[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7728-7732]
[FR Doc No: 2018-03608]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Medical Device Labeling Regulations.

DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2014-N-1048 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Labeling
Regulations.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device Labeling Regulations--21 CFR parts 800, 801, and 809

OMB Control Number 0910-0485--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 352), among other things, establishes requirements for the
label or labeling of a medical device so that it is not misbranded and
subject to a regulatory action. Certain provisions under section 502 of
the FD&C Act require manufacturers, importers, and distributors of
medical devices to disclose information about themselves or the devices
on the labels or labeling for the devices.
    Section 502(b) of the FD&C Act requires that for packaged devices,
the label must bear the name and place of business of the manufacturer,
packer, or distributor; and an accurate statement of the quantity of
the contents. Section 502(f) of the FD&C Act requires that the labeling
for a device must contain adequate directions for use. FDA may,
however, grant an exemption if the Agency determines that the adequate
directions for use labeling requirements are not necessary for the
particular case as it relates to protection of the public health.
    FDA regulations under parts 800, 801, and 809 (21 CFR parts 800,
801, and 809) require disclosure of specific information by
manufacturers, importers, and distributors of medical devices about
themselves or the devices, on the label or labeling for the devices, to
health professionals and consumers. Most of the regulations under parts
800, 801, and 809 are derived from requirements of section 502 of the
FD&C Act. Section 502 provides, in part, that a device shall be
misbranded if, among other things, its label or labeling fails to bear
certain required information concerning the device, is false or
misleading in any particular way, or fails to contain adequate
directions for use.
Recordkeeping Burden
    Section 801.150(a)(2) establishes recordkeeping requirements for
manufacturers of devices to retain a copy of the agreement containing
the specifications for the processing, labeling, or repacking of the
device for 2 years after the final shipment or delivery of the device.
Section 801.150(a)(2) also requires that the subject respondents make
copies of this

