[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53446-53448]
[FR Doc No: 2019-21834]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4284]

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Endocrinologic and Metabolic
Drugs Advisory Committee. The general function of the committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on November 13, 2019, from 8 a.m. to 5
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability,

visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-4284. The docket will close on November
12, 2019. Submit either electronic or written comments on this public
meeting by November 12, 2019. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before November 12, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of November 12, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before October 29, 2019, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-4284 for ``Endocrinologic and Metabolic Drugs Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.'' FDA 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 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 the 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.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss supplemental new drug
application (sNDA) 204629/S-020 for empagliflozin oral tablet,
sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the
following proposed indication: As an adjunct to insulin therapy to
improve glycemic control in adults with type 1 diabetes mellitus.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 29, 2019, will be provided to

the committee. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 21, 2019. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 22, 2019.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21834 Filed 10-4-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41294-41296]
[FR Doc No: 2017-18427]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0056]

Voluntary Protection Programs Information; Extension of the
Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements contained in Voluntary Protection
Programs Information.

DATES: Comments must be submitted (postmarked, sent, or received) by
October 30, 2017.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, OSHA Docket No. OSHA-2011-0056
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-3653, 200 Constitution Avenue NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 10:00 a.m. to 3:00 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2011-
0056). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments, see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT:  David Hamel, Director, Office of
Partnerships and Recognition, Directorate of Cooperative and State
Programs, OSHA, U.S. Department of Labor, Room N-3700, 200 Constitution
Avenue NW,, Washington, DC 20210; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (PRA

95) [44 U.S.C. 3506(c)(2)(A)]. This program ensures that information is
in the desired format, reporting burden (time and costs) is minimal,
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain
such information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657).
    The Voluntary Protection Programs (VPP) [47 FR 29025], adopted by
OSHA, established the efficacy of cooperative action among government,
industry and labor to address employee safety and health issues and to
expand employee protection. To qualify, employers must meet OSHA's
safety and health management criterion, which focuses on comprehensive
management programs and active employee involvement to prevent or
control worksite safety and health hazards. Employers who qualify
generally view OSHA standards as a minimum level of safety and health
performance, and set their own more stringent standards, wherever
necessary, to improve employee protection. Prospective VPP worksites
must submit an application that includes:
     General applicant information (e.g., site, corporate, and
collective bargaining contact information).
     Injury and illness rate performance information (i.e.,
number of employees and/or applicable contractors onsite, type of work
performed and products produced, North American Industry Classification
System (NAICS) codes, and Recordable Injury and Illness Case Incidence
Rate information).
     Safety and health management program information (i.e.,
description of the applicant's safety and health management programs
including how the programs successfully address management leadership
and employee involvement, worksite analysis, hazard prevention and
control, and safety and health training).
    OSHA uses this information to determine whether an applicant is
ready for a VPP onsite evaluation and as a verification tool during VPP
onsite evaluations. Without this information, OSHA would be unable to
determine which sites are ready for VPP status.
    Each current VPP applicant is also required to submit an annual
self-evaluation which addresses how that applicant is continuing its
adherence to programmatic requirements.
    In 2008, OSHA modified procedures for VPP applicants, OSHA onsite
evaluations, and annual participant self-evaluations for applicants/
participants subject to OSHA's Process Safety Management (PSM)
Standard. Applicants who perform work that uses or produces highly
hazardous chemicals exceeding specified limits covered under the PSM
standard must submit responses to the PSM application supplement along
with their VPP application.
    Once in the VPP, the participant is required to submit an annual
self-evaluation detailing its continued adherence to programmatic
requirements. Applicants covered under the PSM standard are required to
submit a PSM questionnaire, a supplemental document, as part of their
annual submission. OSHA needs this information to ensure that the
participant remains qualified to participate in the VPP between onsite
evaluations. Without this information, OSHA would be unable to
determine whether applicants are maintaining excellent safety and
health management programs during this interim period.
    In 2009, with the publication of the Federal Register Notice (FRN)
(74 FR 927, January 9, 2009), VPP revised its traditional focus on
individual fixed worksites (site-based) by adding two new ways to
participate: mobile workforce and corporate. A significant
reorganization of the program helped clarify the multiple participation
options now available.
    Employees of VPP participants may apply to participate in the
Special Government Employee (SGE) Program. The SGE Program offers
private and public sector safety and health professionals and other
qualified participants the opportunity to exchange ideas, gain new
perspectives, and grow professionally while serving as full-fledged
team members on OSHA's VPP onsite evaluations and helping OSHA with
other VPP-related activities. In this capacity, SGEs may review company
documents, assist with worksite walkthroughs, interview employees,
assist in preparing VPP onsite evaluation reports, assist the Regional
VPP Manager with the review of a site's VPP application or annual self-
evaluation report, co-instruct the SGE course or VPP application
workshop, and mentor potential or current VPP sites. Potential SGEs
must submit an application that includes:
     SGE Eligibility Information Sheet (i.e., applicant's name,
professional credentials, site/corporate contact information,
qualifying activities participation, etc.);
     Current Resume;
     Confidential Financial Disclosure Report (OGE Form 450).
     Optional Application for Federal Employment (OF 612).
    OSHA uses the SGE Eligibility Information Sheet to ensure that the
potential SGE works at a VPP site and meets the minimum eligibility
qualifications. The resume is required to provide a detailed
description of their current duties and responsibilities as they relate
to safety and health and the implementation of an effective safety and
health management program. The OGE Form 450 is used to ensure that SGEs
do not participate on onsite evaluations at VPP sites in which they
have a financial interest.
    OSHA Challenge is designed to reach and guide employers and
companies in all major industry groups who are strongly committed to
improving their safety and health management programs and possibly
pursuing recognition in the VPP. The Challenge Administrator's
application is used to: (1) Conduct a preliminary analysis of the
applicant's knowledge of safety and health management programs; and (2)
make a determination regarding the applicant's qualifications to become
a Challenge Administrator. Once a Challenge Administrator is approved,
the program's Administrator will review each Challenge candidate's
application/annual submissions to ensure that all necessary information
is provided, prior to forwarding them to OSHA's National Office for
analysis and acceptance.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the information collection requirements are
necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of the Agency's estimate of the burden (time
and costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA proposes to extend OMB's approval of the collection of
information (paperwork) requirements necessitated by the Voluntary
Protection Programs. The Agency is requesting an adjustment decrease in
the burden hours from 134,475 hours to 90,863 hours; a total decrease
of 43,612 hours. The decrease is the result of the VPP Participation
Evaluation Report Site-Based Mobile Workforce Corporate in managing
participants is no longer needed. The Agency will summarize the
comments submitted in response to this notice, and will include this
summary in its request to OMB to extend the approval of these
information collection requirements.
    Type of Review: Extension of a currently approved collection.
    Title: Voluntary Protection Programs Information.
    OMB Number: 1218-0239.
    Affected Public: Business or other for-profits; individuals or
households; Federal government; state, local or tribal government.
    Number of Respondents:

VPP
    273 Applications
    55 Process Safety Management Applications Questionnaire-A
    1,406 Annual Self-Evaluations
    55 (PSM) Annual Self-Evaluations/Supplemental Questionnaire B
Challenge
    3 Challenge Administrator's Applications
    27 Challenge Participant's Applications
    143 Challenge Annual Self-Evaluations
Special Government Employees
    348 SGE Eligibility Information Sheets
    261 Resumes
    87 OF-612
    1616 Confidential Financial Disclosure Forms (OGE-Form 450)

    Total Respondents: 4,274.
    Frequency: Various.
    Average Time per Response:
VPP General
    200 hours for VPP Applications
    20 hours for VPP Annual Evaluations
Process Safety Management
    40 hours for Applications
    20 hours for Annual Evaluations
Challenge
    5 hours for Challenge Administrator's Applications
    10 hours for Challenge Candidate Applications
    20 hours for Challenge Annual Evaluations
Special Government Employees (SGE)
    10 minutes (.17 hour) for SGE Eligibility Information Sheet
    30 minutes (.50 hour) for SGE Resume
    40 minutes for Optional Form 612
    1 hour for Confidential Financial Disclosure Form

    Estimated Total Burden Hours: 90,863.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2011-0056). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site.
All submissions, including copyrighted material, are available for
inspection and copying at the OSHA Docket Office. Information on using
the http://www.regulations.gov Web site to submit comments and access
the docket is available at the Web site's ``User Tips'' link. Contact
the OSHA Docket Office for information about materials not available
through the Web site, and for assistance in using the Internet to
locate docket submissions.

V. Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012 (77 FR
3912).

    Signed at Washington, DC, on August 22, 2017.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-18427 Filed 8-29-17; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 88, Number 190 (Tuesday, October 3, 2023)]
[Notices]
[Pages 68151-68153]
[FR Doc No: 2023-21825]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0048]

Powered Platforms for Building Maintenance Standard; Extension of
the Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning the proposal to
extend Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Powered Platforms
for Building Maintenance.

DATES: Comments must be submitted (postmarked, sent, or received) by
December 4, 2023.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov. Documents in the docket are
listed in the http://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection through the OSHA
Docket Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for assistance in locating docket submissions.
    Instructions: All submissions must include the agency name and OSHA
docket number OSHA-2010-0048 for the Information Collection Request
(ICR). OSHA will place all comments, including any personal
information, in the public docket, which may be made available online.
Therefore, OSHA cautions interested parties about submitting personal
information such as social security numbers and birthdates.
    For further information on submitting comments, see the ``Public
Participation'' heading in the section of this notice titled
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Seleda Perryman or Theda Kenney,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of the continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, the collection instruments are clearly understood, and
OSHA's estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of effort in
obtaining information (29 U.S.C. 657).
    Paragraph (e)(9) of the Standard requires that employers develop
and implement a written emergency action plan for each type of powered
platform operation. The plan must explain the emergency procedures that
workers are to follow if they encounter a disruption of the power
supply, equipment failure, or other emergency. Prior to operating a
powered platform, employers must notify workers how they can inform
themselves about alarm systems and emergency escape routes, and
emergency procedures that pertain to the building on which they will be
working. Employers are to review with each worker those parts of the
emergency action plan that the worker must know to ensure their
protection during an emergency; these reviews must occur when the
worker receives an initial assignment involving a powered platform
operation and after the employer revises the emergency action plan.
    According to paragraph (f)(5)(i)(C), employers must affix a load
rating plate to a conspicuous location on each suspended unit that
states the unit's weight and the rated load capacity. Paragraph
(f)(5)(ii)(N) requires employers to mount each emergency electric
operating device in a secured compartment and label the device with
instructions for its use. After installing a suspension wire rope,
paragraphs (f)(7)(vi) and (f)(7)(vii) mandate that employers attach a
corrosion-resistant tag with specified information to one of the wire
rope fastenings if the rope is to remain at one location. In addition,
paragraph (f)(7)(viii) requires employers who resocket a wire rope to
either stamp specified information on the original tag or put that
information on a supplemental tag and attach it to the fastening.
    Paragraphs (g)(2)(i) and (g)(2)(ii) require that building owners,
at least annually, have a competent person inspect the supporting
structures of their buildings; inspect and, if necessary, test the
components of the

