[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Proposed Rules]
[Pages 60096-60100]
[FR Doc No: 2012-24165]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 8

[Docket No. USCG-2012-0861]
RIN 1625-AB90

Adding International Energy Efficiency (IEE) Certificate to List
of Certificates a Recognized Classification Society May Issue

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to amend its Vessel Inspection
Alternatives regulations to add the International Energy Efficiency
(IEE) Certificate to the list of certificates that a recognized
classification society may issue on behalf of the Coast Guard. We make
this proposal because Annex VI of the International Convention for the
Prevention of Pollution by Ships, 1973, as modified by the Protocol of
1978, has been amended to address energy efficiency for ships, and
these amendments call for the issuance of IEE Certificates starting
January 1, 2013. This proposed rule would enable recognized
classification societies to apply to the Coast Guard to issue IEE
Certificates to vessel owners and help to ensure that the demand for
IEE Certificates is met.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before November 1,
2012 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0861 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.

    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Wayne Lundy, Systems Engineering Division,
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation and Request for Comments
    A. Submitting Comments
    B. Viewing Comments and Documents
    C. Privacy Act
    D. Public Meeting
II. Abbreviations
III. Background
IV. Discussion of Proposed Rule
V. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0861), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov,
and insert ``USCG-2012-0861'' in the ``Search'' box. Click on ``Submit
a Comment'' in the ``Actions'' column. If you submit your comments by
mail or hand delivery, submit them in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying and electronic filing. If you
submit comments by mail and would like to know that they reached the
Facility, please enclose a stamped, self-addressed postcard or
envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments.

B. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
insert ``USCG-2012-0861'' in the ``Search'' box and click ``Search.''
Click the ``Open Docket Folder'' in the ``Actions'' column. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. We have an agreement
with the Department of Transportation to use the Docket Management
Facility.

C. Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

D. Public Meeting

    We do not plan to hold a public meeting. But you may submit a
request for one to the docket using one of the methods specified under
ADDRESSES. In your request, please explain why you believe a public
meeting would be beneficial. If we determine that one would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

II. Abbreviations

APPS Act to Prevent Pollution from Ships
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
IEE International Energy Efficiency
IMO International Maritime Organization
MARPOL Protocol International Convention for the Prevention of
Pollution from Ships, 1973 as modified by the Protocol of 1978
MEPC Maritime Environment Protection Committee
NPRM Notice of Proposed Rulemaking
OMB Office of Management and Budget
Sec.  Section
U.S.C. United States Code

III. Background

    The Act to Prevent Pollution from Ships (APPS), 33 U.S.C. et seq.,
implements the International Convention for the Prevention of Pollution
from Ships, 1973 as modified by the Protocol of 1978 (MARPOL Protocol),
which includes MARPOL Annex VI: Regulations for the Prevention of Air
Pollution from Ships. See 33 U.S.C. 1901(a)(4) and (5). APPS directs
the Secretary of Homeland Security to prescribe any necessary or
desired regulations to carry out the provisions of the MARPOL Protocol
and it directs the Secretary to designate those persons authorized to
issue MARPOL Protocol certificates on behalf of the United States. See
33 U.S.C. 1903(c) and 1904. This authority was delegated to the Coast
Guard. See Department of Homeland Security Delegation No. 0170.1. As
required by APPS, the Coast Guard has consulted with the U.S.
Environmental Protection Agency regarding this proposed rule.
    On July 15, 2011, in resolution MEPC.203(62), the International
Maritime Organization's (IMO) Marine Environment Protection Committee
(MEPC) adopted amendments to MARPOL Annex VI. Those amendments, which
were accepted July 1, 2012, and come into force January 1, 2013,
contain energy efficiency provisions for new and existing ships. These
amended regulations call for the issuance of an International Energy
Efficiency (IEE) Certificate to document compliance with Annex VI's new
Chapter 4, Regulations on Energy Efficiency for Ships. See amended
Annex VI Regulations 5.4 and 6.4. Since the mid-1990s, under authority
of 46 U.S.C. 3103, 3306, 3316, and 3703, and

regulations in 46 CFR part 8--Vessel Inspection Alternatives, the Coast
Guard has authorized recognized classification societies to issue
international certificates to vessels. The Coast Guard regularly adds
to the list, in 33 CFR 8.320(b), of international certificates that
classification societies may apply to issue to vessels on the Coast
Guard's behalf--including recent additions of the MARPOL 73/78
International Air Pollution Prevention Certificate and the
International Anti-Fouling System Certificate. See, respectively, 74 FR
21554, May 8, 2009; and 76 FR 76896, Dec. 9, 2011. The United States
currently recognizes seven classification societies for purposes of
issuing international certificates: The American Bureau of Shipping
(ABS, United States); Det Norske Veritas (DNV, Norway); Lloyd's
Register (LR, Great Britain); Germanischer Lloyd (GL, Germany); Bureau
Veritas (BV, France); RINA S.p.A. (RINA, Italy), and ClassNK (NKK,
Japan).
    Recognized classification societies assist the Coast Guard and help
to ensure that U.S.-flagged ships that qualify for an international
certificate are able to obtain it promptly. As we stated in 1996, to
avoid duplication of effort between the Coast Guard and classification
societies that results in extra costs to U.S. vessel owners, it is best
to take full advantage of inspections done by classification societies:

insurance companies require that, before a vessel is insured, it be
classed. This means that a classification society must survey a
vessel for compliance with its class rules. Class rules are rules
developed by the particular classification society to cover design,
construction and safety of vessels. To ensure compliance with these
class rules and with international standards, classification
societies perform surveys on vessels using qualified marine
surveyors. Many of the items examined by the classification society
surveyors are the same as those examined by Coast Guard marine
inspectors in their inspections for certification.

61 FR 68510-11, December 27, 1996.

    Starting January 2013, U.S.-flagged ships that are 400 gross
tonnage or more as measured under 46 U.S.C. 14302, Convention
Measurement System, (hereafter 400 GT ITC or more) may be subject to
detention or delay in foreign ports if they do not have an IEE
certificate to document compliance with Annex VI. See amended Annex VI
Regulation 19.
    Section 8.320 of 46 CFR allows the Coast Guard to delegate issuance
of an international convention certificate to a recognized
classification society only if the certificate is listed in Sec.
8.320(b). The IEE Certificate is not currently listed in Sec.
8.320(b).

