[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Proposed Rules]
[Pages 60809-60817]
[FR Doc No: 2015-25627]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 /
Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2015-N-0701]

General Hospital and Personal Use Devices: Renaming of Pediatric
Hospital Bed Classification and Designation of Special Controls for
Pediatric Medical Crib; Classification of Medical Bassinet

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to rename
pediatric hospital beds as pediatric medical cribs and establish
special controls for these devices. FDA is also proposing to establish
a separate classification regulation for medical bassinets, previously
under the pediatric hospital bed classification regulation, as a class
II (special controls) device. The proposed regulation for both
pediatric medical cribs and medical bassinets would also include the
Consumer Product Safety Commission's (CPSC) mattress flammability
standards for the mattresses intended for use with these devices. In
addition, this proposed rule would require prescription use of
pediatric medical cribs and bassinets.

DATES: Submit either electronic or written comments by December 7,
2015. See section VII of this document for the proposed effective date
of a final rule based on this proposed rule.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-0701 for ``General Hospital and Personal Use Devices:
Renaming of Pediatric Hospital Bed Classification and Designation of
Special Controls for Pediatric Medical Crib; Classification of Medical
Bassinet.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-6283.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), the Safe Medical Device Amendments
of 1990 (SMDA) (Pub. L. 101-629), the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115), the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), and the FDA
Safety and Innovation Act (Pub. L. 112-

144), among other amendments, establishes a comprehensive system for
the regulation of medical devices intended for human use. Section 513
of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes)
of devices, based on the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Most generic types of devices that were on the market before May
28, 1976, the date of the 1976 amendments (generally referred to as
preamendments devices), have been classified by FDA through the
issuance of regulations in accordance with the procedures set forth in
section 513(c) and (d) of the FD&C Act into one of these three
regulatory classes. Devices introduced into interstate commerce for the
first time on or after May 28, 1976 (generally referred to as post-
amendments devices), are classified automatically by statute (section
513(f) of the FD&C Act) into class III without any FDA rulemaking
process. These devices remain in class III and require premarket
approval, unless FDA initiates one of the following procedures: (1) FDA
reclassifies the device into class I or II; (2) FDA issues an order
classifying the device into class I or II in accordance with section
513(f)(2) of the FD&C Act; or (3) FDA issues an order finding the
device to be substantially equivalent, under section 513(i), to a
predicate device that is already legally marketed. The Agency
determines whether new devices are substantially equivalent to
predicate devices through review of premarket notifications under
section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of
the FD&C Act and its implementing regulations, codified in Title 21 of
the Code of Federal Regulations (21 CFR part 807, subpart E), require
persons who intend to market a new device that does not require a
premarket approval application under section 515 of the FD&C Act (21
U.S.C. 360e) to submit a premarket notification report (510(k))
containing information that allows FDA to determine whether the new
device is ``substantially equivalent'' within the meaning of section
513(i) of the FD&C Act to a legally marketed device that does not
require premarket approval.
    Section 513(a)(1)(B) of the FD&C Act defines class II devices as
those devices for which the general controls in section 513(a)(1)(A) by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance, including the
issuance of performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and any other appropriate actions the Agency deems
necessary to provide such assurance (see also 21 CFR 860.3(c)(2)).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
class II device from the premarket notification requirements on its own
initiative or upon petition of an interested person, if FDA determines
that a 510(k) is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. Devices under the pediatric
hospital bed classification regulation were exempted from premarket
notification, subject to certain limitations, in accordance with
section 510(m) of the FD&C Act (63 FR 59222 at 59229, November 3,
1998).

II. Regulatory History and Description of the Devices

    FDA classified pediatric hospital beds (21 CFR 880.5140) as class
II devices (45 FR 69678 at 69694, October 21, 1980), and later exempted
them from premarket notification (510(k)), in a final rule published in
the Federal Register of November 3, 1998 (63 FR 59222 at 59229). In
Sec.  880.5140, a pediatric hospital bed is defined as ``a device
intended for medical purposes that consists of a bed or crib designed
for the use of a pediatric patient, with fixed end rails and movable
and latchable side rails. The contour of the bed surface may be
adjustable.''
    A medical bassinet is a non-powered device that consists of two
components: (1) A basket, the sleep or bed component, which is
typically made of plastic and (2) a durable frame with wheels, which
holds the basket or bed component (FDA refers to this component as a
``basket or bed component'' in this proposed rule). The basket or bed
component is a box-like structure, generally made of a clear, high-
impact resistant plastic material, with an open top and four stationary
walls to keep the baby in place. Medical bassinets are typically used
in hospital settings for infants up to 5 months in age. Medical
bassinets currently fall under the pediatric hospital bed
classification regulation.

III. Proposed Regulation

    Pediatric medical cribs that meet the definition of a device in
section 201(h) of the FD&C Act (21 U.S.C. 321(h)) are regulated by FDA
(referred to as pediatric medical cribs or cribs intended for medical
purposes) (product code FMS) and, if this rule is finalized, will have
to comply with the special controls identified in the final regulation
for pediatric medical cribs. Cribs outside of the device definition
(referred to as cribs for non-medical purposes) must meet the CPSC's
regulations and guidelines. A crib designed for the use of a pediatric
patient may meet the medical device definition if it is intended for
use in the cure, mitigation or treatment of disease (see section 201(h)
of the FD&C Act).
    In the Federal Register of December 28, 2010 (75 FR 81766), the
CPSC issued a final rule prohibiting the use of the drop-side rail
design for non-medical cribs in consumer households as of June 28,
2011. Child care facilities, family child care homes, and places of
public accommodation (e.g., hotels and motels) had to comply with the
rule as of December 28, 2012. CPSC's rule establishes new standards for
full-size and non-full-size cribs used for non-medical purposes, which
effectively prohibit the manufacture or sale of cribs for non-medical
purposes with a drop-side rail design in households, child care
facilities, family child care homes, and places of public
accommodation. This rule did not affect pediatric medical cribs
regulated by FDA, which may contain a drop-side rail design that
includes movable and latchable side and end rails.
    Because drop-side rail cribs for non-medical purposes and pediatric
medical cribs are regulated by different agencies, CPSC consulted with
FDA about the impact their final rule could have on settings, such as
nursery schools and day care centers, where pediatric medical cribs
with drop-side rails are often used for pediatric patients after they
have been discharged from a health care facility. CPSC, which regulates
consumer products, including drop-side rail cribs not intended for
medical purposes, received reports of deaths of children attributable
to entrapment and/or strangulation caused by the malfunctioning of
drop-side rail cribs.
    Although drop-side cribs for non-medical purposes are now
prohibited, there is still a need for pediatric medical cribs with
drop-side rails inside and outside of traditional health care settings.
CPSC and FDA have heard from medical device consumers and health care
providers that pediatric medical cribs with drop-side rails are
extremely helpful for patient care in hospital settings and even
outside of traditional health care settings, such as day care centers
caring for infants and children with disabilities, because they allow
parents and care givers easy

