[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Notices]
[Pages 2190-2191]
[FR Doc No: 2022-00582]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-224, OMB Control No. 3235-0217]

Proposed Collection; Comment Request; Extension: Rule 17e-1

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 17e-1 (17 CFR 270.17e-1) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) (the ``Investment Company Act'') deems a
remuneration as ``not exceeding the usual and customary broker's
commission'' for purposes of Section 17(e)(2)(A) of the Investment
Company Act (15 U.S.C. 80a-17(e)(2)(A)) if, among other things, a
registered investment company's (``fund's'') board of directors has
adopted procedures reasonably designed to provide that the remuneration
to an affiliated broker is reasonable and fair compared to that
received by other brokers in connection with comparable transactions
involving similar securities being purchased or sold on a securities
exchange during a comparable period of time and the board makes and
approves such changes as it deems necessary. In addition, each quarter,
the board must determine that all transactions effected under the rule
during the preceding quarter complied with the established procedures
(``review requirement''). Rule 17e-1 also requires the fund to (i)
maintain permanently a written copy of the procedures adopted by the
board for complying with the requirements of the rule; and (ii)
maintain for a period of six years, the first two in an easily
accessible place, a written record of each transaction subject to the
rule, setting forth the amount and source of the commission, fee, or
other remuneration received; the identity of the broker; the terms of
the transaction; and the materials used to determine that the
transactions were effected in compliance with the procedures adopted by
the board (``recordkeeping requirement''). The review and recordkeeping
requirements under rule 17e-1 enable the Commission to ensure that
affiliated brokers receive compensation that does not exceed the usual
and customary broker's commission. Without the recordkeeping
requirement, Commission inspectors would have difficulty ascertaining
whether funds were complying with rule 17e-1.
    Based upon an analysis of fund filings on Form N-CEN, approximately
1,640 funds report reliance on rule 17e-1. Based on staff experience
and conversations with fund representatives, we estimate that the
burden of compliance with rule 17e-1 is approximately 50 hours per fund
per year. This time is spent, for example, reviewing the applicable
transactions and maintaining records. Accordingly, we calculate the
total estimated annual internal burden of complying with the review and
recordkeeping requirements of rule 17e-1 to be approximately 82,000
hours.\1\ We further estimate that, of these:
---------------------------------------------------------------------------

    \1\ 1,604 funds x 50 hours per fund = 82,000 hours.
---------------------------------------------------------------------------

     60 percent (49,200 hours) are spent by senior accountants,
at an estimated hourly wage of $221,\2\ for a total of approximately
$10,873,200 per year; \3\
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    \2\ The Commission's estimates concerning the allocation of
burden hours and the relevant wage rates are based on consultations
with industry representatives and on salary information for the
securities industry compiled by the Securities Industry and
Financial Markets Association. The estimated wage figures are also
based on published rates for senior accountants and in-house
attorneys, modified to account for an 1800-hour work-year and
multiplied by 5.35 to account for bonuses, firm size, employee
benefits, and overhead, yielding effective hourly rates of $221 and
$425, respectively. See Securities Industry and Financial Markets
Association, Report on Management & Professional Earnings in the
Securities Industry 2013.
    \3\ 49,200 hours x $221 per hour = $10,873,200.
---------------------------------------------------------------------------

     30 percent (24,600 hours) are spent by in-house attorneys
at an estimated

hourly wage of $425, for a total of approximately $10,455,000 per year;
\4\ and
---------------------------------------------------------------------------

    \4\ 24,600 hours x $425 per hour = $10,455,000.
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     10 percent (8,200) are spent by the funds' board of
directors at an hourly cost of $4,770, for a total of approximately
$39,114,000 per year.\5\
---------------------------------------------------------------------------

    \5\ 8,200 hours x $4,770 per hour = $39,114,000. The estimate
for the cost of board time as a whole is derived from estimates made
by the staff regarding typical board size and compensation that is
based on information received from fund representatives and publicly
available sources.
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    Based on these estimated wage rates, the total cost to the industry
of the hour burden for complying with the review and recordkeeping
requirements of rule 17e-1 is approximately $60,442,200.\6\ The
Commission staff estimates that there is no cost burden associated with
the information collection requirement of rule 17e-1 other than this
cost.
---------------------------------------------------------------------------

    \6\ $10,873,200 + $10,455,000 + $39,114,000 = $60,442,200.
---------------------------------------------------------------------------

    Estimates of average burden hours are made solely for the purposes
of the Paperwork Reduction Act and are not derived from a comprehensive
or even a representative survey or study of the costs of Commission
rules and forms. The collection of information under rule 17e-1 is
mandatory. The information provided under rule 17e-1 will not be kept
confidential. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the Commission's estimate
of the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, C/O John R.
Pezzullo, 100 F Street NE, Washington, DC 20549; or send an email to:
[email protected].

    Dated: January 10, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-00582 Filed 1-12-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Rules and Regulations]
[Pages 12166-12170]
[FR Doc No: 2012-4428]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1311; Directorate Identifier 2009-NM-229-AD;
Amendment 39-16938; AD 2012-02-15]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for certain Model 757-200, -200PF, -200CB, and -300 series airplanes.
That AD currently requires inspecting certain power feeder wire bundles
for damage, inspecting the support clamps for these wire bundles to
determine whether the clamps are properly installed, and performing
corrective actions if necessary. This new AD requires additional
inspections for certain airplanes. This AD was prompted by a report
that a power feeder wire bundle chafed against the number six auxiliary
slat track, causing electrical wires in the bundle to arc, which
damaged both the auxiliary slat track and power feeder wires. We are
issuing this AD to prevent arcing that could be a possible ignition
source for leaked flammable fluids, which could result in a fire.
Arcing could also result in a loss of power from the generator
connected to the power feeder wire bundle, and consequent loss of
systems, which could reduce controllability of the airplane.

