[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Page 9717]
[FR Doc No: 2013-03027]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3354-EM; Docket ID FEMA-2013-0001]

New Jersey; Amendment No. 3 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of New Jersey (FEMA-3354-EM), dated October 28, 2012, and
related determinations.

DATES: Effective Date: January 25, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, William L.
Vogel, of FEMA is appointed to act as the Federal Coordinating Officer
for this emergency.
    This action terminates the appointment of Michael J. Hall as
Federal Coordinating Officer for this emergency.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-03027 Filed 2-8-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: September 22, 2009 (Volume 74, Number 182)]
[Rules and Regulations]
[Page 48135-48138]
[DOCID:fr22se09-1]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

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

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

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2006-25173; Directorate Identifier 2006-NE-24-AD;
Amendment 39-16021; AD 2009-19-04]
RIN 2120-AA64

Airworthiness Directives; McCauley Propeller Systems Propeller
Models B5JFR36C1101/114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/
114HCA-0, and C5JFR36C1104/L114HCA-0

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

ACTION: Final rule.

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SUMMARY: The FAA is superseding an existing airworthiness directive
(AD) for McCauley Propeller Systems propeller models B5JFR36C1101/
114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/114HCA-0, and
C5JFR36C1104/L114HCA-0. That AD currently requires initial and
repetitive fluorescent penetrant inspections (FPI) and eddy current
inspections (ECI) of propeller blades for cracks, and if any crack
indications are found, removing the blade from service. That AD also
mandates a life limit for the blades. This AD requires the same
inspections, adds a visual inspection, and mandates a new propeller
blade life limit. This AD also requires removing propeller blades with
more than 10,000 operating hours time-since-new (TSN), before further
flight. This AD also requires removal from service of all the propeller
blades and the propeller hub if one or more propeller blades have been
found cracked on a propeller assembly. This AD also requires removing
from service all C-5963 split retainers. This AD results from eight
reports of propeller blades found cracked since May of 2006. We are
issuing this AD to detect cracks in the propeller blade that could
cause failure and separation of the propeller blade and loss of control
of the airplane.

DATES: This AD becomes effective October 27, 2009. The Director of the
Federal Register approved the incorporation by reference of certain
publications listed in the regulations as of October 27, 2009.

ADDRESSES: You can get the service information identified in this AD
from McCauley Propeller Systems, 5800 E. Pawnee, Wichita, KS 67218,
telephone<PHONE_NUMBER>.
    The Docket Operations office is located at Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.

FOR FURTHER INFORMATION CONTACT: Jeff Janusz, Aerospace Engineer,
Wichita Aircraft Certification Office, FAA, Small Airplane Directorate,
1801 Airport Road, Room 100, Wichita, KS 67209; e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39 by
superseding AD 2008-08-01, Amendment 39-15453 (73 FR 19971, April 14,
2008). The proposed AD applies to McCauley Propeller Systems propeller
models B5JFR36C1101/114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/
114HCA-0, and C5JFR36C1104/L114HCA-0. We published the proposed AD in
the Federal Register on January 21, 2009 (74 FR 3462). That action
proposed to require an FPI and ECI of propeller blades for cracks,
visual inspection of the blade shank for a step condition, and a new
propeller blade life limit of 3,500 hours TSN. That action also
proposed to require removal of blades with more than 10,000 operating
hours TSN before further flight. That action also proposed to require
removal from service of all the propeller blades and the propeller hub
if one or more propeller blades have been found cracked on a propeller
assembly. That action also proposed to require removing from service
all C-5963 split retainers at time of next inspection.

Guidance From McCauley Product Support

    If there is any question as to the acceptability of a blade shank
``step condition'', the ability to accurately measure 0.005-inch wear,
or the acceptability of any other wear present, we recommend that you
contact McCauley Product Support for guidance.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is provided in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comments received.

Claim That Blade Failure Is Primarily Due to a Blade Material Condition

    Four commenters provided numerous observations that infer the
probable cause for propeller blade failure is primarily due to a
propeller blade material condition, which is the result of a
manufacturing defect. The commenters did not present any examination or
determination as to the cause of initiation of the propeller blade
fatigue cracks. They did not present any evaluation or determination of
the effect airplane operations in the restricted propeller RPM ranges
have on propeller blade cracking, or any evaluation or determination of
the effect the propeller blade material condition has, with respect to
propeller fatigue life and thus propeller blade operating life.
    We respect the commenters' observations, but the observations do
not provide factual data to state a singular probable cause of
propeller blade cracking. Therefore, as stated in the NPRM we have not
yet determined if the blade cracking is the result of a design issue,
an operational issue, or a combination of the two. We did not change
the AD.

Concern Over Cost of Airplane Operations

    Three commenters highlight and express their concern with the
increase in cost of airplane operations associated with the proposed
AD.
    Per Order FAA-IR-M-8040.1B, we must consider the cost impact of an
AD, including the direct cost to operators. We performed the economic
analysis to include initial labor and parts costs, but we did not
include the cost of aircraft down time, as we are not required to
include it. Since we published the proposed AD, we became aware there
are more affected airplanes with the subject propeller on the U.S.
registry, bringing the number of propellers from 8 to 34. We also
became aware that the total cost estimate we gave in the proposed AD
was for the worldwide fleet. We changed the cost of compliance
paragraph to cover only the U.S. fleet, and to reflect a corrected
estimated cost, including the cost of prorated propeller life lost,
which is a total of $1,523,049.

