[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35995-36005]
[FR Doc No: 2017-15876]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2015-0024]

Jardon and Howard Technologies, Incorporated; Application for
Permanent Variance and Interim Order; Grant of Interim Order; Request
for Comments

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, the Occupational Safety and Health
Administration (``OSHA'' or ``the Agency'') announces the application
of Jardon and Howard Technologies, Incorporated (``JHT'' or ``the
applicant'') for a permanent variance from several provisions in OSHA's
standards that regulate commercial diving operations. Additionally, the
applicant requests an interim order based on the conditions specified
in the variance application. JHT's variance request is based on the
conditions that were specified in the alternate standards that OSHA
granted to the National Oceanic and Atmospheric (NOAA) on September 5,
2014. OSHA announces its preliminary finding to grant the permanent
variance, and also announces that it is granting the applicant's
request for an interim order. OSHA invites the public to submit
comments on whether to grant the applicant a permanent variance based
on the conditions specified in the notice.

DATES: Submit comments, information, documents in response to this
notice, and request for a hearing on or before September 1, 2017. The
interim order specified by this notice becomes effective on August 2,
2017, and shall remain in effect until it is modified or revoked, or
until OSHA publishes a decision on the permanent variance application,
whichever occurs first.

ADDRESSES: Submit comments by any of the following methods:
    1. Electronically: Submit comments and attachments electronically
at http://www.regulations.gov, which is the Federal eRulemaking portal.
Follow the instructions online for making electronic submissions.
    2. Facsimile: If submissions, including attachments, are not longer
than 10 pages, commenters may fax them to the OSHA Docket Office at
(202) 693-1648.
    3. Regular or express mail, hand delivery, or messenger (courier)
service: Submit comments, requests, and any attachments to the OSHA
Docket Office, Docket No. OSHA-2015-0024, Technical Data Center, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-2625,
Washington, DC 20210; telephone:<PHONE_NUMBER> (TTY number: (877) 889-
5627). Note that security procedures may result in significant delays
in receiving comments and other written materials by regular mail.
Contact the OSHA Docket Office for information about security
procedures concerning delivery of materials by express mail, hand
delivery, or messenger service. The hours of operation for the OSHA
Docket Office are 10:00 a.m.-2:30 p.m.
    4. Instructions: All submissions must include the Agency name and
the OSHA docket number (OSHA-2015-0024). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
http://www.regulations.gov. Therefore, the Agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    5. Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket are listed in the http://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through the Web site. All submissions, including copyrighted material,
are available for inspection at the OSHA Docket Office. Contact the
OSHA Docket Office for assistance in locating docket submissions.
    6. Copies of this Federal Register notice: Electronic copies of the
Federal Register notice are available at http://www.regulations.gov.
This Federal Register notice, as well as new releases and other
relevant information, also are available at OSHA's Web page at http://www.osha.gov.
    7. Extension of comment period: Submit requests for an extension of
the comment period on or before September 1, 2017 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW., Room N-3655, Washington, DC 20210, or by fax to (202) 693-
1644.

    8. Hearing requests: According to 29 CFR 1905.15, hearing requests
must include: (1) A short and plain statement detailing how the
variance would affect the requesting party; (2) a specification of any
statement or representation in the variance application that the
commenter denies, and a concise summary of the evidence adduced in
support of each denial; and (3) any views or arguments on any issue of
fact or law presented in the variance application.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration phone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of Application

    On September 25, 2015, Jardon and Howard Technologies,
Incorporated, (``JHT'' or ``the applicant''), submitted an application
for a permanent, multi-state variance under Section 6(d) of the
Occupational Safety and Health Act of 1970 (``OSH Act''; 29 U.S.C. 655)
and 29 CFR 1905.11 (``Variances and other relief under section 6(d)''),
from provisions of OSHA's commercial diving operations (CDO) standard
that regulate the use of inflatable flotation devices and decompression
chambers (Exhibit OSHA-2015-0024-0001, Request for Variance). JHT's
application also requested an interim order pending OSHA's decision on
the variance application. JHT's corporate offices are located at 2710
Discovery Drive, Suite 600, Orlando, FL 32826, and JHT also identified
two field office locations as places of employment involved in its
variance application: (1) NOAA/NOS Center for Coastal Fisheries and
Habitat Research, 101 Pivers Island Road, Beaufort, North Carolina,
28516; and (2) NOAA CCFHBR Laboratory, 219 Fort Johnson Road,
Charleston, South Carolina, 29412. After receiving JHT's variance
application, OSHA sent two rounds of follow-up questions to JHT, on
October 13, 2015 and June 27, 2016, to which JHT responded on November
16, 2015 and July 27, 2016, respectively (see Exhibits OSHA-2015-0024-
0002, OSHA-2015-0024-0004, OSHA-2015-0024-0003, and OSHA-2015-0024-
0005).
    Specifically, the applicant seeks a permanent variance and interim
order from the provisions of OSHA's CDO standard that require:
    (1) A buoyancy compensator to have an inflation source separate
from the breathing gas supply when used for SCUBA diving (29 CFR
1910.430(d)(3));
    (2) use of an inflatable flotation device capable of maintaining
the diver at the surface in a face-up position, having a manually
activated inflation source independent of the breathing supply, an oral
inflation device, and an exhaust valve (29 CFR 1910.430(d)(4));
    (3) the employer to instruct the diver to remain awake and in the
vicinity of the decompression chamber which is at the dive location for
at least one hour after the dive (including decompression or treatment
as appropriate) for any dive outside the no-decompression limits,
deeper than 100 feet of sea water (fsw), or using mixed gas as a
breathing mixture (29 CFR 1910.423(b)(2));
    (4) the employer to make available at the dive location a
decompression chamber capable of recompressing the diver at the surface
to a minimum of 165 fsw (6 ATA) (29 CFR 1910.423(c)(1)); \1\
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    \1\ The full text of 29 CFR 1910.423(c)(1)(i)-(iii) reads: ``A
decompression chamber capable of recompressing the diver at the
surface to a minimum of 165 fsw (6 ATA) shall be available at the
dive location for: (i) Surface-supplied air diving to depths deeper
than 100 fsw and shallower than 220 fsw; (ii) Mixed gas diving
shallower than 300 fsw; (iii) Diving outside the no-decompression
limits shallower than 300 fsw.''
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    (5) the employer to make available within 5 minutes of the dive
location a dual-lock, multiplace decompression chamber (29 CFR
1910.423(c)(3)); and
    (6) that self-contained underwater breathing apparatus (SCUBA)
diving not be conducted at depths deeper than 100 fsw or outside the
no-decompression limits unless a decompression chamber is ready for use
(29 CFR 1910.424(b)(2)).
    JHT is a contractor for the U.S. Department of Commerce, National
Oceanic and Atmospheric Administration (NOAA), a federal government
agency that conducts and promotes undersea research using a variety of
modes, including diving operations. On September 5, 2014, OSHA granted
NOAA alternate standards \2\ regulating its use of inflatable flotation
devices and decompression chambers during NOAA diving operations
(Exhibit OSHA-2015-0024-0003, OSHA's Comments and Decisions to NOAA's
Request for an Alternate Standard on Diving) (``NOAA Alternate Diving
Standards''). To account for the technological advances and design
improvements that have been made to buoyancy compensatory devices
(BCDs) since OSHA first published its CDO standard in 1977 (see 42 FR
37662 (July 22, 1977)), the NOAA Alternate Diving Standards permit NOAA
to use modern BCDs during diving operations that deviate from the
configuration requirements in OSHA's CDO standard, but provide equal or
greater safeguards to the diver. The NOAA Alternate Diving Standards
also provide NOAA with modified requirements regarding the use of
decompression chambers, including expanding the depth limit for SCUBA
dives within the no-decompression limits \3\ (from 100 to 130 feet of
sea water (fsw)), and modifying decompression chamber availability
requirements for certain no-decompression dives up to 130 fsw in depth.
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    \2\ An alternate standard is the federal agency equivalent to a
variance, and federal agency heads may seek and obtain alternate
standards from OSHA pursuant to 29 CFR 1960.17.
    \3\ The definitions provided in Subpart T, 29 CFR 1910.402,
define ``no-decompression limits'' as ``the depth-time limits of the
`no-decompression limits and repetitive dive group designation table
for no-decompression air dives', U.S. Navy Diving Manual, or
equivalent limits which the employer can demonstrate to be equally
effective.''
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    JHT's divers who conduct diving operations for NOAA typically dive
from NOAA-operated ``uninspected vessels'' in U.S. navigable waters;
such diving operations fall under OSHA's jurisdiction.\4\ When
conducting dives for NOAA, JHT divers are obliged to follow all of the
requirements of the NOAA Diving Program (NDP), which include the NOAA
Alternate Diving Standards. JHT therefore seeks the interim order and
permanent variance from the provisions of OSHA's CDO standard based on
the conditions that apply to NOAA divers under the NOAA Alternate
Diving Standards, thus permitting JHT's divers to dive under the same
standards as their NOAA-employed colleagues.
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    \4\ For more information on OSHA's enforcement authority over
uninspected vessels on U.S. navigable waters, see OSHA Directive
Number: CPL-02-01-047, ``OSHA Authority over Vessels and Facilities
on or Adjacent to U.S. Navigable Waters and the Outer Continental
Shelf (OCS)'' [Dated: 02/22/2010], available at: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=4254.
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    The applicant contends that the proposed variance conditions
outlined in its application provide its workers with a place of
employment that is at least as safe and healthful as they would obtain
under the existing provisions of OSHA's CDO standard. The applicant
certifies that it provided affected

workers with a copy of the variance application. In addition, the
applicant informed its workers and their representatives of their right
to petition the Assistant Secretary of Labor for Occupational Safety
and Health for a hearing on the variance application. The applicant
also certified that it is not contesting any citations involving the
standards that are the subject of this application.

