Control of Firearms, Guns, Ammunition and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List (USML); Notifying the Public of the Bureau's Interim Measures With Respect to March 6, 2020 Court Order
| Published date | 02 April 2020 |
| Citation | 85 FR 18438 |
| Record Number | 2020-05934 |
| Section | Rules and Regulations |
| Court | Industry And Security Bureau |
18438
Federal Register / Vol. 85, No. 64 / Thursday, April 2, 2020 / Rules and Regulations
which could result in fuel leakage and
reduced structural integrity of the wing.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Requirements
Except as specified in paragraphs (h) and
(i) of this AD: Comply with all required
actions and compliance times specified in,
and in accordance with, Brazilian AD 2019–
06–01.
(h) Optional Terminating Action
Accomplishing the installation of doublers
reinforcement on the wing forward and rear
lower skin panel, in accordance with the
Accomplishment Instructions of Embraer
Service Bulletin SB190–57–0056, dated
December 5, 2019, terminates the repetitive
inspections required by this AD, as specified
in Brazilian AD 2019–06–01.
(i) Exceptions to Brazilian AD 2019–06–01
For purposes of determining compliance
with the requirements of this AD:
(1) Where Brazilian AD 2019–06–01 refers
to its effective date, this AD requires using
the effective date of this AD.
(2) The ‘‘Alternative method of compliance
(AMOC)’’ section of Brazilian AD 2019–06–
01 does not apply to this AD.
(3) Where paragraph (a)(1) of Brazilian AD
2019–06–01 specifies an initial inspection
time, this AD requires an initial inspection at
the applicable time specified in paragraph
(i)(3)(i) or (ii) of this AD, whichever occurs
later.
(i) Before the accumulation of 17,000 total
flight cycles or 27,000 total flight hours,
whichever occurs first.
(ii) Within 680 flight cycles or 900 flight
hours after the effective date of this AD,
whichever occurs first.
(4) Where paragraph (a)(1)(ii) of Brazilian
AD 2019–06–01 specifies to do a special
detailed inspection (SDI) in case of any
‘‘signal’’ of cracks, this AD requires doing an
SDI before further flight after the detection of
any ‘‘sign’’ of structural cracks in the
inspected area.
(j) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Section, Transport Standards 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 International Section, send it
to the attention of the person identified in
paragraph (k) of this AD. Information may be
emailed to: 9-ANM-116-AMOC-REQUESTS@
faa.gov. Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(2) 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, International Section,
Transport Standards Branch, FAA; or ANAC;
or ANAC’s authorized Designee. If approved
by the ANAC Designee, the approval must
include the Designee’s authorized signature.
(k) Related Information
For more information about this AD,
contact Krista Greer, Aerospace Engineer,
International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des
Moines, WA 98198; telephone and fax 206–
231–3221; email krista.greer@faa.gov.
(l) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(i) Age
ˆncia Nacional de Aviac
¸a
˜o Civil
National Civil Aviation Agency (ANAC)
Brazilian AD 2019–06–01, effective June 17,
2019.
(ii) Embraer Service Bulletin SB190–57–
0056, dated December 5, 2019.
(3) For information about Brazilian AD
2019–06–01, contact National Civil Aviation
Agency, Aeronautical Products Certification
Branch (GGCP), Rua Laurent Martins, n° 209,
Jardim Esplanada, CEP 12242–431—Sa
˜o Jose
´
dos Campos—SP, Brazil; telephone 55 (12)
3203–6600; email pac@anac.gov.br; internet
www.anac.gov.br/en/. You may find this IBR
material on the ANAC website at https://
sistemas.anac.gov.br/certificacao/DA/
DAE.asp. For information about Embraer
service information, contact Embraer S.A.,
Technical Publications Section (PC 060), Av.
Brigadeiro Faria Lima, 2170—Putim—12227–
901 Sa
˜o Jose dos Campos—SP—Brazil;
telephone +55 12 3927–5852 or +55 12 3309–
0732; fax +55 12 3927–7546; email distrib@
embraer.com.br; internet http://
www.flyembraer.com.
(4) You may view this material at the FAA,
Transport Standards Branch, 2200 South
216th St., Des Moines, WA. For information
on the availability of this material at the
FAA, call 206–231–3195. This material may
be found in the AD docket on the internet at
https://www.regulations.gov by searching for
and locating Docket No. FAA–2019–0701.
