[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Page 30176]
[FR Doc No: 2011-12624]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0066] (Formerly Docket No. 2001D-0107)

Expedited Review for New Animal Drug Applications for Human
Pathogen Reduction Claims; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a guidance that was issued on March 9, 2001.

DATES: May 24, 2011.

FOR FURTHER INFORMATION CONTACT:  Steven Vaughn, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 9, 2001 (66 FR 14155), FDA announced the availability
of a guidance for industry 121 entitled ``Expedited Review for
New Animal Drug Applications for Human Pathogen Reduction Claims.''
    The guidance predates the enactment of the Animal Drug User Fee Act
(ADUFA) of 2003, which was reauthorized by Congress in 2008. ADUFA
authorized FDA to collect fees for certain animal drug applications and
for the establishments, products, and sponsors associated with these
and previously approved animal drug applications, in support of the
review of animal drug products. As a result of these increased
resources, the efficiencies of our current administrative processes,
including the phased review and end review amendment processes, we have
significantly reduced our review timeframes and afford sponsors a more
efficient pathway to regulatory approval.
    At the time the guidance was issued, FDA's review timeframes for
new animal drug applications were considerably longer. As noted
previously, significant changes have occurred in the Agency's processes
and timeframes for reviewing new animal drug applications and the
process for expedited review status contained in this guidance is
outdated and no longer needed to assure the efficient review of these
new animal drug applications.

    Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12624 Filed 5-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Page 16208]
[FR Doc No: 2021-06312]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2017-0380; FRL-10022-20-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Generic Clearance for the
Collection of Qualitative Feedback on Agency Service Delivery (EPA ICR
Number 2434.99, OMB Control Number 2010-0042) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through March 31, 2021. Public comments
were previously requested via the Federal Register on July 16, 2020
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before April 26,
2021.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OEI-2017-0380, online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 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.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Mark Purdy, Office of Mission Support,
Regulatory Support Division, 2822T, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-
566-2792; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The information collection activity provides the Agency
with an opportunity to efficiently engage its customers and
stakeholders by gathering qualitative information about their
interaction with Agency. Getting such feedback in a timely manner is
critical if the Agency is to know how and where it should focus while
seeking to improve, or expand upon, its products and services.
    The Agency will submit a collection request for approval under this
generic clearance only if the collections are: Voluntary; low burden
and low-cost for both the respondents and the Federal Government;
noncontroversial; targeted to respondents who have experience with the
program or may have experience with the program in the near future; and
abstain from collecting personally identifiable information (PII) to
the greatest extent possible. Information gathered will be used
internally for general service improvement and program management
purposes and released publicly only in an anonymized or aggregated
fashion. It will not be used in statistical analysis intended to yield
results that can be generalized to the population of study nor will it
be used to substantially inform influential policy decisions.
    Form Numbers: None.
    Respondents/affected entities: Individuals and Households;
Businesses and Organizations; State, Local or Tribal Government.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 180,000 (total).
    Frequency of response: Once per request.
    Total estimated burden: 45,000 hours (total). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: There are no annualized capital or operation
& maintenance costs.
    Changes in the estimates: There is an increase of 15,000 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This requested increase is made in anticipation of
continued growth in the Agency's use this collection to survey the
public on its delivery of services.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-06312 Filed 3-25-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Page 15895]
[FR Doc No: 2018-07576]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2018-29]

Petition for Exemption; Summary of Petition Received; Turtles Fly
Too, Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation 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 May 2, 2018.

ADDRESSES: Send comments identified by docket number FAA-2017-1167
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: Keira Jones,<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on April 6, 2018.
Lirio Liu,
Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2017-1167.
    Petitioner: Turtles Fly Too, Inc.
    Section(s) of 14 CFR Affected: Sec.  61.113(c).
    Description of Relief Sought: The petitioner seeks relief from
Sec.  61.113(c) to the extent necessary to allow Turtles Fly Too to
reimburse its volunteer pilots for fuel costs incurred while conducting
charitable flights for humanitarian assistance to animals.

