[Federal Register Volume 88, Number 37 (Friday, February 24, 2023)]
[Rules and Regulations]
[Pages 11784-11787]
[FR Doc No: 2023-03979]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0161; Project Identifier MCAI-2022-01434-T;
Amendment 39-22331; AD 2023-03-06]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. This AD
was prompted by the determination that radio altimeters cannot be
relied upon to perform their intended function if they experience
interference from wireless broadband operations in the 3.7-3.98 GHz
frequency band (5G C-Band), and a recent determination that this
interference can result in unavailable or misleading radio altimeter
information, adversely affecting the performance of the automatic
flight control system (AFCS) and resulting in increased flightcrew
workload during takeoff, approach, and landing below 400 feet above
ground level (AGL). This AD requires revising the existing airplane
flight manual (AFM) with new limitations to mitigate identified hazards
due to 5G C-Band interference as identified by Notices to Air Missions
(NOTAMs). The FAA is issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective March 13, 2023.
    The FAA must receive comments on this AD by April 10, 2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0161; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Steven Dzierzynski, Aerospace
Engineer, Avionics and Electrical Systems Section, FAA, New York ACO
Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone
516-228-7367; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this final rule. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2023-0161; Project
Identifier MCAI-2022-01434-T'' at the beginning of your comments. The
most helpful comments reference a specific portion of the final rule,
explain the reason for any recommended change, and include supporting
data. The FAA will consider all comments received by the closing date
and may amend this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Steven
Dzierzynski, Aerospace Engineer, Avionics and Electrical Systems
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected]. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    The FAA issued AD 2021-23-12, Amendment 39-21810 (86 FR 69984,
December 9, 2021) (AD 2021-23-12), to address the effect of
interference from wireless broadband operations in the 3.7-3.98 GHz
frequency band (5G C-Band) on all transport and commuter category
airplanes equipped with a radio (also known as radar) altimeter. AD
2021-23-12 was prompted by a determination that radio altimeters cannot
be relied upon to perform their intended function if they experience
interference from wireless broadband operations in the 5G C-Band. AD
2021-23-12 requires revising the limitations section of the existing
AFM to incorporate limitations prohibiting certain operations, which
require radio altimeter data to land in low visibility conditions, when
in the presence of 5G C-Band interference as identified by NOTAMs.
Transport Canada, which is the aviation authority for Canada, issued
corresponding AD CF-2021-52, dated December 24, 2021, to prohibit
certain flight operations requiring radio altimeter data in U.S.
airspace affected by 5G C-Band wireless signals.
    Since Transport Canada issued AD CF-2021-52, Transport Canada
evaluated whether additional 5G-related hazards exist in certain
Bombardier model airplanes. Bombardier has determined that 5G C-Band
interference can result in unavailable or misleading radio altimeter
information, adversely affecting the performance of the AFCS as
follows:
     Erroneous radio altimeter information has the potential to
cause incorrect gains on approach, flight guidance oscillation, and
crew over-correction. The flight director uses the glideslope to
linearize the angular deviation and if the radio altimeter erroneously
changes to an incorrect value, the resulting pitch command may be
inadequate, resulting in flight path oscillations.
     Misleading radio altimeter information can adversely
impact the autothrottle function, resulting in early or late activation
of the retard mode, leading to an inappropriate level of thrust. This
may result in a low energy state or longer landing distance. This

malfunction will increase pilot workload as the crew disconnects the
autothrottle and overrides the throttle levers.
     In the event of a weight-on-wheels (WOW) signal failure in
combination with a related Master Minimum Equipment List (MMEL)
dispatch, interference may result in the radio altimeter deploying the
two pairs of ground spoilers at heights above 7 feet AGL.
    These effects may lead to increased flightcrew workload and
adversely affect the safe operation of the airplane during takeoff,
approach, and landing below 400 feet AGL. Accordingly, Transport Canada
determined that additional actions are necessary to address the unsafe
condition and issued AD CF-2022-60, dated November 4, 2022 (Transport
Canada AD CF-2022-60) (referred to after this as ``the MCAI''), on all
Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes.
Transport Canada AD CF-2022-60 prohibits dispatch under MMEL item ``WOW
FAULT (ADVISORY)'' and requires revising the AFM with new limitations
to prohibit autopilot and autothrottle operation below 400 feet AGL
when in the presence of 5G C-Band interference as identified by NOTAMs.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0161.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
described above. The FAA is issuing this AD after determining that the
unsafe condition described previously is likely to exist or develop on
other products of the same type design.

AD Requirements

    This AD requires revising the existing AFM with new limitations to
prohibit dispatch under MMEL Section 2, CAS Messages, item ``WOW FAULT
(ADVISORY)'' and to prohibit autopilot and autothrottle operation below
400 feet AGL when in the presence of 5G C-Band interference as
identified by NOTAMs.

Interim Action

    The FAA considers this AD interim action. If final action is later
identified, the FAA might consider further rulemaking then.

Justification for Immediate Adoption and Determination of the Effective
Date

    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 providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies forgoing notice and comment prior to adoption of this rule
because radio altimeters cannot be relied upon to perform their
intended function if they experience interference from wireless
broadband operations in the 5G C-Band. Further, this interference can
result in unavailable or misleading radio altimeter information,
adversely affecting the performance of the AFCS, which could lead to
increased flightcrew workload and adversely affect the safe operation
of the airplane during takeoff, approach, and landing. The required
actions to address the unsafe condition must be accomplished within 30
days, which is shorter than the time necessary to allow for public
comment and for the FAA to publish a final rule. Accordingly, notice
and opportunity for prior public comment are impracticable and contrary
to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 165 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                        Estimated Costs for AFM Revisions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................              $0             $170          $28,050
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:

    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2023-03-06 Bombardier, Inc.: Amendment 39-22331; Docket No. FAA-
2023-0161; Project Identifier MCAI-2022-01434-T.

