[Federal Register: October 12, 2007 (Volume 72, Number 197)]
[Notices]
[Page 58147]
[DOCID:fr12oc07-113]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at Lafayette Regional Airport, Lafayette, LA

AGENCY: Federal Aviation Administration (FAA) DOT.

ACTION: Request for public comment.

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SUMMARY: The FAA proposes to rule and invites the public comment on the
release of land at the Lafayette Regional Airport that is neither
Surplus property (49 U.S.C. 47151 et seq.) no property acquired with
any Airport Improvement Program (AIP) funds (49 U.S.C. 47107).

DATES: Comments must be received on or before November 13, 2007.

ADDRESSES: Comments on this application may be mailed or delivered to
FAA at the following address: Mr. Lacey D. Spriggs, Manager, Federal
Aviation Administration, Southwest Region, Airports Division,
Louisiana/New Mexico Airports Development Office, ASW-640, Fort Worth,
Texas 76137-4298.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Gregory M. Roberts, Director of Aviation,
Lafayette Regional Airport at the following address: Lafayette Regional
Airport, 200 Terminal Drive, Lafayette, Louisiana 70508-2159.

FOR FURTHER INFORMATION CONTACT: Ilia A. Quinones, Program Manager,
Federal Aviation Administration, Louisiana/New Mexico Airports
Development Office, ASW-640F, 2601 Meacham Boulevard, Fort Worth, Texas
76137-4298.
    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
airport sponsor's request to release property at the Lafayette Regional
Airport. The Lafayette Airport Commission requests the release of
 6.013 acres (five parcels) of airport property. The
release of this airport property along the existing U.S. Highway 90
will allow for the sale of these five parcels of airport property to
the State of Louisiana, Department of Transportation and Development,
which will allow for the construction of the I-49 Connector Project to
proceed. The sale is estimated to provide $1,324,370.00 to the
Lafayette Airport Commission that will allow the Lafayette Airport
Commission to pay the airport sponsor's share for the development of a
major cargo apron facility at the Lafayette Regional Airport.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the application,
notice and other documents germane to the application in person at the
Lafayette Regional Airport.

    Dated: Issued in Fort Worth, Texas, on October 3, 2007.
Joseph G. Washington,
Acting Manager, Airports Division.
[FR Doc. 07-5035 Filed 10-11-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Page 8911]
[FR Doc No: 2022-03358]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No.--2022-06]

Petition for Exemption; Summary of Petition Received;
Ameriflight, LLC

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

ACTION: Notice.

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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 nor 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 March 8, 2022.

ADDRESSES: Send comments identified by docket number FAA-2021-1095
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, 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 20590-0001, 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 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nia Daniels,<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.

Timothy R. Adams,
Deputy Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2021-1095.
    Petitioner: Ameriflight, LLC.
    Sections of 14 CFR Affected: Sec. Sec.  61.3(a)(1), 91.7(a),
91.9(a) and (b), 91.113(b), 91.119(b) and (c), 91.121(a)(1),
91.127(c), 91.129(c)(1), 91.130(c)(1) and (d), 91.131(b)(1), (c)(2),
and (d), 91.151, 91.203(a) and (b), 91.209(a)(1), 135.25(a)(1) and
(a)(2), 135.63(c)2, (c)(3), (c)(4), and (d), 135.65(a) and (d),
135.143(c)(2), 135.149(a), 135.161(a) and (b)(1), 135.203, 135.209,
135.243(b)(1), (b)(2), and (b)(3), 135.337(b)(1), 135.338(b)(1),
135.339(e)(3) and (e)(4), and 135.340(e)(3) and (e)(4).
    Description of Relief Sought: Ameriflight, LLC (Ameriflight)
seeks an exemption to operate its Matternet M2 (M2) unmanned
aircraft system (UAS) for package delivery in dense urban and
suburban environments, for on-demand airborne direct delivery.
Customer deliveries will be initiated from pre-established locations
called nodes. Once the cargo delivery is finished, the visual
observer will be responsible for delivering the cargo to the end
user or notifying the customer that the cargo has arrived and can be
picked up.

[FR Doc. 2022-03358 Filed 2-15-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 34 (Friday, February 18, 2011)]
[Notices]
[Page 9584]
[FR Doc No: 2011-3712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0528]

Unapproved Animal Drugs; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to April
19, 2011, the comment period for the notice that appeared in the
Federal Register of December 20, 2010 (75 FR 79383). In the notice FDA
requested comments on strategies to address the prevalence of animal
drug products marketed in the United States without approval or other
legal marketing status. The Agency is taking this action in response to
requests for an extension to allow interested persons additional time
to submit comments.

