[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Rules and Regulations]
[Pages 27416-27419]
[FR Doc No: 2017-12172]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9432; Directorate Identifier 2016-NM-116-AD;
Amendment 39-18922; AD 2017-12-07]
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 adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 737-800, -900, and -900ER series airplanes.
This AD was prompted by reports of in-flight failure of the left
temperature control valve and control cabin trim air modulating valve.
This AD requires replacing the left temperature control valve and
control cabin trim air modulating valve. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective July 20, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 20,
2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9432.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9432; 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: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Stanley Chen, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA
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 by adding an AD that would apply to certain The Boeing Company
Model 737-800, -900, and -900ER series airplanes. The NPRM published in
the Federal Register on December 5, 2016 (81 FR 87494). The NPRM was
prompted by reports of in-flight failure of the left temperature
control valve and control cabin trim air modulating valve. The NPRM
proposed to require replacing the left temperature control valve and
control cabin trim air modulating valve. We are issuing this AD to
prevent temperatures in excess of 100 degrees Fahrenheit in the flight
deck or the passenger cabin during cruise, which could lead to the
impairment of the flight crew and prevent continued safe flight and
landing.

Comments

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

Support for the NPRM

    The Air Line Pilots Association, International and United Airlines
(UAL) stated that they support the NPRM.

Request To Clarify the Unsafe Condition

    Boeing requested that we change a sentence in the Discussion
section of the NPRM from ``This condition, if not corrected, could
result . . . .'' to ``This condition, if not corrected or mitigated by
crew completion of the cabin temperature hot procedure under Section
2.8 of the quick reference handbook (QRH), could result. . . .'' Boeing
stated that the cabin temperature hot procedure was created
specifically to address failed open temperature control valves. They
further stated that this procedure is an effective remedy for failed
valves and enhances safety.
    We disagree with the request to revise the description of the
unsafe condition in the Discussion section. More than half of the
affected fleets are operated by non-U.S. air carriers, who are not
required to incorporate the revised Flight Crew Operations Manual
(FCOM), which includes the QRH. Since this AD does not require
incorporation of the FCOM, or the QRH, and instead requires replacement
of two control valves, we do not find it appropriate to reference the
QRH as a mitigating factor in the description of the unsafe condition.
We have not changed this AD regarding this issue.

Request To Allow Maintenance Records Review To Determine Installed
Parts

    Alaska Airlines (Alaska) asked that we revise paragraph (g) of the
proposed AD, which mandates replacement of certain valves, to state
that a records review is acceptable for compliance with the
requirements of that paragraph (by determining which valves must be
replaced). Alaska noted that a similar statement is included as a note
in Boeing Alert Service Bulletin 737-21A1203, dated June 8, 2016, and
that the note and steps 3.B.1.c. and 3.B.1.d. of the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-21A1203, dated June
8, 2016, are not Required for Compliance (RC). (We note that those
steps state that no further action is required for nondiscrepant
parts.) Alaska indicated that because the NPRM does not include a
similar statement, an airline doing only a records check, and finding
no discrepant parts, could be considered non-compliant.
    We agree with the commenter. Paragraph (g) of this AD requires
replacing certain valves in accordance with the Accomplishment
Instructions in Boeing Alert Service Bulletin 737-21A1203, dated June
8, 2016. We did not intend for operators to need an alternative method
of compliance (AMOC) to address the situation described by the
commenter. Therefore, we have revised paragraph (g) of this AD to add
the phrase ``as applicable'' to the requirement for valve replacements
so that operators will not need an AMOC if the correct valve is already
installed.

Request To Correct the Manufacturer Information

    UAL stated that the header section of the NPRM referenced the wrong
aircraft manufacturer, reading: ``Proposed Rule: Airworthiness
Directives: Bombardier, Inc. Airplanes.'' UAL noted that it should say
The Boeing Company Airplanes.
    We acknowledge the commenter's concern. However, the NPRM correctly
identifies the manufacturer as Boeing, as published in the Federal
Register. It was the docket in the Federal Docket Management System
(FDMS) that incorrectly identified the manufacturer as Bombardier. This
information has been corrected. Therefore, we have not changed this
final rule regarding this issue.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that the installation of winglets
per Supplemental Type Certificate (STC)