[FR Doc. 2018-07576 Filed 4-11-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Pages 19898-19899]
[FR Doc No: 2014-08033]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-115-000; PF13-3-000]

Notice of Application: Elba Express Company, L.L.C.

    Take notice that on March 21, 2014, Elba Express Company, L.L.C.
(EEC), 569 Brookwood Village, Suite 749, Birmingham, AL 35209, filed an
application under section 7(c) of the Natural Gas Act to add north-to-
south transportation capacity to the existing EEC pipeline system by
constructing and operating additional compression at EEC's existing
Hartwell Compressor Station in Hart County, Georgia, and constructing
and operating two new compressor stations in Jefferson and Effingham
Counties, Georgia (EEC Modification Project). EEC is proposing the EEC
Modification Project, in part to enable EEC to transport domestically-
produced natural gas on a firm basis to Elba Liquefaction Company,
L.L.C. (ELC) and Southern LNG Company, L.L.C. (SLNG)'s proposed Elba
Liquefaction Project.\1\ The filing is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \1\ ELC and SLNG filed a companion, Docket No. CP14-103-000, on
March 10, 2014 for the Elba Liquefaction Project.
---------------------------------------------------------------------------

    Any questions regarding the EEC Modification Project should be
directed to Glenn A. Sheffield, Director--Rates & Regulatory, Elba
Express Company, L.L.C., 569 Brookwood Village, Suite 749, Birmingham,
AL 35209 or at<PHONE_NUMBER> (phone), or<PHONE_NUMBER>(fax), or
<EMAIL_ADDRESS>or Patricia F. Francis, Assistant
General Counsel, Elba Express Company, L.L.C., 569 Brookwood Village,
Suite 749, Birmingham, AL 35209 or at<PHONE_NUMBER> (phone), or (205)
327-2253(fax), or<EMAIL_ADDRESS>    On March 1, 2013, the Commission staff granted EEC's request to
utilize the National Environmental Policy Act (NEPA) Pre-Filing Process
and assigned Docket No. PF13-3-000 to staff activities involving the
project. Now, as of the filing of this application on March 21, 2014
(CP14-115-000), the NEPA Pre-Filing Process for this project has ended.
From this time forward, this proceeding will be conducted in Docket No.
CP14-115-000, as noted in the caption of this Notice.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance

with the requirements of the Commission's Rules of Practice and
Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA
(18 CFR 157.10). A person obtaining party status will be placed on the
service list maintained by the Secretary of the Commission and will
receive copies of all documents filed by the applicant and by all other
parties. A party must submit 7 copies of filings made with the
Commission and must mail a copy to the applicant and to every other
party in the proceeding. Only parties to the proceeding can ask for
court review of Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: April 24, 2014.

    Dated: April 3, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-08033 Filed 4-9-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25637-25638]
[FR Doc No: 2023-08874]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2016-0178; FRL-10935-01-OMS]

Agency Information Collection Submission to the Office of
Management and Budget for Review and Approval; Comment Request; EPA
Application Materials for the Water Infrastructure Finance and
Innovation Act (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), EPA Application Materials for the
Water Infrastructure Finance and Innovation Act (EPA ICR Number
2549.02, OMB Control Number 2040-0292) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act. This is a proposed extension of the ICR, which is
currently approved through April 30, 2023. Public comments were
previously requested via the Federal Register on September 19, 2022
during a 60-day comment period. This notice allows for an additional 30
days for public comments.

