[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9230-9235]
[FR Doc No: 2014-03353]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0006]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: Under the Food and Drug Administration Modernization Act of
1997 (FDAMA), the Food and Drug Administration (FDA) is required to
report annually in the Federal Register on the status of postmarketing
requirements and commitments required of, or agreed upon by, holders of
approved drug and biological products. This notice is the Agency's
report on the status of the studies and clinical trials that applicants
have agreed to, or are required to, conduct.

FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Food and Drug Administration Modernization Act

    Section 130(a) of FDAMA (Pub. L. 105-115) amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by adding a new provision
requiring reports of certain postmarketing studies, including clinical
trials, for human drug and biological products (section 506B of the
FD&C Act (21 U.S.C. 356b)). Section 506B of the FD&C Act provides FDA
with additional authority to monitor the progress of a postmarketing
study or clinical trial that an applicant has been required to, or has
agreed to, conduct by requiring the applicant to submit a report
annually providing information on the status of the postmarketing
study/clinical trial. This report must also include reasons, if any,
for failure to complete the study/clinical trial. These studies and
clinical trials are intended to further define the safety, efficacy, or
optimal use of a product, and therefore play a vital role in fully
characterizing the product.
    Under FDAMA, commitments to conduct postmarketing studies or
clinical trials included both studies/clinical trials that applicants
agreed to conduct, as well as studies/clinical trials that applicants
were required to conduct under FDA regulations.\1\
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    \1\ Before passage of FDAAA, FDA could require postmarketing
studies and clinical trials under the following circumstances: To
verify and describe clinical benefit for a human drug approved in
accordance with the accelerated approval provisions in section
506(b)(2)(A) of the FD&C Act (21 CFR 314.510 and 601.41); for a drug
approved on the basis of animal efficacy data because human efficacy
trials are not ethical or feasible (21 CFR 314.610(b)(1) and
601.91(b)(1)); and for marketed drugs that are not adequately
labeled for children under section 505B of the FD&C Act (Pediatric
Research Equity Act; Pub. L. 108-155).
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B. The Food and Drug Administration Amendments Act of 2007

    On September 27, 2007, the President signed Public Law 110-85, the
Food and Drug Administration Amendments Act of 2007 (FDAAA). Section
901, in Title IX of FDAAA, created a new section 505(o) of the FD&C Act
authorizing FDA to require certain studies and clinical trials for
human drug and biological products approved under section 505 of the
FD&C Act or section 351 of the Public Health Service Act (42 U.S.C.
262). Under FDAAA, FDA has been given additional authority to require
applicants to conduct and report on postmarketing studies and clinical
trials to assess a known serious risk, assess signals of serious risk,
or identify an unexpected serious risk related to the use of a product.
This new authority became effective on March 25, 2008. FDA may now take
enforcement action against applicants who fail to conduct studies and
clinical trials required under FDAAA, as well as studies and clinical
trials required under FDA regulations (see sections 505(o)(1), 502(z),
and 303(f)(4) of the FD&C Act (21 U.S.C. 355(o)(1), 352(z), and
333(f)(4))).
    Although regulations implementing FDAMA postmarketing authorities
use

the term ``postmarketing commitment'' to refer to both required studies
and studies applicants agree to conduct, in light of the new
authorities enacted in FDAAA, FDA has decided it is important to
distinguish between enforceable postmarketing requirements and
unenforceable postmarketing commitments. Therefore, in this notice and
report, FDA refers to studies/clinical trials that an applicant is
required to conduct as ``postmarketing requirements'' (PMRs) and
studies/clinical trials that an applicant agrees to but is not required
to conduct as ``postmarketing commitments'' (PMCs). Both are addressed
in this notice and report.

C. FDA's Implementing Regulations

    On October 30, 2000 (65 FR 64607), FDA published a final rule
implementing section 130 of FDAMA. This rule modified the annual report
requirements for new drug applications (NDAs) and abbreviated new drug
applications (ANDAs) by revising Sec.  314.81(b)(2)(vii) (21 CFR
314.81(b)(2)(vii)). The rule also created a new annual reporting
requirement for biologics license applications (BLAs) by establishing
Sec.  601.70 (21 CFR 601.70). The rule described the content and format
of the annual progress report, and clarified the scope of the reporting
requirement and the timing for submission of the annual progress
reports. The regulations became effective on April 30, 2001 (66 FR
10815). The regulations apply only to human drug and biological
products approved under NDAs, ANDAs, and BLAs. They do not apply to
animal drugs or to biological products regulated under the medical
device authorities.
    The reporting requirements under Sec. Sec.  314.81(b)(2)(vii) and
601.70 apply to PMRs and PMCs made on or before the enactment of FDAMA
(November 21, 1997), as well as those made after that date. Therefore,
studies and clinical trials required under FDAAA are covered by the
reporting requirements in these regulations.
    Sections 314.81(b)(2)(vii) and 601.70 require applicants of
approved drug and biological products to submit annually a report on
the status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study/clinical trial either
required by FDA or that they have committed to conduct, either at the
time of approval or after approval of their NDA, ANDA, or BLA. The
status of PMCs concerning chemistry, manufacturing, and production
controls and the status of other studies/clinical trials conducted on
an applicant's own initiative are not required to be reported under
Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not addressed in this
report. It should be noted, however, that applicants are required to
report to FDA on these commitments made for NDAs and ANDAs under Sec.
314.81(b)(2)(viii). Furthermore, section 505(o)(3)(E) of the FD&C Act,
as amended by FDAAA, requires that applicants report periodically on
the status of each required study/clinical trial and each study/
clinical trial ``otherwise undertaken * * * to investigate a safety
issue * * *.''
    According to the regulations, once a PMR has been required, or a
PMC has been agreed upon, an applicant must report on the progress of
the PMR/PMC on the anniversary of the product's approval\2\ until the
PMR/PMC is completed or terminated and FDA determines that the PMR/PMC
has been fulfilled or that the PMR/PMC is either no longer feasible or
would no longer provide useful information. The annual progress report
must include a description of the PMR/PMC, a schedule for completing
the PMR/PMC, and a characterization of the current status of the PMR/
PMC. The report must also provide an explanation of the PMR/PMC status
by describing briefly the progress of the PMR/PMC. A PMR/PMC schedule
is expected to include the actual or projected dates for the following:
(1) Submission of the final protocol to FDA, (2) completion of the
study/clinical trial, and (3) submission of the final report to FDA.
The status of the PMR/PMC must be described in the annual report
according to the following definitions:
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    \2\ Some applicants have requested and been granted by FDA
alternate annual reporting dates to facilitate harmonized reporting
across multiple applications.
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     Pending: The study/clinical trial has not been initiated
(i.e., no subjects have been enrolled or animals dosed), but does not
meet the criteria for delayed (i.e., the original projected date for
initiation of subject accrual or initiation of animal dosing has not
passed);
     Ongoing: The study/clinical trial is proceeding according
to or ahead of the original schedule;
     Delayed: The study/clinical trial is behind the original
schedule;
     Terminated: The study/clinical trial was ended before
completion, but a final report has not been submitted to FDA; or
     Submitted: The study/clinical trial has been completed or
terminated, and a final report has been submitted to FDA.
    Databases containing information on PMRs/PMCs are maintained at the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).