DATES: This AD is effective April 4, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of April 4, 2012.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

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: Marie Hogestad, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2007-03-01, amendment 39-14912 (72 FR 3939,
January 29, 2007). That AD applies to the specified products. The NPRM
was published in the Federal Register on January 18, 2011 (76 FR 2848).
That NPRM proposed to continue to require inspecting certain power
feeder wire bundles for damage, inspecting the support clamps for those
wire bundles to determine whether the clamps are properly installed,
and performing corrective actions if necessary. That NPRM also proposed
to require additional inspections for certain airplanes.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Requests To Correct Figure Reference in Paragraph (i) of the NPRM (76
FR 2848, January 18, 2011)

    United Airlines and American Airlines requested that paragraph (i)
of the NPRM (76 FR 2848, January 18, 2011) be changed to reference
Figure 1 rather than Figure 3 of Boeing Special Attention Service
Bulletin 757-24-0105, Revision 5, dated July 30, 2009. Boeing Special
Attention Service Bulletin 757-24-0105, Revision 5, dated July 30,
2009, has a typographical error referencing the incorrect figure.
United Airlines also requested that the NPRM refer to Boeing
Information Notice 757-24-0105 IN 03, dated August 19, 2009. United
Airlines stated that Boeing Information Notice 757-24-0105 IN 03, dated
August 19, 2009, was issued to notify operators of this error.
    We agree to revise paragraph (i) of this AD to refer to Figure 1 of
Boeing Special Attention Service Bulletin 757-24-0105, Revision 5,
dated July 30, 2009. We have confirmed that the correct figure is
Figure 1; therefore, we have revised paragraph (i) of this AD to refer
to Figure 1 of Boeing Special Attention Service Bulletin 757-24-0105,
Revision 5, dated July 30, 2009. We have not revised paragraph (i) of
this AD to refer to Boeing Information Notice 757-24-0105 IN 03, dated
August 19, 2009, because we revised that paragraph to refer to the
correct figure.

Request To Add Inspection To Determine Airplane Configuration

    American Airlines requested that the NPRM (76 FR 2848, January 18,
2011) be revised to include an inspection to determine if the airplane
has one or two attach brackets on the left wing prior to accomplishing
the required rework. American Airlines stated that Group 2 airplanes
were moved to Group 1 in Boeing Special Attention Service Bulletin 757-
24-0105, Revision 5, dated July 30, 2009, because some airplanes have
two attach brackets on the left wing, similar to earlier Group 1
airplanes identified in previous revisions of that service bulletin.
American Airlines stated that the NPRM does not contain a step to
determine the airplane configuration before the rework.
    We disagree with adding an inspection to determine the airplane
configuration; however, we agree to clarify paragraph (i) of this AD.
Therefore, we have revised paragraph (i) of this AD to specify the
affected airplanes on which the actions are required by that paragraph.

Request To Clarify Affected Airplanes in Paragraph (i) of the NPRM (76
FR 2848, January 18, 2011)

    United Airlines requested that a statement be added to clarify that
the new requirement specified in paragraph (i) of the NPRM (76 FR 2848,
January 18, 2011) is only applicable to airplanes with upper and lower
brackets installed in the left wing (Group 1, Configuration 1
airplanes), as defined in Boeing Special Attention Service Bulletin
757-24-0105, Revision 5, dated July 30, 2009. United Airlines stated
that the NPRM is unclear regarding which

airplanes are affected by the new requirements.
    We agree that clarification is needed. Airplanes in Group 1, as
specified in Boeing Special Attention Service Bulletin 757-24-0105,
Revision 5, dated July 30, 2009, could be in the configuration shown in
Figure 1 (Configuration 1 with two attach brackets on the left wing) or
Figure 3 (Configuration 2 with one attach bracket on the left wing).
Therefore, as stated previously, we have clarified paragraph (i) of
this AD to specify the affected airplanes.

Request To Provide Credit for Previous Work Done Using Boeing Special
Attention Service Bulletin 757-24-0105, Revision 5, Dated July 30, 2009

    European Air Transport, a company of DHL, requested that we revise
the NPRM (76 FR 2848, January 18, 2011) to provide credit to operators
that have accomplished inspections and corrective actions prior to the
effective date of this AD in accordance with Boeing Special Attention
Service Bulletin 757-24-0105, Revision 5, dated July 30, 2009. European
Air Transport pointed out that the NPRM provides credit for actions
accomplished using previous revisions of Boeing Special Attention
Service Bulletin 757-24-0106, which is applicable to Model 757-300
airplanes.
    We agree that inspections and corrective actions done before the
effective date of this AD in accordance with Boeing Special Attention
Service Bulletin 757-24-0105, Revision 5, dated July 30, 2009, are
acceptable for accomplishing the applicable actions specified in this
AD. However, operators may always accomplish the actions in an AD using
the required service information at any time before the effective date
of the AD, as allowed by the phrase ``unless the actions have already
been done.'' Therefore, because these actions are not required to be
repeated, it is unnecessary to provide specific credit for these
actions. We have made no change to the AD in this regard.

Additional Changes to Final Rule

    We have revised the headings of Tables 1, 2, 3, 4, and 5 of this AD
to clarify the purpose of the content in those tables.
    We have included headings for paragraphs (i) and (j) of this AD to
clarify the purpose of the content in those paragraphs.
    Boeing Special Attention Service Bulletin 757-24-0105, Revision 3,
dated October 3, 2006; and Revision 4, dated January 4, 2008; have been
added to Table 5, ``Previous Service Information for Paragraph (g) of
this AD,'' of this AD.
    We have also revised the headings for and wording in paragraphs (h)
and (k) of this AD; these changes have not changed the intent of these
paragraphs.

