SUPPORTING STATEMENT FOR

THE COLLECTION OF INFORMATION REQUIREMENTS OF

THE STANDARD ON PERSONAL PROTECTIVE EQUIPMENT (PPE)

FOR SHIPYARD EMPLOYMENT (29 CFR PART 1915, SUBPART I)

OFFICE OF MANAGEMENT AND BUDGET (OMB)

CONTROL NO. 1218-0215

 (December 2015)

JUSTIFICATION

1.  Explain the circumstances that make the collection of information
necessary.  Identify any legal or administrative requirements that
necessitate the collection.  Attach a copy of the appropriate section of
each statute and regulation mandating or authorizing the collection of
information.

The main purpose of the Occupational Safety and Health Act (OSH Act) is
to “assure so far as possible every working man and woman in the
Nation safe and healthful working conditions and to preserve our human
resources” (29 U.S.C. 651).  To achieve this objective, the OSH Act
specifically authorizes “the development and promulgation of
occupational safety and health standards” (29 U.S.C 651).

With regard to recordkeeping, the OSH Act specifies that “[e]ach
employer shall make, keep and preserve, and make available to the
Secretary . . . such records . . . as the Secretary . . . may prescribe
by regulation as necessary or appropriate for the enforcement of this
Act . . .” (29 U.S.C. 657).  The OSH Act states further that “[t]he
Secretary . . . shall prescribe such rules and regulations as [he/she]
may deem necessary to carry out [his/her] responsibilities under this
Act, including rules and regulations dealing with the inspection of an
employer’s establishment” (29 U.S.C. 657).Under the authority
granted by the OSH Act, the Occupational Safety and Health
Administration (OSHA) published at 29 CFR part 1915, subpart I, the
standard on Personal Protective Equipment (PPE) for Shipyard Employment.
 Subpart I requires employers to provide and ensure that each affected
worker uses the appropriate personal protective equipment (PPE) for the
eyes, face, head, extremities, torso, and respiratory system, including
protective clothing, protective shields, protective barriers,
life-saving equipment, personal fall arrest systems, and positioning
device systems that meets the applicable provisions of this subpart,
whenever workers are exposed to hazards that require the use of PPE.
Items 2 and 12 below describe in detail the specific information
collection requirements of subpart I.

2.  Indicate how, by whom, and for what purpose the information is to be
used.  Except for a new collection, indicate the actual use the agency
has made of the information received from the current collection.

Subpart I contains two collection of information requirements, which are
described below.

Hazard Assessment and Verification (§1915.152(b)).  Section 1915.152(b)
requires the employer to assess work activities to determine whether
there are hazards present, or likely to be present, which necessitate
the worker’s use of PPE.  If such hazards are present, or likely to be
present, the employer must:  (1) select the type of PPE that will
protect the affected worker from the hazards identified in the
occupational hazard assessment; (2) communicate selection decisions to
affected workers; (3) select PPE that properly fits each affected
worker; and (4) maintain documentation that verifies that the required
occupational hazard assessment has been performed.  The verification
must contain the following information:  occupation or trade assessed,
the date(s) of the hazard assessment, and the name of the person
performing the hazard assessment.

The hazard assessment assures that potential workplaces hazards
necessitating PPE use have been identified and the PPE selected is
appropriate for those hazards and the affected workers.  The required
certification of the hazard assessment verifies that the required hazard
assessment was conducted.

3.  Describe whether, and to what extent, the collection of information
involves the use of automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses, and the
basis for the decision for adopting this means of collection.  Also
describe any consideration of using information technology to reduce
burden.

Employers may use automated, electronic, mechanical, or other
technological collection techniques, or other forms of information
technology (e.g., electronic submission of responses), when establishing
and maintaining the required records.  The Agency wrote the subpart I
paperwork requirements in performance-oriented language, i.e., in terms
of what data to collect, not how to record the data.

 4.  Describe efforts to identify duplication.  Show specifically why
any similar information already available cannot be used or modified for
use for the purposes described in Item A.2 above.

The requirements to collect and maintain information are specific to
each employer and worker involved, and no other source or agency
duplicates these requirements or can make the required information
available to OSHA (i.e., the required information is available only from
employers).

 5.  If the collection of information impacts small businesses or other
small entities, describe any methods used to minimize burden.

The information collection requirements in subpart I do not have a
significant impact on a substantial number of small entities.

 6.  Describe the consequence to Federal program or policy activities if
the collection is not conducted or is conducted less frequently, as well
as any technical or legal obstacles to reducing burden.

The Agency believes that the information collection frequencies
required by subpart I are the minimum frequencies necessary to
effectively monitor the use of PPE by shipyard employers and, thereby,
fulfill its mandate “to assure so far as possible every working man
and woman in the Nation safe and healthful working conditions and to
preserve our human resources” as specified by the OSH Act (29 U.S.C.
651).

 7.  Explain any special circumstances that would cause an information
collection to be conducted in a manner:

      ·  Requiring respondents to report information to the agency more
often than quarterly;

      ·  Requiring respondents to prepare a written response to a
collection of information in fewer than 30

          days after receipt of it;

      ·  Requiring respondents to submit more than an original and two
copies of any document;

      ·  Requiring respondents to retain records, other than health,
medical, government contract, grant-in-

          aid, or tax records for more than three years;

      ·  In connection with a statistical survey, that is not designed
to produce valid and reliable results that

          can be generalized to the universe of study;

      ·  Requiring the use of a statistical data classification that
has not been reviewed and approved by OMB;

      ·  That includes a pledge of confidentiality that is not
supported by authority established in statute or

          regulation, that is not supported by disclosure and data
security policies that are consistent with the

          pledge, or which unnecessarily impedes sharing of data with
other agencies for compatible confidential

          use; or

      ·  Requiring respondents to submit proprietary trade secret, or
other confidential information unless

       	the agency can demonstrate that it has instituted procedures to
protect the information's confidentiality

		to the extent permitted by law.

No special circumstances exist that require employers to collect
information in the manner or using the procedures specified by this
item.  The information collection requirements are consistent with the
guidelines set forth in 5 CFR 1320.5.

