[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Rules and Regulations]
[Page 36084]
[FR Doc No: 2013-14327]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 23

[Docket No. CE308; Special Conditions No. 23-248-SC]

Special Conditions: Cirrus Design Corporation Model SF50
Airplane; Function and Reliability Testing; Withdrawal

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; withdrawal.

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SUMMARY: The FAA is withdrawing a previously published notice granting
special conditions for the Cirrus Design Corporation model SF50
airplane. We are withdrawing Special Condition No. 23-248-SC through
mutual agreement with Cirrus Design Corporation.

DATES: This special condition published on August 18, 2010 at 75 FR
50853 is withdrawn, effective June 17, 2013.

FOR FURTHER INFORMATION CONTACT: J. Lowell Foster, Federal Aviation
Administration, Small Airplane Directorate, Aircraft Certification
Service, 901 Locust, Room 301, Kansas City, MO 64106; telephone (816)
329-4125; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On August 18, 2010, the FAA published Special Condition No. 23-248-
SC for the Cirrus Design Corporation new model SF50 ``Vision'' Jet. The
SF50 is a low-wing, five-plus-two-place (2 children), single-engine
turbofan-powered aircraft. It incorporates an Electronic Flight
Information System (EFIS), pressurized cabin, retractable gear, and a
V-tail. The turbofan engine is mounted on the upper fuselage/tail cone
along the aircraft centerline. It is constructed largely of carbon and
fiberglass composite materials. Like other Cirrus products, the SF50
includes a ballistically deployed airframe parachute.
    The model SF50 has a maximum operating altitude of 28,000 feet,
where it cruises at speeds up to 300 Knots True Air Speed (KTAS). Its
MMO will not exceed 0.62 Mach. The maximum takeoff weight
will be at or below 6000 pounds with a range at economy cruise of
roughly 1000 nm. Cirrus intends for the model SF50 to be certified for
single-pilot operations under 14 CFR part 91 and 14 CFR part 135
operating rules. The following operating conditions will be included:

 Day and Night VFR
 IFR
 Flight Into Known Icing

Discussion

    Before Amendment 3-4, Section 3.19 of Civil Air Regulation (CAR)
part 3 required service testing of all airplanes type certificated on
or after May 15, 1947. The purpose of the testing was to ``ascertain
whether there is reasonable assurance that the airplane, its
components, and equipment are reliable, and function properly.''
    Amendment 3-4 to CAR part 3 became effective January 15, 1951, and
deleted the service test requirements in Section 3.19 for airplanes of
6,000 pounds maximum weight or less. The introductory text published in
Amendment 3-4 explained that most of the significant changes in the
amendment stemmed from ``the desire for simplification of the rules in
this part with respect to the smaller airplanes, specifically those of
6,000 pounds maximum weight or less, which would be expected to be used
mainly as personal airplanes.'' The introductory material also stated
the service test requirement was removed for airplanes of 6,000 pounds
maximum weight or less because ``experience seems to indicate that this
rule imposes a burden upon the manufacturers not commensurate with the
safety gained.'' The requirement for Function and Reliability (F&R)
testing, and the exception for airplanes of 6,000 pounds or less
maximum weight, is now found in 14 CFR part 21, section 21.35(b)(2).
    The decision to exempt airplanes of 6,000 pounds maximum weight or
less from F&R testing was based on the state of technology envisioned
in 1951. At that time, airplanes of 6,000 pounds maximum weight or less
were expected to be used mainly as personal airplanes. They used
simple, ``stand-alone'' systems whose failure was more likely to be an
inconvenience than an accident. The situation is different today.
Technological advances allow airplanes weighing less than 6,000 pounds
to be more complex and integrated than some transport airplanes. New
part 23 airplanes can incorporate sophisticated equipment not
previously used in a part 23 aircraft. Additionally, part 23 airplanes
are being used for business and commercial transportation. They should
no longer be envisioned mainly as personal airplanes. Therefore, a
special condition to require F&R testing for airplanes weighing 6,000
pounds or less is needed where the level of sophistication is beyond
evaluating failures by inspection.
    The model SF50 certification project was granted an extension on
September 19, 2011. 14 CFR part 21, Amendment 95, published in the
Federal Register (76 FR 64229) on October 18, 2011, incorporated
Special Condition No. 23-248-SC. On December 11, 2012, Cirrus Design
Corporation elected to adjust the model SF50 certification basis to
Amendment 21-95.

