[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Pages 65663-65669]
[FR Doc No: 2014-26304]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1721]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on regulations under which the
clinical investigation of the safety and effectiveness of unapproved
new drugs and biological products can be conducted.

DATES: Submit either electronic or written comments on the collection
of information by January 5, 2015.

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

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food

and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Investigational New Drug (IND) Regulations--21 CFR Part 312 (OMB
Control Number 0910-0014)--Extension

    FDA is requesting OMB approval for the reporting and recordkeeping
requirements contained in FDA regulations entitled ``Investigational
New Drug Application'' in 21 CFR part 312 (part 312). Part 312
implements provisions of section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) (the FD&C Act) to issue regulations
under which the clinical investigation of the safety and effectiveness
of unapproved new drugs and biological products can be conducted.
    FDA is charged with implementing statutory requirements that drug
products marketed in the United States be shown to be safe and
effective, properly manufactured, and properly labeled for their
intended uses. Section 505(a) of the FD&C Act provides that a new drug
may not be introduced or delivered for introduction into interstate
commerce in the United States unless FDA has previously approved a new
drug application (NDA). FDA approves an NDA only if the sponsor of the
application first demonstrates that the drug is safe and effective for
the conditions prescribed, recommended, or suggested in the product's
labeling. Proof must consist, in part, of adequate and well-controlled
studies, including studies in humans, that are conducted by qualified
experts. The IND regulations establish reporting requirements that
include an initial application as well as amendments to that
application, reports on significant revisions of clinical investigation
plans, and information on a drug's safety or effectiveness. In
addition, the sponsor is required to give FDA an annual summary of the
previous year's clinical experience.
    Submissions are reviewed by medical officers and other Agency
scientific reviewers assigned responsibility for overseeing the
specific study. The IND regulations also contain recordkeeping
requirements that pertain to the responsibilities of sponsors and
investigators. The detail and complexity of these requirements are
dictated by the scientific procedures and human subject safeguards that
must be followed in the clinical tests of investigational new drugs.
    The IND information collection requirements provide the means by
which FDA can monitor the clinical investigation of the safety and
effectiveness of unapproved new drugs and biological products,
including the following: (1) Monitor the safety of ongoing clinical
investigations; (2) determine whether the clinical testing of a drug
should be authorized; (3) ensure production of reliable data on the
metabolism and pharmacological action of the drug in humans; (4) obtain
timely information on adverse reactions to the drug; (5) obtain
information on side effects associated with increasing doses; (6)
obtain information on the drug's effectiveness; (7) ensure the design
of well-controlled, scientifically valid studies; (8) obtain other
information pertinent to determining whether clinical testing should be
continued, and information related to the protection of human subjects.
Without the information provided by industry as required under the IND
regulations, FDA cannot authorize or monitor the clinical
investigations which must be conducted prior to authorizing the sale
and general use of new drugs. These reports enable FDA to monitor a
study's progress, to assure subject safety, to assure that a study will
be conducted ethically, and to increase the likelihood that the sponsor
will conduct studies that will be useful in determining whether the
drug should be marketed and available for use in medical practice.
    There are two forms that are required under part 312:
    Form FDA-1571--``Investigational New Drug Application.'' A person
who intends to conduct a clinical investigation submits this form to
FDA. It includes the following information: (1) A cover sheet
containing background information on the sponsor and investigator; (2)
a table of contents; (3) an introductory statement and general
investigational plan; (4) an investigator's brochure describing the
drug substance; (5) a protocol for each planned study; (6) chemistry,
manufacturing, and control information for each investigation; (7)
pharmacology and toxicology information for each investigation; and (8)
previous human experience with the investigational drug.
    Form FDA-1572--``Investigator Statement.'' Before permitting an
investigator to begin participation in an investigation, the sponsor
must obtain and record this form. It includes background information on
the investigator and the investigation, and a general outline of the
planned investigation and the study protocol.
    FDA is requesting OMB approval for the following reporting and
recordkeeping requirements in part 312.

I. Reporting Requirements

21 CFR 312.2(e)--Requests for FDA advice on the applicability of part
312 to a planned clinical investigation.
21 CFR 312.6--Labeling of an investigational new drug. Estimates for
the information collection in this requirement are included under Sec.
312.23(a)(7)(iv)(d).
21 CFR 312.8--Charging for investigational drugs under an IND.
21 CFR 312.10--Applications for waiver of requirements under part 312.
As indicated in Sec.  312.10(a), estimates for the information
collection in this requirement are included under Sec. Sec.  312.23 and
312.31. In addition, other waiver requests under Sec.  312.10 are
estimated in table 1.
21 CFR 312.20(c)--Applications for investigations involving an
exception from informed consent under Sec.  50.24 (21 CFR 50.24).
Estimates for the