access to children to perform routine and emergency medical procedures,
including, but not limited to, CPR, blood collection, IV insertion,
respiratory care, and skin care. These drop-side rail cribs also make
it easier for hospital staff to facilitate safe patient transport and
reduce the chance of caregiver injury. Health care workers have stated
that they need to have continued access to these medical cribs with
drop-side rails (Ref. 1). Therefore, FDA is proposing to permit
manufacturers to continue to manufacture and sell medical cribs with
the drop-side rail design in traditional health care settings and to
permit the use of pediatric medical cribs with drop-side rail designs
outside of traditional health care settings through prescription use
only (it is noted that State child care licensing agencies are
generally responsible for overseeing day care providers while FDA is
responsible for medical devices).
    FDA is proposing to revise the identification in Sec.  880.5140 to
include only pediatric medical cribs, establish special controls for
this device, and change the name of the classification regulation from
``pediatric hospital bed'' to ``pediatric medical crib.'' The Agency is
taking these actions to clarify the devices that fall under this
particular classification regulation and establish special controls the
Agency believes are necessary for a reasonable assurance of safety and
effectiveness. In addition, FDA is proposing that use of a pediatric
medical crib be restricted to prescription use in accordance with 21
CFR 801.109. In order to use or administer use of pediatric medical
cribs, authorization must be made by a practitioner licensed by law
through a prescription for the device.
    This rule also proposes to create a separate regulation for medical
bassinets and establish special controls for this device type to
provide a reasonable assurance of safety and effectiveness. In
addition, FDA is proposing that use of medical bassinets be restricted
to prescription use in accordance with 21 CFR 801.109. In order to use
or administer use of medical bassinets, authorization must be made by a
practitioner licensed by law through a prescription for the device. FDA
proposes not to change the 510(k) exempt status of pediatric medical
cribs and medical bassinets.
    Devices currently under the pediatric hospital bed classification
regulation include: Open pediatric medical cribs, medical bassinets,
pediatric cribs with integrated air mattresses, youth beds, pediatric
stretchers, crib enclosure beds, and cuddle-carrier infant beds. If
this proposed rule is finalized, devices that do not meet the
definition of ``pediatric medical crib'' will be administratively moved
to more appropriate class II regulations, and no longer be under the
revised pediatric hospital bed classification regulation. At that time,
FDA proposes to send manufacturers of the remaining pediatric hospital
beds notices identifying the new classification regulation and product
code under which the device will be classified.
    If this proposed rule is finalized, FDA intends to move the
following medical devices listed under Sec.  880.5140 to devices with
similar intended uses and class II regulations: Pediatric cribs with
integrated air mattresses to 21 CFR 890.5170, ``Powered flotation
therapy bed;'' youth beds to either 21 CFR 880.5100, ``AC powered
adjustable hospital bed,'' or 21 CFR 880.5120, ``Manual adjustable
hospital bed,'' depending on whether they are powered or not; pediatric
stretchers to 21 CFR 880.6910, ``Wheeled stretchers;'' and crib
enclosure beds to 21 CFR 880.6760, ``Protective restraint.'' This
action would not have any substantive effect on the current marketing
status of the devices. However, manufacturers of these devices would
need to refer to the new regulation classification and product code
provided by the Agency in future interactions with FDA.
    As discussed in section IV, an analysis of Medical Device Reports
(MDRs) submitted to the Manufacturer and User Facility Device
Experience (MAUDE) database from January 1, 2005, to September 1, 2015,
indicated 516 adverse events associated with pediatric medical cribs
including 15 serious injuries. The adverse events associated with
pediatric medical cribs were assessed to better understand the risks
and establish the proposed special controls for this device. FDA
believes that sufficient information is available to establish special
controls to provide a reasonable assurance of the safety and
effectiveness of the device.
    As discussed further in section VI, FDA believes risks to health
resulting from use of these cribs would be effectively mitigated by the
special controls proposed in this rule, and that these controls, in
combination with the general controls, would provide a reasonable
assurance of safety and effectiveness for pediatric medical cribs for
their intended use. Therefore, FDA is proposing new safety requirements
and allowing medical cribs in homes and day cares only when medically
necessary.
    FDA is also taking this opportunity to address adverse event
reports pertaining to medical bassinets by proposing to establish
special controls for these devices to provide a reasonable assurance of
safety and effectiveness. FDA has received adverse events from
hospitals regarding incidents of medical bassinet tipping and improper
cleaning of the basket or bed component that caused cracks and crazing,
which have resulted in patient injury. The Agency is proposing to
separate medical bassinets from other types of pediatric hospital beds
to allow for more targeted postmarket surveillance of these devices.
FDA believes the special controls it is proposing here, in combination
with the general controls, would provide a reasonable assurance of
safety and effectiveness for medical bassinets.

IV. Risks to Health

A. Pediatric Medical Crib

    Between January 1, 2005, and September 1, 2015, FDA received 516
adverse event reports, or MDRs, associated with open pediatric medical
cribs, through the Agency's MAUDE database. There were 15 adverse event
reports of serious injuries including 6 reports of entrapment, which
were predominantly extremity entrapments of legs or arms. The majority
of MDRs for medical cribs were for malfunctions such as drop-side rails
not latching or lowering, brakes not holding, wheels or casters
breaking, and where applicable, scales not reading correct weights.
These malfunctions (501 reports) were not associated with any adverse
health effects. After considering available information, FDA determined
that the following risks to health are associated with the use of
pediatric medical cribs:
     Injury resulting from mechanical or structural failure of
the device--Mechanical or structural failure of the crib can result in
failure of load-bearing components such as the wheels or casters, or
failure of the latches or other locking mechanisms that secure the
sides of the crib. These failures can result in injuries, as
demonstrated by the MDRs received in FDA's database.
     Pinching, laceration, splinters, and foreign body
ingestion--Depending on the material of the pediatric crib, certain
cribs may peel or crack and may expose pediatric patients to substances
or materials that may be toxic or may cause abrasions or lacerations if
the surface of the crib material is compromised.
     Entrapment, falls, and strangulation--Pediatric medical
cribs may cause entrapment of patient limbs if the width of the side
rails are not correct and if there are gaps between the mattress and
crib frame that are larger

than the width of two fingers. Depending on the height requirements of
the rails a pediatric patient may escape or fall from the crib. The
term ``entrapment'' refers to circumstances where a patient is caught,
trapped, or entangled in the space in or about the bed rail, mattress,
or hospital bed frame.
     Burns--Certain flammable materials used in the
construction of pediatric medical cribs may allow for the spread of
fire, which may result in serious injuries. Fires can spread easily in
hospital rooms with a patient using oxygen. The free-flowing oxygen can
intensify a fire, which can rapidly spread to flammable objects in the
room, including crib mattresses.
     Use error--Use error may contribute to or exacerbate any
of the previously mentioned adverse events. For example, a user may be
unaware that a side rail did not latch, or may fail to properly
maintain a pediatric medical crib. Therefore, adequate instructions for
use and user education are essential to safe device operation.

B. Medical Bassinet

    Between January 1, 2005, and September 1, 2015, FDA received 40
adverse event reports associated with this device type. The most common
MDRs for medical bassinets include reports of malfunctions such as
casters or wheels not working, which have caused tipping, and broken
bassinet base components, such as doors and drawers, or collapse or
breakage of utility shelves or chart holders. There are also reports of
the plastic sleep basket or bed component crazing (cracking), resulting
in sharp edges and cuts to hospital personnel.
    FDA has considered the available information and determined that
the following risks to health are associated with medical bassinets:
     Injury resulting from mechanical or structural failure of
the device--Mechanical or structural failure of the bassinet can result
in failure of load-bearing components such as the wheels or casters, or
failure of the latches or other locking mechanisms that secure the
drawers of the bassinet. These failures can result in injuries,
particularly if the bassinet tips over, as demonstrated by the MDRs
received in FDA's database.
     Burns--Certain flammable materials used in the
construction of pediatric medical bassinets may allow for the spread of
fire, which may result in serious injuries. Fires can spread easily in
hospital rooms with a patient using oxygen. The free-flowing oxygen can
intensify a fire, which can rapidly spread to flammable objects in the
room, including bassinet mattresses.
     Crazing or cracking of basket or bed component--The basket
or bed component of the bassinet that the pediatric patient is placed
in may craze or crack due to improper care or handling, such as
cleaning the plastic material of the basket or bed component with
inappropriate cleaning solutions. Crazing or cracking may result in
injuries such as cuts.
     Use error--Use error may contribute to, or exacerbate, any
of the previously mentioned risks. For example, a user may accidentally
leave a door or drawer in the base component of the bassinet open or
place too much weight in a drawer or on a shelf, which may present a
tipping hazard. Also, a user may fail to properly maintain a medical
bassinet.

V. Establishment of Special Controls

    Under section 513(a)(1)(B) of the FD&C Act, as amended by the SMDA,
class II devices are defined as devices for which general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance. Special controls
may include the issuance of performance standards, postmarket
surveillance, patient registries, development and dissemination of
guidelines, recommendations, and other appropriate actions the Agency
deems necessary to provide such assurance (see also Sec.  860.3(c)(2)).
    Under this authority, FDA is proposing to establish special
controls for pediatric medical cribs (Sec.  880.5140) and pediatric
medical bassinets (Sec.  880. 5145). The Agency believes that the
applicable special controls, together with the general controls, would
provide reasonable assurance of the safety and effectiveness of these
devices.