DATES: Comments may be submitted on or before May 30, 2023.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OW-2016-0178, to EPA online using www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 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.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Amelia Letnes, Water Infrastructure
Division, Office of Wastewater Management, 4201-T, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR,
which is currently approved through April 30, 2023. An agency may not
conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.
    Public comments were previously requested via the Federal Register
on September 19, 2022 during a 60-day comment period (87 FR 57194).
This notice allows for an additional 30 days for public comments.
Supporting documents which explain in detail the information that the
EPA will be collecting are available in the public docket for this ICR.
The docket can be viewed online at www.regulations.gov or in person at
the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Abstract: The collection of information is necessary in order to
receive applications for credit assistance pursuant to section 5024 of
the Water Infrastructure Finance and Innovation Act (WIFIA) of 2014, 33
U.S.C. 3903. The purpose of the WIFIA program is to provide Federal
credit assistance in the form of direct loans and loan guarantees to
eligible water infrastructure projects.
    WIFIA requires that an eligible entity submit to the Administrator
an application at such time, in such manner, and containing such
information, as the Secretary or the Administrator may require to
receive assistance under WIFIA. In order to satisfy these requirements,
EPA must collect an application from prospective borrowers seeking
funding. The Letters of Interest and Applications collected from
prospective borrowers through this solicitation will be used by the
EPA, WIFIA program staff, and reviewers to evaluate applications for
credit assistance under the WIFIA eligibility requirements and
selection criteria.
    Form Numbers: EPA 6100-030, 6100-031, 6100-32, 6100-033, 6100-054,
6100-080.
    Respondents/affected entities: Corporations, partnerships, joint
ventures, trusts, federal, state, or local government entities, tribal
governments or a consortium of tribal governments, and state
infrastructure finance authorities.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (section 5024 of WIFIA, 33 U.S.C. 3903).
    Estimated number of respondents: 105 per year (total).
    Frequency of response: One per funding round.
    Total estimated burden: 10,450 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $10,772,065 (per year), which includes
$10,000,000 annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 375 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to EPA anticipating fewer
collections based on average numbers in the past 3 years. That decrease
is offset by a small increase due to a new form.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2023-08874 Filed 4-26-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 10, 2008 (Volume 73, Number 133)]
[Notices]
[Page 39691]
[DOCID:fr10jy08-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10854-080-MI]

Upper Peninsula Power Company; Notice of Availability of
Environmental Assessment

July 2, 2008.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR part
380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has
reviewed Upper Peninsula Power Company's proposed shoreline management
plan for the Cataract Hydroelectric Project, located on the Middle
Branch of the Escanaba River in Marquette County, Michigan, and has
prepared an Environmental Assessment (EA).
    A copy of the EA is on file with the Commission and is available
for public inspection. The EA may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number (P-10854) excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-
3676, or for TTY,<PHONE_NUMBER>.
    Any comments on the EA should be filed by August 1, 2008, and
should be addressed to the Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Room 1-A, Washington, DC 20426.
Please reference the project name and project number (P-10854) on all
comments. Comments may be filed electronically via Internet in lieu of
paper. The Commission strongly encourages electronic filings. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site under the ``eFiling'' link. For further information, contact Jon
Cofrancesco at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-15700 Filed 7-9-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Notices]
[Page 28313]
[FR Doc No: 2019-12827]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4337-DR; Docket ID FEMA-2019-0001]

Florida; Amendment No. 17 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for State of Florida (FEMA-4337-DR), dated September 10, 2017, and
related determinations.

DATES: This change occurred on May 1, 2019.

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, Gary R.
Stanley, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Thomas J. McCool as
Federal Coordinating Officer for this disaster.

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.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-12827 Filed 6-17-19; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Proposed Rules]
[Pages 55045-55049]
[FR Doc No: 2015-22724]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3628; Directorate Identifier 2015-NM-025-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2012-12-
04, which applies to certain The Boeing Company Model 737-300, -400,
and -500 series airplanes. AD 2012-12-04 currently requires repetitive
external detailed inspections and nondestructive inspections to detect
cracks in the fuselage skin along the chem-mill steps at stringers S-1
and S-2R, between station (STA) 400 and STA 460, and repair if
necessary. Since we issued AD 2012-12-04, we have determined that, for
certain airplanes, the skin pockets adjacent to the Air Traffic Control
(ATC) antenna are susceptible to widespread fatigue damage. This
proposed AD would require a preventive modification of the fuselage
skin at crown stringers S-1 and S-2R. This proposed AD would reduce
inspection thresholds and repetitive intervals for certain airplanes.
We are proposing this AD to detect and correct fatigue cracking of the
fuselage skin panels at the chem-mill steps, which could result in
sudden fracture and failure of the fuselage skin panels,

and consequent rapid decompression of the airplane.