information collection in this requirement are included under Sec.
312.23.
21 CFR 312.23--IND (content and format).
    .23(a)(1)--Cover sheet FDA-1571.
    .23(a)(2)--Table of Contents.
    .23(a)(3)--Investigational plan for each planned study.
    .23(a)(5)--Investigator's brochure.
    .23(a)(6)--Protocols--Phase 1, 2, and 3.
    .23(a)(7)--Chemistry, manufacturing, and control information.
    .23(a)(7)(iv)(a),(b),(c)--A description of the drug substance, a
list of all components, and any placebo used.
    .23(a)(7)(iv)(d)--Labeling: Copies of labels and labeling to be
provided each investigator.
    .23(a)(7)(iv)(e)--Environmental impact analysis regarding drug
manufacturing and use.
    .23(a)(8)--Pharmacological and toxicology information.
    .23(a)(9)--Previous human experience with the investigational drug.
    .23(a)(10)--Additional information.
    .23(a)(11)--Relevant information.
    .23(f)--Identification of exception from informed consent.
21 CFR 312.30--Protocol amendments.
    .30(a)--New protocol
    .30(b)--Changes in protocol
    .30(c)--New investigator.
    .30(d)--Content and format.
    .30(e)--Frequency.
21 CFR 312.31--Information amendments.
    .31(b)--Content and format.
    --Chemistry, toxicology, or technical information.
21 CFR 312.32--Safety reports.
    .32(c)(1)--Written reports to FDA and to investigators.
    .32(c)(2)--Telephone reports to FDA for fatal or life-threatening
experience.
    .32(c)(3)--Format or frequency.
    .32(d)--Followup submissions.
21 CFR 312.33--Annual reports.
    .33(a)--Individual study information.
    .33(b)--Summary information.
    (b)(1)--Adverse experiences.
    (b)(2)--Safety report summary.
    (b)(3)--List of fatalities and causes of death.
    (b)(4)--List of discontinuing subjects.
    (b)(5)--Drug action.
    (b)(6)--Preclinical studies and findings.
    (b)(7)--Significant changes.
    .33(c)--Next year general investigational plan.
    .33(d)--Brochure revision.
    .33(e)--Phase I protocol modifications.
    .33(f)--Foreign marketing developments.
21 CFR 312.38(b) and (c)--Notification of withdrawal of an IND.
21 CFR 312.41--Comment and advice on an IND. Estimates for the
information collection in this requirement are included under Sec.
312.23.
21 CFR 312.42--Sponsor requests that a clinical hold be removed, and
submits a complete response to the issues identified in the clinical
hold order.
21 CFR 312.44(c) and (d)--Opportunity for sponsor response to FDA when
IND is terminated.
21 CFR 312.45(a) and (b)--Sponsor request for, or response to, an
inactive status determination of an IND.
21 CFR 312.47--Meetings, including ``End-of-Phase 2'' meetings and
``Pre-NDA'' meetings.
21 CFR 312.48--Dispute resolution. Estimates for the information
collection in this requirement are included under Sec.  312.47.
21 CFR 312.53(c)--Investigator information. Investigator report (Form
FDA-1572) and narrative; Investigator's background information; Phase 1
outline of planned investigation and Phase 2 outline of study protocol.
21 CFR 312.54(a) and (b)--Sponsor submissions concerning investigations
involving an exception from informed consent under Sec.  50.24.
21 CFR 312.55(b)--Sponsor reports to investigators on new observations,
especially adverse reactions and safe use. Only ``new observations''
are estimated under this section; investigator brochures are included
under Sec.  312.23.
21 CFR 312.56(b), (c), and (d)--Sponsor monitoring of all clinical
investigations, investigators, and drug safety; notification to FDA and
others.
21 CFR 312.58(a)--Sponsor's submission of records to FDA on request.
21 CFR 312.64--Investigator reports to the sponsor.
    .64(a)--Progress reports.
    .64(b)--Safety reports
    .64(c)--Final reports.
    .64(d)--Financial disclosure reports.
21 CFR 312.66--Investigator reports to institutional review board
(IRB). Estimates for the information collection in this requirement are
included under Sec.  312.53.
21 CFR 312.70--Investigator disqualification; opportunity to respond to
FDA.
21 CFR 312.83--Sponsor submission of treatment protocol. Estimates for
this requirement are included under Sec.  312.320.
21 CFR 312.85--Sponsors conducting phase 4 studies. Estimates for the
information collection in this requirement are included under Sec.
312.23, and under Sec. Sec.  314.50, 314.70, and 314.81 in OMB control
number 0910-0001.
21 CFR 312.110(b)--Requests to export an investigational drug.
21 CFR 312.120--Submissions related to foreign clinical studies not
conducted under an IND.
21 CFR 312.130--Requests for disclosable information in an IND and from
investigations involving an exception from informed consent under Sec.
50.24.
21 CFR 312.310(b); 312.305(b)--Submissions related to expanded access
and treatment of an individual patient.
21 CFR 312.310(d)--Submissions related to emergency use of an
investigational new drug.
21 CFR 312.315(c); 312.305(b)--Submissions related to expanded access
and treatment of an intermediate-size patient population.
21 CFR 312.320--Submissions related to a treatment IND or treatment
protocol.