II. NOAA's Alternate Diving Standards and JHT's Variance Application

A. Background

    In June 2011, NOAA submitted an application to OSHA proposing a
total of 12 alternate standards to 29 CFR 1910, Subpart T, and included
with its application extensive introductory, background, and
explanatory information in support of the application (see Exhibit
OSHA-2015-0024-0006, Proposed Alternate Diving Standards for the
National Oceanic and Atmospheric Administration). After fully
considering NOAA's application and its responses to OSHA's follow up
questions (see Exhibit OSHA-2015-0024-0007, Responses from the NOAA
Diving Program to OSHA Regarding Requested Alternate Standards for
Commercial Diving Operations), OSHA decided to grant some, but not all,
of the alternate standards that NOAA proposed (see Exhibit OSHA-2015-
0024-0008). JHT now seeks an interim order and permanent variance based
on six of the alternate standards that OSHA granted to NOAA in the NOAA
Alternate Diving Standards. Because JHT's application proposes to adopt
the same conditions under which OSHA granted the alternate standards to
NOAA, JHT's application included as an attachment the introductory,
background, and explanatory material that NOAA previously submitted to
OSHA with its initial application.
    NOAA explained in its application materials that it conducts dives
under two major programs: The NOAA Diving Program (NDP) and the
National Undersea Research Program (NURP). The NDP primarily supports
intramural (within the agency) research programs conducted by personnel
within NOAA's major line offices, while NURP primarily supports
extramural (outside the agency) research programs conducted by
scientists from various academic and marine institutions. The NDP is
responsible for overseeing all NOAA and contractor (including JHT)
diving personnel, equipment, and activities, and ensuring that dives
performed by NOAA and its contractor divers are completed safely and
efficiently. The NDP, the NOAA Diving Control and Safety Board, and the
NOAA Diving Medical Review Board all work together to ensure that
qualified personnel and certified systems are available to safely meet
NOAA's undersea research objectives.
    NOAA's application also explained that it provides a robust
training program to NDP divers, including contractor divers. NOAA
stated that the primary training program used to prepare NOAA and
contractor divers to perform work is NOAA's three-week, 140-hour
``Working Diver'' course, which trains divers to perform a wide range
of skills utilizing a variety of power and hand tools and specialized
equipment. All NOAA divers and contractors are also required to: (1)
Have annual refresher training in oxygen administration (academic and
practical components); (2) stay current in CPR/AED and First Aid
training; (3) maintain proficiency in diving by making at least three
dives per quarter; (4) complete an annual swim test; (5) have their
life support gear serviced annually by a certified technician; (6)
complete an annual skills test to demonstrate their ability to safely
operate underwater; and (7) complete annual rescue drills to
demonstrate their ability to surface, extricate, treat and evacuate the
victim of a diving accident.
    NOAA's application further stated that it has developed many
advances in diving equipment and procedures that are now widely
recognized and accepted as industry best practices. NOAA publishes many
of these advances in the ``NOAA Diving Manual: Diving for Science and
Technology,'' which serves as a reference manual for all NDP divers.
NOAA also maintains two additional manuals (the ``NOAA Scientific
Diving Standards and Safety Manual'' and the ``NOAA Working Diving
Standards and Safety Manual'') that provide in-depth operational
guidance for all dives, and include the standards, policies,
regulations, requirements, and responsibilities for all aspects of
NOAA's diving operations.
    Additionally, NOAA stated that OSHA's CDO standard, which was first
published in 1977, does not account for many of the advancements that
have been made in diving technology and safety. For that reason, NOAA
sought alternate standards that would permit the NDP to conduct diving
operations using equipment and procedures that reflected modern diving
advancements. NOAA also stated that OSHA's regulations are not always
consistent with other related federal diving regulations, such as 46
CFR 197, Subpart B, which provides safety and health standards for
commercial diving operations conducted from vessels and facilities
under the jurisdiction of the U.S. Coast Guard.
    As a NOAA contractor, JHT asserts that its divers are required to
strictly follow the requirements of the NDP, which include following
the conditions of the NOAA Alternate Diving Standards. But, even though
NOAA-employed and JHT-employed divers work side-by-side during NDP
operations, contractor divers (such as those employed by JHT) are not
authorized to dive under the NOAA Alternate Diving Standards. JHT
states that its divers undergo exactly the same training as NOAA
employees who are also part of the NDP, and that there are no
differences between NOAA and JHT divers regarding medical clearance
procedures and standards, training materials, equipment used, equipment
maintenance, and diving procedures used (see Ex. OSHA-2015-0024-0003,
p. 1). JHT stated that the majority of the dives that JHT performs
under the NDP are ``scientific dives'' that are exempted from OSHA's
CDO standard,\5\ but JHT divers also assist NOAA employees with diving
operations that are not exempt under OSHA's CDO standard. Accordingly,
when JHT conducts dives for NOAA under the NDP that would be subject to
OSHA's CDO standard, JHT seeks permission from OSHA to dive under the
same standards regulating the use of inflatable flotation devices and
decompression changes that apply to NOAA-employed NDP divers, pursuant
to the NOAA Alternate Diving Standards.
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    \5\ Section 1910.401(a)(2)(iv) of the CDO standard provides the
exemption for scientific diving from the CDO standard's coverage,
and Appendix B to the CDO standard provides guidelines for
identifying the scientific diving programs that are exempt.
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B. Requested Variance From Paragraphs (d)(3) and (d)(4) of 29 CFR
1910.430, Requirements for Inflatable Flotation Devices

    OSHA's standards regulating the buoyancy control of inflatable
flotation devices include requirements that: (1) When used for SCUBA
diving, a buoyancy compensator shall have an inflation source separate
from the breathing gas supply (29 CFR 1910.430(d)(3)); and (2) an
inflatable flotation device capable of maintaining the diver at the
surface in a face-up position, having a manually activated inflation
source independent of the breathing supply, an oral inflation device,
and an exhaust valve shall be used for SCUBA diving (29 CFR
1910.430(d)(4)).