powered platforms, including control systems; inspect/test components
subject to wear (e.g., wire ropes, bearings, gears, and governors); and
certify these inspections and tests. Under paragraph (g)(2)(iii),
building owners must maintain and, on request, disclose to OSHA a
written certification record of these inspections/tests; this record
must include the date of the inspection/test, the signature of the
competent person who performed it, and the number/identifier of the
building support structure and equipment inspected/tested.
    Paragraph (g)(3)(i) mandates that building owners use a competent
person to inspect and, if necessary, test each powered platform
facility according to the manufacturer's recommendations every 30 days,
or prior to use if the work cycle is less than 30 days. Under paragraph
(g)(3)(ii), building owners must maintain and, on request, disclose to
the agency a written certification record of these inspections/tests;
this record is to include the date of the inspection/test, the
signature of the competent person who performed it, and the number/
identifier of the powered platform facility inspected/tested.
    According to paragraph (g)(5)(iii), building owners must use a
competent person to thoroughly inspect suspension wire ropes for a
number of specified conditions once a month, or before placing the wire
ropes into service if the ropes are inactive for 30 days or longer.
Paragraph (g)(5)(v) requires building owners to maintain and, on
request, disclose to OSHA a written certification record of these
monthly inspections; this record must consist of the date of the
inspection, the signature of the competent person who performed it, and
the number/identifier of the wire rope inspected.
    Upon completion of this training, paragraph (i)(1)(v) specifies
that employers must prepare a written certification that includes the
identity of the worker trained, the signature of the employer or the
trainer, and the date the worker completed the training. In addition,
the employer must maintain a worker's training certificate for the
duration of their employment and, on request, make it available to
OSHA.
    Emergency action plans allow employers and workers to anticipate,
and effectively respond to, emergencies that may arise during powered
platform operations. Affixing load rating plates to suspended units,
instructions to emergency electric operating devices, and tags to wire
rope fasteners prevent workplace accidents by providing information to
employers and workers regarding the conditions under which they can
safely operate these system components.
    Requiring building owners to establish and maintain written
certification of inspections and testing conducted on the supporting
structures of buildings, powered platform systems, and suspension wire
ropes provides employers and workers with assurance that they can
operate safely from the buildings using equipment that is in safe
operating condition.
    The training requirements increase worker safety by allowing them
to develop the skills and knowledge necessary to effectively operate,
use, and inspect powered platforms, recognize and prevent safety
hazards associated with platform operation, respond appropriately under
emergency conditions, and maintain and use their fall protection arrest
system. In addition, the paperwork requirements specified by the
Standard provide the most efficient means for an OSHA compliance
officer to determine whether or not employers and building owners are
providing the required notification and certification.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the agency's functions to
protect workers, including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection, and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend the approval of the information
collection requirements contained in the Powered Platforms for Building
Maintenance Standard. The agency will retain the current number of
burden hours of 130,776 for this Information Collection Request.
    OSHA will summarize the comments submitted in response to this
notice and will include this summary in the request to OMB to extend
the approval of the information collection requirements.
    Type of Review: Extension of a currently approved collection.
    Title: Powered Platforms for Building Maintenance Standard.
    OMB Control Number: 1218-0121.
    Affected Public: Business or other for-profits.
    Number of Respondents: 900.
    Number of Responses: 181,612.
    Frequency of Responses: On occasion, initially, monthly, annually.
    Average Time per Response: Varies.
    Estimated Total Burden Hours: 130,776.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on this Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); if your comments, including
attachments, are not longer than 10 pages you may fax them to the OSHA
Docket Office at<PHONE_NUMBER>. or (3) by hard copy. All comments,
attachments, and other material must identify the agency name and the
OSHA docket number for the ICR OSHA-2010-0048. You may supplement
electronic submissions by uploading document files electronically.
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
Contact the OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>)
for information about materials not available from the website, and for
assistance in using the internet to locate docket submissions.

V. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506

et seq.) and Secretary of Labor's Order No. 8-2020 (85 FR 58393).

    Signed at Washington, DC, on September 22, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-21825 Filed 10-2-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46158-46159]
[FR Doc No: 2018-19807]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-542-000]

KO Transmission Company; Notice of Amendment

    Take notice that on August 24, 2018, KO Transmission Company (KOT),
139 East 4th Street, Cincinnati, Ohio, filed an application under
section 7(c) of the Natural Gas Act and Part 157 of the Commission's
regulations requesting authorization to amend its Certificate of Public
Convenience and Necessity issued on April 22, 1998, in Docket No. CP97-
720-000 \1\ in order to properly reflect the capacity acquired in that
proceeding. KOT further requests authorization to amend its
certificated capacity north of the Foster Station to reflect current
operating capacity, all as more fully set forth in the request which is
on file with the Commission and opens to public inspection. The filing
may be viewed on the web 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. For assistance, contact
FERC at [email protected] or call toll-free,<PHONE_NUMBER> or
TYY,<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \1\ KO Transmission Company, 83 FERC ] 62,066 (1998).
---------------------------------------------------------------------------

    Any questions regarding the proposed amendment should be directed
to Lance Stotts, Administrator, KO Transmission Company, 4720 Piedmont
Row Drive, Room 864, Charlotte, North Carolina 28210; telephone
(704)731-4360; email energy.com">[email protected]energy.com.
    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 analysis (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 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 5 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 commenters 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 commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters 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 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5 p.m., September 27, 2018.