 8.  If applicable, provide a copy and identify the date and page number
of publication in the Federal Register of the agency's notice, required
by 5 CFR 1320.8(d), soliciting comments on the information collection
prior to submission to OMB.  Summarize public comments received in
response to that notice and describe actions taken by the agency in
response to these comments.  Specifically address comments received on
cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain
their views on the availability of data, frequency of collection, the
clarity of instructions and recordkeeping, disclosure, or reporting
format (if any), and on the data elements to be recorded, disclosed, or
reported.

Consultation with representatives of those from whom information is to
be obtained or those who must compile records should occur at least once
every 3 years, even if the collection of information activity is the
same as in prior periods.  There may be circumstances that may preclude
consultation in a specific situation.  These circumstances should be
explained.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3506(c)(2)(A)), OSHA published a notice in the Federal Register,
soliciting comments on its proposal to extend the Office of Management
and Budget’s approval of the collection of information requirements
specified by the Standard on Personal Protective Equipment (PPE) for
Shipyard Employment (29 CFR part 1915, subpart I).  This notice was part
of a preclearance consultation program that provided the general public
and government agencies with an opportunity to comment.  The Agency will
address any comments in response to this notice.

9.  Explain any decision to provide any payments or gift to respondents,
other than reenumeration of contractors or grantees.

The Agency will not provide payments or gifts to the respondents.

10.  Describe any assurance of confidentiality provided to respondents
and the basis for the assurance in statute, regulation, or agency
policy.

No elements of confidentiality are involved.

11.  Provide additional justification for any questions of a sensitive
nature, such as sexual behavior and attitudes, religious beliefs, and
other matters that are commonly considered private.  This justification
should include the reasons why the Agency considers the questions
necessary, the specific uses to be made of the information, the
explanation to be given to persons from whom the information is
requested, and any steps to be taken to obtain their consent.

None of the provisions in subpart I require the collection of sensitive
information.

12.  Provide estimates of the hour burden of the collection of
information.  The statement should:

Indicate the number of respondents, frequency of response, annual hour
burden, and an explanation of how the burden was estimated.  Unless
directed to do so, agencies should not conduct special surveys to obtain
information on which to base hour burden estimates.  Consultation with a
sample (fewer than 10) of potential respondents is desirable.  If the
hour burden on respondents is expected to vary widely because of
differences in activity, size, or complexity, show the range of
estimated hour burden, and explain the reasons for the variance.
Generally, estimates should not include burden hours for customary and
usual business practices.

If this request for approval covers more than one form, provide separate
hour burden estimates for each form.

Provide estimates of annualized cost to respondents for the hour burdens
for collections of information, identifying and using appropriate wage
rate categories.  The cost of contracting out or paying outside parties
for information collection activities should not be included here.
Instead, this cost should be included in Item 14.

Burden Hour and Cost Determinations

OSHA estimates that there are 103,285 shipyard workers potentially
exposed to workplace hazards that may require the use of PPE. The number
of establishments is estimated to be 2,759.  These estimates were taken
from the Final Rule on General Working Conditions in Shipyard
Employment; (76 FR 24576) published on May 2, 2011. The number of
affected establishments is based on the final rule’s Final Economic
Analysis and the expertise of the Office of Regulatory Analysis. Table 1
provides a comparison of shipyard establishments by size:

Table 1

Affected Establishments and Employees by Size

Industry Code	Industry Name	Size Class	Affected Establishments	Affected
Employees

NAICS 336611	Shipyards	1000 & Up	36	43,148

500-999	29	4,370

250-499	34	5,496

100-249	44	3,097

20-99	30	902

	Offsite	20-99*	82	1,355

1-19*	384	1,521

NAICS 11411	Commercial Fishing	1000 & Up	7	4,200

500-999	3	840

250-499	1	210

100-249	10	857

20-99	21	467

1-19	1,099	1,196

NAICS 311712	Fish Processing	1000 & Up	44	16,740

500-999	10	1,340

250-499	8	1,407

100-249	15	1,360

20-99	41	1,545

1-19	96	458

NAICS 488330	Tug & Towing Services	1000 & Up	45	4,282

500-999	14	1,702

250-499	5	808

100-249	16	1,450

20-99	88	2,437

1-19	471	1,239

NAICS	Passenger Vessels	20-99	21	532

1-19	105	326

	TOTAL

2,759	103,285

Wage Rates for Shipyards

The Agency determined average wage rates for PPE for Shipyard Employment
using an average hourly earning, including benefits, to represent the
cost of employee time.  The Agency adopted the mean wages rates from May
2014 National Industry-Specific Occupational Employment and Wages
Estimates, U.S. Department of Labor, Bureau of Labor Statistics.  Total
compensation for occupational category includes an adjustment of 30.5
percent (Employer Costs for Compensation, June 2015) (  HYPERLINK
"http://www.bls.gov/news.release/ecec.nr0.htm"
http://www.bls.gov/news.release/ecec.nr0.htm ) for fringe benefits; this
figure represents the average level of fringe benefits in the private
sector.  The cost of labor used in this analysis is, therefore, an
estimate of total hourly compensation.  The hourly wage is:

Shipyard Supervisors				$66.05

Commercial Fishing Supervisors		$29.83

Fish Processing Supervisors			$29.23

Tug & Towing Supervisors			$36.77

Passenger Vessel Supervisors		$36.77

 Hazard Assessment and Verification Record (1915.152(b)).  Subpart I
requires that employers conduct a hazard assessment and make a
determination regarding their need for PPE.  Employers must assess work
activities to determine whether there are hazards present, or likely to
be present, which necessitate the worker’s use of PPE.  If such
hazards are present, or likely to be present, the employer must:  (1)
select the type of PPE that will protect the affected worker from the
hazards identified in the occupational hazard assessment; (2)
communicate selection decisions to affected workers; (3) select PPE that
properly fits each affected worker; and (4) verify that the required
occupational hazard assessment has been performed.  The verification
must contain the following information:  Occupation, the date(s) of the
hazard assessment, and the name of the person performing the hazard
assessment.