    Following the terms of the NOAA Alternate Diving Standards, JHT's
variance application seeks permission to use modern buoyancy
compensator devices (BCDs) that deviate from the requirements in
1910.430(d)(3) and (d)(4) that such devices have an inflation source
that is ``separate from'' or ``independent of'' the diver's breathing
gas. NOAA's application for the alternate standards explained that the
overwhelming majority of commercial-off-the-shelf (COTS) BCDs are
designed to use the diver's breathing gas for inflation, making it
difficult to comply with OSHA's requirement for a BCD to have an
independent inflation source. According to NOAA, older systems that
utilize separate, non-breathing gas inflation sources--particularly,
carbon-dioxide cartridges--pose potential safety problems for the
diver, including potential cartridge failure, and accidental
activation, leading to an unexpected and potentially dangerous over-
inflation of the BCD, which could cause a rapid and uncontrolled ascent
of the diver to the surface. NOAA's application stated that industry
recognition of these inherent safety problems prompted manufacturers to
discontinue production of systems relying on such inflation sources.
NOAA also explained that using a diver's emergency air supply to
inflate the BCD is potentially problematic, as connecting the BCD to an
auxiliary cylinder would impede a diver who is ``ditching'' components
of a SCUBA unit during an emergency, and would also create additional
points of potential equipment failure and entanglement. JHT echoed
NOAA's concerns regarding the use of BCDs that are inflated by a source
other than the diver's breathing gas (see Ex. OSHA-2015-0024-0003, p.
9).
    The training that NOAA provides to its divers and contractors,
including JHT, mitigates the risk of using breathing gas to inflate
BCDs. NDP divers are trained to continually monitor their gas supplies
and return to the surface with no less than 500 psi in their SCUBA
cylinders, and NOAA stated that this practice, which has been used for
more than 30 years, has proven to be an effective method for managing a
diver's breathing gas. NDP divers are also trained in techniques to
manually inflate their BCDs, both underwater and at the surface, to
control their buoyancy. NOAA also explained that the amount of gas
needed to inflate a BCD is minimal compared to the amount of breathing
gas that is available in a standard SCUBA cylinder, and that most BCDs
can be fully inflated with a volume of gas equivalent to that consumed
in three or fewer breaths, and therefore asserted that taking such
small amounts of gas from the SCUBA cylinder would have minimal effect
on the duration of a dive.
    Under the alternate conditions that OSHA granted NOAA in the NOAA
Alternate Diving Standards, which JHT adopts as the proposed conditions
for the variance, NDP divers may use BCDs that are inflated by the
breathing gas supply so long as all divers carry an independent reserve
cylinder of breathing gas with a separate regulator, which allows
divers to orally inflate their BCDs using gas from their reserve gas
supplies even if their primary breathing gas supply is depleted. When
granting the NOAA Alternate Diving Standards, OSHA explained that this
requirement is consistent with 29 CFR 1910.424(c)(4), which requires
SCUBA divers to carry a reserve breathing-gas supply. As OSHA stated in
the preamble to the CDO standard final rule (42 FR 37650, 37633), ``[a
reserve] supply is essential to the safety of the SCUBA diver,'' and
employers must take precautions to ``assure that the air reserve will
not be depleted inadvertently during the dive.'' OSHA ultimately
concluded that NOAA's proposed alternate standard provides equivalent
safety protection to divers as 1910.430(d)(3) so long as the diver
carries a reserve breathing gas supply, does not connect the reserve
breathing gas to the BCD's inflation source, and uses the BCD in
accordance with the manufacturer's instructions.
    Further, OSHA noted in the NOAA Alternate Diving Standards that
1910.430(d)(4)'s requirement that SCUBA divers use a BCD with a
manually activated inflation source (e.g., via a carbon-dioxide
cartridge) in addition to an oral inflation device is intended to allow
the diver to quickly inflate the BCD in an emergency, but technological
improvements in manual BCD power inflators now allow for rapid
inflation of BCDs with breathing gas, but with less safety risk (e.g.,
over-inflation) than using carbon-dioxide cartridges. Using these
manual BCD power inflators to inflate a BCD with breathing gas
therefore provides protection to a diver that is equivalent to the
standard, and obviates the need for 1910.430(d)(4)'s requirement that
the BCD's inflation source be independent of the breathing supply. In
addition, OSHA stated that NOAA's policy that, except when line-tended,
divers never dive alone and always have topside support, expedites the
rescue of divers who must make emergency ascents to the surface,
thereby reducing their risk of drowning should an inflatable flotation
device malfunction.
    Additionally, JHT's proposed variance conditions would follow the
NOAA Alternate Diving Standards by replacing 1910.430(d)(4)'s
requirement that BCDs used for SCUBA dives be capable of maintaining
the diver at the surface in a ``face-up position'' with a requirement
that the BCD be capable of maintaining the diver at the surface in a
``positively buoyant state.'' NOAA's application materials explained
that the majority of COTS BCDs available today are not designed to
maintain unconscious divers in a face-up position on the surface, as
systems capable of meeting that requirement have inherent safety-
related problems that lead most manufacturers to abandon them in favor
of more modern systems.
    Specifically, NOAA asserted that the only BCD able to maintain a
diver in a face-up position at the surface was the ``horse-collar''
style BCD, which has been widely replaced by jacket-style BCDs (also
known as stabilizing, or stab, jackets) or back-mounted systems, both
of which have greater operational and safety features compared to the
older style. NOAA explained that newer BCDs have more lift, fewer
straps (reducing entanglement hazards, particularly when ditching the
BCD in an emergency, or when used in conjunction with a weight
harness), require fewer steps to don, will not choke divers when fully
inflated on the surface, and most significantly, do not impede
operation of chest-mounted drysuit inflation valves. Additionally, NOAA
explained that the inability of stab-jacket or back-mounted BCDs to
maintain a diver in a face-up position is off-set by NOAA's requirement
that divers always dive in buddy pairs (or be line-tended), and receive
training in the proper technique for inflating their buddy's BCD while
keeping their buddy's head face-up during rescues. Accordingly, NOAA
stated that the chance of a stricken diver drowning while wearing a BCD
that does not provide for face-up flotation is very remote. JHT added
that horse-collar BCDs were not originally designed for emergency
buoyancy ascents, and many are thus not equipped with the over-pressure
relief valves that are essential for safe emergency ascents.
    When granting the NOAA Alternate Diving Standards, OSHA noted that
the preamble to the CDO final rule explained that ``[t]he provision for
an inflatable flotation device for SCUBA diving [was] given design
specifications because an improperly designed device can be a greater
safety hazard than aid'' (42 FR 37650, 37666). BCDs were not

commercially available when the CDO standard was published, and OSHA
therefore articulated minimum design standards for inflatable flotation
devices in the final rule. OSHA agreed in the NOAA Alternate Diving
Standards that the flotation design of contemporary BCDs is superior to
the equipment that was in use when OSHA published the CDO standard in
1977, and explained that modern BCDs are equipped to maintain a diver
at the surface in a positively buoyant state, even if they do not
``prop up'' the diver's head. OSHA thus granted NOAA's proposed
alternative standard on the condition that NOAA continues its policy of
requiring that SCUBA divers not dive alone unless they are line-tended,
and providing topside support to those divers.
    OSHA determined that those conditions would provide NOAA's divers
with protection equivalent to the CDO standard, and JHT's proposed
variance includes the very same conditions under which OSHA approved
the NOAA's Alternate Diving Standards for NOAA-employed NDP divers. As
stated above, there are no differences in the training requirements,
medical clearance procedures and standards, equipment use and
maintenance requirements, or diving procedures that apply to NOAA-
employed and JHT-employed divers who conduct diving operations for the
NDP. Additionally, OSHA believes that diver safety is best promoted
where diving safety rules are clear and consistently applicable to all
divers at a worksite. Accordingly, OSHA accepts JHT's proposal to adopt
the conditions from the NOAA Alternate Diving Standards as the basis
for its requested variance from the inflatable flotation device
requirements in 1910.430(d)(3) and (d)(4), and has preliminarily
decided to grant the interim order and permanent variance to JHT on
those same conditions.

C. Requested Variance From Paragraphs (b)(2), (c)(1), (c)(3) of 29 CFR
1910.423, and (b)(2) of 29 CFR 1910.424, Requirements for Decompression
Chambers.\6\
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    \6\ A decompression chamber is ``a pressure vessel for human
occupancy such as a surface decompression chamber, closed bell, or
deep diving system used to decompress divers and to treat
decompression sickness'' (29 CFR 1910.402).
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    OSHA's standards regulating the availability and use of
decompression chambers require that: (1) For any dive outside the no-
decompression limits, deeper than 100 fsw, or using mixed gas as a
breathing mixture, the employer shall instruct the diver to remain
awake and in the vicinity of the decompression chamber which is at the
dive location for at least one hour after the dive (including
decompression or treatment as appropriate) (1910.423(b)(2)); (2) for
mixed gas diving shallower than 300 fsw, or diving outside the no-
decompression limits shallower than 300 fsw, a decompression chamber
capable of recompressing the diver at the surface to a minimum of 165
fsw (6 ATA) shall be available at the dive location, and must be dual-
lock, multiplace, and accessible within 5 minutes of the dive location
(1910.423(c)(1) and (c)(3)(i)-(iii)); and (3) SCUBA dives shall not be
conducted at depths deeper than 100 fsw or outside the no-decompression
limits unless a decompression chamber is ready for use
(1910.424(b)(2)).
    Adopting the conditions of the NOAA Alternate Diving Standards,
JHT's application proposes conditions that would allow it deviate from
these decompression chamber availability and capability requirements in
OSHA's CDO standard. As OSHA explained when it granted the NOAA
Alternate Diving Standards, the purpose of having a decompression
chamber available and ready for use at a dive site is to treat
decompression sickness (DCS) and arterial gas embolism (AGE). DCS may
occur from breathing air or mixed gases at diving depths and durations
that require decompression, while AGE may result from over-pressurizing
the lungs, usually following a rapid ascent to the surface during a
dive without proper exhalation. In the event that DCS or AGE develops,
a decompression chamber, oxygen or treatment gas mixtures, and
treatment tables and instructions must be readily available to treat
these conditions effectively. Decompression chambers provide the most
effective therapy--recompression--for DCS and AGE.
    First, JHT's proposed variance would adopt the conditions of the
NOAA Alternate Diving Standards that permit NOAA to deviate from the
requirement of 1910.423(b)(2) that the employer instruct all divers who
dive deeper than 100 fsw remain awake and in the vicinity of a
decompression chamber for one hour after the dive, and the requirement
of 1910.424(b)(2) that SCUBA diving not be conducted at depths deeper
than 100 fsw or outside the no-decompression limits unless a
decompression chamber is ``ready for use.'' In other words, Sections
1910.423(b)(2) and 1910.424(b)(2) require that any diver who conducts a
dive deeper than 100 fsw or outside the no-decompression limits to
remain alert and near a decompression chamber for at least one hour to
ensure immediate treatment should DCS or AGE develop. Addressing the
100 fsw limit in the preamble to the CDO rule, OSHA stated:

    By adding a depth limit to the decompression chamber
requirement, the standard sets a specified depth at which all diving
operations will require a chamber, eliminating the safety hazard
inherent in operations which are planned below that depth . . . .
OSHA believes that this provision will result in recompression
capability being available for the great majority of diving
situations where the probability of its being needed is greatest.