(a) Effective Date

    This airworthiness directive (AD) is effective March 13, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Bombardier, Inc., Model BD-700-1A10 and
BD-700-1A11 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Reason

    This AD was prompted by the determination that radio altimeters
cannot be relied upon to perform their intended function if they
experience interference from wireless broadband operations in the
3.7-3.98 GHz frequency band (5G C-Band), and a recent determination
that this interference can result in unavailable or misleading radio
altimeter information, adversely affecting the performance of the
automatic flight control system (AFCS) and resulting in increased
flightcrew workload during takeoff, approach, and landing below 400
feet above ground level. The FAA is issuing this AD to address the
resulting effects on the performance of the AFCS. The unsafe
condition, if not addressed, could result in increased flightcrew
workload and adversely affect the safe operation of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revision of Existing Airplane Flight Manual (AFM): Master Minimum
Equipment List (MMEL) Restriction

    Within 30 days after the effective date of this AD, revise the
Limitations section of the existing AFM to include the information
specified in figure 1 to paragraph (g) of this AD.

Figure 1 to paragraph (g)--MMEL Restriction
[GRAPHIC] [TIFF OMITTED] TR24FE23.104

(h) Revision of Existing AFM: AFCS

    For airplane serial numbers 9002 through 9998 inclusive, 60001
through 60060 inclusive, and 60062 through 60064 inclusive: Within
30 days after the effective date of this AD, revise the Limitations
section of the existing AFM to include the information specified in
figure 2 to paragraph (h) of this AD. Using a document with language
identical to that of figure 2 to paragraph (h) of this AD is
acceptable for compliance with the requirements of this paragraph.

Figure 2 to paragraph (h): AFM Limitations revision
[GRAPHIC] [TIFF OMITTED] TR24FE23.105

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the New York ACO
Branch, mail it to ATTN: Program Manager, Continuing Operational
Safety, at the address identified in paragraph (j)(2) of this AD or
email to: [email protected]. If mailing information, also
submit information by email. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the responsible Flight Standards Office.
    (2) Previous AMOCs: AMOCs approved for AD 2021-23-12, Amendment
39-21810 (86 FR 69984, December 9, 2021), providing relief for
specific radio altimeter installations are approved as AMOCs for the
provisions of this AD.
    (3) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch,

FAA; or Transport Canada; or Bombardier, Inc.'s Transport Canada
Design Approval Organization (DAO). If approved by the DAO, the
approval must include the DAO-authorized signature.

(j) Additional Information

    (1) Refer to Transport Canada AD CF-2022-60, dated November 4,
2022, for related information. This AD may be found in the AD docket
at regulations.gov under Docket No. FAA-2023-0161.
    (2) For more information about this AD, contact Steven
Dzierzynski, Aerospace Engineer, Avionics and Electrical Systems
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

(k) Material Incorporated by Reference

    None.

    Issued on February 1, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-03979 Filed 2-22-23; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 20 (Tuesday, January 31, 2023)]
[Notices]
[Pages 6262-6281]
[FR Doc No: 2023-01987]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0249]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: The Authorization issued to BD for the VIASURE Monkeypox virus
Real Time PCR Reagents for BD MAX System is effective as of December
23, 2022. The Authorization issued to DiaCarta, Inc. for the
QuantiVirus MPXV Test Kit is effective as of January 10, 2023.

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

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

SUPPLEMENTARY INFORMATION:

I. Background

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

II. Criteria for EUA Authorization

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

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

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

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

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

III. The Authorizations

    The Authorizations follow the August 9, 2022, determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves
monkeypox virus. Notice of the Secretary's determination was provided
in the Federal Register on August 15, 2022 (87 FR 50090). On the basis
of such determination, the Secretary of HHS declared, on September 7,
2022, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
pursuant to section 564 of the FD&C Act, subject to the terms of any
authorization issued under that section. Notice of the Secretary's
declaration was provided in the Federal Register on September 13, 2022
(87 FR 56074). On December 23, 2022, having concluded that the criteria
for issuance of the Authorization under section 564(c) of the FD&C Act
are met, FDA

issued an EUA to BD for the VIASURE Monkeypox virus Real Time PCR
Reagents for BD MAX System, subject to the terms of the Authorization.
On January 10, 2023, having concluded that the criteria for issuance of
the Authorization under section 564(c) of the FD&C Act are met, FDA
issued an EUA to DiaCarta, Inc. for the QuantiVirus MPXV Test Kit,
subject to the terms of the Authorization. The Authorizations, which
are included below in their entirety after section IV of this document
(not including the authorized versions of the fact sheets and other
written materials), provide an explanation of the reasons for issuance,
as required by section 564(h)(1) of the FD&C Act. Any subsequent
revision to the Authorizations can be found from FDA's web page at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN31JA23.064

