Definition of Private Carrier for Premium PO Box Delivery, 17124-17125 [2019-08222]
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Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Proposed Rules
(ii) Usability testing and a labeling
comprehension study must demonstrate
that the clinician can correctly select
and use the device, as identified in the
labeling, based on reading the directions
for use.
(iii) The elements of the device that
may contact the patient must be
demonstrated to be biocompatible.
(iv) Performance data must
demonstrate the sterility of the device.
(v) Validation of cleaning and
sterilization instructions must
demonstrate that any reusable device
components can be safely and
effectively reprocessed per the
recommended cleaning and sterilization
protocol in the labeling.
(vi) Performance data must support
the shelf life of the device by
demonstrating continued device
functionality, sterility, and package
integrity over the identified shelf life.
(vii) Labeling of the device must
include the following:
(A) Unless data demonstrates the
safety of doing so, contraindications
must be identified regarding use of the
device on tissues for which the risk of
stapling outweighs any reasonably
foreseeable benefit due to known
complications, including the stapling of
necrotic or ischemic tissues and tissues
outside of the labeled limits of tissue
thickness.
(B) Unless available information
demonstrates that the specific warnings
do not apply, the labeling must provide
appropriate warnings regarding how to
avoid known hazards associated with
device use including:
(i) Avoidance of obstructions to the
creation of the staple line and the
unintended stapling of other anatomic
structures;
(ii) Avoidance of clamping and
unclamping of delicate tissue structures
to prevent tissue damage;
(iii) Avoidance of use of the stapler on
large blood vessels, such as the aorta;
(iv) Establishing and maintaining
proximal control of blood vessels prior
to stapling;
(v) Appropriate measures to take if a
stapler malfunction occurs while
applying staples across a blood vessel,
such as clamping or ligating the vessel
before releasing the stapler, while the
stapler is still closed on the tissue; and
(vi) Ensuring stapler compatibility
with staples.
(C) Specific user instructions for
proper device use including measures
associated with the prevention of device
malfunction, evaluation of the
appropriateness of the target tissue for
stapling, and evaluation of the resultant
staple line.
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18:03 Apr 23, 2019
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(D) List of staples with which the
stapler has been demonstrated to be
compatible.
(E) Identification of key performance
parameters and technical characteristics
of the stapler and the compatible staples
needed for safe use of the device.
(F) Information regarding tissues on
which the stapler is intended to be used.
(G) Identification of safety
mechanisms of the stapler.
(H) Validated methods and
instructions for reprocessing of any
reusable device components.
(I) An expiration date/shelf life.
(viii) Package labels must include
critical information and technical
characteristics necessary for proper
device selection.
■ 3. In § 878.4800, revise paragraph (a)
to read as follows:
§ 878.4800 Manual surgical instrument for
general use.
(a) Identification. A manual surgical
instrument for general use is a
nonpowered, hand-held, or handmanipulated device, either reusable or
disposable, intended to be used in
various general surgical procedures. The
device includes the applicator, clip
applier, biopsy brush, manual
dermabrasion brush, scrub brush,
cannula, ligature carrier, chisel, clamp,
contractor, curette, cutter, dissector,
elevator, skin graft expander, file,
forceps, gouge, instrument guide, needle
guide, hammer, hemostat, amputation
hook, ligature passing and knot-tying
instrument, knife, blood lancet, mallet,
disposable or reusable aspiration and
injection needle, disposable or reusable
suturing needle, osteotome, pliers, rasp,
retainer, retractor, saw, scalpel blade,
scalpel handle, one-piece scalpel, snare,
spatula, disposable or reusable stripper,
stylet, suturing apparatus for the
stomach and intestine, measuring tape,
and calipers. A surgical instrument that
has specialized uses in a specific
medical specialty is classified in
separate regulations in parts 868
through 892 of this chapter.
*
*
*
*
*
Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08260 Filed 4–23–19; 8:45 am]
BILLING CODE 4164–01–P
POSTAL SERVICE
39 CFR Part 551
Definition of Private Carrier for
Premium PO Box Delivery
AGENCY:
PO 00000
Postal ServiceTM.
Frm 00036
Fmt 4702
Sfmt 4702
Advanced Notice of Proposed
Rulemaking.
ACTION:
The Postal Service seeks
customer and other stakeholder
feedback to define the phrase ‘‘packages
from private carriers,’’ as used in
connection with PO Box Street
Addressing. The Postal Service is
contemplating an amendment to Mailing
Standards of the United States Postal
Service, Domestic Mail Manual (DMM®)
to clarify the Street Addressing
Additional Service available at many
Premium Post Office Box Service
locations.
