[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51626-51627]
[FR Doc No: 2017-24148]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-185-000.
    Applicants: Enerwise Global Technologies, Inc.
    Description: Request for Limited Waiver of ISO New England, Inc.
Tariff of Enerwise Global Technologies, Inc.
    Filed Date: 10/30/17.
    Accession Number: 20171030-5220.
    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER18-195-000.
    Applicants: American Electric Power Service Corporation, Southwest
Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: AEP Formula Rate Revisions
to be effective 1/1/2018.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5311.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-196-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: DEC-Central Electric Fifth
Amended and Restated RS No. 336 to be effective 1/1/2017.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5321.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-197-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: FPU NITSA Amendment Filing
to be effective 1/1/2018.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5334.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-198-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: Q3 2017 Quarterly Filing of
City and County of San Francisco's WDT SA (SA 275) to be effective 9/
30/2017.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5336.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-199-000.
    Applicants: Otter Tail Power Company.
    Description: Sec.  205(d) Rate Filing: Revisions to CASOT Service
Agreement No. 4 with East River Electric Power Cooper to be effective
1/1/2018.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5362.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-200-000.
    Applicants: Otter Tail Power Company.
    Description: Sec.  205(d) Rate Filing: Notice of Termination of
Rate Schedule No. 168, East River ITSA to be effective 12/31/2017.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5373.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-201-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 33--WAPA
Triangle Agreement, Exhibit A Revision No. 52 to be effective 12/31/
2017.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5376.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-202-000.
    Applicants: Startrans IO, LLC.
    Description: Sec.  205(d) Rate Filing: TRBAA 2018 Update to be
effective 1/1/2018.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5379.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-203-000.
    Applicants: Appalachian Power Company.
    Description: Sec.  205(d) Rate Filing: APCo-Radford PSA
Cancellation to be effective 9/30/2017.
    Filed Date: 11/1/17.
    Accession Number: 20171101-5036.
    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-204-000.
    Applicants: PacifiCorp.
    Description: Notice of Termination of PacifiCorp (Rate Schedule No.
607) Lease Agreement.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5387.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-205-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Notice of Termination of Pacific Gas and Electric
Company (Rate Schedule No. 240) Lease Agreement.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5388.
    Comments Due: 5 p.m. ET 11/21/17.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES18-5-000.
    Applicants: Baltimore Gas and Electric Company.
    Description: Application of Baltimore Gas and Electric Company
under Section 204 of the Federal Power Act for Authorization of the
Issuance of Securities.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5382.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ES18-6-000.
    Applicants: Commonwealth Edison Company.
    Description: Application of Commonwealth Edison Company under
Section 204 of the Federal Power Act for Authorization of the Issuance
of Securities.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5383.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ES18-7-000.
    Applicants: PECO Energy Company.
    Description: Application of PECO Energy Company under Section 204
of the Federal Power Act for Authorization of the Issuance of
Securities.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5385.
    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ES18-8-000.
    Applicants: Delmarva Power & Light Company, Potomac Electric Power
Company.
    Description: Joint Application of Delmarva Power & Light Company
and Potomac Electric Power Company under Section 204 of the Federal
Power Act for Authorization to Issue Securities.
    Filed Date: 10/31/17.
    Accession Number: 20171031-5386.
    Comments Due: 5 p.m. ET 11/21/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 1, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-24148 Filed 11-6-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Page 50670]
[FR Doc No: 2018-21790]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4337-DR; Docket ID FEMA-2018-0001]

Florida; Amendment No. 16 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-4337-DR), dated September 10, 2017, and
related determinations.

DATES: The change occurred on August 29, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Thomas J.
McCool, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Allan Jarvis as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-21790 Filed 10-5-18; 8:45 am]
BILLING CODE 9111-11-P


[Federal Register: April 18, 2006 (Volume 71, Number 74)]
[Notices]
[Page 19884-19885]
[DOCID:fr18ap06-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2150-033]

Puget Sound Energy, Inc., Washington; Notice of Intent To Hold
Public Meetings for the Baker River Hydroelectric Project

April 11, 2006.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the application for a license for the
Baker River Hydroelectric Project (FERC No. 2150-033), located on the
Baker River in Whatcom and Skagit counties, Washington and has prepared
a Draft Environmental Impact Statement (EIS) for the project. The
project occupies 5,207 acres of lands within the Mt. Baker-Snoqualmie
National Forest managed by the U.S. Forest Service.
    Copies of the draft EIS are available for review in the
Commission's Public Reference Branch or may be viewed on the
Commission's Web site at http://www.ferc.gov under the eLibrary link.

Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866) 208-
3676, or for TTY,<PHONE_NUMBER>.
    You are invited to attend one or both public meetings we are
holding to receive comments on the draft EIS. The time and location of
these meetings are:

    Date: Monday, May 1, 2006.
    Time: 9 a.m.-5 p.m. (pst).
    Place: U.S. Army Corps of Engineers District Office in Seattle,
Washington.
    Address: 4735 E. Marginal Way S., Seattle, Washington.
    Room: Galaxy Meeting Room.

    Date: Tuesday, May 2, 2006.
    Time: 6 p.m.-9 p.m. (pst).
    Place: Best Western Cotton Tree Inn.
    Address: 2300 Market Street, Mt. Vernon, Washington.

    At these meetings, resource agency personnel and other interested
persons will have the opportunity to provide oral and written comments
and recommendations regarding the draft EIS. The meetings will be
recorded by a court reporter, and all statements (verbal and written)
will become part of the Commission's public record for the project.
These meetings are posted on

the Commission's calendar located at: http://www.ferc.gov/EventCalendar/EventsADay.aspx?Date=5/1/2006&CalendarID=0
 along with

other related information.
    Whether, or not you attend one of these meetings, you are invited
to submit written comments on the draft EIS. Comments should be filed
with Magalie R. Salas, Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. All comments must be filed
by May 30, 2006, and should reference Project No. 2150-033. Comments
may be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and instructions on the Commission's Web site at
http://www.ferc.gov under the e-Library link.

    The Commission staff will consider comments made on the draft EIS
in preparing a final EIS for the project. Before the Commission makes a
licensing decision, it will take into account all concerns relevant to
the public interest. The final EIS will be part of the record from
which the Commission will make its decision.
    By this notice, we are modifying our processing schedule for
Puget's license application. The modified schedule is:
    Issue Final Environmental Impact Statement: June 2006.
    Ready for Commission Decision on Application: September 2006.
    For further information, contact Steve Hocking at<PHONE_NUMBER> or
at<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
[FR Doc. E6-5730 Filed 4-17-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91722-91731]
[FR Doc No: 2016-30382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 878, 880, and 895

[Docket No. FDA-2015-N-5017]
RIN 0910-AH02

Banned Devices; Powdered Surgeon's Gloves, Powdered Patient
Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's
Glove

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Powdered Surgeon's Gloves, Powdered Patient Examination
Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present
an unreasonable and substantial risk of illness or injury and that the
risk cannot be corrected or eliminated by labeling or a change in
labeling. Consequently, FDA is banning these devices.

DATES: This rule is effective on January 18, 2017.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the

heading of this final rule into the ``Search'' box and follow the
prompts, and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of Final Rule
    D. Clarifying Changes to the Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA's Responses
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Description of Comments That Oppose the Regulation and FDA
Response
    D. Description of Comments on Scope of Ban and FDA Response
    E. Description of Other Specific Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References