(5) You may view this material that is
incorporated by reference at the National
Archives and Records Administration
(NARA). For information on the availability
of this material at NARA, email fedreg.legal@
nara.gov, or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
Issued on February 25, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020–06793 Filed 4–1–20; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 732 and 734
[Docket No. 200312–0076]
RIN 0694–AF47
Control of Firearms, Guns,
Ammunition and Related Articles the
President Determines No Longer
Warrant Control Under the United
States Munitions List (USML);
Notifying the Public of the Bureau’s
Interim Measures With Respect to
March 6, 2020 Court Order
AGENCY
: Bureau of Industry and
Security, Department of Commerce.
ACTION
: Notification of court order.
SUMMARY
: The Bureau of Industry and
Security (BIS) is publishing this
notification to alert the public of the
Bureau’s interim measures with respect
to a court order issued on March 6,
2020.
DATES
: The court order was effective
March 6, 2020.
FOR FURTHER INFORMATION CONTACT
:
Steven Clagett, Office of
Nonproliferation Controls and Treaty
Compliance, Nuclear and Missile
Technology Controls Division, tel. (202)
482–1641 or email steven.clagett@
bis.doc.gov.
SUPPLEMENTARY INFORMATION
: On March
6, 2020, the Honorable Richard A. Jones,
District Judge of the U.S. District Court
for the Western District of Washington
issued an order enjoining the U.S.
Department of State from implementing
or enforcing the regulation entitled
International Traffic In Arms
Regulations: U.S. Munitions List
Categories I, II, and III, 85 FR 3819 (Jan.
23, 2020) ‘‘insofar as it alters the status
quo restrictions on technical data and
software directly related to the
production of firearms or firearm parts
using a 3D-printer or similar
equipment.’’ (Case No. 2:20–cv–00111–
RAJ).
As a result, any request for licenses of
items that would otherwise fall under
the U.S. Department of Commerce
regulation, 15 CFR 732.2(b) and 734.7(c)
(added by the final rule, entitled,
Control of Firearms, Guns, Ammunition
and Related Articles the President
Determines No Longer Warrant Control
Under the United States Munitions List
(USML); 85 FR 4136, Jan. 23, 2020),
should instead be directed to the U.S.
Department of State.
BIS posted information on its website
to alert the public of the Bureau’s
VerDate Sep<11>2014 16:30 Apr 01, 2020 Jkt 250001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\02APR1.SGM 02APR1
jbell on DSKJLSW7X2PROD with RULES
18439
Federal Register / Vol. 85, No. 64 / Thursday, April 2, 2020 / Rules and Regulations
interim measures with respect to this
court order. See https://
www.bis.doc.gov/index.php/
component/docman/?task=doc_
download&gid=2535. For additional
information about the court ordered
injunction pertaining to revisions to the
U.S. https://www.pmddtc.state.gov/
ddtc_public?id=ddtc_public_portal_
news_and_events&timeframe=week.
Dated: March 16, 2020.
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
[FR Doc. 2020–05934 Filed 4–1–20; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 5, 801, 803, 807, 814, 820,
821, 822, 830, 860, 884, 900, and 1002
[Docket No. FDA–2020–N–0011]
Medical Devices; Technical
Amendments
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Final rule; technical
amendments.
SUMMARY
: The Food and Drug
Administration (FDA, the Agency, or
we) is amending its medical device
regulations. These revisions are
necessary to reflect changes to the
Agency’s Center for Devices and
Radiological Health’s organizational
structure, including the reorganization
of its offices. The revisions replace
references to the obsolete offices and
positions with the current information,
update the physical addresses for such
offices, and correct inaccurate citations.
In addition, as part of this effort we
made other editorial non-substantive
changes to correct other addresses,
references, and citations, as appropriate.
The rule does not impose any new
regulatory requirements on affected
parties. This action is editorial in nature
and is intended to improve the accuracy
of the Agency’s regulations.
DATES
: This rule is effective April 1,
2020.
FOR FURTHER INFORMATION CONTACT
:
Madhusoodana Nambiar, Office of
Policy, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5519,
Silver Spring, MD 20993–0002, 301–
796–5837.