DATES: We must receive comments on this proposed AD by October 29,
2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<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-2015-
3628.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3628; 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 proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6590; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-3628;
Directorate Identifier 2015-NM-025-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On May 31, 2012, we issued AD 2012-12-04, Amendment 39-17083 (77 FR
36134, June 18, 2012), for certain The Boeing Company Model 737-300, -
400, and -500 series airplanes. AD 2012-12-04 requires repetitive
external detailed inspections and nondestructive inspections to detect
cracks in the fuselage skin along the chem-mill steps at stringers S-1
and S-2R, between station (STA) 400 and STA 460, and repair if
necessary. AD 2012-12-04 resulted from reports of crack findings of the
fuselage skin at the chem-mill steps. We issued AD 2012-12-04 to detect
and correct fatigue cracking of the fuselage skin panels at the chem-
mill steps, which could result in sudden fracture and failure of the
fuselage skin panels, and consequent rapid decompression of the
airplane.

Widespread Fatigue Damage

    Structural fatigue damage is progressive. It begins as minute
cracks, and those cracks grow under the action of repeated stresses.
This can happen because of normal operational conditions and design
attributes, or because of isolated situations or incidents such as
material defects, poor fabrication quality, or corrosion pits, dings,
or scratches. Fatigue damage can occur locally, in small areas or
structural design details, or globally. Global fatigue damage is
general degradation of large areas of structure with similar structural
details and stress levels. Multiple-site damage is global damage that
occurs in a large structural element such as a single rivet line of a
lap splice joining two large skin panels. Global damage can also occur
in multiple elements such as adjacent frames or stringers. Multiple-
site-damage and multiple-element-damage cracks are typically too small
initially to be reliably detected with normal inspection methods.
Without intervention, these cracks will grow, and eventually compromise
the structural integrity of the airplane, in a condition known as
widespread fatigue damage (WFD). As an airplane ages, WFD will likely
occur, and will certainly occur if the airplane is operated long enough
without any intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be mandated by airworthiness
directives through separate rulemaking actions.
    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.

Actions Since AD 2012-12-04, Amendment 39-17083 (77 FR 36134, June 18,
2012), Was Issued

    The preamble to AD 2012-12-04, Amendment 39-17083 (77 FR 36134,
June 18, 2012), specified that we considered the requirements ``interim
action.'' AD 2012-12-04 explained that we might consider further
rulemaking if final action is later identified. We now

have determined that it is necessary to initiate further rulemaking to
require modification of the fuselage skin at crown stringers S-1 and S-
2R, and to reduce inspection thresholds and repetitive intervals for
certain airplanes.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1293, Revision 3,
dated January 23, 2015. The service information describes procedures
for repetitive external detailed inspections and non-destructive
inspections to detect cracks in the fuselage skin along the chem-mill
steps at stringers S-1 and S-2R, between STA 400 and STA 460, and
repair of any cracking. The service information also describes
procedures for a modification of the chem-milled steps at the locations
identified, including related investigative actions and corrective
actions. 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 of this
NPRM.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2012-12-04, Amendment 39-17083 (77 FR 36134, June
18, 2012), this proposed AD would retain all of the requirements. Those
requirements are referenced in the service information identified
previously, which, in turn, is referenced in this proposed AD. This
proposed AD would require accomplishing the actions specified in the
service information described previously, except as discussed under
``Difference Between This Proposed AD and the Service Bulletin.'' For
information on the procedures and compliance times, see this service
information at http://www.regulations.gov by searching for and locating
Docket No. FAA-2015-3628.
    The phrase ``related investigative actions'' is used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that (1) are related to the primary action, and (2) further investigate
the nature of any condition found. Related investigative actions in an
AD could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.

Explanation of Compliance Time

    The compliance time for the modification specified in this proposed
AD for addressing WFD was established to ensure that discrepant
structure is modified before WFD develops in airplanes. Standard
inspection techniques cannot be relied on to detect WFD before it
becomes a hazard to flight. We will not grant any extensions of the
compliance time to complete any AD-mandated service bulletin related to
WFD without extensive new data that would substantiate and clearly
warrant such an extension.