DATES: Submit electronic or written comments by April 19, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0528 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2010-N-0528. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
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.

FOR FURTHER INFORMATION CONTACT: Tracey H. Forfa, Center for Veterinary
Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 20, 2010 (75 FR 79383), FDA
published a notice with a 60-day comment period to request comments
from stakeholders on strategies to address the prevalence of animal
drug products marketed in the United States without approval or other
legal marketing status. The notice expressed FDA's interest in
receiving comments on strategies that utilize FDA's existing regulatory
framework for addressing this issue as well as on novel strategies not
currently employed by the Agency.
    The Agency has received requests for a 60-day extension of the
comment period. The requests conveyed concern that the current 60-day
comment period does not allow respondents sufficient time to address
fully the many important issues FDA raised in the notice.
    FDA has considered the requests and is extending the comment period
for the notice for 60 days, until April 19, 2011. The Agency believes
that a 60-day extension allows adequate time for interested persons to
submit comments without significantly delaying the Agency's
consideration of these important issues.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 15, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-3712 Filed 2-17-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23626-23627]
[FR Doc No: 2013-09233]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities; Requests for Comments;
Clearance of Renewed Approval of Information Collection: Report of
Inspections Required by Airworthiness Directives

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. OMB has requested that this information collection request
(ICR) be converted to a generic ICR. The Federal Register Notice with a
60-day comment period soliciting comments on the following collection
of information was published on December 7, 2012, vol. 77, no. 236,
page 73114. Airworthiness Directives are regulations issued to require
action to correct unsafe conditions in aircraft, engines, propellers,
and appliances. Reports of inspections are often needed when emergency
corrective action is taken to determine if the action was adequate to
correct the unsafe condition.

DATES: Written comments should be submitted by May 20, 2013.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

    OMB Control Number: 2120-0056.
    Title: Report of Inspections Required by Airworthiness Directives.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: Title 14 CFR part 39, Airworthiness Directives (AD),
authorized by Sec. Sec.  40113(a), 44701, and 44702 of Title 49 United
States Code, prescribes how the FAA issues ADs. The FAA issues ADs when
an unsafe condition is discovered on a specific aircraft type. If the
condition is serious enough and more information is needed to develop
corrective action, specific information may be required from aircraft
owners/operators. If it is necessary for the aircraft manufacturer or
airworthiness authority to evaluate the information, owners/operators
will be instructed to send the information to them.
    Respondents: Approximately 1,120 aircraft owners/operators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 5 minutes.
    Estimated Total Annual Burden: 3,080 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on April 15, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-09233 Filed 4-18-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 14, 2008 (Volume 73, Number 31)]
[Notices]
[Page 8661-8663]
[DOCID:fr14fe08-56]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2008-0118; FRL-8529-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Title of ICR; EPA ICR No. 2292.01, OMB Control No.
2060-NEW

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44

U.S.C. 3501 et seq), this document announces that EPA is planning to
submit a request for a new Information Collection Request (ICR) to the
Office of Management and Budget (OMB). Before submitting the ICR to OMB
for review and approval, EPA is soliciting comments on specific aspects
of the proposed information collection as described below.

DATES: Comments must be submitted on or before April 14, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2008-0118, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Percent High Evaporative Emitters in Fleet,
Environmental Protection Agency, EPA Docket Center (EPA/DC), Air and
Radiation Docket and Information Center, Mail code 6102T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: Environmental Protection Agency, EPA Docket
Center (EPA/DC), Air and Radiation Docket and Information Center, Mail
code 6102T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2008-0118. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Constance Hart, Assessment and
Standards Division, Office of Transportation and Air Quality,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI
48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments:

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2008-0118, which is available for online viewing at
http://www.regulation.gov, or in person viewing at the OTAQ Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Office of Air and Radiation Docket is (202)
566-1742.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search'', then key in the docket ID number
identified in this document.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What information collection activity or ICR does this apply to?

