[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28853-28854]
[FR Doc No: 2018-13295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0108]

Prescription Drug User Fee Act Waivers, Reductions, and Refunds
for Drug and Biological Products; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled
``Prescription Drug Act User Fee Waivers, Reductions, and Refunds for
Drug and Biological Products.'' This revised draft guidance provides
recommendations to applicants planning to request a waiver or reduction
in user fees. This draft guidance is a revision of the guidance for
industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug
and Biological Products,'' issued in September 2011.

DATES: Although you can comment on any draft guidance at any time (see
21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment
on this draft guidance before it begins work on the final version of
the guidance, submit either electronic or written comments on the draft
guidance by August 20, 2018.

ADDRESSES: 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-2011-D-0108 for ``Prescription Drug Act User Fee Waivers,
Reductions, and Refunds for Drug 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.
     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.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or to 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 the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sungjoon ``Alvin'' Chi, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 2185, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Prescription Drug User Fee Waivers, Reductions, and Refunds
for Drug and Biological Products.'' This draft guidance provides
recommendations to applicants regarding requests for waivers,
reductions, or refunds of user fees assessed under sections 735 and 736
(21 U.S.C. 379g and 379h) of the Federal Food, Drug, and Cosmetic
(FD&C) Act. This revised draft guidance describes the types of waivers,
reductions, and refunds permitted

under the user fee provisions of the FD&C Act and the procedures for
submitting requests for waivers, reductions, refunds, and requests for
reconsiderations or appeals. The revised draft guidance also provides
additional clarification on certain issues such as user fee exemptions
for orphan drugs and FDA's current thinking on considerations relevant
to eligibility for user fee waivers, reductions, and refunds under the
applicable statutory provisions.
    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 ``Prescription
Drug User Fee Waivers, Reductions, and Refunds for Drug 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.
This draft guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party.
    The information collection of this draft guidance has been
submitted for OMB renewal of approval under OMB control number 0910-
0693. In addition, the collection of information associated with Form
FDA 3397 has been previously approved under OMB control number 0910-
0297. Collection of information associated with new drug application or
biologics license applications have been previously approved under OMB
control numbers 0910-0001 and 0910-0338, respectively. See section X of
the draft guidance document.

III. Electronic Access

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

    Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13295 Filed 6-20-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 30, 2006 (Volume 71, Number 209)]
[Notices]
[Page 63312-63313]
[DOCID:fr30oc06-82]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests and Comments

October 18, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12737-000.
    c. Date Filed: September 15, 2006.
    d. Applicant: Hydro Matrix Limited Partnership.
    e. Name of Project: Gathright Hydroelectric Project.
    f. Location: On the Jackson River, in Alleghany County, Virginia.
The Gathright Dam is owned and maintained by the U.S. Army Corps of
Engineers.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)--825(r).
    h. Applicant Contact: Mr. Dean Edwards, Mayo Hydro LLC, General
Partner, 5400 Downing Street, Dover, FL, 33527,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    i. FERC Contact: Patricia W. Gillis at<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Please include the project
number (P-12737-000) on any comments, protests, or motions filed.
    k. Description of Project: The proposed project would utilize the
existing U.S. Army Corps of Engineers' Gathright Dam and would consist
of: (1) A proposed penstock; (2) a proposed powerhouse containing one
generating unit with an installed capacity of 5,000-kilowatts; (3) a
proposed 1.7-mile-long, 46-kV transmission line; and (4) appurtenant
facilities. The proposed project would have an estimated annual
generation of approximately 20-gigawatts. The applicant plans to sell
the generated energy.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the

specified comment date for the particular application (see 18 CFR
4.36). Submission of a timely notice of intent allows an interested
person to file the competing preliminary permit application no later
than 30 days after the specified comment date for the particular
application. A competing preliminary permit application must conform
with 18 CFR 4.30(b) and 4.36.
    o. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent--a notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', ``MOTION TO INTERVENE'',
``NOTICE OF INTENT'', or ``COMPETING APPLICATION'', as applicable, and
the Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. A copy of any motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
[FR Doc. E6-18098 Filed 10-27-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7591-7593]
[FR Doc No: 2012-3198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Request for Notification From Consumer Organizations Interested
in Participating in the Selection Process for Nominations for Voting
and/or Nonvoting Consumer Representatives and Consumer Representatives
on Public Advisory Committees or Panels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may either be self-nominated or may be nominated by a
consumer organization. Nominations will be accepted for current
vacancies and for those that will or may occur through February 2013.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by March
14, 2012, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by March 14, 2012.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be sent electronically to
<EMAIL_ADDRESS>by mail to Advisory Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD
20993-0002, or by fax to<PHONE_NUMBER>. Information about becoming a
member of an FDA advisory committee can be obtained by visiting FDA's
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Doreen Brandes, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5122, Silver Spring, MD 20993-0002, 301-
796-8858<EMAIL_ADDRESS>    For questions relating to specific advisory committees or panels,
contact the persons listed in table 2 in the SUPPLEMENTARY INFORMATION
section of this document:

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 1 of this document:

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
  Committee/panel/areas of expertise
                needed                     Current and upcoming vacancies          Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenic Products--Knowledgeable in   1--Voting..........................  08/31/12.
 the field of allergenic extracts that
 are used for the diagnosis and
 treatment of allergic diseases such
 as allergic rhinitis (``hay fever''),
 allergic sinusitis, allergic
 conjunctivitis, bee venom allergy,
 and food allergy.
Peripheral and Central Nervous          1--Voting..........................  01/31/13.
 Systems--Knowledgeable in the fields
 of neurology, neuropharmacology,
 neuropathology, otolaryngology,
 epidemiology or statistics, and
 related specialties.
Non-Prescription Drugs--Knowledgeable   1--Voting..........................  01/31/13.
 in the fields of internal medicine,
 family practice, clinical toxicology,
 clinical pharmacology, pharmacy,
 dentistry, and related specialties.
National Mammography Quality            2--Nonvoting.......................  01/31/13.
 Assurance--Knowledgeable in clinical
 practice, research specialization, or
 professional work that has a
 significant focus on mammography.
----------------------------------------------------------------------------------------------------------------
                            Certain Panels of the Medical Devices Advisory Committee
----------------------------------------------------------------------------------------------------------------
Clinical Chemistry and Clinical         1--Nonvoting.......................  02/28/13.
 Toxicology Devices--Knowledgeable in
 the fields of clinical chemistry and
 toxicology in vitro diagnostic
 devices (IVDs); clinical use of
 related IVDs in laboratories and in
 home; data concerning safety and
 effectiveness of related IVDs for
 clinical use in diseases/disorders/
 conditions such as diabetes,
 cardiovascular disease, endocrine
 disorders, women's health, drug
 abuse, therapeutic drug monitoring,
 and general chemistry conditions.
Microbiology Devices Panel--            1--Voting..........................  Immediately.
 Knowledgeable in infectious and
 pulmonary disease, pediatric
 infectious diseases, tropical
 diseases, and clinical microbiology.
----------------------------------------------------------------------------------------------------------------

I. Functions

A. Allergenic Products Advisory Committee

    The Committee reviews and evaluates available data concerning the
safety, effectiveness, and adequacy of labeling of marketed and
investigational allergenic biological products or materials that are
administered to humans for the diagnosis, prevention, or treatment of
allergies and allergic disease, and makes appropriate recommendations
to the Commissioner of Food and Drugs of its findings.

B. Peripheral and Central Nervous Systems Advisory Committee

    The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases and makes appropriate
recommendations to the Commissioner of Food and Drugs.

C. Non-Prescription Drugs Advisory Committee

    The Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (non-prescription) human
drug products, or any other FDA-regulated product, for use in the
treatment of a broad spectrum of human symptoms and diseases and
advises the Commissioner either on the promulgation of monographs
establishing conditions under which these drugs are generally
recognized as

safe and effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee will serve as a forum for
the exchange of views regarding the prescription and non-prescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency-sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.

D. National Mammography and Quality Assurance Advisory Committee

    The Committee reviews and evaluates (1) Developing appropriate
quality standards and regulations for mammography facilities; (2)
developing appropriate standards and regulations for bodies accrediting
mammography facilities under this program; (3) developing regulations
with respect to sanctions; (4) developing procedures for monitoring
compliance with standards; (5) establishing a mechanism to investigate
consumer complaints; (6) reporting new developments concerning breast
imaging that should be considered in the oversight of mammography
facilities; and (7) determining whether there exists a shortage of
mammography facilities in rural and health professional shortage areas
and determining the effects of personnel on access to the services of
such facilities in such areas; (8) determining whether there will exist
a sufficient number of medical physicists after October 1, 1999; and
(9) determining the costs and benefits of compliance with these
requirements.