IV. Discussion of Proposed Rule

    Our proposed amendment to 46 CFR 8.320(b) would add the
International Energy Efficiency (IEE) Certificate to the list of
certificates that may be issued by a recognized classification society
on behalf of the Coast Guard. This proposed change would initiate the
process that would allow recognized classification societies to issue
IEE Certificates on behalf of the Coast Guard. Any recognized
classification society that wishes to issue IEE Certificates on the
Coast Guard's behalf would be required to request a delegation of
authority from the Coast Guard pursuant to the procedures in 46 CFR
part 8. See 46 CFR 8.230 for criteria that must be met to become a
recognized classification society. In response, the Coast Guard would
evaluate the application, and review the applicant's relevant class
rules and classification society procedures, before deciding whether to
issue a delegation of authority to a recognized classification society.
As noted above, we propose this amendment to Sec.  8.320(b) to allow
the Coast Guard to enlist the assistance of recognized classification
societies to ensure that U.S.-flagged ships that are 400 GT ITC or more
that engage in one or more voyages to ports or offshore terminals under
the jurisdiction of other contracting parties to the MARPOL Protocol
will be able to promptly obtain an IEE certificate.
    Also, the Presidential Memorandum of May 20, 2009 titled
``Preemption,'' states that ``preemption of State law by executive
departments and agencies should be undertaken only with full
consideration of the legitimate prerogatives of the States and with a
sufficient legal basis for preemption.'' The memorandum also required
agencies to include preemption provisions in the codified regulations
when regulatory preambles discussed its intention to preempt State law
through the regulation. Furthermore, it directed that these preemption
provisions must be justified under the legal principles governing
preemption, including those outlined in Executive Order (EO) 13132 on
Federalism. Consistent with this May 2009 Presidential Memorandum, EO
13132, and our Federalism discussion below, we have proposed inserting
a specific statement regarding preemption in the purpose section, Sec.
8.300, of Part 8's subpart C, International Convention Certificate
Issuance, and renaming that section heading ``Purpose and Preemption.''

V. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 14 of these statutes or executive orders.

A. Regulatory Planning and Review

    Executive Orders 12866 (``Regulatory Planning and Review'') and
13563 (``Improving Regulation and Regulatory Review'') direct agencies
to assess the costs and benefits of available regulatory alternatives
and, if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety effects, distributive impacts, and equity).
Executive Order 13563 emphasizes the importance of quantifying both
costs and benefits, of reducing costs, of harmonizing rules, and of
promoting flexibility. This proposed rule has not been designated a
``significant regulatory action'' under section 3(f) of Executive Order
12866. Accordingly, this proposed rule has not been reviewed by the
Office of Management and Budget. A draft regulatory assessment follows:
    Under the authority of 33 U.S.C. 1903, 1904, and 46 U.S.C. 3103,
3306, 3316, and 3703, the Coast Guard proposes to amend 46 CFR 8.320,
to enable the Coast Guard to delegate the activity of issuing IEE
Certificates to a recognized classification society which would act on
behalf of the Coast Guard. The intent of this proposed rule is only to
allow for the delegation of IEE Certification to recognized class
societies and thus create options for industry in obtaining these
certificates; it does not impose mandatory actions on the U.S. maritime
industry.
    Although requesting the delegation of authority to conduct IEE
surveys, inspections, and certifications is voluntary, classification
societies may incur minor costs associated with this process. The Coast
Guard may incur costs associated with the evaluation of these requests
and the issuance of delegations of authority to recognized
classification societies.
    The Coast Guard estimates that this proposed rule would potentially
affect seven classification societies which may request a delegation of
authority to issue IEE Certificates. The Coast Guard used an Office of
Management and Budget (OMB)-approved collection of information (1625-
0041) to estimate the costs and burden.
    The Coast Guard estimates that it will take classification society
employees

about 5.25 hours to review the rulemaking requirements and prepare the
delegation request, at an average one-time cost of $428.75 per
classification society (3.5 hours at $112 per hour \1\ for a director
and 1.75 hours at $21 per hour for an administrative assistant). The
total one-time cost for all seven classification societies is estimated
to be $3,000 (rounded).
---------------------------------------------------------------------------

    \1\ All hourly wages shown are ``fully loaded'' wages. Fully
loaded wages include the costs of employer paid benefits such as
health insurance.
---------------------------------------------------------------------------

    In addition, the Coast Guard estimates that it will incur a one-
time cost to review and approve the requests for delegation. Based on
the OMB-approved collections of information discussed above, the Coast
Guard estimates that it will take about 5 hours to review, approve, and
issue an order to delegate authority, at an average cost of $360 per
event (3.5 hours for reviewing/approving and 1.5 hours for issuing at
$72 per hour for a lieutenant (O-3)). The Coast Guard estimates a total
one-time Government cost of $2,500 (rounded) based on OMB-approved
collection of information estimates.
    The Coast Guard estimates the total one-time cost of this proposed
rule to be approximately $5,500 (non-discounted) for classification
societies and the Government combined.
    This proposed rule may result in several benefits to the U.S.
maritime industry. First, it may result in a reduction of potential
wait time for IEE Certificates. In the absence of delegation of
authority to classification societies, vessel owners and operators may
experience delays while the Coast Guard processes and issues IEE
Certificates. Combined with the Coast Guard's other activities and
responsibilities, such a process may result in an unnecessary and
burdensome wait for vessels. The Coast Guard also might have to
redirect resources that could be used for other missions, resulting in
a less efficient use of Government resources. Finally, this proposed
rule may mitigate potential consequences to U.S.-flagged vessels due to
non-compliance with the Convention, including costly vessel detentions
in foreign ports.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule will, if promulgated, have a
significant economic impact on a substantial number of small entities.
The term ``small entities'' comprises small businesses, not-for-profit
organizations that are independently owned and operated and are not
dominant in their fields, and governmental jurisdictions with
populations of less than 50,000.
    Affected classification societies are classified under one of the
following North American Industry Classification System codes for water
transportation: 488330--Navigational Services to Shipping, 488390--
Other Support Activities for Water Transportation, or 541611--
Administrative Management and General Management Consulting Services.
    The only predominate U.S. classification society is the American
Bureau of Shipping (ABS). ABS is a privately owned non-profit
organization that is dominant in its field (Source: 2011 Hoovers,
http://www.hoovers.com/company/American Bureau of Shipping Inc/rfsksji-
1.html). Based on publicly available information, ABS has more than
3,000 employees and annual revenues of more than $800 million.\2\ We do
not consider ABS to be a small entity using the Small Business Act
definitions of a small entity.
---------------------------------------------------------------------------