[GRAPHIC] [TIFF OMITTED] TN31JA23.065

[GRAPHIC] [TIFF OMITTED] TN31JA23.066

[GRAPHIC] [TIFF OMITTED] TN31JA23.067

[GRAPHIC] [TIFF OMITTED] TN31JA23.068

[GRAPHIC] [TIFF OMITTED] TN31JA23.069

[GRAPHIC] [TIFF OMITTED] TN31JA23.070

[GRAPHIC] [TIFF OMITTED] TN31JA23.071

[GRAPHIC] [TIFF OMITTED] TN31JA23.072

[GRAPHIC] [TIFF OMITTED] TN31JA23.073

[GRAPHIC] [TIFF OMITTED] TN31JA23.074

[GRAPHIC] [TIFF OMITTED] TN31JA23.075

[GRAPHIC] [TIFF OMITTED] TN31JA23.076

[GRAPHIC] [TIFF OMITTED] TN31JA23.077

[GRAPHIC] [TIFF OMITTED] TN31JA23.078

[GRAPHIC] [TIFF OMITTED] TN31JA23.079

[GRAPHIC] [TIFF OMITTED] TN31JA23.080

[GRAPHIC] [TIFF OMITTED] TN31JA23.081

    Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01987 Filed 1-30-23; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Notices]
[Pages 64632-64633]
[FR Doc No: 2018-27214]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2018-0086]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
provides the public notice that on October 5, 2018, the Texas State
Railroad (TSR), on behalf of the Texas & Eastern Railroad, a subsidiary
of The Western Group, petitioned the Federal Railroad Administration
(FRA) for a waiver of compliance from certain provisions of the Federal
railroad safety regulations contained at 49 CFR parts 215 and 224. FRA
assigned the petition Docket Number FRA-2018-0086.
    Specifically, TSR requests relief from 49 CFR 215.303, Stenciling
of restricted cars, and 49 CFR part 224, Reflectorization of Rail
Freight Rolling Stock, for 14 TSR freight cars. Each of these freight
cars is more than 50 years old, measured from the date of original
construction, and is the subject of a parallel petition for Special
Approval for continued operation under Sec.  [thinsp]215.203(c). TSR
states that the required stenciling and reflectorization would violate
the historic impression that the cars are maintained to preserve.
    TSR further states that these freight cars have been inspected by
its shop personnel and have been deemed safe for service. The
restricted cars are limited in their service by speed, lading and
territory, specifically, its 29-mile railroad, at speeds not exceeding
25 miles per hour, with light tonnage (if any), in accordance with Part
215. The cars will never be subject to regular railroad interchange
operations. TSR states that its restricted cars will always be operated
in a context that ensures that each car and its restrictions and

limitations are readily accessible and known both to TSR and to FRA.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 31, 2019 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.). In
accordance with 5 U.S.C. 553(c), DOT solicits comments from the public
to better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2018-27214 Filed 12-14-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79001-79005]
[FR Doc No: 2010-31693]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0627]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for Food and Drug Administration Approval
to Market a New Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements governing
applications for FDA approval to market a new drug.

DATES: Submit either electronic or written comments on the collection
of information by February 15, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal

Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Application for FDA Approval to Market a New Drug--(OMB Control Number
0910-0001)--Extension

    Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially
marketed in the United States, imported or exported from the United
States, unless an approval of an application filed with FDA under
section 505(b) or 505(j) of the FD&C Act is effective with respect to
such a drug. Under the FD&C Act, it is the sponsor's responsibility to
provide the information needed by FDA to make a scientific and
technical determination whether the product is safe and effective for
use.
    This information collection approval request is for all information
requirements imposed by the regulations under part 314 (21 CFR 314) on
sponsors who apply for approval of a new drug application (NDA) or
abbreviated new drug application (ANDA) in order to market or to
continue to market a drug.
    Section 314.50(a) requires that the applicant submit an application
form (Form FDA 356h) that includes introductory information about the
drug as well as a checklist of enclosures.
    Section 314.50(b) requires that the applicant submit an index with
the archival copy of the application and that it reference certain
sections of the application.
    Section 314.50(c) requires that the applicant submit a summary of
the application that presents a good general synopsis of all the
technical sections and other information in the application.
    Section 314.50(d) requires that the NDA contain the following
technical sections about the new drug: Chemistry, manufacturing, and
controls; nonclinical pharmacology and toxicology; human
pharmacokinetics and bioavailability; microbiology; clinical data;
statistical; and pediatric use sections.
    Section 314.50(e) requires that the applicant submit samples of the
drug if requested by FDA. In addition, the archival copy of the
application must include copies of the label and all labeling for the
drug.
    Section 314.50(f) requires that the applicant submit case report
forms and tabulations with the archival copy.
    Section 314.50(h) requires that the applicant submit patent
information, as described under Sec.  314.53, with the application.
(The burden hours for Sec.  314.50(h) are already approved by OMB under
OMB control number 0910-0513 and are not included in the burden
estimates in table 1 of this document.)
    Section 314.50(i) requires that the applicant submit patent
certification information in section 505(b)(2) applications for patents
claiming the drug, drug product, or method of use.
    Section 314.50(j) requires that applicants that request a period of
marketing exclusivity submit certain information with the application.
    Section 314.50(l) requires that the applicant submit an archival,
review, and field copy of the application.
    Section 314.52 requires that a section 505(b)(2) applicant that
relies on a listed drug send any notice of certification of invalidity
or noninfringement of a patent to each patent owner and the NDA holder
. At the time notice is provided, a 505(b)(2) applicant is required to
amend its application to include a statement certifying that the
required notice has been provided. A section 505(b)(2) applicant also
is required to amend its application to document receipt of the
required notice.
    Section 314.54 sets forth the content requirements for applications
filed under section 505(b)(2) of the FD&C Act. (The information
collection burden estimate for section 505(b)(2) applications is
included in table 1 of this document under the estimates for Sec.
314.50(a), (b), (c), (d), (e), (f), and (k)).
    Section 314.60 sets forth reporting requirements for sponsors who
amend an unapproved application.
    Section 314.65 states that the sponsor must notify FDA when
withdrawing an unapproved application.
    Sections 314.70 and 314.71 require that applicants submit
supplements to FDA for certain changes to an approved application.
    Section 314.72 requires that sponsors report to FDA any transfer of
ownership of an application.
    Section 314.80(c)(1) and (c)(2) sets forth requirements for
expedited adverse drug experience postmarketing reports and followup
reports, as well as for periodic adverse drug experience postmarketing
reports (Form FDA 3500A). (The burden hours for Sec.  314.80(c)(1) and
(c)(2) are already approved by OMB under OMB control numbers 0910-0230
and 0910-0291 and are not included in the burden estimates in table 1
of this document.)
    Section 314.80(i) establishes recordkeeping requirements for
reports of postmarketing adverse drug experiences. (The burden hours
for Sec.  314.80(i) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the burden
estimates in table 1 of this document.)
    Section 314.81(b)(1) requires that applicants submit field alert
reports to FDA (Form FDA 3331).
    Section 314.81(b)(2) requires that applicants submit annual reports
to FDA (Form FDA 2252).
    Section 314.81(b)(3)(i) requires that applicants submit drug
advertisements and promotional labeling to FDA (Form FDA 2253).
    Section 314.81(b)(3)(iii) sets forth reporting requirements for
sponsors who withdraw an approved drug product from sale. (The burden
hours for Sec.  314.81(b)(3)(iii) are already approved by OMB under OMB
control number 0910-0045 and are not included in the burden estimates
in table 1 of this document.)
    Section 314.90 sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.50 through 314.81.
(The information collection burden estimate for NDA waiver requests is
included in table 1 of this document under estimates for Sec. Sec.
314.50, 314.60, 314.70, and 314.71.)