    Docket ID No. EPA-HQ-OAR-2008-0118.
    Affected entities: Entities potentially affected by this action are
individual owners of light duty passenger cars and trucks.
    Title: Determine Percentage of High Evaporative Emission Vehicles
in On-road Fleet of Motor Vehicle Passenger Cars and Light Trucks
    ICR numbers: EPA ICR No. 2292.01, OMB Control No. 2060-NEW.
    ICR status: This ICR is for a new information collection activity.
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. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register when approved, are
listed in 40 CFR part 9, are displayed either by publication in the
Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB
control numbers in certain EPA regulations is consolidated in 40 CFR
part 9.
    Abstract: The purpose of this study is to investigate the fractions
of passenger cars and light trucks in the on-road fleet that have
atypically high emissions of evaporative hydrocarbons. In past and
current programs, vehicles with high evaporative emissions have been
measured in the laboratory. In some cases, high emissions represented
the state of the vehicle in use, and in others, high emissions were
induced for experimental purposes. However, a critical data gap in the
utilization of these data is reasonably accurate estimates for the
prevalence of high emitting vehicles in the fleet. In addressing this
need, the results of this study will be used to improve the accuracy of
evaporative emission inventories for EPA's planning and regulations as
well as for States in analyses supporting compliance with the Clean Air
Act.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.0
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 4350.
    Frequency of response: One time for 95%, twice for 5%.
    Estimated total average number of responses for each respondent:
2.88.
    Estimated total annual burden hours: 3785.
    Estimated total annual costs: $111,934. This includes an estimated
burden cost of $111,934 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: February 7, 2008.
Chester France,
Assessment and Standards Division.
 [FR Doc. E8-2782 Filed 2-13-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Page 13355]
[FR Doc No: 2022-04995]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2010-0045]

Metro-North Commuter Railroad's Request To Amend Its Positive
Train Control Safety Plan and Positive Train Control System

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document provides the public with notice that, on
February 22, 2022, Metro-North Commuter Railroad (MNR) submitted a
request for amendment (RFA) to its FRA-approved Positive Train Control
Safety Plan (PTCSP). As this RFA may involve a request for FRA's
approval of proposed material modifications to an FRA-certified
positive train control (PTC) system, FRA is publishing this notice and
inviting public comment on the railroad's RFA to its PTCSP.

DATES: FRA will consider comments received by March 29, 2022. FRA may
consider comments received after that date to the extent practicable
and without delaying implementation of valuable or necessary
modifications to a PTC system.

ADDRESSES:
    Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name and the
applicable docket number. The relevant PTC docket number for this host
railroad is Docket No. FRA-2010-0045. For convenience, all active PTC
dockets are hyperlinked on FRA's website at https://railroads.dot.gov/train-control/ptc/ptc-annual-and-quarterly-reports. All comments
received will be posted without change to https://www.regulations.gov;
this includes any personal information.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
Train Control, and Crossings Division, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: In general, Title 49 United States Code
(U.S.C.) Section 20157(h) requires FRA to certify that a host
railroad's PTC system complies with 49 CFR part 236, subpart I, before
the technology may be operated in revenue service. Before making
certain changes to an FRA-certified PTC system or the associated FRA-
approved PTCSP, a host railroad must submit, and obtain FRA's approval
of, an RFA to its PTCSP under Title 49 Code of Federal Regulations
(CFR) Section 236.1021.
    Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will
publish a notice in the Federal Register and invite public comment in
accordance with 49 CFR part 211, if an RFA includes a request for
approval of a material modification of a signal and train control
system. Accordingly, this notice informs the public that, on February
22, 2022, MNR submitted an RFA to its PTCSP for its Advanced Civil
Speed Enforcement System II (ACSES II) and that RFA is available in
Docket No. FRA-2010-0045.
    Interested parties are invited to comment on MNR's RFA to its PTCSP
by submitting written comments or data. During FRA's review of this
railroad's RFA, FRA will consider any comments or data submitted within
the timeline specified in this notice and to the extent practicable,
without delaying implementation of valuable or necessary modifications
to a PTC system. See 49 CFR 236.1021; see also 49 CFR 236.1011(e).
Under 49 CFR 236.1021, FRA maintains the authority to approve, approve
with conditions, or deny a railroad's RFA to its PTCSP at FRA's sole
discretion.

Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
public to better inform its decisions. DOT posts these comments,
without edit, including any personal information the commenter
provides, to https://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate
comment tracking, we encourage commenters to provide their name, or the
name of their organization; however, submission of names is completely
optional. If you wish to provide comments containing proprietary or
confidential information, please contact FRA for alternate submission
instructions.

    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
Director, Office of Railroad Systems and Technology.
[FR Doc. 2022-04995 Filed 3-8-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26308-26312]
[FR Doc No: 2016-10277]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Environmental Impact Statement (EIS) for the Hudson Tunnel
Project in Hudson County, New Jersey and New York County, New York

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of intent (NOI) to prepare an Environmental Impact
Statement (EIS).