VI. Proposed Special Controls

A. Pediatric Medical Crib

    FDA consulted with health care providers in children's hospitals,
registered nurses in pediatric units, biomedical engineers, and
technicians, and analyzed the associated adverse events with pediatric
medical cribs. Specifically, FDA consulted with MedSun hospitals
regarding their 2011 survey on clinicians' experiences with pediatric
medical cribs with drop-side rails used in MedSun's hospitals (Ref. 1).
The MedSun survey summary highlights the clinical perspective and the
importance of this device in medical and health care settings. The most
common issues and concerns in the survey were the lack of understanding
of side rail operation and the need for reinforcing patient safety when
the side rails are raised or lowered. Many respondents of the survey
suggested further improvements for pediatric medical cribs, for
instance, improved labeling, specific distance between slats and
emergency releases on side rails for faster access to pediatric
patients. The adverse events identified in the MedSun survey are
similar to the MDRs FDA has received on this device. FDA believes that
the special controls proposed in this proposed rule, in combination
with the general controls, would provide a reasonable assurance of
safety and effectiveness for pediatric medical cribs their intended
use.

Table 1--Health Risks and Mitigation Measures for Pediatric Medical Crib
------------------------------------------------------------------------
       Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Injury Resulting from Mechanical or      Performance Testing.
 Structural Failure of the Device.       Design Testing.
Pinching, Lacerations, Splinters, and    Appropriate Materials Free From
 Foreign Body Ingestion.                  Surface Defects.
                                         Labeling.
Entrapment, Falls, and Strangulation...  Performance Testing.
                                         Rail and End Panel Design.
                                         Side Rail Spacing and Safety
                                          Features.
                                         Appropriate Fitting of
                                          Mattress.
Burns..................................  CPSC's Mattress Flammability
                                          Standard.
Use Error..............................  Labeling.
------------------------------------------------------------------------

    As provided in Table 1, the Agency believes the following special
controls, in combination with the general controls, would effectively
mitigate the identified risks to health and provide reasonable
assurance of the safety and effectiveness of the device:
    1. Design and performance testing must be conducted to ensure the
mechanical and structural stability of the crib under expected
conditions of use, including the security of latches and other locking
mechanisms when engaged. These requirements are derived from sections
6.2 and 6.3 of ASTM (formerly the American Society for Testing and
Materials) International Standard F1169-13, entitled ``Standard
Consumer Safety Specification for Full-Size Baby Cribs'' (Ref. 2) and
sections 5.7 and 6.3 of ASTM International Standard F2710-13, entitled
``Standard Consumer Safety Performance Specification for Commercial
Cribs'' (Ref. 3), which was developed with input from crib
manufacturers.
    2. To reduce possible injury of pinching, lacerations, and
crushing, the crib shall be designed and constructed in a manner that
eliminates hardware accessible to a child within the crib. This
requirement is derived from section 5.10 of ASTM International Standard
F1169-13, entitled ``Standard Consumer Safety Specification for Full-
Size Baby Cribs'' (Ref. 2), which was developed with input from crib
manufacturers. Also, materials used shall be appropriate for the
conditions of use, allow for proper sanitation, and free from surface
defects of the device that could result in injuries.
    3. To reduce the risk of head and limb entrapment, the distance
between side rail components (such as slats, spindles, corner posts,
and rods) shall be designed to reduce potential entrapment of pediatric
patients and the distance between such components shall not exceed 2\3/
8\ inches (6 centimeters) apart. In addition, the rails and end panels
of a crib must be of a height to mitigate the possibility of falls and/
or escapes by the patient. These requirements are derived from sections
5.7.2 and 5.8.1 of ASTM International Standard F1169-13, entitled
``Standard Consumer Safety Specification for Full-Size Baby Cribs''
(Ref. 2), which was developed with input from crib manufacturers.
    4. To reduce the risk of head and limb entrapment, no gap shall
exist between the edge of the bottom rail and the top of the mattress
surface and the mattress must fit tightly around all four sides of the
crib. These requirements are derived from section 5.9 of ASTM
International Standard F1169-13, entitled ``Standard Consumer Safety
Specification for Full-Size Baby Cribs'' (Ref. 2), which was developed
with input from crib manufacturers.
    5. To reduce flammability and the risk of burns, the mattress for
the crib shall meet the CPSC Standard for the Flammability of
Mattresses and Mattress Pads and its Standard for the Flammability
(Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633,
respectively. This proposed special control would clarify for
manufacturers the standards necessary for mattresses intended to be
used with pediatric medical cribs to prevent the spread of fires that
can easily occur in hospital rooms with a patient using oxygen. The
free-flowing oxygen can intensify a fire, which can rapidly spread to
most of the flammable objects in the room especially mattresses. The
consumer standards for flammability of mattresses in 16 CFR parts 1632
and 1633 are also accepted by the Joint Commission (formerly the Joint
Commission on Accreditation of Healthcare Organizations). CPSC's
mattress and mattress pad flammability standard under 16 CFR part 1632
addresses mattress fires ignited by open flame sources, including
matches, candles, lighters, and other related scenarios. It prescribes
a test to determine the ignition resistance of a mattress or a mattress
pad when exposed to a lighted cigarette. CPSC's standard for the
flammability of mattress sets under 16 CFR part 1633 is a broader
standard designed to reduce deaths and injuries caused by mattress
fires, particularly those fires ignited by, among others things, oxygen
use or electrical equipment sources that may occur in a patient's room.
In addition, CPSC's regulations require that manufacturers meet an
established fire safety performance standard, based on ASTM E2187-09,
entitled ``International's Standard Test Method for Measuring the
Ignition Strength of Cigarettes'' (Ref. 4), which was developed with
input from crib manufacturers.
    6. To reduce flammability and the risk of burns, the labeling must
bear all information required pursuant to the CPSC Standard for the
Flammability of Mattresses and Mattress Pads and its Standard for the
Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633,
respectively.
    7. To reduce the risk of use error, which may result in mechanical
or structural failure of the crib due to inadequate care or
maintenance, pediatric medical crib labeling must include adequate
instructions for users to care for and maintain their crib. These
requirements are derived from sections 5.18 of ASTM International
Standard F1169-13, entitled ``Standard Consumer Safety Specification
for Full-Size Baby Cribs'' (Ref. 2).
    FDA believes that the special controls proposed in this rule would
provide a reasonable assurance of safety and effectiveness of pediatric
medical cribs in their intended use. The ASTM and CPSC standards noted
above apply to all mattresses and mattress pads intended or promoted
for sleeping upon, as defined in 16 CFR 1632.1(a), including medical
mattresses that are regulated by FDA as an accessory to medical beds.
Therefore, FDA anticipates that manufacturers would be able to meet the
requirements imposed by the proposed special controls in this proposed
rule without undue burden. FDA invites comments on this conclusion,
including comments regarding the types of performance testing
manufacturers conduct for pediatric medical cribs, particularly to
ensure the performance of medical crib latches on drop-side rails.
    In addition, FDA is proposing to restrict these devices to
prescription use under section 520(e) of the FD&C Act (see Sec.
801.109 (prescription devices)). In order to use or administer use of
pediatric medical cribs, authorization must be made by a practitioner
licensed by law.

B. Medical Bassinet

    Table 2 lists the risks to health FDA has identified for Medical
Bassinets, as described in the Risks to Health, section IV of this
proposed rule, along with the corresponding proposed mitigation
measures for each risk.

   Table 2--Health Risks and Mitigation Measures for Medical Bassinet
------------------------------------------------------------------------
       Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Injury Resulting from Mechanical or      Performance Testing.
 Structural Failure of the Device.
                                         Labeling.
Burns..................................  CPSC's Mattress Flammability
                                          Standard.