Reason for Withdrawal

    The FAA is withdrawing Special Condition No. 23-248-SC because
Cirrus elected to revise the model SF50 certification basis to
Amendment 21-95.
    The authority citation for this Special Condition withdrawal is 49
U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and 21.17; and 14 CFR
11.38 and 11.19.

Conclusion

    Withdrawal of this special condition does not preclude the FAA from
issuing another notice on the subject matter in the future or
committing the agency to any future course of action.

    Issued in Kansas City, Missouri on June 7, 2013.
Earl Lawrence,
Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2013-14327 Filed 6-14-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10356-10358]
[FR Doc No: 2023-03373]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2044]

Termination of Authorization of Emergency Use of an In Vitro
Diagnostic for Detection of Enterovirus D68

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
termination of the May 12, 2015, Emergency Use Authorization (EUA)
(authorization) issued under the Federal Food, Drug, and Cosmetic Act
(FD&C Act) for the Centers for Disease Control and Prevention's (CDC)
Enterovirus D68 (EV-D68) 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-
PCR) (CDC EV-D68 EUA). Issuance of the CDC EV-D68 EUA

was supported by former Secretary of Health and Human Services (HHS)
Sylvia M. Burwell's February 6, 2015, declaration that circumstances
exist justifying the authorization of emergency use of new in vitro
diagnostics for detection of EV-D68, pursuant to the FD&C Act. On
February 6, 2023, the Secretary of HHS terminated the February 6, 2015,
declaration, effective February 20, 2023, an action that automatically
terminated any EUAs issued by the FDA pursuant to the declaration, in
this case, the CDC EV-D68 EUA.

DATES: The CDC EV-D68 EUA is terminated as of February 20, 2023.

ADDRESSES: Submit written requests for single copies of the EUA
termination 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 EUA termination may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the EUA termination.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. EUA 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), the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5), 21st
Century Cures Act of 2016 (Pub. L. 114-255), and Public Law 115-92
(2017), allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents and other agents
that may cause, or are otherwise associated with, an imminently life-
threatening and specific risk to U.S. military forces. 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.
    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, United States Code, of attack with
(i) a biological, chemical, radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; (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 under 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.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, 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 CDC (to the extent feasible
and appropriate given the applicable circumstances), FDA \1\ concludes
that the statutory criteria for issuance of an EUA are met.
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    \1\ 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.
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    Under section 564(b)(2) of the FD&C Act, an EUA declaration shall
be terminated upon the earlier of: (1) a determination by the Secretary
of HHS that the circumstances described in the EUA declaration have
ceased to exist or (2) a change in the approval status of the product.
Under section 564(b)(3)(4) of the FD&C Act, HHS shall provide advance
notice that an EUA declaration will be terminated and shall publish in
the Federal Register the advance notice of termination. Termination of
an EUA declaration will automatically terminate any EUAs that FDA
issued under the declaration. Under section 564(h)(1) of the FD&C Act,
FDA is required to publish in the Federal Register a notice of each
EUA, and each termination or revocation of an EUA, and an explanation
of the reasons for the action.

II. EUA Declaration and EUA for EV-D68 2014 rRT-PCR

    On February 6, 2015, Sylvia M. Burwell, former Secretary of HHS,
determined that there is a significant potential for a public health
emergency that has a significant potential to affect national security
or the health and security of U.S. citizens living abroad and that
involves EV-D68. On the basis of such determination, on February 6,
2015, the former Secretary of HHS also declared that circumstances
exist justifying the authorization of emergency use of new in vitro
diagnostics for detection of EV-D68, subject to the terms of any
authorization issued under 21 U.S.C. 360bbb-3(a) (80 FR 10685). On May
12, 2015, and on the basis of the February 6, 2015, HHS declaration,
FDA issued the CDC EV-D68 EUA. Notice of the issuance of the EUA was
published in the Federal Register on July 1, 2015 (80 FR 37625).
    On September 12, 2022, CDC requested the Secretary of HHS to
terminate the February 6, 2015, determination, and as a result, FDA to
revoke the CDC EV-D68 EUA. The EV-D68 2014 rRT-PCR for which an EUA was
issued is no longer produced and all test kits were destroyed. CDC's
EV-D68 2014 rRT-PCR was never distributed.
    On February 6, 2023, pursuant to section 564 of the FD&C Act, the
Secretary of HHS determined that there is no longer a significant
potential for a public health emergency that has a significant
potential to affect national security or the health and security of
United States citizens living abroad and that involves EV-D68. Also on
February 6, 2023, the Secretary of HHS determined that circumstances
justifying the authorization of emergency use of new in vitro
diagnostics for detection of EV-D68 no longer exist. Based on these
determinations, the Secretary of HHS terminated, effective February 20,
2023, the February 6, 2015, declaration that circumstances exist
justifying the authorization of emergency use of new in vitro
diagnostics for detection of EV-D68. Advance notice of the termination
of the February 6, 2015, declaration was published in the Federal
Register on February 10, 2023, as required under