42 FR at 37662.
    In its application, NOAA sought permission to conduct SCUBA dives
within the no-decompression limit up to 130 fsw (rather than 100 fsw)
without triggering the decompression chamber requirements in
1910.423(b)(2) and 1910.424(b)(2). In support, NOAA cited statistics
published by the U.S. Navy (USN) indicating that no-decompression dives
to 130 fsw actually pose a lower risk of DCS to divers than no-
decompression dives to 100 fsw, and also cited the extremely low DCS
incident rate that NOAA has observed in no-decompression SCUBA dives
that it has conducted between 101 and 130 fsw since 2000.
    When granting NOAA alternate standards to 1910.423(b)(2) and
1910.424(b)(2), OSHA explained that the CDO standard sets the 100 fsw
limit based on the increased risk of developing DCS and AGE on dives
deeper than 100 fsw. However, OSHA explained that the Agency amended
the CDO standard in 2004 to permit employers of recreational diving
instructors and diving guides to comply with an alternative set of
decompression chamber requirements (see 69 FR 7351 (February 17,
2004)).\7\ Under the conditions articulated in Appendix C to Subpart T,
eligible employers are not required to provide a decompression chamber
at the dive site when engaged in SCUBA diving to 130 fsw while
breathing a nitrox gas mixture within the no-decompression limits.
---------------------------------------------------------------------------

    \7\ Appendix C incorporated into the CDO standard essentially
the same terms as those used in a variance that OSHA granted to
Dixie Divers, Inc., a diving school that employed several
recreational diving instructors, in 1999 (see 64 FR 71242, December
20, 1999).
---------------------------------------------------------------------------

    OSHA explained in the NOAA Alternate Diving Standards that it
created this exemption for recreational diving instructors and diving
guides because the Agency determined that the elevated levels of oxygen
in nitrox breathing-gas mixtures reduced the incidence of DCS compared
to breathing air at the same depths, and therefore

found that the risk of DCS was minimal. This determination justified
OSHA's use in Appendix C of the equivalent-air-depth (EAD) formula from
NOAA's 2001 Diving Manual to calculate the no-decompression limits that
should apply to a dive depending on the nitrogen partial pressures in
the gas. As explained in the preamble to the Appendix C final rule (69
Fed Reg. 7351, 7356), the EAD formula assumes that equivalent nitrogen
partial pressures and dive durations will result in similar DCS risk to
dives performed with air, and OSHA concluded that the ``EAD formula can
accurately estimate the DCS risk associated with nitrox breathing-gas
mixtures based on equivalent nitrogen partial pressures and dive
durations used in air diving.''
    After considering the statistics and information regarding NDP
operations that NOAA submitted, OSHA concluded that NOAA's proposed
alternate standards would provide equivalent protection to the CDO
standard when NDP divers use air or nitrox breathing-gas mixtures with
SCUBA, so long as NOAA complies with the no-decompression provisions of
Appendix C of 29 CFR 1910, Subpart T (i.e., Condition 5, ``Use of No-
Decompression Limits'').\8\ Also, when using nitrox breathing-gas
mixtures with SCUBA at depths up to 130 fsw, NOAA must ensure that the
partial pressure of oxygen does not exceed 1.40 ATA or 40 percent by
volume (whichever exposes the diver to less oxygen),\9\ in keeping with
the requirements of Appendix C. JHT's proposed variance would adopt
these same conditions under which OSHA granted the alternate standards
to 1910.423(b)(2) and 1910.424(b)(2) to NOAA for NDP dives in which JHT
divers participate. OSHA believes that in order to maximize diving
safety, it is imperative that, when diving for the NDP, the diving
practices of JHT-employed divers be identical to those of NOAA-employed
divers.
---------------------------------------------------------------------------

    \8\ Condition 5 of Appendix C requires:
    (a) For diving conducted while using nitrox breathing-gas
mixtures, the employer must ensure that each diver remains within
the no-decompression limits specified for single and repetitive air
diving and published in the 2001 NOAA Diving Manual or the report
entitled ``Development and Validation of No-Stop Decompression
Procedures for Recreational Diving: The DSAT Recreational Dive
Planner,'' published in 1994 by Hamilton Research Ltd. (known
commonly as the ``1994 DSAT No-Decompression Tables'').
    (b) An employer may permit a diver to use a dive-decompression
computer designed to regulate decompression when the dive-
decompression computer uses the no-decompression limits specified in
paragraph 5(a) of this appendix, and provides output that reliably
represents those limits.
    \9\ As OSHA explained in the NOAA Alternate Diving Standards, a
key purpose of OSHA's diving standards is to prevent oxygen toxicity
(hypoxia), and the maximum acceptable partial pressure of oxygen
when SCUBA diving is 1.40 ATA or 40 percent by volume, whichever
exposes the diver to less oxygen. ATA, as used here, is the partial
pressure of a constituent gas in the total pressure of a breathing
gas.
---------------------------------------------------------------------------

    Additionally, JHT's application would adopt the conditions of the
NOAA Alternate Diving Standards that permit NOAA to deviate from the
decompression chamber availability and capability requirements in
1910.423(c)(1) (that employers have a 6 ATA chamber at the dive
location) and 1910.423(c)(3) (that the chamber be dual-lock,
multiplace, and located within five minutes of the dive location). In
its original application to the Agency, NOAA proposed alternate
standards that would have permitted it to use a 2.8 ATA, mono-lock
chamber available within two (2) hours of the dive location for all
working dives conducted deeper than 130 fsw or outside the no-
decompression limits. NOAA explained that complying with 1910.423(c)(1)
and (c)(3) requires employers to use a large enough boat to carry and
transport a large and powerful decompression chamber to the dive site,
but most NDP dives are conducted from small boats, which are launched
from larger ships or land-based facilities. Accordingly, NOAA sought
permission to use light-weight, portable decompression systems, which
it referred to as ``hyperlite chambers,'' to transport injured divers
from dive sites to larger chambers located elsewhere. Additionally,
NOAA sought to make the hyperlite chamber available within two hours,
rather than within five minutes, of the dive location for dives
conducted deeper than 130 fsw or outside the no-decompression limits.
    OSHA did not grant NOAA the alternate standards based on these
proposed conditions, but rather granted revised alternate standards in
order to ensure that NOAA divers would receive equivalent protection to
the CDO standard. Regarding the chamber capability requirements, OSHA
found that mono-lock chambers provide limited hyperbaric treatment
options (for example, administration of oxygen) to a diver, and
explained that the preamble to the original CDO final rule discusses
and justifies Subpart T's capability requirements for decompression
chambers, including the requirements that the chamber have 6 ATA
capability and be dual-lock (i.e., have two compartments) and
multiplace (i.e., have a main lock large enough to accommodate and
decompress two individuals) (see 42 FR 37650, 37661-63). Accordingly,
OSHA stated that mono-lock chambers may be an option for transporting
divers to bigger chambers, but it does not provide divers with
protection that is equivalent to the CDO standard's requirements, and
OSHA therefore did not approve NOAA's proposed chamber-capability
alternative.
    Regarding the proposed chamber-availability alternative, OSHA noted
that the preamble to the CDO final rule explained that having the
decompression chamber near the dive site was originally considered
necessary ``because the surface decompression tables are commonly
designed to be used with equipment that meets this criterion'' (42 FR
37650, 37662). However, OSHA reexamined 1910.423(c)(3)'s five-minute
availability requirement when it developed Appendix C to Subpart T. In
Appendix C, OSHA found that, for no-decompression dives at 130 fsw or
less, a four-hour travel delay to a 6-ATA decompression chamber is
acceptable when the employer meets specified conditions, including:
verifying before starting diving operations the availability of a
treatment facility, qualified healthcare professionals, and a rescue
service; ensuring that suitable transportation to the decompression
chamber is available at the dive site during diving operations;
ensuring at least two attendants qualified in first-aid and
administering oxygen treatment are available for treatment during
diving operations; and that these attendants administer medical-grade
oxygen to the injured diver during transportation to the treatment
facility. OSHA came to this conclusion because, as explained in the
preamble to the Appendix C final rule, ``a four-hour delay is unlikely
to impair treatment outcomes for [DCS], and that [AGE] is rare among
recreational divers and can be prevented with proper training and
experience'' (69 FR 7351, 7359-60).
    After considering the information that NOAA submitted regarding the
NDP's diving operations, OSHA determined that, for no-decompression
dives using air or nitrox that are 130 fsw or less, a four-hour travel
delay to a 6 ATA chamber provides NDP divers with protection equivalent
to the CDO standard, so long as NOAA meets the medical-treatment
provisions of Appendix C to the CDO rule (i.e., Condition 8, ``Treating
Diving-Related Medical Emergencies''). OSHA thus granted the NOAA
Alternate Diving Standards under these conditions, and JHT now seeks to
conduct NDP dives according to the same conditions.
    Based on its technical review of the JHT's application, the NOAA
Alternate Diving Standards, and related

supporting material, OSHA preliminarily finds that the proposed
conditions would also provide JHT divers with protection equivalent to
the CDO standard; there are no differences in the training
requirements, medical clearance procedures and standards, equipment use
and maintenance requirements, or diving procedures that apply to NOAA-
employed and JHT-employed divers who dive under the NDP, and diver
safety is best promoted where diving safety rules are clear and
consistently applicable to all divers at a worksite. In fact, OSHA
believes that in order to maximize diving safety, it is imperative
that, when diving for the NDP, the diving practices of JHT-employed
divers be identical to those of NOAA-employed divers. Accordingly, OSHA
has preliminarily decided to grant the interim order and permanent
variance to JHT on those same conditions.