Crazing or Cracking of Basket or Bed     Performance Testing.
 Component.
                                         Labeling.
Use Error..............................  Labeling.
------------------------------------------------------------------------

    The Agency believes the following special controls, in combination
with the general controls, would effectively mitigate the identified
risks to health and provide reasonable assurance of the safety and
effectiveness of medical bassinets:
    1. To mitigate crazing, cracking, and deterioration of the basket
or bed component of the device, the manufacturer must conduct
performance testing to determine material compatibility with cleansing
products labeled to clean the device.
    2. To reduce flammability and the risk of burns, the bassinet shall
meet CPSC's Standard for the Flammability of Mattresses and Mattress
Pads and its Standard for the Flammability (Open Flame) of Mattress
Sets, 16 CFR parts 1632 and 1633, respectively.
    3. To reduce the risk of injury resulting from mechanical or
structural failure of the device, and particularly, device tipping that
can result from those failures; manufacturers shall conduct performance
testing to ensure the mechanical and structural stability of the
bassinet under expected use conditions, including transport of patients
in the bassinet.
    4. To reduce the risk of use error, specifically error that may
result in bassinet tipping, FDA proposes that manufacturers shall have
a label on the front of the bassinet cabinet with the following warning
statement:

    WARNING: To avoid tipping hazards of this device, make sure that
the basket or bed component sits firmly in the base and that all
doors, drawers, and casters are secure.

    The label must be affixed to the front of the bassinet base cabinet
and the text shall be in letters not less than 10 millimeters in
height.
    FDA believes this warning is necessary because even if performance
testing demonstrates that a bassinet does not present a tipping hazard
under expected use conditions, users may exceed these expected use
conditions, particularly during transport of a patient in the bassinet.
    5. To reduce the risk of use error, which may result in mechanical
or structural failure of the bassinet due to inadequate care or
maintenance, medical bassinet labeling must include adequate
instructions for users to care for and maintain the bassinet.
    FDA believes that the special controls proposed in this rule would
provide a reasonable assurance of safety and effectiveness of medical
bassinets in their intended use. The CPSC standards noted previously
apply to all mattresses and mattress pads intended or promoted for
sleeping upon, as defined in 16 CFR 1632.1(a), including medical
mattresses that are regulated by FDA as an accessory to medical beds.
Therefore, FDA believes most manufacturers are already complying with
the proposed special control for mattress flammability set forth in
this proposed rule. FDA invites comments on the types of performance
testing manufacturers conduct for medical bassinets.
    In addition, FDA is proposing to restrict these devices to
prescription use under section 520(e) of the FD&C Act (see Sec.
801.109 (Prescription devices)). In order to use or administer use of
medical bassinets, authorization must be made by a practitioner
licensed by law.

VII. Proposed Effective Date

    FDA proposes that any final rule based on this proposal become
effective 60 days after its publication in the Federal Register.

VIII. Environmental Impact, No Significant Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Economic Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the expected costs associated with this rule
are expected to be modest, we propose to certify that this rule would
not have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

A. Objective of the Rule

    Pediatric hospital beds are classified as class II, 510(k) exempt
medical devices intended for the treatment, care, or diagnosis of
diseases or illnesses of pediatric patients. In this proposed rule, FDA
proposes to amend Sec.  880.5140 by revising the identification and
establishing special controls for pediatric medical cribs. This rule
would also change the name of the classification regulation from
``pediatric hospital bed'' to ``pediatric medical crib,'' and place
medical bassinets, previously under the pediatric hospital beds
classification regulation, as a separate class II, 510(k) exempt
device, subject to its own special controls.
    Pediatric medical cribs used in health care settings contain a
drop-side rail design that includes movable and latchable side and end
rails. As stated previously, the CPSC issued a final rule prohibiting
the use of the drop-side rail design for non-medical cribs in consumer
households as of June 28,

2011 (December 28, 2010, 75 FR 81766). CPSC's rule establishes new
standards for full-size and non-full-size cribs used for non-medical
purposes, which effectively prohibit the manufacture or sale of cribs
for non-medical purposes with a drop-side rail design in households,
child care facilities, family child care homes, and places of public
accommodation. The compliance date for this same rule for child care
facilities, family child care homes, and places of public accommodation
was December 28, 2012 (75 FR 81766). CPSC's rule was established in
response to infant deaths that occurred when the side rail of a crib
used for non-medical purposes detached or disengaged. In contrast,
there have been no deaths and a few serious injuries reported to FDA
associated with pediatric medical cribs, which are made of more durable
materials and construction in comparison to cribs used for non-medical
purposes. Additionally, FDA has determined that drop-side rails are
essential for patient care in hospital settings and even outside of
traditional health care settings to allow parents and care givers easy
access to their patients in order to perform both routine and emergency
medical procedures. To address concerns raised by CPSC's reports on
consumer drop-side rail cribs and account for the medical need of this
device, FDA is proposing to establish special controls and require a
prescription for this device when used outside of traditional health
care setting. Thus, FDA has determined that cribs with drop-side rail
designs may remain on the market when intended for medical use, and can
be used outside of traditional health care settings through
prescription use only. In addition, this proposed rule adds specific
special controls for medical bassinets to mitigate health risks such as
tipping of the device and crazing of the plastic basket or bed
component. Regulation of this device under a separate regulation would
also allow for more targeted post market surveillance for this device.

B. Benefits

    FDA's Registration and Listing database identifies 38 manufacturers
of medical cribs and bassinets. FDA has reviewed the safety standards
of several large pediatric crib and bassinet manufacturers in order to
determine the compliance burden associated with the proposed special
controls. The Agency concludes that many of the special controls
proposed by this rule are consistent with current industry practice
among many medical crib and bassinet manufacturers. The proposed
special control that is not currently practiced is the warning labeling
requirements for medical bassinets. For new pediatric medical crib and
bassinet manufacturers entering the market or manufacturers that may
not be currently following the practices required by the proposed
special controls, if this proposed rule is finalized, its special
controls will clarify safety standards and minimize the risk of injury
to pediatric patients.
    The beneficial features of medical bassinets are portability, ease
of cleaning, and, when it is made of a clear material, the ability to
see the baby from all sides. The proposed special controls would
require bassinet manufacturers to place labels on their devices warning
against device tipping. This requirement would apply to new bassinets;
bassinets that have already been sold would not be required to add the
new labels to their devices. The warning label is intended to prevent
tipping of the device, which may be caused by unlatched drawers,
dislodged wheels, or too much weight on the shelves. The Agency has not
received any reports of death or serious injury related to medical
bassinets, although there have been a small number of reports of
malfunctioning casters, which may cause device tipping. The benefits of
the new warning label are not readily quantifiable, but it is expected
to reduce the risk of the bassinet from tipping and thus, reduce
potential injury to pediatric patients.
    The provision allowing for the medical cribs outside of traditional
health care settings would benefit pediatric patients who require the
specialized care provided by these devices outside of traditional
health care settings. Due to the CPSC rule regarding cribs used for
non-medical purposes, discussed previously, consumers and child care
facilities are restricted from using cribs with a drop-side rail
design. If this proposed rule is finalized, it will allow consumers and
child care facilities to utilize the pediatric medical cribs if they
are prescribed by a health care professional.
    The special controls regarding the mechanical structure of
pediatric medical cribs are intended to minimize the risk of injury,
including entrapment or strangulation of pediatric patients. The
spacing specifications of the side rail components are designed to
prevent head or neck entrapment and strangulation incidents in which
infants may slip between the openings of the slats, and the performance
testing requirements are designed to ensure the side rail latches of
pediatric medical cribs will perform as intended and remain secure when
the latches are engaged. The special control requiring specific height
of the rails and end panels may prevent falls and/or escapes by the
patient. Also, by having pediatric medical crib manufacturers use
materials that are appropriate for the conditions of use and allow for
proper sanitation, these special controls may help mitigate surface
defects that can cause injury to the patient.
    Additionally, the mattress size standards for cribs and bassinets
are intended to reduce the risk of significant gaps between the
mattress and the device structure, which could potentially create an
entrapment hazard. The flammability standard is intended to reduce
deaths and injuries related to mattress fires, particularly those
initially ignited by open flame sources such as lighters, candles, and
matches. Although the practices proposed in these special controls are
believed to be followed by almost all manufacturers of products
currently on the market, the proposed special controls would reinforce
safety standards for such manufacturers and ensure that other
manufacturers and manufacturers of new products adhere to the same
safety standards.

