[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Rules and Regulations]
[Pages 77895-77896]
[FR Doc No: 2023-23058]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 89

[Docket No. FAA-2022-0859]

Accepted Means of Compliance; Remote Identification of Unmanned
Aircraft; Correction

AGENCY: Federal Aviation Administration, DOT

ACTION: Acceptable means of compliance; notice of availability;
correction.

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SUMMARY: The FAA is correcting a notice of availability (NOA) published
on August 11, 2022 (87 FR 49520). In that NOA, the FAA provided an
acceptable means of compliance (MOC) in accordance with a rule issued
by the FAA on January 21, 2021, that went into effect on April 21,
2021. In that NOA, the FAA accepted ASTM International (ASTM) F3586-22,
with additions identified, as an acceptable means, but not the only
means of demonstrating compliance with the requirements for producing
standard remote identification unmanned aircraft and remote
identification broadcast modules. The FAA is correcting the means of
compliance of ASTM F3586-22 by correcting a typographical reference
error in Table 3 and clarifying a testing requirement by revising a
heading and adding clarifying language, as noted in the ``Means of
Compliance Accepted In This Policy'' section of this document. This
document includes acceptance of previously accepted MOCs with the
corrections described.

DATES: This corrective action is effective November 14, 2023.

FOR FURTHER INFORMATION CONTACT:
    FAA Contact: Avi Acharya, Avionics Communications & Surveillance
Unit, AIR-626C, Technical Policy Branch, Policy & Standards Division,
Aircraft Certification Service, Federal Aviation Administration, AIR-
600: 800 Independence Ave. SW, Washington, DC 20591; telephone 1-844-
FLY-MY-UA; email: [email protected].
    ASTM Contact: Gabriel Cox, Chair, ASTM Remote ID Workgroup, 7325 NE
Imbrie Drive #231, Hillsboro, OR 97124; Telephone 1-503-941-0099;
email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Title 14 Code of Federal Regulations, part 89 establishes remote
identification requirements for unmanned aircraft operated in the
airspace of the United States. With a few exceptions, unmanned aircraft
produced for operation in the airspace of the United States are subject
to the production requirements of part 89. A person producing a
standard remote identification unmanned aircraft or remote
identification broadcast module for operation in the United States must
show that the unmanned aircraft or broadcast module meets the
requirements of subpart D of part 89 by following an FAA-accepted means
of compliance (MOC).
    An FAA-accepted MOC describes one means by which a person may
comply with the minimum performance requirements for remote
identification in subpart D of part 89. To be accepted by the FAA, an
MOC must meet the requirements of both subparts D and E of part 89. The
MOC must address the minimum performance requirements, as well as the
testing and validation necessary to demonstrate compliance with the
part 89 subpart D requirements. The FAA indicates its acceptance of an
MOC by publishing a Notice of Availability in the Federal Register
identifying the MOC as accepted and informing the applicant of its
acceptance.\1\
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    \1\ 14 CFR part 89, subpart D.
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    A holder of an FAA-accepted MOC notified the FAA of a typographical
error in a table and a deficient testing requirement in its FAA-
accepted MOC, as discussed in the ``Means of Compliance Accepted In
This Policy'' section of this document. This document includes
acceptance of the previously accepted MOC with the requested
corrections and describes the effect on existing Declaration of
Compliance (DOC) holders based on the previously accepted MOC and on
new and revised DOC submittals.

Means of Compliance Accepted in This Policy

    On August 10, 2022, the FAA accepted ASTM ``Standard Practice for
Remote ID Means of Compliance to Federal Aviation Administration
Regulation 14 CFR part 89'', ASTM F3586-22, with certain additions, as
an MOC to the requirements of part 89 Subpart D in NOA Docket No. FAA-
2022-0859.
    The FAA has determined that a correction to the typographical error
in table 3 of the FAA-accepted ASTM F3586-22 MOC standard, and a
clarification to a deficient testing requirement in section 8.6 of the
ASTM standard are necessary.
    The FAA-accepted MOC update provided in this NOA is comprised of
the MOC in Docket No.FAA-2022-0859 (i.e., ASTM F3586-22, with the FAA-
specified additions) with the following corrections:
    1. F3586-22 Table 3, 89.320(h)(5), page 11, line 5: The test method
must be MOC section 8.6, not section 8.9.3.
    2. F3586-22 Section 8.6: revise heading to--Broadcast Protocol,
Message Elements, Periodicity and Latency Testing:
    3. F3586-22 Section 8.6: Add the following--In addition to the
passing criteria, using a time-accurate test setup, the difference in
time between the broadcasted timestamp and received packet time must be
measured to be less than or equal to 1 second.

Effect of This Notice on Current FAA-Accepted Declarations of
Compliance

    Current valid FAA-accepted DOC for a standard remote identification
unmanned aircraft or remote identification broadcast module that used
the original FAA-accepted MOC (including all provisions of ASTM F3586-
22 and the additions identified in NOA Docket No.FAA-2022-0859) with
tracking number RID-ASTM-F3586-22-NOA-22-01 remain FAA-accepted, and
holders of those DOC do not need to resubmit a DOC for the MOC in this
document.