    Section 314.93 sets forth requirements for submitting a suitability
petition in accordance with 21 CFR 10.20 and 10.30. (The burden hours
for Sec.  314.93 are already approved by OMB under OMB control number
0910-0183 and are not included in the burden estimates in table 1 of
this document.)
    Section 314.94(a) and (d) requires that an ANDA contain the
following information: Application form; table of contents; basis for
ANDA submission; conditions of use; active ingredients; route of
administration, dosage form, and strength; bioequivalence; labeling;
chemistry, manufacturing, and controls; samples; patent certification.
    Section 314.95 requires that ANDA applicants send any notice of
certification of invalidity or noninfringement of a patent to each
patent owner and the NDA holder.
    Section 314.96 sets forth requirements for amendments to an
unapproved ANDA.
    Section 314.97 sets forth requirements for submitting supplements
to an approved ANDA for changes that require FDA approval.
    Section 314.98(a) sets forth postmarketing adverse drug experience
reporting and recordkeeping requirements for ANDAs. (The burden hours
for Sec.  314.98(a) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the burden
estimates in table 1 of this document.)
    Section 314.98(c) requires other postmarketing reports for ANDAs:
Field alert reports (Form FDA 3331), annual reports (Form FDA 2252),
and advertisements and promotional labeling (Form FDA 2253). (The
information collection burden estimate for field alert reports is
included in table 1 of this document under Sec.  314.81(b)(1); the
estimate for annual reports is included under Sec.  314.81(b)(2); the
estimate for advertisements and promotional labeling is included under
Sec.  314.81(b)(3)(i).)
    Section 314.99(a) requires that sponsors comply with certain
reporting requirements for withdrawing an unapproved ANDA and for a
change in ownership of an ANDA.
    Section 314.99(b) sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.92 through 314.99.
(The information collection burden estimate for ANDA waiver requests is
included in table 1 of this document under estimates for Sec.
314.94(a) and (d) and Sec. Sec.  314.96 and 314.97.)
    Section 314.101(a) states that if FDA refuses to file an
application, the applicant may request an informal conference with FDA
and request that the application be filed over protest.
    Section 314.107(c) requires that the first applicant who submits a
substantially complete ANDA containing a certification that a relevant
patent is invalid, unenforceable, or will not be infringed submit
notice to FDA of the date of first commercial marketing of its drug
product.
    Section 314.107(e) requires that an applicant submit a copy of the
entry of the order or judgment to FDA within 10 working days of a final
judgment.
    Section 314.107(f) requires that ANDA or section 505(b)(2)
applicants notify FDA immediately of the filing of any legal action
filed within 45 days of receipt of the notice of certification. A
patent owner may also notify FDA of the filing of any legal action for
patent infringement. If the patent owner or approved application holder
who is an exclusive patent licensee waives its opportunity to file a
legal action for patent infringement within the 45-day period, the
patent owner or approved application holder must submit to FDA a waiver
in the specified format.
    Section 314.110(b)(3) states that, after receipt of an FDA complete
response letter, an applicant may request an opportunity for a hearing
on the question of whether there are grounds for denying approval of
the application. (The burden hours for Sec.  314.110(b)(3) are included
under parts 10 through 16 (21 CFR parts 10 and 16) hearing regulations,
in accordance with Sec.  314.201, and are not included in the burden
estimates in table 1 of this document.)
    Section 314.110(c) states that, after receipt of a complete
response letter, an applicant may notify FDA that it agrees to an
extension of the review period so that it can determine whether to
respond further.
    Section 314.122(a) requires that an ANDA or a suitability petition
that relies on a listed drug that has been voluntarily withdrawn from
sale must be accompanied by a petition seeking a determination whether
the drug was withdrawn for safety or effectiveness reasons. (The burden
hours for Sec.  314.122(a) are already approved by OMB under OMB
control number 0910-0183 and are not included in the burden estimates
in table 1 of this document.)
    Section 314.122(d) sets forth requirements for relisting petitions
for unlisted discontinued products. (The burden hours for Sec.
314.122(d) are already approved by OMB under OMB control number 0910-
0183 and are not included in the burden estimates in table 1 of this
document.)
    Section 314.126(c) sets forth requirements for a petition to waive
criteria for adequate and well-controlled studies. (The burden hours
for Sec.  314.126(c) are already approved by OMB under OMB control
number 0910-0183 and are not included in the burden estimates in table
1 of this document.)
    Section 314.151(a) and (b) sets forth requirements for the
withdrawal of approval of an ANDA and the applicant's opportunity for a
hearing and submission of comments. (The burden hours for Sec.
314.151(a) and (b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.151(c) sets forth the requirements for withdrawal of
approval of an ANDA and the applicant's opportunity to submit written
objections and participate in a limited oral hearing. (The burden hours
for Sec.  314.151(c) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.153(b) sets forth the requirements for suspension of an
ANDA when the listed drug is voluntarily withdrawn for safety and
effectiveness reasons, and the applicant's opportunity to present
comments and participate in a limited oral hearing. (The burden hours
for Sec.  314.152(b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.161(b) and (e) sets forth the requirements for
submitting a petition to determine whether a listed drug was
voluntarily withdrawn from sale for safety or effectiveness reasons.
(The burden hours for Sec.  314.161(b) and (e) are already approved by
OMB under OMB control number 0910-0183 and are not included in the
burden estimates in table 1 of this document.)
    Section 314.200(c), (d), and (e) requires that applicants or others
subject to a notice of opportunity for a hearing who wish to
participate in a hearing file a written notice of participation and
request for a hearing as well as the studies and data on which they
relied. Other interested persons may also submit comments on the
notice. The section also sets forth the content and format requirements
for the applicants' submission in response to notice of opportunity for
hearing. (The burden hours for Sec.  314.200(c), (d), and (e) are
included under parts 10 through 16 hearing regulations, in accordance
with