II. Summary of Information From Postmarketing Status Reports

    This report, published to fulfill the annual reporting requirement
under FDAMA, summarizes the status of PMRs and PMCs as of September 30,
2012. If a requirement or commitment did not have a schedule, or a
postmarketing progress report was not received in the previous 12
months, the PMR/PMC is categorized according to the most recent
information available to the Agency.\3\
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    \3\ Although the data included in this report do not include a
summary of reports that applicants have failed to file by their due
date, the Agency notes that it may take appropriate regulatory
action in the event reports are not filed on a timely basis.
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    Information in this report covers any PMR/PMC that was made, in
writing, at the time of approval or after approval of an application or
a supplement to an application, including PMRs required under FDAAA
(section 505(o) (3) of the FD&C Act), PMRs required under FDA
regulations (e.g., PMRs required to demonstrate clinical benefit of a
product following accelerated approval (see footnote 1 of this
document)), and PMCs agreed to by the applicant.
    Information summarized in this report includes the following: (1)
The number of applicants with open PMRs/PMCs, (2) the number of open
PMRs/PMCs, (3) FDA-verified status of open PMRs/PMCs reported in Sec.
314.81(b)(2)(vii) or Sec.  601.70 annual reports, (4) the status of
concluded PMRs/PMCs as determined by FDA, and (5) the number of
applications for which an annual report was expected, but was not
submitted within 60 days of the anniversary date of U.S. approval or an
alternate reporting date that has been granted by FDA.\4\
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    \4\ The type of information included in this report is the same
as in previous ones. However, as a result of improved data capture
and refinement of analytical methods, some values in the fiscal year
(FY) 2012 report are notably different from those reported in the
previous reports. FDA intends to use the data capture and analytical
methods applied to the FY2012 report in future annual reports. For
clarity and comparison purposes, relevant data for the FY2012 report
are provided using both the updated and previously used methods (see
footnotes 5, 7, and 8).
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    Additional information about PMRs/PMCs is provided on FDA's Web
site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm. Neither the Web site nor this
notice include information about PMCs concerning chemistry,
manufacturing, and controls. It is FDA

policy not to post information on the Web site until it has been
verified and reviewed for suitability for public disclosure. Numbers
published in this notice cannot be compared with the numbers resulting
from searches of the Web site because this notice incorporates totals
for all PMRs/PMCs in FDA databases, including PMRs/PMCs undergoing
review for accuracy. In addition, the status information reported in
this notice will be updated annually while the Web site is updated
quarterly (i.e., in January, April, July, and October).
    An applicant may have multiple approved products, and an approved
product may have multiple PMRs and/or PMCs. As of September 30, 2012,
there were 172 unique applicants with 1,069 open PMRs/PMCs under 476
unique NDAs/ANDAs.\5\ For BLAs, there were 72 unique applicants with
430 open PMRs/PMCs under 101 unique applications.
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    \5\ The number of unique NDAs/ANDAs (476) is noticeably
different from the corresponding number in the FY2011 Report on the
Performance of Drug and Biologics Firms in Conducting Postmarketing
Requirements and Commitments (77 FR 13339, March 6, 2012). The
FY2011 calculation (198) was based on PMRs/PMCs that were both open
at the end of the FY and had received a status update during the
year. The FY2012 calculation includes all PMRs/PMCs open at the end
of FY2012, regardless of when the last status update occurred.
Applying FY2011 calculation methods to FY2012 results in 252 unique
NDAs/ANDAs with open PMRs/PMCs.
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    Applicants must submit an annual status report on the progress of
each open PMR/PMC within 60 days of the anniversary date of U.S.
approval of the original application or an alternate reporting date
that has been granted by FDA. There were 432 NDAs/ANDAs with an annual
status report due in fiscal year (FY) 2012.\6\ Of the 432 annual status
reports due, 61 percent (264/432) were received on time; \7\ 19 percent
(82/432) were received, but not on time; and 20 percent (86/432) were
not received at any time during FY2012.\8\
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    \6\ The number of expected annual status reports (432) is
different from the total number of unique NDAs/ANDAs with open PMRs/
PMCs (476) because not all NDAs/ANDAs had an annual status report
due during FY2012. PMRs/PMCs associated with multiple NDAs/ANDAs may
submit the annual status report to only one of the applications. In
addition, if all of the PMRs/PMCs for an application were
established in FY2012, or if all PMRs/PMCs for an application were
concluded before the annual status report due date, submission of an
annual status report would not be expected.
    \7\ In the FY2011 FR notice, the percentage of NDA/ANDA annual
status reports submitted on time (79 percent) was based on
applications that had both an open PMR/PMC as of September 30, 2011,
and had received an annual report during the FY. The corresponding
FY2012 calculation is based on applications with an annual status
report due date during FY2012, regardless of whether a report was
actually received during the FY or whether PMRs/PMCs were closed as
of September 30, 2012. Applying the FY2011 calculation method to
FY2012 results in 84 percent (166/197) of NDA/ANDA annual status
reports submitted on time.
    \8\ The FY2011 FR notice reported that 100 percent of the annual
status reports due, but not submitted on time, were submitted before
the close of FY2011. The corresponding percentage is only 49 percent
in FY2012. In FY2011, the percentage of annual reports not received
on time was based only on reports received within FY2011. The FY2012
calculation considers all reports expected, not just those actually
received during FY2012. Applying the FY2011 calculation method to
FY2012 results in 100 percent (31/31) of annual status reports due,
but not submitted on time, that were submitted before the close of
FY2012.
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    For BLAs, there were 101 annual status reports expected in FY2012.
Of those expected, 68 percent (69/101) were received on time; 12
percent (12/101) were received, but not on time; and 20 percent (20/
101) were not received at any time during FY2012.