C. Costs

    The economic impact of the proposed regulation is determined
primarily by whether manufacturers currently comply with the proposed
special controls. As stated previously, the special controls that are
not currently practiced by industry, of which FDA is aware, are the
bassinet warning labeling and the performance testing requirements. FDA
is also aware that many manufacturers of pediatric medical cribs and
medical bassinets registered with the FDA currently conform to the risk
mitigations and structural requirements that are being proposed as
special controls, and thus conforming to these special controls, if
finalized, would not result in an increase in cost to pediatric medical
crib manufacturers and only cause a small increase in cost for medical
bassinet manufactures. Additionally, the renaming of pediatric medical
cribs and redesignation in the CFR for medical bassinets and the
remaining devices under the pediatric hospital bed classification are
administrative in nature, and are not expected to result in any cost
burdens.
    The new warning labeling requirements for medical bassinets will
apply to manufacturers of new bassinets only. FDA does not expect
bassinets that are currently on the market to be relabeled. If
manufacturers of new bassinets add labels to the devices at the

time of production, the cost burden to manufacturers would be
minimized. Although we do not have direct estimates of labeling costs
for these devices, the best estimate of these costs is derived from
FDA's labeling cost model. Because FDA would require specific language
and format of the labels, we consider this to be a minor labeling
change that would not require label design, market tests, or analytical
tests. Labeling costs would include labor and material, and are
estimated to be, on average, approximately $140 per unit. Then we use
the number of live births per year as reported by the Center for
Disease Control and Prevention in order to determine the number of
bassinets produced per year for medical use (Ref. 5). Using an estimate
of 4 million births per year and 11,000 births per day, we estimate
that each birth requires an average hospital stay of 3 days. This
yields a total supply of approximately 33,000 medical bassinets in the
United States. Given an average yearly replacement rate of 20 percent
for all medical bassinets, we estimate that approximately 6,600 new
bassinets will be produced annually. Applying the $140 per unit
labeling cost yields a total yearly cost of $924,000 associated with
the new bassinet warning label requirement.
    The special controls require performance testing for medical
bassinets to reduce the risk of crazing of the plastic basket or bed
component. We assume that the performance testing may be conducted as
an extension to current product testing and may be performed at the
same testing facilities currently utilized by bassinet manufacturers.
FDA projects that a maximum of an additional week of testing would be
required. The costs associated with the performance testing include the
labor costs of mechanical engineers, who typically perform these tests.
The mean 2012 hourly wage for mechanical engineers is $40.75, as
reported by the Occupational Employment Statistics provided by the
Bureau of Labor Statistics (Ref. 6). Applying a multiplier of 1.45 to
adjust for benefits, hourly labor costs are estimated to be
approximately $59. Assuming a 40-hour work week, the total maximum
estimated cost for each manufacturer to perform these additional tests
is approximately $2,360. It is uncertain the exact number of
manufacturers that do not currently conduct performance testing and
would therefore be required to extend current testing practices.
However, given the relatively small number of medical bassinet
manufacturers, FDA anticipates that even the upper-bound total cost
would be modest.
    The prescription use of pediatric medical cribs outside of
traditional health care settings may potentially increase Medicaid
spending for eligible pediatric patients. According to our review of
Healthcare Common Procedure Coding System billing codes for the
Medicaid program, currently, States typically offer Medicaid coverage
for prescribed rental or purchase of hospital beds and pediatric cribs
(Ref. 7). We estimate the number of additional prescriptions for
pediatric medical cribs to be filled annually as a result of this
proposed rule would be less than 100. Medicaid expenditure on pediatric
medical cribs is estimated to be on average $2,500 per device. This
yields a maximum annual total cost of $250,000.
    Although it is unlikely that these devices would require physical
modification to meet the standards proposed by the special controls in
this proposed rule, there may be manufacturers on the market of which
we are unaware that do not conform to the requirements proposed in the
special controls. The proposed special controls could have a
significant impact on firms that are not currently in compliance with
the special controls, as their products may require modifications. The
special control that may cause additional costs for manufacturers is
the special control concerning the mechanical structure of pediatric
medical cribs. We are not able to estimate the actual compliance costs
for manufacturers of pediatric medical cribs because such costs may
vary by firm size and the amount of modification required.
Alternatively, we provide an estimate of the modification cost by using
aggregate industry market price information and cost data. The costs
associated with these modifications may include the costs associated
with product design and testing, labor, material, and production. We
use data from the Annual Survey of Manufacturers to calculate aggregate
labor and materials costs as a percentage of total sales for
manufacturers represented by North American Industry Classification
System code 339113 (Ref. 8). The data indicate that labor and materials
represent approximately 45 percent of total sales. Allowing market
price to represent per unit revenue at the firm level, we estimate the
cost of modification to be approximately 45 percent of the average
price of a pediatric medical crib. After surveying market prices of
pediatric medical cribs, we estimate an average per unit price of
$2,500. This yields an average cost of approximately $1,125 to modify a
pediatric medical crib to be in compliance with the proposed special
controls.
    FDA invites comments on the compliance of manufacturers with the
special controls, including the performance testing, mechanical
structure, flammability requirements, and bassinet labeling
requirements, as well as cost information if modifications are
required.

X. Paperwork Reduction Act of 1995

    The proposed rule refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management Budget (OMB) and the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information, regarding premarket notification submissions (21 CFR
part 807, subpart E), are approved under OMB control number 0910-0120.
The collections of information, regarding labeling (21 CFR part 801),
including prescription device labeling and adequate directions for use,
are approved under OMB control number 0910-0485. The collections of
information regarding current good manufacturing practice quality
systems (21 CFR part 820), including design controls (as referenced in
proposed Sec.  880.5140(b)(1) and proposed Sec.  880.5145(b)(1) and
(b)(3) of this document), are approved under OMB control number 0910-
0073. The collections of information in 16 CFR 1632 and 1633, regarding
mattress flammability, are approved under OMB control number 3041-0014.
    In addition, FDA concludes that the warning label for bassinets
does not constitute a ``collection of information'' under the PRA.
Rather, the labeling statement is ``public disclosure(s) of information
originally supplied by the Federal government to the recipient for the
purpose of disclosure to the public.'' (5 CFR 1320.3(c)(2)).

XI. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. MedSun: Newsletter #66: ``Pediatric Hospital Cribs: MedSun Small
Sample Survey Summary'' (November 2011),

available at http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Newsletters/UCM422131.pdf.
2. ASTM International (formerly the American Society for Testing and
Materials), ``Standard Consumer Safety Specifications for Full-Size
Baby Cribs,'' Designation: F1169-13, available at http://www.astm.org/Standards/F1169.htm, 2013.
3. ASTM International (formerly the American Society for Testing and
Materials), ``Standard Consumer Safety Performance Specification for
Commercial Cribs,'' Designation: F2710-13, available at http://www.astm.org/Standards/F2710.htm, 2013.
4. ASTM International, ``Standard Test Method for Measuring the
Ignition Strength of Cigarettes,'' Designation: E2187-09 Standard,
available at http://www.astm.org/Standards/E2187.htm.
5. Centers for Disease Control and Prevention (CDC), National Vital
Statistics System, Birth Data, available at http://www.cdc.gov/nchs/births.htm.
6. Occupational Employment Statistics provided by the Bureau of
Labor Statistics, May 2012 Occupational Employment Statistics,
available at http://www.bls.gov/oes/2012/may/oes_stru.htm.
7. Centers for Medicare & Medicaid Services, HCPCS 2015 Code: E0300,
available at http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html?redirect=/medhcpcsgeninfo/.
8. U.S. Census Bureau, 2013 Annual Survey of Manufacturers,
available at http://www.census.gov/manufacturing/asm/index.html.

List of Subjects in 21 CFR Part 880

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 880 be amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for 21 CFR part 880 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Revise Sec.  880.5140 to read as follows:

Sec.  880.5140  Pediatric medical crib.