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SUMMARY: Through this Notice, FRA announces its intent to jointly
prepare an environmental impact statement (EIS) with the New Jersey
Transit Corporation (NJ TRANSIT) for the Hudson Tunnel Project (the
Proposed Action or the Project) under the National Environmental Policy
Act (NEPA). The Proposed Action is

intended to preserve the current functionality of the Northeast
Corridor's (NEC) Hudson River rail crossing between New Jersey and New
York and strengthen the resilience of the NEC. The Project would
consist of construction of a new rail tunnel beneath the Hudson River,
including railroad infrastructure in New Jersey and New York connecting
the new rail tunnel to the existing NEC, and rehabilitation of the
existing NEC tunnel beneath the Hudson River, referred to as the North
River Tunnel. The EIS will evaluate the potential environmental impacts
of a reasonable range of alternatives, including the No Action (No
Build) Alternative. As appropriate, FRA and NJ TRANSIT will coordinate
with the National Railroad Passenger Corporation (Amtrak), as owner of
the North River Tunnel, and the Port Authority of New York and New
Jersey (PANYNJ) on the EIS.
    FRA invites the public and all interested parties to provide
comments on the scope of the EIS, including the proposed purpose and
need, the Proposed Action and alternatives to be considered in the EIS,
potential environmental impacts of concern and methodologies to be used
in the EIS, the approach for public and agency involvement, and any
other particular concerns about the potential impacts of the Proposed
Action.

DATES: Persons interested in providing written comments on the scope of
the EIS must do so by May 31, 2016. Please submit written comments via
the internet, email, or mail, using the contact information provided
below.
    Persons may also provide comments orally or in writing at the
public scoping meetings. FRA and NJ TRANSIT will hold two scoping
meetings on the following dates:
     May 17, 2016, at the Hotel Pennsylvania, Gold Ballroom,
3rd Floor, 401 Seventh Avenue at West 33rd Street, New York, New York
10001.
     May 19, 2016, at Union City High School, 2500 Kennedy
Boulevard, Union City, New Jersey 07087.
    Both days will include an afternoon session from 3 to 5 p.m. with a
brief presentation about the Proposed Action at 4 p.m., and an evening
session from 6 to 8 p.m. with a brief presentation about the Proposed
Action at 7 p.m. The public can review Project information, talk
informally with members of the study staff, and formally submit
comments to the FRA (to a stenographer or in writing). The meeting
facilities will be accessible to persons with disabilities. Spanish
language translators will be present. If you need special translation
or signing services or other special accommodations, please contact the
Project team five days prior to the meeting at<PHONE_NUMBER>, or email
<EMAIL_ADDRESS>    FRA and NJ TRANSIT will give equal consideration to oral and
written comments.

ADDRESSES: The public and other interested parties are encouraged to
comment via the internet at the Project's Web site
(www.hudsontunnelproject.com) or via email at
<EMAIL_ADDRESS>You can also send written comments by
mail to persons identified below.

FOR FURTHER INFORMATION CONTACT: Amishi Castelli, Ph.D., Environmental
Protection Specialist, Office of Railroad Policy and Development, USDOT
Federal Railroad Administration, One Bowling Green, Suite 429, New
York, NY 10004, or<EMAIL_ADDRESS>or Mr. RJ Palladino, AICP,
PP, Senior Program Manager, NJ TRANSIT Capital Planning, One Penn Plaza
East--8th Floor, Newark, NJ 07105, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FRA and NJ TRANSIT will prepare the EIS in
compliance with NEPA, the Council on Environmental Quality (CEQ)
regulations implementing NEPA (40 CFR parts 1500-1508), and the FRA
Procedures for Considering Environmental Impacts (FRA's Environmental
Procedures) (64 FR 28545, May 26, 1999; 78 FR 2713, Jan. 14, 2013).
Consistent with Section 11503 of the Fixing America's Surface
Transportation Act of 2015 (FAST Act), FRA and NJ TRANSIT will prepare
the EIS consistent with 23 U.S.C. 139. After release and circulation of
a Draft EIS for public comment, FRA intends to issue a single document
that consists of the Final EIS and Record of Decision under Public Law
112-141, 126 Stat. 405, Section 1319(b) unless it determines the
statutory criteria or practicability considerations preclude issuing a
combined document.
    The EIS will also document compliance with other applicable
Federal, state, and local environmental laws and regulations, including
Section 106 of the National Historic Preservation Act (NHPA); the
Conformity requirements of the Clean Air Act; the Clean Water Act;
Section 4(f) of the Department of Transportation Act of 1966 (Section
4(f)); the Endangered Species Act; Executive Order 11988 and USDOT
Order 5650.2 on Floodplain Management; Executive Order 11990 on
Protection of Wetlands; the Magnuson-Stevens Act related to Essential
Fish Habitat; the Coastal Zone Management Act; and Executive Order
12898 on Environmental Justice. The EIS will provide FRA, NJ TRANSIT,
and other cooperating and participating agencies and the public with
information about alternatives that meet the Proposed Action's purpose
and need, including their environmental impacts and appropriate
measures to avoid, minimize, and mitigate those impacts.
    The Proposed Action may affect historic properties and will be
subject to the requirements of Section 106 of the NHPA (54 U.S.C.
306108). Consistent with regulations issued by the Advisory Council on
Historic Preservation (36 CFR part 800), FRA intends to coordinate
compliance with Section 106 of the NHPA with the preparation of the
EIS. The public and interested parties may also provide input relevant
to FRA's review under Section 106 including identifying potentially
eligible resources and the potential effect of the Proposed Action on
those resources. In addition, the public or other interested parties
may also request to participate in the Section 106 process as a
consulting party under 36 CFR part 800.