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 2848, January 18, 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 2848, January 18, 2011).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 683 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                           Average
                                  Work      labor                   Cost per     Number of U.S.-
            Action               hours     rate per    Parts        airplane       registered       Fleet cost
                                             hour                                   airplanes
----------------------------------------------------------------------------------------------------------------
Inspection (required by AD             2        $85         $0  $170 per                    683  $116,110 per
 2007-03-01, Amendment 39-                                       inspection                       inspection
 14912 (72 FR 3939, January                                      cycle.                           cycle.
 29, 2007)).
Inspection for certain Group           5         85          0  $425 per                    646  $274,550 per
 1 Model 757-200, -200CB, -                                      inspection                       inspection
 200PF series airplanes (new                                     cycle.                           cycle.
 action).
Inspections for Model 757-300          4         85          0  $340 per                     37  $12,580 per
 series airplanes (new                                           inspection                       inspection
 action).                                                        cycle.                           cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
a cost estimate for the on-condition actions specified in this AD.

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)
2007-03-01, Amendment 39-14912 (72 FR 3939, January 29, 2007), and
adding the following new AD:

2012-02-15 The Boeing Company: Amendment 39-16938; Docket No. FAA-
2010-1311; Directorate Identifier 2009-NM-229-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective April 4, 2012.

(b) Affected ADs

    This AD supersedes AD 2007-03-01, Amendment 39-14912 (72 FR
3939, January 29, 2007).

(c) Applicability

    This AD applies to The Boeing Company Model 757-200, -200PF, -
200CB, and -300 series airplanes, certificated in any category,
specified in paragraphs (c)(1) and (c)(2) of this AD.
    (1) Model 757-200, -200PF, and -200CB series airplanes, as
identified in Boeing Special Attention Service Bulletin 757-24-0105,
Revision 5, dated July 30, 2009.
    (2) Model 757-300 series airplanes, as identified in Boeing
Special Attention Service Bulletin 757-24-0106, Revision 5, dated
July 30, 2009.

(d) Subject

    Air Transport Association (ATA) of America Code 24: Electrical
power.

(e) Unsafe Condition

    This AD results from a report that a power feeder wire bundle
chafed against the number six auxiliary slat track, causing
electrical wires in the bundle to arc, which damaged both the
auxiliary slat track and power feeder wires. The Federal Aviation
Administration is issuing this AD to prevent arcing that could be a
possible ignition source for leaked flammable fluids, which could
result in a fire. Arcing could also result in a loss of power from
the generator connected to the power feeder wire bundle, and
consequent loss of systems, which could reduce controllability of
the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Restatement of Requirements of AD 2007-03-01, Amendment 39-14912
(72 FR 3939, January 29, 2007), With Revised Service Information and
Affected Airplane Groups: One-Time Inspections and Corrective Actions

    For Model 757-200, -200PF, and -200CB series airplanes
identified in Boeing Special Attention Service Bulletin 757-24-0105,
Revision 5, dated July 30, 2009; and for Model 757-300 series
airplanes identified as Group 1 airplanes in Boeing Special
Attention Service Bulletin 757-24-0106, Revision 5, dated July 30,
2009: Within 24 months after March 5, 2007 (the effective date for
AD 2007-03-01, Amendment 39-14912 (72 FR 3939, January 29, 2007)),
perform a general visual inspection for damage (including but not
limited to chafing) of power feeder wire bundles W3312 and W3412 at
front spar station 148.90 in the left and right wings, and a general
visual inspection of the support clamps for those power feeder wire
bundles to determine whether the clamps are properly installed, and,
before further flight, do all applicable corrective actions. Do
these actions by doing all of the applicable actions in accordance
with the Accomplishment Instructions of the applicable service
bulletin identified in Table 1 of this AD. After the effective date
of this AD, only Boeing Special Attention Service Bulletin 757-24-
0105, Revision 5, dated July 30, 2009 (for Model 757-200, -200CB,
and -200PF series airplanes); or Boeing Special Attention Service
Bulletin 757-24-0106, Revision 5, dated July 30, 2009 (for Model
757-300 series airplanes); may be used.

                      Table 1--Acceptable Service Information for Paragraph (g) of This AD
----------------------------------------------------------------------------------------------------------------
                                           Boeing Special
                                              Attention
                 Model--                       Service        Revision--                   Dated--
                                             Bulletin--
----------------------------------------------------------------------------------------------------------------
757-200, -200CB, and -200PF series             757-24-0105               2  April 20, 2006.
 airplanes.
757-200, -200CB, and -200PF series             757-24-0105               5  July 30, 2009.
 airplanes.
757-300 series airplanes................       757-24-0106               2  April 20, 2006.
757-300 series airplanes................       757-24-0106               5  July 30, 2009.
----------------------------------------------------------------------------------------------------------------

(h) Restatement of Requirements of AD 2007-03-01, Amendment 39-14912
(72 FR 3939, January 29, 2007): Credit for Previous Actions

    This paragraph provides credit for inspections and corrective
actions, as required by paragraph (g) of this AD, if those actions
were performed before March 5, 2007 (the effective date for AD 2007-
03-01, Amendment 39-14912 (72 FR 3939, January 29, 2007)), using the
service information listed in Table 2 of this AD.

      Table 2--Other Acceptable Service Information for Previously
            Accomplished Actions in Paragraph (g) of This AD
------------------------------------------------------------------------
   Boeing Special Attention
      Service Bulletin--         Revision--             Dated--
------------------------------------------------------------------------
757-24-0105..................  ..............  September 30, 2004.
757-24-0105..................               1  June 23, 2005.
757-24-0106..................  ..............  September 30, 2004.
757-24-0106..................               1  June 23, 2005.
------------------------------------------------------------------------

(i) New Requirements of This AD: Additional Work for Model 757-200, -
200CB, and -200PF Series Airplanes Identified in Boeing Special
Attention Service Bulletin 757-24-0105, Revision 5, Dated July 30, 2009

    For Model 757-200, -200CB, and -200PF series airplanes
identified as Group 1, Configuration 1 airplanes, in Boeing Special
Attention Service Bulletin 757-24-0105, Revision 5, dated July 30,
2009, on which inspections have been done before the effective date
of this AD in accordance with any service bulletin specified in
Table 3 of this AD: Within 24 months after the effective date of
this AD, do a general visual inspection to determine if the clamp is
installed on the lower bracket on the left wing, in accordance with
Figure 1 of Boeing Special Attention Service Bulletin 757-24-0105,
Revision 5, dated July 30, 2009. If the clamp is missing, before
further flight, install a clamp on the lower bracket on the left
wing, in accordance with Figure 1 of Boeing Special Attention
Service Bulletin 757-24-0105, Revision 5, dated July 30, 2009.