agreement available for inspection at any reasonable hour to any
officer or employee of the Department of Health and Human Services
(HHS) who requests them.
    Section 801.410(e) requires copies of invoices, shipping documents,
and records of sale or distribution of all impact resistant lenses,
including finished eyeglasses and sunglasses, be maintained for 3 years
by the retailer and made available upon request by any officer or
employee of FDA or by any other officer or employee acting on behalf of
the Secretary of HHS.
    Section 801.410(f) requires that the results of impact tests and
description of the test method and apparatus be retained for a period
of 3 years.
    Section 801.421(d) establishes requirements for hearing aid
dispensers to retain copies of all physician statements or any waivers
of medical evaluation for 3 years after dispensing the hearing aid.
    Section 801.430(f) requires manufacturers of menstrual tampons to
devise and follow an ongoing sampling plan for measuring the absorbency
of menstrual tampons. In addition, manufacturers must use the method
and testing parameters described in Sec.  801.430(f).
    Section 801.435(g) requires latex condom manufacturers to document
and provide, upon request, an appropriate justification for the
application of the testing data from one product on any variation of
that product to support expiration dating in the user labeling.
Third-Party Disclosure Burden
    Sections 800.10(a)(3) and 800.12(c) require that the label for
contact lens cleaning solutions bear a prominent statement alerting
consumers of the tamper-resistant feature. Further, Sec.  800.12
requires that packaged contact lens cleaning solutions contain a
tamper-resistant feature to prevent malicious adulteration.
    Section 800.10(b)(2) requires that the labeling for liquid
ophthalmic preparations packed in multiple-dose containers provide
information on the duration of use and the necessary warning
information to afford adequate protection from contamination during
use.
    Section 801.1 requires that the label for a device in package form
contain the name and place of business of the manufacturer, packer, or
distributor.
    Section 801.5 requires that labeling for a device include
information on intended use as defined under Sec.  801.4 and provide
adequate directions to assure safe use by the lay consumers.
    Section 801.61 requires that the principal display panel of an
over-the-counter (OTC) device in package form must bear a statement of
the identity of the device. The statement of identity of the device
must include the common name of the device followed by an accurate
statement of the principal intended actions of the device. Section
801.62 requires that the label for an OTC device in package form shall
bear a declaration of the net quantity of contents. The label must
express the net quantity in terms of weight, measure, numerical count,
or a combination of numerical count and weight, measure, or size.
    Section 801.109 establishes labeling requirements for prescription
devices, in which the label for the device must describe the
application or use of the device and contain a cautionary statement
restricting the device for sale by, or on the order of, an appropriate
professional.
    Section 801.110 establishes labeling requirements for a
prescription device delivered to the ultimate purchaser or user, by a
licensed practitioner. The device must be accompanied by labeling
bearing the name and address of the licensed practitioner, directions
for use, and cautionary statements, if any, provided by the order.
    Section 801.150(e) requires a written agreement between firms
involved in the assembling or packaging of a nonsterile device
containing labeling that identifies the final finished device as
sterile and then shipping such device in interstate commerce prior to
sterilization. In addition, Sec.  801.150(e) requires that each pallet,
carton, or other designated unit be conspicuously marked to show its
nonsterile nature when introduced into interstate commerce and while
being held prior to sterilization. When both requirements are met, FDA
will take no regulatory action against the device as being misbranded
or adulterated.
    Section 801.405(b)(1) provides for labeling requirements for
articles, including repair kits, re-liners, pads, and cushions,
intended for use in temporary repairs and refitting of dentures for lay
persons. Section 801.405(b)(1) also requires that the labeling contain
the word ``emergency'' preceding and modifying each indication-for-use
statement for denture repair kits, and the word ``temporary'' preceding
and modifying each indication-for-use statement for re-liners, pads,
and cushions.
    Section 801.405(c) provides for labeling requirements that contain
essentially the same information described under Sec.  801.405(b)(1).
The information is intended to enable a lay person to understand the
limitations of using OTC denture repair kits and denture re-liners,
pads, and cushions.
    Section 801.420(c)(1) requires that manufacturers or distributors
of hearing aids develop a user instructional brochure to be provided by
the dispenser of the hearing aid to prospective users. The brochure
must contain detailed information on the use and maintenance of the
hearing aid.
    Section 801.420(c)(4) establishes requirements that the user
instructional brochure or separate labeling provide for technical data
elements useful for selecting, fitting, and checking the performance of
a hearing aid. In addition, Sec.  801.420(c)(4) provides for testing
requirements to determine that the required data elements must be
conducted in accordance with the American National Standards Institute
(ANSI) ``Specification of Hearing Aid Characteristics,'' ANSI S3.22-
2003 (Revision of ANSI S3.22-1996), which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    Section 801.421(b) establishes requirements for the hearing aid
dispenser to provide prospective users with a copy of the user
instructional brochure along with an opportunity to review content,
either orally or by the predominant method of communication used during
the sale.
    Section 801.421(c) establishes requirements for the hearing aid
dispenser to provide a copy of the user instructional brochure to the
prospective purchaser of any hearing aid upon request, or, if the
brochure is unavailable, provide the name and address of the
manufacturer or distributor from which it may be obtained.
    Section 801.430(d) establishes labeling requirements for menstrual
tampons to provide information on signs, risk factors, and ways to
reduce the risk of Toxic Shock Syndrome (TSS).
    Section 801.430(e)(2) requires menstrual tampon package labels to
provide information on the ranges of absorbency and absorbency term
based on testing required under Sec.  801.430(f) and an explanation of
selecting absorbencies that reduce the risk of contracting TSS.
    Section 801.435(b), (c), and (h) establishes requirements for
condom labeling to bear an expiration date that is supported by testing
that demonstrates the integrity of three random lots of the product.
    Section 809.10(a) and (b) establishes requirements that a label for
an in vitro