ST00830SE does not affect the accomplishment of the manufacturer's
service instructions.
    We agree with the commenter that STC ST00830SE does not affect the
accomplishment of the manufacturer's service instructions. Therefore,
the installation of STC ST00830SE does not affect the ability to
accomplish the actions required by this AD. We have not changed this AD
in this regard.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-21A1203, dated June
8, 2016. The service information describes procedures for replacing the
left temperature control valve and control cabin trim air modulating
valve, part number 398908-4, with new part number 398908-3 or 398908-5.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 319 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Replacement of valves..........  9 work-hours x $85 per           $4,800  $5,565 per valve..  $1,775,235 per
                                  hour = $765 per valve.                                       valve.
----------------------------------------------------------------------------------------------------------------

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

    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 adding the following new airworthiness
directive (AD):

2017-12-07 The Boeing Company: Amendment 39-18922; Docket No. FAA-
2016-9432; Directorate Identifier 2016-NM-116-AD.

(a) Effective Date

    This AD is effective July 20, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 737-800, -900, and -
900ER series airplanes, certificated in any category, as identified
in Boeing Alert Service Bulletin 737-21A1203, dated June 8, 2016.

(d) Subject

    Air Transport Association (ATA) of America Code 21, Air
conditioning.

(e) Unsafe Condition

    This AD was prompted by reports of in-flight failure of the left
temperature control valve and control cabin trim air modulating
valve. We are issuing this AD to prevent temperatures in excess of
100 degrees Fahrenheit in the flight deck or the passenger cabin
during cruise, which could lead to the impairment of the flight crew
and prevent continued safe flight and landing.

(f) Compliance

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

(g) Replacement of the Left Temperature Control Valve and Control Cabin
Trim Air Modulating Valve

    Within 60 months after the effective date of this AD, replace
the left temperature control valve and control cabin trim air
modulating valve, as applicable, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
21A1203, dated June 8, 2016.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install a
temperature control valve, part number 398908-4, in either the left
temperature control valve location or the control cabin trim air
modulating valve location on any Model 737-800, -900, or -900ER
airplane.

(i) 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
paragraph (j) 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) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(i)(4)(i) and (i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    For more information about this AD, contact Stanley Chen,
Aerospace Engineer, Cabin Safety and Environmental Systems Branch,
ANM-150S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 737-21A1203, dated June 8,
2016.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on June 2, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-12172 Filed 6-14-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46007-46010]
[FR Doc No: 2015-18916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]

Outsourcing Facility Fee Rates for Fiscal Year 2016

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2016 rates for the establishment and reinspection fees
related to human drug compounding outsourcing facilities (outsourcing
facilities) that elect to register under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and
collect an annual establishment fee from outsourcing facilities that
have elected to register, as well as a reinspection fee for each
reinspection of an outsourcing facility. This document establishes the
FY 2016 rates for the small business establishment fee ($5,203), the
non-small business establishment fee ($16,465), and the reinspection
fee ($15,610) for outsourcing facilities; provides information on how
the fees for FY 2016 were determined; and describes the payment
procedures outsourcing facilities should follow.

FOR FURTHER INFORMATION CONTACT:
    For information on pharmacy compounding and pharmacy compounding
user fees: Visit FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.
    For questions relating to this notice: Rachel Richter, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14216, Silver Spring, MD 20933-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, President Obama signed the Drug Quality and
Security Act (DQSA), legislation that contains important provisions
relating to the oversight of compounding of human drugs. Title I of
this law, the Compounding Quality Act, creates a new section 503B in
the FD&C Act (21 U.S.C. 353b). Under section 503B of the FD&C Act, a
human drug compounder can become an ``outsourcing facility.''
    Outsourcing facilities, as defined in section 503B(d)(4) of the
FD&C Act, are facilities that meet all of the conditions described in
section 503B(a), including registering with FDA as an outsourcing
facility and paying an annual establishment fee. If these conditions
are satisfied, a drug compounded by or under the direct supervision of
a licensed pharmacist in an outsourcing facility is exempt from two
sections of the FD&C Act: (1) Section 502(f)(1) (21 U.S.C. 352(f)(1))
concerning the labeling of drugs with adequate directions for use and
(2) section 505 (21 U.S.C. 355) concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs). Drugs compounded in outsourcing facilities are
not exempt from the requirements of section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)) concerning current good manufacturing
practice for drugs.
    Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to
assess and collect the following fees associated with outsourcing
facilities that elect to register under section 503B of the FD&C Act:
(1) An annual establishment fee from each outsourcing facility and (2)
a reinspection fee from each outsourcing facility subject to a
reinspection (see section 744K(a)(1) of the FD&C Act). Under
statutorily defined conditions, a qualified applicant may pay a reduced
small business establishment fee (see section 744K(c)(4) of the FD&C
Act).
    FDA announced in the Federal Register of November 24, 2014 (79 FR
69856), the availability of a final guidance for industry entitled
``Fees for Human Drug Compounding Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act.'' The guidance provides additional
information on the annual fees for registered outsourcing facilities
and adjustments required by law, reinspection fees, how to submit
payment, the effect of failure to pay fees,