I. Executive Summary

A. Purpose and Coverage of the Final Rule

    Medical gloves play a significant role in the protection of both
patients and health care personnel in the United States. Health care
personnel rely on medical gloves as barriers against transmission of
infectious diseases and contaminants when conducting surgery, as well
as when conducting more limited interactions with patients. Various
types of powder have been used to lubricate gloves so that wearers
could don the gloves more easily. However, the use of powder on medical
gloves presents numerous risks to patients and health care workers,
including inflammation, granulomas, and respiratory allergic reactions.
    A thorough review of all currently available information supports
FDA's conclusion that powdered surgeon's gloves, powdered patient
examination gloves, and absorbable powder for lubricating a surgeon's
glove should be banned. FDA has concluded that the risks posed by
powdered gloves, including health care worker and patient sensitization
to natural rubber latex (NRL) allergens, surgical complications related
to peritoneal adhesions, and other adverse health events not
necessarily related to surgery, such as inflammatory responses to glove
powder, are important, material, and significant in relation to the
benefit to public health from their continued marketing. FDA has
carefully evaluated the risks and benefits of powdered gloves and the
risks and benefits of the state of the art, which includes viable non-
powdered alternatives that do not carry any of the risks associated
with glove powder, and has determined that the risk of illness or
injury posed by powdered gloves is unreasonable and substantial.
Further, FDA believes that this ban would likely have minimal economic
and shortage impact on the health care industry. Thus, a transition to
alternatives in the marketplace should not result in any detriment to
public health.
    This rule applies to powdered patient examination gloves, powdered
surgeon's gloves, and absorbable powder for lubricating a surgeon's
glove. This includes all powdered medical gloves except powdered
radiographic protection gloves. Because we are not aware of any
powdered radiographic protection gloves that are currently on the
market, FDA lacks the evidence to determine whether the banning
standard would be met for this particular device. The ban does not
apply to powder used in the manufacturing process (e.g., former-release
powder) of non-powdered gloves, where that powder is not intended to be
part of the final finished glove. Finished non-powdered gloves are
expected to include no more than trace amounts of residual powder from
these processes, and the Agency encourages manufacturers to ensure
finished non-powdered gloves have as little powder as possible. In our
2008 Medical Glove Guidance Manual (Ref. 1), we recommended that non-
powdered gloves have no more than 2 milligrams (mg) of residual powder
and debris per glove, as determined by the Association for Testing and
Materials (ASTM) D6124 test method (Ref. 2). The Agency continues to
believe this amount is an appropriate maximum level of residual powder.
The ban also does not apply to powder intended for use in or on other
medical devices, such as condoms. FDA has not seen evidence that powder
intended for use in or on other medical devices, such as condoms,
presents the same public health risks as that on powdered medical
gloves.

B. Summary of the Major Provisions of the Final Rule

    In this final rule, FDA is banning the following devices: (1)
Powdered surgeon's gloves, (2) powdered patient examination gloves, and
(3) absorbable powder for lubricating a surgeon's glove. Because the
classification regulations for these device types do not distinguish
between powdered and non-powdered versions, FDA is amending the
descriptions of these devices in the regulations to specify that the
regulations for patient examination and surgeon's gloves will apply
only to non-powdered gloves while the powdered version of each type of
glove will be added to the listing of banned devices in the
regulations.
    Many comments requested that FDA revise the scope of the ban to
include all NRL gloves. Many comments from industry requested that the
proposed effective date be extended beyond 30 days after the date of
publication of the final rule. Of the comments that do not support the
ban, commenters noted the need for powdered gloves to aid in donning
gloves and tactile sense and the reduced risks associated with current
powdered gloves that have less powder. The remaining comments are not
clearly in support or opposition to the proposal.

C. Legal Authority

    Powdered surgeon's gloves, powdered patient examination gloves, and
absorbable powder for lubricating a surgeon's glove are defined as
devices under section 201(h) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 321(h)). Section 516 of the FD&C Act (21
U.S.C. 360f) authorizes FDA to ban a device if it finds, on the basis
of all available data and information, that the device presents
substantial deception or unreasonable and substantial risks of illness
or injury, which cannot be corrected by labeling or a change in
labeling. This rule amends 21 CFR 878.4460, 878.4480, 880.6250,
895.102, 895.103, and 895.104. FDA's legal authority to modify
Sec. Sec.  878.4460, 878.4480, 880.6250, 895.102, 895.103, and 895.104
arises from the device and general administrative provisions of the
FD&C Act (21 U.S.C. 352, 360f, 360h, 360i, and 371).

D. Costs and Benefits

    The final rule is expected to provide a positive net benefit
(estimated benefits minus estimated costs) to society. Banning powdered
glove products is not expected to impose any costs to society, but is
expected to reduce the number of adverse events associated with using
powdered gloves. The primary public health benefit from adoption of the
rule would be the value of the reduction in adverse events associated
with using powdered gloves. The Agency estimates maximum total annual
net benefits to range between $26.8 million and $31.8 million.