diagnostic (IVD) device and the accompanying labeling (package insert)
must contain information identifying its intended use, instructions for
use, lot or control number, and source.
    Section 809.10(d) provides that the labeling requirements for
general purpose laboratory reagents may be exempt from the requirements
of Sec.  809.10(a) and (b) if the labeling contains information to
include, identifying its intended use, instructions for use, lot or
control number, and source.
    Section 809.10(e) provides that the labeling for ``Analyte Specific
Reagents'' (ASRs) shall provide information to include, identifying the
quantity, proportion, or concentration of each reagent ingredient,
instructions for use, lot or control number, and source.
    Section 809.10(f) provides that the labeling for OTC test sample
collection systems for drugs of abuse shall include, among other
things, information on the intended use, specimen collection
instructions, identification system, and information about use of the
test results.
    Section 809.30(d) requires that advertising and promotional
materials for ASRs include the identity and purity of the ASR and the
identity of the analyte.
    Section 1040.20(d) (21 CFR 1040.20) provides that manufacturers of
sunlamp products and ultraviolet lamps are subject to the labeling
regulations under part 801.
    The burden estimates are based on FDA's current registration and
listing data and shipment information.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of
        Activity/21 CFR section            Number of      records per    Total annual     Average burden per recordkeeping           Total hours
                                         recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Processing, labeling, or repacking               6,331             887       5,615,597  .5 (30 minutes)....................                    2,807,799
 agreement--801.150(a)(2).
Impact resistant lenses; invoices,               1,119          47,050      52,648,950  0.0008 (.05 minutes)...............                       42,119
 shipping documents, and records of
 sale or distribution--801.410(e) and
 (f).
Hearing aid records--801.421(d).......          10,000             160       1,600,000  .25 (15 minutes)...................                      400,000
Menstrual tampons, sampling plan for                16              11             176  80.................................                       14,080
 measuring absorbency--801.430(f).
Latex condoms; justification for the                51            3.65             186  1..................................                          186
 application of testing data to the
 variation of the tested product--
 801.435(g).
                                       -----------------------------------------------------------------------------------------------------------------
    Total.............................  ..............  ..............  ..............  ...................................                    3,264,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                                                 Number of      disclosures    Total annual
           Activity/21 CFR section              respondents         per         disclosures          Average burden per disclosure          Total hours
                                                                respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contact lens cleaning solution labeling--                 25               8             200  1.........................................             200
 800.10(a)(3) and 800.12(c).
Liquid ophthalmic preparation labeling--                  25               8             200  1.........................................             200
 800.10(b)(2).
Manufacturer, packer, or distributor                  18,137               7         126,959  1.........................................         126,959
 information--801.1.
Adequate directions for use--801.5..........           8,526               6          51,156  22.35.....................................       1,143,337
Statement of identify--801.61...............           8,526               6          51,156  1.........................................          51,156
Declaration of net quantity of contents--              8,526               6          51,156  1.........................................          51,156
 801.62.
Prescription device labeling--801.109.......           9,681               6          58,086  17.77.....................................       1,032,188
Retail exemption for prescription devices--           30,000             667      20,010,000  .25 (15 minutes)..........................       5,002,500
 801.110.
Processing, labeling, or repacking; non-                 453              34          15,402  4.........................................          61,608
 sterile devices--801.150(e).
Labeling of articles intended for lay use in              35               1              35  4.........................................             140
 the repairing and/or refitting of dentures--
 801.405(b)(1).
Dentures; information regarding temporary                 35               1              35  4.........................................             140
 and emergency use--801.405(c).
Labeling requirements for hearing aids--                 124              12           1,488  40........................................          59,520
 801.420(c)(1).
Technical Data for hearing aids--                        124              12           1,488  80........................................         119,040
 801.420(c)(4).
Hearing aids, opportunity to review User              10,000             160       1,600,000  .30 (20 minutes)..........................         480,000
 Instructional Brochure--801.421(b).
Hearing aids, availability of User                    10,000               5          50,000  .17 (10 minutes)..........................           8,500
 Instructional Brochure--801.421(c).
User labeling for menstrual tampons--                     16               8             128  2.........................................             256
 801.430(d).