Project Background

    The existing NEC rail tunnel beneath the Hudson River is known as
the North River Tunnel. This tunnel is used by Amtrak for intercity
passenger rail service and by NJ TRANSIT for commuter rail service. The
approach to the tunnel begins east of NJ TRANSIT's Frank R. Lautenberg
Station in Secaucus, New Jersey (which is 5 miles east of Amtrak and NJ
TRANSIT's Newark Penn Station). East of the Secaucus station, the NEC
has two tracks that approach the tunnel on a raised embankment through
the towns of Secaucus and North Bergen, New Jersey. Tracks enter a
tunnel portal in North Bergen, passing beneath Union City and
Weehawken, New Jersey and the Hudson River before emerging within the
Penn Station New York (PSNY) rail complex in New York City. The tunnel
has two separate tubes, each accommodating a single track for
electrically powered trains, and extends approximately 2.5 miles from
the tunnel portal in North Bergen to PSNY. The existing North River
Tunnel is a critical NEC asset and is the only intercity passenger rail
crossing into New York City from New Jersey and areas west and south.
    The NEC is the most heavily used passenger rail line in the U.S.,
both in terms of ridership and service frequency. Amtrak operates over
the

entire NEC, providing regional service, long distance service, and
high-speed Acela Express service. Amtrak owns the majority of the NEC,
including the North River Tunnel. NJ TRANSIT operates an extensive
commuter rail network in New Jersey that extends to Philadelphia,
Pennsylvania; Orange and Rockland Counties in New York; and New York
City. Amtrak's NEC service and NJ TRANSIT's commuter rail service
provide connections between the major cities of the Mid-Atlantic and
Northeast states and commuter access for thousands of people who work
in the region. Therefore, both services are important to the region's
economy. In 2014, Amtrak carried approximately 24,000 weekday
passengers each day on more than 100 trains between New York and New
Jersey. NJ TRANSIT carried almost 90,000 weekday passengers each day on
approximately 350 trains between New York and New Jersey.
    Extensive engineering work and environmental documentation have
been prepared over the past two decades for a new Hudson River rail
tunnel. This has included the detailed studies and design conducted for
the Access to the Region's Core (ARC) project from 1995 through 2010.
The ARC project evaluated several options for construction of a new
tunnel under the Hudson River in combination with an expansion of
station capacity in midtown Manhattan to accommodate growing passenger
demand. In addition, Amtrak conducted the Gateway Program Feasibility
Study in 2011-2013, which assessed options for constructing a new
Hudson River tunnel. Amtrak's Gateway Program envisions a series of
improvement projects to upgrade and expand the capacity of the NEC.
While many of the Gateway improvements are still being fully defined, a
new Hudson Tunnel on the NEC is urgently needed to maintain existing
service.
    In 2012, the FRA launched the NEC FUTURE study to consider the role
of rail passenger service in the context of current and future
transportation demands and to evaluate the appropriate level of
capacity improvements to make across the NEC. The intent of the NEC
FUTURE program is to help develop a long-term vision and investment
program for the NEC. Through NEC FUTURE, FRA is currently evaluating
overall capacity improvements and environmental consequences associated
with improved NEC rail services, including trans-Hudson service.
However, as described above, this Proposed Action addresses a specific
need due to the deterioration of the existing North River Tunnel and
can be considered independently from the other projects analyzed in the
NEC FUTURE EIS. All three build alternatives evaluated in the NEC
FUTURE Tier 1 Draft EIS FRA released in November 2015 included new
Hudson River tunnel investments similar to this Proposed Action. This
EIS may incorporate the appropriate analysis and other relevant
elements from the NEC FUTURE Tier 1 EIS while focusing on the issues
specific to this independent Project.
    As appropriate, FRA and NJ TRANSIT will use the work conducted for
the ARC project and Amtrak's feasibility study to provide baseline
information for the study of the Proposed Action. While the Proposed
Action addresses maintenance and resilience of the NEC Hudson River
crossing, it would not increase rail capacity. At the same time, the
Proposed Action would not preclude other future projects to expand rail
capacity in the area. Accordingly, although the Proposed Action may
also be an element of a larger program to expand rail capacity, it
would meet an urgent existing need and will be evaluated as a separate
project from any larger initiative. Ultimately, an increase in service
between Newark Penn Station and PSNY would not occur until other
substantial infrastructure capacity improvements are built in addition
to a new Hudson River rail tunnel. These improvements will be the
subject of one or more separate design, engineering, and appropriate
environmental reviews.