    \2\ Source: 2011 Bloomberg, http://investing.businessweek.com/research/stocks/private/person.asp?personId=28915205&privcapId=4217113&previousCapId=764755&previousTitle=ABS%20Group%20of%20Companies,%20Inc.
---------------------------------------------------------------------------

    The Coast Guard expects that this proposed rule, if promulgated,
would not have a significant economic impact on a substantial number of
small entities. As described in section V.A. of this preamble,
``Regulatory Planning and Review,'' the anticipated cost of this
proposed rule, per class society, would be less than $500. This
proposed rule is not mandatory, and classification societies,
regardless of size, would choose to participate only if the benefits
are greater than the costs.
    Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that
this proposed rule, if promulgated, will not have a significant
economic impact on a substantial number of small entities. If you think
that your business, organization, or governmental jurisdiction
qualifies as a small entity and that this proposed rule would have a
significant economic impact on it, please submit a comment to the
Docket Management Facility at the address under ADDRESSES. In your
comment, explain why you think it qualifies and how and to what degree
this proposed rule would economically affect it.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
proposed rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please consult Mr. Wayne Lundy,
Systems Engineering Division, Coast Guard, telephone<PHONE_NUMBER> or
email<EMAIL_ADDRESS>The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

D. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) because
the Coast Guard expects that the number of applications would be fewer
than 10 in any given year.

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it does not have implications for federalism.
    As noted above, APPS implements the MARPOL Protocol. APPS also
directs the Secretary to ``designate those persons authorized to issue
on behalf of the United States the certificates required by the MARPOL
Protocol.'' 33 U.S.C. 1904. By enacting this specific provision, it was
the intent of Congress to give the Coast Guard, as delegated by the
Secretary, the exclusive authority to regulate within this field.
Therefore, we have determined that this rule does not have implications
for federalism.

F. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such expenditure, we do discuss the effects of this proposed
rule elsewhere in this preamble.

G. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under

Executive Order 12630, Governmental Actions and Interference with
Constitutionally Protected Property Rights.

H. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This proposed rule is not an economically significant rule and
would not create an environmental risk to health or a risk to safety
that might disproportionately affect children.

J. Indian Tribal Governments

    This proposed rule does not have Tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Tribal governments, on the relationship between the Federal
Government and Tribal governments, or on the distribution of power and
responsibilities between the Federal Government and Tribal governments.

K. Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866, supplemented by
Executive Order 13563, and is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. The Administrator
of the Office of Information and Regulatory Affairs has not designated
it as a significant energy action. Therefore, it does not require a
Statement of Energy Effects under Executive Order 13211.

L. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

M. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. A preliminary environmental analysis
checklist supporting this determination is available in the docket
where indicated under the ``Public Participation and Request for
Comments'' section of this preamble. This proposed rule involves the
delegation of authority, the inspection and documentation of vessels,
and congressionally-mandated regulations designed to improve or protect
the environment.
    This action falls under section 2.B.2, figure 2-1, paragraphs
(34)(b) and (d), of the Instruction, and under section 6(b) of the
``Appendix to National Environmental Policy Act: Coast Guard Procedures
for Categorical Exclusions, Notice of Final Agency Policy'' (67 FR
48243, July 23, 2002). We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

List of Subjects in 46 CFR Part 8

    Administrative practice and procedure, Organization and functions
(Government agencies), Reporting and recordkeeping requirements,
Vessels.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 46 CFR part 8 as follows:

PART 8--VESSEL INSPECTION ALTERNATIVES

    1. The authority citation for part 8 is revised to read as follows:

    Authority: 33 U.S.C. 1903, 1904, 3803 and 3821; 46 U.S.C. 3103,
3306, 3316, and 3703; Department of Homeland Security Delegation No.
0170.1 and Aug. 8, 2011 Delegation of Authority, Anti-Fouling
Systems.

    2. Revise Sec.  8.300 to read as follows:

Sec.  8.300  Purpose and preemption.

    This subpart establishes options for vessel owners and operators to
obtain required international convention certification through means
other than those prescribed elsewhere in this chapter. The regulations
in this subpart have preemptive effect over any State or local
regulation within the same field.
    3. Amend Sec.  8.320 as follows:
    a. In paragraph (b)(12), remove the word ``and'';
    b. In paragraph (b)(13), remove the period at the end of the
sentence and add, in its place, the text ``; and''; and
    c. Add paragraph (b)(14) to read as follows:

Sec.  8.320  Classification society authorization to issue
international certificates.

* * * * *
    (b) * * *
    (14) MARPOL 73/78 International Energy Efficiency Certificate.
* * * * *

    Dated: September 25, 2012.
F.J. Sturm,
Acting Director of Commercial Regulations and Standards, U.S. Coast
Guard.
[FR Doc. 2012-24165 Filed 10-1-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 85 (Friday, May 2, 2014)]
[Notices]
[Page 25173]
[FR Doc No: 2014-10101]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Piedmont Triad International Airport, Greensboro, NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for Public Comment

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

SUMMARY: The Federal Aviation Administration is requesting public
comment on the release of land at the Piedmont Triad International
Airport, Greensboro, North Carolina. This property, approximately 16.93
acres of fee simple release, will change to a non-aeronautical use.
This action is taken under the provisions of Section 125 of the Wendell
H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).

DATES: Comments must be received on or June 2, 2014.