and how to qualify as a small business to obtain a reduction of the
annual establishment fee. This guidance can be accessed on FDA's Web
site at http://wcms.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.

II. Fees for FY 2016 \1\
---------------------------------------------------------------------------

    \1\ FY 2016 runs from October 1, 2015, through September 30,
2016.
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A. FY 2016 Rates for Small Business Establishment Fee, Non-Small
Business Establishment Fee, and Reinspection Fee

1. Establishment Fee for Qualified Small Businesses \2\
---------------------------------------------------------------------------

    \2\ To qualify for a small business reduction of the FY 2016
establishment fee, entities had to submit their exception requests
by April 30, 2015. See section 744K(c)(4)(B) of the FD&C Act.
Although the time for requesting a small business exception for FY
2016 has now passed, an entity that wishes to request a small
business exception for FY 2017 should consult section 744K(c)(4) of
the FD&C Act and section III.D of FDA's guidance for industry
entitled ``Fees for Human Drug Compounding Outsourcing Facilities
Under Sections 503B and 744K of the FD&C Act,'' which can be
accessed on FDA's Web site at http://wcms.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.
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    The amount of the establishment fee for a qualified small business
fee is equal to $15,000 multiplied by the inflation adjustment factor
for that fiscal year, divided by three (see section 744K(c)(4)(A) and
(c)(1)(A) of the FD&C Act). The inflation adjustment factor for FY 2016
is 1.040646. See section II.B.1 for the methodology used to calculate
the FY 2016 inflation adjustment factor. Therefore, the establishment
fee for a qualified small business for FY 2016 is one third of $15,610,
which, rounded to the nearest dollar, equals $5,203.
2. Establishment Fee for Non-Small Businesses
    Under section 744K(c) of the FD&C Act, the amount of the
establishment fee for a non-small business fee is equal to $15,000
multiplied by the inflation adjustment factor for that fiscal year,
plus the small business adjustment factor for that fiscal year, and
plus or minus an adjustment factor to account for over- or under-
collections due to the small business adjustment factor in the prior
year. The inflation adjustment factor for FY 2016 is 1.040646. The
small business adjustment amount for FY 2016 is $855. See section
II.B.2 for the methodology used to calculate the small business
adjustment factor for FY 2016. Therefore, the establishment fee for a
non-small business for FY 2016 is $15,000 multiplied by 1.040646 plus
$855, which equals $16,465.3.
3. Reinspection Fee
    Section 744K(c)(1)(B) of the FD&C Act provides that the amount of
the FY 2016 reinspection fee is equal to $15,000, multiplied by the
inflation adjustment factor for that fiscal year. The inflation
adjustment factor for FY 2016 is 1.040646. Therefore, the reinspection
fee for FY 2016 is $15,000 multiplied by 1.040646, which equals
$15,610. There is no reduction in this fee for small businesses.

B. Methodology for Calculating FY 2016 Adjustment Factors

1. Inflation Adjustment Factor
    Section 744K(c)(2) of the FD&C Act specifies the annual inflation
adjustment for outsourcing facility fees. The inflation adjustment has
two components: One based on FDA's payroll costs and one based on FDA's
non-pay costs for the first three of the four previous fiscal years.
The payroll component of the annual inflation adjustment is calculated
by taking the average change in the FDA's per-full time equivalent
(FTE) personnel compensation and benefits (PC&B) in the first three of
the four previous fiscal years (see section 744K(c)(2)(A)(ii) of the
FD&C Act). FDA's total annual spending on PC&B is divided by the total
number of FTEs per fiscal year to determine the average PC&B per FTE.
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first three of the four
fiscal years preceding FY 2016. The 3-year average is 2.2328 percent.

