[Federal Register: March 11, 2008 (Volume 73, Number 48)]
[Notices]
[Page 12973-12974]
[DOCID:fr11mr08-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12963-000]

Grays Landing Hydro, LLC; Notice of Application Accepted for
Filing and Soliciting Motions To Intervene, Protests, and Comments

March 4, 2008.
    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.: 12963-000.
    c. Date filed: August 15, 2007.
    d. Applicant: Grays Landing Hydro, LLC.
    e. Name of Project: Grays Landing Lock and Dam Hydroelectric
Project
    f. Location: Monongahela River in Greene County, Pennsylvania. It
would use the U.S. Army Corps of Engineers' Grays Landing Lock and Dam.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Brent L. Smith, COO, Symbiotics, LLC,
P.O. Box 535, Rigby, ID 83442,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<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:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. 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 the ``e-Filing'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-12963-000) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project using the U.S. Army
Corps of Engineers' Grays Landing Lock and Dam and operated in a run-
of-river mode would consist of: (1) A new powerhouse and switchyard;
(2) two turbine/generator units with a combined installed capacity of
15 megawatts; (3) a new 1.4-mile-long above ground 25-kilovolt
transmission line extending from the switchyard to an interconnection
point with West Penn Power Company's distribution system; and (4)
appurtenant facilities. The proposed Grays Landing Lock and Dam Project
would have an average annual generation of 47 gigawatt-hours.
    l. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. 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. 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
and 4.36.
    n. 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 and 4.36.
    o. 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.
    p. 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.
    q. 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.
    r. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', 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. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. 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.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-4742 Filed 3-10-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38762-38763]
[FR Doc No: 2018-16826]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2018-63]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before August 27, 2018.

ADDRESSES: Send comments identified by docket number FAA-2018-0725
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the

West Building Ground Floor at 1200 New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: Mark Forseth, AIR-673, Federal
Aviation Administration, 2200 S 216th St., WA 98198-6547, email
[email protected], phone<PHONE_NUMBER>; or Alphonso Pendergrass,
ARM-200, Office of Rulemaking, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591, email
[email protected], phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington, on July 31, 2018.
Suzanne Masterson,
Acting Manager, Transport Standards Branch.

Petition for Exemption

    Docket No.: FAA-2018-0725.
    Petitioner: Gulfstream Aerospace Corporation.
    Section of 14 CFR Affected: Sec.  25.1309(b) and Special Conditions
No. 25-662-SC.
    Description of Relief Sought: Provide relief to allow for the
installation of seat airbag systems equipped with lithium batteries on
Gulfstream Model GVII-G500/G600 airplanes.

[FR Doc. 2018-16826 Filed 8-6-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: October 30, 2008 (Volume 73, Number 211)]
[Notices]
[Page 64661]
[DOCID:fr30oc08-90]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

CSX Transportation (Waiver Petition Docket Number FRA-2008-0111)

    CSX Transportation (CSXT) petitioned FRA for a waiver from 49 CFR
213.113(a) to permit variance from the accepted practice of stop/start
rail test hand verification for a continuous rail test pilot project
for a period of 8 weeks on the main tracks of the North End subdivision
between Richmond, Virginia, and Rocky Mount, North Carolina, milepost
limits A0.0-123.2. Prior to beginning the pilot project, the North End
subdivision main tracks will be rail tested with a conventional stop/
start rail test vehicle and any normally scheduled intervals during the
pilot project will be maintained by convention stop/start rail test
vehicle.
    The continuous high speed rail test vehicle will be a self
propelled rail-bound ultrasound Sperry car operating at speeds up to 25
miles per hour in non-stop mode making weekly runs. Upon completion of
each run, data will be analyzed offline by a group of experts with
experience in this process. The analysis will categorize and prioritize
suspect defect locations. Two teams of verifiers will then be sent out
with field instruments to check locations based upon Global Positioning
System (GPS) coordinates. Locations will be checked 60 feet either side
of suspect GPS point. Remedial actions will be applied as per 49 CFR
213.113 for confirmed rail defects. CSXT states that continuous rail
testing will provide the capability to test track more frequently,
minimizing the risk of rail service failure.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2008-0111) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on October 23, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E8-25844 Filed 10-29-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: June 22, 2006 (Volume 71, Number 120)]
[Notices]
[Page 35882-35883]
[DOCID:fr22jn06-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP06-383-000]