III. About This Report

    This report provides six separate summary tables. The tables in
this document distinguish between PMRs and PMCs and between on-schedule
and off-schedule PMRs and PMCs according to the original schedule
milestones. On-schedule PMRs/PMCs are categorized as pending, ongoing,
or submitted. Off-schedule PMRs/PMCs that have missed one of the
original milestone dates are categorized as delayed or terminated. The
tables include data as of September 30, 2012.
    Table 1 of this document provides an overall summary of the data on
all PMRs and PMCs. Tables 2 and 3 of this document provide detail on
PMRs. Table 2 of this document provides additional detail on the status
of on-schedule PMRs.
    Table 1 of this document shows that most open PMRs (81 percent for
NDAs/ANDAs and 83 percent for BLAs) and most open PMCs (73 percent for
NDAs/ANDAs and 76 percent for BLAs) are progressing on schedule (i.e.,
are not delayed or terminated). Overall, of the PMRs that are pending
(i.e., have not been initiated, but do not meet the definition for
delayed), 78 percent (411/527) were created within the past 3 years.
    Table 2 of this document shows that 53 percent (260/527) of pending
PMRs for drug and biological products are in response to the Pediatric
Research and Equity Act (PREA), under which FDA requires sponsors to
study new drugs, when appropriate, for pediatric populations. Under
section 505B(a)(3) (21 U.S.C. 355c(a)(3)) of the FD&C Act, the
initiation of these studies generally is deferred until required safety
information from other studies has first been submitted and reviewed.
PMRs for products approved under the animal efficacy rule (21 CFR
314.600 for drugs; 21 CFR 601.90 for biological products) can be
conducted only when the product is used for its indication as a
counterterrorism measure. In the absence of a public health emergency,
these studies/clinical trials will remain pending indefinitely. The
next largest category of pending PMRs for drug and biological products
(45 percent, 253/527) comprises those studies/clinical trials required
by FDA under FDAAA, which became effective on March 25, 2008.
    Table 3 of this document provides additional detail on the status
of off-schedule PMRs. The majority of off-schedule PMRs (which account
for 19 percent of the total for NDAs/ANDAs and 17 percent for BLAs) are
delayed according to the original schedule milestones (98 percent (141/
144) for NDAs/ANDAs; 93 percent (26/28) for BLAs). In certain
situations, the original schedules may have been adjusted for
unanticipated delays in the progress of the study/clinical trial (e.g.,
difficulties with subject enrollment in a trial for a marketed drug or
need for additional time to analyze results). In this report, study/
clinical trial status reflects the status in relation to the original
study/clinical trial schedule regardless of whether FDA has
acknowledged that additional time may be required to complete the
study/;clinical trial.
    Tables 4 and 5 of this document provide additional detail on the
status of PMCs. Table 4 of this document provides additional detail on
the status of on-schedule PMCs. Pending PMCs comprise 52 percent (111/
215) of the on-schedule NDA/ANDA PMCs and 40 percent (79/200) of the
on-schedule BLA PMCs.
    Table 5 of this document provides additional details on the status
of off-schedule PMCs. The majority of off-schedule PMCs (which account
for 27 percent for NDAs/ANDAs and 24 percent for BLAs) are delayed
according to the original schedule milestones (92 percent (72/78) for
NDAs/ANDAs; 97 percent (61/63) for BLAs).
    Table 6 of this document provides details about PMRs and PMCs that
were concluded in FY2012. The majority of concluded PMRs and PMCs were
fulfilled (67 percent of NDA/ANDA PMRs and 63 percent of BLA PMRs; 58
percent of NDA/ANDA PMCs and 85 percent of BLA PMCs).

                                             Table 1--Summary of Postmarketing Requirements and Commitments
                                                           [Numbers as of September 30, 2012]
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                                       Number of NDA/ANDA PMRs/PMCs  (% of total PMR or % of     Number of BLA PMRs/PMCs  (% of total PMR or % of total
                                                             total PMC)                                                 PMC) \1\
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Number of open PMRs................  776......................................................  167
    On-schedule open PMRs (see       632 (81%)................................................  139 (83%)
     table 2 of this document).
    Off-schedule open PMRs (see      144 (19%)................................................  28 (17%)
     table 3 of this document).
    Number of open PMCs............  293......................................................  263
    On-schedule open PMCs (see       215 (73%)................................................  200 (76%)
     table 4 of this document).
    Off-schedule open PMCs (see      78 (27%).................................................  63 (24%)
     table 5 of this document).
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\1\ On October 1, 2003, FDA completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER. Consequently, CDER now
  reviews many BLAs. Fiscal year statistics for postmarketing requirements and commitments for BLAs reviewed by CDER are included in BLA totals in this
  table.

                                               Table 2--Summary of On-Schedule Postmarketing Requirements
                                                           [Numbers as of September 30, 2012]
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       On-Schedule Open PMRs                  Number of NDA/ANDA PMRs (% of total PMR)                   Number of BLA PMRs (% of total PMR) \1\
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Pending (by type):
    Accelerated approval...........  10.......................................................  2
    PREA \2\.......................  236......................................................  24
    Animal efficacy \3\............  2........................................................  0
    FDAAA safety (since March 25,    203......................................................  50
     2008).
                                    --------------------------------------------------------------------------------------------------------------------
        Total......................  451 (58%)................................................  76 (46%)
                                    ====================================================================================================================
Ongoing:
    Accelerated approval...........  11.......................................................  8
    PREA \2\.......................  40.......................................................  6
    Animal efficacy \3\............  0........................................................  0
                                    --------------------------------------------------------------------------------------------------------------------
    FDAAA safety (since March 25,    68.......................................................  28
     2008).
                                    ====================================================================================================================
        Total......................  119 (15%)................................................  42 (25%)
                                    ====================================================================================================================
Submitted:
    Accelerated approval...........  0........................................................  1
    PREA \2\.......................  20.......................................................  7
    Animal efficacy \3\............  0........................................................  0
    FDAAA safety (since March 25,    42.......................................................  13
     2008).
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        Total......................  62 (8%)..................................................  21 (13%)
                                    ====================================================================================================================
        Combined total.............  632 (81%)................................................  139 (84%)
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\1\ See note 1 for table 1 of this document.
\2\ Many PREA studies have a pending status. PREA studies are usually deferred because the product is ready for approval in adults. Initiation of these
  studies may be deferred until additional safety information from other studies has first been submitted and reviewed.
\3\ PMRs for products approved under the animal efficacy rule (Sec.   314.600 for drugs; Sec.   601.90 for biological products) can be conducted only
  when the product is used for its indication as a counterterrorism measure. In the absence of a public health emergency, these studies/clinical trials
  will remain pending indefinitely.