  Table 3--Service Information for Previously Accomplished Actions for
           Model 757-200, -200CB, and -200PF Series Airplanes
------------------------------------------------------------------------
   Boeing Special Attention
      Service Bulletin--         Revision--             Dated--
------------------------------------------------------------------------
757-24-0105..................  ..............  September 30, 2004.
757-24-0105..................               1  June 23, 2005.
757-24-0105..................               2  April 20, 2006.
757-24-0105..................               3  October 3, 2006.
757-24-0105..................               4  January 4, 2008.
------------------------------------------------------------------------

(j) New Requirements of This AD: Additional Work for Model 757-300
Series Airplanes Identified in Boeing Special Attention Service
Bulletin 757-24-0106, Revision 5, Dated July 30, 2009

    For Model 757-300 series airplanes in Group 2, as identified in
Boeing Special Attention Service Bulletin 757-24-0106, Revision 5,
dated July 30, 2009: Within 24 months after the effective date of
this AD, perform a general visual inspection for damage (including,
but not limited to chafing) of power feeder wire bundles W5784 and
W5786 at front spar station 148.90 in the left and right wings, and
a general visual inspection of the support clamps for those power
feeder wire bundles to determine if the clamps are properly
installed, and, before further flight, do all applicable corrective
actions. Do all applicable actions in accordance with the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 757-24-0106, Revision 5, dated July 30, 2009.

(k) New Requirements of This AD: Credit for Previous Actions

    (1) This paragraph provides credit for inspections and
corrective actions, as required by paragraph (j) of this AD, if
those actions were performed before the effective date of this AD
using Boeing Special Attention Service Bulletin 757-24-0106,
Revision 4, dated January 4, 2008.
    (2) This paragraph provides credit for inspections and
corrective actions, as required by paragraph (j) of this AD, if
those actions were performed before the effective date of this AD
using the service information listed in table 4 of this, provided
that power feeder wire bundles W5784 and W5786 were inspected and
all applicable correction actions were done.

   Table 4--Previous Service Information for Paragraph (j) of This AD
------------------------------------------------------------------------
   Boeing Special Attention
      Service Bulletin--         Revision--             Dated--
------------------------------------------------------------------------
757-24-0106..................  ..............  September 30, 2004.
757-24-0106..................               1  June 23, 2005.
757-24-0106..................               2  April 20, 2006.
757-24-0106..................               3  October 3, 2006.
------------------------------------------------------------------------

    (3) This paragraph provides credit for inspections and
corrective actions, as required by paragraph (g) of this AD, if
those actions were performed before the effective date of this AD
using the service information listed in table 5 of this AD.

   Table 5--Previous Service Information for Paragraph (g) of This AD
------------------------------------------------------------------------
   Boeing Special Attention
      Service Bulletin--         Revision--             Dated--
------------------------------------------------------------------------
757-24-0105..................               3  October 3, 2006.
757-24-0105..................               4  January 4, 2008.
757-24-0106..................               3  October 3, 2006.
757-24-0106..................               4  January 4, 2008.
------------------------------------------------------------------------

(l) Special Flight Permit

    Special flight permits may be issued in accordance with sections
21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199) to operate the airplane to a location where the
requirements of this AD can be accomplished, provided that the
generator served by the power feeder wire bundles specified in
paragraph (g) or (j) of this AD, as applicable, is disconnected.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (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. Information may be emailed to<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.
    (3) AMOCs approved previously in accordance with AD 2007-03-01,
Amendment 39-14912 (72 FR 3939, January 29, 2007), are approved as
AMOCs for the corresponding provisions of paragraph (g) of this AD.

(n) Related Information

    For more information about this AD, contact Marie Hogestad,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW.,
Renton, Washington 98057-3356; phone:<PHONE_NUMBER>; fax: 425-917-
6590; email<EMAIL_ADDRESS>
(o) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) under 5 U.S.C. 552(a) and 1 CFR part 51 of the
following service information on the date specified:
    (i) Boeing Special Attention Service Bulletin 757-24-0105,
Revision 5, dated July 30, 2009, approved for IBR April 4, 2012.
    (ii) Boeing Special Attention Service Bulletin 757-24-0106,
Revision 5, dated July 30, 2009, approved for IBR April 4, 2012.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; phone: 206-
544-5000, extension 1; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on January 18, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-4428 Filed 2-28-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42741-42742]
[FR Doc No: 2016-15513]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2015-0014]

Maritime Advisory Committee for Occupational Safety and Health

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of Maritime Advisory Committee for Occupational Safety
and Health (MACOSH) meeting.

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SUMMARY: This Federal Register notice announces meetings of the full
Committee and the workgroups on August 9 and 10, 2016 in Washington,
DC.

DATES: MACOSH meeting: MACOSH will meet from 9 a.m. until approximately
5 p.m. on August 9 and 10, 2016.
    Submission of comments, requests to speak, and requests for special
accommodation: Submit comments, requests to speak at the full Committee
meeting, and requests for special accommodations for these meetings
(postmarked, sent, or transmitted) by July 25, 2016.