Revise the AD To Include the BAE Systems Regional Aircraft Proposal To
Increase the Propeller Blade Life to 5,000 Hours

    Five commenters, including BAE Systems (Operations) Ltd., point out
that European Aviation Safety Agency (EASA) AD 2009-0038 mandates the
installation of a propeller speed warning system per BAE Systems
(Operations) Ltd. Service Bulletin No. SB J41-61-014. BAE Systems
(Operations) Ltd. proposed that the propeller blade life could be
increased to 5,000 hours with the installation of new, zero-time-since-
new propeller blades. The commenters suggest that we revise our AD to
do the same actions.
    We do not agree. The above suggestions were not proposed as part of
the proposed AD. The commenters state the reason for cracking as that
stated in the McCauley Propeller Systems Service Bulletin No. ASB255A,
included in the NPRM by reference; which is ``The blade cracks are
caused by operation in the restricted and placarded regions.'' We have
not yet determined if the blade cracking is the result of a design
issue, an operational issue, or a combination of the two. The
commenters presented observations that propellers have operated beyond
the proposed AD 3,500-hour life limit satisfactorily without cracking.
The commenters present that EASA is mandating by AD the propeller speed
warning system and state that this system will provide a means to keep
the propeller out of the restricted operating range. The proposed AD
does not mandate a propeller speed warning system. We agree that this
type of system has the potential to help limit the amount of time a
propeller is operated in the restricted range. However, this type of
system does not guarantee operations of the propeller will be conducted
outside of the restricted operating range. The commenters did not
examine or determine the cause of initiation of the propeller blade
fatigue cracks, nor evaluate or determine the effect airplane
operations in the restricted propeller RPM ranges have on propeller
blade cracking. The commenters did not evaluate or determine the effect
the propeller blade material condition has with respect to propeller
fatigue life and thus propeller blade operating life. The commenters
did not present any factual data to support increasing the life limit
to 5,000 hours. Since May of 2006, we have received reports of eight
propeller blades which were found cracked at fewer than 5,000 hours
time-since-new. We did not change the AD.

Credit for Monitoring Propeller Operations

    Two commenters present observations that infer credit should be
given to operators for Digital Flight Data Recorder (DFDR) downloads to
monitor operations of the airplane and hence monitor operations of the
propeller in the restricted RPM ranges.
    We do not agree. We find merit in monitoring of propeller
operations, but as stated in the NPRM we have not yet determined if the
blade cracking is the result of a design issue, an operational issue,
or a combination of the two. We do not have any control over how the
airplane is operated, as this AD relates to the type certification of
the propeller. We did not change the AD.

Revise AD To Include a Wear Measurement Technique That Is Not Difficult
and Is Practical

    One commenter believes the wear measurement technique provided in
the McCauley Propeller Systems Service Bulletin No. ASB255A and
included in the proposed AD by reference, will be difficult and not
practical, and requests a revised and more appropriate procedure be
developed and included in the AD. McCauley Propeller Systems has
defined this wear measurement criteria in the past in other Service
Bulletins related to this propeller model. FAA has previously mandated
the same criteria in now superseded ADs. There were no adverse comments
to the superseded ADs while they were being proposed, from the
propeller repair shops that are tasked with addressing the AD
requirements at the propeller hardware level.
    We find some merit to elaborate on the criticality of the wear
measurement criteria and we have added wording to the Supplementary
Information section of this AD, recommending that McCauley Product
Support be contacted for additional guidance with this measurement.

Correction to Paragraph (i)

    We found incorrect compliance information that was inadvertently
placed in the first sentence of paragraph (i) of the proposed AD. We
corrected that sentence in the AD from ``Remove the serial number (SN)
propeller blades and the hubs listed in Table 1 of this AD from
service, using the inspection compliance schedule in Table 2 of this
AD'' to ``Before further flight, remove the serial number (SN)
propeller blades and the hubs listed in Table 1 of this AD from
service.''

Paragraph Added To Address Parts Not Reported on

    We realized that since we state in paragraph (i) of the proposed AD
that there may be other affected propeller assemblies, blades, hubs, or
hub assemblies that we have not received reports on, and that we should
address that population in a separate paragraph. We added a new
paragraph (j) to the AD that states: ``Before further flight, remove
from service any propeller blades and hubs found or documented to have
been installed in any propeller assembly that has had one or more
cracked propeller blades at any time. Propeller blades and the
propeller hub of a propeller assembly that has had one or more cracked
propeller blades are prohibited from installation in any configuration
on any airframe.''

Conclusion

    We have carefully reviewed the available data, including the
comments received, and determined that air safety and the public
interest require adopting the AD with the changes described previously.
We have determined that these changes will neither increase the
economic burden on any operator nor increase the scope of the AD.

Costs of Compliance

    We estimate that this AD will affect 34 propeller assemblies
installed on airplanes of U.S. registry. We estimate that it will take
about 44 work-hours per propeller to perform the required actions, and
that the average labor rate is $80 per work-hour. Required parts will
cost about $260 per propeller, if no cracks are found. We estimate that
one

propeller will fail the blade inspection required by this AD, and the
propeller replacement cost will be about $67,067. Prorated life lost
for the propeller assembly will cost about $39,043 per propeller. Based
on these figures, we estimate the total cost of the AD to U.S.
operators to be $1,523,049.

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); and
    (3) 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.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the Federal Aviation Administration 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 Amendment 39-15453 (73 FR
19971, April 14, 2008) and by adding a new airworthiness directive,
Amendment 39-16021, to read as follows:

2009-19-04 McCauley Propeller Systems: Amendment 39-16021. Docket
No. FAA-2006-25173; Directorate Identifier 2006-NE-24-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective October
27, 2009.

Affected ADs

    (b) This AD supersedes AD 2008-08-01, Amendment 39-15453.

Applicability

    (c) This AD applies to McCauley Propeller Systems propeller
models B5JFR36C1101/114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/
114HCA-0, and C5JFR36C1104/L114HCA-0. These propellers are installed
on, but not limited to, BAE Systems (Operations) Limited Jetstream
Model 4100 and 4101 series airplanes (Jetstream 41).

Unsafe Condition

    (d) This AD results from eight reports of propeller blades found
cracked since May of 2006. We are issuing this AD to detect cracks
in the propeller blade that could cause failure and separation of
the propeller blade and loss of control of the airplane.