section 564 of the FD&C Act (88 FR 8874). Termination of the February
6, 2015, declaration automatically terminated the CDC EV-D68 EUA, which
was the only EUA issued under the declaration.

III. Electronic Access

    An electronic version of this document is available on the internet
at https://www.regulations.gov.

IV. Notice of EUA Termination

    Based on the Secretary of HHS's February 6, 2023, termination of
the February 6, 2015, declaration that circumstances exist justifying
the authorization of emergency use of new in vitro diagnostics for
detection of EV-D68, FDA is issuing, under section 564(h)(1) of the
FD&C Act, this notice of termination of the May 12, 2015, CDC EV-D68
EUA. Section 564(h)(1) of the FD&C Act requires FDA to provide notice
of each termination of an authorization under section 564 of the FD&C
Act, and an explanation of the reasons therefor.

    Dated: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03373 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Rules and Regulations]
[Pages 13410-13411]
[FR Doc No: 2018-06335]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 93

[Docket No. FAA-2004-17005; Amdt. No. 93-91A]
RIN 2120-AI17

Washington, DC Metropolitan Area Special Flight Rules Area;
Technical Amendment

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; technical amendment.

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SUMMARY: Currently, FAA regulations require all pilots operating
aircraft to or from College Park Airport, Potomac Airfield or
Washington Executive/Hyde Field Airport to file instrument flight rules
(IFR), DC Flight Restricted Zone (FRZ), or DC Special Flight Rules Area
(SFRA) flight plans with the Washington Hub Flight Service Station
(FSS). The FAA is transferring the responsibility for processing flight
plans within the DC FRZ from the Washington Hub FSS to the Washington
Air Route Traffic Control Center (ARTCC). This document revises the
regulations by updating the organization responsible for processing the
flight plans and by updating the flight plans required for flight
operations in the DC FRZ.

DATES: Effective on March 29, 2018.

FOR FURTHER INFORMATION CONTACT: Scott Rosenbloom, Airspace and Rules,
AJV-113, Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC 20591; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Good Cause for Immediate Adoption Without Prior Notice

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency for ``good cause'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without seeking comment prior to the
rulemaking.
    Section 553(d)(3) of the Administrative Procedure Act requires that
agencies publish a rule not less than 30 days before its effective
date, except as otherwise provided by the agency for good cause found
and published with the rule.
    This document revises Sec.  93.343(a) of title 14 of the Code of
Federal Regulations (14 CFR) by updating the organization responsible
for processing IFR and FRZ flight plans from/to College Park, Potomac
Airfield, and Washington Executive/Hyde Field airports. This revision
will not impose any additional restrictions on the persons affected by
these regulations. Furthermore, any additional delay in revising the
regulations would be contrary to the public interest because it would
create confusion among pilots operating in the DC SFRA including the DC
FRZ. Accordingly, the FAA finds that (i) public comment on this change
prior to promulgation is unnecessary and contrary to public interest,
and (ii) good cause exists to make this rule effective in less than 30
days.

