipment.
Sec.   63.10(b)(2)(iv)-(v).........  Actions Taken to        Records of actions taken     Yes...........................  No.
                                      Minimize Emissions      during SSM to minimize
                                      During SSM.             emissions.
Sec.   63.10(b)(2)(vi) and (x)-(xi)  CMS Records...........  Malfunctions, inoperative,   Yes...........................  Yes.
                                                              out-of-control.
Sec.   63.10(b)(2)(vii)-(ix).......  Records...............  Measurements to demonstrate  Yes...........................  Yes.
                                                              compliance with compliance
                                                              options and operating
                                                              requirements; performance
                                                              test, performance
                                                              evaluation, and visible
                                                              emission observation
                                                              results; measurements to
                                                              determine conditions of
                                                              performance tests and
                                                              performance evaluations.
Sec.   63.10(b)(2)(xii)............  Records...............  Records when under waiver..  Yes...........................  Yes.
Sec.   63.10(b)(2)(xiii)...........  Records...............  Records when using           Yes...........................  Yes.
                                                              alternative to relative
                                                              accuracy test.
Sec.   63.10(b)(2)(xiv)............  Records...............  All documentation            Yes...........................  Yes.
                                                              supporting initial
                                                              notification and
                                                              notification of compliance
                                                              status.
Sec.   63.10(b)(3).................  Records...............  Applicability                Yes...........................  Yes.
                                                              determinations.
Sec.   63.10(c)(1)-(6), (9)-(14)...  Records...............  Additional records for CMS.  Yes...........................  Yes.
Sec.   63.10(c)(7)-(8).............  Records...............  Records of excess emissions  No............................  No.
                                                              and parameter monitoring
                                                              exceedances for CMS.
Sec.   63.10(c)(15)................  Use of SSMP...........  Use SSMP to satisfy          Yes...........................  No.
                                                              recordkeeping requirements
                                                              for identification of
                                                              malfunction, correction
                                                              action taken, and nature
                                                              of repairs to CMS.
Sec.   63.10(d)(1).................  General Reporting       Requirement to report......  Yes...........................  Yes.
                                      Requirements.
Sec.   63.10(d)(2).................  Report of Performance   When to submit to Federal    Yes...........................  Yes.
                                      Test Results.           or State authority.
Sec.   63.10(d)(3).................  Reporting Opacity or    What to report and when....  NA............................  NA.
                                      VE Observations.
Sec.   63.10(d)(4).................  Progress Reports......  Must submit progress         Yes...........................  Yes.
                                                              reports on schedule if
                                                              under compliance extension.
Sec.   63.10(d)(5)(i)..............  Periodic SSM Reports..  Contents and submission of   Yes...........................  No, see Sec.   63.2281(d)-(e)
                                                              periodic SSM reports.                                        for malfunction reporting
                                                                                requirements.
Sec.   63.10(d)(5)(ii).............  Immediate SSM Reports.  Contents and submission of   Yes...........................  No.
                                                              immediate SSM reports.
Sec.   63.10(e)(1)-(2).............  Additional CMS Reports  Must report results for      Yes...........................  Yes.
                                                              each CEM on a unit;
                                                              written copy of
                                                              performance evaluation; 3
                                                              copies of COMS performance
                                                              evaluation.
Sec.   63.10(e)(3).................  Reports...............  Excess emission reports....  No............................  No.
Sec.   63.10(e)(4).................  Reporting COMS Data...  Must submit COMS data with   NA............................  NA.
                                                              performance test data.
Sec.   63.10(f)....................  Waiver for              Procedures for EPA           Yes...........................  Yes.
                                      Recordkeeping/          Administrator to waive.
                                      Reporting.
Sec.   63.11.......................  Control Device and      Requirements for flares and  NA............................  NA.
                                      Work Practice           alternative work practice
                                      Requirements.           for equipment leaks.
Sec.   63.12.......................  State Authority and     State authority to enforce   Yes...........................  Yes.
                                      Delegations.            standards.
Sec.   63.13.......................  Addresses.............  Addresses where reports,     Yes...........................  Yes.
                                                              notifications, and
                                                              requests are sent.
Sec.   63.14.......................  Incorporations by       Test methods incorporated    Yes...........................  Yes.
                                      Reference.              by reference.
Sec.   63.15.......................  Availability of         Public and confidential      Yes...........................  Yes.
                                      Information and         information.
                                      Confidentiality.
Sec.   63.16.......................  Performance Track       Requirements for             Yes...........................  Yes.
                                      Provisions.             Performance Track member
                                                              facilities.
--------------------------------------------------------------------------------------------------------------------------------------------------------
a New or reconstructed affected sources that commenced construction or reconstruction after September 6, 2019 must comply with the requirements in
  column 5 of this table beginning on [DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register] or upon initial startup, whichever is later.