Difference Between This Proposed AD and the Service Bulletin

    Although Boeing Alert Service Bulletin 737-53A1293, Revision 3,
dated January 23, 2015, specifies that operators may contact the
manufacturer for disposition of certain repair conditions, this
proposed AD would require repairing those conditions in one of the
following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 186 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost    Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Retained inspections from AD 2012- Between 7 and 15               $0  Between $595 and      Between $110,670 and
 12-04, Amendment 39-17083 (77 FR   work-hours x $85                   $1,275 per            $237,150 per
 36134, June 18, 2012).             per hour, depending                inspection cycle.     inspection cycle.
                                    on airplane
                                    configuration =
                                    between $595 and
                                    $1,275 per
                                    inspection cycle.
New modification.................  236 work-hours x $85        (\1\)  $20,060.............  $3,731,160.
                                    per hour = $20,060.
----------------------------------------------------------------------------------------------------------------
\1\ We currently have no specific cost estimates associated with the parts necessary for the proposed
  modification. We cannot determine the cost of the materials because the modification parts must be sized at
  the time the modification is installed, taking into account any existing repairs in the area.

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

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or

on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2012-12-04, Amendment 39-17083 (77 FR 36134, June 18, 2012), and adding
the following new AD:

The Boeing Company: Docket No. FAA-2015-3628; Directorate Identifier
2015-NM-025-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by October 29,
2015.

(b) Affected ADs

    This AD replaces AD 2012-12-04, Amendment 39-17083 (77 FR 36134,
June 18, 2012).

(c) Applicability

    This AD applies to The Boeing Company Model 737-300, -400, and -
500 series airplanes, certificated in any category, as identified in
Boeing Alert Service Bulletin 737-53A1293, Revision 3, dated January
23, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of cracks found on the fuselage
skin at the chem-mill steps, and the determination that, for certain
airplanes, the skin pockets adjacent to the Air Traffic Control
(ATC) antenna are susceptible to widespread fatigue damage. We are
issuing this AD to detect and correct fatigue cracking of the
fuselage skin panels at the chem-mill steps, which could result in
sudden fracture and failure of the fuselage skin panels, and
consequent rapid decompression of the airplane.

(f) Compliance

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

(g) Inspections

    At the applicable time specified in tables 1, 2, 3, and 5 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1293, Revision 3, dated January 23, 2015, except as required
by paragraphs (j)(1) and (j)(2) of this AD: Do the actions specified
in paragraphs (g)(1) and (g)(2) of this AD, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1293, Revision 3, dated January 23, 2015, except as required by
paragraph (j)(3) of this AD. Repeat the applicable inspections
thereafter at the applicable times specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1293,
Revision 3, dated January 23, 2015.
    (1) Do an external detailed inspection for cracking of the
fuselage skin chem-mill steps.
    (2) Do an external non-destructive (medium frequency eddy
current, magneto optical imaging, C-Scan, or ultrasonic phased
array) inspection for cracking of the fuselage skin chem-mill steps.

(h) Preventive Modification or Repair

    If any cracking is found during any inspection required by
paragraph (g) of this AD, do the applicable actions specified in
paragraph (h)(1) or (h)(2) of this AD.
    (1) Repair before further flight in accordance with Part 2 of
the Accomplishment Instructions of Boeing Alert Service Bulletin
737-53A1293, Revision 3, dated January 23, 2015.
    (2) At the applicable time specified in tables 1, 2, 3, and 5 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1293, Revision 3, dated January 23, 2015, except as required
by paragraphs (j)(1) and (j)(2) of this AD: Do a preventive
modification of the fuselage skin at crown stringers S-1 and S-2R,
including all applicable related investigative actions in accordance
with Part 9 of the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-53A1293, Revision 3, dated January 23, 2015. Do
all applicable related investigative actions concurrently with the
modification.

(i) Post-Repair Inspections/Post-Modification Inspections

    The post-repair/post-modification inspections specified in
tables 4 and 6 of paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 737-53A1293, Revision 3, dated January 23, 2015,
are not required by this AD.