Transcontinental Gas Pipe Line Corporation; Notice of Application

June 15, 2006.
    Take notice that on June 12, 2006, Transcontinental Gas Pipe Line
Corporation (``Transco''), Post Office Box 1396, Houston, Texas 77251,
filed an application pursuant to section 7(c) of the Natural Gas Act
(NGA), for a certificate of public convenience and necessity
authorizing Transco to relocate and replace approximately 740 feet of
30-inch pipeline on its Mobile Bay Lateral in Mobile County, Alabama.
This application is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
    Transco states that due to the Alabama Department of
Transportation's planned relocation of U.S. Highway 98 in Mobile
County, Alabama, Transco must relocate approximately 740 feet of
pipeline. Transco estimates that the proposed replacement project will
cost approximately $870,000.
    Any questions about this application should be directed to Stephen
A. Hatridge, Senior Counsel, Transcontinental Gas Pipe Line
Corporation, Post Office Box 1396, Houston, Texas 77251-1396, at (713)
215-2312 or<EMAIL_ADDRESS>    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 listed 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 14 copies of this filing and all subsequent filings made with
the Commission and must mail a copy of all filing 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, other persons do 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 this
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, or in support of or in opposition to 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. The Commission's rules require that persons filing
comments in opposition to the project provide copies of their protests
only to the applicant. 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 via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

    Comment Date: July 6, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-9803 Filed 6-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Notices]
[Pages 1587-1597]
[FR Doc No: 2023-00394]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-3351]

Authorization of Emergency Use of an In Vitro Diagnostic Device
in Response to an Outbreak of Mpox; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the issuance of an Emergency Use Authorization (EUA) (the
Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) in response to an outbreak of mpox. FDA has issued an
Authorization for an in vitro diagnostic device as requested by Life
Technologies Corporation (a part of Thermo Fisher Scientific Inc.). The
Authorization contains, among other things, conditions on the emergency
use of the authorized product. The Authorization follows the August 9,
2022, determination by the Secretary of Health and Human Services (HHS)
that there is a public health emergency, or a significant potential for
a public health emergency, that affects, or has a significant potential
to affect, national security or the health and security of U.S.
citizens living abroad, and that involves monkeypox virus. On the basis
of such determination, the Secretary of HHS declared, on September 7,
2022, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
pursuant to the FD&C Act, subject to terms of any authorization issued
under that section. The Authorization, which includes an explanation of
the reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of December 13, 2022.

ADDRESSES: Submit written requests for a single copy of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive

label to assist that office in processing your request or include a Fax
number to which the Authorization may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Jennifer Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives (among other criteria).

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50, U.S. Code, of attack with (A) a
biological, chemical, radiological, or nuclear agent or agents or (B)
an agent or agents that may cause, or are otherwise associated with, an
imminently life-threatening and specific risk to U.S. military forces;
\1\ (3) a determination by the Secretary of HHS that there is a public
health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in an actual or potential emergency when the
Secretary of HHS has declared that circumstances exist justifying the
authorization of emergency use. Products appropriate for emergency use
may include products and uses that are not approved, cleared, or
licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21
U.S.C. 355, 360(k), 360b, or 360e) or section 351 of the PHS Act (42
U.S.C. 262), or conditionally approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc).
    FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) that an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii) of the FD&C Act, that the request for emergency use is
made by the Secretary of Defense; and (5) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. The Authorization

    The Authorization follows the August 9, 2022, determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves
monkeypox virus. Notice of the Secretary's determination was provided
in the Federal Register on August 15, 2022 (87 FR 50090). On the basis
of such determination, the Secretary of HHS declared, on September 7,
2022, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
pursuant to section 564 of the FD&C Act, subject to the terms of any
authorization issued under that section. Notice of the Secretary's
declaration was provided in the Federal Register on September 13, 2022
(87 FR 56074). On December 13, 2022, having concluded that the criteria
for issuance

of the Authorization under section 564(c) of the FD&C Act are met, FDA
issued an EUA to Life Technologies Corporation (a part of Thermo Fisher
Scientific Inc.) for the TaqPath Monkeypox/Orthopox Virus DNA Kit,
subject to the terms of the Authorization. The Authorization, which is
included below in its entirety after section IV of this document (not
including the authorized versions of the fact sheets and other written
materials), provides an explanation of the reasons for issuance, as
required by section 564(h)(1) of the FD&C Act. Any subsequent revision
to the Authorization can be found on FDA's web page at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. Electronic Access

    An electronic version of this document and the full text of the
Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN11JA23.004