ADDRESSES: The Committee and workgroups will meet at the U.S.
Department of Labor, Frances Perkins Building, 200 Constitution Avenue
NW., Washington, DC 20210, in Conference Room S-4215. Meeting attendees
must use the visitor's entrance located at 3rd & C Streets NW.
    Submission of comments and requests to speak: Submit comments and
requests to speak at the MACOSH meetings, identified by the docket
number for this Federal Register notice (Docket No. OSHA 2015-0014), by
one of the following methods:
    Electronically: Submit comments and attachments electronically at
http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for submitting comments.
    Facsimile: If comments, including attachments, are not longer than
10 pages, commenters may fax them to the OSHA Docket Office at (202)
693-1648.
    Regular mail, express mail, hand (courier) delivery, and messenger
service: When using this method, submit a copy of comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2015-0014, U.S.
Department of Labor, Occupational Safety and Health Administration,
Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210. The
Docket Office accepts deliveries (express mail, hand (courier)
delivery, and messenger service) during the Department of Labor's and
Docket Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Requests for special accommodations: Submit requests for special
accommodations for MACOSH and its workgroup meetings by hard copy,
telephone, or email to: Gretta Jameson, OSHA, Office of Communications,
Room N-3647, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    Instructions: All submissions must include the Agency name and
docket number for this Federal Register notice (Docket No. OSHA-2015-
0014). Because of security-related procedures, submissions by regular
mail may result in a significant delay in receipt. Please contact the
OSHA Docket Office for information about security procedures for making
submissions by express mail, hand (courier) delivery, and messenger
service.
    OSHA will place comments and requests to speak, including personal
information, in the public docket, which may be available online.
Therefore, OSHA cautions interested parties about submitting personal
information such as Social Security numbers and birthdates.
    Docket: To read or download documents in the public docket for this
MACOSH meeting, go to http://www.regulations.gov. All documents in the
public docket are listed in the index; however, some documents (e.g.,
copyrighted material) are not publicly available to read or download
through http://www.regulations.gov. All submissions are available for
inspection and, when permitted, copying at the OSHA Docket Office at
the above address. For information on using http://www.regulations.gov
to make submissions or to access the docket, click on the ``Help'' tab
at the top of the Home page. Contact the OSHA Docket Office for
information about materials not available through that Web site and for
assistance in using the Internet to locate submissions and other
documents in the docket.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Frank Meilinger,
Director, OSHA Office of Communications, U.S. Department of Labor, Room
N-3647, 200 Constitution Avenue NW., Washington, DC 20210; telephone:
(202) 693-1999; email<EMAIL_ADDRESS>    For general information about MACOSH and this meeting: Amy
Wangdahl, Director, Office of Maritime and Agriculture, OSHA, U.S.
Department of Labor, Room N-3609, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    Copies of this Federal Register notice: Electronic copies of this
Federal Register notice are available at http://www.regulations.gov.
This notice, as well as news releases and other relevant information,
are also available at OSHA's Web page at: http://www.osha.gov.

SUPPLEMENTARY INFORMATION: All MACOSH committee and workgroup meetings
are open to the public. Interested persons may attend the full
Committee and its workgroup meetings at the time and place listed
above. The Longshoring and Shipyard workgroups will meet from 9 a.m.
until approximately 5 p.m. on August 9, 2016, in Conference Rooms S-
4215A and S-4215C. The workgroups will discuss protecting workers from
toxic preservative coatings, personal protective equipment in
shipyards, assessing current provisions of 29 CFR part 1915 subpart E,
lashing safety, and mechanic safety.
    The full Committee will meet from 9 a.m. until approximately 5 p.m.
on August 10, 2016, in Conference Room S-4215. The tentative agenda
will include: Updates from OSHA National Office Directorates; updates
on maritime enforcement activities from OSHA Regions; and reports from
the Longshoring and Shipyard workgroups.
    Public Participation: Any individual attending the MACOSH meeting,
including the workgroup meetings, at the U.S. Department of Labor,
Frances Perkins Building, must use the entrance located at 3rd & C
Streets NW and pass through Building Security. Attendees must have
valid government-issued photo identification to enter the building.
Please contact Gretta Jameson at<PHONE_NUMBER> (email:
<EMAIL_ADDRESS>for additional information about building
security measures for attending the MACOSH Committee and workgroup
meetings. Interested parties may submit a request to make an oral
presentation to MACOSH by any one of the methods listed in the
ADDRESSES section above. The request must state the amount of time
requested to speak, the interest represented (e.g., organization name),
if any, and a brief outline of the presentation. The MACOSH Chair has
discretion to grant requests to address the full Committee as time
permits.
    Interested parties also may submit written comments, including data
and

other information, using any one of the methods listed in the ADDRESSES
section above. OSHA will provide all submissions to MACOSH members
prior to the meeting. Individuals who need special accommodations to
attend the MACOSH meeting should contact Gretta Jameson as specified
above under the heading ``Requests for special accommodations'' in the
ADDRESSES section.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by 29 U.S.C. 655, 656, 5 U.S.C. App.
2, Secretary of Labor's Order No. 1-2012 (77 FR 3912), and 29 CFR part
1912.

    Signed at Washington, DC, on June 27, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-15513 Filed 6-29-16; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Notices]
[Pages 37504-37507]
[FR Doc No: 2018-16387]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Prescription Drug User Fee Rates for Fiscal Year 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2019. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription
Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect
application fees for certain applications for the review of human drug
and biological products, and prescription drug program fees for certain
approved products. This notice establishes the fee rates for FY 2019.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14541B, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively) establish two different kinds of user fees. Fees are
assessed as follows: (1) Application fees are assessed on certain types
of applications for the review of human drug and biological products;
and (2) prescription drug program fees are assessed on certain approved
products (section 736(a) of the FD&C Act). When specific conditions are
met, FDA may waive or reduce fees (section 736(d) of the FD&C Act).
    For FY 2018 through FY 2022, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA VI. The base
revenue amount for FY 2019 is $935,903,507. The FY 2019 base revenue
amount is adjusted for inflation and for the resource capacity needs
for the process for the review of human drug applications (the capacity
planning adjustment). An additional dollar amount specified in the
statute (see section 736(b)(1)(F) of the FD&C Act) is then added to
provide for additional full-time equivalent (FTE) positions to support
PDUFA VI initiatives. The FY 2019 revenue amount may be adjusted
further, if necessary, to provide for sufficient operating reserves of
carryover user fees. Finally, the amount is adjusted to provide for
additional direct costs to fund PDUFA VI initiatives. Fee amounts are
to be established each year so that revenues from application fees
provide 20 percent of the total revenue, and prescription drug program
fees provide 80 percent of the total revenue.
    This document provides fee rates for FY 2019 for an application
requiring clinical data ($2,588,478), for an application not requiring
clinical data ($1,294,239), and for the prescription drug program fee
($309,915). These fees are effective on October 1, 2018, and will
remain in effect through September 30, 2019. For applications that are
submitted on or after October 1, 2018, the new fee schedule must be
used.