ADDRESSES: Documents are available for review at the Piedmont Triad
International Airport, 1000-A Ted Johnson Parkway, Greensboro, NC 27409
and the FAA Memphis Airports District Office, 2600 Thousand Oaks
Boulevard, Suite 2250, Memphis, TN 38118. Written comments on the
Sponsor's request must be delivered or mailed to: Mr. Phillip J.
Braden, Manager, FAA Memphis Airports District Office, 2600 Thousand
Oaks Boulevard, Suite 2250, Memphis, TN 38118.
    In addition, a copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Kevin J. Baker, Executive Director, Piedmont
Triad Airport Authority, 1000-A Ted Johnson Parkway, Greensboro, NC
27409.

FOR FURTHER INFORMATION CONTACT: Mr. Tommy L. Dupree, Team Lead/Civil
Engineer, FAA Memphis Airports District Office, 2600 Thousand Oaks
Boulevard, Suite 2250, Memphis, TN 38118. The application may be
reviewed in person at this same location, by appointment.

SUPPLEMENTARY INFORMATION: The FAA proposes to rule and invites public
comment on the request to release property at the Piedmont Triad
International Airport, Greensboro, North Carolina. Under the provisions
of AIR 21 (49 U.S.C. 47107(h)(2)).
    On April 8, 2014, the FAA determined that the request to release
property at Piedmont Triad International Airport, meets the procedural
requirements of the Federal Aviation Administration. The FAA may
approve the request, in whole or in part, no later June 2, 2014.
    The following is a brief overview of the request:
    The Piedmont Triad International Airport is proposing the release
of approximately 16.93 acres of fee simple release, to accommodate the
construction of the North Carolina Department of Transportation's
Interstate 73 Connector Project (TIP Project NO. I-5110).
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon appointment and request, inspect
the request, notice and other documents germane to the request in
person at the Piedmont Triad International Airport address above.

    Issued in Memphis, TN on April 23, 2014.
Tommy L. Dupree,
Acting Manager, Memphis Airports District Office, Southern Region.
[FR Doc. 2014-10101 Filed 5-1-14; 8:45 am]
BILLING CODE P


[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14273-14275]
[FR Doc No: 2022-05310]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]

Revocation of Two Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to LifeHope Labs for the LifeHope 2019-nCoV
Real-Time RT-PCR Diagnostic Panel, and Omnipathology Solutions Medical
Corporation for the Omni COVID-19 Assay by RT-PCR. FDA revoked these
Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C
Act). The revocations, which include an explanation of the reasons for
each revocation, are reprinted in this document.

DATES: The Authorization for the LifeHope 2019-nCoV Real-Time RT-PCR
Diagnostic Panel is revoked as of February 7, 2022. The Authorization
for the Omni COVID-19 Assay by RT-PCR is revoked as of February 14,
2022.

ADDRESSES: Submit written requests for a single copy of the revocations
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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer J. 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) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the 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. On June 29, 2020, FDA issued an
EUA to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT-PCR
Diagnostic Panel, subject to the terms of the Authorization. Notice of
the issuance of this Authorization was published in the Federal
Register on November 20, 2020 (85 FR 74346), as required by section
564(h)(1) of the FD&C Act. On June 17, 2020, FDA issued an EUA to
Omnipathology Solutions Medical Corporation for the Omni COVID-19 Assay
by RT-PCR, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of
the FD&C Act. Subsequent updates to the Authorizations were made
available on FDA's website. The authorization of a device for emergency
use under section 564 of the FD&C Act may, pursuant to section
564(g)(2) of the FD&C Act, be revoked when the criteria under section
564(c) of the FD&C Act for issuance of such authorization are no longer
met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make
such revocation appropriate to protect the public health or safety
(section 564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Requests

    In a request received by FDA on January 6, 2022, LifeHope Labs
requested discontinuation of, and on February 7, 2022, FDA revoked, the
Authorization for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic
Panel. Because LifeHope Labs notified FDA that it is no longer using
the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel and requested
FDA discontinue the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic
Panel, FDA has determined that it is appropriate to protect the public
health or safety to revoke this Authorization.
    In requests received by FDA on February 7, 2022, and February 9,
2022, Omnipathology Solutions Medical Corporation requested revocation
of, and on February 14, 2022, FDA revoked, the Authorization for the
Omni COVID-19 Assay by RT-PCR. Because Omnipathology Solutions Medical
Corporation notified FDA that it is no longer using the Omni COVID-19
Assay by RT-PCR and requested FDA revoke the EUA for the Omni COVID-19
Assay by RT-PCR, FDA has determined that it

is appropriate to protect the public health or safety to revoke this
Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of LifeHope Labs for the LifeHope 2019-nCoV Real-
Time RT-PCR Diagnostic Panel and of Omnipathology Solutions Medical
Corporation for the Omni COVID-19 Assay by RT-PCR. The revocations in
their entirety follow and provide an explanation of the reasons for
each revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN14MR22.000

[GRAPHIC] [TIFF OMITTED] TN14MR22.001

    Dated: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05310 Filed 3-11-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register: January 29, 2010 (Volume 75, Number 19)]
[Notices]
[Page 4897-4900]
[DOCID:fr29ja10-127]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61407; File No. SR-NYSE-2010-02]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC To
Amend Certain of Its Initial Listing Requirements

January 21, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on January 7, 2010, New York Stock Exchange LLC (the
``NYSE'' or the ``Exchange'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule changes 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 changes from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend certain of its initial listing
requirements as they relate to companies listing in connection with a
firm commitment underwritten public offering whose common stock is
registered under the Securities Exchange Act of 1934 prior to listing
but not listed on a national securities exchange.
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.nyse.com), at the Exchange's Office of the
Secretary 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 these statements may be examined at
the places specified in Item IV below. The NYSE 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 102.01B of the Exchange's Listed Company Manual (the
``Manual'') requires that a company listing at the time of its initial
public offering (``IPO'') or as a result of a spin-off or under the
Affiliated Company standard of Section 102.01C(iii) must demonstrate an
aggregate market value of publicly-held shares (``public float'') of
$40 million at the time of listing. All other companies must have a
public float of $100 million at the time of initial listing. For
purposes of Section 102.01B, an IPO is defined as an offering by an
issuer which, immediately prior to its original listing, does not have
a class of common stock registered under the Act. The distribution
requirements set forth in Section 103.01A for companies listing under
the NYSE's listing standards for non-U.S. companies also utilize the
same definition of an IPO. Section 102.01B and 103.01A both provide
that--in connection with an IPO--the NYSE will rely on a written
commitment from the company's underwriter to represent the anticipated
value of the company's offering to demonstrate the company's compliance
with the applicable public float requirement.\4\
---------------------------------------------------------------------------