    Dated: September 6, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-19807 Filed 9-11-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76280-76281]
[FR Doc No: 2015-30847]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-505-000]

Natural Gas Pipeline Company of America, LLC; Notice of Schedule
for Environmental Review of the Chicago Market Expansion Project

    On June 1, 2015, Natural Gas Pipeline Company of America, LLC
(Natural) filed an application in Docket No. CP15-505-000 requesting a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act to construct and operate certain natural
gas pipeline facilities. The proposed project is known as the Chicago
Market Expansion Project (Project), and would provide about 238,000
dekatherms of incremental northbound firm transportation capacity to
the city of Chicago, Illinois and neighboring areas.
    On June 12, 2015, the Federal Energy Regulatory Commission
(Commission or

FERC) issued its Notice of Application for the Project. Among other
things, that notice alerted agencies issuing federal authorizations of
the requirement to complete all necessary reviews and to reach a final
decision on a request for a federal authorization within 90 days of the
date of issuance of the Commission staff's Environmental Assessment
(EA) for the Project. This instant notice identifies the FERC staff's
planned schedule for the completion of the EA for the Project.

                    Schedule for Environmental Review
------------------------------------------------------------------------

------------------------------------------------------------------------
Issuance of EA........................  January 11, 2016.
90-day Federal Authorization Decision   April 11, 2016.
 Deadline.
------------------------------------------------------------------------

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The proposed Project would construct a new 30,000 horsepower
natural gas-fired compressor station with suction and discharge piping
and ancillary equipment in Livingston County, Illinois.

Background

    On July 9, 2015, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Chicago Market
Expansion Project and Request for Comments on Environmental Issues
(NOI). The NOI was sent to affected landowners; federal, state, and
local government agencies; elected officials; environmental and public
interest groups; Native American tribes; other interested parties; and
local libraries and newspapers. In response to the NOI, the Commission
received a consultation letter from United States Department of
Agriculture regarding impacts of farmland conversion.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC Web site (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP15-505), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
Web site also provides access to the texts of formal documents issued
by the Commission, such as orders, notices, and rule makings.

    Dated: December 2, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-30847 Filed 12-7-15; 8:45 am]
 BILLING CODE 6717-01-P


J-22-0021 Sanitized Support Documents Index:
 J-22-0021 Sanitized Biotech Form (linked)
 J-22-0021 Sanitized Determination Document (linked)
 J-22-0021 Sanitized Risk Assessment Report (attached)


[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Page 60458]
[FR Doc No: 2020-21174]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9053-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed September 14, 2020 10 a.m. EST Through September 21, 2020 10 a.m.
EST
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20200188, Draft Supplement, USFS, WV, Mountain Valley Pipeline
and Equitrans Expansion Project Draft Supplemental Environmental Impact
Statement, Comment Period Ends: 11/09/2020, Contact: Ken Arney 888-603-
0261.
EIS No. 20200189, Draft, USAF, GA, Moody Air Force Base Comprehensive
Airspace Initiative, Comment Period Ends: 11/24/2020, Contact: Lorence
Busker<PHONE_NUMBER>.
EIS No. 20200190, Draft, USAF, TX, B-21 Main Operating Base (MOB 1)
Beddown at Dyess AFB, Texas or Ellsworth AFB South Dakota, Comment
Period Ends: 11/09/2020, Contact: Julianne Turko<PHONE_NUMBER>.
EIS No. 20200191, Final, USFS, AK, Rulemaking for Alaska Roadless
Areas, Review Period Ends: 10/26/2020, Contact: Ken Tu<PHONE_NUMBER>.
EIS No. 20200192, Final Supplement, FDOT, FHWA, FL, Tampa Interstate
Study, Contact: Luis D. Lopez Rivera<PHONE_NUMBER>. Pursuant to U.S.C.
139(n)(2), FHWA has issued a single document that consists of a final
supplemental environmental impact statement and record of decision.
Therefore, the 30-day wait/review period under NEPA does not apply to
this action.
EIS No. 20200193, Final, BR, CA, Truckee Canal Extraordinary
Maintenance, Review Period Ends: 10/26/2020, Contact: Laurie Nicholas
775-884-8360.
EIS No. 20200194, Final, NNSA, SC, Plutonium Pit Production at the
Savannah River Site in South Carolina, Review Period Ends: 10/26/2020,
Contact: Ms. Jennifer Nelson<PHONE_NUMBER>.

Amended Notice

EIS No. 20200168, Draft, FAA, CA, Bob Hope Hollywood Burbank Airport
Replacement Passenger Terminal Project, Comment Period Ends: 10/27/
2020, Contact: Edvige B. Mbakoup<PHONE_NUMBER>. Revision to FR Notice
Published 8/21/2020; Extending the Comment Period from 10/5/2020 to 10/
27/2020.
EIS No. 20200182, Final, USFS, AZ, WITHDRAWN--Fossil Creek Wild and
Scenic River Comprehensive River Management Plan, Contact: Mike Dechter
928-527-3416. Revision to FR Notice Published 09/18/2020; Officially
Withdrawn per request of the submitting agency.