Compliance

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

Life Limit

    (f) For propeller blades with more than 10,000 operating hours
time-since-new (TSN) on the effective date of this AD, remove the
propeller blades from service before further flight. These propeller
blades are prohibited from installation in any configuration on any
airframe.
    (g) For propeller blades with more than 3,000 operating hours
TSN on the effective date of this AD, remove the propeller blades
from service within the next 500 operating hours, not to exceed
10,000 operating hours TSN. These propeller blades are prohibited
from installation in any configuration on any airframe.
    (h) For propeller blades with 3,000 or fewer operating hours TSN
on the effective date of this AD, remove the propeller blades from
service at or before reaching 3,500 operating hours TSN. These
propeller blades are prohibited from installation in any
configuration on any airframe.

Removal From Service of Propeller Blades and Hubs From Propeller
Assemblies That Have Had One or More Cracked Propeller Blades

    (i) Before further flight, remove the propeller blades and the
hubs listed in Table 1 of this AD from service. The propeller blades
and hubs listed in Table 1 are prohibited from installation in any
configuration on any airframe.
    (j) Before further flight, remove from service any propeller
blades and hubs found or documented to have been installed in any
propeller assembly that has had one or more cracked propeller blades
at any time. Propeller blades and the propeller hub of a propeller
assembly that has had one or more cracked propeller blades are
prohibited from installation in any configuration on any airframe.

 Table 1--Propeller Blade and Hub Serial Numbers Requiring Removal From
  Service Before Further Flight and Are Prohibited from Installation in
                    Any Configuration on Any Airframe
------------------------------------------------------------------------
          Hub Serial No.                      Blade Serial No.
------------------------------------------------------------------------
023062............................  XH31043, XH31131, XE31002, XH31025,
                                     XI31014
040296............................  YA31058, YA31055, YB31084, YB31088,
                                     YB31090
041016............................  XB31009, XA31073, XA31071, XA31063,
                                     WK31013
051193............................  XH31018, XH31077, XH31081, XL31008,
                                     XL31043
040282............................  XG31015, XG31016, XH31113, XH31117,
                                     XI31017
051204............................  XI31049, XH31140, XH31129, XH31084,
                                     XH31074
051194............................  WF31010, WD31032, WF31002, WF31029,
                                     WF31078
------------------------------------------------------------------------

Propeller Blade Inspection

    (k) Perform a fluorescent penetrant inspection and eddy current
inspection of the propeller blades, and a visual inspection for a
``step condition'' of the blade shank. Use the Equipment Required
and Accomplishment Instructions of McCauley Propellers Alert Service
Bulletin (ASB) No. ASB255A, dated October 6, 2008, and the
compliance schedule in Table 2 of this AD:

                 Table 2--Inspection Compliance Schedule
------------------------------------------------------------------------
  If on the effective date of this AD,      Then inspect the propeller
          the propeller blade:                        blade:
------------------------------------------------------------------------
(1) Has more than 2,400 operating hours  Upon reaching 2,500 operating
 TSN, time-since-last inspection          hours TSLI. See TSLI
 (TSLI), or time-since-overhaul (TSO)     definition paragraph (p) of
 and has been inspected using AD 2008-    this AD.
 08-01 or McCauley Propellers ASB No.
 ASB255, dated January 8, 2007 within
 the past 2,400 operating hours.
(2) Has more than 2,400 operating hours  Within the next 100 operating
 TSN, TSLI, or TSO and has not been       hours time-in-service.
 inspected using AD 2008-08-01 or
 McCauley Propellers ASB No. ASB255,
 dated January 8, 2007 within the past
 2,400 operating hours.
(3) Has 2,400 or fewer operating hours   Upon reaching 2,500 operating
 TSN, TSLI, or TSO.                       hours TSN, TSLI, or TSO.
------------------------------------------------------------------------

Propellers Failing Blade Inspection

    (l) Remove from service all of the propeller blades, and the
propeller hub, if one or more propeller blades are found cracked on
a propeller assembly. Propeller blades and the propeller hub of a
propeller assembly that has had one or more cracked propeller blades
are prohibited from installation in any configuration on any
airframe.
    (m) Remove from service all propeller blades that exhibit a
blade shank ``step condition'' of 0.005-inch or greater. Blades
removed from service are prohibited from installation in any
configuration on any airframe.

Removal of C-5963 Split Retainers From Service

    (n) Remove from service all C-5963 split retainers at the time
of blade inspection specified in paragraph (k) of this AD. C-5963
split retainers removed from service are prohibited from
installation in any configuration on any airframe.
    (o) After the effective date of this AD, do not install
propeller assemblies with C-5963 split retainers on any airframe.

Definition

    (p) For the purpose of this AD, TSLI refers only to inspections
performed using AD 2008-08-01 or McCauley ASB No. ASB255, dated
January 8, 2007.

Reporting Requirements

    (q) Within 10 calendar days of the inspection, use the Reporting
Form in McCauley ASB No. ASB255A, to report all inspection findings
to the FAA, Wichita Aircraft Certification Office, 1801 Airport
Road, Room 100, Wichita, KS 67209, Attention: Jeff Janusz; telephone
(316) 946-4148; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    (r) Include any photographs, and any other information related
to the means of detection of the crack, and the history of the
propeller and blades.
    (s) The Office of Management and Budget (OMB) has approved the
reporting requirements and assigned OMB control number 2120-0056.

Alternative Methods of Compliance

    (t) The Manager, Wichita Aircraft Certification Office, has the
authority to approve alternative methods of compliance for this AD
if requested using the procedures found in 14 CFR 39.19.

Special Flight Permits

    (u) Under 39.23, we are limiting the availability of special
flight permits for this AD. Special flight permits are available
only if:
    (1) The operator has not seen signs of external oil leakage from
the hub;
    (2) The operator has not observed abnormal propeller vibration
or abnormal engine vibration;
    (3) The operator has not observed any other abnormal operation
from the propeller;
    (4) The operator has not made earlier reports of abnormal
propeller vibration, abnormal engine vibration, or other abnormal
propeller operations that have not been addressed.