    (a) Identification. A pediatric medical crib is a prescription
device intended for medical purposes for use with a pediatric patient
that consists of an open crib, fixed-end rails, movable and latchable
side rail components, and possibly an accompanying mattress. The
contour of the crib surface may be adjustable.
    (b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec.  880.9. The special controls for
this device are:
    (1) Crib design and performance testing shall demonstrate the
mechanical and structural stability of the crib under expected
conditions of use, including the security of latches and other locking
mechanisms when engaged;
    (2) Materials used shall be appropriate for the conditions of use,
allow for proper sanitation and free from surface defects that could
result in injuries;
    (3) Rails and end panels shall be designed taking into account the
crib's height at its lowest point to the top of the mattress to prevent
patient falls and/or escape. Hardware and fasteners shall be designed
and constructed to eliminate mechanical hazards to the patient;
    (4) The distance between components of the side rail (such as
slats, spindles, and corner posts) shall not be greater than 2\3/8\
inches (6 centimeters (cm)) apart at any point. Side rails shall
contain safety features for locking and adjust the lowest position of
the crib to a height that shall be 20 inches (51 cm) above the top of
the mattress;
    (5) The device shall not have a gap between the bottom of the rail
and the top surface of the mattress and the mattress pad must fit
tightly around all four sides of the crib;
    (6) The mattress for the crib shall meet the Consumer Product
Safety Commission (CPSC) Standard for the Flammability of Mattresses
and Mattress Pads and Standard for the Flammability (Open Flame) of
Mattress Sets, 16 CFR parts 1632 and 1633, respectively;
    (7) The labeling must bear all information required pursuant to the
CPSC Standard for the Flammability of Mattresses and Mattress Pads and
Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR
parts 1632 and 1633, respectively; and
    (8) Pediatric medical crib labeling must include adequate
instructions for users to care for and maintain their crib.
0
3. Add Sec.  880.5145 to subpart F to read as follows:

Sec.  880.5145  Medical bassinet.

    (a) Identification. A medical bassinet is a prescription device
that is a small bed intended for use with pediatric patients, generally
from birth to approximately 5 months of age. It is intended for medical
purposes for use in a nursery, labor and delivery unit, or patient
room, but may also be used outside of traditional health care settings.
A medical bassinet is a non-powered device that consists of two
components: The plastic basket or bed component and a durable frame
with wheels, which holds the basket or bed component. The basket or bed
component is a box-like structure, generally made of a clear, high
impact-resistant plastic material, with an open top and four stationary
walls to hold the pediatric patient. The frame can include drawers,
shelving or cabinetry that provides space to hold baby care items. The
wheels or casters allow the bassinet to transport the baby throughout
the care setting.
    (b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec.  880.9. The special controls for
this device are:
    (1) The manufacturer must conduct performance testing to determine
material compatibility with cleansing products labeled to clean the
device. Testing must demonstrate that the cleaning instructions
provided by the manufacturer do not cause crazing, cracking, or
deterioration of the device;
    (2) The mattress for the device shall meet the Consumer Product
Safety Commission Standard for the Flammability of Mattresses and
Mattress Pads and Standard for the Flammability (Open Flame) of
Mattress Sets, 16 CFR parts 1632 and 1633, respectively;
    (3) Manufacturers shall conduct performance testing to ensure the
mechanical and structural stability of the bassinet under expected use
conditions, including transport of patients in the bassinet. Testing
must demonstrate that failures such as wheel or caster breakage do not
occur, and that the device does not present a tipping hazard due to any
mechanical failures, under expected use conditions;
    (4) Each device must have affixed a label on the front of the
bassinet cabinet with the following language in text of at least 10
millimeters in height:

    WARNING: To avoid tipping hazards of this device, make sure that
the basket or bed component sits firmly in the base and that all
doors, drawers, and casters are secure.

    (5) Labeling must include adequate instructions for users to care
for and maintain their bassinet.

    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25627 Filed 10-7-15; 8:45 a.m.]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 85 (Wednesday, May 5, 2021)]
[Notices]
[Pages 24090-24093]
[FR Doc No: 2021-09438]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91709; File No. SR-NYSENAT-2021-12]

Self-Regulatory Organizations; NYSE National, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Extend
the Effective Date in Commentary .10 Under NYSE National Rule 2.1210

April 29, 2021.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Exchange Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is
hereby given that on April 19, 2021, NYSE National, Inc. (``NYSE
National'' or the ``Exchange'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the self-regulatory organization. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes a rule change to extend the effective date in
Commentary .10 (Temporary Extension of the Limited Period for
Registered Persons to Function as Principals) under NYSE National Rule
2.1210 (Registration Requirements) applicable to ETP Holders, from
April 30, 2021 to June 30, 2021. The Exchange does not anticipate
providing any further extensions to the temporary relief identified in
this proposed rule change beyond June 30, 2021.\4\ The proposed rule
change is available on the Exchange's website at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.
---------------------------------------------------------------------------

    \4\ If due to unforeseen circumstances a further extension is
necessary, the Exchange will submit a separate rule filing to
further extend the temporary relief.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to extend the effective date in Commentary
.10 (Temporary Extension of the Limited Period for Registered Persons
to Function as Principals) under NYSE National Rule 2.1210
(Registration Requirements) applicable to ETP Holders,\5\ from April
30, 2021 to June 30, 2021. The proposed rule change would extend the
120-day period that

certain individuals can function as a principal without having
successfully passed an appropriate qualification examination through
June 30, 2021, and would apply only to those individuals who were
designated to function as a principal prior to March 3, 2021. This
proposed rule change is based on a filing recently submitted by the
Financial Industry Regulatory Authority, Inc. (``FINRA'') \6\ and is
intended to harmonize the Exchange's registration rules with those of
FINRA so as to promote uniform standards across the securities
industry.
---------------------------------------------------------------------------

    \5\ The term ``ETP Holder'' means the Exchange-approved holder
of an ETP. See NYSE National Rule 1.1(i). The term ``ETP'' refers to
an Equity Trading Permit issued by the Exchange for effecting
approved securities transactions on the Exchange. See NYSE National
Rule 1.1(h).
    \6\ See Exchange Act Release No. 91506 (April 8, 2021) 86 FR
19671 (April 14, 2021) (SR-FINRA-2021-005) (the ``FINRA Filing'').
The Exchange notes that the FINRA Filing also provides temporary
relief to individuals registered with FINRA as Operations
Professionals under FINRA Rule 1220. The Exchange does not have a
registration category for Operations Professionals and therefore,
the Exchange is not proposing to adopt that aspect of the FINRA
Filing.
---------------------------------------------------------------------------

    In response to COVID-19 global pandemic, last year FINRA began
providing temporary relief by way of frequently asked questions
(``FAQs'') \7\ to address disruptions to the administration of FINRA
qualification examinations caused by the pandemic that have
significantly limited the ability of individuals to sit for
examinations due to Prometric test center capacity issues.\8\
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    \7\ See https://www.finra.org/rules-guidance/key-topics/covid-19/faq#qe.
    \8\ At the outset of the COVID-19 pandemic, all FINRA
qualification examinations were administered at test centers
operated by Prometric. Based on the health and welfare concerns
resulting from COVID-19, in March 2020 Prometric closed all of its
test centers in the United States and Canada and began to slowly
reopen some of them at limited capacity in May. Currently, Prometric
has resumed testing in many of its United States and Canada test
centers, at either full or limited occupancy, based on local and
government mandates.
---------------------------------------------------------------------------

    FINRA published the first FAQ on March 20, 2020, providing that
individuals who were designated to function as principals under FINRA
Rule 1210.04 \9\ prior to February 2, 2020, would be given until May
31, 2020, to pass the appropriate principal qualification
examination.\10\ FINRA revised the FAQ to extend the expiration of the
temporary relief to pass the appropriate principal examination until
June 30, 2020, and then until August 31, 2020.
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    \9\ NYSE National Rule 2.1210.03 is the corresponding rule to
FINRA Rule 1210.04.
    \10\ FINRA Rule 1210.04 (Requirements for Registered Persons
Functioning as Principals for a Limited Period) allows a member firm
to designate certain individuals to function in a principal capacity
for 120 calendar days before having to pass an appropriate principal
qualification examination NYSE National Rule 2.1210.03 provides the
same allowance to ETP Holders.
---------------------------------------------------------------------------