[GRAPHIC] [TIFF OMITTED] TN11JA23.005

[GRAPHIC] [TIFF OMITTED] TN11JA23.006

[GRAPHIC] [TIFF OMITTED] TN11JA23.007

[GRAPHIC] [TIFF OMITTED] TN11JA23.008

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[GRAPHIC] [TIFF OMITTED] TN11JA23.010

[GRAPHIC] [TIFF OMITTED] TN11JA23.011

[GRAPHIC] [TIFF OMITTED] TN11JA23.012

    Dated: January 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00394 Filed 1-10-23; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Notices]
[Pages 40756-40758]
[FR Doc No: 2011-17245]

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SECURITIES AND EXCHANGE COMMISSION

[RELEASE NO. 34-64804; File No. SR-MSRB-2011-07]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of Revisions to the
Study Outline for the Municipal Fund Securities Limited Principal
Qualification Examination (Series 51)

July 5, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 21, 2011, the Municipal Securities Rulemaking Board
(``Board'' or ``MSRB'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') a proposed rule change (File No.
SR-MSRB-2011-07) (the ``proposed rule change'') as described in Items
I, II, and III below, which Items have been prepared by the MSRB. The
MSRB has designated the proposed rule change as constituting a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule of the self-
regulatory organization pursuant to Section 19(b)(3)(A)(i) \3\ of the
Act and Rule 19b-4(f)(1) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The implementation date of
the proposed rule change is August 1, 2011, which is when the revised
study outline will indicate its effective date. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB is filing with the Commission revisions to the study
outline for the Municipal Fund Securities Limited Principal
Qualification Examination (Series 51).
    The text of the proposed rule change is available on the MSRB's Web
site at http://www.msrb.org/Rules-and-Interpretations/SEC-Filings/2011-Filings.aspx, at the MSRB's principal office, 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 MSRB 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 these statements may be examined at the places specified in
Item IV below. The Board has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    Section 15B(b)(2)(A) of the Act \5\ authorizes the MSRB to
prescribe standards of training, experience, competence, and such other
qualifications as the Board finds necessary or appropriate in the
public interest or for the protection of investors and municipal
entities or obligated persons. The MSRB has developed examinations that
are designed to establish that persons associated with brokers, dealers
and municipal securities dealers that effect transactions in municipal
securities have attained specified levels of competence and knowledge.
The MSRB periodically reviews the content of the examinations to
determine whether revisions are necessary or appropriate in view of
changes pertaining to the subject matter covered by the examinations.
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    \5\ 15 U.S.C. 78o-4(b)(2)(A).
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    MSRB Rule G-3(b)(iv) states that the municipal fund securities
limited principal has responsibility to oversee the municipal
securities activities of a securities firm or bank dealer solely as
such activities relate to transactions in municipal fund securities. In
this capacity, the municipal fund securities