D. Multi-State Variance

    As previously stated in this notice, JHT seeks a permanent variance
from several provisions of OSHA's CDO standard in order to carry out
NDP diving projects conducted from NOAA vessels in accordance with the
conditions of the NOAA Alternate Diving Standards. JHT's land-based
operations, which are responsible for managing and administering these
diving projects, are located at: (1) NOAA CCEHBR Laboratory, 219 Fort
Johnson Road, Charleston, South Carolina, 29412; and (2) NOAA/NOS
Center for Coastal Fisheries and Habitat Research, 101 Pivers Island
Road, Beaufort, North Carolina, 28516. JHT conducts diving operations
with NOAA with essentially no geographical limitations, and have
conducted diving operations in various navigable waters within OSHA's
geographical authority, including the navigable waters of the Virginia,
North Carolina, South Carolina, Georgia and Florida, the Florida Keys,
the Gulf of Mexico, the Caribbean (e.g., U.S. Virgin Islands and Puerto
Rico) and the Pacific (e.g., Hawaii, Guam, Palau, Marianas and American
Samoa).
    Twenty-eight state safety and health plans have been approved by
OSHA under section 18 of the OSH Act.\10\ The scope and application
section of the CDO standard, 29 CFR 1910.401, explains that OSHA has
jurisdiction over commercial diving operations when the dive location
is within OSHA's geographical authority, and when such operations are
not covered by the U.S. Coast Guard. As explained in OSHA's Directive
regarding its enforcement of Subpart T (``CDO Directive''),\11\ OSHA's
CDO standard covers private-sector employers in federal enforcement
states, and employers who dive in association with maritime standards
(i.e., shipyard employment, longshoring, and marine terminals) when
these operations are not covered by a State with an OSHA-approved State
Plan. States with approved State Plans enforce the diving standard: (1)
When commercial diving operations are being conducted by private-sector
employees not engaged in shipyard employment or marine terminal
activities (e.g., equipment repair, sewer maintenance, or
construction); (2) in maritime operations (i.e., shipyard employment
and marine terminals) as provided by their plans in California,
Minnesota, Vermont, and Washington; and (3) with regard to state and
local government employees. The location of the dive determines which
entity has authority over the dive conditions.
---------------------------------------------------------------------------

    \10\ Six State Plans (Connecticut, Illinois, Maine, New Jersey,
New York, and the Virgin Islands) limit their occupational safety
and health authority to state and local employers only. State Plans
that exercise their occupational safety and health authority over
both public- and private-sector employers are: Alaska, Arizona,
California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan,
Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico,
South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and
Wyoming.
    \11\ See OSHA Directive Number: CPL-02-00-151, ``29 CFR part
1910, subpart T--Commercial Diving Operations'' [Dated: 06/13/2011],
available at: http://www.osha.gov/OshDoc/Directive_pdf/CPL_02-00-151.pdf].
---------------------------------------------------------------------------

    Under 29 CFR 1902.8(c), an employer may apply to Federal OSHA for a
variance where a state standard is identical to a federal standard
addressed to the same hazard, and the variance would be applicable to
employment or places of employment in more than one state, including at
least one state with an approved plan. Of the twenty-eight State Plans,
only California, Michigan, Oregon, and Washington have promulgated
their own state diving standards; Arizona has adopted 29 CFR 1910,
subpart T with the exception of one provision that is not germane to
this application,\12\ and all other State Plans have fully adopted 29
CFR part 1910, subpart T by reference. Both Michigan's and Oregon's
diving standards also adopt 29 CFR part 1910, subpart T by reference,
although Oregon's diving standards include additional State-specific
rules.\13\ Washington's diving standards do not adopt 29 CFR part 1910,
subpart T by reference, but include rules that are identical to each of
the federal requirements at issue in JHT's application (see Washington
Administrative Code, Chapter 296-37, Sec. Sec.  510-595). California's
diving operations standards contain two rules that are substantively
identical to two of the OSHA standards at issue in JHT's application
(see California Code of Regulations, Title 8, Subchapter 7, Group 26
Sec. Sec.  6062(b)(1) and (3)((A)-(C)) (substantively identical to 29
CFR 1910.423(c)(1) and (c)(3)). Exhibit OSHA-2015-0024-0009 provides a
side-by-side comparison of the Washington and California standards that
are identical in substance and requirements to the Federal OSHA
standards at issue in this variance application.
---------------------------------------------------------------------------

    \12\ See 20 A.A.C. 5 Sec.  R20-5-602.01 (adopting OSHA's CDO
Standard with the exception of 29 CFR 1910.401(a)(2)(ii)), available
at: http://apps.azsos.gov/public_services/Title_20/20-05.pdf.
    \13\ See Michigan's Occupational Health Standards, Part 504,
Sec.  R 325.50303, ``Adoption by reference of federal standard,''
available at: http://www.michigan.gov/documents/lara/lara_miosha_OH_504_417497_7.pdf; Oregon Admin. Rule<PHONE_NUMBER>,
``Adoption by Reference,'' available at: http://osha.oregon.gov/OSHARules/div2/div2T.pdf#page=7.
---------------------------------------------------------------------------

    JHT certified in its application that it has not filed an
application for a permanent variance on the same material facts with a
State Plan program. JHT's variance application fits the parameters of
29 CFR 1902.8, and Federal OSHA's action on this application will be
deemed prospectively an authoritative interpretation of JHT's
compliance obligations regarding the applicable state standards in the
places of employment covered by the application. As part of the
permanent variance process, OSHA's Directorate of Cooperative and State
Programs will notify all State Plans that are potentially affected by
JHT's variance application, and the states will have the opportunity to
comment.

III. Description of the Conditions Specified by the Interim Order and
the Application for a Permanent Variance

    This section describes the alternative means of compliance with the
provisions of 29 CFR 1910.430(d)(3), 1910.430(d)(4), 1910.423(b)(2),
1910.423(c)(1), 1910.423(c)(3), and 1910.424(b)(2), and provides
additional detail regarding the proposed conditions that form the basis
of JHT's application for an interim order and permanent variance. As
indicated earlier in this notice, JHT is seeks the interim order and
permanent variance based on proposed conditions derived from the
conditions of the alternate standards that OSHA granted to NOAA on
September 5, 2014 (Exhibit OSHA-2015-0024-0003, OSHA's Comments and
Decisions to NOAA's Request for an

Alternate Standard on Diving)(``NOAA Alternate Diving Standards'').
After reviewing all available information, including JHT's variance
application, NOAA's application for the alternate diving standards, and
OSHA's analysis and subsequent granting of the NOAA Alternate Diving
Standards, OSHA has added additional conditions to this proposal from
those adopted from the NOAA Alternate Diving Standard, which the Agency
believes are necessary to ensure the safety of JHT's divers who conduct
dives under the NOAA Diving Program (NDP). The below-described
conditions form the basis of the interim order and the requested
permanent variance.\14\
---------------------------------------------------------------------------

    \14\ In these conditions, the present tense form of the verb
(e.g., ``must'') pertains to the interim order, while the future
conditional form of the verb (e.g., ``would'') pertains to the
application for a permanent variance (designated as ``permanent
variance'').
---------------------------------------------------------------------------

Proposed Condition A: Scope

    The interim order/proposed permanent variance will/would apply only
to JHT commercial diving operations that are conducted for NOAA as part
of the NDP from a NOAA vessel. Additionally, coverage is/would be
limited to the work situations specified under the ``Scope and
application'' section of Subpart T, Commercial Diving Operations
(1910.401(a)), and will/would not apply to commercial diving operations
that are already exempted under 1910.401(a)(2).\15\ Accordingly the
scope specifies that the interim order/proposed variance will/would
only apply when the dive location is an uninspected vessel operated by
NOAA, within OSHA's geographical authority, and when such operations
are not covered by the U.S. Coast Guard. When implementing the
conditions of the interim order/proposed permanent variance, JHT will/
would have to comply fully with all safety and health provisions that
are applicable to commercial diving operations as specified by 29 CFR
1910, Subpart T, except for the requirements specified by 29 CFR
1910.430(d)(3), 1910.430(d)(4), 1910.423(b)(2), 1910.423(c)(1),
1910.423(c)(3), and 1910.424(b)(2).
---------------------------------------------------------------------------

    \15\ Section 1910.401(a)(2) provides that the CDO standard does
not apply to any dive (i) performed solely for instructional
purposes, using open-circuit, compressed-air SCUBA and conducted
within the no-decompression limits; (ii) performed solely for
search, rescue, or related public safety purposes by or under the
control of a governmental agency; (iii) governed by 45 CFR part 46
(Protection of Human Subjects, U.S. Department of Health and Human
Services) or equivalent rules or regulations established by another
federal agency, which regulate research, development, or related
purposes involving human subjects; or (iv) fitting the standard's
definition of ``scientific diving.''
---------------------------------------------------------------------------

    The interim order only applies to JHT's employees when they conduct
diving operations under the NDP, as would the permanent variance should
OSHA decide to grant it.

