[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Page 3557]
[FR Doc No: 2016-01193]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2016-07]

Petition for Exemption; Summary of Petition Received; Hazon
Solutions LLC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

DATES: Comments on this petition must identify the petition docket
number and must be received on or before February 10, 2016.

ADDRESSES: Send comments identified by docket number FAA-2015-0218
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: Dan Ngo,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on January 15, 2016.
James M. Crotty,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-0218.
    Petitioner: Hazon Solutions Inc.
    Section(s) of 14 CFR Affected: 91.119(c).
    Description of Relief Sought: The petitioner requests to conduct
commercial UAS operations within 500 feet of any person, vessel,
vehicle, or structure in a manner consistent with 14CFR 91.119(d). The
petitioner states that they will not operate over persons non-
participating in the operation unless they are under a covered
structure.

[FR Doc. 2016-01193 Filed 1-20-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54107-54108]
[FR Doc No: 2018-23425]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3614]

Biopharmaceutics Classification System-Based Biowaivers;
International Council for Harmonisation; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Biopharmaceutics Classification System-Based Biowaivers.'' The draft
guidance was prepared under the auspices of the International Council
for Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance will provide recommendations to
support the biopharmaceutics classification of drug substances and the
Biopharmaceutics Classification System (BCS)-based waiver of in vivo
bioequivalence (BE) studies for drug products. In vivo BE studies are
needed to demonstrate lack of impact of significant formulation changes
on a drug's bioavailability during its development, for post-approval
line extensions, and when developing a generic product. Utilizing the
critical properties of the drug substance and the drug product, and
applying the BCS framework, assurance of in vivo BE findings can be
obtained using extensive in vitro studies. The draft guidance is
intended to avoid unnecessary human BE trials based on extensive in
vitro characterization of the drug substance and drug product
properties.

DATES: Submit either electronic or written comments on the draft
guidance by January 24, 2019 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-3614 for ``Biopharmaceutics Classification System-Based
Biowaivers.'' 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 this 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, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Mehul Mehta, Center for Drug Evaluation and
Research, Food and Drug Administration, Bldg. 51, Rm. 2178, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization, and FDA is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
Agencies.
    ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidance.
    In May 2018, the ICH Assembly endorsed the draft guideline entitled
``Biopharmaceutics Classification System-Based Biowaivers'' and agreed
that the guideline should be made available for public comment. The
draft guideline is the product of the Multidisciplinary M9 Expert
Working Group of the ICH. Comments about this draft will be considered
by FDA and the Multidisciplinary M9 Expert Working Group.
    The draft guidance provides guidance on the biopharmaceutics
classification of drug substances and the BCS-based waiver of in vivo
BE studies for drug products.
    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
``Biopharmaceutics Classification System-Based Biowaivers.'' 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. Electronic Access

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

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23425 Filed 10-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Proposed Rules]
[Page 2308]
[FR Doc No: 2016-31636]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R09-OAR-2016-0287; FRL-9957-63-Region 9]

Approval of Arizona Air Plan Revisions; Ajo and Morenci, Arizona;
Second 10-Year Sulfur Dioxide Maintenance Plans and Technical
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the second ten-year maintenance plans for the Ajo and Morenci
areas in Arizona for the 1971 National Ambient Air Quality Standards
(NAAQS) for sulfur dioxide (SO2), and to correct an error in
the description of the Ajo, Arizona SO2 maintenance area in
the Code of Federal Regulations.

DATES: Any comments on this proposal must arrive by February 8, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2016-0287 at http://www.regulations.gov, or via email to Wienke
Tax, at<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be removed or edited from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Wienke Tax, EPA Region IX, (415) 947-
4192<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA. This proposal addresses the second ten-year
maintenance plans submitted by the Arizona Department of Environmental
Quality to address the 1971 SO2 NAAQS in the Ajo and Morenci
maintenance areas, AZ. In the Rules and Regulations section of this
Federal Register, we are approving these second ten-year maintenance
plans in a direct final action without prior proposal because we
believe these SIP revisions are not controversial. If we receive
adverse comments, however, we will publish a timely withdrawal of the
direct final rule and address the comments in subsequent action based
on this proposed rule. If we receive adverse comment on a distinct
provision of this rulemaking, i.e., our action regarding only one
maintenance plan, we will publish a timely withdrawal in the Federal
Register indicating which provisions we are withdrawing. The provisions
that are not withdrawn, i.e., our approval of the other maintenance
plan that is not the subject of an adverse comment, will become
effective on the date set out above, notwithstanding adverse comment on
the other maintenance plan.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: December 15, 2016.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2016-31636 Filed 1-6-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14035-14036]
[FR Doc No: 2014-05381]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2013-0566; FRL-9907-85-OAR]

Release of Draft Integrated Review Plan for the Primary National
Ambient Air Quality Standard for Sulfur Dioxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and public comment period.