Effect of This Action on New and Revised Declaration of Compliance
Submittals

    Effective upon issuance of this NOA, the FAA will no longer accept
new or revised DOC submissions using the original MOC identified in NOA
Docket No. FAA-2022-0859. Applicants must submit new and revised DOC
submittals using the MOC in this document and must use the tracking
number identified in ``Tracking Number'' below.

Tracking Number

    Producers submitting a new or revised DOC to the FAA declaring the
standard remote identification unmanned aircraft or remote
identification broadcast module meets the requirements of this FAA-
accepted MOC (including all provisions of ASTM F3586-22, the additions
identified in NOA Docket No.FAA-2022-0859, and the corrections to ASTM
F3586-22 identified in this document) must include the following
tracking number: RID-ASTM-F3586-22-NOA-23-01.

Availability

    ASTM F3586-22, ``Standard Practice for Remote ID Means of
Compliance to Federal Aviation Administration Regulation 14 CFR part
89,'' is available online at https://www.astm.org/f3586-22.html. ASTM
International copyrights these consensus standards and charges the
public a fee for service. Individual downloads or reprints of a
standard (single or multiple copies, or special compilations and other
related technical information) may be obtained through www.astm.org.
The FAA maintains a list of accepted means of compliance on the FAA
website at www.https://uasdoc.faa.gov/listMOC.
    This NOA serves as acceptance by the Federal Aviation
Administration of the ASTM Remote Identification Standard F3586-22,
with additions specified in NOA Docket No.FAA-2022-0859 and corrections
to ASTM F3586-22 specified in this NOA, as a means of compliance for
meeting the requirements of part 89, subpart D.

    Issued in Kansas City, Missouri, on October 13, 2023.
Patrick R. Mullen,
Manager, Technical Policy Branch, Policy and Standards Division,
Aircraft Certification Service.
[FR Doc. 2023-23058 Filed 11-13-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37275-37276]
[FR Doc No: 2015-16011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2261]

Premarket Notification Requirements Concerning Gowns Intended for
Use in Health Care Settings; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Premarket Notification
Requirements Concerning Gowns Intended for Use in Health Care
Settings.'' FDA is issuing this draft guidance to describe the Agency's
premarket regulatory requirements and the performance testing needed to
support liquid barrier claims for gowns intended for use in health care
settings. This draft guidance is being issued in light of the public
health importance of personal protective equipment in health care
settings and the recognition that terminology used to describe gowns
has evolved, including by industry, the standards community, and health
care professionals. This draft guidance is not final nor is it in
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 31, 2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Premarket Notification Requirements Concerning Gowns Intended for Use
in Health Care Settings'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Claverie, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993-0002, 301-
796-6298.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued a final rule on June 24, 1988 (53 FR 23874), defining
``surgical apparel'' under 21 CFR 878.4040. Under this 1988 final rule,
surgical gowns and surgical masks were classified as Class II subject
to premarket review under section 510(k) (21 U.S.C. 351) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), and surgical apparel other
than surgical gowns and surgical masks were classified as Class I also
subject to 510(k) premarket review requirements. On January 14, 2000,
FDA issued a final rule (65 FR 2318) to designate as exempt from
premarket notification requirements surgical apparel other than
surgical gowns and surgical masks, subject to the limitations of
exemptions under 21 CFR 878.9, which includes requiring a premarket
notification for devices intended for a use different from the intended
use of a legally marketed device in that generic type of device.
    Since the original 1988 final rule, a number of terms have been
used to refer to gowns intended for use in health care settings
including, but not limited to, surgical gowns, isolation gowns,
surgical isolation gowns, nonsurgical gowns, procedural gowns, and
operating room gowns. In 2004, FDA recognized the consensus standard
American National Standards Institute/Association of the Advancement of
Medical Instrumentation (ANSI/AAMI) PB70:2003, ``Liquid barrier
performance and classification of protective apparel and drapes
intended for use in health care facilities.'' ANSI/AAMI PB 70 utilized
new terminology for barrier performance of gowns. This terminology
described and assessed the barrier protection levels of gowns and other
protective apparel intended for use in health care facilities, by
specifying test methods and performance results necessary to verify and
validate the newly defined levels of barrier protection. The
definitions and terminology used in this standard are inconsistent with
FDA's historical definitions of these terms and thus have added
confusion in the marketplace. The purpose of this draft guidance is to
clarify and describe the premarket regulatory requirements pertaining
to gowns regulated under Sec.  878.4040 and the performance testing
needed to support liquid barrier claims for gowns intended for use in
health care settings.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the Agency's current thinking on performance testing to
support liquid barrier claims for gowns intended for use in health care
settings. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Premarket Notification

Requirements Concerning Gowns Intended for Use in Health Care
Settings'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 1500025 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. 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. 3501-3520). The
collections of information in 21 CFR part 807, subparts A through D
have been approved under OMB control number 0910-0625; the collections
of information in 21 CFR part 807, subpart E have been approved under
OMB control number 0910-0120; the collections of information in 21 CFR
part 803 have been approved under OMB control number 0910-0437; the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801 have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16011 Filed 6-29-15; 8:45 am]
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