    \4\ Section 103.01A requires a worldwide public float of $100
million for all listings.
---------------------------------------------------------------------------

    The Exchange proposes to add a new definition for use in Sections
102.01B and 103.01A. The proposed definition would classify a company
as listing at the time of its ``Initial Firm Commitment Underwritten
Public Offering'' if (i) Such company has a class of common stock
registered under the Act, (ii) such common stock has not been listed on
a national securities exchange during the period since the commencement
of its current registration under the Act,\5\ and (iii) such company is
listing in connection with a firm commitment underwritten public
offering that is its first firm commitment underwritten public offering
of its common stock since the registration of its common stock under
the Act. The Exchange would apply the $40 million public float
requirement of Section 102.01B to a company listing in connection with
its Initial Firm Commitment Underwritten Public Offering.
Notwithstanding the fact that a company is listing in connection with
its Initial Firm Commitment Underwritten Public Offering, the Exchange
will apply the $100 million market value of publicly-held shares
standard of Section 102.01B if there is significant trading volume in
the company's securities in the over-the-counter market prior to
listing. In addition, the Exchange will generally apply the $100
million test if the company has previously registered on one or more
Securities Act registration statements the sale of significant numbers
of shares of the class that the company proposes to list, unless there
is evidence that subsequent trading has been very limited.
---------------------------------------------------------------------------

    \5\ A company which had previously been listed but was taken
private prior to its current registration under the Act would
qualify.
---------------------------------------------------------------------------

    Companies not listing in connection with an IPO are generally
transferring their listing from another national securities exchange.
These companies have a history of trading in a liquid market and, in
general, there is no reason to believe that their public float will
significantly increase in size simply as a result of transferring to
the NYSE. On the other hand, companies listing in connection with an
IPO have generally not previously had a trading market with significant
liquidity and it has been the NYSE's experience that officers,
directors and holders of more than 10% of the company's stock--whose
shares are not counted as part of the public float--in many cases sell
significant amounts of stock into the public markets after listing.
This possibility of sales of shares by insiders after the IPO gives
rise to a reasonable expectation that a company's public float will
increase significantly over time after its IPO and the Exchange
believes that the lower public float requirement for IPOs is an
appropriate response to that fact.
    While most companies listing on the NYSE do so upon consummation of
an IPO, a spin-off or a carve-out or upon transfer from another
exchange, the NYSE occasionally receives applications for listing from
companies whose common stock was registered under the Act prior to
listing but which were neither listed on another exchange nor had a
liquid trading market prior to listing. Typically, these are companies
that have never undertaken a firm commitment underwritten public
offering but have voluntarily registered their common stock under the
Act or incurred an obligation to register under Section 12(g) of the
Act because the number of holders of their common stock exceeded the
minimum established under SEC rules. These companies may seek to list
in connection with a public offering which the company and the market
will view as essentially identical to an IPO--as it is the first
broadly distributed public equity offering by the company--but which
will not meet the NYSE's definition of an IPO, as the company's common
stock was registered under the Act immediately prior to the listing.
These companies will generally not have a large public float at the
time of initial listing, as there will not have been any prior
transaction that led to a significant distribution event and, in the
absence of a listing, the company will not have had a liquid trading
market. The Exchange believes that these companies are more similar to
companies listing in connection with an IPO than to companies
transferring from another exchange. As with companies listing in
connection with an IPO, these companies are undertaking their first
major public distribution of their stock and will have their first
truly liquid trading market after listing. As such, the Exchange
believes that there is a reasonable basis for concluding that the
public float of these companies will increase over time in the same way
as is the case for a company after its IPO. Consequently, the Exchange
believes it is generally appropriate to subject companies listing in
connection with an Initial Firm Commitment Underwritten Public Offering
to the same public float requirements as companies listing in
connection with an IPO. Notwithstanding the foregoing, the Exchange
recognizes that there are companies that have significant trading
volume on the over-the-counter market and which are more similar to
companies trading on a national securities exchange than to the
closely-held companies with illiquid stocks for which the Initial Firm
Commitment Underwritten Public Offering provision is proposed. The
Exchange will continue to apply the $100 million public float
requirement to those types of companies. In addition, there are
companies traded on the over-the-counter market that have sold
significant numbers of equity securities pursuant to Securities Act
registration statements, either in direct placements or best efforts
underwritings. The Exchange will generally apply the $100 million
public float requirement to those companies, unless there is only very
limited trading activity in such securities in the over-the-counter
market, as they are also more similar to companies trading on a
national securities exchange than to the closely-held companies with
illiquid stocks for which the Initial Firm Commitment Underwritten
Public Offering provision is proposed.
    The Exchange also believes that it is appropriate to amend Sections
102.01B and 103.01A to allow the Exchange to