E. Certain Panels of the Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, advises on the classification or reclassification of
devices into one of three regulatory categories; advises on any
possible risks to health associated with the use of devices; advises on
formulation of product development protocols; reviews premarket
approval applications for medical devices; reviews guidelines and
guidance documents; recommends exemption of certain devices from the
application of portions of the Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
may also make appropriate recommendations to the Commissioner of Food
and Drugs on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on the
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations, (2) be
able to analyze technical data, (3) understand research design, (4)
discuss benefits and risks, and (5) evaluate the safety and efficacy of
products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing three to five
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Potential candidates will be required to provide detailed information
concerning such matters as financial holdings, employment, and research
grants and/or contracts to permit evaluation of possible sources of
conflicts of interest.
    All nominations should include: A cover letter; a curriculum vitae
or resume that includes the nominee's home or office address, telephone
number, and email address; and a list of consumer or community-based
organizations for which the candidate can demonstrate active
participation.
    Nominations also should specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the nomination
and is willing to serve as a member of the advisory committee or panel
if selected. The term of office is up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of three to five
qualified nominees. Names not selected will remain on a list of
eligible nominees and be reviewed periodically by FDA to determine
continued interest. Upon selecting qualified nominees for the ballot,
FDA will provide those consumer organizations that are participating in
the selection process with the opportunity to vote on the listed
nominees. Only organizations vote in the selection process. Persons who
nominate themselves to serve as voting or nonvoting consumer
representatives will not participate in the selection process.
    FDA has a special interest in ensuring that women, minority groups,
and individuals with physical disabilities are adequately represented
on its advisory committees and panels and, therefore, encourages
nominations for appropriately qualified candidates from these groups.
    For questions relating to specific advisory committees or panels,
contact the following persons listed in table 2 of this document:

                                                     Table 2
----------------------------------------------------------------------------------------------------------------
                               Contact person                                          Committee/panel
----------------------------------------------------------------------------------------------------------------
Donald Jehn, Center for Biologics Evaluation and Research, Food and Drug     Allergenic Products.
 Administration, 5515 Security Lane, Rockwall Bldg. 2 (HFM-71), rm. 1118, ,
 Rockville, MD 20852,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug    Peripheral and Central Nervous
 Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver         Systems Drugs.
 Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug    Non-Prescription Drugs.
 Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and  National Mammography and Quality
 Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver    Assurance.
 Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and  Clinical Chemistry and Clinical
 Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver    Toxicology Devices.
 Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug  Ear, Nose, and Throat Devices.
 Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver
 Spring, MD 20993-0003,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>Shanika Craig, Center for Devices and Radiological Health, Food and Drug     Microbiology Devices Panel.
 Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1613, Silver
 Spring, MD 20993-0003,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

    Dated: February 7, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-3198 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36114-36116]
[FR Doc No: 2014-14778]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72433; File No. SR-NYSEArca-2014-69]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to
Holdings in Equity Securities by the Peritus High Yield ETF

June 19, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on June 10, 2014, NYSE Arca, Inc. (``Exchange'' or ``NYSE Arca'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to reflect a change to the holdings to be
implemented by the Peritus High Yield ETF to achieve its investment
objective with respect to holdings in equity securities. The text of
the proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Commission has approved a proposal to list and trade on the
Exchange shares (``Shares'') of the Peritus High Yield ETF (``Fund'')
under NYSE Arca Equities Rule 8.600,\4\ which governs the listing and
trading of Managed Fund Shares.\5\
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    \4\ See Securities Exchange Act Release No. 63329 (November 17,
2010), 75 FR 71760 (November 24, 2010) (SR-NYSEArca-2010-86) (the
``Prior Order''). The notice with respect to the Prior Order was
published in Securities Exchange Act Release No. 63041 (October 5,
2010), 75 FR 62905 (October 13, 2010) (``Prior Notice'' and,
together with the Prior Order, the ``Prior Release'').
    \5\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a-1) (``1940 Act'') organized as an
open-end investment company or similar entity that invests in a
portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Investment Company Units,
listed and traded on the Exchange under NYSE Arca Equities Rule
5.2(j)(3), seeks to provide investment results that correspond
generally to the price and yield performance of a specific foreign
or domestic stock index, fixed income securities index or
combination thereof.
---------------------------------------------------------------------------

    The Shares are offered by AdvisorShares Trust (the ``Trust''), a
statutory trust organized under the laws of the State of Delaware and
registered with the Commission as an open-end management investment
company.\6\ The Fund's Shares are currently listed and traded on the
Exchange under NYSE Arca Equities Rule 8.600.
---------------------------------------------------------------------------

    \6\ The Trust is registered under the 1940 Act. On October 29,
2012, the Trust filed with the Commission an amendment to its
registration statement on Form N-1A under the Securities Act of 1933
(15 U.S.C. 77a) and the 1940 Act relating to the Fund (File Nos.
333-157876 and 811-22110) (the ``Registration Statement''). The
description of the operation of the Trust and the Fund herein is
based, in part, on the Registration Statement. In addition, the
Commission has issued an order granting certain exemptive relief to
the Trust under the 1940 Act. See Investment Company Act Release No.
29291 (May 28, 2010) (File No. 812-13677) (``Exemptive Order'').
---------------------------------------------------------------------------