Sec.  314.201, and are not included in the burden estimates in table 1
of this document.)
    Section 314.200(f) states that participants in a hearing may make a
motion to the presiding officer for the inclusion of certain issues in
the hearing. (The burden hours for Sec.  314.200(f) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, and are not included in the burden estimates in table 1 of
this document.)
    Section 314.200(g) states that a person who responds to a proposed
order from FDA denying a request for a hearing provide sufficient data,
information, and analysis to demonstrate that there is a genuine and
substantial issue of fact which justifies a hearing. (The burden hours
for Sec.  314.200(g) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.420 states that an applicant may submit to FDA a drug
master file in support of an application, in accordance with certain
content and format requirements.
    Section 314.430 states that data and information in an application
are disclosable under certain conditions, unless the applicant shows
that extraordinary circumstances exist. (The burden hours for Sec.
314.430 are included under parts 10 through 16 hearing regulations, in
accordance with Sec.  314.201, and are not included in the burden
estimates in table 1 of this document.)
    Section 314.530(c) and (e) states that if FDA withdraws approval of
a drug approved under the accelerated approval procedures, the
applicant has the opportunity to request a hearing and submit data and
information. (The burden hours for Sec.  314.530(c) and (e) are
included under parts 10 through 16 hearing regulations, in accordance
with Sec.  314.201, and are not included in the burden estimates in
table 1 of this document.)
    Section 314.530(f) requires that an applicant first submit a
petition for stay of action before requesting an order from a court for
a stay of action pending review. (The burden hours for Sec.  314.530(f)
are already approved by OMB under OMB control number 0910-0194 and are
not included in the burden estimates in table 1 of this document.)
    Section 314.610(b)(1) requires that applicants include a plan or
approach to postmarketing study commitments in applications for
approval of new drugs when human efficacy studies are not ethical or
feasible, and that applicants provide status reports of postmarketing
study commitments. (The information collection burden estimate for
Sec.  314.610(b)(1) is included in table 1 of this document under the
estimates for Sec. Sec.  314.50 (a), (b), (c), (d), (e), (f), and (k)
and 314.81(b)(2)).
    Section 314.610(b)(3) requires that in applications for approval of
new drugs when human efficacy studies are not ethical or feasible
applicants propose labeling to provide to patient recipients. (The
information collection burden estimate for Sec.  314.610(b)(3) is
included in table 1 of this document under the estimates for Sec.
314.50(e)).
    Section 314.630 requires that applicants provide postmarketing
safety reporting for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. (The burden hours for
Sec.  314.630 are already approved by OMB under OMB control numbers
0910-0230 and 0910-0291 and are not included in the burden estimates in
table 1 of this document.)
    Section 314.640 requires that applicants provide promotional
materials for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. (The information
collection burden estimate for Sec.  314.640 is included in table 1 of
this document under the estimates for Sec.  314.81(b)(3)(i)).
    Respondents to this collection of information are all persons who
submit an application or abbreviated application or an amendment or
supplement to FDA under part 314 to obtain approval of a new drug, and
any person who owns an approved application or abbreviated application.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
  21 CFR Section; [Form Number]       No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
314.50 (a), (b), (c), (d), (e),               92            1.36             126           1,917         241,542
 (f), and (k)...................
314.50(i) and 314.94(a)(12).....              96            9.61             923               2           1,846
314.50(j).......................              71            4.02             286               2             572
314.52 and 314.95...............              71            3.66             260              16           4,160
314.60..........................             349           21.67           7,564              80         605,120
314.65..........................              10            1.20              12               2              24
314.70 and 314.71...............             620            4.91           3,050             150         457,500
314.72..........................             104            2.98             310               2             620
314.81(b)(1) [3331].............             147            2.57             378               8           3,024
314.81(b)(2) [2252].............             656           13.84           9,084              40         363,360
314.81(b)(3)(i) [2253]..........             490           61.48          30,130               2          60,260
314.94(a)(1)-(11) and (d).......             110            7.83             862             480         413,760
314.96..........................             292           35.82          10,461              80         836,880
314.97..........................             197           26.23           5,169              80         413,520
314.99(a).......................              53            2.30             122               2             244
314.101(a)......................               1            1                  1             .50             .50
314.107(c)--....................              56            4.1              230             .50             115
314.107(e)--....................              25            3.92              98             .50              49
314.107(f)--....................              56            4.1              230             .50             115
314.110(c)......................              11            1.36              15             .50             7.5
314.420.........................             524            1.98           1,038              61          63,318
----------------------------------------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       3,466,037
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31693 Filed 12-16-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50681-50683]
[FR Doc No: 2015-20550]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31761; File No. 812-14434]