(i) base its determination as to whether a company listing in
connection with an Initial Firm Commitment Underwritten Public Offering
has complied with the $4 stock price initial listing requirement on the
public offering price in the Initial Firm Commitment Underwritten
Public Offering and (ii) rely on a letter from the company's
underwriter in the Initial Firm Commitment Underwritten Public Offering
as evidence of compliance with the applicable public float requirement.
These changes do not modify the quantitative public float requirement
for companies whose common stock was registered prior to listing but
which are not transferring from another exchange. Rather, (i) in the
case of the $4 stock price requirement, it recognizes the fact that the
offering price is a better gauge of the stock's likely trading price
after listing than would be provided by any limited trading occurring
in the over-the-counter market, and (ii) in the case of the public
float requirement, it recognizes the fact that companies listing in
connection with an Initial Firm Commitment Underwritten Public Offering
typically will not have a significant public float prior to
consummating their offering, but will be able to demonstrate the
required public float at the time of listing. The Exchange also
proposes to amend the domestic company financial listing standards of
Section 102.01C and the non-U.S. company financial listing standards of
Section 103.01B to permit the Exchange to rely on a letter from the
company's underwriter as evidence of compliance with the market
capitalization requirements of the various financial listing standards
for companies listing in connection with an Initial Firm Commitment
Underwritten Public Offering.
    The Exchange believes that the proposed rule change is consistent
with the protection of investors and the public interest and does not
raise any novel regulatory issues. The Exchange notes that the $40
million public float requirement for domestic IPOs and $100 million
worldwide public float requirement for non-U.S. companies are both
higher than the public float requirements under the various Nasdaq
Global Market initial listing standards, which range from $8 million to
$20 million. The Exchange also notes that Nasdaq Global Market does not
distinguish between IPOs and other new listing for purposes of
establishing its quantitative public float requirements.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \6\ of the Act, in general, and furthers the
objectives of Section 6(b)(5) of the Act,\7\ in particular in that it
is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
The Exchange believes that the proposed amendment is consistent with
the investor protection objectives of the Act in that, while it will
allow certain companies to list subject to a lower public float
requirement, that lower requirement is still set at a high enough level
that only companies that are suitable for listing on the Exchange will
qualify to list. In addition, in expanding the circumstances in which
the Exchange may rely on underwriters' letters to determine compliance
with market capitalization requirements, the proposed rule change is
not substantively changing the Exchange's quantitative initial listing
requirements.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 purposes of the Act.

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.

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

    Because the proposed rule change: (i) Does not significantly affect
the protection of investors or the public interest; (ii) does not
impose any significant burden on competition; and (iii) does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest, provided that the self-regulatory
organization has given 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 proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-
4(f)(6) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, the Commission notes
that Rule 19b-4(f)(6)(iii) 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 such proposed rule
change, the Commission may summarily abrogate 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 Exchange 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2010-02 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-NYSE-2010-02. 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 Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission,\10\ 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 inspection and copying in the Commission's Public
Reference Room, on official business days between the hours of 10 a.m.
and 3 p.m. Copies of the filing also will 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-NYSE-2010-02 and should be
submitted on or before February 19, 2010.
---------------------------------------------------------------------------

    \10\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-1849 Filed 1-28-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60022-60024]
[FR Doc No: 2017-27155]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6356]

Investigational In Vitro Diagnostics Used in Clinical
Investigations of Therapeutic Products; Draft Guidance for Industry,
Food and Drug Administration Staff, Sponsors, and Institutional Review
Boards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Investigational IVDs
Used in Clinical Investigations of Therapeutic Products.'' This draft
guidance is intended to assist sponsors of clinical investigations of
therapeutic products that also include investigational in vitro
diagnostics (IVDs) and institutional review boards (IRBs) that review
such investigations in complying with the Investigational Device
Exemption (IDE) regulation. This draft guidance is also intended to
assist FDA staff participating in the review of these investigations.
This draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by March 19, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2017-N-6356 for ``Investigational IVDs Used in Clinical
Investigations of Therapeutic 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Investigational IVDs Used in Clinical Investigations of Therapeutic
Products'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: David Litwack, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993-0002,<PHONE_NUMBER> 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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to assist sponsors of clinical
investigations of therapeutic products that also include
investigational IVDs and IRBs that review such investigations in
complying with the IDE regulation. This draft guidance is also intended
to assist FDA staff participating in the review of these
investigations.
    This draft guidance describes when the IDE regulation may apply to
certain clinical investigations of therapeutic products; certain
regulatory requirements that sponsors should be aware of as they
develop and conduct such investigations; recommendations for
determining the risk of investigational IVD use in a therapeutic
product investigation; recommendations for IRBs in reviewing such
investigations; and recommendations for content to provide in an IDE
application, when required.
    Additionally, FDA is seeking feedback on the policy in the draft
guidance regarding the need for an IDE for a significant risk study of
an investigational IVD device with a therapeutic product under an IND.
Specifically, FDA requests stakeholder perspectives on whether it would
be beneficial to allow submission of all IDE components to an IND
rather than require both an IDE and an IND. If such an approach would
be beneficial, please identify any specific circumstances, for example
a companion diagnostic and the associated therapeutic product, where
efficiency may be improved or burden may be decreased, or both, without
compromising patient safety.

II. Significance of Guidance

    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 Agency's current thinking on
investigational IVDs used in clinical investigations of therapeutic
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 guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft
guidance is also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Investigational IVDs Used in
Clinical Investigations of Therapeutic Products'' may send an email
request to [email protected]ov to receive an electronic copy of
the document. Please use the document number 1400025 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 809 have been approved under OMB control number 0910-0485; the
collections of information in parts 50 and 56 have been approved under
OMB control number 0910-0755; the collections of information in 21 CFR
56.115 have been approved under OMB control number 0910-0130; the
collections of information in 21 CFR 50.23 have been approved under OMB
control number 0910-0586; the collections of information in 21 CFR part
812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 820 have

been approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; and the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001. The collections
of information in the guidance document entitled ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0756.

    Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27155 Filed 12-15-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 220 (Thursday, November 16, 2023)]
[Notices]
[Pages 78807-78808]
[FR Doc No: 2023-25334]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration Aviation Rulemaking Advisory
Committee Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Aviation Rulemaking Advisory Committee (ARAC)
meeting.

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

SUMMARY: This notice announces a meeting of ARAC.

DATES: FAA will hold the meeting on Thursday, December 14, 2023, from
1:00 p.m. to 4:00 p.m. Eastern Time.
    FAA must receive requests to attend the meeting by Tuesday,
November 28, 2023.
    FAA must receive requests for accommodations to a disability by
Tuesday, November 28, 2023.
    FAA must receive any written materials for review during the
meeting by Tuesday, November 28, 2023.