Proposed Condition B: List of Abbreviations

    In proposed condition B, OSHA defines a number of abbreviations
used in the interim order/proposed permanent variance. OSHA believes
that defining these abbreviations serves to clarify and standardize
their usage, thereby enhancing the applicant's and its employees'
understanding of the conditions specified by the interim order/proposed
permanent variance.

Proposed Condition C: Requirements for Inflatable Flotation Devices

    This proposed condition will/would require that, when using a
buoyancy compensator device (BCD) for SCUBA diving, JHT will/would
ensure that: The device is used in accordance with the manufacturer's
instructions; is capable of being inflated orally and via the diver's
primary breathing gas supply; and, all divers carry an independent
reserve cylinder of breathing gas with a separate regulator that could
be used for BCD inflation in an emergency. It will/would also require
that, when SCUBA diving, JHT will/would ensure divers use an inflatable
flotation device that is: Capable of maintaining the diver at the
surface in a positively buoyant state; and, has a manually activated
inflation source, an oral inflation device, and an exhaust valve. Also,
when SCUBA diving, JHT will/would ensure divers are never permitted to
dive alone unless they are line-tended and provided with topside
support.
    Based upon the technical review of the proposed alternate
conditions described above (see section II.B.), OSHA preliminarily
determined that these conditions will/would provide JHT's divers with
protection equivalent to the provisions in the CDO standard that
regulate inflatable flotation devices. OSHA approved these same
conditions for NOAA-employed NDP divers when it granted the NOAA
Alternate Diving Standards on September 5, 2014, and because there are
no differences in training requirements, medical clearance procedures,
equipment use and maintenance requirements, and diving procedures for
NOAA-employed and JHT-employed divers under the NDP, OSHA grants JHT's
request for an interim order, and proposes to grant JHT's request for a
permanent variance, using the conditions of the NOAA Alternate Diving
Standards, in combination with the additional conditions specified in
this notice.

Proposed Condition D: Requirements for Decompression Chambers

    This proposed condition will/would require that, for any dive that
is outside the no-decompression limits or deeper than 130 fsw or using
mixed gas with a percentage of oxygen less than air as a breathing
mixture, JHT will/would instruct the diver to remain awake and in the
vicinity of the decompression chamber which is at the dive location for
at least one hour after the dive (including decompression or treatment
as appropriate). Additionally, for any dive using air or a nitrox
breathing-gas mixture within the no-decompression limits that is deeper
than 100 fsw but no deeper than 130 fsw, JHT will/would make available
within four hours of the dive location a dual-lock and multi-place
decompression chamber capable of recompressing the diver at the surface
to a minimum of 165 fsw (6 ATA). JHT will/would also be required to
meet the medical-treatment provisions of Appendix C to the CDO rule
(i.e., Condition 8, ``Treating Diving-Related Medical Emergencies''),
and will/would be prohibited from conducting SCUBA diving using air or
nitrox breathing-gas mixture at depths deeper than 100 fsw but no
deeper than 130 fsw, or outside the no-decompression limits, unless a 6
ATA decompression chamber is ready for use (diving operations performed
for instructional purposes in accordance with Sec.  1910.401(a)(2)(i)
are exempt). When using a nitrox breathing-gas mixture, JHT will/would
be required to meet the no-decompression provisions of Appendix C to
the CDO rule (i.e., Condition 5, ``Use of No-Decompression Limits'')
and ensure that the partial pressure of oxygen in breathing-gas
mixtures does not exceed 1.40 ATA or 40% by volume, whichever exposes
the diver to less oxygen.
    Based upon the technical review of the proposed alternate
conditions regarding its use of decompression chambers (see section
II.C.), OSHA preliminarily determined the specified conditions will/
would provide JHT's divers with protection equivalent to the CDO
standard. OSHA approved these same conditions for NOAA-employed NDP
divers when it granted the NOAA Alternate Diving Standards on September
5, 2014, and because there are no differences in training requirements,
medical clearance procedures, equipment use and maintenance
requirements, and required diving procedures for NOAA-employed and JHT-
employed divers under the

NDP, OSHA grants JHT's request for an interim order, and proposes to
grant the requested permanent variance, using the conditions of the
NOAA Alternate Diving Standards in combination with the additional
conditions specified in this notice.

Proposed Condition E: Worker Qualification and Training

    OSHA added this proposed condition, which will/would require JHT to
develop and implement an effective qualification and training program
for its affected divers that, at a minimum, meets the requirements set
forth in 29 CFR 1910.410 qualifications of a dive team. The proposed
condition specifies that as members of the NDP, JHT's affected divers
must/would be required to successfully complete the three-week, 140-
hour ``Working Diver'' course that trains NOAA and contractor divers to
perform a wide range of skills utilizing a variety of power and hand
tools and specialized equipment. The proposed condition also specifies
that JHT's diver must/would be required to complete NDP's diver
training requirements, which include: (1) Instruction in the conditions
of the proposed variance; (2) annual refresher training in oxygen
administration (academic and practical components); (3) instruction in
maintaining current CPR/AED and First Aid certification; (4)
maintaining proficiency in diving by making at least three (3) dives
per quarter; (5) completing and passing an annual swim test; (6)
completing and passing an annual skills test to demonstrate the diver's
ability to safely operate underwater; (7) successfully completing one
or more annual rescue drills to demonstrate the diver's ability to
surface, extricate, treat and evacuate the victim of a diving accident;
and (8) instruction in properly verifying that the diver's life support
gear was serviced annually by a certified technician.
    OSHA believes that having well-trained and qualified divers
performing the required dive tasks ensures that they recognize, and
respond appropriately to underwater safety and health hazards. These
qualification and training requirements will/would enable affected JHT
divers to cope effectively with emergencies, as well as the discomfort
and physiological effects of hyperbaric exposure, thereby preventing
injury, illness, and fatalities.

Proposed Condition F: Recordkeeping

    OSHA also includes proposed condition F, which will/would require
the applicant to maintain records of specific factors associated with
each dive. The information gathered and recorded under this provision,
in concert with the information provided under proposed condition G
(using OSHA 301 Incident Report form to investigate and record dive-
related recordable injuries as defined by 29 CFR 1904.4, 1904.7, 1904.8
through 1904.12), will/would enable the applicant and OSHA to determine
the effectiveness of the interim order and proposed permanent variance
in preventing DCS and other dive-related injuries and illnesses.\16\
---------------------------------------------------------------------------

    \16\ See 29 CFR 1904, Recording and Reporting Occupational
Injuries and Illnesses (http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9631); recordkeeping
forms and instructions (http://www.osha.gov/recordkeeping/RKform300pkg-fillable-enabled.pdf); and updates to OSHA's
recordkeeping rule, 79 Fed Reg. 56130, September 18, 2014 (more
information available at: http://www.osha.gov/recordkeeping2014/index.html).
---------------------------------------------------------------------------