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SUMMARY: On or about March 17, 2014, the Environmental Protection
Agency (EPA) is making available for public review the draft titled,
Integrated Review Plan for the Primary National Ambient Air Quality
Standard for Sulfur Dioxide (draft IRP). This document contains the
plans for the review of the air quality criteria for sulfur oxides and
the national ambient air quality standard (NAAQS) for sulfur dioxide
(SO2). The primary SO2 NAAQS provides for the
protection of public health from exposure to sulfur oxides in ambient
air.

DATES: Comments should be submitted on or before April 17, 2014.

ADDRESSES: This document will be available primarily via the Internet
at the following Web site: http://www.epa.gov/ttn/naaqs/standards/so2/s_so2_index.html.
    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2013-
0566, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket and Information Center,
U.S. Environmental Protection Agency, Mail Code 2822T, 1200
Pennsylvania Ave. NW., Washington, DC 20460. Please include a total of
two copies.
     Hand Delivery: 1301 Constitution Ave. NW., Room 3334,
Washington, DC, EPA Docket Center, 1301 Constitution Ave. NW., Room
3334, Washington DC. 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-
2013-0566. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at 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 www.regulations.gov
(or email). The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email 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, the 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 the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the 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 the EPA's public
docket, visit the

EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air and Radiation Docket
and Information Center, EPA/DC, William Jefferson Clinton Building,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air and
Radiation Docket and Information Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dr. Michael J. Stewart, Office of Air
Quality Planning and Standards, Mail Code C504-06, U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; telephone number:
919-541-7524; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What should I consider as I prepare my comments for the EPA?

    1. Submitting CBI. Do not submit this information to the EPA
through www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-
ROM as CBI and then identify electronically within the disk or CD-ROM
the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Information Specific to This Document

    Two sections of the Clean Air Act (CAA) govern the establishment
and revision of the NAAQS. Section 108 (42 U.S.C. 7408) directs the
Administrator to identify and list certain air pollutants and then to
issue air quality criteria for those pollutants. The Administrator is
to list those air pollutants that in her ``judgment, cause or
contribute to air pollution which may reasonably be anticipated to
endanger public health or welfare;'' ``the presence of which in the
ambient air results from numerous or diverse mobile or stationary
sources;'' and ``for which . . . [the Administrator] plans to issue air
quality criteria . . .'' Air quality criteria are intended to
``accurately reflect the latest scientific knowledge useful in
indicating the kind and extent of all identifiable effects on public
health or welfare which may be expected from the presence of [a]
pollutant in the ambient air . . .'' 42 U.S.C. 7408(b). Under section
109 (42 U.S.C. 7409), the EPA establishes primary (health-based) and
secondary (welfare-based) NAAQS for pollutants for which air quality
criteria are issued. Section 109(d) requires periodic review and, if
appropriate, revision of existing air quality criteria. The EPA is also
required to periodically review and, if appropriate, revise the NAAQS
based on the revised criteria. Section 109(d)(2) requires that an
independent scientific review committee ``shall complete a review of
the criteria . . . and the national primary and secondary ambient air
quality standards . . . and shall recommend to the Administrator any
new . . . standards and revisions of existing criteria and standards as
may be appropriate. . . .'' Since the early 1980's, this independent
review function has been performed by the Clean Air Scientific Advisory
Committee (CASAC).
    Presently, the EPA is reviewing the primary NAAQS for
SO2.\1\ The draft document, announced today, has been
developed as part of the planning phase for the review. This phase
began with a science policy workshop to identify issues and questions
to frame the review.\2\ Drawing from the workshop discussions, the
draft IRP has been prepared jointly by EPA's National Center for
Environmental Assessment, within the Office of Research and
Development, and EPA's Office of Air Quality Planning and Standards,
within the Office of Air and Radiation. The draft IRP presents the
current plan and specifies the schedule for the entire review, the
process for conducting the review, and the key policy-relevant science
issues that will guide the review. This document will be available on
the EPA's Technology Transfer Network (TTN) Web site at http://www.epa.gov/ttn/naaqs/standards/so2/s_so2_index.htmlhttp://www.epa.gov/ttn/naaqs/standards/pb/s_pb_index.html, accessible in the
``Documents from Current Review'' section under ``Planning Documents.''
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    \1\ The EPA's call for information for this review was issued on
May 10, 2013 (78 FR 27387).
    \2\ The EPA held a workshop titled, ``Kickoff Workshop to Inform
EPA's Review of the Primary SO2 NAAQS'' on June 12-13,
2013 (78 FR 27387).
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    The draft IRP is being made available for CASAC review and for
public comment. Comments should be submitted to the docket, as
described above, by April 17, 2014. Information about the CASAC review
meeting on this planning document, including the dates and location,
will be published as a separate notice in the Federal Register. The
final IRP will be prepared after considering comments from CASAC and
the public. This draft document does not represent and should not be
construed to represent any final EPA policy, viewpoint or
determination.

    Dated: March 6, 2014.
Mary E. Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2014-05381 Filed 3-11-14; 8:45 am]
BILLING CODE 6560-50-P