                                Table 1--FDA PC&B's Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2012               2013               2014          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,824,703,000     $1,927,703,000     $2,054,937,000  .................
Total FTE...........................             13,382             13,974             14,555  .................
PC&B per FTE........................           $136,355           $137,949           $141,184  .................
Percent change from previous year...            3.1843%            1.1690%            2.3451%            2.2328%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this
2.2328 percent should be multiplied by the proportion of PC&B to total
costs of an average FTE of FDA for the same three fiscal years.

                      Table 2--FDA PC&B's as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2012               2013               2014          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,824,703,000     $1,927,703,000     $2,054,937,000  .................
Total Costs.........................     $3,550,496,000     $4,151,343,000      4,298,476,000  .................
PC&B Percent........................           51.3929%           46.4356%           47.8062%           48.5449%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.2328 percent multiplied by 48.5449
percent, or 1.0839 percent.
    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the
portion of the inflation adjustment for non-payroll costs for FY 2016
is equal to the average annual percent change in the Consumer Price
Index (CPI) for urban consumers (U.S. City Average; 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 non-PC&B costs to total costs of an average FTE of the FDA for the
same period.

    Table 2 provides the summary data for the percent change in the
specified CPI for U.S. cities. These data are published by the Bureau
of Labor Statistics and can be found on its Web site at http://data.bls.gov/cgi-bin/surveymost?cu by checking the box marked ``U.S.
All items, 1982-84 = 100 - CUUR0000SA0'' and then clicking on the
``Retrieve Data'' button.

                   Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
----------------------------------------------------------------------------------------------------------------
                Year                         2012               2013               2014          3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            229.594            232.957            236.736  .................
Annual Percent Change...............            2.0694%            1.4648%            1.6222%            1.7188%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this
1.7188 percent should be multiplied by the proportion of all non-PC&B
costs to total costs of an average FTE for the same three fiscal years.
The proportion of all non-PC&B costs to total costs of an average FTE
of FDA for FYs 2012 to 2014 is 51.4551 percent (100 percent - 48.5449
percent = 51.4551 percent). Therefore, the non-pay adjustment is 1.7188
percent times 51.4551 percent, or 0.8844 percent.
    The PC&B component (1.0839 percent) is added to the non-PC&B
component (0.8844 percent), for a total inflation adjustment of 1.9683
percent (rounded), and then one is added, making the inflation
adjustment 1.019683.
    Section 744K(c)(2)(B) of the FD&C Act provides for this inflation
adjustment to be compounded after FY 2015. This factor for FY 2016
(1.9683 percent) is compounded by adding one to it, and then
multiplying it by one plus the inflation adjustment factor for FY 2015
(2.0558 percent), as published in the Federal Register of August 1,
2014 (79 FR 44805). The result of this multiplication of the inflation
factors for the 1 year since FY 2015 (1.019683 x 1.020558) becomes the
inflation adjustment for FY 2016. For FY 2016, the inflation adjustment
is 4.0646 percent (rounded). We then add one, making the FY 2016
inflation adjustment factor 1.040646.
2. Small Business Adjustment Factor
    Section 744K(c)(3) of the FD&C Act specifies that in addition to
the inflation adjustment factor, the establishment fee for non-small
businesses is to be further adjusted for a small business adjustment
factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small
business adjustment factor is the adjustment to the establishment fee
for non-small businesses that is necessary to achieve total fees
equaling the amount that FDA would have collected if no entity
qualified for the small business exception in section 744K(c)(4) of the
FD&C Act. Additionally, section 744K(c)(5)(A) states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year.
    Therefore, to calculate the small business adjustment to the
establishment fee for non-small businesses for FY 2016, FDA must
estimate: (1) The number of outsourcing facilities that will pay the
reduced fee for small businesses for FY 2016 and (2) the total fee
revenue it would have collected if no entity had qualified for the
small business exception (i.e., if each outsourcing facility that
registers for FY 2016 were to pay the inflation-adjusted fee amount of
$15,610).
    With respect to (1), FDA estimates that eight entities will qualify
for small business exceptions and will pay the reduced fee for FY 2016.
With respect to (2), to estimate the total number of outsourcing
facilities that will register for FY 2016, FDA used data submitted by
outsourcing facilities through the voluntary registration process,
which began in December 2013. Accordingly, FDA estimates that 55
outsourcing facilities, including 8 small businesses, will register
with FDA in FY 2016.
    If the projected 55 outsourcing facilities paid the full inflation-
adjusted fee of $15,610, this would result in total revenue of $858,550
in FY 2016 ($15,610 x 55). However, because 8 of the outsourcing
facilities expected to register for FY 2016 are estimated to qualify
for the small business exception and will pay one-third of the full fee
($5,203 x 8), totaling $41,624 instead of paying the full fee ($15,610
x 8), which totals $124,880. This would leave a shortfall of $83,256
($124,880 - $41,624).
    Additionally, section 744K(c)(5)(A) of the FD&C Act states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year. For each year, total
target collections are calculated as (15,000 x [inflation adjustment
factor] x [number of registrants]). This would have been $887,864 for
FY 2015 ($15,308 x 58). However, because FDA did not have the exact
number of registrants and had to rely on estimates of the number of
small businesses and non-small businesses that would register in FY
2015, FDA's FY 2015 small business adjustment factor resulted in excess
collections of $43,094 ($930,958 - $887,864) as of June 30, 2015.\3\
---------------------------------------------------------------------------