The final rulemaking record showed that shipyards were already
performing hazard assessments and reassessments as a normal and routine
shipyard practice (61 FR 26345) so no burden is associated with this
requirement; however, they were not documenting these assessments.
Therefore, the ICR only includes burden hours and costs for documenting
assessments and reassessments.  The Summary of Final Economic Analysis,
Regulatory Flexibility Certification, and Environmental Impact
Assessment (Final Economic Analysis) in the final rule (61 FR 26322
(5/24/1996)) estimated it takes 5 minutes (.08 hour) to record the
hazard assessment for each occupation covered.

The initial hazard assessment is a one-time obligation unless new or
different workplace hazards arise or changes in workplace conditions are
such that such hazards are likely to be present in the workplace, in
which case the employer must perform an updated or revised hazard
reassessment. Thus, for purposes of this ICR, the Agency assumes that
all 2,759 establishments have conducted their initial assessments.  In
addition, because the number of establishments in this industry is
declining, OSHA estimates that there is virtually no establishment
turnover rate in this industry.

OSHA estimates that 10 percent of the original number of hazard
assessments per establishment will be reassessed in a given year.  The
total number of hazard assessments is determined by multiplying the
number of establishments by the number of hazard assessments for that
size of establishment.  The number of hazard assessments per
establishment is based on the Final Economic Analysis, which stated that
assessments and reassessments would be conducted for occupations at the
shipyard.

Table 2

 Burden Hours and Costs for Recording

	Size Class	Affected Establishments	Number of Assess- ments per
Establishment	10% per Year	Time in Hours	Total Hours	Supervisor’s Wage
Rate	Cost

Shipyards	1000 & Up	36	40	10%	0.08 hour	12	$66.05	$793

	500-999	29	30	10%	0.08 hour	7	$66.05	$462

	200-499	34	30	10%	0.08 hour	8	$66.05	$528

	100-199	44	10	10%	0.08 hour	4	$66.05	$264

	20-99	30	5	10%	0.08 hour	1	$66.05	$66

Offsite	20 – 99*	82	5	10%	0.08 hour	3	$66.05	$198

	1 – 19*	384	5	10%	0.08 hour	15	$66.05	$991

Commercial

Fishing	1000 & Up	7	40	10%	0.08 hour	2	$29.83	$60

	500-999	3	30	10%	0.08 hour	1	$29.83	$30

	200-499	1	30	10%	0.08 hour	1	$29.83	$30

	100-199	10	10	10%	0.08 hour	1	$29.83	$30

	20-99	21	5	10%	0.08 hour	1	$29.83	$30

	1-19	1099	5	10%	0.08 hour	44	$29.83	$1,313

Fish Processing	1000 & Up	44	40	10%	0.08 hour	14	$37.83	$530

	500-999	10	30	10%	0.08 hour	2	$29.23	$58

	200-499	8	30	10%	0.08 hour	2	$29.23	$58

	100-199	15	10	10%	0.08 hour	1	$29.23	$29

	20-99	41	5	10%	0.08 hour	2	$29.23	$58

	1-19	96	5	10%	0.08 hour	4	$29.23	$117

Tug & Towing Services	1000 & Up	45	40	10%	0.08 hour	14	$36.77	$515

	500-999	14	30	10%	0.08 hour	3	$36.77	$110

	200-499	5	30	10%	0.08 hour	1	$36.77	$37

	100-199	16	10	10%	0.08 hour	1	$36.77	$37

	20-99	88	5	10%	0.08 hour	4	$36.77	$147

	1-19	471	5	10%	0.08 hour	19	$36.77	$699

Passenger Vessels	20-99	21	5	10%	0.08 hour	1	$36.77	$37

	1-19	105	5	10%	0.08 hour	4	$36.77	$147

	TOTAL	2,759

172

$7,374

Source: Office of Regulatory Analysis, OSHA.

13.  Provide an estimate of the total annual cost burden to respondents
or recordkeepers resulting from the collection of information.  (Do not
include the cost of any hour burden shown in Items 12 and 14.)

The cost determinations made under Item 12 account for the total annual
cost burden to respondents or record keepers resulting from these
collection of information requirements.

14.  Provide estimates of annualized cost to the Federal government.
Also, provide a description of the method used to estimate cost, which
should include quantification of hours, operational expenses (such as
equipment, overhead, printing, and support staff), and any other expense
that would not have been incurred without this collection of
information.  Agencies also may aggregate cost estimates from Items 12,
13, and 14 in a single table.

There are no costs to the Federal Government.

15.  Explain the reasons for any program changes or adjustments.

The Agency is requesting an increase of 120 burden hours (from 52 to 172
hours).  This increase is the result of identifying additional
establishments that have been covered by the shipyard industry.

16.  For collections of information whose results will be published,
outline plans for tabulation, and publication.  Address any complex
analytical techniques that will be used.  Provide the time schedule for
the entire project, including beginning and ending dates of the
collection information, completion of report, publication dates, and
other actions.

OSHA will not publish the information collected under subpart I.

17.  If seeking approval to not display the expiration date for OMB
approval of the information collection, explain the reasons that display
would be appropriate.

OSHA lists current valid control numbers in §§1910.8, 1915.8, 1917.4,
1918.4, and 1926.5 and publishes the expiration date in the Federal
Register notice announcing OMB approval of the information collection
requirement.  (see 5 CFR 1320.3(f)(3)).   OSHA believes that this is the
most appropriate and accurate mechanism to inform interested parties of
these expiration dates.

18.  Explain each exception to the certification statement.

OSHA is not seeking an exception to the certification statement.

B. COLLECTIONS OF INFORMATON EMPLOYING STATISTICAL METHODS.

This supporting statement does not contain any collection of information
requirements that employ statistical methods.

Table 2:  Requested Burden Hour Adjustments

Information Collection Requirement

Current

Burden Hours

Requested

Burden Hours

Adjustment

Cost Under

Item 12

Responses

Explanation of Adjustment

Hazard Assessment and Verification (1915.152(b))

51

172

121

$7,374

2,144

	There is an increase in the burden hours as a result of including all
industries covered under the scope of the Shipyard standard.

Disclosure of Hazard Assessment and

1

n/a

-1

n/a

n/a	This requirement is no longer a collection of information.