Related Information

    (v) Contact Jeff Janusz, Aerospace Engineer, Wichita Aircraft
Certification Office, FAA, Small Airplane Directorate, 1801 Airport
Road, Room 100, Wichita, KS 67209; e-mail<EMAIL_ADDRESS>
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>, for more information
about this AD.

Material Incorporated by Reference

    (w) You must use McCauley Propellers Alert Service Bulletin No.
ASB255A, dated October 6, 2008 to perform the actions required by
this AD. The Director of the Federal Register approved the
incorporation by reference of this service bulletin in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Contact McCauley Propeller
Systems, 5800 E. Pawnee, Wichita, KS 67218, telephone<PHONE_NUMBER>
for a copy of this service information. You may review copies at the
FAA, New England Region, 12 New England Executive Park, Burlington,
MA; or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call
202-741-6030, or go to: http://www.archives.gov/federal-register/
cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on September 3, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-21919 Filed 9-21-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Notices]
[Page 76442]
[FR Doc No: 2014-29796]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2014-143]

Petition for Exemption; Summary of Petition Received; Hoovy LLC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before January 12, 2015.

ADDRESSES: Send comments identified by docket number FAA-2014-0975
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on December 16, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2014-0975.
    Petitioner: Hoovy LLC.
    Section(s) of 14 CFR Affected: part 21; Sec. Sec.  45.23(b), 61.3,
91.7, 91.9(b)(2), 91.103, 91.109, 91.119, 91.121, 91.151(a), 91.203(a)
and (b), 91.205(b), 91.215, 91.405(a), 91.407(a)(1), 91.409(a)(2) and
91.417(a) and (b).
    Description of Relief Sought: The petitioner is requesting relief
to commercially operate its small unmanned aircraft systems (sUAS) for
banner towing to offer advertising services to businesses in the Los
Angeles Metropolitan Area.
[FR Doc. 2014-29796 Filed 12-19-14; 8:45 am]
BILLING CODE 4910-13-P


USA, Strawberry Nurseries, Response to June 2004 Questions Page 1 NOMINATING PARTY: The United States of America BRIEF DESCRIPTIVE TITLE OF NOMINATION: Methyl Bromide Critical Use Nomination for Preplant Soil Use on Strawberries Nurseries Grown in Open Fields or in Protected Environments DOCUMENT NUMBER CUN 2003/ 060, Usc6N12 DATE August 12, 2004 CRITICAL NEED FOR METHYL BROMIDE TABLE 1. REGION, KEY PESTS, AND SPECIFIC REASON FOR METHYL BROMIDE IN STRAWBERRY NURSERIES REGION WHERE METHYL BROMIDE USE IS REQUESTED KEY DISEASE( S) AND WEED( S) TO GENUS AND, IF KNOWN, TO SPECIES LEVEL SPECIFIC REASONS WHY METHYL BROMIDE IS NEEDED Southeastern US Weeds: Yellow nutsedge ( Cyperus esculentus), Purple nutsedge ( Cyperus rotundus)

Diseases: Black root rot ( Rhizoctonia and Pythium spp.); Crown rot ( Phytophthora cactorum); root knot nematodes ( Meloidogyne spp.) None of the available alternatives provide an acceptable level of control of nutsedge; the affected states' regulatory requirements to meet certification standards which amount to virtually complete control of fungal diseases and nematodes, is only attainable with methyl bromide California Diseases: Phytophthora Crown and Root Rots ( Phytophthora spp.); Red Stele ( Phytophthora fragariae); Verticillium Wilt ( Verticillium dahliae); and possibly others Nematodes: Root knot ( Meloidogyne spp.); sting ( Belonolaimus spp.); dagger ( Xiphinema spp.); lesion ( Pratylenchus spp.); foliar ( Aphelenchoides spp.); needle ( Longidorus spp.); stem ( Ditylenchus spp.)

Weeds: numerous weeds listed ( e. g., annual bluegrass, bur clover, carpetweed, chickweed, field bindweed, goat grass, hairy nightshade, lambsquarter, malva, nutsedge, pig weed, portulaca, prostate spurge, puncture vine, purslane, vetch) The State mandatory certification program has strict requirements for control of diseases and nematodes which amount to virtually complete control of the key pests. Given the growing situations encountered over the course of the 5 year transplant production cycle ( a different growing location is used each year), none of the alternatives have thus far been shown to be consistently perform at a highly effective level at soil depths to 3 feet.

Methyl iodide is considered by most researchers to be viable potential alternative, which is currently proposed for registration in the US.

AMOUNT OF METHYL BROMIDE NOMINATED TABLE 2. AMOUNT OF METHYL BROMIDE NOMINATED BY THE U. S. IN 2005 AND 2006. 2005 ( KG) 2006 ( KG) DESCRIPTION 54,988 56,291 We estimated a more representative average historical use for 2006 than 2005. Research amount included in increase. USA, Strawberry Nurseries, Response to June 2004 Questions Page 2 FIGURE 1. U. S. REQUESTED, QUARANTINE AND PRESHIPMENT AND NOMINATED HECTARES OF STRAWBERRY NURSERIES 0 200 400 600 800 1000 1200 1400 1600 1800 2000 Strawberry Nurseries Requested by applicants QPS Nominated by U. S.

Footnote: The requested hectares are sum total of all acreages in the CUE applications. QPS = number of hectares qualifying as quarantine and pre shipment. The nominated hectares reflect reductions of the requested hectares to ensure that no double counting, growth, etc. were included and that the amount was only sufficient to cover situations ( key pests, regulatory requirements, etc.) where alternatives could not be used. Total pounds of methyl bromide nominated by the United States government for this sector are based on these nominated hectares. See the accompanying spreadsheet 2006 Bromide Usage Numerical Index or " BUNI" ( Filename: USA 2006 BUNI   Refined Nomination Package. xls) for more detailed information on how the nominated amount was determined.