Purpose and Need

    The purpose of the Proposed Action is: (1) To preserve the current
functionality of Amtrak's NEC service and NJ TRANSIT's commuter rail
service between New Jersey and PSNY by repairing the deteriorating
North River Tunnel; and (2) to strengthen the NEC's resiliency to
support reliable rail service by providing redundant capacity under the
Hudson River for Amtrak and NJ TRANSIT NEC trains between New Jersey
and the existing PSNY. These improvements must be achieved while
maintaining uninterrupted commuter and intercity rail service and by
optimizing the use of existing infrastructure.
    Service reliability through the tunnel has been compromised due to
damage to tunnel components Superstorm Sandy caused, when it inundated
both tubes in the North River Tunnel with seawater in October 2012.
That storm resulted in the cancellation of all Amtrak and NJ TRANSIT
service into New York City for five days. Although the tunnel was
restored to service and is now safe for travel, chlorides from the
seawater remain in the tunnel's concrete liner and bench walls, causing
ongoing damage to the bench walls, imbedded steel, track, and signaling
and electrical components.
    The damage Superstorm Sandy caused is compounded by the tunnel's
age and the intensity of its current use (operating at capacity to meet
current demands), resulting in frequent delays due to component
failures within the tunnel. With no other Hudson River passenger rail
crossing into PSNY, single-point failures can suspend rail service,
causing delays that cascade up and down the NEC as well as throughout
NJ TRANSIT's commuter system, disrupting service for hundreds of
thousands of passengers. For example, on March 17, 2016, a NJ TRANSIT
train became disabled in one of the tunnel's tubes during the morning
peak period, resulting in delays to 57 other Amtrak and NJ TRANSIT
trains headed into and out of PSNY that day. Service disruptions will
continue and will over time happen more frequently as the deterioration
from the seawater inundation continues and components fail in an
unpredictable manner.
    Because of the importance of the North River Tunnel to essential
commuter and intercity rail service between New Jersey and New York,
City, rehabilitation of the existing North River Tunnel must be
accomplished without unacceptable reductions in weekday service.
Removing one tube in the existing North River Tunnel from operation
without new capacity in place would reduce weekday service to volumes
well below the current maximum capacity of 24 peak direction trains per
hour.
    In addition, the existing two-track North River Tunnel is operating
at full capacity and does not provide redundancy for reliable train
operations during disruptions or maintenance. Therefore, any service
disruption results in major passenger delays and substantial reductions
to overall system flexibility, reliability and on-time performance.
This condition is exacerbated by the need to perform increased
maintenance to address damage Superstorm Sandy caused. These
maintenance demands are difficult to meet because of the intensity of
rail service in the tunnel. Efforts to maintain the North River Tunnel
in a functional condition currently require nightly and weekend tunnel
outages with reductions in service due to single-track operations.
Train service is adjusted to allow the closure of one tube of the North
River Tunnel each weekend for maintenance for a 55-hour window
beginning Friday evening and ending early Monday morning.