Background

    Currently, Sec.  93.343(a) requires pilots to file IFR, DC FRZ, or
DC SFRA flight plans with the Washington Hub FSS for each departure and
arrival from/to College Park, Potomac Airfield, and Washington
Executive/Hyde Field Airports, whether or not the aircraft makes an
immediate stop.
    An objective of the Administrator's Flight Service National
Airspace System (NAS) Efficient Streamlined Services Initiative is to
realign activities through more efficient delivery of services. As part
of this initiative, the FAA is

transferring the responsibility for processing IFR and DC FRZ flight
plans within the Washington DC Flight Restricted Zone from the
Washington Hub FSS to the Flight Data Unit (FDU) at Washington ARTCC.
This transition will occur on March 29, 2018. As a result, the FAA is
updating Sec.  93.343(a) to reflect the change in responsibility.\1\
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    \1\ The FAA notes that this change in responsibility will also
generate a change in the dedicated phone number used for pilots to
confirm their flight plan. Therefore, the FAA is also revising its
Orders to update the phone number and organization responsible for
filing IFR and DC FRZ flight plans.
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    Also as a result of the transition, the FAA is removing from
Sec. Sec.  93.341(d) and 93.343(a)(2) the references to the DC SFRA
flight plan. Both regulations govern flight operations within the DC
FRZ, which require a DC FRZ flight plan. Because a single entity was
responsible for processing both DC SFRA and DC FRZ flight plans, the
FAA has effectively construed any request for a DC SFRA flight plan to/
from a location within the DC FRZ as a DC FRZ flight plan. Once the
responsibilities for processing DC SFRA and DC FRZ flight plans are
divided between two entities, however, the FAA will no longer be able
to re-characterize a DC SFRA flight plan as a DC FRZ flight plan. The
FAA is, therefore, removing the references to the DC SFRA from
Sec. Sec.  93.341(d) and 93.343(a)(2) to make clear that a pilot must
file either an IFR or DC FRZ flight plan when operating to or from the
DC FRZ.
    Furthermore, the FAA notes that it has communicated with the
Transportation Security Administration (TSA) about a corresponding
technical amendment that must be made to 49 CFR 1562.3(g)(1) to include
the new organization responsible for processing IFR and DC FRZ flight
plans.

Technical Amendment

    In this technical amendment, the FAA is revising Sec.  93.343(a)(2)
and (3) by removing the references to the Washington Hub FSS. In their
place, the FAA is inserting references to the Washington ARTCC, which
is the new organization responsible for processing the flight plans.
Furthermore, the FAA is revising Sec. Sec.  93.341(d) and 93.343(a)(2)
by removing the references to the DC SFRA flight plan.

List of Subjects in 14 CFR Part 93

    Air traffic control, Airports, Navigation (air), Reporting and
recordkeeping requirements.

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends chapter I of title 14, Code of Federal
Regulations as follows:

PART 93--SPECIAL AIR TRAFFIC RULES

0
1. The authority citation for part 93 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40109,
40113, 44502, 44514, 44701, 44715, 44719, 46301.

0
 2. Amend Sec.  93.341 by revising paragraph (d) to read as follows:

Sec.  93.341   Aircraft operations in the DC FRZ.

* * * * *
    (d) Before departing from an airport within the DC FRZ, or before
entering the DC FRZ, all aircraft, except DOD, law enforcement, and
lifeguard or air ambulance aircraft operating under an FAA/TSA airspace
authorization must file and activate an IFR or a DC FRZ flight plan and
transmit a discrete transponder code assigned by an Air Traffic Control
facility. Aircraft must transmit the discrete transponder code at all
times while in the DC FRZ or DC SFRA.

0
 3. Amend Sec.  93.343 by revising paragraphs (a)(2) and (a)(3) to read
as follows:

Sec.  93.343  Requirements for aircraft operations to or from College
Park Airport, Potomac Airfield, or Washington Executive/Hyde Field
Airport.

    (a) * * *
    (2) Before departing, the pilot files an IFR or DC FRZ flight plan
with the Washington Air Route Traffic Control Center for each departure
and arrival from/to College Park, Potomac Airfield, and Washington
Executive/Hyde Field airports, whether or not the aircraft makes an
intermediate stop;
    (3) When filing a flight plan with the Washington Air Route Traffic
Control Center, the pilot identifies himself or herself by providing
the assigned pilot identification code. The Washington Air Route
Traffic Control Center will accept the flight plan only after verifying
the code; and
* * * * *

    Issued under the authority of 49 U.S.C. 106(f) and (g) and 40103
in Washington, DC.
Lirio Liu,
Executive Director, Office of Rulemaking.
[FR Doc. 2018-06335 Filed 3-28-18; 8:45 am]
 BILLING CODE 4910-13-P