    \3\ If FDA receives additional excess collections for FY 2015
after June 30, 2015, then FDA will credit this amount when it
establishes the small business adjustment factor for FY 2017.
---------------------------------------------------------------------------

    Therefore, to calculate the small business adjustment factor for FY
2016, FDA subtracts the $43,094 overage from FY 2015 from the $83,256
projected shortfall for FY 2016 to arrive at the numerator for the
small business adjustment amount, which equals $40,162. This number
divided by 47 (the number of expected non-small businesses for FY 2016)
is the small business adjustment amount for FY 2016, which is $855.
Therefore, the establishment fee for a non-small business for FY 2016
is $15,000 multiplied by 1.040646 plus $855, which equals $16,465.

C. Summary of FY 2016 Fee Rates

                   Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------

------------------------------------------------------------------------
Qualified Small Business Establishment Fee..............          $5,203
Non-Small Business Establishment Fee....................          16,465
Reinspection Fee........................................          15,610
------------------------------------------------------------------------

III. Fee Payment Options and Procedures

A. Establishment Fee

    Once an entity submits registration information and FDA has
determined that the information is complete, the entity will incur the
annual establishment fee. FDA will send an invoice to the entity, via
email to the

email address indicated in the registration file, or via regular mail
if email is not an option. The invoice will contain information
regarding the obligation incurred, the amount owed, and payment
procedures. A facility will not be deemed registered as an outsourcing
facility until it has paid the annual establishment fee under section
744K of the FD&C Act. Accordingly, it is important that facilities
seeking to operate as registered outsourcing facilities pay all fees
immediately upon receiving an invoice. If an entity does not pay the
full invoiced amount within 15 calendar days after FDA issues the
invoice, FDA will consider the submission of registration information
to have been withdrawn and adjust the invoice to reflect that no fee is
due.
    Outsourcing facilities that registered in FY 2015 and wish to
maintain their status as an outsourcing facility in FY 2016 must
register during the annual registration period that lasts from October
1, 2015, to December 31, 2015. Failure to register and complete payment
by December 31, 2015, will result in a loss of status as an outsourcing
facility on January 1, 2016. Entities should submit their registration
information no later than December 10, 2015, to allow enough time for
review of the registration information, invoicing, and payment of fees
before the end of the registration period.

B. Reinspection Fee

    FDA will issue invoices for each reinspection after the conclusion
of the reinspection, via email to the email address indicated in the
registration file or via regular mail if email is not an option.
Invoices must be paid within 30 days.