0
23. Subpart DDDD is amended by adding Appendix B to read as follows:

 Appendix B to Subpart DDDD of Part 63--List of Hazardous Air Pollutants
That Must Be Counted Relative to the Plywood and Composite Wood Products
``Non-HAP Coating'' Definition if Present at 0.1 Percent or More by Mass
------------------------------------------------------------------------
                     Chemical name                           CAS No.
------------------------------------------------------------------------
1,1,2,2-Tetrachloroethane.............................           79-34-5
1,1,2-Trichloroethane.................................           79-00-5
1,1-Dimethylhydrazine.................................           57-14-7
1,2-Dibromo-3-chloropropane...........................           96-12-8
1,2-Diphenylhydrazine.................................          122-66-7
1,3-Butadiene.........................................          106-99-0
1,3-Dichloropropene...................................          542-75-6
1,4-Dioxane...........................................          123-91-1
2,4,6-Trichlorophenol.................................           88-06-2
2,4/2,6-Dinitrotoluene (mixture)......................        25321-14-6
2,4-Dinitrotoluene....................................          121-14-2
2,4-Toluene diamine...................................           95-80-7
2-Nitropropane........................................           79-46-9
3,3'-Dichlorobenzidine................................           91-94-1
3,3'-Dimethoxybenzidine...............................          119-90-4
3,3'-Dimethylbenzidine................................          119-93-7
4,4'-Methylene bis(2-chloroaniline)...................          101-14-4
Acetaldehyde..........................................           75-07-0
Acrylamide............................................           79-06-1
Acrylonitrile.........................................          107-13-1
Allyl chloride........................................          107-05-1
alpha-Hexachlorocyclohexane (a-HCH)...................          319-84-6
Aniline...............................................           62-53-3
Benzene...............................................           71-43-2
Benzidine.............................................           92-87-5
Benzotrichloride......................................           98-07-7
Benzyl chloride.......................................          100-44-7
beta-Hexachlorocyclohexane (b-HCH)....................          319-85-7
Bis(2-ethylhexyl)phthalate............................          117-81-7
Bis(chloromethyl)ether................................          542-88-1
Bromoform.............................................           75-25-2
Captan................................................          133-06-2
Carbon tetrachloride..................................           56-23-5
Chlordane.............................................           57-74-9
Chlorobenzilate.......................................          510-15-6
Chloroform............................................           67-66-3
Chloroprene...........................................          126-99-8
Cresols (mixed).......................................         1319-77-3
DDE...................................................         3547-04-4
Dichloroethyl ether...................................          111-44-4
Dichlorvos............................................           62-73-7
Epichlorohydrin.......................................          106-89-8
Ethyl acrylate........................................          140-88-5
Ethylene dibromide....................................          106-93-4
Ethylene dichloride...................................          107-06-2
Ethylene oxide........................................           75-21-8
Ethylene thiourea.....................................           96-45-7
Ethylidene dichloride (1,1-Dichloroethane)............           75-34-3
Formaldehyde..........................................           50-00-0
Heptachlor............................................           76-44-8
Hexachlorobenzene.....................................          118-74-1
Hexachlorobutadiene...................................           87-68-3
Hexachloroethane......................................           67-72-1
Hydrazine.............................................          302-01-2
Isophorone............................................           78-59-1
Lindane (hexachlorocyclohexane, all isomers)..........           58-89-9
m-Cresol..............................................          108-39-4
Methylene chloride....................................           75-09-2
Naphthalene...........................................           91-20-3
Nitrobenzene..........................................           98-95-3
Nitrosodimethylamine..................................           62-75-9
o-Cresol..............................................           95-48-7
o-Toluidine...........................................           95-53-4
Parathion.............................................           56-38-2
p-Cresol..............................................          106-44-5
p-Dichlorobenzene.....................................          106-46-7
Pentachloronitrobenzene...............................           82-68-8
Pentachlorophenol.....................................           87-86-5
Propoxur..............................................          114-26-1
Propylene dichloride..................................           78-87-5