    On September 25, 2020, NYSE National filed with the Commission a
proposed rule change for immediate effectiveness to extend the
temporary relief provided via the FAQ by adopting temporary Commentary
.10 (Temporary Extension of the Limited Period for Registered Persons
to Function as Principals) under NYSE National Rule 2.1210
(Registration Requirements).\11\ Pursuant to this rule filing,
individuals who were designated prior to September 3, 2020, to function
as a principal under NYSE National Rule 2.1210.10 had until December
31, 2020, to pass the appropriate qualification examination. The
Exchange thereafter filed a proposed rule change to extend the
expiration date of the temporary relief from December 31, 2020, to
April 30, 2021.\12\
---------------------------------------------------------------------------

    \11\ See Exchange Act Release No. 90117 (October 7, 2020), 85 FR
65116 (October 14, 2020) (Notice of Filing and Immediate
Effectiveness of SR-NYSENAT-2020-30).
    \12\ See Exchange Act Release No. 90771 (December 22, 2020), 85
FR 86629 (December 30, 2020) (Notice of Filing and Immediate
Effectiveness of SR-NYSENAT-2020-38).
---------------------------------------------------------------------------

    As mentioned in the prior filings, FINRA began providing, and then
extended, temporary relief to address the interruptions in the
administration of FINRA qualification examinations at Prometric test
centers and the limited ability of individuals to sit for the
examinations caused by the COVID-19 pandemic.\13\ The prior filings
also noted that the pandemic could result in firms potentially
experiencing significant disruptions to their normal business
operations that may be exacerbated by being unable to keep principal
positions filled. Specifically, the limitation of in-person activities
and staff absenteeism as a result of the health and welfare concerns
stemming from COVID-19 could result in firms having difficulty finding
other qualified individuals to transition into that role or requiring
them to reallocate employee time and resources away from other critical
responsibilities at the firm.
---------------------------------------------------------------------------

    \13\ Information about the continued impact of COVID-19 on
FINRA-administered examinations is available at https://www.finra.org/rules-guidance/key-topics/covid-19/exams.
---------------------------------------------------------------------------

    While there are signs of improvement, the COVID-19 conditions
necessitating the temporary relief persist and FINRA has determined
that there is a continued need for this temporary relief beyond April
30, 2021. Although Prometric has resumed testing in many of its U.S.
test centers, Prometric's safety practices mean that currently not all
test centers are open, some of the open test centers are at limited
capacity, and some open test centers are delivering only certain
examinations that have been deemed essential by the local
government.\14\ In addition, while certain states have started to ease
COVID-19 restrictions on businesses and social activities, public
health officials continue to emphasize the importance for individuals
to keep taking numerous steps to protect themselves and help slow the
spread of the disease.\15\
---------------------------------------------------------------------------

    \14\ Information from Prometric about its safety practices and
the impact of COVID-19 on its operations is available at https://www.prometric.com/covid-19-update/corona-virus-update. See also
supra note 13.
    \15\ See, e.g., Centers for Disease Control and Prevention, How
to Protect Yourself & Others, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
---------------------------------------------------------------------------

    Although the COVID-19 conditions necessitating the temporary relief
persist, in the FINRA Filing, FINRA stated that an extension of the
relief is necessary only until June 30, 2021, because FINRA recently
expanded the availability of online examinations. Prior to this
expansion, the ongoing effects of the pandemic made it impracticable
for FINRA members to ensure that the individuals who they had
designated to function in a principal capacity, as set forth in FINRA
Rule 1210.04, could successfully sit for and pass an appropriate
qualification examination within the 120-calendar day period required
under the rule.\16\ Specifically, if the individual wanted to take a
qualifying examination, they were required to accept the health risks
associated with taking an in-person examination because those
examinations were not available online. On February 24, 2021, however,
FINRA adopted an interim accommodation request process to allow
candidates to take additional FINRA examinations online, including the
General Securities Principal (``Series 24'') examination.\17\ Because
the qualifying examination has been made available online only
recently, FINRA is concerned that individuals who have been designated
to function in a principal capacity may not have sufficient time to
schedule, study for, and take the applicable examination before April
30, 2021, the date the temporary relief is set to expire.
---------------------------------------------------------------------------

    \16\ See supra note 13.
    \17\ Id.
---------------------------------------------------------------------------

    These ongoing circumstances make it impracticable for ETP Holders
to ensure that the individuals whom they have designated to function in
a principal capacity, as set forth in NYSE National Rule 2.1210.03, are
able to successfully sit for and pass an appropriate qualification
examination within the 120-calendar day period required under the rule,
or to find other qualified staff to fill this position. Therefore, NYSE

National is proposing to extend the effective date of the temporary
relief provided through SR-NYSENAT-2020-38 until June 30, 2021. The
proposed rule change would apply only to those individuals who were
designated to function as a principal prior to March 3, 2021. Any
individuals designated to function as a principal on or after March 3,
2021, would need to successfully pass an appropriate qualification
examination within 120 days.
    NYSE National believes that this proposed continued extension of
time is tailored to address the needs and constraints on an ETP
Holder's operations during the COVID-19 pandemic, without significantly
compromising critical investor protection. The proposed extension of
time will help to minimize the impact of COVID-19 on ETP Holders by
providing continued flexibility so that ETP Holders can ensure that
principal positions remain filled. The potential risks from the
proposed extension of the 120-day period are mitigated by the ETP
Holder's continued requirement to supervise the activities of these
designated individuals and ensure compliance with federal securities
laws and regulations, as well as NYSE National rules. NYSE National has
filed the proposed rule change for immediate effectiveness and has
requested that the Commission waive the requirement that the proposed
rule change not become operative for 30 days after the date of the
filing, so NYSE National can implement the proposed rule change
immediately.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Exchange Act,\18\ in general, and furthers the objectives of Section
6(b)(5),\19\ in particular, because it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to, and perfect the mechanism of, a free and open
market and a national market system and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f(b).
    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed rule change is intended to minimize the impact of
COVID-19 on ETP Holder operations by extending the 120-day period
certain individuals may function as a principal without having
successfully passed an appropriate qualification examination under NYSE
National Rule 2.1210.03 until June 30, 2021. The proposed rule change
does not relieve ETP Holders from maintaining, under the circumstances,
a reasonably designed system to supervise the activities of their
associated persons to achieve compliance with applicable securities
laws and regulations, and with applicable NYSE National rules that
directly serve investor protection. In a time when faced with unique
challenges resulting from the COVID-19 pandemic, NYSE National believes
that the proposed rule change is a sensible accommodation that will
continue to afford ETP Holders the ability to ensure that critical
positions are filled and client services maintained, while continuing
to serve and promote the protection of investors and the public
interest in this unique environment.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Exchange Act. As set forth in the
prior filings, the proposed rule change is intended solely to extend
temporary relief necessitated by the continued impacts of the COVID-19
pandemic and the related health and safety risks of conducting in-
person activities. In its filing, FINRA noted that the proposed rule
change is necessary to temporarily rebalance the attendant benefits and
costs of the obligations under FINRA Rule 1210 in response to the
impacts of the COVID-19 pandemic that would otherwise result if the
temporary relief was to expire on April 30, 2021. The Exchange
accordingly incorporates FINRA's abbreviated economic impact assessment
by reference.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \20\ and Rule 19b-
4(f)(6) thereunder.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
pursuant to Rule 19b-4(f)(6)(iii), the Commission may designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has asked the
Commission to waive the 30-day operative delay so that the proposed
rule change may become operative immediately upon filing. As noted
above, the Exchange stated that the conditions necessitating the
temporary relief continue to exist and the proposed extension of time
will help minimize the impact of the COVID-19 outbreak on NYSE National
ETP Holders' operations by allowing them to keep principal positions
filled and minimizing disruptions to client services and other critical
responsibilities. Despite signs of improvement, the Exchange further
stated that the ongoing extenuating circumstances of the COVID-19
pandemic make it impractical to ensure that individuals designated to
act in these capacities are able to take and pass the appropriate
qualification examination during the 120-calendar day period required
under the rules.
    The Exchange observed that, following a nationwide closure of all
test centers earlier in the year, some test centers have re-opened, but
are operating at limited capacity or are only delivering certain
examinations that have been deemed essential by the local
government.\22\ However, on February 24, 2021, FINRA began providing
the General Securities Principal (Series 24) Examination online through
an interim accommodation request process.\23\ Prior to this change, if
individuals wanted to take these qualifying examinations, they were
required to accept the health risks associated with taking an in-person
examination. Even with the expansion of online qualifications
examinations, the Exchange stated that extending the

expiration date of the relief set forth in SR-NYSENAT-2020-38 until
June 30, 2021 is still needed. The Exchange stated that this temporary
relief will provide flexibility to allow individuals who have been
designated to function in a principal sufficient time to schedule,
study for and take the applicable examination before the temporary
relief expires. Notably, the Exchange stated that it does not
anticipate providing any further extensions to the temporary amendments
and that any individuals designated to function as a principal on or
after March 3, 2021 will need to successfully pass an appropriate
qualification examination within 120 days.
---------------------------------------------------------------------------