Proposed Action and Alternatives

    The Proposed Action, the Hudson Tunnel Project, consists of:
     A new NEC rail tunnel with two tubes and electrified
tracks beneath the Hudson River, extending from a new tunnel portal in
North Bergen, New Jersey to the PSNY rail complex;
     Ventilation shaft buildings above the tunnel on both sides
of the Hudson River to provide smoke ventilation during emergencies;
     Modifications to the existing NEC tracks in New Jersey and
additional track on the NEC to connect the new tunnel to the NEC,
beginning just east of Frank R. Lautenberg Station in Secaucus, New
Jersey, and approaching the new tunnel portal in North Bergen, New
Jersey;
     Modifications to connecting rail infrastructure at PSNY to
connect the new tunnel's tracks to the existing tracks at PSNY; and
     Rehabilitation of the existing North River Tunnel.
Once the North River Tunnel rehabilitation is complete, both the old
and new tunnel would be in service, providing redundant capacity and
increased operational flexibility for Amtrak and NJ TRANSIT.
    In addition to those permanent features, the Proposed Action would
involve the following types of construction activities, which will be
described and evaluated in the Draft EIS:
     Construction of new tracks along the NEC between Frank R.
Lautenberg Station and the new tunnel portal;
     Construction of the new tunnel using Tunnel Boring Machine
(TBM) technology, which is conducted underground from a tunnel portal.
At this time, it is anticipated that tunneling would likely occur from
the New Jersey side of the new tunnel;
     Construction staging sites near the tunnel portal and at
the vent shaft site in New Jersey. These locations would be used to
access the tunnel and to remove rock from the tunnel while it is being
bored;
     Construction staging site at the vent shaft site in
Manhattan; and
     Potential construction activities that affect the Hudson
River riverbed above the tunnel location.
    Alternatives will be developed based on the purpose of and need for
the Project, information obtained through the scoping process, and
information from previous studies. The EIS process will consider a No
Action Alternative and a reasonable range of Build Alternatives
identified through an alternatives development process. The Draft EIS
will document the alternatives development and screening process. On
the basis of that screening process and further analysis in the Draft
EIS itself, FRA anticipates that the Draft EIS will also identify and
describe the Preferred Alternative consistent with 40 CFR 1502.14(e).

Possible Effects

    Consistent with NEPA and FRA's Environmental Procedures, the EIS
will consider the potential direct, indirect, and cumulative effects of
the Project alternatives on the social, economic, and environmental
resources in the study area. This analysis will include identification
of study areas; documentation of the affected environment; evaluation
of direct and indirect effects of the alternatives; and identification
of measures to avoid and/or mitigate adverse impacts.
    The analysis will include detailed consideration of impacts that
would occur during the Project's construction--including construction
of the new tunnel and rehabilitation of the existing tunnel--as well as
consideration of the impacts once the construction is complete. The
Proposed Action would not expand capacity on this portion of the NEC as
compared to the No Action Alternative, and therefore service changes
are not an anticipated consequence of the Proposed Action. FRA and NJ
TRANSIT will evaluate direct, indirect and cumulative changes to the
human and natural environment resulting from the alternatives,
including analyses of the following resource areas:
     Transportation;
     Social and economic conditions;
     Property acquisition;
     Parks and recreational resources;
     Visual and aesthetic resources;
     Historic and archaeological resources;
     Air quality;
     Greenhouse gas emissions and resilience;
     Noise and vibration;
     Ecology (including wetlands, water and sediment quality,
floodplains, and biological resources);
     Threatened and endangered species;
     Contaminated materials; and
     Environmental justice.
A Section 4(f) evaluation will also be included in the Draft EIS.

Scoping, Public Involvement, and Agency Coordination

    This NOI initiates the scoping process under NEPA, which helps
guide the development of the Draft EIS. FRA and NJ TRANSIT invite all
interested individuals, organizations, and federal, state, and local
agencies to comment on the scope of the EIS. Comments are encouraged on
the Proposed Action's purpose and need; the alternatives to consider in
the EIS; the analyses to include in the EIS and the study area and
methodologies to be used; the approach for public and agency
involvement; and any particular concerns about the anticipated impacts
of the Proposed Action.
    Public agencies with jurisdiction are requested to advise FRA of
the applicable permit and environmental review requirements of each
agency, and the scope and content of the environmental information
germane to the agency's statutory responsibilities in connection with
the Proposed Action. Public agencies are requested to advise FRA if
they anticipate taking a major action in connection with the Proposed
Action and if they wish to cooperate in the preparation of the EIS
under 40 CFR 1501.16.
    FRA will coordinate with participating agencies during development
of the Draft EIS under 23 U.S.C. 139. FRA will also coordinate with
federally recognized tribes and Consulting Parties established under
Section 106 of the NHPA.
    The lead agencies will invite all Federal and non-Federal agencies
and Native American tribes that may have an interest in the Proposed
Action to become participating agencies for the EIS. If an agency or
tribe is not invited and would like to participate, please contact FRA
at the contact information listed above. The lead agencies will develop
a Coordination Plan summarizing how they will engage the public,
agencies, and tribes in the process. The Coordination Plan will be
posted to the Project Web site (www.hudsontunnelproject.com) and to
FRA's Web site (www.fra.dot.gov/Page/P0214). NJ TRANSIT will lead the
outreach activities during the public scoping process, beginning with
the scoping meeting and comment period identified under DATES above.
Public meetings, open houses and other public involvement initiatives,
including newsletters and outreach, will be held and used throughout
the course of this study. Public outreach activities will be announced
on the Project Web site (www.hudsontunnelproject.com) and through
mailings, public notices, advertisements and press releases.