Propylene oxide.......................................           75-56-9
Quinoline.............................................           91-22-5
Tetrachloroethene.....................................          127-18-4
Toxaphene.............................................         8001-35-2
Trichloroethylene.....................................           79-01-6
Trifluralin...........................................         1582-09-8
Vinyl bromide.........................................          593-60-2
Vinyl chloride........................................           75-01-4
Vinylidene chloride...................................           75-35-4
------------------------------------------------------------------------

[FR Doc. 2019-18827 Filed 9-5-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 241 (Monday, December 16, 2013)]
[Notices]
[Pages 76142-76143]
[FR Doc No: 2013-29808]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9904-13-Region-3]

Adequacy Status of the Submitted Attainment Plan for the Delaware
Portion of the Philadelphia-Wilmington-New Jersey 1997 Fine Particulate
Matter National Ambient Air Quality Standard Nonattainment Area for
Transportation Conformity Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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

SUMMARY: In this notice, EPA is notifying the public that EPA has found
that the Motor Vehicle Emissions Budgets (MVEBs) in the Delaware
portion of the Philadelphia-Wilmington-New Jersey 1997 fine particulate
matter (PM2.5) National Ambient Air Quality Standard (NAAQS)
Attainment Plan, submitted as a State Implementation Plan (SIP)
revision on April 25, 2012 by the Delaware Department of Natural
Resources and Environmental Control (DNREC), are adequate for
transportation conformity purposes. As a result of EPA's finding, the
State of Delaware must use the out-year 2012 MVEBs from the April 25,
2012 Attainment Plan for future conformity determinations for the 1997
PM2.5 NAAQS.

DATES: This final rule is effective on December 31, 2013.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat, Environmental
Scientist, Office of Air Program Planning (3AP30), United States
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, PA 19103,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Today's notice is simply an announcement of
a finding that EPA has already made. EPA Region III sent a letter to
the Delaware Department of Natural Resources and Environmental Control
on November 7, 2013 stating that EPA has found that the MVEBs in the
Attainment Plan for budget year 2009 and out-year 2012, submitted on
April 25, 2012 by DNREC, are adequate for transportation conformity
purposes. As a result of EPA's finding, the State of Delaware

must use the out-year 2012 MVEBs from the April 25, 2012 Attainment
Plan for future conformity determinations in the Delaware portion of
the Philadelphia-Wilmington-New Jersey 1997 PM2.5 NAAQS
nonattainment area. Receipt of the submittal was announced on EPA's
transportation conformity Web site. No comments were received. The
findings letter is available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm. The adequate
direct PM and nitrogen oxides (NOX) MVEBs are provided in
Table 1.

Table 1. Delaware Portion of the Philadelphia-Wilmington-New Jersey 1997
    PM2.5 NAAQS Attainment Demonstration MVEBs for Direct PM and NOX
------------------------------------------------------------------------
                                          Mobile vehicle
                                             emissions    Mobile vehicle
              Budget years                  budget for       emissions
                                          direct PM-tons  budget for NOX-
                                             per year      tons per year
------------------------------------------------------------------------
2009....................................             257           8,448
2012....................................             199           6,273
------------------------------------------------------------------------

    Transportation conformity is required by section 176(c) of the
Clean Air Act (CAA). EPA's conformity rule requires that transportation
plans, transportation improvement programs, and projects conform to
SIPs and establishes the criteria and procedures for determining
whether or not they do. Conformity to a SIP means that transportation
activities will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the national ambient air
quality standards.
    The criteria by which we determine whether a SIP's MVEBs are
adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4).
EPA described the process for determining the adequacy of submitted SIP
budgets in a July 1, 2004 preamble starting at 69 FR 40038 and used the
information in these resources in making this adequacy determination.
Delaware did not provide emission budgets for sulfur dioxide
(SO2), volatile organic compounds (VOCs), or ammonia for the
Delaware portion of the Philadelphia-Wilmington-New Jersey
nonattainment area because it concluded that emissions of these
precursors from motor vehicles are not significant contributors to the
area's PM2.5 air quality problem. The transportation
conformity rule provision at 40 CFR 93.102(b)(2)(v) indicates that
conformity does not apply for these precursors, due to the lack of
MVEBs for these precursors and the State's conclusion that motor
vehicle emissions of SO2, VOCs, and ammonia do not
contribute significantly to the area's PM2.5 nonattainment
problem. This provision of the transportation conformity rule predates
and was not disturbed by the January 4, 2013 decision in the litigation
on the PM2.5 implementation rule.\1\ EPA has preliminarily
concluded that the State's decision to not include budgets for
SO2, VOCs, and ammonia is consistent with the requirements
of the transportation conformity rule. That decision does not affect
EPA's adequacy finding for the submitted direct PM and NOX
MVEBs for the Delaware portion of the Philadelphia-Wilmington-New
Jersey nonattainment area.
---------------------------------------------------------------------------