II. Recordkeeping Requirements

21 CFR 312.52(a)--Transfer of obligations to a contract research
organization.
21 CFR 312.57--Sponsor recordkeeping on the investigational drug.
21 CFR 312.59--Sponsor recordkeeping of disposition of unused supply of
drugs. Estimates for the information collection in this requirement are
included under Sec.  312.57.
21 CFR 312.62(a)--Investigator recordkeeping of disposition of drugs.
21 CFR 312.62(b)--Investigator recordkeeping of case histories of
individuals.
21 CFR 312.120(d)--Recordkeeping requirements for submissions related
to foreign clinical studies not conducted under an IND. Estimates for
the information collection in this requirement are included under Sec.
312.57.
21 CFR 312.160(a)(3)--Records pertaining to the shipment of drugs for
investigational use in laboratory research animals or in vitro tests.
21 CFR 312.160(c)--Shipper records of alternative disposition of unused
drugs.

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

                         Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
312.2(e), Requests for FDA                   800            1                800              24          19,200
 advice on the applicability of
 part 312 to a planned clinical
 investigation..................
312.8, Requests to charge for an              56            1.25              70              48           3,360
 investigational drug...........
312.10, Requests to waive a                   50            1.76              88              24           2,112
 requirement in part 312........
312.23(a) through (f), IND                 1,689            1.57           2,648           1,600       4,236,800
 content and format (including
 Form FDA 1571).................
312.30(a) through (e), Protocol            3,739            5.77          21,588             284       6,130,992
 amendments.....................
312.31(b), Information                     4,537            3.39          15,377             100       1,537,700
 amendments.....................
312.32(c) and (d), IND Safety                755           24.28          18,332              32         586,624
 reports........................
312.33(a) through (f), IND                 2,877            2.76           7,953             360       2,863,080
 Annual reports.................
312.38(b) and (c), Notifications             862            1.54           1,328              28          37,184
 of withdrawal of an IND........
312.42, Sponsor requests that a              158            1.30             205             284          58,220
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d), Sponsor                    12            1                 12              16             192
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b), Sponsor                   260            1.73             451              12           5,412
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47, Meetings, including                  225            1.86             419             160          67,040
 ``End-of-Phase 2'' meetings and
 ``Pre-NDA'' meetings...........
312.53(c), Investigator reports            1,444            8.38          12,087              80         966,960
 submitted to the sponsor,
 including Form FDA 1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure. (Third party
 disclosure)....................
312.54(a), Sponsor submissions                 7            5                 35              48           1,680
 to FDA concerning
 investigations involving an
 exception from informed consent
 under 21 CFR 50.24.............
312.54(b), Sponsor notifications               7            1                  7              48             336
 to FDA and others concerning an
 IRB determination that it
 cannot approve research because
 it does not meet the criteria
 in the exception from informed
 consent in Sec.   50.24(a).
 (Includes third party
 disclosure)....................
312.55(a), Investigator                      590            3.50           2,067              48          99,216
 brochures submitted by the
 sponsor to each investigator.
 (Third party disclosure).......
312.55(b), Sponsor reports to                590            3.50           2,067              48          99,216
 investigators on new
 observations, especially
 adverse reactions and safe use.
 (Third party disclosure).......
312.56(b), (c), and (d), Sponsor           3,584            6.52          23,355              80       1,868,400
 notifications to FDA and others
 resulting from: (1) The
 sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects.
 (Includes third party
 disclosure)....................
312.58(a), Sponsor's submissions              60            1                 60               8             480
 of clinical investigation
 records to FDA on request
 during FDA inspections.........
312.64, Investigator reports to            1,444            1              1,444              24          34,656
 the sponsor, including progress
 reports, safety reports, final
 reports, and financial
 disclosure reports. (Third
 party disclosure)..............
312.70, During the                             4            1                  4              40             160
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5),                     11           26.28             289              75          21,675
 Written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
312.120(b), Submissions to FDA             1,414            8.63          12,198              32         390,336
 of ``supporting information''
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.120(c), Waiver requests                   35            2.34              82              24           1,968
 submitted to FDA related to the
 use of foreign clinical studies
 not conducted under an IND.....
312.130, Requests for                          3            1                  3               8              24
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................