                                               Table 3--Summary of Off-Schedule Postmarketing Requirements
                                                           [Numbers as of September 30, 2012]
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       Off-schedule open PMRs                 Number of NDA/ANDA PMRs (% of total PMR)                   Number of BLA PMRs (% of total PMR) \1\
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Delayed:
    Accelerated approval...........  5........................................................  2
    PREA...........................  107......................................................  14
    Animal efficacy................  1........................................................  0
    FDAAA safety (since March 25,    28.......................................................  10
     2008).
                                    --------------------------------------------------------------------------------------------------------------------
        Total......................  141 (18.2%)..............................................  26 (16%)
                                    --------------------------------------------------------------------------------------------------------------------
        Terminated.................  3 (0.4%).................................................  2 (1%)
                                    ====================================================================================================================

        Combined total.............  144 (19%)................................................  28 (17%)
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\1\ See note 1 for table 1 of this document.

                                                Table 4--Summary of On-Schedule Postmarketing Commitments
                                                           [Numbers as of September 30, 2012]
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       On-schedule open PMCs                  Number of NDA/ANDA PMCs (% of total PMC)                   Number of BLA PMCs (% of total PMC) \1\
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Pending............................  111 (38%)................................................  79 (30%)
Ongoing............................  56 (19%).................................................  71 (27%)
Submitted..........................  48 (16%).................................................  50 (19%)
                                    --------------------------------------------------------------------------------------------------------------------
    Combined total.................  215 (73%)................................................  200 (76%)
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\1\ See note 1 for table 1 of this document.

                                               Table 5--Summary of Off-Schedule Postmarketing Commitments
                                                           [Numbers as of September 30, 2012]
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       Off-schedule open PMCs                 Number of NDA/ANDA PMCs (% of total PMC)                   Number of BLA PMCs (% of total PMC) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Delayed............................  72 (25%).................................................  61 (23%)
Terminated.........................  6 (2%)...................................................  2 (0.8%)
                                    --------------------------------------------------------------------------------------------------------------------
    Combined tota..................  78 (27%).................................................  63 (24%)
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\1\ See note 1 for table 1 of this document.

                                        Table 6--Summary of Concluded Postmarketing Requirements and Commitments
                                                          [October 1, 2011 to October 1, 2012]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Number of NDA/ANDA PMRs/PMCs (% of Total)                  Number of BLA PMRs/PMCs (% of Total) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Concluded PMRs:
    Requirement met (fulfilled)....  74 (67%).................................................  12 (63%)
    Requirement not met (released    6 (6%)...................................................  1 (5%)
     and new revised requirement
     issued).
    Requirement no longer feasible   30 (27%).................................................  6 (32%)
     or product withdrawn
     (released).
                                    --------------------------------------------------------------------------------------------------------------------
        Total......................  110......................................................  19
                                    ====================================================================================================================
Concluded PMCs:
    Commitment met (fulfilled).....  66 (58%).................................................  34 (85%)
    Commitment not met (released     0 (0)....................................................  0 (0)
     and new revised requirement/
     commitment issued).
                                    --------------------------------------------------------------------------------------------------------------------
    Commitment no longer feasible    47 (42%).................................................  6 (15%)
     or product withdrawn
     (released).
                                    --------------------------------------------------------------------------------------------------------------------
        Total......................  113......................................................  40
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\1\ See note 1 for table 1 of this document.

    Dated: February 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03353 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 146 (Tuesday, August 3, 2021)]
[Proposed Rules]
[Pages 41786-41788]
[FR Doc No: 2021-16464]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0602; Project Identifier 2019-CE-022-AD]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries GmbH
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Diamond Aircraft Industries GmbH Models DA 42, DA 42 NG, and DA
42 M-NG airplanes. This proposed AD was prompted by mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as failure of the nose landing gear (NLG) actuator attachment
lever and detachment from the NLG leg. This proposed AD would require
repetitively inspecting the NLG actuator attachment lever for cracks
and damage and taking any necessary corrective actions. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this NPRM by September 17,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Diamond
Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700 Wiener
Neustadt, Austria; phone: +43 2622 26700; fax: +43 2622 26780; email:
<EMAIL_ADDRESS>website: https://www.diamondaircraft.com. You
may view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 901 Locust St, Kansas City, MO
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0602; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the MCAI,
any comments received, and other information. The street address for
Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Penelope Trease, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 26805 E. 68th Avenue, Denver, CO 80249; phone:
(303) 342-1094; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0602; Project Identifier
2019-CE-022-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI

as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Penelope Trease, Aviation Safety Engineer, General Aviation &
Rotorcraft Section, International Validation Branch, FAA, 26805 E. 68th
Avenue, Denver, CO 80249. Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2019-0066, dated March 27, 2019 (referred to after this as
``the MCAI''), to correct an unsafe condition for Diamond Aircraft
Industries GmbH (Austria) and Diamond Aircraft Industries Inc. (Canada)
Model DA 42, DA 42 M, DA 42 NG, and DA 42 M-NG airplanes. The MCAI
states:

    An occurrence was reported of a failed NLG actuator attachment
lever, resulting in disconnection from the NLG leg. When the landing
gear (LG) was retracted, the NLG actuator interfered with the rudder
control rods, forcing the rudder into left-hand deflection. After
lowering the LG, full rudder control was restored. The investigation
results showed that the actuator lever failed due to a crack that
had developed over a longer time period.
    This condition, if not detected and corrected, could lead to
restricted rudder travel in LG retracted configuration, possibly
resulting in reduced control of the aeroplane.
    To address this potential unsafe condition, [Diamond Aircraft
Industries] DAI issued the applicable [mandatory service bulletin]
MSB, providing instructions to inspect the affected part.
    For the reason described above, this [EASA] AD requires
repetitive inspections of the NLG leg actuator attachment lever and,
depending on findings, replacement of the NLG leg.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0602.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Diamond Aircraft Industries Work Instruction WI-
MSB 42-136 and WI-MSB 42NG-078, Revision 1, dated January 24, 2019
(published as one document with Mandatory Service Bulletin MSB 42-136/1
and MSB 42NG-078, dated January 24, 2019). This service information
provides instructions for repetitively inspecting the NLG actuator
attachment lever with replacement of the NLG leg assembly as necessary.
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.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA is issuing this NPRM
after determining the unsafe condition described previously is likely
to exist or develop on other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information already described.

Differences Between This Proposed AD and the MCAI

    The MCAI applies to Models DA 42, DA 42 M, DA 42 NG, and DA 42 M-NG
airplanes. This proposed AD would not apply to the Model DA 42 M
because they do not have an FAA type certificate.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 40 airplanes of U.S. registry. The FAA also estimates that it
would take about 1 work-hour per airplane to comply with the inspection
requirement of this proposed AD, and no parts would be necessary. Based
on these figures, the FAA estimates the cost of the inspection for U.S.
operators to be $3,400, or $85 per airplane.
    In addition, the FAA estimates that any necessary replacement
actions would take about 6 work-hours and require parts costing $1,500,
for a cost of $2,010 per airplane. The FAA has no way of determining
the number of airplanes that may need these actions.