    \1\ EPA issued conformity regulations to implement the 1997
PM2.5 NAAQS in July 2004 and May 2005 (69 FR 40004, July
1, 2004 and 70 FR 24280, May 6, 2005, respectively). Those actions
were not part of the final rule recently remanded to EPA by the
Court of Appeals for the District of Columbia in NRDC v. EPA, No.
08-1250 (Jan. 4, 2013), in which the Court remanded to EPA the
implementation rule for the PM2.5 NAAQS because it
concluded that EPA must implement that NAAQS pursuant to the PM-
specific implementation provisions of subpart 4 of Part D of Title I
of the CAA, rather than solely under the general provisions of
subpart 1.
---------------------------------------------------------------------------

    Please note that an adequacy review is separate from EPA's
completeness review, and should not be used to prejudge EPA's ultimate
approval action for the SIP. Even if EPA finds a budget adequate, the
SIP could later be disapproved. The finding and the response to
comments are available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm.

    Authority: 42 U.S.C. 7401-7671q.

    Dated: November 25, 2013.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2013-29808 Filed 12-13-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Page 8571]
[FR Doc No: 2016-03400]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension: Rule 14f-1, SEC File No. 270-127, OMB Control No. 3235-
0108.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Under Exchange Act Rule 14f-1 (17 CFR 240.14f-1), if a person or
persons have acquired securities of an issuer in a transaction subject
to Sections 13(d) or 14(d) of the Exchange Act, and changes a majority
of the directors of the issuer otherwise than at a meeting of security
holders, then the issuer must file with the Commission and transmit to
security holders information related to the change in directors within
10 days prior to the date the new majority takes office as directors.
The information filed under Rule 14f-1 must be filed with the
Commission and is publicly available. We estimate that it takes
approximately 18 burden hours to provide the information required under
Rule 14f-1 and that the information is filed by approximately 64
respondents for a total annual reporting burden of 1,152 hours (18
hours per response x 64 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the performance of the
functions of the agency, including whether the information will have
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collection of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: February 12, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-03400 Filed 2-18-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16796-16797]
[FR Doc No: 2011-7055]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0155]

Pediatric Anesthesia Safety Initiative (PASI)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Pediatric Anesthesia
Safety Initiative (PASI). The goal of PASI is to bridge the scientific
and clinical gaps in the field of pediatrics to ensure the safe use of
anesthetic and sedative agents in children. FDA seeks under PASI to
encourage and facilitate scientific collaboration among multiple
stakeholders within a public-private partnership (PPP) framework and to
support the conduct of non-clinical and clinical studies to answer
unknown questions regarding the effects of anesthetics and sedatives in
the pediatric population. The output from PASI will help to inform the
work of FDA as part of its public health mission.

DATES: Important dates are as follows:
    1. The application due date is April 29, 2011.
    2. The anticipated start date is July 14, 2011.
    3. The opening date is March 30, 2011.
    4. The expiration date is April 30, 2011.
    For Further Information and Additional Requirements Contact:
ShaAvhree Buckman, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4554,
Silver Spring, MD 20993,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>Vieda Hubbard, Office of Acquisitions &
Grant Services, Food and Drug Administration, 5630 Fishers Lane (HFA-
500), Rockville, MD 20857,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://grants.nih.gov/grants/guide/ (select the ``Request
for Applications'' link), http://www.grants.gov/ (see ``For
Applicants'' section), and http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm166082.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-11-005.
    93.103.

A. Background

    Non-clinical studies in juvenile animal models have shown that
exposure to some anesthestics and sedatives is associated with
neurodegenerative changes in the central nervous system, as well as
memory and learning deficits. Anesthetic agents that have been
specifically implicated are N-methyl-D-aspartate (NMDA) receptor
antagonists, such as ketamine, and gamma aminobutyric acid (GABA)
agonists, such as sevoflurane. The anesthesia community and FDA
acknowledge that there are insufficient human data to either support or
refute the clinical relevance of these findings for pediatric patients.
Therefore, numerous non-clinical and clinical studies are needed to
assess the effect of anesthetics and sedatives on the developing human
brain, including long-term studies in neonates and young children.
However, the planning and performance of the numerous studies needed to
address the aforementioned issues will involve enormous challenges in
terms of design, assurance of validity and reliability of the outcome
measures, and ethical considerations. It is unlikely that any one
entity will possess the necessary expertise and resources to accomplish
all the work needed to address the issues in an expeditious manner.