II. Background

A. Need for the Regulation/History of the Rulemaking

    On March 22, 2016, FDA issued a proposed rule to ban powdered
surgeon's gloves, powdered patient examination gloves, and absorbable
powder for lubricating a surgeon's glove (81 FR 15173). Section
516(a)(1) of the FD&C Act authorizes FDA to ban a device intended for
human use by regulation if it finds, on the basis of all available data
and information, that such a device ``presents substantial deception or
an unreasonable and substantial risk of illness or injury.'' For a more
detailed discussion of the banning standard, we refer you to the
preamble of the proposed rule. FDA issued the proposed regulation
because it determined that powdered surgeon's gloves, powdered patient
examination gloves, and absorbable powder for lubricating a surgeon's
glove present an unreasonable and substantial risk of illness or injury
and that the risk cannot be corrected or eliminated by labeling or a
change in labeling.
    The preamble to the proposed rule describes the history of powdered
gloves and the citizen petitions received by the Agency that request a
ban on powdered gloves. We refer readers to that preamble for
information about the development of the proposed rule. The level and
types of risk presented by powdered gloves varies depending on the
composition and intended use of the glove. In aggregate, the risks of
powdered gloves include severe airway inflammation, hypersensitivity
reactions, allergic reactions (including asthma), allergic rhinitis,
conjunctivitis, dyspnea, as well as granuloma and adhesion formation
when exposed to internal tissue. We refer readers to the preamble of
the proposed rule for details on the level and types of risks presented
by powdered gloves. The benefits of powdered gloves appear to only
include greater ease of donning and doffing, decreased tackiness, and a
degree of added comfort, which FDA believes are nominal when compared
to the risks posed by these devices.
    The state of the art of both surgeon's and patient examination
gloves includes non-powdered alternatives that provide similar
performance as the various powdered glove types do. That is, there are
many non-powdered gloves available that have the same level of
protection, dexterity, and performance. Thus, based on a careful
evaluation of the risks and benefits of powdered gloves and the risks
and benefits of the current state of the art, which includes readily
available alternatives that carry none of the risks posed by powdered
gloves, FDA has determined that the standard to ban powdered gloves has
been met, and that it is appropriate to issue this ban.
    Finally, as discussed in the proposed rule, FDA also determined the
ban should apply to devices already in commercial distribution and
devices already sold to the ultimate user, as well as to devices that
would be sold or distributed in the future (see 21 CFR 895.21(d)(7)).
This means that powdered gloves currently being used in the marketplace
would be subject to this ban and adulterated under section 501(g) of
the FD&C Act (21 U.S.C. 351(g)), and thus subject to enforcement
action.

B. Summary of Comments to the Proposed Rule

    The Agency requested public comments on the proposed rule, and the
comment period closed on June 20, 2016. The Agency received
approximately 100 comment letters on the proposed rule by the close of
the comment period, each containing one or more comments on one or more
issues. We received comments from a cross-section of patients and
consumers, medical professionals, device manufacturers, and
professional and trade associations. A majority of the comments
supported the objectives of the rule in whole or in part, while a
minority of the comments opposed the objectives of the rule. Some
comments suggested changes to specific elements of the proposed rule or
requested clarification of matters discussed in the proposed rule. See
Section IV for the description of comments on the proposed rule and
FDA's responses.

C. General Overview of the Final Rule

    FDA published a proposed rule to ban powdered surgeon's gloves,
powdered patient examination gloves, and absorbable powder for
lubricating a surgeon's glove, because FDA determined that these
devices present an unreasonable and substantial risk of illness or
injury and that the risk cannot be corrected or eliminated by labeling
or a change in labeling (81 FR 15173).
    In this final rule, FDA is banning the following devices: (1)
Powdered surgeon's gloves (21 CFR 878.4460), (2) powdered patient
examination gloves (21 CFR 880.6250), and (3) absorbable powder for
lubricating a surgeon's glove (21 CFR 878.4480). Because the
classification regulations for these device types do not distinguish
between powdered and non-powdered versions, FDA is amending the
descriptions of these devices in the regulations to specify that the
regulations for surgeon's gloves (21 CFR 878.4460) and patient
examination gloves (21 CFR 880.6250) will apply only to non-powdered
gloves while the powdered version of each type of glove will be added
to 21 CFR part 895, subpart B--Listing of Banned Devices.

D. Clarifying Changes to the Rule

    While FDA believes that the preamble to the proposed rule was clear
that the proposed ban would apply to all powdered surgeon's gloves and
all powdered patient examination gloves, in reviewing the terminology
used in the proposed additions to 21 CFR part 895, FDA determined that
term ``synthetic latex'' would not cover every type of non-NRL material
that is used to manufacture powdered gloves. It was not FDA's intent to
limit the ban to only powdered NRL and powdered synthetic latex gloves,
and we believe that this intent was clear from the content of the
preamble to the proposed rule, which stated that the ban ``would apply
to all powdered gloves except powdered radiographic protection
gloves.'' As such, FDA has now revised the identification in this final
rule to clarify that the ban applies to all powdered surgeon's gloves
and powdered patient examination gloves without reference to the type
of material from which they are made. Additionally, the identification
of non-powdered surgeon's gloves and non-powdered patient examination
gloves is also being revised to remove reference to material.