312.310(b) and 312.305(b),                   228            1.76             401               8           3,208
 Submissions related to expanded
 access and treatment of an
 individual patient.............
312.310(d), Submissions related              410            2.19             899              16          14,384
 to emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b),                    44            7.07             311             120          37,320
 Submissions related to expanded
 access and treatment of an
 intermediate-size patient
 population.....................
312.320(b), Submissions related               12           12.67             152             300          45,600
 to a treatment IND or treatment
 protocol.......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      19,134,039
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                            Table 2--Estimated Annual Recordkeeping Burden for Human Drugs\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Number of       Number of records     Total annual
              21 CFR Section                 recordkeepers     per recordkeeper        records       Average burden per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for the                       335                1.50                503  2...............................              1,006
 transfer of obligations to a contract
 research organization.
312.57, Sponsor recordkeeping showing the              1,689                1                 1,689  100.............................            168,900
 receipt, shipment, or other disposition
 of the investigational drug, and any
 financial interests.
312.62(a), Investigator recordkeeping of               1,444                1                 1,444  40..............................             57,760
 the disposition of drugs.
312.62(b), Investigator recordkeeping of               1,444                1                 1,444  40..............................             57,760
 case histories of individuals.
312.160(a)(3), Records pertaining to the                 547                1.40                782  0.50 (30 minutes)...............                391
 shipment of drugs for investigational
 use in laboratory research animals or in
 vitro tests.
312.160(c) Shipper records of alternative                547                1.40                782  0.50 (30 minutes)...............                391
 disposition of unused drugs.
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  .................  ..................  .................  ................................            286,190
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                           Table 3--Estimated Annual Reporting Burden for Biologics\1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
312.2(e), Requests for FDA                   217            1.18             255              24           6,120
 advice on the applicability of
 part 312 to a planned clinical
 investigation..................
312.8, Requests to charge for an              20            1.50              30              48           1,440
 investigational drug...........
312.10, Requests to waive a                    2            1                  2              24              48
 requirement in part 312........
312.23(a) through (f), IND                   335            1.35             452           1,600         723,200
 content and format.............
312.30(a) through (e), Protocol              694            5.84           4,050             284       1,150,200
 amendments.....................
312.31(b), Information                        77            2.43             187             100          18,700
 amendments.....................
312.32(c) and (d), IND Safety                161            8.83           1,421              32          45,472
 reports........................
312.33(a) through (f), IND                   745            2.14           1,595             360         574,200
 Annual reports.................
312.38(b) and (c), Notifications             134            1.69             227              28           6,356
 of withdrawal of an IND........
312.42, Sponsor requests that a               67            1.30              87             284          24,708
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d), Sponsor                    34            1.15              39              16             624
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b), Sponsor                    55            1.38              76              12             912
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47, Meetings, including                   88            1.75             154             160          24,640
 ``End-of-Phase 2'' meetings and
 ``Pre-NDA'' meetings...........
312.53(c), Investigator reports              453            6.33           2,869              80         229,520
 submitted to the sponsor,
 including Form FDA-1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure.....................

312.54(a), Sponsor submissions                 1            1                  1              48              48
 to FDA concerning
 investigations involving an
 exception from informed consent
 under Sec.   50.24.............
312.54(b), Sponsor notifications               1            1                  1              48              48
 to FDA and others concerning an
 IRB determination that it
 cannot approve research because
 it does not meet the criteria
 in the exception from informed
 consent in Sec.   50.24(a).....
312.55(a), Number of                         239            1.91             457              48          21,936
 investigator brochures
 submitted by the sponsor to
 each investigator..............
312.55(b), Number of sponsor                 243            4.95           1,203              48          57,744
 reports to investigators on new
 observations, especially
 adverse reactions and safe use.
312.56(b), (c), and (d), Sponsor             108            2.21             239              80          19,120
 notifications to FDA and others
 resulting from: (1) The
 sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects...
312.58(a), Number of sponsor's                 7            1                  7               8              56
 submissions of clinical
 investigation records to FDA on
 request during FDA inspections.
312.64, Number of investigator             2,728            3.82          10,411              24         249,864
 reports to the sponsor,
 including progress reports,
 safety reports, final reports,
 and financial disclosure
 reports........................
312.70, During the                             5            1                  5              40             200
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5), Number              18            1                 18              75           1,350
 of written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
312.120(b), Number of                        280            9.82           2,750              32          88,000
 submissions to FDA of
 ``supporting information''
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.120(c), Number of waiver                   7            2.29              16              24             384
 requests submitted to FDA
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.130, Number of requests for              350            1.34             470               8           3,760
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................
312.310(b) and 312.305(b),                    78            1.08              84               8             672
 Number of submissions related
 to expanded access and
 treatment of an individual
 patient........................
312.310(d), Number of                         76            2.76             210              16           3,360
 submissions related to
 emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b),                     9            1                  9             120           1,080
 Number of submissions related
 to expanded access and
 treatment of an intermediate-
 size patient population........
312.320(b), Number of                          1            1                  1             300             300
 submissions related to a
 treatment IND or treatment
 protocol.......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       3,254,062
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                             Table 4--Estimated Annual Recordkeeping Burden for Biologics\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Number of       Number of records     Total annual
              21 CFR Section                 recordkeepers     per recordkeeper        records       Average burden per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for the                        75                1.40                105  2...............................                210
 transfer of obligations to a contract
 research organization.