TOTALS	52

	172	120	  =SUM(ABOVE)  $7,374 	2,144

The purpose of this Supporting Statement is to analyze and describe the
burden hours and costs associated with provisions of the subpart that
contain paperwork requirements; this Supporting Statement does not
provide information or guidance on how to comply with, or how to
enforce, these provisions.  This Supporting Statement does not include
burden hours and costs associated with the collection of  information
requirements for subpart I, Respiratory Protection (29 CFR 1915.154),
which OSHA addressed in a separate ICR.  See OMB Control No. 1218-0099.

 The mean hourly wage rate for Shipyards ($50.61) corresponds to SOC
code 11-3071, “Transportation, Storage, and Distribution Managers,”
(Source: May2014 National Industry-Specific Occupational Employment and
Wage Estimates, United States, U.S. Department of Labor, Bureau of Labor
Statistics.)  May Data: 2014   HYPERLINK
"http://www.bls.gov/oes/current/naics4_336600.htm"
http://www.bls.gov/oes/current/naics4_336600.htm  .   Archived Data:
 HYPERLINK "http://www.bls.gov/oes/oes_arch.htm"
http://www.bls.gov/oes/oes_arch.htm

 The mean hourly wage rate for Commercial Fishing ($22.86) corresponds
to SOC code 45-1011, “First-Line Supervisors of Farming, Fishing, and
Forestry Workers,” (Source: May2014 National Industry-Specific
Occupational Employment and Wage Estimates, United States, U.S.
Department of Labor, Bureau of Labor Statistics.)  May Data:
HYPERLINK "http://www.bls.gov/oes/current/oes451011.htm"
http://www.bls.gov/oes/current/oes451011.htm   .  Archived Data:
HYPERLINK "http://www.bls.gov/oes/oes_arch.htm"
http://www.bls.gov/oes/oes_arch.htm

 The mean hourly wage rate for Fish Processing ($22.40) corresponds to
SOC code 51-1011, “First-Line Supervisors of Production and Operation
Workers,” (Source: May2014 National Industry-Specific Occupational
Employment and Wage Estimates, United States, U.S. Department of Labor,
Bureau of Labor Statistics.)  May Data: 2014   HYPERLINK
"http://www.bls.gov/oes/current/naics4_311700.htm#51-0000"
http://www.bls.gov/oes/current/naics4_311700.htm#51-0000  .  Archived
Data:    HYPERLINK "http://www.bls.gov/oes/oes_arch.htm"
http://www.bls.gov/oes/oes_arch.htm

 The mean hourly wage rate for Tug and Towing Services ($28.18)
corresponds to SOC code 53-0000, “Transportation and Material Moving
Machine and Vehicle Operations,” (Source: May2014 National
Industry-Specific Occupational Employment and Wage Estimates, United
States, U.S. Department of Labor, Bureau of Labor Statistics.)  May
Data: 2014;   HYPERLINK
"http://www.bls.gov/oes/current/naics488300.htm#53-0000"
http://www.bls.gov/oes/current/naics488300.htm#53-0000 .  Archived
Data:    HYPERLINK "http://www.bls.gov/oes/oes_arch.htm"
http://www.bls.gov/oes/oes_arch.htm

 The mean hourly wage rate for Passenger Vessels ($28.18) corresponds to
SOC code 53-0000, “Transportation and Material Moving Machine and
Vehicle Operations,” (Source: May2014 National Industry-Specific
Occupational Employment and Wage Estimates, United States, U.S.
Department of Labor, Bureau of Labor Statistics.)  May Data: 2014;
HYPERLINK "http://www.bls.gov/oes/current/naics4_311700.htm#51-0000"
http://www.bls.gov/oes/current/naics488300.htm#53-0000 .  Archived
Data:    HYPERLINK "http://www.bls.gov/oes/oes_arch.htm"
http://www.bls.gov/oes/oes_arch.htm

 	The number of authorized employees was estimated based on the number
of authorized employees in the

FEA and the change in total employment from 2007 to 2001 as reported by
County Business Patterns. The number

of systems per authorized employee was then estimated using the number
of systems per authorized employee based

on the FEA.

U S Department of Labor

Occupational Safety and Health Administration

Preclearance Supporting Statement

 PAGE  11


[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70132-70139]
[FR Doc No: 2021-26635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 056

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 056'' (Recognition List Number: 056), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable December 9, 2021.

ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 056.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
FDA will consider any comments received in determining whether to amend
the current listing of modifications to the list of recognized
standards, Recognition List Number: 056.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    An electronic copy of Recognition List Number: 056 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA-recognized consensus standards, including Recognition List Number:
056 modifications and other standards-related information. Submit
written requests for a single hard copy of the document entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 056'' to Scott Colburn, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5606, Silver Spring, MD 20993,<PHONE_NUMBER>. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
allows FDA to recognize consensus standards developed by international
and national organizations for use in satisfying portions of device
premarket review submissions or other requirements.
    In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standards
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
Modifications to the initial list of recognized standards, as published
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
    These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains on its
website hypertext markup language (HTML) and portable document format
(PDF) versions of the list of FDA Recognized Consensus Standards,
available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents. Additional
information on the Agency's Standards and Conformity Assessment Program
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 056

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List

Number: 056'' to identify the current modifications.
    In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that
involve new entries and consensus standards added as modifications to
the list of recognized standards under Recognition List Number: 056.