limited principal manages, directs or supervises one or more of the
following activities relating to municipal fund securities:
underwriting, trading or selling municipal fund securities; rendering
financial advisory or consultant services to issuers of municipal fund
securities; research or investment advice, or communications with
customers, about any of the activities named heretofore; maintaining
records on activities in municipal fund securities; processing,
clearing, and (in the case of securities firms) safekeeping of
municipal fund securities; and training of principals and
representatives.\6\ The only examination that qualifies a municipal
fund securities limited principal is the Municipal Fund Securities
Limited Principal Qualification Examination.
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    \6\ A municipal securities principal (Series 53) is also
qualified to supervise these responsibilities.
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    The Municipal Fund Securities Limited Principal Qualification
Examination is designed to determine whether an individual meets the
MSRB's qualification standards for municipal fund securities limited
principals. To do this, the examination measures a candidate's
knowledge of MSRB rules, rule interpretations and Federal statutory
provisions applicable to the activities listed above. It also measures
the candidate's ability to apply these rules and interpretations to
given fact situations in the context of municipal fund securities
activities. In addition to passing this examination, a candidate must
also have previously or concurrently qualified as a general securities
principal or investment company/variable contracts limited principal.
The examination consists of 60 multiple-choice questions and each
question is worth one point. The passing grade is 70%. Candidates are
allowed one and one-half hours to complete the examination.
    Recent changes to MSRB rules have necessitated revisions to the
Series 51 study outline to indicate the current rule requirements and
rule citations. A summary of the changes to the study outline for the
Series 51 examination, detailed by major topic headings, is provided
below. Changes are stated as revisions to the current outline.
Part Three: General Supervision
Qualification and Registration
     The topic for Rule A-15 has been revised to indicate the
current rule requirements for notification to the MSRB of change in
status, name or address.
Part Six: Underwriting and Disclosure Obligations
Obligations of Municipal Underwriters
     The topic ``Delivery of official statement and Form G-
36(OS) to the MSRB'' has been replaced with ``Submission of official
statements, advance refunding documents and other required information
to EMMA'' to reflect the current requirements pursuant to Rule G-32(b).
     The topic ``Responsibility of primary distributors'' has
been deleted because the current requirements for primary distributors
are included under the topic ``Submission of official statements,
advance refunding documents and other required information to EMMA''
pursuant to Rule G-32(b).
Disclosures to Customers
     The rule citation for the topic ``Delivery of official
statement to customer and other disclosure requirements'' has been
revised to reflect current Rule G-32.
2. Statutory Basis
    The MSRB believes that the proposed revisions to the study outline
for the Series 51 examination are consistent with the provisions of
Section 15B(b)(2)(A) of the Act, which authorizes the MSRB to prescribe
standards of training, experience, competence, and such other
qualifications as the Board finds necessary or appropriate in the
public interest or for the protection of investors and municipal
entities or obligated persons. Section 15B(b)(2)(A) of the Act also
provides that the Board may appropriately classify municipal securities
brokers, municipal securities dealers, and municipal advisors, and
persons associated with municipal securities brokers, municipal
securities dealers, and municipal advisors and require persons in any
such class to pass tests prescribed by the Board.
    The MSRB believes that the proposed revisions to the study outline
for the Series 51 examination are consistent with the provisions of
Section 15B(b)(2)(A) of the Act in that the revisions will ensure that
certain key concepts or rules are tested on each administration of the
examination in order to test the competency of individuals seeking to
qualify as municipal fund securities limited principals with respect to
their knowledge about MSRB rules and the municipal securities market.

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

    The MSRB does not believe that the proposed rule change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received on the
proposed rule change.

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

    The proposed rule change has become effective pursuant to Section
19(b)(3)(A)(i) of the Act \7\ and Rule 19b-4(f)(1) \8\ thereunder, in
that the proposed rule change constitutes a stated policy, practice, or
interpretation with respect to the meaning, administration, or
enforcement of an existing rule of the self-regulatory organization.
The implementation date of the proposed rule change is August 1, 2011,
which is when the revised study outline will indicate its effective
date. 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.\9\
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    \7\ 15 U.S.C. 78s(b)(3)(A)(i).
    \8\ 17 CFR 240.19b-4(f)(1)
    \9\ See Section 19(b)(3)(C) of the Act, 15 U.S.C. 78s(b)(3)(C).
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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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2011-07 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission,

100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-MSRB-2011-07. This file
number should be included on the subject line if e-mail 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 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 a.m. and 3
p.m.. Copies of such filing also will be available for inspection and
copying at the MSRB's offices. 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-MSRB-2011-07 and
should be submitted on or before August 1, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-17245 Filed 7-8-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Page 95265]
[FR Doc No: 2016-31234]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of a New Approval of Information Collection: Alternative
Pilot Physical Examination and Education Requirements

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval of a new information collection.
The information collected is used to verify that pilots in command meet
the requirements of section 2307 of Public Law 114-190. The new
information collection is in response to implementation of section
2307, medical certification of certain small aircraft pilots, of Public
Law 114-190, the Federal Aviation Administration (FAA) Extension,
Safety, and Security Act of 2016 (FESSA). Section 2307 of FESSA
established a new voluntary program of physical examination and
education requirements for certain pilots in command in lieu of those
pilots holding a medical certificate.

DATES: Written comments should be submitted by February 27, 2017.

ADDRESSES: Send comments to the FAA at the following address: Ronda
Thompson, Room 441, Federal Aviation Administration, ASP-110, 950
L'Enfant Plaza SW., Washington, DC 20024.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson by email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: Not assigned.
    Title: Alternative Pilot Physical Examination and Education
Requirements.
    Form Numbers: FAA form 8700-2 and 8700-3.
    Type of Review: New information collection.
    Background: The Federal Aviation Administration (FAA) Extension,
Safety, and Security Act of 2016 (Pub. L. 114-190) (FESSA) was enacted
on July 15, 2016. Section 2307 of FESSSA, medical certification of
certain small aircraft pilots, directed the FAA to ``issue or revise
regulations to ensure that an individual may operate as pilot in
command of a covered aircraft'' if the pilot and aircraft meet certain
prescribed conditions as outlined in FESSA. The FAA notes that the use
of section 2307 by any eligible pilot is voluntary. Persons may elect
to use these alternative pilot physical examination and education
requirements or may continue to operate using any FAA medical
certificate.
    The FAA is publishing a final rule, Alternative Pilot Physical
Examination and Education Requirements, to implement the provisions of
section 2307 (RIN 2120-AK96).
    Respondents: Approximately 453,993 individuals.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 21 minutes.
    Estimated Total Annual Burden: 159,000 hours.