    Issued in Washington, DC, on April 27, 2016.
Amitabha Bose,
Chief Counsel.
[FR Doc. 2016-10277 Filed 4-28-16; 11:15 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Pages 32136-32137]
[FR Doc No: 2018-14749]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1835]

Smallpox (Variola Virus) Infection: Developing Drugs for
Treatment or Prevention; Draft 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 draft guidance for industry entitled ``Smallpox
(Variola Virus) Infection: Developing Drugs for Treatment or
Prevention.'' The purpose of this draft guidance is to assist sponsors
in all phases of development of antiviral drugs for the treatment or
prevention of smallpox (variola virus) infection. This draft guidance
revises the draft guidance for industry entitled ``Smallpox (Variola)
Infection: Developing Drugs for Treatment or Prevention'' issued on
November 23, 2007.

DATES: Submit either electronic or written comments on the draft
guidance by September 10, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-1835 for ``Smallpox (Variola Virus) Infection: Developing
Drugs for Treatment or Prevention; Draft Guidance for Industry;
Availability.'' 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 draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6370, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Smallpox (Variola Virus) Infection: Developing Drugs for
Treatment or Prevention.'' The purpose of this draft guidance is to
assist sponsors in all phases of development of antiviral drugs for the
treatment or prevention of smallpox (variola virus) infection. This
draft guidance addresses nonclinical development, key study design
considerations for animal efficacy studies to support potential new
drug application (NDA)/biologics license application (BLA) submissions
under the animal rule (21 CFR part 314, subpart I, for drugs and 21 CFR
part 601, subpart H, for biologics), and considerations for obtaining a
human safety database.
    This draft guidance revises the draft guidance for industry
entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment
or Prevention'' issued on November 23, 2007 (72 FR 65750). The
revisions intend to streamline the guidance and incorporate input from
a public workshop in 2009 and an advisory committee meeting in 2011.
This revision contains the following changes:
     Modification and integration of several sections to focus
on multidisciplinary considerations for studies in animal models of
orthopoxvirus disease, including:

[cir] Considerations for preliminary assessments of antiviral activity
in animal models
[cir] Key study design considerations for animal efficacy studies to
support potential NDA/BLA submissions under the animal rule
[cir] Selection of an effective dose in humans

     Additional clarification on the following:

[cir] Key nonclinical virology issues related to drug development under
the animal rule
[cir] Key pharmacology/toxicology issues
[cir] Considerations regarding healthy volunteer safety trials, safety
data from non-smallpox clinical experience, clinical trials in the
event of a public health emergency, individual patient expanded access
investigational new drug applications for emergency use, and emergency
use authorization
[cir] Key clinical pharmacology issues that may be affected by
limitations in collecting clinical data
[cir] Key chemistry, manufacturing, and controls issues, such as the
importance of developing formulations for patients who are unable to
swallow solid oral dosage formulations, as well as the importance of
generating stability data needed to support a long expiration dating
period

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on developing
drugs for the treatment and prevention of smallpox (variola virus)
infection. 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. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR part 312
(investigational new drug applications) has been approved under OMB
control number 0910-0014. The collection of information in 21 CFR part
314 (NDAs) has been approved under OMB control number 0910-0001. The
collection of information resulting from special protocol assessments
has been approved under OMB control number 0910-0470. The collection of
information resulting from emergency use authorization of medical
products has been approved under OMB control number 0910-0595. The
collection of information resulting from individual patient expanded
access applications has been approved under OMB control number 0910-
0814. The collection of information resulting from good laboratory
practices has been approved under OMB control number 0910-0119.

III. Electronic Access

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

    Dated: July 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14749 Filed 7-10-18; 8:45 am]
 BILLING CODE 4164-01-P