ECONOMIC IMPACTS The economic impacts were assessed using four economic parameters: 1. loss per hectare, 2. loss per kilogram of methyl bromide, 3. loss as a percentage of gross revenue, and 4. loss as a percentage of net revenue. This assessment compares methyl bromide to the best available alternative to determine the economic feasibility of using that alternative. A range of alternatives were examined to determine the best available alternative scenario taking into account yield loss estimates and cost increase estimates. The result of the economic impact analysis is presented in the BUNI analysis. In this sector, no alternatives were found to be both technically and economically feasible for the particular circumstances nominated for the CUE.

RESPONSE TO QUESTIONS MBTOC Comment  A large amount ( 88%) of MB use has been exempted to meet certification requirements for QPS as determined under U. S. regulatory controls. Technical data provided with the nomination indicates that metam sodium and chloropicrin are providing effective disease control for runner production, but 1,3 D/ Pic or 1,3 D alone followed by metam sodium, are reported not to be fully effective." USA, Strawberry Nurseries, Response to June 2004 Questions Page 3 MBTOC Question 1  The Party is requested to clarify how that part of the nomination that is not classified under the QPS exemption differs from that categorized as QPS. In particular information is sought on whether it is required to meet the same performance standards as that categorized as QPS.

US Response  The same quality standards apply to the non QPS nursery stock as the QPS plants, since in county or in state fruit grower customers would not want to purchase lesser quality plants and would be expected to obtain high quality plants elsewhere in the country to ensure they were the most robust specimens. This is based in part on available data that seems to indicate that runner plants produced in fields where lower yields and/ or smaller plants were produced as a result of using less effective alternatives results in carryover losses at the fruit production level. Additionally, if one or more growers in the same general production area were trying to produce two quality levels of plants they would run the risk of having the mobile pests moving from the lesser quality plants to the high quality plants and possibly lose their certification status on the high quality plants.

MBTOC Question 2  Clarification is requested on why metam sodium and chloropicrin as an alternative cannot be adopted more widely. The Party is requested to supply data to support the claimed lack of effectiveness of 1,3 D/ Pic to the necessary depth.

US Response  The data summarized in the nomination document, which appear to indicate that metam sodium and chloropicrin are suitable alternatives, are derived from tests which all lacked a full spectrum of the potential pest types ( weeds, nematodes, diseases) and generally did not appear to have adequate and uniform levels of those pests that were present. This weakness appears to be true for all or most of the available studies designed for strawberry nursery uses, as well as those designed for fruit production situations. Accordingly, the results from such studies will give a number of false positives for certain alternatives simply because they were able to provide adequate control when limited pest species were present, or when non uniform or low pest levels were present. Numerous studies exist for strawberries and other crops that indicate the strengths and weaknesses of the various alternatives under different pest control situations. Collectively these data have value in providing an overview of the strengths and weaknesses of each potential alternative. The U. S. has not been able to find a comprehensive analysis of this nature. Such an analysis would be extremely time consuming, but would be the only way to validate the comparative performance opinions of the available researchers.

Although fumigation in the Southeastern States is generally accomplished in the fall, delays associated with a late harvest of the preceding crop and/ or cold weather often necessitate that fumigation be conducted in March and April, which is immediately prior to planting. A similar situation exists in California. Use of the alternative metam sodium will result in an additional 1 2 week plant back delay when applied alone and longer planting delays when applied sequentially before/ after another fumigant ( e. g., Telone, chloropicrin). Southeastern States have historically experienced 10 15% plant yield ( runner) losses as a result of a 1 week planting delay. Therefore even greater losses are possible with the longer plant back delays associated with metam sodium use, even if metam sodium were capable of providing levels of pest control USA, Strawberry Nurseries, Response to June 2004 Questions Page 4 comparable to methyl bromide at the required soil depths.

Another consideration is that certain studies indicate that chloropicrin can increase nutsedge weed populations rather than control them. Nutsedge is the principal weed pest in the Southeastern States and it is projected to become a problem in California nurseries when methyl bromide is no longer available.

Long term performance of these alternatives is still not available. The applicants in California stated that they intend to look for additional studies, which better, defined the comparative efficacy and/ or performance of chloropicrin, metam sodium, and other alternatives at the deeper soil depths. They intend to submit such studies with their next application.

MBTOC Question 3  The rate of MB used in the Southeastern States in MB/ Pic mixtures is very high ( 413 kg/ ha) by world standards. Clarification is sought as to why such a high rate is required and what scope there is for reduction to more normal levels, perhaps combined with emission reduction technologies such as barrier film use. [ Note: Originally this comment was linked with Michigan growers; subsequently MBTOC was contacted and it was learned that this comment pertained to the SE States, rather than Michigan]

US Response  The methyl bromide rates currently used in the Southeastern States ( 413 kg/ ha) are about 57 percent higher than those currently used in California ( 263 kg/ ha). The applicant has stated that the higher use rate is required because of their need to control nutsedge. This weed is currently not present in California nurseries. Their experiences have shown that in many cases rates as high as 487 kg/ ha of methyl bromide have been needed to control nutsedge. Previously, the Southeastern states indicated that they intend to evaluate the performance of methyl bromide rates as low as 310 kg/ ha, so that growers could conceivably switch from the 67: 33 to the 50: 50 formulation. However, until these performances are fully evaluated, it would not be possible to lower methyl bromide rates and ensure efficacy. In any case, all methyl bromide use is done under tarps, and emissions and use have been controlled to the extent feasible.

References 2006 Bromide Usage Numerical Index ( BUNI)   Refined Nomination Package. Attached to U. S. Response to Questions as an Excel Spreadsheet.


[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2786-2787]
[FR Doc No: 2018-00914]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1267]

Compounded Drug Products That Are Essentially Copies of Approved
Drug Products Under Section 503B of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Compounded Drug
Products That Are Essentially Copies of Approved Drug Products Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' For a drug
product compounded by an outsourcing facility to qualify for the
exemptions under section 503B of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), it must not be essentially a copy of one or more
approved drug products and must meet other conditions in section 503B.
This guidance sets forth FDA's policies concerning the ``essentially a
copy'' provision of section 503B of the FD&C Act.