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.
    The FAA is 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.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would 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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:

Diamond Aircraft Industries GmbH: Docket No. FAA-2021-0602; Project
Identifier 2019-CE-022-AD.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by September 17, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Diamond Aircraft Industries GmbH Models DA
42, DA 42 NG, and DA 42 M-NG airplanes, all serial numbers,
certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 3221, Nose/Tail
Landing Gear Attach Section.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and address an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as failure of the
nose landing gear (NLG) actuator attachment lever and detachment
from the NLG leg. The FAA is issuing this AD to detect and correct
cracks in the NLG actuator attachment lever, which could result in
restricted rudder travel with the NLG retracted and reduced airplane
control.

(f) Compliance

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

(g) Definition of Airworthy Part

    For the purposes of this AD, an airworthy part is an NLG leg
assembly that has accumulated 1,800 or fewer hours time-in-service
(TIS) since first installation on an airplane or that has passed the
inspection (no cracks and no damage) required by paragraph (h)(1) of
this AD.

(h) Required Actions

    (1) Inspect the NLG actuator attachment lever for cracks and
damage in the areas shown in paragraph 2 of the Instructions in
Diamond Aircraft Work Instruction WI-MSB 42-136 and WI-MSB 42NG-078,
Revision 1, dated January 24, 2019 (published as one document with
Mandatory Service Bulletin MSB 42-136/1 and MSB 42NG-078, dated
January 24, 2019) at the following applicable compliance times:
    (i) For airplanes with an NLG assembly that has accumulated less
than 1,800 hours TIS as of the effective date of this AD: Within 200
hours TIS after the NLG assembly accumulates 1,800 hours TIS or
within 12 months after the NLG assembly accumulates 1,800 hours TIS,
whichever occurs first, and thereafter at intervals not to exceed
200 hours TIS; or
    (ii) For airplanes with an NLG assembly that has accumulated
1,800 or more hours TIS as of the effective date of this AD: Within
210 hours TIS after the effective date of this AD or within 12
months after the effective date of this AD, whichever occurs first,
and thereafter at intervals not to exceed 200 hours TIS.
    (2) After each inspection required by paragraph (h)(1) of this
AD, if there is a crack or damage on the NLG actuator attachment
lever, before further flight, replace the NLG leg assembly with an
airworthy part as defined by this AD.
    (3) As of the effective date of this AD, do not install an NLG
leg assembly on any airplane unless it is an airworthy part as
defined by this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, 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 the
attention of the person identified in Related Information or email:
<EMAIL_ADDRESS>    (2) 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.

(j) Related Information

    (1) For more information about this AD contact Penelope Trease,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 26805 E. 68th Avenue, Denver,
CO 80249; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) 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) Refer to European Union Aviation Safety Agency (EASA) AD No.
2019-0066, dated March 27, 2019, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0602.
    (3) For service information identified in this AD, contact the
Diamond Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700
Wiener Neustadt, Austria; phone: +43 2622 26700; fax: +43 2622
26780; email<EMAIL_ADDRESS>website: https://www.diamondaircraft.com. You may review this referenced service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on July 21, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-16464 Filed 8-2-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46116-46117]
[FR Doc No: 2017-21131]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32836; 812-14681]

Wells Fargo Exchange-Traded Funds Trust, et al.

September 27, 2017.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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

    Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1
under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act. The requested order would permit (a) index-
based series of certain open-end management investment companies
(``Funds'') to issue shares redeemable in large aggregations
(``Creation Units''); (b) secondary market transactions in Fund shares
to occur at negotiated market prices rather than at net asset value
(``NAV''); (c) certain Funds to pay redemption proceeds, under certain
circumstances, more than seven days after the tender of shares for
redemption; (d) certain affiliated persons of a Fund to deposit
securities into, and receive securities from, the Fund in connection
with the purchase and redemption of Creation Units; (e) certain
registered management investment companies and unit investment trusts
outside of the same group of investment companies as the Funds (``Funds
of Funds'') to acquire shares of the Funds; (f) certain Funds (``Feeder
Funds'') to create and redeem Creation Units in-kind in a master-feeder
structure; and (g) certain Funds to issue Shares in less than Creation
Unit size to investors participating in a distribution reinvestment
program.
    Applicants: Wells Fargo Exchange-Traded Funds Trust (the
``Trust''), a Delaware statutory trust, which will register under the
Act as an open-end management investment company with multiple series,
Wells Fargo Funds Management, LLC (the ``Initial Adviser''), a Delaware
limited liability company registered as an investment adviser under the
Investment Advisers Act of 1940, and Wells Fargo Funds Distributor, LLC
(the ``Initial Distributor''), a Delaware limited liability company
(together with any future distributor, the ``Distributor'').
    Filing Dates: The application was filed on August 5, 2016, and
amended on December 2, 2016, April 19, 2017, and September 15, 2017.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on October 23, 2017, and should be accompanied by proof of
service on applicants, in the form of an affidavit, or for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street
NE., Washington, DC 20549-1090; Applicants: Devin F. Sullivan, Esq.,
Wells Fargo Funds Management, LLC, 45 Fremont Street, 26th Floor, San
Francisco, CA 94105.

FOR FURTHER INFORMATION CONTACT: Laura L. Solomon, Senior Counsel, at
(202) 551-6915, or Daniele Marchesani, Assistant Chief Counsel at (202)
551-6821 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Summary of the Application

    1. Applicants request an order that would allow Funds to operate as
index-based exchange traded funds (``ETFs'').\1\ Fund shares will be
purchased and redeemed at their NAV in Creation Units (other than
pursuant to a distribution reinvestment program), as described in the
application. All orders to purchase Creation Units and all redemption
requests will be placed by or through an ``Authorized Participant'',
which will have signed a participant agreement with the Distributor.
Shares will be listed and traded individually on a national securities
exchange, where share prices will be based on the current bid/offer
market. Certain Funds may operate as Feeder Funds in a master-feeder
structure. Any order granting the requested relief would be subject to
the terms and conditions stated in the application.
---------------------------------------------------------------------------

    \1\ Applicants request that the order apply to the initial fund
and any additional series of the Trust, and any other existing or
future open-end management investment company or existing or future
series thereof (each, included in the term ``Fund''), each of which
will operate as an ETF, and their respective existing or future
master funds, and will track a specified index comprised of domestic
and/or foreign equity securities and/or domestic and/or foreign
fixed income securities (each, an ``Underlying Index''). Any Fund
will (a) be advised by the Initial Adviser or an entity controlling,
controlled by, or under common control with the Initial Adviser
(each, an ``Adviser'') and (b) comply with the terms and conditions
of the application.
---------------------------------------------------------------------------