II. Fee Revenue Amount for FY 2019

    The base revenue amount for FY 2019 is $935,903,507 prior to
adjustments for inflation, capacity planning, additional FTE, operating
reserve, and additional direct costs (see section 736(b)(1) of the FD&C
Act).

A. FY 2018 Statutory Fee Revenue Adjustments for Inflation

    PDUFA VI specifies that the $935,903,507 is to be adjusted for
inflation increases for FY 2019 using two separate adjustments--one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see section 736(c)(1) of the FD&C Act).
    The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all PC&B
paid per FTE positions at FDA for the first 3 of the preceding 4 FYs,
multiplied by the proportion of PC&B costs to total FDA costs of the
process for the review of human drug applications for the first 3 of
the preceding 4 FYs (see section 736(c)(1)(A) and (c)(1)(B) of the FD&C
Act).
    Table 1 summarizes the actual cost and FTE data for the specified
FYs and provides the percent changes from the previous FYs and the
average percent changes over the first three of the four FYs preceding
FY 2019. The 3-year average is 2.4152 percent.

                                  Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     Fiscal year                                2015                     2016                     2017                3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B..........................................           $2,232,304,000           $2,414,728,159           $2,581,551,000  .......................
Total FTE...........................................                   15,484                   16,381                   17,022  .......................
PC&B per FTE........................................                 $144,168                 $147,408                 $151,660  .......................
Percent Change From Previous Year...................                   2.1136                   2.2474                   2.8845                   2.4152
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The statute specifies that this 2.4152 percent be multiplied by the
proportion of PC&B costs to the total FDA costs of the process for the
review of human drug applications. Table 2 shows the PC&B and the total
obligations for the process for the review of human drug applications
for the first three of the preceding four FYs.

                            Table 2--PC&B as a Percent of Total Cost of the Process for the Review of Human Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     Fiscal year                                2015                     2016                     2017                3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B..........................................             $615,483,892             $652,508,273             $711,016,627  .......................
Total Costs.........................................           $1,127,664,528           $1,157,817,695           $1,206,657,269  .......................
PC&B Percent........................................                  54.5804                  56.3567                  58.9245                  56.6205
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.4152 percent from table 1 multiplied by
56.6205 percent (or 1.3675 percent).
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual index) for the first 3 years of the preceding 4 years of
available data multiplied by the proportion of all costs other than
PC&B costs to total costs of the process for the review of human drug
applications for the first 3 years of the preceding 4 FYs (see section
736(c)(1)(B) of the FD&C Act). Table 3 provides the summary data for
the percent changes in the specified CPI for the Washington-Baltimore
area. The data are published by the Bureau of Labor Statistics and can
be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0.

           Table 3--Annual and Three-Year Average Percent Change in CPI for Washington-Baltimore Area
----------------------------------------------------------------------------------------------------------------
                                                                                3-year
                      Year                             2015            2016            2017           average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         155.353         157.180         159.202  ..............
Annual Percent Change...........................          0.3268          1.1760          1.2864          0.9297
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 0.9297 percent be multiplied by the
proportion of all costs other than PC&B to total costs of the process
for the review of human drug applications obligated. Since 56.6205
percent was obligated for PC&B (as shown in table 2), 43.3795 percent
is the portion of costs other than PC&B (100 percent minus 56.6205
percent equals 43.3795 percent). The non-payroll adjustment is 0.9297
percent times 43.3795 percent, or 0.4033 percent.
    Next, we add the payroll adjustment (1.3675 percent) to the non-
payroll adjustment (0.4033 percent), for a total inflation adjustment
of 1.7708 percent (rounded) for FY 2019.
    We then multiply the base revenue amount for FY 2019 ($935,903,507)
by 1.017708, yielding an inflation-adjusted amount of $952,476,486.

B. FY 2019 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that after $935,903,507 has been adjusted for
inflation, the inflation-adjusted amount shall be further adjusted to
reflect changes in the resource capacity needs for the process of human
drug application reviews (see section 736(c)(2) of the FD&C Act). The
statute prescribes an interim capacity planning adjustment be utilized
until a new methodology can be developed through a process involving an
independent evaluation as well as obtaining public comment. The interim
capacity planning adjustment is applied to FY 2019 fee setting.
    To determine the FY 2019 capacity planning adjustment, FDA
calculated the average number of each of the five elements specified in
the capacity planning adjustment provision: (1) Human drug applications
(new drug applications (NDAs)/biologics license applications (BLAs));
(2) active commercial investigational new drug applications (INDs) (IND
applications that have at least one submission during the previous 12
months); (3) efficacy supplements; (4) manufacturing supplements; and
(5) formal meetings, type A, B, B(EoP), C, and written responses only
(WRO) issued in lieu of such formal meetings, over the 3-year period
that ended on June 30, 2017, and the average number of each of these
elements over the most recent three-year period that ended June 30,
2018.
    The calculations are summarized in table 4. The three-year averages
for each element are provided in column 1 (``Three-Year Average Ending
2017'') and column 2 (``Three-Year Average Ending 2018''). Column 3
reflects the percent change from column 1 to column 2. Column 4 shows
the weighting factor for each element. The weighting factor methodology
has been updated for PDUFA VI. The previous methodology relied on the
relative value of the standard costs for the elements included in the
adjuster, and summed to 100 percent. The weighting factor now is the
time invested in activities related to the element expressed as a
percentage of total time invested in PDUFA activities, and will adjust
only the costs attributed to the elements included in the model (hence
the weighting factor does not now sum to 100 percent). Column 5 is the
weighted percent change in each element. This is calculated by
multiplying the weighting factor in each line in column 4 by the
percent change in column 3. The values in column 5 are summed,
reflecting an adjustment of 2.9067 percent (rounded).