ADDRESSES: The meeting will be held at the Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591, and
virtually on Zoom. However, if FAA is unable to hold the meeting in
person due to circumstances outside of its control, FAA will hold a
virtual meeting, notifying registrants with the meeting details and
posting any updates on FAA Committee website. Members of the public who
wish to observe the meeting must RSVP by emailing [email protected].
General committee information, including copies of the meeting minutes,
will be available on FAA Committee website at https://www.faa.gov/regulations_policies/rulemaking/committees/documents/.

FOR FURTHER INFORMATION CONTACT: Aliah Duckett, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591,
telephone<PHONE_NUMBER>; email [email protected]. Any committee-
related request should be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    ARAC was created under the Federal Advisory Committee Act, in
accordance with Title 5 of the United States Code (5 U.S.C. Ch.10) to
provide advice and recommendations to FAA concerning rulemaking
activities, such as aircraft operations, airman and air agency
certification, airworthiness standards and certification, airports,
maintenance, noise, and training.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 Status Updates
    [cir] Active Working Groups
    [cir] Transport Airplane and Engine (TAE) Subcommittee
 Recommendation Reports
 Any Other Business

    Detailed agenda information will be posted on FAA Committee website
address listed in the ADDRESSES section at least one week in advance of
the meeting.

III. Public Participation

    The meeting will be open to the public for virtual or in person
attendance on a first-come, first-served basis, as there is limited
space. Please confirm your attendance with the person listed in the FOR
FURTHER INFORMATION CONTACT section and provide the following
information: full legal name, country of citizenship, and name of your
industry association or applicable affiliation. Please indicate if you
plan to observe the meeting in person or virtually. FAA will email
registrants the meeting access information in a timely manner prior to
the start of the meeting.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    FAA is not accepting oral presentations at this meeting due to time
constraints. Any member of the public may present a written statement

to the committee at any time. The public may present written statements
to ARAC by providing a copy to the Designated Federal Officer via the
email listed in the FOR FURTHER INFORMATION CONTACT section.

    Issued in Washington, DC, on November 13, 2023.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2023-25334 Filed 11-15-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14462-14464]
[FR Doc No: 2012-5706]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Space Transportation Infrastructure Matching Grants Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request for grant proposals for the Space
Transportation Infrastructure Matching Grants Program.

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

SUMMARY: This notice solicits Fiscal Year (FY) 2012 grant proposals to
continue the development of a Commercial Space Transportation
infrastructure system that supports the National Space Policy and
Congressional intent. Begun in 2010, the program supports the
Commercial Space Transportation industry by identification,
prioritization, and funding for Commercial Space Transportation
infrastructure projects. This program has been previously referred to
as the Commercial Space Transportation Grants Program.
    The FAA/AST intends to continue funding the Space Transportation
Infrastructure Matching Grants Program for FY 2012. However, funding
has not been determined at this time. In order for the FAA/AST to
swiftly execute grant awards within FY 2012, should funding be
available, the FAA/AST is requesting grant applications at this time.
The FAA/AST intends to receive, process, and evaluate the applications
in a timely manner, and in accordance with the notional schedule listed
below, so should there be available funding, the recipients will
already be selected and the awards can be made within FY 2012. There
remains the possibility that no funds will be available in FY 2012 for
the Space Transportation Infrastructure Matching Grants Program. If no
funds are available, no grant applications submitted in response to
this Notice will be approved and funded.
    This Notice will be the only solicitation made for FY 2012 projects
and proposals. The FAA/AST will review and evaluate all applications
for a grant received by the deadline, pursuant to 51 U.S.C. Chapter
511. The FAA/AST may make one or more grant awards based upon its
evaluations of the submissions. All grants awarded under the Space
Transportation Infrastructure Matching Grants Program are discretionary
awards. Projects to be funded under the Space Transportation
Infrastructure Matching Grants Program must carry out commercial space
transportation infrastructure development, as defined in 51 U.S.C.
51101.

DATES: In order for the FAA/AST to award funds (if appropriated) before
the end of FY 2012, the following notional schedule is provided.
    Submission Open Period Opens: March 8, 2012.
    Submission Open Period Closes: May 11, 2012.
    Review, Selection, and Approval Period: May 14, 2012 to June 1,
2012.
    Announcement: July 17, 2012.

ADDRESSES: Applicants can get more information about the Space
Transportation Infrastructure Matching Grants Program, to include a
checklist for the submission package, by:
    1. Accessing the Office of Commercial Space Transportation Web site
at: http://www.faa.gov/go/ast; or
    2. Contacting Julie Price or Glenn Rizner, AST-100, for program
questions; or
    3. Contacting Greg Carter, AGC-510, for legal questions.

----------------------------------------------------------------------------------------------------------------
                                           Office            Fax                         Email
----------------------------------------------------------------------------------------------------------------
Julie Price..........................<PHONE_NUMBER><PHONE_NUMBER><EMAIL_ADDRESS>Glenn Rizner.........................<PHONE_NUMBER><PHONE_NUMBER><EMAIL_ADDRESS>Greg Carter..........................<PHONE_NUMBER><PHONE_NUMBER><EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION:

Background

    The Space Transportation Infrastructure Matching Grants Program is
intended to ``ensure the resiliency of the space transportation
infrastructure in the United States.'' To help further establish United
States' Commercial Space Transportation-related goals, Congress
established the Space Transportation Infrastructure Matching Grants
Program, now found in 51 U.S.C. Chapter 511--Space Transportation
Infrastructure Matching Grants. Congressional authorization was
established FY 1994 for the use of Federal monies to fund up to fifty

percent (50%) of total project cost in conjunction with state and local
government funding. The legislation also requires a minimum of ten
percent (10%) of the total project cost come from private funding. The
first Congressional appropriation for the Space Transportation
Infrastructure Matching Grants Program came in FY 2010. Should Space
Transportation Infrastructure Matching Grants be awarded in FY 2012,
this will be the third year of the program.
    The FAA/AST reviews, evaluates, and oversees the Space
Transportation Infrastructure Matching Grants Program. Notionally, the
award of the grant monies will be on or about July 17, 2012. To meet
this award date, applicants must submit their grant proposals on or
before May 11, 2012. Additional information related to the Space
Transportation Infrastructure Matching Grants Program can be found at
the Office of Commercial Space Transportation Web site or by contacting
one of the Points of Contacts; this information is listed above.