DATES: Comments must be received on
or before June 24, 2019.
ADDRESSES: Mail or deliver written
comments to the Manager, Product
Classification, U.S. Postal Service, 475
L’Enfant Plaza SW, Room 4446,
Washington, DC 20260–5015. Email
comments and questions to
ProductClassification@usps.gov using
the subject line ‘‘Street Addressing at
Premium PO Box Service Locations.’’
Faxed comments will not be accepted.
FOR FURTHER INFORMATION CONTACT:
Derek F. Hatten, Sr. Retail Services
Specialist, Retail Partners and Services,
202–268–6919, derek.f.hatten@usps.gov.
SUPPLEMENTARY INFORMATION: On June
17, 2010, the Postal Regulatory
Commission (PRC) approved the initial
request of the Postal Service to transfer
some Post Office Box (PO BoxTM)
Service locations from the market
dominant list to the competitive product
list (see Order No. 473, Order
Approving Request to Transfer Selected
Post Office Box Service Locations to the
Competitive Product List, PRC Docket
No. MC2010–20). Additional locations
were transferred following PRC
approval in subsequent Order No. 780,
Order Approving Request to Transfer
Additional Post Office Box Service
Locations to the Competitive Product
List, PRC Docket No. MC2011–25 (Jul.
29, 2011). At these locations, the Postal
Service now provides some of the same
services offered by its competitors.
These ‘‘Additional Services,’’ which are
available at Premium PO Box service
locations (formerly referred to as ‘‘Move
To Competitive’’ locations) for no
additional fee above the PO Box fees,
include a service called ‘‘Street
Addressing.’’
On February 14, 2013, language was
added to the Mail Classification
Schedule (MCS) describing the Street
Addressing feature, including the option
of receiving ‘‘packages from private
carriers’’ (see Order No. 1657, Order on
Elective Filing Regarding Post Office
Box Service Enhancements, PRC Docket
SUMMARY:
E:\FR\FM\24APP1.SGM
24APP1
jbell on DSK30RV082PROD with PROPOSALS
Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Proposed Rules
No. MC2012–26; MCS § 2640.1.g). In
related proceedings, the Postal Service
explained that the delivery of private
carrier packages would provide a
service frequently requested by its
customers, addressing a concern posed
by the fact that some eCommerce
merchants will not ship to a PO Box
address (See id. at 6). A description of
the Street Addressing feature was
subsequently added to DMM
508.4.5.4.a, which states that customers
who choose to use the street addressing
designation also have the option of
receiving packages from private carriers
at the customer’s Post Office Box
address, if the packages conform to the
maximum standards of 70 pounds in
weight and 130 inches in combined
length and girth. The street addressing
feature may be used when the merchant
or retailer does not accept the PO Box
address format as a deliverable address.
When the Postal Service first
introduced PO Box Street Addressing,
there were very few private carriers or
delivery competitors who would deliver
packages to a PO Box customer. This
made it simple for Premium PO Box
Post Offices to accept and deliver
packages that bore the street address
equivalent of the PO Box address. They
could easily recognize a private carrier,
and accept and deliver the PO Box
customer’s packages with little concern
as to whether the carrier was legitimate
or the customer actually had requested
that the package be delivered to the PO
Box. However, as the shipping and
delivery industry has evolved, so has
the competition for last mile delivery.
Since the introduction of PO Box
Street Addressing, a number of pilot
efforts have aimed to reduce the
delivery time of packages to the
customer. These efforts include, but are
not limited to, employees delivering
packages using their personally owned
vehicles, online retailers creating their
own delivery operations, and retailers
using crowdsourcing or taxi services to
deliver packages. Where once the term
‘‘private carriers’’ would be commonly
understood to include traditional
shipping providers such as UPS and
FedEx, now there are many more
delivery options, including ‘‘regional’’
delivery companies such as LaserShip
and localized or crowdsourced delivery
startups such as PostMates and Deliv.
Not all employees or persons who might
deliver a package to a PO Box wear
uniforms or are readily identified as
being associated with a legitimate
‘‘private carrier.’’ Nor do all items
submitted for delivery meet the
traditional definition of a ‘‘package’’
according to Postal Service mailability
standards. As one example, some Post
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16:04 Apr 23, 2019
Jkt 247001
Offices have been asked to accept open,
tote-style shopping bags containing
merchandise, in lieu of a sealed box or
envelope. Others have been presented
with packages labeled only with the
customer’s name but without the street
address, and delivered by employees or
contractors of a merchant with no clear
indication of where the package
originated.