Proposed Condition G: Notifications

    OSHA added this proposed condition to JHT's application in order to
ensure that the applicant provides timely notification regarding the
continued use and effectiveness of the proposed conditions in
maintaining the safety and health of affected divers and preventing
dive-related incidents.
    Under this proposed condition, the applicant will/would be required
to: (1) Notify the Office of Technical Programs and Coordination
Activities (OTPCA) and the Area Office closest to the dive location of
any recordable injuries, illnesses, in-patient hospitalizations,
amputations, loss of an eye, or fatality that occur as a result of
diving operations within eight (8) hours of the incident; (2) provide
OTPCA and the Area Office closest to the dive location within twenty-
four (24) hours of the incident with a copy of the incident
investigation report (using OSHA 301 form); (3) include on the OSHA 301
form information on the diving conditions associated with the
recordable injury or illness, the root-cause determination, and
preventive and corrective actions identified and implemented; (4)
provide its certification that it informed affected divers of the
incident and the results of the incident investigation; (5) notify
OTPCA and the Area Office closest to the dive location within fifteen
(15) working days should the applicant need to revise its dive
procedures to accommodate changes in its diving operations that affect
its ability to comply with the conditions of the proposed permanent
variance; and (6) by the fifteenth (15th) of January, at the beginning
of each new calendar year, provide OTPCA, and the Area and Regional
Offices closest to the preceding year's dive locations, with a report
summarizing the dives completed during the year just ended and
evaluating the effectiveness of the variance conditions in providing a
safe and healthful work environment and in preventing dive-related
incidents.
    It should be noted that the requirement of completing and
submitting the dive-related (recordable) incident investigation report
(OSHA 301 form) will/would be more restrictive than the current
recordkeeping requirement of completing the OSHA 301 form within seven
(7) calendar days of the incident (29 CFR 1904.29(b)(3)). This modified
and more stringent incident investigation and reporting requirement
will/would be restricted to dive-related (recordable) incidents only.
Providing notification will/would be essential because time is a
critical element in OSHA's ability to determine the continued
effectiveness of the variance conditions in preventing dive-related
incidents, and the applicant's identification and implementation of
appropriate corrective and preventive actions.
    Further, these notification requirements will/would enable the
applicant, its employees, and OSHA to determine the effectiveness of
the proposed permanent variance in providing the requisite level of
safety to the applicant's divers, and based on this determination,
whether to revise or revoke the conditions of the proposed permanent
variance. Timely notification will/would permit OSHA to take whatever
action may be necessary and appropriate to prevent further injuries and
illnesses. Providing notification to affected employees will/would
inform them of the precautions taken by the applicant to prevent
similar incidents in the future.
    Additionally, this proposed condition also will/would require the
applicant to notify OSHA if it ceases to do business, has a new address
or location for its main office, or transfers the operations covered by
the proposed permanent variance to a successor company. Further, the
condition will/would specify that OSHA must approve the transfer of the
interim order or proposed permanent variance to a successor company.
These requirements will/would: (1) Provide assurance that the successor
company has knowledge of, and would comply with, the conditions
specified by the interim order or proposed permanent variance; (2)
allow OSHA to communicate effectively with the applicant regarding the
status of the interim order or proposed permanent variance; and (3)
expedite the Agency's administration and enforcement of the

interim order or proposed permanent variance, thereby ensuring the
continued safety of affected divers.

IV. Grant of Interim Order

    In Addition to a permanent variance, JHT requested an interim
order, which would remain in effect until the Agency modifies or
revokes the interim order, or until the Agency makes a decision on its
application for a permanent variance, whichever occurs first. During
this interim period, the applicant is required to comply fully with the
conditions of the interim order as an alternative to complying with the
inflatable flotation device requirements of 29 CFR 1910.430(d)(3) and
(4), and the decompression chamber requirements of 29 CFR
1910.423(b)(2), (c)(1), and (c)(3), and 1910.424(b)(2).
    As described earlier in this notice, JHT proposes to adopt the
conditions of the NOAA Alternate Diving Standards, which were granted
to NOAA on September 5, 2014, as the conditions of the interim order
and permanent variance. In addition to adopting the NOAA Alternate
Diving Standards' conditions for deviating from the applicable
inflatable flotation device and decompression chamber provisions of
Subpart T, OSHA added several conditions, which the Agency believes are
necessary to ensure the safety of JHT's divers who conduct commercial
diving operations for NOAA under the NDP.
    After comprehensively reviewing the record discussed above, the
Agency preliminarily finds that when the employer complies with the
conditions of the proposed variance, the working conditions of the
applicant's workers would be at least as safe and healthful as if the
employer complied with the working conditions specified by 29 CFR
1910.430(d)(3), 1910.430(d)(4), 1910.423(b)(2), 1910.423(c)(1),
1910.423(c)(3), and 1910.424(b)(2). Accordingly, OSHA is issuing an
interim order to the applicant pursuant to the provisions of 29 CFR
1910.11(c). In lieu of complying with the provisions listed of Subpart
T specified above, the applicant will: (1) Comply with the conditions
listed below in Section V (``Specific Conditions of the Interim Order
and the Application for a Permanent Variance'') of this notice for as
long as the interim order remains in effect; (2) comply fully with all
other applicable provisions of 29 CFR part 1910; and (3) provide a copy
of this Federal Register notice to all employees affected by the
proposed conditions, using the same means it used to inform these
employees of its application for a permanent variance. During the
period starting with the publication of this notice, the interim order
shall remain in effect until the Agency publishes a final decision on
the application for a permanent variance, or until the Agency modifies
or revokes the interim order in accordance with 29 CFR 1905.13,
whichever occurs first.

V. Specific Conditions of the Interim Order and the Application for a
Permanent Variance

    After comprehensively reviewing the evidence, OSHA has
preliminarily determined that the proposed conditions will provide a
place of employment as safe and healthful as that provided by 29 CFR
1910.430(d)(3), 1910.430(d)(4), 1910.423(b)(2), 1910.423(c)(1),
1910.423(c)(3), and 1910.424(b)(2). The following conditions apply to
the interim order that OSHA is granting to JHT. In addition, these
conditions specify the alternative means of compliance that OSHA
proposes for JHT's requested permanent variance from the above-listed
provisions of Subpart T of 29 CFR part 1910. The conditions will/would
apply to all of JHT's commercial diving operations conducted from NOAA
vessels under the NOAA Diving Program (NDP). These conditions include:

A. Scope

    1. This interim order/permanent variance applies/would apply only
to JHT's commercial diving operations conducted for NOAA under the NDP
from a NOAA vessel.
    2. The interim order/permanent variance only applies/would apply to
JHT diving operations that are covered under Subpart T of 29 CFR part
1910 (see 29 CFR 1910.401(a)). Accordingly, the variance will/would
only apply when the dive location is an uninspected vessel within
OSHA's geographical authority, as defined by 29 U.S.C. 653(a), and when
such operations are not covered by the U.S. Coast Guard.
    3. The interim order/permanent variance will/would not apply to
commercial diving operations exempted by 29 CFR 1910.401(a)(2),
including diving operations performed solely for instructional
purposes, using open-circuit, compressed-air SCUBA and conducted within
the no-decompression limits; diving performed solely for search,
rescue, or related public safety purposes by or under the control of a
governmental agency; or; diving for research, development, or related
purposes involving human subjects, as governed by 45 CFR part 46 or
equivalent rules or regulations established by another federal agency;
and scientific diving. To qualify for the scientific diving exemption,
all of the requirements in 29 CFR 1910.401(a)(2)(iv) and Appendix B to
29 CFR part 1910, subpart T, must be met.
    4. Except for the requirements specified by 29 CFR 1910.430(d)(3),
1910.430(d)(4), 1910.423(b)(2), 1910.423(c)(1), 1910.423(c)(3), and
1910.424(b)(2), JHT must/would be required to comply fully with all
other applicable provisions of Subpart T of 29 CFR part 1910 when
conducting commercial diving operations.
    5. The interim order will remain in effect until the Agency
publishes a final decision on the application for a permanent variance,
or until the Agency modifies or revokes the interim order in accordance
with 29 CFR 1905.13, whichever occurs first.

B. List of Abbreviations

    Abbreviations used throughout this proposed permanent variance
would include the following:

ATA--Atmosphere Absolute
BCD--Buoyancy Compensator Device
CDO--Commercial Diving Operations
DCS--Decompression Sickness
fsw--feet of seawater
JHT--Jardon and Howard Technologies, Incorporated
NDP--NOAA Diving Program
OSHA--Occupational Safety and Health Administration
OTPCA--OSHA's Office of Technical Programs and Coordination
Activities
p.s.i.--pounds per square inch
SCUBA--Self Contained Underwater Breathing Apparatus

C. Requirements for Inflatable Flotation Devices

    1. When using a BCD for SCUBA diving, JHT will/would ensure that:
The device is used in accordance with the manufacturer's instructions;
is capable of being inflated orally and via the diver's primary
breathing gas supply; and all divers carry an independent reserve
cylinder of breathing gas with a separate regulator that could be used
for BCD inflation in an emergency.
    2. When SCUBA diving, JHT will/would ensure that divers use an
inflatable flotation device that is: Capable of maintaining the diver
at the surface in a positively buoyant state; and have a manually
activated inflation source, an oral inflation device, and an exhaust
valve.
    3. When SCUBA diving, JHT will/would ensure that divers are never
permitted to dive alone unless they are line-tended and provided with
topside support (as a minimum, topside support includes a designated
person-in-charge and a standby diver).

D. Requirements for Decompression Chambers

    1. For any dive that is outside the no-decompression limits or
deeper than 130 fsw or using mixed gas with a percentage of oxygen less
than air as a breathing mixture, JHT will/would instruct the diver to
remain awake and in the vicinity of the decompression chamber, which is
at the dive location for at least one hour after the dive (including
decompression or treatment as appropriate).
    2. For any dive using air or a nitrox breathing-gas mixture within
the no-decompression limits that is deeper than 100 fsw but no deeper
than 130 fsw, JHT will/would make available within four hours of the
dive location, a decompression chamber capable of recompressing the
diver at the surface to a minimum of 165 fsw (6 ATA).
    3. For any dive using air or nitrox breathing-gas mixture within
the no-decompression limits that is deeper than 100 fsw but no deeper
than 130 fsw, JHT will/would make available a decompression chamber
that is: dual-lock, multiplace, and located within four hours of the
dive location.
    4. JHT will/would have to meet the medical-treatment provisions of
Appendix C to the CDO rule (i.e., Condition 8, ``Treating Diving-
Related Medical Emergencies'').
    5. JHT will/would be prohibited from conducting SCUBA diving using
air or nitrox breathing-gas mixture at depths deeper than 100 fsw but
no deeper than 130 fsw, or outside the no-decompression limits, unless
a 6 ATA decompression chamber is ready for use (diving operations
performed for instructional purposes in accordance with Sec.
1910.401(a)(2)(i) are exempt).
    6. When using a nitrox breathing-gas mixture, JHT will/would have
to meet the no-decompression provisions of Appendix C to the CDO rule
(i.e., Condition 5, ``Use of No-Decompression Limits'') and ensure that
the partial pressure of oxygen in breathing-gas mixtures does not
exceed 1.40 ATA or 40% by volume, whichever exposes the diver to less
oxygen.