    Note 1 to paragraph (h) of this AD: The post-repair/post-
modification inspections specified in tables 4 and 6 of paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-53A1293,
Revision 3, dated January 23, 2015, may be used in support of
compliance with section 121.1109(c)(2) or 129.109(c)(2) of the
Federal Aviation Regulations (14 CFR 121.1109(c)(2) or 14 CFR
129.109(c)(2)). The corresponding actions specified in the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1293, Revision 3, dated January 23, 2015, are not required by
this AD.

(j) Exceptions to Service Bulletin Specifications

    (1) Where Boeing Alert Service Bulletin 737-53A1293, Revision 3,
dated January 23, 2015, specifies a compliance time ``after the
Revision 3 date of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Where the Condition column of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1293,
Revision 3, dated January 23, 2015, specifies a condition based on
when an airplane has or has not been inspected, this AD bases the
condition on whether an airplane has or has not been inspected on
the effective date of this AD.
    (3) Where Boeing Alert Service Bulletin 737-53A1293, Revision 3,
dated January 23, 2015, specifies to contact Boeing for repair
instructions: Before further flight, repair using a method approved
in accordance with the procedures specified in paragraph (k) of this
AD.

(k) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraphs (g) and (h) of this AD, if those actions were performed
before July 23, 2012 (the effective date of AD 2012-12-04, Amendment
39-17083 (77 FR 36134, June 18, 2012)), using Boeing Alert Service
Bulletin 737-53A1293, Revision 1, dated July 7, 2010, which is not
incorporated by reference in this AD.
    (2) This paragraph provides credit for actions required by
paragraphs (g) and (h) of this AD, if those actions were performed
before the effective date of this AD using Boeing Alert Service
Bulletin 737-53A1293, Revision 2, dated August 10, 2011, which was
incorporated by reference in AD 2012-12-04, Amendment 39-17083 (77
FR 36134, June 18, 2012).

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles 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 (l)(1) 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 required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) AMOCs approved for AD 2012-12-04, Amendment 39-17083 (77 FR
36134, June 18, 2012), are approved as AMOCs for the corresponding
provisions of paragraph (g) of this AD.

(m) Related Information

    (1) For more information about this AD, contact Wayne Lockett,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<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>.

    Issued in Renton, Washington, on September 1, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-22724 Filed 9-11-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73774-73776]
[FR Doc No: 2015-29992]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4166]

Public Meeting on Patient-Focused Drug Development for Psoriasis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on Patient-Focused Drug
Development for Psoriasis. Patient-Focused Drug Development is part of
FDA's performance commitments made as part of the fifth authorization
of the Prescription Drug User Fee Act (PDUFA V). The public meeting is
intended to allow FDA to obtain patient perspectives on the impact of
psoriasis, including on daily life and patient views on treatment
approaches. FDA is interested in patients' perspectives for the types
of psoriasis with primarily skin symptoms (such plaque psoriasis, nail
psoriasis, guttate psoriasis, etc.), patient views on treatment
approaches, and decision factors taken into account when selecting a
treatment.

DATES: The public meeting will be held on March 17, 2016, from 10 a.m.
to 6 p.m. Registration to attend the meeting must be received by March
10, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit
electronic or written comments to the public docket by May 17, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-0418 for ``An Evaluation of the Prescription Drug User Fee
Act Workload Adjuster; Request for Comments.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected psoriasis as the focus of a public meeting under
Patient-Focused Drug Development, an initiative that involves obtaining
a better understanding of patient perspectives on the severity of a
disease and the available therapies for that condition. Patient-Focused
Drug Development is being conducted to fulfill FDA performance
commitments that are part of the reauthorization of the PDUFA under
Title I of the Food and Drug Administration Safety and Innovation Act
(FDASIA) (Pub. L. 112-144). The full set of performance commitments is
available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtain the patient perspective on at least 20
disease areas during the course of PDUFA V. For each disease area, the
Agency is conducting a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefit that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient communities, and other
interested stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 08441) announcing the disease areas for meetings in fiscal years
(FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame.
The Agency used several criteria outlined in that notice to develop the
list of disease areas. FDA obtained public comment on the Agency's
proposed criteria and potential disease areas through a public docket
and a public meeting that was convened on October 25, 2012. In
selecting the set of disease areas, FDA carefully considered the public
comments received and the perspectives of review divisions at FDA. FDA
initiated a second public process for determining the disease areas for
FY 2016-2017, and published a notice in the Federal Register on July 2,
2015, announcing the selection of eight disease areas. More
information, including the list of disease areas and a general schedule
of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on the symptoms of psoriasis that
matter most to patients and on current approaches to treating
psoriasis. Psoriasis is a chronic, immune-mediated skin condition that
is associated with both a physical and psychological burden. It is
characterized by areas of red, thickened, scaling skin and may be
accompanied by itching or soreness. While there is currently no cure,
treatments for psoriasis include topical therapies such as
corticosteroids