Archstone Alternative Solutions Fund and A.P. Management Company,
LLC; Notice of Application

August 14, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (the ``Act'') for an exemption from sections 18(c)
and 18(i) of the Act and for an order pursuant to section 17(d) of the
Act and rule 17d-1 under the Act.

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

SUMMARY: Summary of Application: Applicants request an order to permit
a registered closed-end management investment company to issue multiple
classes of shares (``Classes'') with varying sales loads and to impose
asset-based service and/or distribution fees.
    Applicants: Archstone Alternative Solutions Fund (``Fund'') and
A.P. Management Company, LLC (``Adviser'').

DATES: Filing Dates: The application was filed on March 19, 2015 and
amended on July 14, 2015.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on September 9, 2015, and should be accompanied by proof of
service on the applicants, in the form of an affidavit, or, for
lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act,
hearing requests should state the nature of the writer's interest, any
facts bearing upon the desirability of a hearing on the matter, the
reasons for the request, and the issues contested. Persons who wish to
be notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090; Applicants: 360 Madison Avenue,
20th Floor, New York, NY 10017.

FOR FURTHER INFORMATION CONTACT: Jaea F. Hahn, Senior Counsel, at (202)
551-6870, or David P. Bartels, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Fund will be a continuously offered non-diversified, closed-
end management investment company registered under the Act and
organized as a Delaware statutory trust. The Adviser, a New York
limited liability company, is registered as an investment adviser under
the Investment Advisers Act of 1940 and serves as investment adviser to
the Fund.
    2. The Fund will continuously offer its shares pursuant to its
currently effective registration statement under the Securities Act of
1933 (``Securities Act'').\1\ The Fund's shares are not listed on any
securities exchange and do not trade on an over-the-counter system such
as Nasdaq. Applicants do not expect that any secondary market will
develop for the Fund's shares.
---------------------------------------------------------------------------

    \1\ Shares of the Fund will only be sold to ``accredited
investors'' as defined in regulation D under the Securities Act.
---------------------------------------------------------------------------

    3. The Fund currently intends to offer a Class of shares at net
asset value per share (``NAV'') which will not be subject to any sales
load or distribution and/or service fees. The Fund proposes to offer an
additional Class of shares that will adopt a distribution and service
plan in compliance with rules 12b-1 and 17d-3 under the Act as if such
rules applied to closed-end management investment companies
(``Distribution and Service Plan'') and which may be subject to a sales
load, a distribution fee (``Distribution Fee''), and/or a service fee
(``Service Fee'').\2\
---------------------------------------------------------------------------

    \2\ All Classes of shares will be subject to an ``early
withdrawal charge'' (``Repurchase Fee'') if a shareholder has shares
repurchased during the first eleven months following such
shareholder's initial investment in the Fund. The Repurchase Fee
will apply equally to all shareholders of a Fund, regardless of
Class, consistent with section 18 of the Act and rule 18f-3
thereunder. With respect to any waiver of, scheduled variation in,
or elimination of the Repurchase Fee, the Fund will comply with rule
22d-1 under the Act as if the Repurchase Fee were a contingent
deferred sales charge (``CDSC'') and as if the Fund were an open-end
investment company and the Fund's waiver of, scheduled variation in,
or elimination of the Repurchase Fee will apply uniformly to all
shareholders of the Fund regardless of Class.
---------------------------------------------------------------------------

    4. In order to provide a limited degree of liquidity to
shareholders, the Fund may from time to time offer to repurchase shares
at their then-current NAV in accordance with rule 13e-4 under the 1934
Act pursuant to written

tenders by shareholders. Repurchases of the Fund's shares are made at
such times, in such amounts and on such terms as may be determined by
the board of trustees of the Fund (``Board'') in its sole discretion.
The Adviser anticipates recommending that the Board authorize the Fund
to offer to repurchase shares from shareholders quarterly.
    5. Applicants represent that any asset-based Distribution and
Service Fees will comply with the provisions of rule 2830(d) of the
Conduct Rules of the National Association of Securities Dealers, Inc.
(``NASD Conduct Rule 2830'').\3\ Applicants also represent that the
Fund will disclose in its prospectus, the fees, expenses and other
characteristics of each Class offered for sale by the prospectus, as is
required for open-end, multiple class funds under Form N-1A. As if it
were an open-end management investment company, the Fund will disclose
fund expenses in shareholder reports, and disclose in its prospectus
any arrangements that result in breakpoints in, or elimination of,
sales loads.\4\ Applicants will also comply with any requirements that
may be adopted by the Commission or FINRA regarding disclosure at the
point of sale and in transaction confirmations about the costs and
conflicts of interest arising out of the distribution of open-end
investment company shares, and regarding prospectus disclosure of sales
loads and revenue sharing arrangements as if those requirements applied
to the Fund and any distributor of shares of the Fund.\5\
---------------------------------------------------------------------------