III. Legal Authority

    Powdered surgeon's gloves, powdered patient examination gloves, and
absorbable powder for lubricating a surgeon's glove are defined as
medical devices under section 201(h) of the FD&C Act (21 U.S.C. 321).
Section 516 of the FD&C Act (21 U.S.C. 360f) authorizes FDA to ban a
device if it finds, on the basis of all available data and information,
that the device

presents substantial deception or unreasonable and substantial risks of
illness or injury, which cannot be corrected by labeling or a change in
labeling. This rule amends Sec. Sec.  878.4460, 878.4480, 880.6250,
895.102, 895.103, and 895.104. FDA's legal authority to modify
Sec. Sec.  878.4460, 878.4480, 880.6250, 895.102, 895.103, and 895.104
arises from the device and general administrative provisions of the
FD&C Act (21 U.S.C. 352, 360f, 360h, 360i, and 371).

IV. Comments on the Proposed Rule and FDA's Responses

A. Introduction

    We received approximately 100 comment letters on the proposed rule
by the close of the comment period, each containing one or more
comments on one or more issues. We received comments from a cross-
section of patients and consumers, medical professionals, device
manufacturers, and professional and trade associations. A majority of
the comments supported the objectives of the rule in whole or in part,
while a minority of the comments opposed the objectives of the rule.
Some comments suggested changes to specific elements of the proposed
rule or requested clarification of matters discussed in the proposed
rule.
    We describe and respond to the comments in section IV.B through E.
We have numbered each comment to help distinguish between different
comments. We have grouped similar comments together under the same
number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment or
comment topic is purely for organizational purposes and does not
signify the comment's value or importance or the order in which
comments were received.

B. Description of General Comments and FDA Response

    Many comments made general remarks supporting or opposing the
proposed rule without focusing on a particular proposed provision. In
the following paragraphs, we discuss and respond to such general
comments.
    (Comment 1) Many comments support the proposed ban on powdered
patient examination gloves and powdered surgeon's gloves. These
comments from individual consumers, health care professionals,
academia, and industry highlight several risks of the continued use of
powdered gloves, including, among others, allergic reactions, post-
operative adhesions, and delayed wound healing.
    (Response 1) FDA agrees with these comments. After further review
of all available information and the comments submitted to the proposed
rule, FDA has concluded that the public's exposure to the risks of
powdered gloves is unreasonable and substantial in relation to the
nominal public health benefit derived from the continued marketing of
these devices, especially when considering the benefits and risks posed
by readily available alternative devices. Therefore, FDA has determined
that the standard for a ban on these devices has been met.