----------------------------------------------------------------------------------------------------------------
                                  Replacement
      Old recognition No.         recognition             Title of standard \1\                   Change
                                      No.
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-115.........................           1-151  ISO 80601-2-70 Second edition 2020-11     Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 70: Particular requirements for the
                                                 basic safety and essential performance
                                                 of sleep apnea breathing therapy
                                                 equipment.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-191.........................           2-289  ISO 10993-12 Fifth edition 2021-01        Withdrawn and replaced
                                                 Biological evaluation of medical          with newer version.
                                                 devices--Part 12: Sample preparation
                                                 and reference materials.
2-241.........................  ..............  ISO/TR 37137 First edition 2014-05-15     Withdrawn. See 2-290.
                                                 Cardiovascular biological evaluation of
                                                 medical devices--Guidance for
                                                 absorbable implants.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-92..........................           3-170  ISO 14708-5 Second edition 2020-05        Withdrawn and replaced
                                                 Implants for surgery--Active              with newer version.
                                                 implantable medical devices--Part 5:
                                                 Circulatory support devices.
3-129.........................  ..............  ANSI/AAMI EC53:2013/(R)2020 ECG trunk     Extent of recognition.
                                                 cables and patient leadwires.
3-166.........................  ..............  ISO 81060-2 Third edition 2018-11         Extent of recognition.
                                                 Noninvasive sphygmomanometers--Part 2:
                                                 Clinical investigation of intermittent
                                                 automated measurement type [Including:
                                                 Amendment 1 (2020)].
3-168.........................  ..............  IEEE Std 1708-2014 Standard for           Extent of recognition.
                                                 Wearable, Cuffless Blood Pressure
                                                 Measuring Devices [Including: Amendment
                                                 1 (2019)].
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-105.........................  ..............  ANSI/ADA Standard No. 75--1997 (R2014)    Withdrawn.
                                                 Resilient Lining Materials for
                                                 Removable Dentures, Part 1: Short-Term
                                                 Materials.
4-164.........................           4-273  ANSI/ASA S3.7-2016 (Reaffirmed 2020)      Withdrawn and replaced
                                                 American National Standard Method for     with newer version.
                                                 Measurement and Calibration of
                                                 Earphones.
4-183.........................           4-274  ANSI/ASA S3.2-2020 American National      Withdrawn and replaced
                                                 Standard Method for Measuring the         with newer version.
                                                 Intelligibility of Speech over
                                                 Communication Systems.
4-194.........................  ..............  ANSI/ADA Standard No. 78--2006 Dental     Withdrawn.
                                                 obturating cones (Modified adoption of
                                                 ISO 6877-1:1995, Dental obturating
                                                 points).
4-195.........................  ..............  ISO 14801 Second edition 2007-11-15       Withdrawn.
                                                 Dentistry--Implants--Dynamic fatigue
                                                 test for endosseous dental implants.
4-203.........................           4-275  ANSI/ASA S3.6-2018 American National      Withdrawn and replaced
                                                 Standard Specification for Audiometers.   with newer version.
4-206.........................           4-276  ISO 14457 Second edition 2017-10          Withdrawn and replaced
                                                 Dentistry--Handpieces and motors.         with newer version.
4-216.........................           4-277  ANSI/IEEE C63.19-2019 American National   Withdrawn and replaced
                                                 Standard Methods of Measurement of        with newer version.
                                                 Compatibility between Wireless
                                                 Communication Devices and Hearing Aids.
4-225.........................           4-278  ISO 4823 Fifth edition 2021-02            Withdrawn and replaced
                                                 Dentistry--Elastomeric impression and     with newer version.
                                                 bite registration materials.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-23.........................           19-40  IEC 60086-4 Edition 5.0 2019-04 Primary   Withdrawn and replaced
                                                 batteries--Part 4: Safety of lithium      with newer version.
                                                 batteries [Including: Corrigendum 1
                                                 (2019) and Corrigendum 2 (2020)].

                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-385.........................           6-461  IEC 60601-2-19 Edition 3.0 2020-09        Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 19: Particular requirements for the
                                                 basic safety and essential performance
                                                 of infant incubators.
6-386.........................           6-462  IEC 60601-2-20 Edition 3.0 2020-09        Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 20: Particular requirements for the
                                                 basic safety and essential performance
                                                 of infant transport incubators.
6-388.........................           6-463  IEC 60601-2-21 Edition 3.0 2020-09        Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 21: Particular requirements for the
                                                 basic safety and essential performance
                                                 of infant radiant warmers.
6-389.........................  ..............  IEC 60601-2-2 Edition 6.0 2017-03         Extent of recognition.
                                                 Medical electrical equipment--Part 2-2:
                                                 Particular requirements for the basic
                                                 safety and essential performance of
                                                 high frequency surgical equipment and
                                                 high frequency surgical accessories.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-193.........................           7-306  CLSI EP06 2nd Edition Evaluation of the   Withdrawn and replaced
                                                 Linearity of Quantitative Measurement     with newer version.
                                                 Procedures.
7-209.........................           7-307  CLSI POCT05 2nd Edition Performance       Withdrawn and replaced
                                                 Metrics for Continuous Interstitial       with newer version.
                                                 Glucose Monitoring.
7-236.........................  ..............  CLSI M43-A October 2011 Methods for       Extent of recognition.
                                                 Antimicrobial Susceptibility Testing
                                                 for Human Mycoplasmas; Approved
                                                 Guideline.
7-262.........................  ..............  CLSI M45 3rd Edition Methods for          Extent of recognition.
                                                 Antimicrobial Dilution and Disk
                                                 Susceptibility Testing of Infrequently
                                                 Isolated or Fastidious Bacteria.
7-292.........................  ..............  CLSI M62 1st Edition Performance          Extent of recognition.
                                                 Standards for Susceptibility Testing of
                                                 Mycobacteria, Nocardia spp., and Other
                                                 Aerobic Actinomycetes.
7-294.........................           7-308  CLSI M100 31st Edition Performance        Withdrawn and replaced
                                                 Standards for Antimicrobial               with newer version.
                                                 Susceptibility Testing.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-394.........................           8-555  ASTM F1472-20a Standard Specification     Withdrawn and replaced
                                                 for Wrought Titanium-6Aluminum-           with newer version.
                                                 4Vanadium Alloy for Surgical Implant
                                                 Applications (UNS R56400).
8-418.........................           8-556  ASTM F640-20 Standard Test Methods for    Withdrawn and replaced
                                                 Determining Radiopacity for Medical       with newer version.
                                                 Use.
8-445.........................  ..............  ISO 17296-4 First edition 2014-09-01      Withdrawn. See 8-561.
                                                 Additive manufacturing--General
                                                 principles--Part 4: Overview of data
                                                 processing.
8-486.........................           8-557  ASTM F3268--18a Standard Guide for in     Withdrawn and replaced
                                                 vitro Degradation Testing of Absorbable   with newer version.
                                                 Metals.
8-490.........................  ..............  ASTM F3303-18 Standard for additive       Withdrawn. See 8-562.
                                                 manufacturing--Process characteristics
                                                 and performance--Practice for metal
                                                 powder bed fusion process to meet
                                                 critical applications.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  K. Neurology
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                      L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-39..........................           9-131  ISO 8600-5 Second Edition 2020-10 Optics  Withdrawn and replaced
                                                 and photonics--Medical endoscopes and     with newer version.
                                                 endotherapy devices--Part 5:
                                                 Determination of optical resolution of
                                                 rigid endoscopes with optics.
9-44..........................           9-132  ASTM F623-19 Standard Performance         Withdrawn and replaced
                                                 Specification for Foley Catheter.         with newer version.
9-53..........................  ..............  ASTM F1992-99 (Reapproved 2007) Standard  Withdrawn.
                                                 Practice for Reprocessing of Reusable,
                                                 Heat-Stable Endoscopic Accessory
                                                 Instruments (EAI) Used with Flexible
                                                 Endoscopes.
9-95..........................  ..............  CENEN 1615:2000 Enteral Feeding           Withdrawn. See 9-138.
                                                 Catheters and Enteral Giving Sets for
                                                 Single Use and their Connectors-Design
                                                 and Testing.
9-97..........................  ..............  ISO 13958 Third edition 2014-04-01        Withdrawn. See 9-136.
                                                 Concentrates for haemodialysis and
                                                 related therapies.