    Dated: September 21, 2020.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2020-21174 Filed 9-24-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62384-62385]
[FR Doc No: 2023-19501]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3452]

Institutional Review Board Review of Individual Patient Expanded
Access Submissions for Investigational Drugs and Biological Products;
Guidance for Institutional Review Boards and Clinical Investigators;
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 final guidance for institutional review boards
(IRBs) and clinical investigators entitled ``Institutional Review Board
(IRB) Review of Individual Patient Expanded Access Submissions for
Investigational Drugs and Biological Products.'' FDA is issuing this
final guidance to provide recommendations regarding the key factors and
procedures IRBs should consider when reviewing individual patient
expanded access submissions, including for reviews conducted by a
single member of the IRB, to fulfill its obligations under FDA
regulations. Although FDA has issued guidance on expanded access
requests, including expanded access for individual patients, the Agency
is aware that IRBs seek further clarity on this topic.

DATES: The announcement of the guidance is published in the Federal
Register on September 11, 2023.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-3452 for ``Institutional Review Board (IRB) Review of
Individual Patient Expanded Access Submissions for Investigational
Drugs and Biological Products.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    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 final 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, 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. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Anne
Taylor, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for IRBs and
clinical investigators entitled ``Institutional Review Board (IRB)
Review of Individual Patient Expanded Access Submissions for
Investigational Drugs and Biological Products.'' FDA is issuing this
guidance to provide recommendations regarding the key factors and
procedures IRBs should consider when reviewing individual patient
expanded access submissions, including for reviews conducted by a
single member of the IRB, to fulfill its obligations under 21 CFR part
56.

Although FDA has issued guidance on expanded access requests, including
expanded access for individual patients, the Agency is aware that IRBs
seek further clarity on this topic.
    Under FDA regulations, there are three categories of expanded
access: individual (also known as single) patient, including for
emergency use; intermediate-size for intermediate-size patient
populations; and ``treatment'' for larger populations. This guidance
only applies to IRB review of individual patient expanded access
submissions, as outlined in 21 CFR 312.310. The recommendations in this
guidance are intended to provide additional clarity to assist IRBs in
conducting efficient reviews of individual patient expanded access
requests.
    In the Federal Register of June 9, 2020 (85 FR 35311), FDA
announced the availability of a guidance for IRBs and investigators
entitled ``Institutional Review Board (IRB) Review of Individual
Patient Expanded Access Requests for Investigational Drugs and
Biological Products During the COVID-19 Public Health Emergency:
Guidance for IRBs and Clinical Investigators'' (2020 COVID-19 guidance)
to support public health efforts following a determination, under
section 319 of the Public Health Service (PHS) Act (42 U.S.C. 247d), by
the Secretary of Health and Human Services that a public health
emergency existed related to Coronavirus Disease 2019 (COVID-19 public
health emergency). The 2020 COVID-19 guidance focused on addressing the
COVID-19 public health emergency and was intended to remain in effect
only for the duration of the COVID-19 public health emergency. However,
the 2020 COVID-19 guidance explained we expected the recommendations
would assist the Agency more broadly in its continued efforts to
facilitate access to drugs through expanded access for individual
patients beyond the COVID-19 public health emergency and that FDA would
replace the 2020 COVID-19 guidance with any appropriate changes based
on comments received and the Agency's experience with implementation.
FDA continues to believe that many of the recommendations set forth in
the 2020 COVID-19 guidance are applicable outside the context of the
COVID-19 public health emergency and are applicable to key factors and
procedures IRBs should consider when reviewing individual patient
expanded access submissions. In addition, in the Federal Register of
March 13, 2023 (88 FR 15417), FDA listed the 2020 COVID-19 guidance as
one of the guidances FDA was revising to continue in effect for 180
days after the COVID-19 PHE declaration issued under the PHS Act
expired on May 11, 2023, during which time FDA planned to further
revise those guidances. Consistent with what we said in the Federal
Register of March 13, 2023, FDA is therefore issuing this revised final
guidance, which supersedes the 2020 COVID-19 guidance. FDA revised the
guidance to remove references to the COVID-19 public health emergency
and made editorial changes to improve clarity. FDA also clarified
recommendations on IRB procedures and factors to consider for
individual patient expanded access submissions.
    FDA is issuing this guidance for immediate implementation in
accordance with our good guidance practices regulation (21 CFR
10.115(g)(3)) without initially seeking prior comment because the
Agency has determined that prior public participation is not feasible
or appropriate (see 21 CFR 10.115(g)(2) and section 701(h)(1)(C)(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))).
Specifically, we are not seeking prior comment because public health
emergencies (PHEs) and the need to address individual patient expanded
access submissions for patient access to investigational drugs for
diagnosing, monitoring, or treating diseases or conditions related to
PHEs may occur without notice and, as we have learned from experience
during the COVID-19 PHE, may hinder physicians seeking to treat their
patients in a timely manner. It is thus important to public health to
provide recommendations regarding the key factors and procedures IRBs
should consider when reviewing requests. Interested parties had an
opportunity to comment on the recommendations in the 2020 COVID-19
guidance, and FDA considered those comments when revising the guidance.
Although this guidance document is being implemented immediately, it
remains subject to comment in accordance with FDA's good guidance
practices regulation (Sec.  10.115(g)(3)(D)).
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Institutional Review Board (IRB) Review of
Individual Patient Expanded Access Submissions for Investigational
Drugs and Biological Products.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 and Form FDA 1571 have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR
parts 50 and 56 relating to the protection of human subjects, informed
consent, and IRBs have been approved under OMB control number 0910-
0130. The collections of information in 21 CFR 312.300 through 312.320
relating to expanded access to investigational drugs for treatment use
and Form FDA 3926 have been approved under OMB control number 0910-
0814. The collections of information in 21 CFR part 11 relating to
electronic records and signatures have been approved under OMB control
number 0910-0303.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19501 Filed 9-8-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Rules and Regulations]
[Pages 64666-64669]
[FR Doc No: 2014-25884]