DATES: The announcement of the guidance is published in the Federal
Register on January 19, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1267 for ``Compounded Drug Products That Are Essentially
Copies of Approved Drug Products Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Compounded Drug Products That Are Essentially Copies of
Approved Drug Products Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' In 2013, the Drug Quality and Security Act, created
new section 503B of the FD&C Act (21 U.S.C. 353b), which describes a
new category of compounders called outsourcing facilities. Section 503B
of the FD&C Act describes the conditions that must be satisfied for
human drug products compounded by or under the direct supervision of a
licensed pharmacist in an outsourcing facility to qualify for
exemptions from the following three sections of the FD&C Act:
     Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning
labeling of drugs with adequate directions for use);

     Section 505 (21 U.S.C. 355) (concerning the approval of
drugs under new drug applications or abbreviated new drug
applications); and
     Section 582 (21 U.S.C. 360eee-1) (concerning drug supply
chain security requirements).
    One of the conditions that must be met for a compounded drug
product to qualify for the exemptions under section 503B of the FD&C
Act is that the drug is not essentially a copy of one or more approved
drugs (section 503B(a)(5)).
    Section 503B(d)(2) defines essentially a copy of an approved drug
as:
     A drug that is identical or nearly identical to an
approved drug, or a marketed drug not subject to section 503(b) and not
subject to approval in an application submitted under section 505,
unless, in the case of an approved drug, the drug appears on the drug
shortage list in effect under section 506E at the time of compounding,
distribution, and dispensing (section 503B(d)(2)(A)) or
     a drug, a component of which is a bulk drug substance that
is a component of an approved drug or a marketed drug that is not
subject to section 503(b) and not subject to approval in an application
submitted under section 505, unless there is a change that produces for
an individual patient a clinical difference, as determined by the
prescribing practitioner, between the compounded drug and the
comparable approved drug (section 503B(d)(2)(B)).
    This guidance sets forth FDA's policies concerning the
``essentially a copy'' provision of section 503B of the FD&C Act.
    In the Federal Register of July 11, 2016 (81 FR 44879), FDA issued
a notice announcing the availability of the draft version of this
guidance. The comment period on the draft guidance ended on October 11,
2016. FDA received 29 comments on the draft guidance. In response to
received comments or on its own initiative, FDA made several changes.
For example, in response to requests in comments for direction on
records retention, FDA added a recommendation that compounders maintain
the records described in the guidance for at least 3 years. In
addition, to address questions raised in comments, FDA clarified that
the Agency does not intend to take action against an outsourcing
facility for failing to compound in accordance with section 503B(a)(5)
if it fills orders for a compounded drug that is essentially a copy of
an approved drug that has been discontinued and is no longer marketed.
    FDA received comments from hospital organizations regarding the
potential implications of proposed policies for the preparation of
compounded drugs used in in-patient settings. The final guidance notes
that FDA is considering the applicability of the policies described in
this guidance to hospitals and health systems. We recognize that this
issue is of interest to many stakeholders and will publicly convey our
further thinking on the applicability of these policies to hospitals
and health systems with an opportunity for comment.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Compounded Drug Products That Are
Essentially Copies of Approved Drug Products Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject
to review by OMB under the PRA (44 U.S.C. 3501-3520). Under the PRA,
Federal Agencies must obtain approval from OMB for each collection of
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information before submitting the
collection to OMB for approval. To comply with this requirement, in the
Federal Register of July 11, 2016, we gave interested persons 60 days
to comment on the information collection provisions in the draft
guidance.
    The information collection provisions in this guidance have been
submitted to OMB for review as required by section 3507(d) of the PRA.
These provisions are not in effect until they display a currently valid
OMB control number. FDA will publish a notice in the Federal Register
announcing OMB's decision regarding the information collection
provisions in this guidance.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00914 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 140 (Tuesday, July 22, 2014)]
[Notices]
[Pages 42512-42513]
[FR Doc No: 2014-17240]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2014-0229; FRL-9914-10-OAR]

Confidentiality of Business Information Submitted in Compliance
Documents for 2014 and Subsequent Model Year Vehicles, Engines and
Equipment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for comment.

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

SUMMARY: The Environmental Protection Agency (EPA) is seeking comment
on a draft Class Determination regarding the confidentiality of
business information submitted in compliance documents for 2014 and
subsequent model year vehicles, engines and equipment.

DATES: Comments must be submitted on or before September 5, 2014.

ADDRESSES: Submit your comments referencing Docket ID No. EPA-HQ-OAR-
2014-0229 online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mailcode 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Holly Pugliese, Compliance Division,
Office of Transportation and Air Quality, Environmental Protection
Agency, 2000 Traverwood, Ann Arbor, Michigan, 48105; telephone number:
734-214-4288; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA's Office of General Counsel (OGC) issues
class determinations to describe the categories of business information
submitted to the Agency that can be considered confidential and when
and if such information can be released to the public when disclosure
is requested under the Freedom of Information Act (``FOIA'' or ``the
Act''). On March 28, 2013, OGC issued ``Class Determination 1-13,
Confidentiality of Business Information Submitted in Certification
Applications for 2013 and Subsequent Model Year Vehicles, Engines and
Equipment'' (www.epa.gov/ogc/documents/1-13.pdf ). Class

Determination 1-13 addresses the information submitted to the
Compliance Division (CD) in EPA's Office of Transportation and Air
Quality (OTAQ) by vehicle, engine, and equipment manufacturers for the
purpose of obtaining certificates of conformity which are required
before a manufacturer can legally sell vehicles, engines, or equipment
in the United States.
    As a follow-up to that class determination, OGC will be issuing a
new class determination that will address the confidentiality of
business information submitted in compliance reports for 2014 and
subsequent model year vehicles, engines and equipment. This class
determination will apply prospectively for 2014 and subsequent model
year vehicles, engines and equipment regulated by OTAQ and covers
information that is submitted by manufacturers to satisfy post-
certification compliance reporting requirements as required by
applicable Clean Air Act regulatory requirements. A copy of the draft
class determination can be found under Docket ID No. EPA-HQ-OAR-2014-
0229 at www.regulations.gov.
    For the class determination covering certification information, EPA
solicited comment directly from manufacturers through trade
associations. However, because this is the first class determination
issued by EPA that addresses compliance documents and information, EPA
believes that a more formal approach is appropriate. EPA will review
all comments submitted to the docket and will issue the final class
determination later this year.