    Issued in Washington, DC, on December 19, 2016.
Ronda L. Thompson,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2016-31234 Filed 12-23-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 132 (Thursday, July 10, 2014)]
[Notices]
[Pages 39412-39413]
[FR Doc No: 2014-16144]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0027]

Respiratory Protection 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 its proposal to
extend OMB approval of the information collection requirements
specified by the Respiratory Protection Standard (29 CFR 1910.134).

DATES: Comments must be submitted (postmarked, sent, or received) by
September 8, 2014.

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, Docket No. OSHA-2011-0027, U.S.
Department of Labor, Occupational Safety and Health Administration,
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 the
OSHA docket number (OSHA-2011-0027) for the Information Collection
Request (ICR). 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 from 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 at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

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 (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 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 Respiratory Protection Standard (29 CFR 1910.134; hereafter,
``the Standard'') contains information collection requirements that
require employers to: develop a written respirator program; conduct
worker medical evaluations and provide follow-up medical evaluations to
determine the worker's ability to use a respirator; provide the
physician or other licensed healthcare professional with information
about the worker's respirator and the conditions under which the worker
will use the respirator; and administer fit tests for workers who will
use negative- or positive-pressure, tight-fitting facepieces. In
addition, employers must ensure that workers store emergency-use
respirators in compartments clearly marked as containing emergency-use
respirators. For respirators maintained for emergency use, employers
must label or tag the respirator with a certificate stating the date of
the inspection, the name of the individual who did the inspection, the
findings of the inspection, required remedial action, and the identity
of the respirator.
    The Standard also requires employers to ensure that cylinders used
to supply breathing air to respirators have a certificate of analysis
from the supplier stating that the breathing air meets the requirements
for Type 1--Grade D breathing air; such certification assures employers
that the purchased breathing air is safe. Compressors used to supply
breathing air to respirators must have a tag containing the most recent
change date and the signature of the individual authorized by the
employer to perform the change. Employers must maintain

this tag at the compressor. These tags provide assurance that the
compressors are functioning properly.

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 information
collection requirements contained in the Respiratory Protection
Standard (29 CFR 1910.134). The Agency is requesting an adjustment
decrease in the number of burden hours from 6,801,711 hours to
6,643,220 hours, a total decrease of 158,491 burden hours. This
decrease is based on updated data showing a decrease in the number of
covered establishments. In addition, OSHA is requesting an adjustment
increase of $3,265,756 in operation and maintenance costs (from
$185,578,935 to $188,844,691) associated with increased estimated costs
for employee medical exams, fit-testing materials and fit-tests. 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: Respiratory Protection Standard (29 CFR 1910.134).
    OMB Control Number: 1218-0099.
    Affected Public: Business or other for-profits.
    Number of Respondents: 610,213.
    Frequency of Responses: Initially; annually; on occasion.
    Total Responses: 21,447,539.
    Average Time per Response: Varies from 5 minutes (.08 hour) to mark
a storage compartment or protective cover to 8 hours for large
employers to gather and prepare information to develop a written plan.
    Estimated Total Burden Hours: 6,643,220.
    Estimated Cost (Operation and Maintenance): $188,844,691.

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 (Docket No. OSHA-2011-0027) for the ICR. 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 from 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 from 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 July 7, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-16144 Filed 7-9-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Rules and Regulations]
[Pages 12434-12435]
[FR Doc No: 2020-04262]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0328; Airspace Docket No. 18-ANM-5]
RIN 2120-AA66

Amendment of Class E Airspace; Rifle, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Rifle Garfield County
Airport, Rifle, CO. The action increases the circular radius of the
Class E airspace, designated as a surface area, to the west and
northwest of the airport. Also, this action amends the Class E airspace
by adding an airspace area, designated as an extension to a Class D or
Class E surface area, to the east of the airport. Additionally, this
action amends the Class E airspace extending upward from 700 feet above
the surface by increasing the radius of the airspace around most of the
airport and reducing the radius to the north and northeast of the
airport. This action also removes the extensions from this airspace
area. Lastly, this action makes several administrative corrections to
the airspace legal descriptions for the airport.