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

Federal Aviation Administration

14 CFR Part 33

[Docket No. FAA-2014-0376; Notice No. 33-014-SC]

Special Conditions: SNECMA, Silvercrest-2 SC-2D; Rated 10-Minute
One Engine Inoperative Takeoff Thrust at High Ambient Temperature

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These final special conditions are issued for the SNECMA,
Silvercrest-2 SC-2D engine model. This engine will have a novel or
unusual design feature--an additional takeoff rating that increases the
exhaust gas temperature (EGT) limit to maintain takeoff thrust in
certain high ambient temperature conditions with one engine inoperative
(OEI) for a maximum of 10 minutes. The applicable airworthiness
regulations do not contain adequate or appropriate safety standards for
this design feature. These final special conditions contain the
additional safety standards that the Administrator considers necessary
to establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: The effective date of these special conditions is December 1,
2014.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this rule, contact Tara Fitzgerald, ANE-111, Engine and Propeller
Directorate, Aircraft Certification Service, 12 New England Executive
Park, Burlington, Massachusetts 01803-5213; telephone<PHONE_NUMBER>;
facsimile<PHONE_NUMBER>; email<EMAIL_ADDRESS>For legal
questions concerning this rule, contact Vincent Bennett, ANE-7, Engine
and Propeller Directorate, Aircraft Certification Service, 12 New
England Executive Park, Burlington, Massachusetts 01803-5299; telephone
(781) 238-7044; facsimile<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On April 19, 2011, SNECMA applied for a new type certificate (TC)
for the Silvercrest-2 SC-2D engine model. For

their Silvercrest-2 SC-2D engine model, SNECMA requested an additional
takeoff rating to maintain takeoff thrust in certain high ambient
temperature conditions with OEI. Therefore, the Silvercrest-2 SC-2D
engine model will have two different takeoff ratings. The first rating
corresponds with the rated takeoff thrust of the engine. The second
takeoff rating maintains the takeoff thrust in certain high ambient
temperature conditions for a maximum of 10 minutes when one engine is
inoperative. This additional takeoff rating is named, ``Rated 10-Minute
OEI Takeoff Thrust at High Ambient Temperature'' (Rated 10-minute OEI
TOTHAT).
    These final special conditions are necessary because current part
33 regulations do not contain airworthiness standards for airplane
applications of OEI ratings. For an airplane application, the OEI
rating is the same as the rated thrust of the engine. All OEI ratings
in current part 33 regulations are only applicable to rotorcraft
applications. These final special conditions were modeled based on the
rotorcraft requirements for the 30-second and 2-minute OEI ratings, and
modified to represent the airplane application. The Rated 10-minute OEI
TOTHAT shares common features, such as the need to notify the pilot and
maintenance personnel about the rating's use, provides data needed for
power assurance check, and continued validation of the related
maintenance procedures.
    The Rated 10-minute OEI TOTHAT is for use during OEI events that
occur during takeoff in high ambient temperature conditions, up to 5
degrees Celsius hotter than the rated takeoff thrust corner point.
Under these unique conditions (extreme hot day and OEI), the Rated 10-
minute OEI TOTHAT leads to an increase in EGT to maintain the takeoff
thrust of the engine. These final special conditions contain additional
mandatory post-flight inspection and maintenance action requirements
associated with any use of the Rated 10-minute OEI TOTHAT. These
requirements add a rating definition in part 1.1; mandatory inspections
in the ICA; instructions for installing and operating the engine;
engine rating and operating limitations; instrument connection; and
endurance testing.
    The current requirements of the endurance test under Sec.  33.87
represent a typical airplane flight profile and the severity of the
takeoff rating. Therefore, the endurance test under Sec.  33.87 covers
normal, all-engines-operating takeoff conditions for which the engine
control system limits the engine to the takeoff thrust rating. These
final special conditions for the endurance testing requirements are
intended to represent the airplane flight profile when an OEI event
occurs during takeoff under specified ambient temperatures, and until
the mandatory inspection and maintenance actions can be performed.
These final special conditions require endurance testing that is not
less than 135 minutes in duration and demonstrates the engine is
capable of the additional Rated 10-minute OEI TOTHAT rating at the
higher EGT limit following completion of the tests required by Sec.
33.87(b), without disassembly or modification.
    The associated engine deterioration after use of the Rated 10-
minute OEI TOTHAT is not known without the intervening mandatory
inspections in these special conditions. The mandatory inspections
ensure the engine will continue to comply with its certification basis
after any use of the Rated 10-minute OEI TOTHAT. The applicant is
expected to assess the deterioration from use of the Rated 10-minute
OEI TOTHAT. The Airworthiness Limitations section must prescribe the
mandatory post-flight inspections and maintenance actions associated
with any use of the Rated 10-minute OEI TOTHAT.
    These special conditions are necessary because the applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for the additional takeoff rating, and their requirements
maintain a level of safety equivalent to the level intended by the
applicable airworthiness standards in effect on the date of
application.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.17, SNECMA must show that the Silvercrest-2 SC-2D meets the
applicable provisions of the applicable regulations in effect on the
date of application, except as detailed in paragraphs 21.101(b) and
(c). The FAA has determined the following certification basis for the
Silvercrest-2 SC-2D engine model:
    1. 14 CFR part 33, ``Airworthiness Standards Aircraft Engines,''
dated February 1, 1965, with Amendments 33-1 through 33-31, dated July
18, 2011.
    If the FAA finds that the regulations in effect on the date of the
application for the change do not provide adequate or appropriate
safety standards for the Silvercrest-2 SC-2D because of a novel or
unusual design feature, special conditions are prescribed under the
provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, these special conditions would also
apply to the other model under Sec.  21.101.
    In addition to complying with the applicable product airworthiness
regulations and the requirements of these special conditions, the
Silvercrest-2 SC-2D engine model must also comply with the fuel venting
and exhaust emission requirements of 14 CFR part 34.
    The FAA issues special conditions, as defined in 14 CFR 11.19, per
Sec.  11.38, and they become part of the type certification basis under
Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The SNECMA Silvercrest-2 SC-2D engine model will incorporate an
additional takeoff rating to maintain takeoff thrust in certain high
ambient temperature OEI takeoff conditions for a maximum of 10 minutes.
The result will be two different takeoff ratings, one for the rated
takeoff thrust of the engine and the other to maintain the takeoff
thrust in certain high ambient temperature OEI takeoff conditions for a
maximum of 10 minutes. The additional takeoff rating is referred to as
``Rated 10-Minute OEI Takeoff Thrust at High Ambient Temperature''
(Rated 10-minute OEI TOTHAT).
    The Rated 10-minute OEI TOTHAT is a novel and unusual design
feature that requires additional airworthiness standards for type
certification of the SNECMA Silvercrest-2 SC-2D engine model.