9-98..........................  ..............  ISO 13959 Third edition 2014-04-01 Water  Withdrawn. See 9-135.
                                                 for haemodialysis and related
                                                 therapies.
9-99..........................  ..............  ISO 23500 Second edition 2014-04-01       Withdrawn. See 9-133.
                                                 Guidance for the preparation and
                                                 quality management of fluids for
                                                 haemodialysis and related therapies.
9-100.........................  ..............  ISO 11663 Second edition 2014-04-01       Withdrawn. See 9-137.
                                                 Quality of dialysis fluid for
                                                 haemodialysis and related therapies.
9-101.........................  ..............  ISO 26722 Second edition 2014-04-01       Withdrawn. See 9-134.
                                                 Water treatment equipment for
                                                 haemodialysis applications and related
                                                 therapies.
9-113.........................  ..............  CENEN 1618:1997 Catheters other than      Withdrawn. See 9-138.
                                                 intravascular catheters--Test methods
                                                 for common properties.
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-35.........................          10-122  ISO 10939 Third edition 2017-05           Withdrawn and replaced
                                                 Ophthalmic instruments--Slit-lamp         with newer version.
                                                 microscopes.
10-72.........................          10-123  ISO 15004-1 Second edition 2020-5         Withdrawn and replaced
                                                 Ophthalmic instruments--Fundamental       with newer version.
                                                 requirements and test methods--Part 1:
                                                 General requirements applicable to all
                                                 ophthalmic instruments.
10-79.........................          10-124  ISO 11979-1 Fourth edition 2018-11        Withdrawn and replaced
                                                 Ophthalmic implants--Intraocular          with newer version.
                                                 lenses--Part 1: Vocabulary.
10-81.........................          10-125  ISO 11979-7 Fourth edition 2018-03        Withdrawn and replaced
                                                 Ophthalmic implants--Intraocular          with newer version.
                                                 lenses--Part 7: Clinical investigations
                                                 of intraocular lenses for the
                                                 correction of aphakia.
10-90.........................  ..............  ISO 11979-9 First edition 2006-09-01      Withdrawn.
                                                 Ophthalmic implants--Intraocular
                                                 lenses--Part 9: Multifocal intraocular
                                                 lenses [Including: Amendment 1 (2014)].
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-238........................          11-376  ASTM F2033-20 Standard Specification for  Withdrawn and replaced
                                                 Total Hip Joint Prosthesis and Hip        with newer version.
                                                 Endoprosthesis Bearing Surfaces Made of
                                                 Metallic, Ceramic, and Polymeric
                                                 Materials.
11-258........................          11-377  ASTM F2083-21 Standard Specification for  Withdrawn and replaced
                                                 Knee Replacement Prosthesis.              with newer version.
11-270........................          11-378  ASTM F2502-17 Standard Specification and  Withdrawn and replaced
                                                 Test Methods for Absorbable Plates and    with newer version.
                                                 Screws for Internal Fixation Implants.
11-285........................          11-379  ASTM F2978-20 Standards Guide to          Withdrawn and replaced
                                                 Optimize Scan Sequences for Clinical      with newer version.
                                                 Diagnostic Evaluation of Metal-on-Metal
                                                 Hip Arthroplasty Devices using Magnetic
                                                 Resonance Imaging.
11-286........................          11-380  ASTM F2979-20 Standard Guide for          Withdrawn and replaced
                                                 Characterization of Wear from the         with newer version.
                                                 Articulating Surfaces in Retrieved
                                                 Metal-on-Metal and other Hard-on-Hard
                                                 Hip Prostheses.
11-293........................          11-381  ASTM F2582-20 Standard Test Method for    Withdrawn and replaced
                                                 Dynamic Impingement Between Femoral and   with newer version.
                                                 Acetabular Hip Components.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-260........................          12-335  IEC 60336 Edition 5.0 2020-12 Medical     Withdrawn and replaced
                                                 electrical equipment--X-ray tube          with newer version.
                                                 assemblies for medical diagnosis--Focal
                                                 spot dimensions and related
                                                 characteristics.
12-269........................          12-336  IEC 60601-1-3 Edition 2.2 2021-01         Withdrawn and replaced
                                                 CONSOLIDATED VERSION Medical electrical   with newer version.
                                                 equipment--Part 1-3: General
                                                 requirements for basic safety and
                                                 essential performance--Collateral
                                                 Standard: Radiation protection in
                                                 diagnostic X-ray equipment.
12-284........................          12-337  NEMA NU 1-2018 Performance Measurements   Withdrawn and replaced
                                                 of Gamma Cameras.                         with newer version.
12-285........................          12-338  IEC 60601-2-1 Edition 4.0 2020-10         Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-1:   with newer version.
                                                 Particular requirements for the basic
                                                 safety and essential performance of
                                                 electron accelerators in the range 1
                                                 MeV to 50 MeV.
12-310........................          12-339  IEC 60601-2-63 Edition 1.2 2021-05        Withdrawn and replaced
                                                 CONSOLIDATED VERSION Medical electrical   with newer version.
                                                 equipment--Part 2-63: Particular
                                                 requirements for the basic safety and
                                                 essential performance of dental extra-
                                                 oral X-ray equipment.