    \3\ Any references to NASD Conduct Rule 2830 include any
successor or replacement Financial Industry Regulatory Authority
Rule to NASD Conduct Rule 2830.
    \4\ See Shareholder Reports and Quarterly Portfolio Disclosure
of Registered Management Investment Companies, Investment Company
Act Release No. 26372 (Feb. 27, 2004) (adopting release); and
Disclosure of Breakpoint Discounts by Mutual Funds, Investment
Company Act Release No. 26464 (June 7, 2004) (adopting release).
    \5\ See Confirmation Requirements and Point of Sale Disclosure
Requirements for Transactions in Certain Mutual Funds and Other
Securities, and Other Confirmation Requirement Amendments, and
Amendments to the Registration Form for Mutual Funds, Investment
Company Act Release No. 26341 (Jan. 29, 2004) (proposing release).
---------------------------------------------------------------------------

    6. The Fund will allocate all expenses incurred by it among the
various Classes based on net assets of the Fund attributable to each
such Class, except that the NAV and expenses of each Class will reflect
the expenses associated with the Distribution and Service Plan of that
Class (if any), and any other incremental expenses of that Class
(including transfer agency fees, if any). Expenses of the Fund
allocated to a particular Class of the Fund's shares will be borne on a
pro rata basis by each outstanding share of that Class. Applicants
state that the Fund will comply with the provisions of rule 18f-3 under
the Act as if it were an open-end investment company.
    7. In the event the Fund imposes a CDSC, applicants will comply
with the provisions of rule 6c-10 under the Act, as if that rule
applied to closed-end management investment companies. With respect to
any waiver of, scheduled variation in, or elimination of the CDSC, the
Fund will comply with the requirements of rule 22d-1 under the Act as
if the Fund were an open-end investment company.

Applicants' Legal Analysis

Multiple Classes of Shares

    1. Section 18(c) of the Act provides, in relevant part, that a
closed-end investment company may not issue or sell any senior security
if, immediately thereafter, the company has outstanding more than one
class of senior security. Applicants state that the creation of
multiple Classes of the Fund may be prohibited by section 18(c).
    2. Section 18(i) of the Act provides that each share of stock
issued by a registered management investment company will be a voting
stock and have equal voting rights with every other outstanding voting
stock. Applicants state that permitting multiple Classes of the Fund
may violate section 18(i) of the Act because each Class would be
entitled to exclusive voting rights with respect to matters solely
related to that Class.
    3. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction or any class or classes of persons,
securities or transactions from any provision of the Act, or from any
rule under the Act, if and to the extent such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policy and
provisions of the Act. Applicants request an exemption under section
6(c) from sections 18(c) and 18(i) to permit the Fund to issue multiple
Classes.
    4. Applicants submit that the proposed allocation of expenses and
voting rights among multiple classes is equitable and will not
discriminate against any group or class of shareholders. Applicants
submit that the proposed system would permit the Fund to facilitate the
distribution of Classes through diverse distribution channels and would
provide investors with a broader choice of shareholder options.
Applicants assert that the proposed closed-end investment company
multiple class structure does not raise the concerns underlying section
18 of the Act to any greater degree than open-end investment companies'
multiple class structures that are permitted by rule 18f-3 under the
Act. Applicants state the Fund will comply with the provisions of rule
18f-3 as if it were an open-end investment company. Applicants believe
that the requested relief meets the standards of Section 6(c) of the
1940 Act.

CDSCs

    5. Applicants believe that the requested relief meets the standards
of section 6(c) of the Act. Rule 6c-10 under the Act permits open-end
investment companies to impose CDSCs, subject to certain conditions.
Applicants state that the Fund does not anticipate imposing CDSCs and
would only do so in compliance with rule 6c-10 under the Act as if that
rule were applied to closed-end investment companies. The Fund also
will make all required disclosures in accordance with the requirements
of Form N-1A concerning CDSCs. Applicants further state that, in the
event the Fund imposes CDSCs, the Fund will apply the CDSCs (and any
waivers or scheduled variations of the CDSCs) uniformly to all
shareholders in a given class and consistently with the requirements of
rule 22d-1 under the Act.

Asset-Based Service and/or Distribution Fees

    6. Section 17(d) of the Act and rule 17d-1 under the Act prohibit
an affiliated person of a registered investment company or an
affiliated person of such person, acting as principal, from
participating in or effecting any transaction in which such registered
company is a joint or a joint and several participant unless the
Commission issues an order permitting the transaction. In reviewing
applications submitted under section 17(d) and rule 17d-1, the
Commission considers whether the participation of the investment
company in a joint enterprise or joint arrangement is consistent with
the provisions, policies and purposes of the Act, and the extent to
which the participation is on a basis different from or less
advantageous than that of other participants.
    7. Rule 17d-3 under the Act provides an exemption from section
17(d) and rule 17d-1 to permit open-end investment companies to enter
into distribution arrangements pursuant to rule 12b-1 under the Act.
Applicants request an order under section 17(d) and rule 17d-1 under
the Act to permit the

Fund to impose Distribution Fees and/or Service Fees. Applicants have
agreed to comply with rules 12b-1 and 17d-3 as if those rules applied
to closed-end investment companies.