Discussion of Comments

    A notice of proposed special conditions, No. 33-14-01-SC, for the
Silvercrest-2 SC-2D engine model was published in the Federal Register
on July 31, 2014 (79 FR 44321). We did not receive any public comments.
We did, however, modify the proposed special conditions by removing
requirement (b) under ``Sec.  33.28, Engine control systems.'' These
requirements are addressed at the aircraft level.

Applicability

    As discussed above, these special conditions are applicable to the
Silvercrest-2 SC-2D engine model. Should SNECMA apply at a later date
for a change to the type certificate to include another engine model
incorporating the same novel or unusual

design feature, these special conditions would apply to that model as
well.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting these special conditions. This
action affects only the Rated 10-minute OEI TOTHAT features on the
Silvercrest-2 SC-2D engine model. It is not a rule of general
applicability and applies only to SNECMA, who requested FAA approval of
this engine feature.

List of Subjects in 14 CFR Part 33

    Air Transportation, Aircraft, Aviation, Aviation safety, Safety.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the SNECMA Silvercrest-2 SC-2D engine
model.

1. Part 1.1, Definitions

    ``Rated 10-Minute One Engine Inoperative Takeoff Thrust at High
Ambient Temperature'' (Rated 10-minute OEI TOTHAT) means the approved
engine thrust developed under specified altitudes and temperatures
within the operating limitations established for the engine, and for
continuation of flight operation after failure or shutdown of one
engine in a multi-engine airplane during takeoff operation. Use is
limited to two periods, no longer than 10 minutes each in any one
flight, and followed by mandatory inspection and maintenance actions.

2. Part 33 Requirements

    In addition to the airworthiness standards in 14 CFR part 33,
effective February 1, 1965, Amendments 33-1 through 33-31 applicable to
the engine and the Rated 10-minute OEI TOTHAT, the following special
conditions apply:

Sec.  33.4  Instructions for Continued Airworthiness.

    (a) The Airworthiness Limitations section must prescribe the
mandatory post-flight inspections and maintenance actions associated
with any use of the Rated 10-minute OEI TOTHAT.
    (b) The applicant must validate the adequacy of the inspections and
maintenance actions required under paragraph Sec.  33.4(a) of these
special conditions.
    (c) The applicant must establish an in-service engine evaluation
program to ensure the continued adequacy of the instructions for
mandatory post-flight inspections and maintenance actions prescribed
under paragraph Sec.  33.4(a) of these special conditions, and of the
data for thrust assurance procedures required by Sec.  33.5(b)(1) of
these special conditions. The program must include service engine tests
or equivalent service engine test experience on engines of similar
design and evaluations of service use of the Rated 10-minute OEI
TOTHAT.

Sec.  33.5  Instruction manual for installing and operating the engine.

    (a) Installation instructions:
    (1) The applicant must identify the means, or provisions for means,
provided in compliance with the requirements of Sec.  33.29 of these
special conditions.
    (2) The applicant must specify that the engine thrust control
system automatically resets the thrust on the operating engine to the
Rated 10-minute OEI TOTHAT level when one engine fails during takeoff
at specified altitudes and temperatures, and that the Rated 10-minute
OEI TOTHAT is not available when all engines are operational.
    (b) Operating instructions:
    (1) The applicant must provide data on engine performance
characteristics and variability to enable the airplane manufacturer to
establish airplane thrust assurance procedures.