As a practical matter, the advances in
last mile delivery have created
confusion as to who may deliver
packages to a Premium PO Box
customer when the customer uses the
street address equivalent of their PO
Box address to order merchandise.
Therefore, the Postal Service seeks input
on how the term ‘‘private carriers,’’ as
used in DMM 508.4.5.4.a, should be
defined, and how best to clarify that
only properly sealed items mailed as a
‘‘package’’ may be delivered. These
clarifications are necessary to ensure
that Postal Service employees follow
proper procedures, which helps prevent
fraud and ensures the safety and
security of customers and Postal Service
personnel.
We will publish an appropriate
amendment to 39 CFR part 551 if the
Postal Service adopts any changes to the
definition of ‘‘packages from private
carriers,’’ as used in connection with
Street Addressing, in DMM 508.4.5.4.a.
Ruth B. Stevenson,
Attorney, Federal Compliance.
[FR Doc. 2019–08222 Filed 4–23–19; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2019–0036; FRL–9992–64–
Region 3]
Approval and Promulgation of Air
Quality Implementation Plans;
Maryland; Infrastructure Requirements
for the 2015 Ozone National Ambient
Air Quality Standards
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve a
state implementation plan (SIP) revision
submittal from the State of Maryland for
the 2015 ozone national ambient air
quality standard (NAAQS or standard).
Whenever EPA promulgates a new or
revised NAAQS, states are required to
make a SIP submission showing how
the existing approved SIP has all the
SUMMARY:
PO 00000
Frm 00037
Fmt 4702
Sfmt 4702
17125
provisions necessary to meet the
requirements of the new or revised
NAAQS, or to add any needed
provisions necessary to meet the revised
NAAQS. The SIP revision is required to
address basic program elements,
including, but not limited to, regulatory
structure, monitoring, modeling, legal
authority, and adequate resources
necessary to assure attainment and
maintenance of the standards. These
elements are referred to as infrastructure
requirements. Maryland has made a
submittal addressing the infrastructure
requirements for the 2015 ozone
NAAQS. EPA is proposing to approve
Maryland’s SIP revision addressing the
infrastructure requirements for the 2015
ozone NAAQS in accordance with the
requirements of section 110(a) of the
Clean Air Act (CAA).
DATES: Written comments must be
received on or before May 24, 2019.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R03–
OAR–2019–0036 at https://
www.regulations.gov, or via email to
spielberger.susan@epa.gov. For
comments submitted at Regulations.gov,
follow the online instructions for
submitting comments. Once submitted,
comments cannot be edited or removed
from Regulations.gov. For either manner
of submission, EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
confidential business information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. EPA will generally not consider
comments or comment contents located
outside of the primary submission (i.e.
on the web, cloud, or other file sharing
system). For additional submission
methods, please contact the person
identified in the FOR FURTHER
INFORMATION CONTACT section. For the
full EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Ellen Schmitt, Planning and
Implementation Branch (3AD30), Air
and Radiation Division, U.S.
Environmental Protection Agency,
Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The
telephone number is (215) 814–5787.
Ms. Schmitt can also be reached via
E:\FR\FM\24APP1.SGM
24APP1
Agencies
[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Proposed Rules]
[Pages 17124-17125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08222]
=======================================================================
-----------------------------------------------------------------------
POSTAL SERVICE
39 CFR Part 551
Definition of Private Carrier for Premium PO Box Delivery
AGENCY: Postal Service\TM\.
ACTION: Advanced Notice of Proposed Rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Postal Service seeks customer and other stakeholder
feedback to define the phrase ``packages from private carriers,'' as
used in connection with PO Box Street Addressing. The Postal Service is
contemplating an amendment to Mailing Standards of the United States
Postal Service, Domestic Mail Manual (DMM[supreg]) to clarify the
Street Addressing Additional Service available at many Premium Post
Office Box Service locations.
DATES: Comments must be received on or before June 24, 2019.
ADDRESSES: Mail or deliver written comments to the Manager, Product
Classification, U.S. Postal Service, 475 L'Enfant Plaza SW, Room 4446,
Washington, DC 20260-5015. Email comments and questions to
[email protected] using the subject line ``Street
Addressing at Premium PO Box Service Locations.'' Faxed comments will
not be accepted.
FOR FURTHER INFORMATION CONTACT: Derek F. Hatten, Sr. Retail Services
Specialist, Retail Partners and Services, 202-268-6919,
[email protected].