Menstrual tampons, ranges of absorbency--                 16               8             128  2.........................................             256
 801.430(e)(2).
User labeling for latex condoms--801.435(b),              51               6             306  100.......................................          30,600
 (c), and (h).
Labeling for IVDs--809.10(a) and (b)........           1,700               6          10,200  80........................................         816,000
Labeling for general purpose laboratory                  300               2             600  40........................................          24,000
 reagents--809.10(d)(1).
Labeling for analyte specific reagents--                 300              25           7,500  1.........................................           7,500
 809.10(e).
Labeling for OTC test sample collection                   20               1              20  100.......................................           2,000
 systems for drugs of abuse testing--
 809.10(f).
Advertising and promotional materials for                300              25           7,500  1.........................................           7,500
 ASRs--809.30(d).
Labeling of sunlamp products--1040.20(d)....              19               1              19  10........................................             190
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       9,024,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of recordkeepers/respondents and records/disclosures has
been adjusted to reflect updated Agency data. These adjustments result
in an increase of 1,598,48 hours since the last OMB approval.

    Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03608 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Proposed Rules]
[Pages 72971-72972]
[FR Doc No: 2023-23430]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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

========================================================================

Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-1006; Airspace Docket No. 22-AWP-65]
RIN 2120-AA66

Modification of Class E Airspace; Minden-Tahoe Airport, Minden,
NV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM).

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

SUMMARY: This action proposes to modify the Class E airspace extending
upward from 700 feet above the surface at Minden-Tahoe Airport, Minden,
NV. Additionally, this action proposes administrative amendments to
update the airport's Class E airspace legal description. These actions
would support the safety and management of instrument flight rules
(IFR) operations at the airport.

DATES: Comments must be received on or before December 8, 2023.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-1006 and
Airspace Docket No. 22-AWP-65 using any of the following methods:
    * Federal eRulemaking Portal: Go to www.regulations.gov and follow
the online instructions for sending your comments electronically.
    * Mail: Send comments to Docket Operations, M-30; U.S. Department
of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
    * Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    * Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or go to the Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    FAA Order JO 7400.11H, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Keith T. Adams, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify Class E airspace to support IFR operations
at Minden-Tahoe Airport, Minden, NV.

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal. The most
helpful comments reference a specific portion of the proposal, explain
the reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one time if comments are filed electronically, or
commenters should send only one copy of written comments if comments
are filed in writing.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or delay. The FAA may change this proposal in light
of the comments it receives.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

Availability of Rulemaking Documents

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Operations office (see ADDRESSES section for address, phone number, and
hours of operations). An informal docket may also be examined during
normal business hours at the Northwest Mountain Regional Office of the
Federal Aviation Administration, Air Traffic Organization, Western
Service Center, Operations Support Group, 2200 S 216th Street, Des
Moines, WA 98198.

Incorporation by Reference

    Class E5 airspace areas are published in paragraph 6005 of FAA
Order JO 7400.11, Airspace Designations and Reporting Points, which is
incorporated by reference in 14 CFR 71.1 on an

annual basis. This document proposes to amend the current version of
that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective
September 15, 2023. These updates would be published in the next update
to FAA Order JO 7400.11. That order is publicly available as listed in
the ADDRESSES section of this document.
    FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