    The investment adviser to the Fund is AdvisorShares Investments,
LLC (the ``Adviser''). Peritus I Asset Management, LLC is the Fund's
sub-adviser (``Peritus'' or the ``Sub-Adviser'').
    According to the Registration Statement and as stated in the Prior
Release, the Fund's investment objective is to achieve high current
income with a secondary goal of capital appreciation. The Sub-Adviser
seeks to achieve the Fund's investment objective by selecting, among
other investments, a focused portfolio of high yield debt securities,
which include senior and subordinated corporate debt obligations (such
as bonds, debentures, notes and commercial paper). The Fund does not
have any portfolio maturity limitation and may invest its assets from
time to time primarily in instruments with short-term, medium-term or
long-term maturities. The Adviser represents that the investment
objective of the Fund is not changing.
    The Fund currently is permitted to invest no more than 10% of the
Fund's net assets in equity securities that the Sub-Adviser believes
will yield high dividends.\7\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 66818 (April 17,
20120 [sic], 77 FR 24233 (April 23, 2012) (SR-NYSEArca-2012-33)
(notice of filing and immediate effectiveness of proposed rule
change relating to the Fund's investment in equity securities)
(``Equity Investment Release''). The Exchange also filed a proposed
rule change to reflect a change in the Fund's holdings to allow
investment of up to 20% of the Fund's net assets in leveraged loans.
See Securities Exchange Act Release No. 70284 (August 29, 2013), 78
FR 54715 (September 5, 2013) (SR-NYSEArca-2013-83) (notice of filing
and immediate effectiveness of proposed rule change relating to Fund
investments in leveraged loans) (``Leveraged Loan Release'' and,
together with the Prior Release and the Equity Investment Release,
the ``Prior Releases'').
---------------------------------------------------------------------------

    The Exchange proposes to reflect a change to be implemented by the
Fund with respect to the holdings in equity securities to increase the
percentage of Fund assets that generally may be invested in equity
securities to no more than 20% of the Fund's net assets. Thus, in
addition to the investments referenced in the Prior Release and the
Leveraged Loan Release, the Fund will seek to invest generally no more
than 20% of its net assets in equity securities that the Sub-Adviser
believes will yield high dividends.\8\ According to the Registration
Statement and, as stated in the Equity Investment Release, equity
securities in which the Fund may invest will include common stock,
preferred stock, warrants, convertible securities, rights, master
limited partnerships, depositary receipts (including American
Depositary Receipts (``ADRs'') and Global Depositary Receipts
(``GDRs'', together with ADRs, ``Depositary

Receipts''),\9\ and real estate investment trusts. Depositary Receipts
held by the Fund may be sponsored or unsponsored, provided that no more
than 10% of the Fund's net assets will be invested in unsponsored
Depositary Receipts. With the exception of unsponsored Depositary
Receipts, all equity securities held by the Fund will be listed and
traded on U.S national securities exchanges, all of which are members
of the Intermarket Surveillance Group (``ISG'').
---------------------------------------------------------------------------

    \8\ The change to the Fund's holdings to include equity
securities will be effective upon filing with the Commission of an
amendment to the Trust's Registration Statement on Form N-1A, and
shareholders will be notified of such change by means of such
amendment.
    \9\ According to the Registration Statement, ADRs and GDRs are
certificates evidencing ownership of shares of a foreign issuer.
These certificates are issued by depositary banks and generally
trade on an established market in the United States or elsewhere.
The underlying shares are held in trust by a custodian bank or
similar financial institution in the issuer's home country. The
depositary bank may not have physical custody of the underlying
securities at all times and may charge fees for various services,
including forwarding dividends and interest and corporate actions.
---------------------------------------------------------------------------