DATES: Effective 0901 UTC, May 21, 2020. The Director of the Federal
Register approves this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov//air_traffic/publications/. For further information, you
can contact the Airspace Policy Group, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace at Rifle Garfield County Airport,
Rifle, CO, to ensure the safety and management of Instrument Flight
Rules (IFR) operations at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 69346; December 18, 2019) for Docket No. FAA-2019-0328
to amend Class E airspace at Rifle Garfield County Airport, Rifle, CO.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E2, E4, and E5 airspace designations are published in
paragraph 6002, 6004 and 6005, respectively, of FAA Order 7400.11D,
dated August 8, 2019, and effective September 15, 2019, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document will be published subsequently in
the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace at the Rifle Garfield County Airport,
Rifle, CO. The action amends the Class E airspace, designated as a
surface area, by increasing the circular radius in the west and
northwest of the airport to contain IFR arrivals descending below 1,000
above the surface. The airspace is described as follows: That airspace
extending upward from the surface within a 4.1-mile radius of the
airport beginning at the 339[deg] bearing from the airport, clockwise
to the 243[deg] bearing from the airport, thence along the 243[deg]
bearing to a 5.2-mile radius of the airport, clockwise to the 339[deg]
bearing from the airport, thence along 339[deg] bearing back to the
4.1-mile radius of the Rifle Garfield County Airport.
    Also, this action amends the Class E airspace by adding an area
designated as an extension to Class D and Class E2 surface areas. This
area is described as follows: That airspace extending upward from the
surface within 1 mile north and 2.5 miles south of the 078[deg] bearing
from the airport, extending from the 4.1-mile radius to 8.5 miles east
of the Rifle Garfield County Airport.
    Additionally, this action amends the Class E airspace extending
upward from 700 feet above the surface by increasing the radius of the
airspace around the most of the airport and reducing it to the north
and northwest of the airport. This action also removes the extensions
from this airspace area. This area is described as follows: That
airspace extending upward from 700 feet above the surface within a 5.5-
mile radius of the airport beginning at the 336[deg] bearing from the
airport, clockwise to the 065[deg] bearing from the airport, thence
along the 065[deg] bearing to an 11-mile radius of the airport,
clockwise to the 336[deg] bearing from the airport, thence along the
336[deg] bearing back to the 5.5-mile radius of the Rifle Garfield
County Airport.

    Lastly, the action makes several administrative corrections to the
airspace's legal description. The geographic coordinates are updated to
lat. 39[deg]31'36'' N, long. 107[deg]43'41'' W to match the FAA's
aeronautical database. The airport name is updated to ``Rifle Garfield
County Airport, Rifle, CO'', to match the FAA's aeronautical database.
The Class E2 surface airspace is full time; the following two sentences
do not accurately represent the time of use for the Class E2 airspace
and are removed from the legal description: ``This Class E airspace
area is effective during specific dates and times established in
advance by a Notice to Airmen. The effective date and time will
thereafter be continuously published in the Airport/Facility
Directory.''
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

     Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.

* * * * *

ANM CO E2 Rifle, CO [Amended]

Rifle Garfield County Airport, Rifle, CO
    (Lat. 39[deg]31'36'' N, long. 107[deg]43'41'' W)

    That airspace extending upward from the surface within a 4.1-
mile radius of airport beginning at the 339[deg] bearing from the
airport, clockwise to the 243[deg] bearing from the airport, thence
along the 243[deg] bearing to a 5.2-mile radius of the airport,
clockwise to the 339[deg] bearing from the airport, thence along
339[deg] bearing back to the 4.1-mile radius of the Rifle Garfield
County Airport.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

ANM CO E4 Rifle, CO [New]

Rifle Garfield County Airport, Rifle, CO
    (Lat. 39[deg]31'36'' N, long. 107[deg]43'41'' W)

    That airspace extending upward from the surface within 1 mile
north and 2.5 miles south of the 078[deg] bearing from the airport
extending from the 4.1-mile radius to 8.5 miles east of the Rifle
Garfield County Airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM CO E5 Rifle, CO [Amended]

Rifle Garfield County Airport, Rifle, CO
    (Lat. 39[deg]31'36'' N, long. 107[deg]43'41'' W)

    That airspace extending upward from 700 feet above the surface
within a 5.5-mile radius of the airport beginning at the 336[deg]
bearing from the airport, clockwise to the 065[deg] bearing from the
airport, thence along the 065[deg] bearing to an 11-mile radius of
the airport, clockwise to the 336[deg] bearing from the airport,
thence along the 336[deg] bearing back to the 5.5-mile radius of the
Rifle Garfield County Airport.