The Space Transportation Infrastructure Matching Grants Program

    To meet the intent of the program, development projects eligible
for funding include:
    1. Technical and environmental studies; or
    2. Construction, improvement, design, and engineering of space
transportation infrastructure (including facilities and associated
equipment).
    The Space Transportation Infrastructure Matching Grants Program
will not fund more than 50% of the total project cost, and project
financing must include a private component of at least 10% of the total
project cost.
    Given that the FAA/AST may award multiple grants, applicants may
submit multiple grant proposals, provided they are for separate
projects and meet the matching requirements independently.

Environmental Requirements

    Approval of grant funding is a major federal action subject to
review under the National Environmental Policy Act (NEPA) of 1969, 42
U.S.C. 4321 et seq., as implemented by the regulations of the Council
on Environmental Quality at 40 CFR part 1500 and FAA Order 1050.1E,
Change 1, and other Federal environmental laws. Because of this, the
FAA anticipates that it may be most cost-effective for applicants who
have already undergone NEPA review to apply for a grant this fiscal
year.
    In order for a launch site to receive a license to operate, a NEPA
review will already have been conducted. The launch site operator could
seek a grant for projects that the FAA considered as part of that
license. Although having a license is not a requirement for a grant
award, the environmental requirements may already be met for launch
sites with a license.
    Under 51 U.S.C. 51104, infrastructure development projects selected
for a Space Transportation Infrastructure Matching Grant must meet
three additional environmental requirements:
    1. The project must provide for the protection and enhancement of
the natural resources and the quality of the environment of the United
States. Specifically, if a project will have a significant, adverse
environmental impact, the FAA/AST shall approve the grant application
only after finding that no feasible and prudent alternative to the
project exists and that all reasonable steps have been taken to
minimize the adverse effect.
    2. The sponsor must certify that an opportunity for a public
hearing has been provided to consider the economic, social, and
environmental impacts of the project and its consistency with the goals
of any planning carried out by the community.
    3. The Governor of the State in which the project is located, or
his/her designee, must certify that there is reasonable assurance the
project will be located, designed, constructed, and operated to comply
with applicable air and water quality standards.
    Planning projects, such as technical and environmental studies,
normally qualify for categorical exclusion (CATEX) under NEPA and would
not trigger the requirements listed above. If the project normally
qualifies for a CATEX from environmental review, the grant proposal
should reference the relevant paragraph in FAA Order 1050.1E, Polices
and Procedures from Considering Environmental Impacts, and address
whether extraordinary circumstances exist that warrant preparation of
an environmental assessment (EA) or environmental impact statement
(EIS).
    For more details about the environmental review for commercial
space transportation activities, please see Guidelines for Compliance
with the National Environmental Policy Act and Related Environmental
Review Statutes for the Licensing of Commercial Launches and Launch
Sites at http://www.faa.gov/about/office_org/headquarters_offices/ast/environmental/review.

Who May Apply for a Space Transportation Infrastructure Matching Grant

    The FAA/AST may make project grant awards to ``sponsors,'' per 51
U.S.C 51102. Per 51 U.S.C. 51101(6), a ``sponsor'' is a public agency
that submits an application for a project grant. Per 51 U.S.C 51101(5),
a ``public agency'' is a State or agency of a State, a political
subdivision of a State, or a tax-supported organization.

Grant Award

    The FAA/AST intends to award Space Transportation Infrastructure
Matching Grants on or about July 17, 2012. An FAA/AST grant offer
letter may contain requirements for assurances to ensure the grants are
consistent with 51 U.S.C Chapter 511.

How To Apply for a Space Transportation Infrastructure Matching Grant

    The application submission must include the following:
    1. Cover letter, signed by public agency senior official,
demonstrating the legal authority to engage in the project,
    2. Detail as to how the proposed grant project meets the
requirements of Chapter 703:
    a. Documentation demonstrating authority as a public agency,
    b. Demonstration that the grant will not be for more than 50% of
the total cost of the project,
    c. Letter(s) of Commitment from the private sector for at least 10%
of the total cost of the project,
    d. Detailed description of the project,
    e. Contributions to capabilities that serve the United States'
space transportation needs,
    f. Impacts on the competitiveness of the United States space
transportation industry, and
    g. Discussion of environmental considerations, if applicable,
    3. Consent from the head of the appropriate agency, should the
project use Government property (land, equipment, etc.),
    4. SF-424, Application for Federal Assistance (OMB Number 4040-
0004),
    5. One of the following:
    a. SF-424A for non-construction proposals, or
    b. SF-424C for construction proposals.
    The forms request specific applicant information, project
information, and an estimate of the funding and duration of the
project. They are available at http://www.grants.gov.
    Applicants for the Space Transportation Infrastructure Matching

Grants Program must submit grant applications to the FAA/AST.
Applicants must submit an original copy of the completed grant
proposal, plus four additional copies. One copy (not the original) may
be submitted electronically to Ms. Julie Price at<EMAIL_ADDRESS>
however the original and additional copies must be submitted to:
Federal Aviation Administration, Office of Commercial Space
Transportation, AST-100, c/o Ms. Julie Price, 800 Independence Avenue
SW., Suite 325, Washington, DC 20591.
    Should one copy be submitted electronically, a time stamp will be
recorded for the submission. The original and all other copies must
reach the office on or before 12 p.m. (noon), Eastern Time, Friday, May
11, 2012. If no copy is submitted electronically, the original and
additional copies still must reach the office on or before 12 p.m.
(noon), Eastern Time, Friday, May 11, 2012. There will be no allowance
for extensions of time.
    Previously submitted grant applications do not carry over and will
not be considered. Applicants must resubmit past projects for
consideration in the new fiscal year.

    Issued in Washington, DC, on March 1, 2012.
George C. Nield,
Associate Administrator for Commercial Space Transportation.
[FR Doc. 2012-5706 Filed 3-8-12; 8:45 am]
BILLING CODE 4910-13-P