and vitamin D analogs, systemic drugs, biologic products, and
phototherapy. FDA is interested in the perspectives of patients with
psoriasis on (1) the impact of their skin disease, including the extent
and location (e.g., nail, palm, scalp, genital) of involvement, (2)
treatment approaches, and (3) decision factors taken into account when
selecting a treatment.
    The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, organized by
topic. For each topic, a brief initial patient panel discussion will
begin the dialogue. This will be followed by a facilitated discussion
inviting comments from other patient and patient stakeholder
participants. In addition to input generated through this public
meeting, FDA is interested in receiving patient input addressing these
questions through written comments, which can be submitted to the
public docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
    (1) Of all the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include red, thickened, scaling skin,
itching, burning, or soreness, etc.)
    (2) Are there specific activities that are important to you but
that you cannot do at all or as fully as you would like because of your
condition? (Examples of activities may include sleeping through the
night, daily hygiene, participation in sports or social activities,
intimacy with a spouse or partner, etc.)
    (3) How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days?
    (4) How have your condition and its symptoms changed over time?
    (a) Would you define your condition today as being well managed?
    (5) What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treatment
    (1) What are you currently doing to help treat your condition or
its symptoms? (Examples may include prescription medicines, over-the-
counter products, phototherapy, and other therapies including non-drug
therapies such as diet modification.)
    (a) How has your treatment regimen changed over time, and why?
    (2) How well does your current treatment regimen control your
condition?
    (a) How well do your treatments address specific skin symptoms?
Which symptoms are not addressed as well?
    (b) How well have these treatments worked for you as your condition
has changed over time?
    (3) What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include going to the hospital or clinic for treatment,
time devoted to treatment, etc.)
    (4) Assuming there is no complete cure for your condition, what
specific things would you look for in an ideal treatment for your
condition?
    (a) What would you consider to be a meaningful improvement (for
example symptom improvements or functional improvements) in your
condition that a treatment could provide?
    (5) What factors do you take into account when making decisions
about selecting a course of treatment?
    (a) What information on the potential benefits of these treatments
factors most into your decision?
    (b) How do you weigh the potential benefits of these treatments
versus the common side effects of the treatments? (Common side effects
could include headache, nausea, injection site reactions.)
    (c) How do you weigh potential benefits of these treatments versus
the less common but serious risks associated with the treatments?
(Examples of less common but serious risks are infections, cancer,
liver damage, kidney damage, birth defects, blood disorders, etc.)

B. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://psoriasispfdd.eventbrite.com. Please register by March 10, 2016. If you
are unable to attend the meeting in person, you can register to view a
live Webcast of the meeting. You will be asked to indicate in your
registration if you plan to attend in person or via the Webcast.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of a disability, please contact Meghana
Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
    Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. These patients also
must send to<EMAIL_ADDRESS>a brief summary of responses to
the topic questions by February 29, 2016. Panelists will be notified of
their selection approximately 7 days before the public meeting. We will
try to accommodate all patients and patient stakeholders who wish to
speak, either through the panel discussion or audience participation;
however, the duration of comments may be limited by time constraints.
    Docket Comments: Regardless of whether you attend the public
meeting, you can submit electronic or written responses to the
questions pertaining to Topics 1 and 2 to the public docket (see
ADDRESSES) by May 17, 2016.
    Transcripts: As soon as a transcript is available, FDA will post it
at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

    Dated: November 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29992 Filed 11-24-15; 8:45 am]
BILLING CODE 4164-01-P