    2. Each Fund will hold investment positions selected to correspond
closely to the performance of an Underlying Index. In the case of Self-
Indexing

Funds, an affiliated person, as defined in section 2(a)(3) of the Act
(``Affiliated Person''), or an affiliated person of an Affiliated
Person (``Second-Tier Affiliate''), of the Trust or a Fund, of the
Adviser, of any sub-adviser to or promoter of a Fund, or of the
Distributor will compile, create, sponsor or maintain the Underlying
Index.\2\
---------------------------------------------------------------------------

    \2\ Each Self-Indexing Fund will post on its Web site the
identities and quantities of the investment positions that will form
the basis for the Fund's calculation of its NAV at the end of the
day. Applicants believe that requiring Self-Indexing Funds to
maintain full portfolio transparency will help address, together
with other protections, conflicts of interest with respect to such
Funds.
---------------------------------------------------------------------------

    3. Shares will be purchased and redeemed in Creation Units and
generally on an in-kind basis, or issued in less than Creation Unit
size to investors participating in a distribution reinvestment program.
Except where the purchase or redemption will include cash under the
limited circumstances specified in the application, purchasers will be
required to purchase Creation Units by depositing specified instruments
(``Deposit Instruments''), and shareholders redeeming their shares will
receive specified instruments (``Redemption Instruments''). The Deposit
Instruments and the Redemption Instruments will each correspond pro
rata to the positions in the Fund's portfolio (including cash
positions) except as specified in the application.
    4. Because shares will not be individually redeemable, applicants
request an exemption from Section 5(a)(1) and Section 2(a)(32) of the
Act that would permit the Funds to register as open-end management
investment companies and issue shares that are redeemable in Creation
Units (other than pursuant to a dividend reinvestment program).
    5. Applicants also request an exemption from section 22(d) of the
Act and rule 22c-1 under the Act as secondary market trading in shares
will take place at negotiated prices, not at a current offering price
described in a Fund's prospectus, and not at a price based on NAV.
Applicants state that (a) secondary market trading in shares does not
involve a Fund as a party and will not result in dilution of an
investment in shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand.
Therefore, applicants assert that secondary market transactions in
shares will not lead to discrimination or preferential treatment among
purchasers. Finally, applicants represent that share market prices will
be disciplined by arbitrage opportunities, which should prevent shares
from trading at a material discount or premium from NAV.
    6. With respect to Funds that effect creations and redemptions of
Creation Units in kind and that are based on certain Underlying Indexes
that include foreign securities, applicants request relief from the
requirement imposed by section 22(e) in order to allow such Funds to
pay redemption proceeds within fifteen calendar days following the
tender of Creation Units for redemption. Applicants assert that the
requested relief would not be inconsistent with the spirit and intent
of section 22(e) to prevent unreasonable, undisclosed or unforeseen
delays in the actual payment of redemption proceeds.
    7. Applicants request an exemption to permit Funds of Funds to
acquire Fund shares beyond the limits of section 12(d)(1)(A) of the
Act; and the Funds, and any principal underwriter for the Funds, and/or
any broker or dealer registered under the Exchange Act, to sell shares
to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
The application's terms and conditions are designed to, among other
things, help prevent any potential (i) undue influence over a Fund
through control or voting power, or in connection with certain
services, transactions, and underwritings, (ii) excessive layering of
fees, and (iii) overly complex fund structures, which are the concerns
underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
    8. Applicants request an exemption from sections 17(a)(1) and
17(a)(2) of the Act to permit persons that are Affiliated Persons, or
Second Tier-Affiliates, of the Funds, solely by virtue of certain
ownership interests, to effectuate purchases and redemptions in-kind.
The deposit procedures for in-kind purchases of Creation Units and the
redemption procedures for in-kind redemptions of Creation Units will be
the same for all purchases and redemptions and Deposit Instrument and
Redemption Instruments will be valued in the same manner as those
investment positions currently held by the Funds. Applicants also seek
relief from the prohibitions on affiliated transactions in section
17(a) to permit a Fund to sell its shares to and redeem its shares from
a Fund of Funds, and to engage in the accompanying in-kind transactions
with the Fund of Funds.\3\ The purchase of Creation Units by a Fund of
Funds directly from a Fund will be accomplished in accordance with the
policies of the Fund of Funds and will be based on the NAVs of the
Funds.
---------------------------------------------------------------------------

    \3\ The requested relief would apply to direct sales of shares
in Creation Units by a Fund to a Fund of Funds and redemptions of
those shares. Applicants, moreover, are not seeking relief from
section 17(a) for, and the requested relief will not apply to,
transactions where a Fund could be deemed an Affiliated Person, or a
Second-Tier Affiliate, of a Fund of Funds because an Adviser or an
entity controlling, controlled by or under common control with an
Adviser provides investment advisory services to that Fund of Funds.
---------------------------------------------------------------------------

    9. Applicants also request relief to permit a Feeder Fund to
acquire shares of another registered investment company having
substantially the same investment objectives as the Feeder Fund
(``Master Fund'') beyond the limitations in section 12(d)(1)(A) and
permit the Master Fund, and any principal underwriter for the Master
Fund, to sell shares of the Master Fund to the Feeder Fund beyond the
limitations in section 12(d)(1)(B).
    10. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-21131 Filed 10-2-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Rules and Regulations]
[Pages 6663-6666]
[FR Doc No: 2012-1998]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1128; Directorate Identifier 2011-CE-031-AD;
Amendment 39-16933; AD 2012-02-10]
RIN 2120-AA64

Airworthiness Directives; CPAC, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
for all CPAC, Inc. (type certificate formerly held by Commander
Aircraft Corporation, Gulfstream Aerospace Corporation, and Rockwell
International) Models 112, 112B, 112TC, 112TCA, 114, 114A, 114B, and
114TC airplanes. That AD currently requires a one-time inspection of
the elevator spar for cracks and, if any crack is found, either replace
with a serviceable elevator spar that is found free of cracks or
repair/modify the elevator spar with an FAA-approved method. That AD
also requires reporting to the FAA the results of the inspection. Since
we issued that AD, using the data collected through the reporting
requirement, we have determined there is a need for continued
inspections. This new AD requires repetitive inspections of the
elevator spar for cracks and, if any crack is found, either replacing
with a serviceable elevator spar that is free of any cracks and/or
corrosion or repairing/modifying the elevator spar with an FAA-approved
procedure. We are issuing this AD to correct the unsafe condition on
these products.