312.57, Sponsor recordkeeping showing the                335                2.70                904  100.............................             90,400
 receipt, shipment, or other disposition
 of the investigational drug, and any
 financial interests.
312.62(a), Investigator recordkeeping of                 453                1                   453  40..............................             18,120
 the disposition of drugs.
312.62(b), Investigator recordkeeping of                 453                1                   453  40..............................             18,120
 case histories of individuals.
312.160(a)(3), Records pertaining to the                 111                1.40                155  0.50 (30 minutes)...............                 78
 shipment of drugs for investigational
 use in laboratory research animals or in
 vitro tests.
312.160(c), Shipper records of                           111                1.40                155  0.50 (30 minutes)...............                 78
 alternative disposition of unused drugs.
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  .................  ..................  .................  ................................            127,006
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26304 Filed 11-4-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Page 66720]
[FR Doc No: 2014-26572]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1904-073]

TransCanada Hydro Northeast Inc.; Notice of Technical Conference
and Environmental Site Review

    TransCanada Hydro Northeast Inc. (TransCanada) is currently using
the Integrated Licensing Process to prepare an application for a new
license (due to be filed on April 30, 2016) for the Vernon
Hydroelectric Project No. 1904-73 (Vernon Project). The 32.4-megawatt
Vernon Project is located on the Connecticut River in Cheshire County,
New Hampshire and Windsor and Windham Counties, Vermont. On February
21, 2014, the Director of the Office of Energy Projects issued a Study
Plan Determination requiring TransCanada to conduct 21 studies,
including the development of a plan to conduct hydroacoustic studies of
downstream passage of juvenile American shad and adult American eel. On
March 24, 2014, TransCanada filed a request for rehearing of the
requirement to conduct hydroacoustic studies, which is currently
pending before the Commission.
    On September 15, 2014, TransCanada filed its proposed Vernon
Hydroacoustic Study Plan. To gather additional information and assist
the Commission in its review of the proposed study, Commission staff
will hold a technical conference on November 20, 2014. The technical
conference will focus on discussing the information and studies needed
to evaluate downstream passage of juvenile American shad and adult
American eel at the Vernon Project, including the methods proposed in
TransCanada's Vernon Hydroacoustic Study Plan. Discussion topics for
the technical conference are included in Appendix A.
    In addition to the technical conference, Commission staff will hold
an environmental site review of the Vernon Project on November 19,
2014. All local, state, and federal agencies, Indian tribes, and other
interested parties are invited to attend the site review and technical
conference. The technical conference will be transcribed by a court
reporter. If the number of participants wishing to speak at the
technical conference creates time constraints, Commission staff may, at
its discretion, limit the speaking time of participants. The dates,
times, and meeting locations for the site review and technical
conference are listed below.

Site Review

    Date: Wednesday, November 19, 2014.
    Time: 2:00 p.m.
    Place: 152 Governor Hunt Road, Vernon, VT 05354.

Technical Conference

    Date: Thursday, November 20, 2014.
    Time: 9:00 a.m.-4:00 p.m.
    Place: The Emerson Room, Courtyard Keene Downtown, 75 Railroad
Street, Keene, NH 03431.
    If you plan to attend the site review, you must call or email John
Ragonese (phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
by November 17, 2014, and identify the number of individuals in your
group. During the site review, participants will be required to wear
steel-toed shoes. A limited number of toe protection devices will be
available, but participants are strongly encouraged to bring their own.
    If you have any questions, please contact Bill Connelly at 202-502-
8587.

    Dated: October 31, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

APPENDIX A

Technical Conference Discussion Topics

Information Needs

    1. Timing of juvenile American shad and adult American eel runs.
    2. Relative abundance and/or magnitude of juvenile American shad
and adult American eel runs.
    3. Delay of juvenile American shad and adult American eel
downstream passage.
    4. Downstream passage route selection by juvenile American shad
and adult American eel.

Study Methods

    1. Radio telemetry or other individual tracking technologies:
What information can be obtained with these methods? What are the
benefits of using these methods? What are the drawbacks?
    2. Hydroacoustics and other fixed recording technologies: What
information can be obtained with these methods? What are the
benefits of using these methods? What are the drawbacks?
    3. Other study methods: Are there other study methods that could
be used to obtain information about downstream passage of juvenile
American shad and adult American eel? What are the benefits of using
these methods? What are the drawbacks?

[FR Doc. 2014-26572 Filed 11-7-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 30, 2010 (Volume 75, Number 229)]
[Notices]
[Page 74046-74048]
[DOCID:fr30no10-79]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9234-1]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Proposed Consent Decree; Request for Public Comment.

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

SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``Act''), 42 U.S.C. 7413(g), notice is hereby given of a
proposed consent decree, to address a lawsuit filed by WildEarth
Guardians: WildEarth Guardians v. Jackson, Civil Action No. 1:10-cv-
01672-RPM (D. CO). On or about July 14, 2010, WildEarth Guardians filed
a complaint alleging that EPA Administrator Jackson failed to fulfill a
mandatory duty to respond to an administrative petition to object to
issuance of air permit No. 96OPMR129 to the Public Service Company of
Colorado doing business as Xcel Energy to operate the Pawnee coal-fired
power plant in Morgan County, Colorado (the ``Pawnee Petition'') within
the 60 days specified in section 505(b)(2) of the Clean Air Act and
asking the court to enter judgment: (i) Declaring that EPA has violated
the Clean Air Act by failing to grant or deny the administrative
petition; and, (ii) Ordering EPA to grant or deny the administrative
petition in accordance with an expeditious schedule prescribed by the
Court. On September 1, 2010, WildEarth Guardians filed a first amended
complaint alleging that EPA Administrator Jackson failed to fulfill a
mandatory duty to respond to administrative petitions to object to the
issuance of air permit No. 96OPAD137 to Xcel Energy to operate the
Cherokee

coal-fired power plant in Denver, Colorado (the ``Cherokee Petition'')
and air permit No. 960PBO131 to Xcel Energy to operate the Valmont
coal-fired power plant in Boulder County, Colorado (the ``Valmont
Petition''). Under the terms of the proposed consent decree, EPA agrees
to: (i) Sign a response to the Pawnee Petition no later than June 30,
2011; (ii) sign a response to the Valmont Petition no later than
September 30, 2011; and, (iii) sign a response to the Cherokee Petition
no later than October 31, 2011.