    Dated: July 15, 2014.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality.
[FR Doc. 2014-17240 Filed 7-21-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Proposed Rules]
[Pages 29112-29114]
[FR Doc No: 2019-13219]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2019-N-2514]

Standards for Future Opioid Analgesic Approvals and Incentives
for New Therapeutics To Treat Pain and Addiction; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, we) is holding
a public hearing on September 17, 2019, entitled ``Standards for Future
Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat
Pain and Addiction.'' The Agency today is issuing a draft guidance on
the application of FDA's existing benefit-risk assessment framework to
applications for approval of opioid analgesic drugs. This public
hearing is intended to receive stakeholder input on the approval
process for new opioids and how FDA might best consider the existing
armamentarium of therapies, among other factors, in reviewing
applications for new opioids to treat pain. FDA also seeks input on
potential new preapproval incentives aimed at fostering the development
of new therapeutics to treat pain, as well as new treatments for
addiction.

DATES: The public hearing will be held on September 17, 2019, from 9
a.m. to 5 p.m. The public hearing may be extended or may end early
depending on the level of public participation. Persons can attend the
event in person or via webcast. In-person attendees can also request to
give a formal presentation or to speak during the open public comment
portion of the hearing. Section II provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until November 18, 2019.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503 B/C), Silver Spring, MD 20993-0002. Entrance for public
hearing participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 18, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 18, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date. You may submit
comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-2514 for ``Standards for Future Opioid Analgesic Approvals
and Incentives for New Therapeutics to Treat Pain and Addiction; Public
Hearing.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the received electronic and written/paper comments, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nicole Zelenak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6249, Silver Spring, MD 20993, 301-796-
9030<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (or SUPPORT for Patients
and Communities Act) \1\ was signed into law on October 24, 2018. One
provision of this law requires FDA to hold not less than one public
meeting to address the challenges and barriers of developing non-
addictive medical products intended to treat acute or chronic pain or
addiction, which may include the manner in which the risks of abuse or
misuse of a controlled substance may be incorporated into the benefit-
risk assessment for new drug approvals under section 505(d) and (e) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d) and (e)).\2\
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    \1\ Public Law 115-271.
    \2\ Id., section 3001(a).
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    All opioids approved to treat pain are controlled substances. They
are a crucial component of the armamentarium available for treatment of
pain, but they carry serious risks of addiction, overdose, and death.
Potent novel analgesics that do not carry these risks could
significantly reduce or even obviate the need for opioid analgesics,
but development of such drugs has remained elusive. FDA is optimistic
that the enormous societal need, and the efforts of all stakeholders to
meet that need, will drive scientific advances in the development of
novel, safer analgesics. In the meantime, however, opioid analgesics
are likely to remain a necessary part of medical practice despite their
risks. FDA's goal is to regulate opioid analgesics in such a way as to
reduce their serious risks to the greatest extent possible, while
ensuring their continued availability to the patients who need them.
    Under our existing authorities, FDA determines whether each new
drug application--including each new opioid drug application--meets
applicable standards for safety and effectiveness. In applying these
standards, FDA evaluates whether the benefits of the drug outweigh its
risks. Benefit-risk assessment is the foundation of FDA's regulatory
review of human drugs and biologics. It reflects the Agency's
consideration of the evidence, identification of uncertainties, and the
reasoning the Agency uses to make specific regulatory decisions,
including product approvals. Additionally, the benefit-risk assessment
for a particular medical product serves as a tool for communicating the
Agency's findings about the product.
    FDA today issued a draft guidance on the application of FDA's
benefit-risk assessment framework to applications for approval of
opioid analgesic drugs entitled ``Opioid Analgesic Drugs:
Considerations for Benefit-Risk Assessment Framework--Guidance for
Industry.'' This draft guidance discusses the Agency's application of
the existing benefit-risk assessment framework, which takes into
account not only the benefits and risks of a proposed new opioid to
patients when used as prescribed, but also the effectiveness and safety
of the proposed product relative to currently available analgesics as
well as the public health impact of anticipated inappropriate use.
Comments on that draft guidance may be submitted to the docket number
for the draft guidance, FDA-2019-D-1536. Comments are requested to be
submitted by [enter DATE that is 60 days after issuance of the draft
guidance] to ensure that your comments will be considered before
finalization of the guidance.
    The existing benefit-risk assessment process has been, and
continues to be, a comprehensive and effective mechanism for evaluating
all new drug approvals, including new opioid approvals. Given the
current opioid crisis, however, it is critical that FDA explore every
possible option for effectively responding to opioid misuse and abuse.
To this end, the Agency is announcing this public hearing to gather
input on additional factors the Agency could consider during the
approval process for new opioid therapies. For example, should a new
opioid analgesic be required to demonstrate an advantage over existing
drugs to justify its addition to the market? If so, what new
authorities would FDA need to impose such a requirement? What other new
authorities might FDA need to fully assess candidate opioid analgesics
given their serious risks and the societal impact of opioids overall?
    As noted above, potent novel analgesics that do not carry the
serious risks of existing opioids could greatly reduce or even
eliminate the need for opioid analgesics in the armamentarium of drugs
available to treat serious pain. In addition, there is an urgent need
for new and better treatment options for opioid use disorder.
Accordingly, FDA is also considering whether new preapproval incentives
(in addition to existing incentives, such as breakthrough designation)
are needed to better support and encourage development of all
therapeutics (opioid or non-opioid drugs, biological products, or
devices) intended to treat pain or addiction. Such new incentives could
be tailored to the development of novel analgesics and could include,
among other things, an FDA commitment to hold a series of meetings and
provide written feedback at various stages of product development, with
a firm seeking approval of a product with the potential to offer an
advantage relative to existing products indicated to treat pain or
addiction. We invite comment on potential new incentives as discussed
below.