    Pursuant to the terms of the Exemptive Order, the Fund will not
invest in options contracts, futures contracts or swap agreements. The
Fund's investments will be consistent with its investment objective and
will not be used to enhance leverage.
    As stated in the Prior Release, on each business day, before
commencement of trading in Shares in the Core Trading Session on the
Exchange, the Fund discloses on its Web site the Disclosed Portfolio,
which will include information relating to equity securities, among
other investments, that will form the basis for the Fund's calculation
of net asset value (``NAV'') at the end of the business day. For
purposes of calculating NAV, unsponsored Depositary Receipts are valued
on the basis of the market closing price on the exchange where the
stock of the foreign issuer that underlies such unsponsored Depositary
Receipts is listed. The intra-day, closing and settlement prices for
exchange-listed equity securities held by the Fund, including exchange-
listed Depositary Receipts are also readily available from the national
securities exchanges trading such securities. Pricing information for
unsponsored Depositary Receipts is available from automated quotation
systems, published or other public sources, or on-line information
services. All representations made in the Prior Release regarding the
availability of information relating to the Shares, trading halts,
trading rules, the Portfolio Indicative Value and surveillance, among
others, will continue to apply to trading in the Shares.
    The Exchange has in place surveillance procedures that are adequate
to properly monitor trading in the Shares in all trading sessions and
to deter and detect violations of Exchange rules and federal securities
laws applicable to trading on the Exchange. The Exchange may obtain
information via the ISG from other exchanges that are members of ISG or
with which the Exchange has entered into a comprehensive surveillance
sharing agreement. No more than 10% of the Fund's net assets will be
invested in unsponsored Depositary Receipts. With the exception of
unsponsored Depositary Receipts, all equity securities held by the Fund
will be listed and traded on U.S national securities exchanges.
    The Adviser represents that the proposed change to permit an
increased investment in equity securities, as described above, is
consistent with the Fund's investment objective, and will further
assist the Adviser and Sub-Adviser to achieve such investment
objective. Specifically, by investing an increased portion of the
Fund's net assets in equity securities, the Fund will have additional
flexibility to achieve high current income through investments in
dividend-paying equity securities, and to achieve the secondary goal of
capital appreciation through possible price appreciation of such equity
investments. Except for the change noted above, all other
representations made in the Prior Releases remain unchanged.\10\ The
Fund will continue to comply with all initial and continued listing
requirements under NYSE Arca Equities Rule 8.600.
---------------------------------------------------------------------------

    \10\ See notes 4 and 7, supra. All terms referenced but not
defined herein are defined in the Prior Release.
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \11\ that an exchange have rules that
are designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will be listed and traded on the Exchange pursuant to the
initial and continued listing criteria in NYSE Arca Equities Rule
8.600. The Exchange has in place surveillance procedures that are
adequate to properly monitor trading in the Shares in all trading
sessions and to deter and detect violations of Exchange rules and
applicable federal securities laws. The Exchange may obtain information
via the ISG from other exchanges that are members of ISG or with which
the Exchange has entered into a comprehensive surveillance sharing
agreement. No more than 10% of the Fund's net assets will be invested
in unsponsored Depositary Receipts. With the exception of unsponsored
Depositary Receipts, all equity securities held by the Fund will be
listed and traded on U.S national securities exchanges.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the NAV per Share is calculated daily and that the NAV and the
Disclosed Portfolio is made available to all market participants at the
same time. In addition, a large amount of information is publicly
available regarding the Fund and the Shares, thereby promoting market
transparency. The Portfolio Indicative Value, as defined in NYSE Arca
Equities Rule 8.600(c)(3), is disseminated by one or more major market
data vendors at least every 15 seconds during the Exchange's Core
Trading Session. On each business day, before commencement of trading
in Shares in the Core Trading Session on the Exchange, the Fund
discloses on its Web site the Disclosed Portfolio that will form the
basis for the Fund's calculation of NAV at the end of the business day.
Information regarding market price and trading volume of the Shares is
and will be continually available on a real-time basis throughout the
day on brokers' computer screens and other electronic services, and
quotation and last sale information is available via the Consolidated
Tape Association high-speed line. The intra-day, closing and settlement
prices for exchange-listed equity securities held by the Fund,
including exchange-listed Depositary Receipts are also readily
available from the national securities exchanges trading such
securities. Pricing information for unsponsored Depositary Receipts is
available from automated quotation systems, published or other public
sources, or on-line information services. Trading in Shares of the Fund
will be halted if the circuit breaker parameters in NYSE Arca Equities
Rule 7.12 have been reached or because of market conditions or for
reasons that, in the view of the Exchange, make trading in the Shares
inadvisable. Trading in the Shares is subject to NYSE Arca Equities
Rule 8.600(d)(2)(D), which sets forth