C. Fee Payment Procedures

    1. 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. Once you search for your invoice, click ``Pay
Now'' to be redirected to Pay.gov. Note that electronic payment options
are based on the balance due. Payment by credit card is available for
balances less than $50,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be drawn on U.S. bank
accounts as well as U.S. credit cards.
    2. If paying with a paper check: Checks must be in U.S. currency
from a U.S. bank and made payable to the Food and Drug Administration.
Payments can be mailed to: Food and Drug Administration, P.O. Box
956733, St. Louis, MO 63195-6733. If a check is sent by a courier that
requests a street address, the courier can deliver the check to: U.S.
Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery
only; do not send mail to this address.)
    3. If paying with a wire transfer: Use the following account
information when sending a wire transfer: New York Federal Reserve
Bank, U.S. Dept of Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Rd., Silver Spring, MD 20993. The
originating financial institution may charge a wire transfer fee. An
outsourcing facility should ask its financial institution about the fee
and add it to the payment to ensure that the order is fully paid. The
tax identification number of FDA is 53-0196965.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18916 Filed 7-31-15; 8:45 am]
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[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Rules and Regulations]
[Page 36993]
[FR Doc No: 2011-15817]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-1997-N-0040] (formerly Docket No. 1997N-0484P)

Medical Devices; Neurological Devices; Clarification of
Classification for Human Dura Mater; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the device
regulations to clarify the applicability of the device classification
for human dura mater. This action is being taken to improve the
accuracy of the regulations.

DATES: This final rule is effective June 24, 2011.

FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is clarifying the regulatory authority
for human dura mater in the Agency's codified regulations for part 882
(21 CFR part 882). In the Federal Register of November 24, 2004 (69 FR
68612), FDA published a final rule regarding current good tissue
practice for establishments that manufacture human cell, tissue, and
cellular and tissue-based products (HCT/Ps). That rule became effective
on May 25, 2005. Prior to the effective date of the final rule, human
dura mater was regulated as a medical device under Sec.  882.5975. As
stated in the final rule, human dura mater is now defined under 21 CFR
1271.3(d) as a HCT/P. As such, it is regulated under section 361 of the
Public Health Service Act (42 U.S.C. 264) and the requirements of 21
CFR part 1271, including requirements related to registration and
listing, donor eligibility determinations, and current good tissue
practice. Accordingly, the device classification contained in Sec.
882.5975 is only applicable for human dura mater recovered prior to the
effective date of the final rule, May 25, 2005. The final rule omitted
a corresponding annotation to Sec.  882.5975 to clarify that the device
classification is only applicable for human dura mater recovered prior
to the effective date of the final rule. This document clarifies the
regulatory authority for human dura mater. Publication of this document
constitutes final action under the Administrative Procedure Act (5
U.S.C. 553). FDA has determined that notice and public comment are
unnecessary because this amendment is nonsubstantive.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 882.5975 is amended by adding paragraph (c) to read as
follows:

Sec.  882.5975  Human dura mater.

* * * * *
    (c) Scope. The classification set forth in this section is only
applicable to human dura mater recovered prior to May 25, 2005.

    Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15817 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 27, 2009 (Volume 74, Number 206)]
[Notices]
[Page 55279]
[DOCID:fr27oc09-116]

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

Federal Railroad Administration

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to Title 49 Code of Federal Regulations (CFR) part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of the signal system or relief from the requirements of
49 CFR part 236, as detailed below.

Docket Number FRA-2009-0083

Applicant: Union Pacific Railroad Company, Mr. William E. Van Trump,
SR. AVP Engineering--Signal/Comm./TCO, 1400 Douglas Street, Stop 0910,
Omaha, Nebraska 68179.
    The Union Pacific Railroad Company (UP) seeks approval of the
proposed discontinuance and removal of the rail locks on the Conley
frogs on the Hudson Swing Bridge at Milepost 18.6 on the UP Altoona
Subdivision, near Hudson, Wisconsin.
    The reason given for the proposed changes is that the Hudson Swing
Bridge has Conley frogs, which are self-aligning and require no locking
device. The Hudson Swing Bridge has wedges with circuit controllers
which measure the required 1'' to determine that the bridge is properly
seated, and circuit controllers and linkage to measure the surface of
the rail to within the required \3/8\''.
    Any interested party desiring to protest the granting of an
application shall set forth specifically the grounds upon which the
protest is made, and include a concise statement of the interest of the
party in the proceeding. Additionally, one copy of the protest shall be
furnished to the applicant at the address listed above.
    FRA expects to be able to determine these matters without an oral
hearing. However, if a specific request for an oral hearing is
accompanied by a showing that the party is unable to adequately present
his or her position by written statements, an application may be set
for public hearing.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0083) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR 19477) or at
http://www.dot.gov/privacy.html.

    Issued in Washington, DC on October 21, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E9-25816 Filed 10-26-09; 8:45 am]

BILLING CODE 4910-06-P