DATES: Written comments on the proposed consent decree must be received
by December 30, 2010.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2010-0984, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Richard H. Vetter, Air and Radiation
Law Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    On or about July 14, 2010, WildEarth Guardians, a non-profit
conservation organization, filed a complaint in the United States
District Court for the District of Colorado (Civil Action No. 1:10-cv-
01672-RPM). In the complaint, WildEarth Guardians alleges that EPA has
failed to fulfill a mandatory duty to respond to an administrative
petition to object to issuance of air permit No. 96OPMR129 to the
Colorado Public Service Company, doing business as Xcel Energy for the
Pawnee coal-fired power plant in Morgan County, Colorado (the ``Pawnee
Petition'') within the 60 days specified in section 505(b)(2) of the
Clean Air Act. On September 1, 2010, WildEarth Guardian filed a first
amended complaint alleging that EPA Administrator Jackson failed to
fulfill a mandatory duty to respond to administrative petitions to
object to the issuance of air permit No. 960PAD137 to Xcel Energy to
operate the Cherokee coal-fired power plant in Denver, Colorado (the
``Cherokee Petition'') and air permit No. 960PBO131 to Xcel Energy to
operate the Valmont coal-fired power plant in Boulder County, Colorado
(the ``Valmont Petition'') within the 60 days specified in section
505(b)(2) of the Clean Air Act.
    The EPA and WildEarth Guardians chose to enter into a proposed
consent decree to avoid protracted and costly litigation and to
preserve judicial resources. Under the terms of the proposed consent
decree, EPA is to: (i) Sign a response to the Pawnee Petition no later
than June 30, 2011; (ii) sign a response to the Valmont Petition no
later than September 30, 2011; and, (iii) sign a response to the
Cherokee Petition no later than October 31, 2011.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will receive written comments relating to
the proposed consent decree from persons who were not named as parties
or intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Clean Air Act. Unless EPA or the
Department of Justice determines that consent to the consent decree
should be withdrawn, the terms of the decree will be affirmed.

II. Additional Information About Commenting On the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    Direct your comments to the official public docket for this action
under Docket ID No. EPA-HQ-OGC-2010-0984 which contains a copy of the
consent decree. The official public docket is available for public
viewing at the Office of Environmental Information (OEI) Docket in the
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use the http://www.regulations.gov
to submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, key in the appropriate docket identification number, then
select ``search.''
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or on paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification,

EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://
www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: November 23, 2010.
Richard B. Ossias,
Associate General Counsel.
[FR Doc. 2010-30106 Filed 11-29-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Rules and Regulations]
[Pages 44898-44900]
[FR Doc No: 2017-20213]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-8434; Product Identifier 2015-NM-082-AD; Amendment
39-19057; AD 2017-19-27]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc., Model DHC-8-401 and -402 airplanes. This AD was
prompted by the discovery of cracking on two test spoiler power control
unit (PCU) manifolds during testing by the manufacturer. This AD
requires replacement of affected spoiler PCUs. We are issuing this AD
to address the unsafe condition on these products.

DATES: This AD is effective November 1, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 1,
2017.

ADDRESSES: For Bombardier, Inc., service information identified in this
final rule, contact Bombardier, Inc., Q-Series Technical Help Desk, 123
Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-
4000; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com.
    For Parker-Hannifin Corporation service information identified in
this final rule, contact Parker Aerospace, 14300 Alton Parkway, Irvine,
CA 92618; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; Internet http://www.parker.com.
    You may view this referenced service information at the FAA,
Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8434.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8434; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a supplemental notice of proposed rulemaking (SNPRM) to
amend 14 CFR part 39 by adding an AD that would apply to certain
Bombardier, Inc., Model DHC-8-401 and -402 airplanes. The SNPRM
published in the Federal Register on July 14, 2017 (82 FR 32496) (``the
SNPRM''). We preceded the SNPRM with a notice of proposed rulemaking
(NPRM) that published in the Federal Register on January 13, 2016 (81
FR 1586) (``the NPRM''). The NPRM proposed to require replacement of
affected spoiler PCUs. The NPRM was prompted by the discovery of
cracking on two test spoiler PCU manifolds during testing by the
manufacturer. The SNPRM proposed to require replacement of affected
spoiler PCUs, and also proposed to add airplanes to the applicability.
We are issuing this AD to prevent cracking of the spoiler PCUs that
could lead to the loss of multiple flight controls and landing gear
systems.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2015-07R2,

dated December 14, 2016 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc., Model DHC-8-401 and -402
airplanes. The MCAI states:

    During endurance and impulse testing of the spoiler PCU, cracks
were discovered on two test spoiler PCU manifolds. Investigation
determined that the crack initiation was due to the heat treat
process. A cracked spoiler PCU manifold could cause the loss of one
of the two hydraulic systems, resulting in the loss of multiple
flight controls and landing gear systems. This condition, if not
corrected, could adversely affect the continued safe operation and
landing of the aeroplane.
    This [Canadian] AD mandates the replacement of the affected
spoiler PCUs.
    Revision 1 of this [Canadian] AD was issued to extend the
applicability to include additional aeroplane serial numbers and
also modify the Corrective Actions to specifically mandate section
3.B of the [Bombardier Service Bulletin] SB 84-27-64, Revision A.
    Revision 2 of this [Canadian] AD was issued to correct the SB
referenced in the Background section. SB 84-27-64, Revision A should
have been referenced in lieu of SB 84-27-63, Revision A.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8434.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the SNPRM or on the determination
of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
SNPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued Service Bulletin 84-27-64, Revision A,
dated July 26, 2016. This service information describes procedures for
replacement of affected spoiler PCU manifolds.
    Parker-Hannifin Corporation has issued Service Bulletin 390700-27-
002, Revision 1, dated April 13, 2016. This service bulletin identifies
affected spoiler PCUs.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 82 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Remove and replace affected PCUs......  2 work-hours x $85 per           $10,000         $10,170        $833,940
                                         hour = $170.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-19-27 Bombardier, Inc.: Amendment 39-19057; Docket No. FAA-
2015-8434; Product Identifier 2015-NM-082-AD.

(a) Effective Date

    This AD is effective November 1, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-401 and -402
airplanes, certificated in any category, serial numbers (S/Ns) 4001,
and 4003 through 4527 inclusive, equipped with spoiler power control
unit (PCU) part numbers (P/Ns)<PHONE_NUMBER> and -1009 and that have
any spoiler PCU serial number identified in paragraph (c)(1),
(c)(2), or (c)(3) of this AD.
    (1) S/Ns 0474 through 1321 inclusive;
    (2) S/Ns identified in section ``4. Appendix'' of Parker Service
Bulletin 390700-27-002, Revision 1, dated April 13, 2016; and
    (3) S/Ns 1394 through 1876 inclusive, without suffix ``A.''

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Reason

    This AD was prompted by the discovery of cracking on two test
spoiler PCU manifolds during testing by the manufacturer. We are
issuing this AD to prevent cracking of the spoiler PCUs that could
lead to the loss of multiple flight controls and landing gear
systems.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Removal/Replacement

    Within 12,000 flight hours or 72 months after the effective date
of this AD, whichever occurs first: Remove and replace the affected
spoiler PCUs in accordance with paragraph 3.B. of the Accomplishment
Instructions of Bombardier Service Bulletin 84-27-64, Revision A,
dated July 26, 2016.

(h) Parts Installation Prohibition

    After the actions required by paragraph (g) of this AD have been
done, no person may install on any airplane, a spoiler PCU, part
number<PHONE_NUMBER> and -1009, with:
    (1) S/Ns 0474 through 1321 inclusive; or
    (2) S/Ns identified in section ``4. Appendix'' of Parker Service
Bulletin 390700-27-002, Revision 1, dated April 13, 2016; or
    (3) S/Ns 1394 through 1876 inclusive, without suffix ``A.''

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Bombardier Service Bulletin 84-27-64, dated
July 15, 2014.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2015-07R2, dated December
14, 2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-8434.
    (2) For more information about this AD, contact Cesar Gomez,
Aerospace Engineer, Airframe and Mechanical Systems Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (l)(3) and (l)(5) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 84-27-64, Revision A, dated July
26, 2016.
    (ii) Parker Service Bulletin 390700-27-002, Revision 1, dated
April 13, 2016.
    (3) For Bombardier, Inc., service information identified in this
AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123
Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-
375-4000; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet http://www.bombardier.com.
    (4) For Parker-Hannifin Corporation service information
identified in this AD, contact Parker Aerospace, 14300 Alton
Parkway, Irvine, CA, 92618; telephone<PHONE_NUMBER>; fax 949-809-
8646; Internet http://www.parker.com.
    (5) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 14, 2017.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2017-20213 Filed 9-26-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: March 2, 2009 (Volume 74, Number 39)]
[Notices]
[Page 9122-9123]
[DOCID:fr02mr09-65]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Approval of Amendment to Noise Compatibility Program Mobile
Regional Airport, Mobile, AL

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the Noise Compatibility Program submitted by the Mobile
Airport Authority under the provisions of 49 U.S.C. (the Aviation
Safety and Noise Abatement Act, hereinafter referred to as ``the Act'')
and 14 CFR Part 150. These findings are made in recognition of the
description of Federal and non-Federal responsibilities in Senate
Report No. 96-52 (1980). On May 1, 2006, the FAA determined that the
noise exposure maps submitted by the Mobile Airport Authority under
Part 150 were in compliance with applicable requirements. On October
26, 2006, the FAA approved the Mobile Regional Airport noise
compatibility program.