circumstances under which Shares of the Fund may be halted. The Web
site for the Fund includes a form of the prospectus for the Fund and
additional data relating to NAV and other applicable quantitative
information. In addition, as stated in the Prior Notice, investors have
ready access to information regarding the Fund's holdings, the
Portfolio Indicative Value, the Disclosed Portfolio, and quotation and
last sale information for the Shares.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest. As noted above, the Exchange has in place surveillance
procedures relating to trading in the Shares and may obtain information
via ISG from other exchanges that are members of ISG or with which the
Exchange has entered into a comprehensive surveillance sharing
agreement. In addition, as stated in the Prior Release, investors have
ready access to information regarding the Fund's holdings, the
Portfolio Indicative Value, the Disclosed Portfolio, and quotation and
last sale information for the Shares.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. The Exchange believes the
proposed rule change, in permitting the Fund utilize a higher
percentage of U.S. exchange-listed equity securities as part of its
portfolio to achieve its investment objective, will enhance competition
among issues of Managed Fund Shares that invest in fixed income and
equity securities.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, if consistent with
the protection of investors and the public interest, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\12\ and Rule 19b-4(f)(6)(iii) thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-69 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2014-69. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2014-69 and should
be submitted on or before July 16, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-14778 Filed 6-24-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59725-59726]
[FR Doc No: 2013-23626]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0008]

Construction Fall Protection Systems Criteria and Practices, and
Training Requirements; 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.

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

SUMMARY: OSHA solicits public comments concerning its proposal to
extend OMB approval of the information collection requirements
contained in the Construction Standards on Fall Protection Systems
Criteria and Practices (29 CFR 1926.502), and Training Requirements (29
CFR 1926.503).

DATES: Comments must be submitted (postmarked, sent, or received) by
November 26, 2013.

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 to Docket No. OSHA-2010-0008.
    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, Docket No. OSHA-2010-0008, OSHA,
U.S. Department of Labor, Room N-2625, 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, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for this Information Collection Request (ICR) (Docket No.
OSHA-2010-0008). 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. You may also contact Theda Kenney,
Directorate of Standards and Guidance, U.S. Department of Labor, Room
N-3621, 200 Constitution Avenue NW., Washington, DC 20110; (202) 693-
2044, to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Eric Kampert, Office of Construction
Services, Directorate of Construction, OSHA, U.S. Department of Labor,
Room N-3476, 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 accord with the Paperwork Reduction Act of
1995 (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 understandable,
and OSHA's estimate of the information collection burden is correct.
The Occupational Safety and Health Act of 1970 (the OSH Act) 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 Standards on Construction Fall Protection Systems Criteria and
Practices (29 CFR 1926.502) and Training Requirements (29 CFR 1926.503)
ensure that employers provide the required fall protection for their
workers. Accordingly, these standards have the following paperwork
requirements: Paragraphs (c)(4)(ii) and (k) of 29 CFR 1926.502, which
specify certification of safety nets and development of fall protection
plans, respectively, and paragraph (b) of 29 CFR 1926.503, which
requires employers to certify training records. The training
certification requirement specified in paragraph (b) of 29 CFR 1926.503
documents the training provided to workers potentially exposed to fall
hazards in construction. A competent person must train these workers to
recognize fall hazards and in the use of procedures and equipment that
minimize these hazards. An employer must verify compliance with this
training requirement by preparing and maintaining a written
certification record that contains the name or other identifier of the
worker receiving the training, the date(s) of the training, and the
signature of the competent person who conducted the training, or of the
employer.

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,
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 its approval of the collection
of information requirements contained in the Construction Standards on
Fall Protection Systems Criteria and Practices (29 CFR 1926.502) and
Training Requirements (29 CFR 1926.503). OSHA is requesting a 33,076
burden hour reduction, from 457,108 hours to 424,032, as a result of
decreasing the number of affected workers based on more recent data.
The Agency will summarize the comments submitted in response to this
notice and will include this summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Construction Fall Protection Systems Criteria and Practices
(29 CFR 1926.502) and Training Requirements (29 CFR 1926.503).
    OMB Control Number: 1218-0197.
    Affected Public: Business or other for-profits; Federal Government;
State, Local, or Tribal Government.
    Number of Responses: 5,291,439.
    Frequency of Recordkeeping: On occasion, annually.
    Average Time per Response: Time per response ranges from 5 minutes
(.08 hour) to certify a safety net to 1 hour to develop a fall
protection plan.
    Estimated Total Burden Hours: 424,032.
    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 this ICR (Docket No. OSHA-2010-0008).
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 full 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
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 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

    David Michaels, Ph.D., MPH, 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 September 24, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-23626 Filed 9-26-13; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: October 29, 2007 (Volume 72, Number 208)]
[Rules and Regulations]
[Page 61056-61057]
[DOCID:fr29oc07-5]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[CGD08-07-035]

Drawbridge Operating Regulations; Gulf Intracoastal Waterway,
Morgan City to Port Allen Alternate Route, Lower Grand River, Bayou
Sorrel, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
State Route 75 (SR 75) pontoon span bridge across the Lower Grand River
at mile 38.4, Gulf Intracoastal Waterway, Morgan City to Port Allen
Alternate Route at Bayou Sorrel, Iberville Parish, Louisiana. This
deviation provides for the bridge to remain closed to navigation for 24
consecutive hours to conduct scheduled maintenance to the drawbridge.