DATES: This AD is effective March 15, 2012.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; 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 address for the
Docket Office (phone:<PHONE_NUMBER>) is Document 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: T.N. Baktha, Senior Aerospace
Engineer, FAA, Wichita Aircraft Certification Office, 1801 Airport
Road, Room 100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:
(316) 946-4107; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2011-07-13, Amendment 39-16650 (76 FR 18376,
April 4, 2011). That AD applies to the specified products. The NPRM
published in the Federal Register on October 17, 2011 (76 FR 64038).
That NPRM proposed to retain all of the requirements of AD 2011-07-13
and make the previous one-time inspection repetitive.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(76 FR 64038, October 17, 2011) and the FAA's response to each comment.

Request for Clarification

    James D. Richards of Aerodyme Corporation requested additional
information be added to the final rule AD action to clarify whether or
not the inspection intervals and procedures in this AD take precedence
over those specified in the FAA-approved Parts Manufacturer Approval
(PMA) Elevator Spars 44211-RE9 and 44211-RE10, Instructions for
Continued Airworthiness, original issue date May 5, 2011.
    James D. Richards obtained a PMA for CPAC, Inc. Models 112, 112B,
112TC, 112TCA, 114, 114A, 114B, and 114TC airplanes elevator spars. The
PMA Instructions for Continued Airworthiness have inspection intervals
and procedures that are different from the intervals and procedures
specified in the proposed AD (76 FR 64038, October 17, 2011).
    We agree with the commenter. We do not want to have two different
inspection intervals and procedures for the same elevator spars. We
revised this AD as requested and added information into paragraph (f)
to clarify that the actions required in this AD take precedence over
those contained in PMA Elevator Spars 44211-RE9 and 44211-RE10,
Instructions for Continued Airworthiness, original issue date May 5,
2011.

Request for Additional Information

    Fredrick E. Maupertuis requested that specific information be added
to paragraph (l) Special Flight Permit of the final rule AD action
about allowable crack criteria. Fredrick E. Maupertuis questioned
whether the number of cracks, the length of the cracks, and/or the
orientation of cracks found during an inspection will be a determining
factor in obtaining a special flight permit.
    We agree with the commenter because the requested information was
not included in the proposed AD (76 FR 64038, October 17, 2011). We
revised this AD as requested by adding crack criteria and allowances
into paragraph (l).

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 64038, October 17, 2011) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 64038, October 17, 2011).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Interim Action

    We consider this AD interim action. We continue to evaluate the
reported data and repair procedures to determine a possible terminating
action. Based on this determination, we may initiate further rulemaking
action if needed to address the unsafe condition identified in this AD.

Costs of Compliance

    We estimate that this AD affects 773 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
----------------------------------------------------------------------------------------------------------------
Inspection of the elevator spar...  8 work-hours x $85 per                N/A             $680         $525,640
                                     hour = $680.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any replacement that will be
required based on the results of the inspection. We have no way of
determining the number of aircraft that might need this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                           Labor cost  per          Parts cost  per       Cost per  product per
                Action                      elevator spar            elevator  spar           elevator spar
----------------------------------------------------------------------------------------------------------------
Replace cracked elevator spar with a   Up to 16 work-hours x    May range from $100 to   May range from $1,460
 serviceable elevator spar.             $85 per hour = $1,360.   $1,000.                  to $2,360.
Replace cracked elevator spar with a   Up to 16 work-hours x    $1,250.................  $2,610.
 new elevator spar.                     $85 per hour = $1,360.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any repair/modification that
will be required based on the results of the inspection. We have no way
of determining the number of aircraft that might need this repair/
modification:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        airplane
----------------------------------------------------------------------------------------------------------------
Repair/modify cracked elevator spar..........  Up to 26 work-hours x $85 per          * $1,690           $3,900
                                                hour = $2,210.
----------------------------------------------------------------------------------------------------------------
* An STC is available to repair the elevator spars and the STC holder sells the repair kit in pairs only. Kits
  to repair only one side of the elevator are not available for sale. The parts cost in the table above is for a
  pair of repair kits. The STC holder currently charges $2,250 to install both repair kits.

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.

Regulatory Findings

    We have 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 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 removing airworthiness directive (AD)
2011-07-13, Amendment 39-16650 (76 FR 18376, April 4, 2011), and adding
the following new AD:

2012-02-10 CPAC, Inc. (Type Certificate Formerly Held by Commander
Aircraft Corporation, Gulfstream Aerospace

Corporation, and Rockwell International): Amendment 39-16933; Docket
No. FAA-2011-1128; Directorate Identifier 2011-CE-031-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective March 15, 2012.

(b) Affected ADs

    This AD supersedes AD 2011-07-13, Amendment 39-16650 (76 FR
18376, April 4, 2011).

(c) Applicability

    This AD applies to CPAC, Inc. (type certificate formerly held by
Commander Aircraft Corporation, Gulfstream Aerospace Corporation,
and Rockwell International) Models 112, 112B, 112TC, 112TCA, 114,
114A, 114B, and 114TC airplanes, all serial numbers, certificated in
any category. Type Certificate No. A12SO does not include Models
112A and 115. The Model 112A is a Rockwell ``marketing name'' for
the Model 112. The Model 115 is a Rockwell ``marketing name'' for
the Model 114. Since they are type-certificated as Model 112 and
Model 114, this AD is applicable to the Models 112A and 115.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 55, Stabilizers.

(e) Unsafe Condition

    This AD was prompted by reports of a total of nine elevator spar
cracks across seven of the affected airplanes, including a crack of
2.35 inches just below the outboard hinge of the right-hand
elevator. We are issuing this AD to prevent structural failure of
the elevator spar due to such cracking, which could result in
separation of the elevator from the airplane with consequent loss of
control.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done. The inspection intervals and procedures in this
AD take precedence over those contained in Parts Manufacturer
Approval (PMA) Elevator Spars 44211-RE9 and 44211-RE10, Instructions
for Continued Airworthiness, original issue date May 5, 2011.

(g) Inspection Requirement Retained From AD 2011-07-13, Amendment 39-
16650 (76 FR 18376, April 4, 2011)

    Within the next 5 hours time-in-service (TIS) after April 4,
2011 (the effective date retained from AD 2011-07-13 (76 FR 18376,
April 4, 2011)), visually inspect the left-hand (LH) and right-hand
(RH) elevator spar behind and around the outboard hinge bracket on
the elevator spar for cracks. Do the inspection following the
procedures specified in paragraph (j) of this AD. If cracks are
found during this inspection, take the necessary corrective actions
specified in paragraph (k) of this AD.