Most of the recommendations of the program were approved. On August 29,
2008, the Mobile Airport Authority requested approval to revise two of
the ten approved proposed action measures.

Effective Date: The effective date of the FAA's approval of the Mobile
Regional Airport Noise Compatibility Program Update is February 18,
2009.

FOR FURTHER INFORMATION CONTACT: Kevin Morgan, Federal Aviation
Administration, Jackson Airports District Office, 100 West Cross
Street, Suite B, Jackson, Mississippi 39208-2307, phone number: (601)
664-9891. Documents reflecting this FAA action may be reviewed at this
same location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the Noise Compatibility Program Update for
Mobile Regional Airport, effective February 18, 2009.
    Under Section 47504 of the Act, an airport operator who has
previously submitted a Noise Exposure Map may submit to the FAA a Noise
Compatibility Program which sets forth the measures taken or proposed
by the airport operator for the reduction of existing non-compatible
land uses and prevention of additional non-compatible land uses within
the area covered by the Noise Exposure Maps. The Act requires such
programs to be developed in consultation with interested and affected
parties including local communities, government agencies, airport
users, and FAA personnel.
    Each airport noise compatibility program developed in accordance
with Title 14 Code of Federal Regulations (CFR) Part 150 is a local
program, not a Federal Program. The FAA does not substitute its
judgment for that of the airport operator with respect to which measure
should be recommended for action. The FAA's approval or disapproval of
14 CFR Part 150 program recommendations is measured according to the
standards expressed in 14 CFR Part 150 and the Act, and is limited to
the following determinations:

    a. The Noise Compatibility Program was developed in accordance with
the provisions and procedures of 14 CFR Part 150;
    b. Program measures are reasonably consistent with achieving the
goals of reducing existing non-compatible land uses around the airport
and preventing the introduction of additional non-compatible land uses;
    c. Program measures would not create an undue burden on interstate
or foreign commerce, unjustly discriminate against types or classes of
aeronautical uses, violate the terms of airport grant agreements, or
intrude into areas preempted by the Federal government; and
    d. Program measures relating to the use of flight procedures can be
implemented within the period covered by the program without derogating
safety, adversely affecting the efficient use and management of the
navigable airspace and air traffic control systems, or adversely
affecting other powers and responsibilities of the Administrator
prescribed by law.
    Specific limitations with respect to FAA's approval of an airport
Noise Compatibility Program are delineated in 14 CFR Part 150, Section
150.5. Approval is not a determination concerning the acceptability of
land uses under Federal, State, or local law. Approval does not by
itself constitute an FAA implementing action. A request for Federal
action or approval to implement specific noise compatibility measures
may be required, and an FAA decision on the request may require an
environmental assessment of the proposed action. Approval does not
constitute a commitment by the FAA to financially assist in the
implementation of the program nor a determination that all measures
covered by the program are eligible for grant-in-aid funding from the
FAA. Where Federal funding is sought, requests for project grants must
be submitted to the FAA Airports District Office in Jackson,
Mississippi.
    Mobile Airport Authority submitted to the FAA on December 30, 2005,
the Noise Exposure Maps, descriptions, and other documentation produced
during the noise compatibility planning study conducted from 2003,
through December 2005. The Mobile Regional Airport Noise Exposure Maps
were determined by FAA to be in compliance with applicable requirements
on May 1, 2006. Notice of this determination was published in the
Federal Register on May 18, 2006.
    The Mobile Regional Airport study contains a proposed Noise
Compatibility Program comprised of actions designed for phased
implementation by airport management and adjacent jurisdictions from
the 2006 to 2011 and beyond. It was requested that FAA evaluate and
approve an amendment to this material as a Noise Compatibility Program
as described in Section 47504 of the Act.
    The FAA began its review of the updated Program on August 29, 2008,
and was required by a provision of the Act to approve or disapprove the
program within 180-days (other than the use of new or modified flight
procedures for noise control). Failure to approve or disapprove such
program within the 180-day period shall be deemed to be an approval of
such program.
    The submitted amended program contained two (2) revised proposed
actions for noise mitigation off the airport. The FAA completed its
review and determined that the procedural and substantive requirements
of the Act and 14 CFR Part 150 have been satisfied. The updated
program, therefore, was approved by the FAA effective February 18,
2009.
    Outright approval was granted for both of the revised specific
program elements.
    These determinations are set forth in detail in a Record of
Approval Amendment signed by the FAA on February 18, 2009. The Record
of Approval Amendment, as well as other evaluation materials and the
documents comprising the submittal, are available for review at the FAA
office listed above and at the administrative office of the Mobile
Airport Authority. The Record of Approval Amendment also will be
available on-line at: http://www.faa.gov/airports_airtraffic/airports/
environmental/airport_noise/part_150/states/.

    Issued in Jackson, Mississippi on February 23, 2009.
Rans Black,
Manager, Jackson Airports District Office, Southern Region.
[FR Doc. E9-4349 Filed 2-27-09; 8:45 am]

BILLING CODE 4910-13-P