    \22\ See supra notes 13 and 14. The Exchange states that
Prometric has also had to close some reopened test centers due to
incidents of COVID-19 cases.
    \23\ See supra note 13 (including the February 24, 2021
announcement of the interim accommodation process for candidates to
take certain examinations, including the General Securities
Principal (Series 24) Examination, online.)
---------------------------------------------------------------------------

    For these reasons, the Commission believes that waiver of the 30-
day operative delay is consistent with the protection of investors and
the public interest.\24\ Accordingly, the Commission hereby waives the
30-day operative delay and designates the proposal operative upon
filing.\25\
---------------------------------------------------------------------------

    \24\ As noted above by the Exchange, this proposal is an
extension of temporary relief provided in SR-NYSENAT-2020-30 and SR-
NYSENAT-2020-38 where the Exchange also requested and the Commission
granted a waiver of the 30-day operative delay. See SR-NYSENAT-2020-
30, 85 FR at 65118 and SR-NYSENAT-2020-38, 85 FR at 86631-32.
    \25\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSENAT-2021-12 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSENAT-2021-12. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSENAT-2021-12 and should be submitted
on or before May 26, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
---------------------------------------------------------------------------

    \26\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09438 Filed 5-4-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Page 56972]
[FR Doc No: 2017-25907]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9036-4]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/ nepa/.
Weekly receipt of Environmental Impact Statements (EISs)
Filed 11/20/2017 Through 11/24/2017
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20170234, Final, USMC, DC, Multiple Projects in Support of
Marine Barracks Washington, DC, Review Period Ends: 01/02/2018,
Contact: Ms. Julie Darsie<PHONE_NUMBER>.
EIS No. 20170235, Final Supplement, FTA, CA, Westside Purple Line
Extension Section 4(f) Evaluation, Review Period Ends: 01/02/2018,
Contact: Mary Nguyen<PHONE_NUMBER>.

    Dated: November 28, 2017.
Kelly Knight,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2017-25907 Filed 11-30-17; 8:45 am]
 BILLING CODE 6560-50-P


Cooling Water Intake Structure ( CWIS) Information Data Required Rig Information Rig Name Deepwater Pathfinder Deepwater Frontier Deepwater Discovery Deepwater Millennium Rig Type Drillship ( Dynamically Positioned) Total Installed Power Generation Capacity 47,736 HP Number of Cooling Water Intake Structures ( CWISs) 12 Brief description of each CWIS ( e. g., sea chest, simple pipe) All CWIS are enclosed within Sea Chests Rough dimensions of each CWIS and indicate whether onboard CWIS has an existing flange Port, aft engine room # 1, 450mm pipe, flange Port, aft engine room # 2, 450mm pipe, flange Center, aft engine rm. # 1, 450mm pipe, flange Center, aft engine. rm. # 2, 450mm pipe, flange Stbd, aft engine room # 1, 450mm pipe, flange Stbd, aft engine room # 2, 450mm pipe, flange Fwd. Machinery space # 1, 450mm pipe, flange Fwd. Machinery space # 2, 450mm pipe, flange Port Bow thruster, 125mm pipe, flange Port Bow thruster, 125mm pipe, flange Ballast Pump # 1, 700mm pipe Ballast Pump # 2, 700mm pipe Screen type ( e. g., strainer, wedge wire) with mesh size Port, aft E/ R # 1 2, Seachest grating 25mm Simplex Basket Strainers with 6mm perforations. Center, aft E/ R # 1 2, Seachest grating 25mm Simplex Basket Strainers with 6mm perforations Stbd, aft E/ R # 1 2, Seachest grating 25mm Simplex Basket Strainers with 6mm perforations Fwd. Machinery space # 1 2, Seachest grating 25mm Simplex Basket Strainers with 6mm perforations Port, Stbd Bow thrusters aft E/ R # 1 2, Seachest grating 25mm Simplex Basket Strainers with 6mm perforations Ballast pumps # 1, 2 Seachest grating 25mm Total Design Specifications for Daily Maximum Water Intake Volume of each CWIS Port, aft engine rooms # 1& 2 4,362,470 gal each ( 16,512 m3/ day) Center, aft engine rooms# 1& 2 6,898,790 gal each ( 6,112 m3/ day) Stbd, aft engine room # 1 & 2 4,362,470 gal each ( 16,512 m3/ day) Fwd. Machinery spaces # 1& 2 4,628,784 gal each ( 17,520 m3/ day) Port & Stbd Bow thruster 443,856 gal each ( 1,680 m3/ day) Pump Rooms # 1& 2 15,852,000 gal each ( 60,000 m3/ day) Total Daily Water Intake Volume of each CWIS ( Set up/ Drilling) Note 1 Note 2 Port, aft engine room # 1 4,362,470 gal Port, aft engine room # 2 Center, aft engine room # 1 6,898,790 gal Center, aft engine room # 2 Stbd, aft engine room # 1 4,362,470 gal Stbd, aft engine room # 2 Fwd. Machinery space # 1, 4,628,784 gal Fwd. Machinery space # 2, Port Bow thruster, 443,856 gal Stbd Bow thruster, 443,856 gal Ballast Pump # 1, 112,285 gal Ballast Pump # 2, Design Specs for Through Screen Velocity of each CWIS ( i. e., Q= V* A) ( Set up/ Drilling) Port, aft engine room # 1 1.64 fps Port, aft engine room # 2 1.64 fps Center, aft engine room # 1 2.59 fps Center, aft engine room # 2 2.59 fps Stbd, aft engine room # 1 1.64 fps Stbd, aft engine room # 2 1.64 fps Fwd. Machinery space # 1 1.74 fps Fwd. Machinery space # 2 1.74 fps Port Bow thruster 0.164 fps Stbd Bow thruster 0.164 fps Ballast Pump # 1 5.97 fps Ballast Pump # 2 5.97 fps List of Purposes of Cooling Water Intakes ( e. g., cool crude oil, produced water, power generators, drill pipe brakes) Port # 1 2, , cooling for central cooler for port E/ R support equipment Center # 1 2, cooling for central cooler for center E/ R support equipment, atmospheric condenser, rig floor equipment Stbd # 1 2 cooling for central cooler for stbd E/ R support equipment Fwd. Machinery space # 1, # 2 cooling for central cooler for all drill floor equipment, center bow thruster and support equipment, accommodation air conditioning & refrigeration, MSD . Port Bow thruster, cooling for central cooler for port Bow thruster support equipment Stbd. Bow thruster, cooling for central cooler for stbd bow thruster support equipment List of Purposes of Non cooling Water Intakes ( e. g., fire water, hotel loads) Ballast Pump # 1, 2 Ballast water Total Volume of Water Intake for Ballasting, Duration of the Ballast intake, and the Through Screen Velocity of the Ballast intake Note 3 Total volume ballast water 7,397,600 gal ( 28,000 m3/ well) Duration of well 65 days Velocity 3.04 fps Mitigation Measures for reducing Exotic Species Migration through Ballast water The rig does not carry much ballast water from location to location. It is taken on and dumped at the same location. Mitigation Measures for reducing Impingement and Entrainment of Aquatic Organisms, as well as Bio fouling Prevention Measures Sea chest screens, simplex baskets, cathodic protection, marine growth protection system Is the Rig equipped with a Radiator Cooling System for the Main Engines? No Note 1: Only one seachest in each of the port, starboard, center and forward machinery will be open at a time.

Note 2: Ballast operations are continually changing this figure represents the estimated average daily ballast intake volume. Only one pump used for this ballast operation.

Note 3: Figures represent estimated values.