E. Worker Qualification and Training

    JHT will/would be required to:
    1. Develop and implement an effective qualification and training
program for its affected divers that as a minimum, meets the
requirements set forth in 29 CFR 1910.410 qualifications of a dive
team;
    2. Ensure that each affected diver (including, but not limited to,
current and newly assigned to be involved in diving operations under
the NDP) successfully completes NOAA's three-week, 140-hour ``Working
Diver'' course;
    3. Ensure that the diver training program also includes the
following: (a) Instruction in the conditions of the proposed variance;
(b) annual refresher training in oxygen administration (academic and
practical components); (c) instruction in maintaining current CPR/AED
and First Aid certification; (d) maintaining proficiency in diving by
making at least three (3) dives per quarter; (e) completing and passing
an annual swim test; (f) completing and passing an annual skills test
to demonstrate the diver's ability to safely operate underwater; (g)
successfully completing one or more annual rescue drills to demonstrate
the diver's ability to surface, extricate, treat and evacuate the
victim of a diving accident; and (h) instruction in properly verifying
that the diver's life support gear was serviced annually by a certified
technician;
    4. Document the training in order to provide a means of tracking
the training received by divers and, consequently, to prompt JHT to
update that training if necessary.

F. Recordkeeping

    JHT will/would be required to:
    1. Maintain records of recordable injuries that occur as a result
of diving operations conducted for NOAA under the NDP;
    2. Ensure that the information gathered and recorded under this
provision, in concert with the information provided under proposed
condition G (using OSHA 301 Incident Report form to investigate and
record dive-related recordable injuries as defined by 29 CFR 1904.4,
1904.7, 1904.8 through 1904.12), would enable the JHT and OSHA to
determine the effectiveness of the proposed permanent variance in
preventing DCS and other dive-related injuries and illnesses.\17\
---------------------------------------------------------------------------

    \17\ See footnote 16.
---------------------------------------------------------------------------

G. Notifications

    JHT will/would be required to:
    1. Notify the OTPCA and the Area Office closest to the dive
location of any recordable injuries, illnesses, in-patient
hospitalizations, amputations, loss of an eye, or fatality that occur
as a result of diving operations within eight (8) hours of the
incident;
    2. Provide OTPCA and the Area Office closest to the dive location
within twenty-four (24) hours of the incident with a copy of the
incident investigation report (using OSHA 301 form);
    3. Include on the OSHA 301 form information on the diving
conditions associated with the recordable injury or illness, the root-
cause determination, and preventive and corrective actions identified
and implemented;
    4. Provide its certification that it informed affected divers of
the incident and the results of the incident investigation;
    5. Notify OTPCA and the Area Office closest to the dive location
within fifteen (15) working days should the applicant need to revise
its dive procedures to accommodate changes in its diving operations
that affect its ability to comply with the conditions of the proposed
permanent variance;
    6. Obtain OSHA's written approval prior to implementing the
revision in its dive procedures to accommodate changes in its diving
operations that affect its ability to comply with the conditions in the
proposed permanent variance;
    7. By the fifteenth (15th) of January, at the beginning of each new
calendar year, provide OTPCA, and the Area and Regional Offices closest
to the preceding year's dive locations, with a report summarizing the
dives completed during the year just ended and evaluating the
effectiveness of the variance conditions in providing a safe and
healthful work environment and in preventing dive-related incidents;
    8. Notify OSHA if it ceases to do business, has a new address or
location for its main office, or transfers the operations covered by
the proposed permanent variance to a successor company; and
    9. Ensure that OSHA would approve the transfer of the interim order
or permanent variance to a successor company.
    OSHA will publish a copy of this notice in the Federal Register.

Authority and Signature

    Thomas M. Galassi, Acting Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
655(d), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1905.11.

    Signed at Washington, DC, on July 19, 2017.
Thomas M. Galassi,
Acting Deputy Assistant Secretary of Labor for Occupational Safety and
Health.
[FR Doc. 2017-15876 Filed 8-1-17; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70373-70375]
[FR Doc No: 2021-26741]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2021-N-0572]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Negative Pressure Wound Therapy Device for
Reduction of Wound Complications

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

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the negative pressure wound therapy device for reduction of
wound complications into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for the negative pressure wound
therapy device for reduction of wound complications' classification. We
are taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices.

DATES: This order is effective December 10, 2021. The classification
was applicable on April 19, 2019.

FOR FURTHER INFORMATION CONTACT: Cynthia Chang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4646, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the negative pressure wound
therapy device for reduction of wound complications as class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness. In addition, we believe this
action will enhance patients' access to beneficial innovation, by
placing the device into a lower device class than the automatic class
III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On March 15, 2018, KCI USA, Inc. submitted a request for De Novo
classification of the PREVENA 125 and PREVENA PLUS 125 Therapy Units.
FDA reviewed the request in order to classify the device under the
criteria for classification set forth in section 513(a)(1) of the FD&C
Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls,

provide reasonable assurance of the safety and effectiveness of the
device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review
of the information submitted in the request, we determined that the
device can be classified into class II with the establishment of
special controls. FDA has determined that these special controls, in
addition to the general controls, will provide reasonable assurance of
the safety and effectiveness of the device.
    Therefore, on April 19, 2019, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
878.4783.\1\ We have named the generic type of device negative pressure
wound therapy device for reduction of wound complications, and it is
identified as a powered suction pump intended for wound management and
reduction of wound complications via application of negative pressure
to the wound, which removes fluids, including wound exudate, irrigation
fluids, and infectious materials. This device type is intended for use
with wound dressings classified under 21 CFR 878.4780. This
classification does not include devices intended for organ space
wounds.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
the Federal Register's (OFR) interpretations of the Federal Register
Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9
and parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Negative Pressure Wound Therapy Device for Reduction of Wound
               Complications Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Electrical shock or electromagnetic      Electromagnetic compatibility
 interference with other devices.         testing, Electrical safety
                                          testing, and Labeling.
Damage to underlying tissue (e.g.,       Clinical data; Non-clinical
 wound maceration, uncontrolled           performance testing; Usability
 bleeding) due to:                        testing; Shelf life testing;
 Mechanical failure............   Software verification,
 Software malfunction..........   validation, and hazard
 Use error.....................   analysis; and Labeling.
Increase in wound complications due to   Clinical data, Usability
 use error.                               testing, and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, negative pressure wound therapy
devices for reduction of wound complications are for prescription use
only. Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109
are met (referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. Add Sec.  878.4783 to subpart E to read as follows:

Sec.  878.4783  Negative pressure wound therapy device for reduction of
wound complications.

    (a) Identification. A negative pressure wound therapy device for
reduction of wound complications is a powered suction pump intended for
wound management and reduction of wound complications via application
of negative pressure to the wound, which removes fluids, including
wound exudate, irrigation fluids, and infectious materials. This device
type is intended

for use with wound dressings classified under Sec.  878.4780. This
classification does not include devices intended for organ space
wounds.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical data must demonstrate that the device performs as
intended under anticipated conditions of use and evaluate the
following:
    (i) Wound complication rates; and
    (ii) All adverse events.
    (2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (3) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (4) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the labeled shelf life.
    (5) Usability testing must demonstrate that intended users can
correctly use the device, based solely on reading the instructions for
use.
    (6) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested in a worst-case scenario for
the intended use life:
    (i) Ability to maintain pressure levels at the wound site under a
worst-case scenario for the intended use life;
    (ii) Fluid removal rate consistent with the wound types specified
in the indications for use; and
    (iii) Timely triggering of all alarms.
    (7) Performance data must demonstrate the electrical safety and
electromagnetic compatibility (EMC) of the device.
    (8) Software verification, validation, and hazard analysis must be
performed.
    (9) Labeling must include the following:
    (i) Instructions for use;
    (ii) A summary of the device technical specifications, including
pressure settings, modes (e.g., continuous or intermittent), alarms,
and safety features;
    (iii) Compatible components and devices;
    (iv) A summary of the clinical evidence for the indications for
use;
    (v) A shelf life for sterile components; and
    (vi) Use life and intended use environments.
    (10) For devices intended for use outside of a healthcare facility,
patient labeling must include the following:
    (i) Information on how to operate the device and its components and
the typical course of treatment;
    (ii) Information on when to contact a healthcare professional; and
    (iii) Use life.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26741 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P