SUPPLEMENTARY INFORMATION
:
I. Background
The FDA Center for Devices and
Radiological Health (CDRH) has
reorganized (84 FR 22854, May 20,
2019) to create an agile infrastructure
that can adapt to future organizational,
regulatory, and scientific needs. The
goal of this change is to implement more
efficient, consistent work processes
across CDRH that better support and
advance CDRH’s public health mission
and vision. The reorganization will
integrate CDRH’s premarket and
postmarket program functions along
product lines, allowing experts to
leverage their knowledge to optimize
decision making across the product life
cycle. Implementation took a phased
approach starting on March 18, 2019,
and was completed on September 30,
2019.
Historically, CDRH has been
organized according to the stage of the
product’s life cycle, e.g., premarket
review, postmarket surveillance, and
compliance, rather than by the type of
product regulated. The reorganization
integrates these functions by product
type within the Office of Product
Evaluation and Quality (OPEQ). OPEQ
was formed by combining the Office of
Compliance, the Office of Device
Evaluation, the Office of Surveillance
and Biometrics, and the Office of In
Vitro Diagnostics and Radiological
Health into one super office focused on
a Total Product Lifecycle approach to
medical device oversight. Within OPEQ,
there are offices divided by product
type, referred to as Offices of Health
Technology (OHT), as well as cross-
cutting offices focusing on specific
policy and programmatic needs
including the Office of Regulatory
Programs and the Office of Clinical
Evidence and Analysis. In addition, the
reorganization established the Office of
Policy, which includes two teams, the
Guidance, Legislation and Special
Projects Team and the Regulatory
Documents and Special Projects Team,
with no changes in the functions for
CDRH Policy. The reorganization also
established the Office of Strategic
Partnerships and Technology
Innovation (OST), which combined the
Science and Strategic Partnerships,
Digital Health, Health Informatics and
Innovation teams. There are no changes
in functions within the different OST
teams. CDRH reorganization also
realigned Management Services within
the Center to ensure administrative
functions in CDRH are optimally
aligned, structured, and deliver
excellent service. The reorganization
streamlined the Center’s communication
functions, by combining the internal
and external communication functions,
including CDRH Executive Secretary
and Speaker Liaison, into the renamed
Division of Communication in the
Office of Communication and
Education, and created an Internal
Communication Branch. The structure
of the Office of Science and Engineering
Laboratories remains unchanged.
As part of this effort, we are also
making other editorial non-substantive
changes to correct other addresses,
references, and citations, as appropriate.
II. Description of the Technical
Amendments
The regulations specified in this rule
have been revised to replace all
references to ‘‘Office of Device
Evaluation’’, ‘‘Office of Compliance’’,
‘‘Office of Surveillance and Biometrics’’
with ‘‘Office of Product Evaluation and
Quality,’’ and where, appropriate, we
have used the term ‘‘Office,’’
‘‘Division,’’ ‘‘Team’’ or ‘‘Office of Health
Technology’’ to reflect the responsible
unit within CDRH. We have also made
conforming edits, as appropriate. In
addition, because of the reorganization,
the physical location for many of the
offices changed, and thus, we have
made non-substantive amendments to
ensure that the room numbers and
addresses reflect the current
information, and other changes as
necessary to update outdated addresses,
references, and citations in the
regulations pertaining to medical
devices. The rule does not impose any
new regulatory requirements on affected
parties. The amendments are editorial in
nature and should not be construed as
modifying any substantive standards or
requirements.
III. Notice and Public Comment
Publication of this document
constitutes final action of these changes
under the Administrative Procedure Act
(5 U.S.C. 553). Section 553 of the
Administrative Procedure Act (APA)
exempts ‘‘rules of agency organization,
procedure, or practice’’ from proposed
rulemaking (i.e., notice and comment
rulemaking). 5 U.S.C. 553(b)(3)(A).
Rules are also exempt when an agency
finds ‘‘good cause’’ that notice and
comment rulemaking procedures would
be ‘‘impracticable, unnecessary, or
contrary to the public interest.’’ 5 U.S.C.
553(b)(3)(B).
FDA has determined that this
rulemaking meets the notice and
comment exemption requirements in 5
U.S.C. 553(b)(3)(A) and (B). FDA’s
revisions make technical or non-
substantive changes that pertain solely
to the CDRH reorganization and office
move and do not alter any substantive
VerDate Sep<11>2014 18:44 Apr 01, 2020 Jkt 250001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\02APR1.SGM 02APR1
jbell on DSKJLSW7X2PROD with RULES