Sec.  33.7  Engine ratings and operating limitations.

    (a) The Rated 10-minute OEI TOTHAT and the associated operating
limitations are established as follows:
    (1) The thrust is the same as the engine takeoff rated thrust with
extended flat rating corner point,
    (2) The rotational speed limits are the same as those associated
with the engine takeoff rated thrust,
    (3) The applicant must establish a gas temperature steady-state
limit and, if necessary, a transient gas overtemperature limit for
which the time duration is no longer than 30 seconds, and
    (4) The use is limited to two periods of no longer than 10 minutes
each in any one flight, and followed by mandatory inspection and
maintenance actions prescribed by Sec.  33.4(a) of these special
conditions.
    (b) The applicant must propose language to include in the type
certificate data sheet specified in Sec.  21.41 for the following:
    (1) The Rated 10-minute OEI TOTHAT and associated limitations.
    (2) As required by Sec.  33.5(b), Operating instructions, include a
note stating that ``Rated 10-Minute One Engine Inoperative Takeoff
Thrust at High Ambient Temperature'' (Rated 10-minute OEI TOTHAT) means
the approved engine thrust developed under specified altitudes and
temperatures within the operating limitations established for the
engine, and for continuation of flight operation after failure or
shutdown of one engine in a multi-engine airplane during takeoff
operation. Use is limited to two periods, no longer than 10 minutes
each in any one flight, and followed by mandatory inspection and
maintenance actions.
    (3) As required by Sec.  33.5(b), Operating instructions, include a
note stating that the engine thrust control system automatically resets
the thrust on the operating engine to the Rated 10-minute OEI TOTHAT
level when one engine fails during takeoff at specified altitudes and
temperatures, and that the Rated 10-minute OEI TOTHAT is not available
when all engines are operational.

Sec.  33.28  Engine control systems.

    The engine must incorporate a means, or a provision for a means,
for automatic availability and automatic control of the Rated 10-minute
OEI TOTHAT.

Sec.  33.29  Instrument connection.

    (a) The engine must:
    (1) Have means, or provisions for means, to alert the pilot when
the Rated 10-minute OEI TOTHAT is in use, when the event begins, and
when the time interval expires.
    (2) Have means, or provision for means, which cannot be reset in
flight, to:
    (i) Automatically record each use and duration of the Rated 10-
minute OEI TOTHAT, and
    (ii) Alert maintenance personnel that the engine has been operated
at the Rated 10-minute OEI TOTHAT, and permit retrieval of recorded
data.
    (iii) Have means, or provision for means, to enable routine
verification of the proper operation of the means in Sec.  33.29(a)(1)
and (a)(2) of these special conditions.

Sec.  33.85(b)  Calibration tests.

    The applicant must base the calibration test on the thrust check at
the end of the endurance test required by Sec.  33.87 of these special
conditions.

Sec.  33.87  Endurance test.

    (a) Following completion of the tests required by Sec.  33.87(b),
and without intervening disassembly, except as needed to replace those
parts described as consumables in the ICA, the

applicant must conduct the following test sequence for a total time of
not less than 135 minutes:
    (1) Ten minutes at Rated 10-minute OEI TOTHAT,
    (2) Sixty-five minutes at rated maximum continuous thrust,
    (3) One minute at 50 percent of rated takeoff thrust,
    (4) Ten minutes at Rated 10-minute OEI TOTHAT,
    (5) One minute at flight idle,
    (6) Ten minutes at Rated 10-minute OEI TOTHAT,
    (7) Five minutes at rated maximum continuous thrust,
    (8) One minute at 50 percent of rated takeoff thrust,
    (9) Five minutes at Rated 10-minute OEI TOTHAT,
    (10) One minute at flight idle,
    (11) Ten minutes at Rated 10-minute OEI TOTHAT,
    (12) Five minutes at rated maximum continuous thrust,
    (13) One minute at 50 percent of rated takeoff thrust,
    (14) Nine minutes at Rated 10-minute OEI TOTHAT, and
    (15) One minute at flight idle
    (b) The test sequence of Sec.  33.87(a)(1) through (a)(15) of these
special conditions must be run continuously. If a stop occurs during
these tests, the interrupted sequence must be repeated unless the
applicant shows that the severity of the test would not be reduced if
the current tests were continued.
    (c) Where the engine characteristics are such that acceleration to
the Rated 10-minute OEI TOTHAT results in a transient overtemperature
in excess of the steady-state temperature limit identified in Sec.
33.7(a)(3) of these special conditions, the transient gas
overtemperature must be applied to each acceleration to the Rated 10-
minute OEI TOTHAT of the test sequence in Sec.  33.87(a) of these
special conditions.

Sec.  33.93  Teardown inspection.

    The applicant must perform the teardown inspection required by
Sec.  33.93(a) after completing the endurance test prescribed by Sec.
33.87 of these special conditions.

Sec.  33.201  Design and test requirements for Early ETOPS eligibility.

    In addition to the requirements of Sec.  33.201(c)(1), the
simulated ETOPS mission cyclic endurance test must include two cycles
of 10 minute duration, each at the Rated 10-minute OEI TOTHAT; one
before the last diversion cycle and one at the end of the ETOPS test.

    Issued in Burlington, Massachusetts, on October 23, 2014.
Colleen M. D'Alessandro,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-25884 Filed 10-30-14; 8:45 am]
BILLING CODE 4910-13-P