II. Topics for Discussion at the Public Hearing

    FDA is seeking feedback from a broad group of stakeholders, both
private and public, who are working on the challenges of improving pain
management and addressing the opioid crisis. Some questions for
consideration at the public hearing are provided below. We welcome
input on other relevant issues as well.
    1. Does the current statutory and regulatory framework, including
the benefit-risk assessment described in the recently issued draft
guidance, allow for an adequate evaluation of applications for new
opioid analgesics, or are new authorities required? If new authorities
are required, please expand on what should be added to the existing
statutory and regulatory paradigm.
    2. Should sponsors of new opioid analgesics be required to
demonstrate some comparative advantage relative to existing analgesics?
If so, what new authorities would be necessary to impose a comparative
advantage requirement for opioid analgesics?
    3. If so, how should that comparative advantage be defined?
    a. Can it be quantified?
    b. Should the assessment encompass any potential comparative
advantage, including, e.g., safety advantages that reduce the
prevalence or consequences of abuse or misuse by non-patient
populations?
    c. For any given application, to which existing products should the
proposed new product be required to demonstrate comparative advantage?
Any other opioid approved for the same analgesic indication(s) for
which approval is sought? What are the implications if the new product
only offers a comparative advantage over some of the other opioid
products approved for the same indication(s)?
    4. If a showing of comparative advantage were made a requirement
for approval of new opioid analgesics, could a proposed product meet
this standard even if the product also carried additional or novel
risks compared to existing products?
    5. If a showing of comparative advantage were made a requirement
for approval of new opioid analgesics, should there be any exceptions,
for

example with regard to medically necessary drugs in shortage?
    6. If a showing of comparative advantage were made a requirement
for approval of new opioid analgesics, what would be the impact on
development of such products?
    7. If a showing of comparative advantage were made a requirement
for approval of new opioid analgesics, what would be the impact on
patients, providers, and on the public health generally? Please
consider that the existing opioid market consists largely of relatively
inexpensive generic drugs.
    8. In what other ways should FDA be considering the existing
armamentarium of therapies to treat pain when reviewing an application
for the approval of a new opioid analgesic? To what extent would new
authorities be required?
    9. Please comment on whether new pre-approval incentives are needed
to better support and encourage development of therapeutics intended to
treat pain or addiction. If so, what new incentives would be most
effective, and what new authorities might FDA need to offer them? If
the new incentives are offered through a designation process (analogous
to breakthrough designation), what should be the criteria for
designation?
    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendees can register at
https://www.eventbrite.com/e/fda-standards-for-future-opioid-therapy-approvals-part-15-meeting-tickets-60645674846. Attendees have the
following options:
     Presenter--Presenters will give a timed presentation
followed by a timed question and answer period by the panel. The
presentation time allotted will be approximately 10 minutes, but this
is subject to change based on the number of presenters who register.
Presenters can opt to use a presentation slide deck. Presenters must
register no later than August 9, 2019. Slide decks are due to<EMAIL_ADDRESS>in PDF or PowerPoint format no later than
August 23, 2019. If presenters choose to not use a slide deck, they are
requested to submit a single slide with name of presentation and
contact information by September 6, 2019.
     Open Public Commenter--Open public commenters will provide
a timed oral testimony. The comment time allotted will be approximately
3 minutes, but this is subject to change based on the number or
commenters who register. Open public commenters shall not have
presentation materials or a question and answer period with the panel.
Commenters must register no later than September 10, 2019.
     In-Person Attendee--In-person attendees will attend the
meeting at the FDA White Oak facility.
     Webcast Attendee--For those unable to attend in person,
FDA will provide a live webcast of the hearing. Webcast attendees will
be provided with a link via email to use to view the streaming webcast
of the public hearing.
    Attendees shall register for only one person. Those without
internet or email access can register and/or request to participate as
an open public hearing speaker or a formal presenter by contacting
Nicole Zelenak by the above dates (see FOR FURTHER INFORMATION
CONTACT).
    FDA will try to accommodate all persons who wish to register.
Registration may close early if slots are full. Individuals and
organizations with common interests may consolidate or coordinate their
presentations and request time for a joint presentation. Individual
organizations are limited to a single presentation slot. FDA will
notify registered Presenters of their scheduled presentation times no
later than 1 week prior to the meeting. The time allotted for each
presentation will depend on the number of individuals who wish to
speak. Persons registered to present are encouraged to arrive at the
hearing room early and check in at the onsite registration table to
confirm their designated presentation time. Actual presentation times,
however, may vary based on how the meeting progresses in real time. An
agenda for the hearing and any other background materials will be made
available 5 days before the hearing at https://www.fda.gov/drugs/development-approval-process-drugs/standards-future-opioid-therapy-approvals-09172019-09172019.
    If you need special accommodations because of a disability, please
contact Nicole Zelenak (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the hearing.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see Comments). A transcript
will also be available in either hard copy or on CD-ROM, after
submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's website at
https://www.fda.gov.

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner, the Center
for Drug Evaluation and Research, Center for Biologics Evaluation and
Research, and the Center for Devices and Radiological Health. Under
Sec.  15.30(f), the hearing is informal and the rules of evidence do
not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under Sec.
10.205, representatives of the media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. Persons attending FDA's public hearings are advised that
FDA is not responsible for providing access to electrical outlets. The
hearing will be transcribed as stipulated in Sec.  15.30(b) (see
Transcripts). To the extent that the conditions for the hearing, as
described in this notice, conflict with any provisions set out in part
15, this notice acts as a waiver of those provisions as specified in
Sec.  15.30(h).

    Dated: June 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13219 Filed 6-20-19; 8:45 am]
 BILLING CODE 4164-01-P