12-311........................          12-340  IEC 60601-2-65 Edition 1.2 2021-05        Withdrawn and replaced
                                                 CONSOLIDATED VERSION Medical electrical   with newer version.
                                                 equipment--Part 2-65: Particular
                                                 requirements for the basic safety and
                                                 essential performance of dental intra-
                                                 oral X-ray equipment.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-511........................          14-562  ANSI/AAMI ST79:2017 & 2020 Amendments     Withdrawn and replaced
                                                 A1, A2, A3, A4 (Consolidated Text)        with newer version.
                                                 Comprehensive guide to steam
                                                 sterilization and sterility assurance
                                                 in health care facilities.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-10.........................  ..............  ASTM F2451-05 (Reapproved 2010) Standard  Withdrawn.
                                                 Guide for in vivo Assessment of
                                                 Implantable Devices Intended to Repair
                                                 or Regenerate Articular Cartilage.
15-32.........................           15-66  ASTM F2260-18 Standard Test Method for    Withdrawn and replaced
                                                 Determining Degree of Deacetylation in    with newer version.
                                                 Chitosan Salts by Proton Nuclear
                                                 Magnetic Resonance (1HNMR)
                                                 Spectroscopy.
15-60.........................           15-67  ASTM F2212-20 Standard Guide for          Withdrawn and replaced
                                                 Characterization of Type I Collagen as    with newer version.
                                                 Starting Materials for Surgical
                                                 Implants and Substrates for Tissue
                                                 Engineered Medical Products (TEMPs).
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 056. These entries are of standards not
previously recognized by FDA.

                                                Table 2--New Entries to the List of Recognized Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Recognition No.                           Title of standard \1\                                      Reference No. and date
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    A. Anesthesiology
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   B. Biocompatibility
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-290............................  Biological evaluation of absorbable medical devices-- ISO/TS 37137-1 First edition 2021-03.
                                    Part 1: General requirements.
2-291............................  Biological evaluation of medical devices--Part 23:    ISO 10993-23 First edition 2021-01.
                                    Tests for irritation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    C. Cardiovascular
                                                               No new entries at this time
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          D. Dental/Ear, Nose, and Throat (ENT)
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-279............................  Part 1: Disposable Prophy Angles....................  ANSI/ADA Standard No. 85-2004 (R2009).
4-280............................  Fluoride Varnishes..................................  ANSI/ADA Standard No. 117-2018.
4-281............................  Dentistry--Shanks for rotary and oscillating          ISO 1797 Third edition 2017-05.
                                    instruments.
4-282............................  Dentistry--Denture adhesives........................  ISO 10873 First edition 2010-09.
4-283............................  Dentistry--Oral care products--Manual interdental     ISO 16409 Second edition 2016-10.
                                    brushes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 E. General I (Quality Systems/Risk Management) (QS/RM)
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  G. General Hospital/General Plastic Surgery (GH/GPS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-460............................  Standard Specification for Barrier Face Coverings...  ASTM F3502-21.
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                              H. In Vitro Diagnostics (IVD)
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      I. Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
8-558............................  Standard Specification for Chopped Carbon Fiber       ASTM F3333-20.
                                    Reinforced (CFR) Polyetheretherketone (PEEK)
                                    Polymers for Surgical Implant Applications.
8-559............................  Standard Test Methods for Vulcanized Rubber and       ASTM D412-16e1.
                                    Thermoplastic Elastomers--Tension.
8-560............................  Standard Test Method for Rubber Property--            ASTM D1415-18.
                                    International Hardness.
8-561............................  Additive manufacturing--General principles--Overview  ISO/ASTM 52950 First edition 2021-01.
                                    of data processing.
8-562............................  Additive manufacturing--Process characteristics and   ISO/ASTM 52904 First edition 2019-08.
                                    performance--Practice for metal powder bed fusion
                                    process to meet critical applications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    J. Nanotechnology
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      K. Neurology
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
--------------------------------------------------------------------------------------------------------------------------------------------------------
9-133............................  Preparation and quality management of fluids for      ISO 23500-1 First edition 2019-02.
                                    haemodialysis and related therapies--Part 1:
                                    General requirements.
9-134............................  Preparation and quality management of fluids for      ISO 23500-2 First edition 2019-02.
                                    haemodialysis and related therapies--Part 2: Water
                                    treatment equipment for haemodialysis applications
                                    and related therapies.
9-135............................  Preparation and quality management of fluids for      ISO 23500-3 First edition 2019-02.
                                    haemodialysis and related therapies--Part 3: Water
                                    for haemodialysis and related therapies.
9-136............................  Preparation and quality management of fluids for      ISO 23500-4 First edition 2019-02.
                                    haemodialysis and related therapies--Part 4:
                                    Concentrates for haemodialysis and related
                                    therapies.
9-137............................  Preparation and quality management of fluids for      ISO 23500-5 First edition 2019-02.
                                    haemodialysis and related therapies--Part 5:
                                    Quality of dialysis fluid for haemodialysis and
                                    related therapies.
9-138............................  Enteral feeding systems--Design and testing.........  ISO 20695 First edition 2020-03.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      M. Ophthalmic
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-126...........................  Medical electrical equipment--Part 2-58: Particular   IEC 80601-2-58 Edition 2.0 2014-09.
                                    requirements for basic safety and essential
                                    performance of lens removal devices and vitrectomy
                                    devices for ophthalmic surgery [Including AMENDMENT
                                    1 (2016)].
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      N. Orthopedic
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-382...........................  Standard Test Method for Fatigue Testing of           ASTM F3090-20.
                                    Acetabular Devices for Total Hip Replacement.
11-383...........................  Standard Test Method for Determination of Frictional  ASTM F3143-20.
                                    Torque and Friction Factor for Hip Replacement
                                    Bearings under Standard Conditions Using a
                                    Reciprocal Friction Simulator.
11-384...........................  Standard Test Method for Determination of Frictional  ASTM F3446-20.
                                    Torque and Friction Factor for Hip Implants Using
                                    an Anatomical Motion Hip Simulator.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  O. Physical Medicine
--------------------------------------------------------------------------------------------------------------------------------------------------------
16-231...........................  Prosthetics--Structural testing of lower-limb         ISO 10328 Second edition 2016-06-01.
                                    prostheses--Requirements and test methods.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      P. Radiology
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Q. Software/Informatics
--------------------------------------------------------------------------------------------------------------------------------------------------------
13-117...........................  Health informatics--Device interoperability Part      IEEE Std 11073-40101-2020.
                                    40101: Foundational--Cybersecurity--Processes for
                                    vulnerability assessment.
13-118...........................  Health informatics--Device interoperability Part      IEEE Std 11073-40102-2020.
                                    40102: Foundational--Cybersecurity--Capabilities
                                    for mitigation.
13-119...........................  Security for industrial automation and control        ANSI/ISA-62443-4-1-2018.
                                    systems Part 4-1: Product security development life-
                                    cycle requirements..
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      R. Sterility
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  S. Tissue Engineering
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 All standard titles in this table conform to the style requirements of the respective organizations

IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

    Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26635 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Rules and Regulations]
[Pages 13062-13063]
[FR Doc No: 2017-04634]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-7850; Directorate Identifier 2016-NE-16-AD;
Amendment 39-18819; AD 2017-05-08]
RIN 2120-AA64

Airworthiness Directives; Safran Helicopter Engines, S.A.
Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Safran Helicopter Engines, S.A. Arriel 2B turboshaft engines. This AD
requires removing any pre-modification (mod) TU 158 hydro-mechanical
metering unit (HMU) and replacing with a part eligible for
installation. This AD was prompted by a report of an uncommanded in-
flight shutdown (IFSD) on a single-engine helicopter, caused by a low
returning spring rate of the needle of the HMU. We are issuing this AD
to correct the unsafe condition on these products.

DATES: This AD becomes effective April 13, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 13,
2017.

ADDRESSES: For service information identified in this final rule,
contact Safran Helicopter Engines, S.A., 40220 Tarnos, France; phone:
(33) 05 59 74 40 00; fax: (33) 05 59 74 45 15. You may view this
service information at the FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2016-7850.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
7850; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The address for the Docket Office (phone:<PHONE_NUMBER>) is
Document Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kenneth Steeves, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: 781-
238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to the specified products. The
NPRM was published in the Federal Register on November 4, 2016 (81 FR
76885). The NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Following a report of an un-commanded in-flight shut-down
(IFSD), Turbomeca carried out an engineering investigation. This
investigation concluded that the cause of the event was a low
returning spring rate of the needle of the hydro-mechanical metering
unit (HMU), which enabled needle oscillation during rapid engine
deceleration.
    This condition, if not corrected, could lead to further cases of
IFSD, possibly resulting in an emergency landing on single engine.
    To address this potential unsafe condition, Turbomeca developed
modification (Mod) TU 158, which increases needle return spring rate
to prevent oscillation during rapid deceleration, thus preventing
the risk of un-commanded IFSD. Turbomeca also published Mandatory
Service Bulletin (MSB) 292 73 3158 for embodiment of this
modification in service.

    You may obtain further information by examining the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2016-7850.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (81 FR 76885, November 4,
2016) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed.

Related Service Information Under 1 CFR Part 51

    Safran Helicopter Engines, S.A., (formerly Turbomeca, S.A.) has
issued Mandatory Service Bulletin (MSB) No. 292 73 3158, Version A,
dated April 7, 2016. The MSB describes procedures for removing the pre-
mod TU 158 HMU and replacing it with an HMU that incorporates mod TU
158. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 124 engines installed on
helicopters of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Removal and replacement of the HMU..  2 work-hours x $85 per               $0             $170          $21,080
                                       hour = $170 per.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII,

Part A, Subpart III, Section 44701: General requirements.'' Under that
section, Congress charges the FAA with promoting safe flight of civil
aircraft in air commerce by prescribing regulations for practices,
methods, and procedures the Administrator finds necessary for safety in
air commerce. This regulation is within the scope of that authority
because it addresses an unsafe condition that is likely to exist or
develop on products identified in this rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-05-08 Safran Helicopter Engines, S.A. (Type Certificate
previously held by Turbomeca, S.A.): Amendment 39-18819; Docket No.
FAA-2016-7850; Directorate Identifier 2016-NE-16-AD.

(a) Effective Date

    This AD becomes effective April 13, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Safran Helicopter Engines S.A. Arriel 2B
turboshaft engines with a pre-modification (mod) TU 158 hydro-
mechanical metering unit (HMU), installed.

(d) Reason

    This AD was prompted by a report of an uncommanded in-flight
shutdown (IFSD) on a single engine helicopter caused by a low
returning spring rate of the needle of the HMU. We are issuing this
AD to prevent failure of the HMU, failure of the engine, IFSD, and
loss of the helicopter.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For an engine in pre-mod TU 158 configuration, within 200
engine hours, or within 5 months, whichever occurs first after the
effective date of this AD, remove the pre-mod TU 158 HMU from
service and replace it with a part eligible for installation.
    (2) Reserved.

(f) Installation Prohibition

    After the effective date of the AD, do not install any pre-mod
TU 158 HMU into any engine.

(g) Definition

    For the purpose of this AD, an HMU eligible for installation is
one that incorporates mod TU 158 in accordance with Safran
Helicopter Engines, S.A. Mandatory Service Bulletin No. 292 73 3158,
Version A, dated April 7, 2016, or other FAA-approved parts.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(i) Related Information

    (1) For more information about this AD, contact Kenneth Steeves,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency (EASA), AD
2016-0098, dated May 23, 2016, for more information. You may examine
the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2016-7850.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Safran Helicopter Engines Mandatory Service Bulletin No. 292
73 3158, Version A, dated April 7, 2016.
    (ii) Reserved.
    (3) For Safran Helicopter Engines service information identified
in this AD, contact Safran Helicopter Engines, S.A., 40220 Tarnos,
France; phone: (33) 05 59 74 40 00; fax: (33) 05 59 74 45 15.
    (4) You may view this service information at FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA. For
information on the availability of this material at the FAA, call
781-238-7125.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on February 27, 2017.
Robert J. Ganley,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2017-04634 Filed 3-8-17; 8:45 am]
BILLING CODE 4910-13-P