Background

    The FAA published an NPRM in the Federal Register for FAA-2023-1006
(88 FR 54252; August 10, 2023) to modify Class E airspace at the
Minden-Tahoe Airport for the purpose of containing the Area Navigation
(RNAV) Global Positioning System (GPS) Runway (RWY) 16 and the RNAV
(GPS) RWY 34 approaches. Subsequent to the publication of the NPRM, the
FAA discovered substantive errors in the description of the proposed
amendment. This SNPRM updates the FAA's proposal to correct those
errors.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to modify the
Class E airspace extending upward from 700 feet above the surface at
Minden-Tahoe Airport, Minden, NV. The Class E airspace's radius is
excessive and should be reduced by 2.3 miles to be within a 4.2-mile
radius of the airport to more appropriately contain IFR operations.
    An 8.9-mile extension should be added to the north to better
contain departing IFR operations until they reach 1,200 feet above the
surface. Additionally, a 7-mile extension should be added to the south
to better contain arriving IFR operations below 1,500 feet above the
surface.
    Finally, the FAA proposes administrative modifications to the
airport's associated legal description. The airport's geographic
coordinates on line three of the text header should be updated to match
the FAA's database.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures,'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11H, Airspace Designations and Reporting Points, dated August 11,
2023, and effective September 15, 2023, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth

* * * * *

AWP NV E5 Minden, NV [Amended]

Minden-Tahoe Airport, NV
    (Lat. 39[deg]00'02'' N, long. 119[deg]45'04'' W)
    That airspace extending upward from 700 feet above the surface
within a 4.2-mile radius of the airport, that airspace 2 miles each
side of the airport's 001[deg] bearing extending from the 4.2-mile
radius to 8.9 miles north of the airport, and that airspace 1.1
miles each side of the airport's 180[deg] bearing extending from the
4.2-mile radius to 7 miles south of the airport.
* * * * *

    Issued in Des Moines, Washington, on October 18, 2023.
B.G. Chew,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2023-23430 Filed 10-23-23; 8:45 am]
BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

January 18, 2011

MEMORANDUM

SUBJECT:	Meeting with the Engine Manufacturers Association (EMA)

FROM:	Angela Cullen

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a meeting held on Thursday, January 13, 2011 between EMA and EPA and included the following individuals:

      EMA: Tim Blubaugh - EMA, Tony Cook  -  Navistar, Dave Kayes  -  Daimler, Dan Kieffer  -  Kenworth, Al Pearson  -  Daimler, Gary Salemme  -  Cummins, Mike Sorrells  -  Volvo, Brian Burton  -  Daimler, Matt Markstaller  -  Daimler, Jason Krajewski  -  Daimler, John Brzustowicz  -  Daimler, Rick Mihelic  -  Peterbilt, Peter Kilcline  -  PACCAR,  Josef Tarp - Kenworth              EPA: Byron Bunker, Cle Jackson, Chien Sze, Sam Waltzer, Arvon Mitcham, and Angela Cullen

The discussion focused on developing a reference method for measuring the aerodynamic performance of heavy-duty vehicles.


 ADVANCE \y63

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	REGION III

1650 Arch Street

	Philadelphia, Pennsylvania 19103-2029

									May 13, 2013

Honorable Collin P. O’Mara, Secretary								 Delaware Department of
Natural Resources

  and Environmental Control

89 Kings Highway

Dover, Delaware 19901

Dear Secretary O’Mara:

On April 2, 2013, the U.S. Environmental Protection Agency (EPA)
received a revision to the Delaware State Implementation Plan (SIP) from
the Delaware Department of Natural Resources and Environmental Control.
The SIP revision addresses the requirements of the Clean Air Act section
110 infrastructure elements for the 2010 nitrogen dioxide national
ambient air quality standards.  EPA has determined that the submittal is
administratively and technically complete, and is being reviewed to
prepare a Notice of Proposed Rulemaking (NPR).

If members of your staff have any questions, they may direct them to
Rose Quinto, Office of Air Program Planning at<PHONE_NUMBER>, or at
<EMAIL_ADDRESS> She is the principal contact for this rulemaking.

Sincerely,

							/s/

        	Diana Esher, Director

Air Protection Division

cc:  Mr. Ali Mirzakhalili, DNREC

       Mr. Ronald D. Amirikian, DNREC

	Customer Service Hotline: 1-800-438-2474