(h) Reporting Requirement Retained From AD 2011-07-13, Amendment 39-
16650 (76 FR 18376, April 4, 2011)

    Within 30 days after the inspection required in paragraph (g) of
this AD, report the results of the inspection to the FAA, Wichita
Aircraft Certification Office (ACO), Attn: T.N. Baktha, Senior
Aerospace Engineer, 1801 Airport Road, Room 100; Wichita, Kansas
67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Include the following information:
    (1) Airplane model and serial number.
    (2) Hours TIS at time of inspection.
    (3) Annotate any cracking found, including the exact location
and length of any cracks.
    (4) Any installations, repairs, modifications, etc. that have
been done on your airplane in the elevator spar area or that could
have affected the elevator spar.
    (5) Type of operation primarily flown.

(i) Repetitive Inspection Requirement

    As a result of the inspection required in paragraph (g) of this
AD, if the elevator spar was:
    (1) Replaced with a new elevator spar, within the next 300 hours
TIS after the replacement, visually inspect the elevator spar behind
the outboard hinge bracket and surrounding area for cracks.
Repetitively inspect thereafter at intervals not to exceed 12 months
or 150 hours TIS, whichever occurs first. Do the inspection
following the procedures specified in paragraph (j) of this AD.
    (2) Replaced with a serviceable elevator spar (one that was in
service before and had no cracks and/or corrosion), within the next
150 hours TIS after the replacement, visually inspect the elevator
spar behind the outboard hinge bracket and surrounding area for
cracks. Repetitively inspect thereafter at intervals not to exceed
12 months or 150 hours TIS, whichever occurs first. Do the
inspection following the procedures specified in paragraph (j) of
this AD.
    (3) Found free of cracks, within the next 150 hours TIS after
the inspection, visually inspect the elevator spar behind the
outboard hinge bracket and surrounding area for cracks. Repetitively
inspect thereafter at intervals not to exceed 12 months or 150 hours
TIS, whichever occurs first. Do the inspection following the
procedures specified in paragraph (j) of this AD.

(j) Inspection Procedures

    (1) Disconnect the elevator trim pushrod at the trim tab.
    (2) Remove the hinge bolts at the horizontal stabilizer points.
    (3) Remove six screws and two bolts at the inboard end of the
elevator and remove the elevator.
    (4) Remove all fasteners common to the elevator outboard aft end
rib, part number (P/N) 44330, and elevator skin, P/N 44323.
    (5) Remove the remaining two fasteners common to the elevator
outboard aft end rib (P/N 44330) and the elevator spar, P/N 44211.
    (6) Remove the elevator aft end rib, P/N 44330, to gain access
to the aft side of the elevator spar.
    (7) Remove the four bolts, washers, and nuts that secure the
outboard elevator hinge bracket, P/N 44285.
    (8) Remove elevator hinge bracket, P/N 44285, from the elevator
spar.
    (9) Clean in and around the location of the elevator outboard
hinge bracket, outboard elevator hinge, and the outboard elevator
hinge bracket (as applicable) on the elevator spar and visually
inspect for cracks. Use a 10x magnifier to facilitate the detection
of any crack.

(k) Corrective Actions

    (1) If cracks are found during any inspection required in
paragraphs (g), (i)(1), (i)(2), or (i)(3) of this AD, before further
flight, either replace the elevator spar with a new spar or a
serviceable spar that is found free of cracks and/or corrosion or
repair/modify the elevator spar following a procedure approved for
this AD by the FAA, Wichita ACO;
    (2) After doing the actions required in paragraph (k)(1) of this
AD, before further flight, reassemble the elevator assembly,
rebalance the elevator, and reinstall on the airplane following
standard repair practices. Ensure elevator rigging is within
tolerance, and that the system operates with ease, smoothness, and
positiveness appropriate to its function; and
    (3) After taking corrective action, continue with the repetitive
inspections required in paragraphs (i)(1), (i)(2), and (i)(3) of
this AD.

(l) Special Flight Permit

    (1) Special flight permits are permitted for daytime visual
flight rules (VFR) only, restricted to crew, calm weather, reduced
speed not to exceed 111 knots calibrated air speed (KCAS), and not
to exceed 5 flight hours when cracks are found in the elevator spar
if:
    (i) The cracks are at or near the outboard hinge bracket;
    (ii) The cracks are 1.25 inches long or less; and
    (iii) There is no more than one crack on the top and one at the
bottom of the hinge bracket.
    (2) Special flight permits are not allowed if:
    (i) The crack length is greater than 1.25 inches; or
    (ii) The number of cracks is more than two.

(m) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the

burden should be directed to the FAA at: 800 Independence Ave. SW.,
Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(n) AMOCs

    (1) The Manager, Wichita ACO, 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
ACO, send it to the attention of the person identified in the
Related Information section of this AD.
    (2) 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.
    (3) AMOCs approved for AD 2011-07-13, Amendment 39-16650 (76 FR
18376, April 4, 2011), are approved for this AD.

(o) Related Information

    For more information about this AD, contact T.N. Baktha, Senior
Aerospace Engineer, Wichita ACO, FAA, 1801 Airport Road, Room 100,
Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
    Issued in Kansas City, Missouri, on January 25, 2012.
John Colomy,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-1998 Filed 2-8-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 112 (Monday, June 14, 2021)]
[Notices]
[Page 31494]
[FR Doc No: 2021-12371]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-2089-000]

Elephant Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Elephant Energy, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 28, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: June 8, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-12371 Filed 6-11-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78974-78975]
[FR Doc No: 2013-30880]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1558]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence
for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information request
regarding the guidance for industry and FDA staff entitled ``Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products.''

DATES: Submit either electronic or written comments on the collection
of information by February 25, 2014.

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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<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.

Information Request Regarding Guidance for Industry and FDA Staff on
Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products (OMB Control Number 0910-0673--Extension)

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act) by adding a new chapter granting FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C.
387e(j)) authorizes FDA to establish the form for the submission of
information related to substantial equivalence. In a Level 1 guidance
document issued under the Good Guidances Practices regulation (21 CFR
10.115), FDA provides recommendations intended to assist persons
submitting reports under section 905(j) of the FD&C Act and explains,
among other things, FDA's interpretation of the statutory sections
related to substantial equivalence.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                         FD&C act sections                              Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
905(j)(1)(A)(i) and 910(a).........................................           1,000                1            1,000              360          360,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA's expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates
that it will receive 1,000 section 905(j) reports each year and that it
will take a manufacturer approximately 360 hours to prepare a report of
substantial equivalence for a new tobacco product. Therefore, FDA
estimates the burden for submission of substantial equivalence
information will be 360,000 hours.

    Dated: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30880 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P