                Table 4--Capacity Planning Adjuster (Interim Methodology) Calculation for FY 2019
----------------------------------------------------------------------------------------------------------------
             Element                 Column 1        Column 2        Column 3        Column 4        Column 5
----------------------------------------------------------------------------------------------------------------
                                      3-year          3-year      Percent change     Weighting       Weighted
                                      average         average       (column 1 to      factor          percent
                                    ending 2017     ending 2018      column 2)       (percent)        change
----------------------------------------------------------------------------------------------------------------
NDAs/BLAs.......................        153.0000        162.0000          5.8824         20.5015          1.2060
Active Commercial INDs..........      7,846.6667      8,057.0000          2.6805         22.2771          0.5971
Efficacy Supplements............        212.3333        234.3333         10.3611          5.2439          0.5433
Manufacturing Supplements.......      2,482.6667      2,561.6667          3.1821          3.7243          0.1185
Meetings Scheduled and WROs.....      2,940.0000      3,136.3333          6.6780          6.6156          0.4418
                                 -------------------------------------------------------------------------------
    FY 2019 Capacity Planning     ..............  ..............  ..............  ..............          2.9067
     Adjuster...................
----------------------------------------------------------------------------------------------------------------

    Table 5 shows the calculation of the inflation and capacity
planning adjusted amount for FY 2019. The FY 2019 base revenue amount,
$935,903,507, shown on line 1 is multiplied by the inflation adjustment
factor of 1.017708, resulting

in the inflation-adjusted amount of $952,476,486 shown on line 3. That
amount is then multiplied by one, plus the capacity planning adjustment
of 2.9067 percent, resulting in the inflation and capacity planning
adjusted amount of $980,162,120 shown on line 5.

  Table 5--PDUFA Inflation and Capacity Planning Adjusted Amount for FY
                        2019, Summary Calculation
------------------------------------------------------------------------

------------------------------------------------------------------------
FY 2019 Revenue Amount...............    $935,903,507  Line 1.
Inflation Adjustment Factor for FY           1.017708  Line 2.
 2019 (1 plus 1.7708 percent).
Inflation Adjusted Amount............     952,476,486  Line 3.
Capacity Planning Adjustment Factor          1.029067  Line 4.
 for FY 2019 (1 plus 2.9067 percent).
Inflation and Capacity Planning           980,162,120  Line 5.
 Adjusted Amount.
------------------------------------------------------------------------

    The capacity planning adjustment adds $27,685,634 to the fee
revenue amount for FY 2019. This increase is driven by the fact that
the counts of elements for 2018 (year ending June 30) are at or near
the highest levels since the first incorporation of the workload
adjuster in 2003. The NDA/BLA count in 2018 is equal to the highest
annual number recorded since the advent of the workload adjuster
methodology in 2003. Active commercial INDs, efficacy supplements, and
meetings/WROs are higher in 2018 than in any previous year recorded in
the workload adjuster (note: Meetings/WROs are only counted back to
2014 while the other elements are counted back to 2003). The
manufacturing supplement count is approximately 2 percent below the
highest number recorded in the history of the workload adjuster.
Comparing 2018 to 2015, the first year included in the average in
column 1 in the adjustment, NDA/BLAs are 17 percent higher, active
commercial INDs are 8 percent higher, efficacy supplements are 36
percent higher, manufacturing supplements are 10 percent higher, and
meetings scheduled and WROs are 21 percent higher. This significant and
across the board increase in submission activity is the driver of the
$27,685,634 upward adjustment to the fee revenue amount.
    Per the commitments made in PDUFA VI, this increase in the revenue
amount will be allocated and used by organizational review components
engaged in direct review work to enhance resources and expand staff
capacity and capability (see II.A.4 on p.37 of the PDUFA VI commitment
letter \1\).
---------------------------------------------------------------------------

    \1\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
---------------------------------------------------------------------------

C. FY 2019 Statutory Fee Revenue Adjustments for Additional Dollar
Amounts

    PDUFA VI provides an additional dollar amount for each of the five
fiscal years covered by PDUFA VI for additional FTE to support PDUFA VI
enhancements outlined in the PDUFA VI commitment letter. The amount for
FY 2019 is $21,317,472 (see section 736(b)(1)(F) of the FD&C Act).
Adding this amount to the inflation and capacity planning adjusted
revenue amount, $980,162,120, equals $1,001,479,592.

D. FY 2019 Statutory Fee Revenue Adjustments for Operating Reserve

    PDUFA VI provides for an operating reserve adjustment to allow FDA
to increase the fee revenue and fees for any given fiscal year during
PDUFA VI to maintain up to 14 weeks of operating reserve of carryover
user fees. If the carryover balance exceeds 14 weeks of operating
reserves, FDA is required to decrease fees to provide for not more than
14 weeks of operating reserves of carryover user fees.
    To determine the 14-week operating reserve amount, the FY 2019
annual base revenue adjusted for inflation and capacity planning,
$980,162,120, is divided by 52, and then multiplied by 14. The 14-week
operating reserve amount for FY 2019 is $263,889,802.
    To determine the end of year operating reserve amount, the Agency
must assess actual operating reserve at the end of the third quarter of
FY 2018, and forecast collections and obligations in the fourth quarter
of FY 2018. The estimated end of year FY 2018 operating reserve is
$235,128,646.
    Because the estimated end of year FY 2019 PDUFA operating reserve
does not exceed the 14-week operating reserve for FY 2019, FDA will not
reduce the FY 2019 PDUFA fee revenue in FY 2019.