    Issued in Seattle, Washington, on February 26, 2020.
Shawn M. Kozica,
Group Manager, Western Service Center, Operations Support Group.
[FR Doc. 2020-04262 Filed 3-2-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73986-73987]
[DOCID:fr04de08-74]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2008-35]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before December 24, 2008.

ADDRESSES: You may send comments identified by Docket Number FAA-2008-
0760 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Laverne Brunache<PHONE_NUMBER> or
Tyneka Thomas<PHONE_NUMBER>, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on December 1, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2008-0760.
    Petitioner: Endless Mountain Pilots.
    Section of 14 CFR Affected: 14 CFR 91.146, 91.147, and part 136,
subpart A.
    Description of Relief Sought: Endless Mountain Pilots requests an
exemption from 14 CFR Sec. Sec.  91.146, 91.147, and part 136, subpart
A to allow the following: (1) An aircraft owner who is not piloting
his/her own aircraft or the airport owner of Seamans Field Airport in
Factoryville, PA (9N3) who rents aircraft in the normal course of
business to

share with the pilot in command (PIC) the fuel, oil, and operating cost
of such flight if such aircraft owner chooses; (2) an aircraft owner
who is not piloting his/her own aircraft or the airport owner of 9N3 to
allow the use of his/her aircraft at no expense to the PIC, if such
aircraft owner so wishes; (3) an airport owner of 9N3 to offer fuel at
a reasonable discount rate which would be no less than his actual cost
of the fuel; and (4) Endless Mountain Pilots to share the cost of fuel,
oil, and aircraft operation with the aircraft owner and/or PIC.

[FR Doc. E8-28718 Filed 12-3-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Page 50887]
[FR Doc No: 2021-18912]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0881]

Consolidation of Devices That Process Autologous Human Cells,
Tissues, and Cellular and Tissue-Based Products at the Point of Care To
Produce a Therapeutic Article

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
consolidating regulatory oversight responsibilities in the Center for
Biologics Evaluation and Research (CBER) for certain devices that
process autologous human cells, tissues, and cellular and tissue-based
products (HCT/Ps) at the point of care where the device output is
intended to mediate the intended therapeutic effect. To support this
consolidation effort, fat transfer devices (described further below)
with the product code MUU that are currently regulated by the Center
for Devices and Radiological Health (CDRH) will be transferred to CBER
for regulation. This action affects only center assignment.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Consolidation in CBER of Devices That Process Autologous Human
Cells, Tissues, and Cellular and Tissue-Based Products at the Point of
Care To Produce a Therapeutic Article

    FDA is consolidating regulatory oversight responsibilities in CBER
for devices that process autologous human cells, tissues, and cellular
and tissue-based products (HCT/Ps) at the point of care to produce a
therapeutic article. To support this consolidation effort, fat transfer
devices (described further below) with the product code MUU that are
currently regulated by CDRH will be transferred to CBER for regulation.
This action affects only center assignment.
    FDA has the authority to regulate devices as defined under section
201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
Devices may be regulated by CDRH or CBER (see, e.g., Ref.1).
    In July 2007, the Agency published the final guidance ``Devices
Used to Process Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)'' to assist sponsors in determining which center at
FDA would have regulatory oversight for devices used at the point of
care to process HCT/Ps (Ref. 2). Assignment of these devices is
determined by whether the point-of-care device creates an HCT/P that is
intended to mediate the intended therapeutic effect. Point-of-care
devices that process autologous materials are assigned to CBER when the
intended therapeutic effect is mediated by the biological output of the
device. For example, a cell sorter that is used to isolate CD34+ cells
from bone marrow for use in hematopoietic reconstitution is assigned to
CBER for review and regulation because the cellular output of the
device is intended to provide the intended therapeutic effect.
    Since the publication of the 2007 guidance, assignment of point-of-
care devices intended to process HCT/Ps has generally been consistent
with that guidance, with a few exceptions. Under 21 CFR 878.5040, a
suction lipoplasty system is a Class II device that is intended for
aesthetic body contouring and consists of a powered suction pump
(containing a microbial filter on the exhaust and a microbial in-line
filter in the connecting tubing between the collection bottle and the
safety trap), collection bottle, cannula, and connecting tube. These
devices act by removal of unwanted fat from areas of the body.
    However, fat transfer devices, that is, devices that process
adipose tissue for return to the body, have also been regulated at CDRH
and assigned the same product code, MUU, as suction lipoplasty systems.
While suction lipoplasty devices for fat removal do not produce an
article for return to the body in order to mediate an intended
therapeutic effect, the output of fat transfer devices is returned to
the body in order to mediate the intended therapeutic effect (e.g.,
administration of fat for the purpose of body contouring). Accordingly,
we are transferring fat transfer devices identified by product code MUU
to CBER so that these devices are regulated by the same center that
regulates other devices that process HCT/Ps where the device output
(HCT/P) mediates the intended therapeutic effect.
    This transfer does not include the suction lipoplasty devices
previously in product code MUU that are solely intended to remove fat
for discard for the purpose of body contouring. These devices have been
assigned a new product code, QPB, and will continue to be regulated by
CDRH. For the transferred MUU products, submissions, communications,
and required reports should be directed to CBER. Submissions,
communications, and required reports for the QPB products should
continue to be directed to CDRH. Additionally, CDRH will continue to
handle submissions under review or on hold (i.e., received prior to the
publication date of this Federal Register document) for MUU products
until a final decision is reached. Subsequent submissions for MUU
products will be directed to CBER.