DATES: This deviation is effective from 7 a.m. on Tuesday, November 6,
2007 until 7 a.m. on Wednesday, November 7, 2007.

ADDRESSES: Materials referred to in this document are available for
inspection or copying at the office of the Eighth Coast Guard District,
Bridge Administration Branch, Hale Boggs Federal Building, Room 1313,
500 Poydras Street, New Orleans, Louisiana, 70130-3310 between 7 a.m.
and 3 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>. The Bridge Administration Branch
maintains the public docket for this temporary deviation.

FOR FURTHER INFORMATION CONTACT: Phil Johnson, Bridge Administration
Branch, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Louisiana Department of Transportation
and Development has requested a temporary deviation in order to replace
the entire winch and related operating mechanism of the SR 75 pontoon
span bridge across the Lower Grand River, Gulf Intracoastal Waterway,
Morgan City to Port Allen Alternate Route at Bayou Sorrel, Iberville
Parish, Louisiana. Replacement of the winch is necessary for continued
operation of the draw span of the bridge. This temporary deviation will
allow the bridge to remain in the closed-to-navigation position from 7
a.m. on Tuesday, November 6, 2007 until 7 a.m. on Wednesday, November
7, 2007. During the closure period, the draw will not be able to open
for emergencies. Currently, the draw opens on signal; except that, from
about August 15 to about June 5 (the school year), the draw need not be
opened from 6 a.m. to 7:30 a.m. Monday through Friday except holidays.
The draw opens on signal at any time for an emergency aboard a vessel.
    The bridge is a floating pontoon span bridge with no available
navigational clearance in the closed-to-navigation position. Thus,
vessels will not be able to transit through the bridge site when the
bridge is closed. Navigation on the waterway consists of tugs with
tows, fishing vessels and recreational powerboats. Due to prior
experience, as well as coordination with waterway users, it has been
determined that this closure will not have a significant effect on
these vessels.

    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: October 18, 2007.
David M. Frank,
Bridge Administrator.
 [FR Doc. E7-21216 Filed 10-26-07; 8:45 am]

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[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76229-76230]
[FR Doc No: 2022-26972]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No.: FAA-2022-1259]

Agency Information Collection Activities: Requests for Comments;
Clearance of Approval of Continuing Information Collection: Service
Availability Prediction Tool (SAPT)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
FAA invites public comments about their intention to request Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on September 26, 2022.

DATES: Written comments should be submitted by December 1, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    By mail: Send comments to FAA at the following address: Mr. Stanton
Brunner, Program Manager, Service Performance and Sustainment Team
(AJM-422), Surveillance and Broadcast Services, Program Management
Organization, Federal Aviation Administration, 600 Independence Ave.
SW, Wilbur Wright Building, Washington, DC 20597.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Mr. Paul Von Hoene, Aviation Safety, Aviation
Safety Inspector (AC/OPS) at [email protected], or Jamal Wilson,
202-267-4301.

SUPPLEMENTARY INFORMATION: The collection involves planned routes of
flight and aircraft avionics equipment. The information that is
collected will be used to predict whether an aircraft flying the
proposed route of flight will have sufficient position accuracy and
integrity for the following:

(1) Navigation, via the Receiver Autonomous Integrity Monitoring (RAIM)
SAPT
(2) Surveillance, via the Automatic Dependent Surveillance--Broadcast
(ADS-B) SAPT

    In addition, the website will allow operators to request
authorization to operate in ADS-B-Out rule airspace with aircraft that
do not fully meet the ADS-B Out requirements via:

(3) ADS-B Deviation Authorization Pre-flight Tool (ADAPT).

    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information.
    OMB Control Number: 2120-0780.
    Title: Service Availability Prediction Tool (SAPT).
    Form Numbers: eXtensible markup language (XML), ADS-B SAPT flight
information entry form, and ADS-B authorization request at https://sapt.faa.gov.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on September 26, 2022 (87 FR 58428).
    Under 14 CFR 91.103, pilots must use all available information in
planning