E. FY 2019 Statutory Fee Revenue Adjustments for Additional Direct Cost

    PDUFA VI specifies that $8,730,000, adjusted for inflation, be
added in addition to the operating reserve adjustment to account for
additional direct costs in FY 2019. This additional direct cost
adjustment is adjusted for inflation by multiplying $8,730,000 by the
Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-
VA-WV; Not Seasonally Adjusted; All Items; Annual Index) for 2017,
which is 159.202, and then divided by such Index for 2016, 157.180 (see
section 736(c)(4)(B) of the FD&C Act). This results in an adjustment
factor of 1.012864, making the additional direct cost adjustment equal
to $8,842,303.
    The final FY 2019 PDUFA target revenue is $1,010,322,000 (rounded
to the nearest thousand dollars).

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate 20 percent of the total
target revenue amount, or $202,064,400 in FY 2019.

B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees

    FDA will estimate the total number of fee-paying full application
equivalents (FAEs) it expects to receive during the next FY by
averaging the number of fee-paying FAEs received in the three most
recently completed FYs. Prior year FAE totals are updated annually to
reflect refunds and waivers processed after the close of the FY.
    In estimating the number of fee-paying FAEs, a full application
requiring clinical data counts as one FAE. An application not requiring
clinical data counts as one-half of an FAE. An application that is
withdrawn before filing, or refused for filing, counts as one-fourth of
an FAE if the applicant initially paid a full application fee, or one-
eighth of an FAE if the applicant initially paid one-half of the full
application fee amount. Prior to PDUFA VI, the FAE amount also included
supplements; supplements have been removed from the FAE calculation as
the supplement fee has been discontinued in PDUFA VI.
    As table 6 shows, the average number of fee-paying FAEs received
annually in the most recent three-year period is 78.063013 FAEs. FDA
will set fees for

FY 2019 based on this estimate as the number of full application
equivalents that will pay fees.

                                            Table 6--Fee-Paying FAEs
----------------------------------------------------------------------------------------------------------------
                                                                                3-year
                       FY                              2015            2016            2017           average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs.................................       81.955603       70.483437       81.750000       78.063013
----------------------------------------------------------------------------------------------------------------
Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the
  FY.

    The FY 2019 application fee is estimated by dividing the average
number of full applications that paid fees over the latest three years,
78.063013, into the fee revenue amount to be derived from application
fees in FY 2019, $202,064,400. The result is a fee of $2,588,478 per
full application requiring clinical data, and $1,294,239 per
application not requiring clinical data.

IV. Fee Calculations for Prescription Drug Program Fees

    PDUFA VI assesses prescription drug program fees for certain
prescription drug products; in addition, an applicant will not be
assessed more than five program fees for a fiscal year for prescription
drug products identified in a single approved NDA or BLA (see section
736(a)(2)(C)). Applicants are assessed a program fee for a fiscal year
only for prescription drug products identified in a human drug
application approved as of October 1 of such fiscal year.
    FDA estimates 2,683 program fees will be invoiced in FY 2019 before
factoring in waivers, refunds, and exemptions. FDA approximates that
there will be 40 waivers and refunds granted. In addition, FDA
approximates that another 35 program fees will be exempted in FY 2019
based on the orphan drug exemption in section 736(k) of the FD&C Act.
FDA estimates 2,608 program fees in FY 2019, after allowing for an
estimated 75 waivers and reductions, including the orphan drug
exemptions. The FY 2019 prescription drug program fee rate is
calculated by dividing the adjusted total revenue from program fees
($808,257,600) by the estimated 2,608 program fees, for a FY 2019
program fee of $309,915.

V. Fee Schedule for FY 2019

    The fee rates for FY 2019 are displayed in table 7:

                    Table 7--Fee Schedule for FY 2019
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2019
------------------------------------------------------------------------
Application:
  Requiring clinical data...............................      $2,588,478
  Not requiring clinical data...........................       1,294,239
Program:                                                         309,915
------------------------------------------------------------------------

VI. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule
must be paid for any application subject to fees under PDUFA that is
received on or after October 1, 2018. Payment must be made in U.S.
currency by electronic check, check, bank draft, wire transfer, or U.S.
postal money order payable to the order of the Food and Drug
Administration. The preferred payment method is online using electronic
check (Automated Clearing House (ACH) also known as eCheck) or credit
card (Discover, VISA, MasterCard, American Express). Secure electronic
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No
partial payments can be made online). Once you search for your invoice,
select ``Pay Now'' to be redirected to Pay.gov. Electronic payment
options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S bank accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after
completing the Prescription Drug User Fee Cover Sheet and generating
the user fee ID number.
    Please include the user fee (ID) number on your check, bank draft,
or postal money order. Mail your payment to: Food and Drug
Administration, P.O. Box 979107, St. Louis, MO 63197-9000. If a check,
bank draft, or money order is to be sent by a courier that requests a
street address, the courier should deliver your payment to: U.S. Bank,
Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis,
MO 63101. (Note: This U.S. Bank address is for courier delivery only.
If you have any questions concerning courier delivery contact the U.S.
Bank at<PHONE_NUMBER>. This telephone number is only for questions about
courier delivery). Please make sure that the FDA post office box number
(P.O. Box 979107) is written on the check, bank draft, or postal money
order.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. Please ask your financial
institution about the fee and add it to your payment to ensure that
your fee is fully paid. The account information for wire transfers is
as follows: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT:
FRNYUS33. If needed, FDA's tax identification number is 53-0196965.

B. Prescription Drug Program Fees

    FDA will issue invoices and payment instructions for FY 2019
program fees under the new fee schedule in August 2018. Payment will be
due on October 1, 2018. FDA will issue invoices in December 2018 for FY
2019 program fees that qualify for fee assessments after the August
2018 billing.

    Dated: July 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16387 Filed 7-31-18; 8:45 am]
 BILLING CODE 4164-01-P