II. Reference

    The following references are on display in the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>
and is available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; it is also available electronically at
https://www.regulations.gov. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.

    1. SMG (FDA Staff Manual Guides) 1410.406, ``Determination of
Classification of Devices,'' November 13, 2018. https://www.fda.gov/media/80114/download.
    2. ``Guidance for industry and FDA staff Devices Used to Process
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps),'' July 2007. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/devices-used-process-human-cells-tissues-and-cellular-and-tissue-based-products-hctps.

    Authority: 21 U.S.C. 321(h).

    Dated: August 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18912 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 217 (Monday, November 13, 2023)]
[Rules and Regulations]
[Page 77509]
[FR Doc No: 2023-25028]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2023-0882]

Special Local Regulations; San Diego Parade of Lights, San Diego,
CA

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the San Diego Parade of Lights
special local regulations on the waters of San Diego Bay, California on
December 10, 2023 and December 17, 2023. These special local
regulations are necessary to provide for the safety of the
participants, crew, spectators, sponsor vessels, and general users of
the waterway. During the enforcement period, persons and vessels are
prohibited from anchoring, blocking, loitering, or impeding within this
regulated area unless authorized by the Captain of the Port Sector San
Diego or a designated representative.

DATES: The regulations in 33 CFR 100.1101 will be enforced from 5 p.m.
through 8 p.m. on December 10, 2023, and from 5 p.m. through 8 p.m. on
December 17, 2023, for Item 5 in Table 1 of Section 100.1101.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
publication of enforcement, call or email Lieutenant Shelley Turner,
Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone
(619) 278-7656, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.1101 for the San Diego Parade of Lights
in San Diego Bay, CA in 33 CFR 100.1101, Table 1, Item 5 of that
section from 5 p.m. until 8 p.m. on December 10, 2023, and on December
17, 2023. This enforcement action is being taken to provide for the
safety of life on navigable waterways during the event. The Coast
Guard's regulation for recurring marine events in the San Diego Captain
of the Port Zone identifies the regulated entities and area for this
event. During the enforcement periods and under the provisions of 33
CFR 100.1101, persons and vessels are prohibited from anchoring,
blocking, loitering, or impeding within this regulated area, unless
authorized by the Captain of the Port, or his designated
representative. The Coast Guard may be assisted by other Federal,
State, or local law enforcement agencies in enforcing this regulation.
    In addition to this document in the Federal Register, the Coast
Guard will provide the maritime community with advance notification of
this enforcement period via the Local Notice to Mariners, marine
information broadcasts, and local advertising by the event sponsor.

J.W. Spitler,
Captain, U.S. Coast Guard, Captain of the Port Sector San Diego.
[FR Doc. 2023-25028 Filed 11-9-23; 8:45 am]
BILLING CODE 9110-04-P


Steven Silverman/ DC/ USEPA/ US 03/ 15/ 2006 12: 17 PM T o Arthur_ G._ Fraas@ omb. eop. gov, Amy_ E._ Flynn@ omb. eop. gov c c Jason Burnett/ DC/ USEPA/ US@ EPA, Alice Wegman/ DC/ USEPA/ US@ EPA S u b j e c t rewrite of FL CAIR reconsideration section sorry for delay, which reflect my lack of skill w WORD. Changes should show up in green on this. THese are some font and marginalia issues which need to be prettified as well.