Applicants' Condition

    Applicants agree that any order granting the requested relief will
be subject to the following condition:
    Applicants will comply with the provisions of rules 6c-10, 12b-1,
17d-3, 18f-3 and 22d-1 under the Act, as amended from time to time or
replaced, as if those rules applied to closed-end management investment
companies, and will comply with the NASD Conduct Rule 2830, as amended
from time to time, as if that rule applied to all closed-end management
investment companies.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-20550 Filed 8-19-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47796-47797]
[FR Doc No: 2020-17161]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1207]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishing and
Maintaining a List of U.S. Manufacturers/Processors of Feed Additives,
Premixes, Compound Feed, Distillers' Dried Grains, and Distillers'
Dried Grains with Solubles for Use with Animals with Interest in
Exporting to The People's Republic of China

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

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by September 8, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0884. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Establishing and Maintaining a List of U.S. Manufacturers/Processors of
Feed Additives, Premixes, Compound Feed, Distillers' Dried Grains, and
Distillers' Dried Grains with Solubles for Use with Animals with
Interest in Exporting to The People's Republic of China OMB Control
Number 0910-0884

    This information collection request allows FDA to include
respondents who are U.S. manufacturers/processors of feed additives,
premixes, compound feed, distillers' dried grains, and distillers'
dried grains with solubles (hereinafter, ``manufacturers/processors''
of ``covered products'') on a list of those who wish to export their
products to The People's Republic of China (China). On January 15,
2020, the United States and China entered into an Economic and Trade
Agreement (the Agreement) which, among other things, will streamline
the procedures for, and improve the efficiencies of, the exportation of
U.S. covered products to China. These provisions of the Agreement are
intended to facilitate trade between the two countries to better meet
the demand for U.S. animal feed products in China and to promote the
development of animal husbandry in China. Since the timing of the
Agreement did not allow for publication of a 60-day notice under the
PRA in advance of its implementation, FDA requested and OMB granted
emergency review under 5 CFR 1320.13 of a new information collection
request.
    In the Federal Register of April 16, 2020 (85 FR 21242), subsequent
to implementation under the emergency clearance, we published a 60-day
notice requesting public comment on the proposed collection of
information. No comments were received.
    Respondents: Manufacturing/processing facilities of covered
products interested in exporting animal feed to China.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR Section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Sec.   1.101(b)(1); Request for              450               1             450           0.083              38
 list placement to export to
 China--data elements
 demonstrating that product
 meets the foreign purchaser's
 specifications.................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have revised our burden table. In the 60-day notice published on
April 16, 2020, the burden table identified types of respondents. Here
we are clarifying that the information being collected is a request
from those respondents to be placed on a list. By requesting to be
placed on the list, respondents agree to disclose data elements, as
agreed upon by the U.S. government and China, that demonstrate the
product meets acceptable entry criteria. Since establishing the
collection, we have 197 facilities on the list to date. There were
fewer emails received, as some of the

companies registered multiple facilities in a single email.
    Based on our experience with a similar information collection, upon
requesting to be placed on the list, data elements that may be provided
to China include the facility name, street address, city, State, and
ZIP code of U.S. manufacturers and processors of covered products, who
want to be included on the list sent to China.
    Manufacturers of these products must currently register with FDA
consistent with 21 CFR part 1, subpart H. Therefore, we believe burden
associated with this collection should be minimal, but we welcome
specific feedback in this regard.

    Dated: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17161 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Rules and Regulations]
[Pages 46103-46104]
[FR Doc No: C2-2018-18766]

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

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No. 180718671-8671-01]
RIN 0694-AH57

Addition of Certain Entities to the Entity List, Revision of
Entries on the Entity List and Removal of Certain Entities From the
Entity List

Correction

    In rule document 2018-18766 beginning on page 44821 in the issue of
Tuesday, September 4, 2018, make the following correction:
    1. On page 44824, in the third column, amendatory instruction
number 2e is corrected to read as follows:
    ``2. * * *
    e. Under Russia,
    i. By removing the entity ``Joint Stock Company Mikron'';
    ii. By adding in alphabetical order two entities ``Joint Stock
Company (JSC) NIIME'' and ``PJSC Mikron'';
    2. On page 44825, in the table, under the country heading for Hong
Kong, the Joinus Freight Systems entry should read as follows:
* * * * *

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

----------------------------------------------------------------------------------------------------------------
Joinus Freight Systems (H.K.)          For all items subject    Presumption of denial..  81 FR 14958, 3/21/16.
 Limited, a.k.a., the following two     to the EAR. (See Sec.                             83 FR [Insert FR Page
 aliases:                                744.11 of the EAR).                              Number] 9/4/2018.
    -JFS Global Logistics; and.......
    -Joinus Freight Systems Global
     Logistics Limited.
Unit 07-07, 25F, Tower B, Regent
 Centre, 63 Wo Yi Hop Road, Kwai
 Chung, N.T. Hong Kong and Units 801-
 803 and 805, Park Sun Building, No.
 97-107 Wo Yi Hop Road, Kwai Chung,
 Hong Kong.
----------------------------------------------------------------------------------------------------------------

* * * * *
    3. On page 44826, in the table, under the country heading for
Russia, the PJSC Mikron entry should read as follows:
* * * * *

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

----------------------------------------------------------------------------------------------------------------
PJSC Mikron, 1st Zapadniy Proezd 12/   For all items subject    Presumption of denial..  81 FR 61601, 9/7/16. 83
 1, Zelenograd, Russia, 124460.         to the EAR. (See Sec.                             FR [Insert FR Page
                                         744.11 of the EAR).                              Number] 9/4/2018.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. C2-2018-18766 Filed 9-11-18; 8:45 am]
 BILLING CODE 1301-00-D