SUPPLEMENTARY INFORMATION: On June 17, 2010, the Postal Regulatory
Commission (PRC) approved the initial request of the Postal Service to
transfer some Post Office Box (PO Box\TM\) Service locations from the
market dominant list to the competitive product list (see Order No.
473, Order Approving Request to Transfer Selected Post Office Box
Service Locations to the Competitive Product List, PRC Docket No.
MC2010-20). Additional locations were transferred following PRC
approval in subsequent Order No. 780, Order Approving Request to
Transfer Additional Post Office Box Service Locations to the
Competitive Product List, PRC Docket No. MC2011-25 (Jul. 29, 2011). At
these locations, the Postal Service now provides some of the same
services offered by its competitors. These ``Additional Services,''
which are available at Premium PO Box service locations (formerly
referred to as ``Move To Competitive'' locations) for no additional fee
above the PO Box fees, include a service called ``Street Addressing.''
On February 14, 2013, language was added to the Mail Classification
Schedule (MCS) describing the Street Addressing feature, including the
option of receiving ``packages from private carriers'' (see Order No.
1657, Order on Elective Filing Regarding Post Office Box Service
Enhancements, PRC Docket
[[Page 17125]]
No. MC2012-26; MCS Sec. 2640.1.g). In related proceedings, the Postal
Service explained that the delivery of private carrier packages would
provide a service frequently requested by its customers, addressing a
concern posed by the fact that some eCommerce merchants will not ship
to a PO Box address (See id. at 6). A description of the Street
Addressing feature was subsequently added to DMM 508.4.5.4.a, which
states that customers who choose to use the street addressing
designation also have the option of receiving packages from private
carriers at the customer's Post Office Box address, if the packages
conform to the maximum standards of 70 pounds in weight and 130 inches
in combined length and girth. The street addressing feature may be used
when the merchant or retailer does not accept the PO Box address format
as a deliverable address.
When the Postal Service first introduced PO Box Street Addressing,
there were very few private carriers or delivery competitors who would
deliver packages to a PO Box customer. This made it simple for Premium
PO Box Post Offices to accept and deliver packages that bore the street
address equivalent of the PO Box address. They could easily recognize a
private carrier, and accept and deliver the PO Box customer's packages
with little concern as to whether the carrier was legitimate or the
customer actually had requested that the package be delivered to the PO
Box. However, as the shipping and delivery industry has evolved, so has
the competition for last mile delivery.
Since the introduction of PO Box Street Addressing, a number of
pilot efforts have aimed to reduce the delivery time of packages to the
customer. These efforts include, but are not limited to, employees
delivering packages using their personally owned vehicles, online
retailers creating their own delivery operations, and retailers using
crowdsourcing or taxi services to deliver packages. Where once the term
``private carriers'' would be commonly understood to include
traditional shipping providers such as UPS and FedEx, now there are
many more delivery options, including ``regional'' delivery companies
such as LaserShip and localized or crowdsourced delivery startups such
as PostMates and Deliv. Not all employees or persons who might deliver
a package to a PO Box wear uniforms or are readily identified as being
associated with a legitimate ``private carrier.'' Nor do all items
submitted for delivery meet the traditional definition of a ``package''
according to Postal Service mailability standards. As one example, some
Post Offices have been asked to accept open, tote-style shopping bags
containing merchandise, in lieu of a sealed box or envelope. Others
have been presented with packages labeled only with the customer's name
but without the street address, and delivered by employees or
contractors of a merchant with no clear indication of where the package
originated.
As a practical matter, the advances in last mile delivery have
created confusion as to who may deliver packages to a Premium PO Box
customer when the customer uses the street address equivalent of their
PO Box address to order merchandise. Therefore, the Postal Service
seeks input on how the term ``private carriers,'' as used in DMM
508.4.5.4.a, should be defined, and how best to clarify that only
properly sealed items mailed as a ``package'' may be delivered. These
clarifications are necessary to ensure that Postal Service employees
follow proper procedures, which helps prevent fraud and ensures the
safety and security of customers and Postal Service personnel.
We will publish an appropriate amendment to 39 CFR part 551 if the
Postal Service adopts any changes to the definition of ``packages from
private carriers,'' as used in connection with Street Addressing, in
DMM 508.4.5.4.a.
Ruth B. Stevenson,
Attorney, Federal Compliance.
[FR Doc. 2019-08222 Filed 4-23-19; 8:45 am]
BILLING CODE 7710-12-P