B. Objectives

    PASI aims to bridge the scientific and clinical gaps in the field
of pediatrics to ensure the safe use of anesthetic and sedative agents
in children. Specific activities to be funded through this announcement
include, but are not limited to:
    1. Project management of PASI PPP:
     Development, implementation, and management of a
scientific and administrative infrastructure to support the creation
and execution of a series of projects aligned with PASI.
     Coordination of the overall governance board, to include
luminary experts to lead the overall PPP; said governance board to
establish necessary

steering committees and working groups to ensure appropriate project
implementation, oversight, and management for all projects under the
PPP.
     Development of a scientific review panel to evaluate the
progress of projects funded under the PPP and development of
feasibility plans for additional projects aligned with PASI.
     Coordination with FDA and other partners; the development
and publication of scientific articles in support of educational and
outreach activities (with data, know-how, and other outcomes from the
aforementioned projects supported under the PPP) and to benefit
patients and other stakeholders.
     Development of a strategy to identify and establish
relationships with key experts in the fields of anesthesia and
sedation, including stakeholders from industry, professional
organizations, academia, and awardees of the projects under the
``research and analysis'' section for leveraging and collaborative
efforts under PASI.
     Coordination of annual scientific workshops with
collaboration by FDA and the aforementioned experts in the fields of
anesthesia and sedation, including stakeholders from industry,
professional organizations, academia, and Government Agencies.
    2. Research projects (which may include, but are not limited to):
     Clinical trials including prospective, randomized, and
blinded investigations assessing the immediate and delayed
neurodevelopmental effects of regional/caudal anesthesia versus general
anesthesia in neonates/infants;
     Observational trials including the comparison of two
groups of children, one group exposed to general anesthesia within the
first 3 years of life and the other, unexposed. Assessments should
utilize neuropsychological tests of attention, memory, motor function,
and behavior; and
     Epidemiologic investigations surveying large existing
population databases for cognitive developmental effects where exposure
to general anesthesia before the age of 3 can be compared to the
overall population.

C. Eligibility Information

    Higher education institutions:
     Public/state-controlled institutions of higher education
     Private institutions of higher education
    The following types of higher education institutions are always
encouraged to apply for National Institutes of Health support as public
or private institutions of higher education:
     Hispanic serving institutions
     Historically Black colleges and universities
     Tribally controlled colleges and universities
     Alaska Native and Native Hawaiian serving institutions
    Nonprofits other than institutions of higher education
     Nonprofits with 501(c)(3) Internal Revenue Service (IRS)
status (other than institutions of higher education)
     Nonprofits without 501(c)(3) IRS status (other than
institutions of higher education)
    For-profit organizations:
     Small businesses
     For-profit organizations (other than small businesses)
    Other:
     Regional organizations
    Non-domestic (non-U.S.) entities (foreign organizations) are not
eligible to apply. Foreign (non-U.S.) components of U.S. organizations
are not allowed.

II. Award Information/Funds Available

A. Award Amount

    FDA intends to fund one or more awards, corresponding to a total of
$1 million, for fiscal year 2011, to carry out the project management
and research project objectives described in Part I of this document.
Future year amounts will depend on annual appropriations. No more than
four awards are anticipated under this FOA. The number of awards is
contingent upon FDA appropriations and the submission of a sufficient
number of meritorious applications.

B. Length of Support

    The anticipated length of the individual awards is 5 years.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://grants.nih.gov/grants/guide/ (select the ``Request for Applications'' link), http://www.grants.gov/ (see ``For Applicants'' section) and http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm166082.htm. (FDA has verified the
Web site addresses throughout this document, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.) For all electronically submitted
applications, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With Central Contractor Registration
     Step 3: Obtain Username and Password
     Step 4: Authorized Organization Representative (AOR)
Authorization
     Step 5: Track AOR Status
     Step 6: Register With Electronic Research Administration
(eRA) Commons Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov/.

    Dated: March 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7055 Filed 3-24-11; 8:45 am]
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