their flight. SAPT is a web-based tool to assist aircraft operators in
achieving compliance with the requirements of 14 CFR 91.103, 91.225.
and 91.227, and/or AC 90-100A Change 2, Paragraph 10a. (5). To ensure
that they will meet the performance requirements for the duration of
the flight, pilots may use the FAA-provided pre-flight Service
Availability Prediction Tool (SAPT) to determine predicted navigation
or surveillance availability before a flight. The SAPT has three main
components: the Receiver Autonomous Integrity Monitoring (RAIM) SAPT,
the ADS-B SAPT, and the ADS-B Deviation Authorization Pre-Flight Tool
(ADAPT). The SAPT models the GPS constellation in order to assess the
predicted accuracy and integrity of GPS position information used in
navigation and surveillance for a few GPS receiver Technical Standard
Orders (TSOs).
    The RAIM SAPT is intended mainly for pilots, dispatchers, and
commercial operators using TSO-C129 equipment to check their predicted
navigation horizontal protection level (HPL). It incorporates TSO-C129
GPS RAIM predictions to check the availability of GPS RAIM satisfying
the RNAV requirements of AC 90-100A Change 2, Paragraph 10(5)).
    The ADS-B SAPT is provided to help operators comply with 14 CFR
91.225 and 91.227 by predicting whether operators will meet regulatory
requirements, and to advise holders of FAA Exemption 12555 whether
back-up surveillance will be available for any waypoints where
installed aircraft avionics are not predicted to meet the requirements
of 14 CFR 91.227(c)(1)(i) and (iii).
    Information collected via ADS-B SAPT is comparable to that provided
by pilots when they file flight plans, with some additional information
about aircraft position source TSO and related capabilities. The ADS-B
SAPT prediction is based on the ability of the aircraft's position
source (i.e., GPS receiver) to meet performance requirements specified
in FAA TSOs C129, C129a, C145c/C146c, and C196, as well as the
predicted status of the GPS constellation.
    The ADS-B SAPT predicts whether GPS position information will be
sufficient throughout the flight to meet the performance requirements
of 14 CFR 91.227(c)(1)(i) and (iii). If a waypoint is in rule airspace
and the aircraft's position source is not predicted to meet the
performance requirements of 14 CFR 91.227, the ADS-B SAPT checks for
the availability of back-up surveillance at that waypoint.
    Operators of aircraft equipped with TSO-C129 (SA-On) GPS receivers
must run a pre-flight prediction. The operator may use their own
prediction tool. Although Exemption 12555 does not require operators
with SA-On to use the ADS-B SAPT for pre-flight availability
prediction, if the operator does use their own tool and receives an
indication that performance will fall below rule requirements, the
operator cannot obtain back-up surveillance information from that tool
and must either replan the flight or use ADS-B SAPT to determine
whether back-up surveillance is available along the planned route of
flight per Exemption 12555.
    ADAPT is mandatory for operators desiring to apply for an ATC
authorization, per 14 CFR 91.225(g), to fly in ADS-B Out rule airspace
using aircraft with avionics that do not meet the ADS-B equipage
requirements. ADAPT allows operators to create an air traffic
authorization request to operate in ADS-B Out rule airspace when either
(1) the aircraft is without ADS-B equipment; (2) that equipment is
inoperative; or (3) their avionics are not expected to meet the ADS-B
performance requirements as identified in 14 CFR 91.227(c)(1)(i) and
(iii). Operators who wish to submit an ADAPT request must complete the
ADS-B SAPT analysis using information entered into the flight
information entry form before filing the ADAPT request.
    Respondents: These prediction tools are primarily intended for
pilots and dispatchers; and for anyone who is planning a flight which
passes through U.S. sovereign airspace, using an aircraft whose GPS
receiver(s) is/are not guaranteed to meet certain performance
requirements or whose aircraft is not equipped to meet the requirements
of 14 CFR 91.225.
    Frequency: As part of the flight planning process, as required by
FAA policy. For some users, this could be every flight. For others it
will depend on the specific conditions and performance requirements.
    Estimated Average Burden per Response:
    RAIM SAPT and ADS-B SAPT can be automated as part of the dispatch
process by operators or flight service providers, thus eliminating
manual data-entry.
    RAIM SAPT--Insignificant, as all transactions are automated in
flight planning systems.
    ADS-B SAPT--5 minutes or less for transactions input via the flight
plan form, including 1 minute or less to note the transaction id.
    ADAPT--7 minutes or less (includes up to 2 minutes to check FAA
email response).
    Estimated Total Annual Burden:
    RAIM SAPT--Insignificant additional burden.
    ADS-B SAPT--Approximately 2159 hours.
    ADAPT--Approximately 590 hours.

    Issued in Washington, DC, on December 7, 2022.
Jamal Wilson,
SAPT Project Lead [verbar] In-Service Performance and Sustainment (AJM-
4220), Federal Aviation Administration.
[FR Doc. 2022-26972 Filed 12-12-22; 8:45 am]
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