C. Description of Comments That Oppose the Regulation and FDA Response

    FDA received some comments that oppose the proposed ban on powdered
patient examination gloves and powdered surgeon's gloves for various
reasons. We address each of these reasons for opposition in this
section. After reviewing these comments, FDA has determined that the
standard to ban powdered gloves has been met, and that it is
appropriate to issue this ban. We are finalizing the ban with only
clarifying changes.
    (Comment 2) Comments oppose the proposed ban on powdered patient
examination gloves and powdered surgeon's gloves because of difficulty
donning or doffing non-powdered gloves. Two commenters specifically
discuss hyperhidrosis with claims that it can add to the difficulty
donning and doffing non-powdered gloves. One commenter has asserted
that double-gloving is more difficult when using non-powdered gloves.
    (Response 2) As described in the preamble of the proposed rule, we
have concluded that the benefit of ease of donning or doffing powdered
gloves is generally nominal (Ref. 3) in comparison to the risks posed
by the continued marketing of powdered gloves, which, among others,
include severe airway inflammation, hypersensitivity reactions, and
allergic reactions (including asthma). Also, as noted in the proposed
rule, a study of various brands of powdered and non-powdered NRL gloves
by Cote et al. found that there are non-powdered latex gloves that are
easily donned with wet or dry hands with relatively low force compared
to the forces required to don powdered latex examination gloves (Ref.
3). Thus, FDA has considered ease of donning and doffing as a benefit
as it applies within the banning standard, and has determined that the
standard is met.
    (Comment 3) Comments oppose the proposed ban on powdered patient
examination gloves and powdered surgeon's gloves because of difficulty
donning non-powdered gloves, leading to greater propensity of non-
powdered gloves to tear. Some of these comments express concern that
the reduced ability to separate the opening of a non-powdered glove or
the greater propensity of non-powdered gloves to tear could potentially
lead to a higher degree of contamination and post-procedure infections.
    (Response 3) FDA disagrees with the assertion that non-powdered
gloves have a higher propensity to tear and thus disagrees that use of
non-powdered gloves presents a greater risk of contamination, post-
procedure infections, or exposure of the user to blood. FDA does not
believe there is compelling evidence to support the assertion that non-
powdered gloves have a higher propensity to tear. Korniewicz, et al.,
determined that the presence of powder did not affect the durability of
gloves or enhance glove donning (Ref. 4). Although Kerr, et al.,
identified a statistically significant difference in the durability of
non-powdered vinyl gloves compared to powdered vinyl gloves, this
difference may be attributed to glove type, manufacturer, and the
fingernail length of users rather than the presence or absence of
powder (Ref. 5). This study also found that vinyl gloves in general are
less durable and have a greater propensity to tear compared to nitrile,
neoprene, and latex gloves. Furthermore, as discussed in the response
to comment 4, several studies have found that alternatives to non-
powdered NRL gloves, such as nitrile and neoprene gloves, offer the
same level of protection against contamination and exposure to blood as
powdered NRL gloves (Refs. 5, 6, 7, 8, 9, and 10). Therefore, FDA has
determined that suitable alternatives to powdered gloves are readily
available in the marketplace.
    (Comment 4) Commenters oppose the proposed ban on powdered patient
examination gloves and powdered surgeon's gloves because the fit of
powdered gloves is more comfortable than non-powdered gloves. Some of
these comments assert that the reduced fit of non-powdered gloves
inhibits the tactile sensation necessary to perform medical procedures.
    (Response 4) FDA disagrees with the assertion that non-powdered
gloves inhibit the tactile sensation necessary to perform medical
procedures. The ban does not include non-powdered NRL gloves, which
offer the same

performance characteristics of powdered NRL gloves, and several studies
have found that alternatives, such as nitrile and neoprene gloves,
offer the same level of protection, dexterity, and performance as NRL
gloves (Refs. 5, 6, 7, 8, 9, and 10). Furthermore, the numerous risks
posed by the continued marketing of powdered gloves outweigh the
benefit of whatever additional level of comfort is provided from using
powdered gloves instead of the non-powdered alternatives that carry
none of these risks.
    (Comment 5) Some comments oppose the proposed ban on powdered
patient examination gloves and powdered surgeon's gloves, citing a lack
of scientific evidence that gloves with reduced powder content, as
those in use today, have the same risks as previously used gloves that
had higher powder content.
    (Response 5) FDA agrees that the maximum residual level of powder
on powdered gloves is less than earlier types of powdered gloves.
Historically, powdered medical gloves contained powder levels ranging
from 50 to over 400 mg of powder per glove. Effective in 2002, the ASTM
International recommended limits on powder levels is 15 mg per square
decimeter for surgical gloves (ASTM D3577-2001) (Ref. 11) and 10 mg per
square decimeter for patient examination gloves (ASTM D3578) (Ref. 12).
As a result, FDA believes that gloves in use after 2002 follow these
recommended limits and generally have lower powder content than earlier
types of powdered gloves. Even so, several studies indicate that gloves
with reduced powder levels continue to present unreasonable and
substantial risks to patients and health care workers. For instance, a
study conducted on the incidence of skin reactions for Greek
endodontists from 2006 to 2012 found that glove powder accounted for
the majority of skin reactions, and the replacement of powdered NRL
gloves with non-powdered gloves resolved the majority of the adverse
reactions (Ref. 13). Similarly, the risks of powdered gloves persist in
non-clinical studies using gloves with reduced powder content, as
demonstrated by the 2013 finding that surgeries performed with powdered
gloves increased the number, density, and fibrotic properties of
peritoneal adhesions in rats compared with surgeries performed with
non-powdered gloves (Ref. 14). Also, the reduction in cases of NRL-
induced occupational contact urticaria coincided with French hospitals
transitioning to non-powdered gloves after 2004-2005 (Ref. 13).
Finally, FDA is not aware of any report in the literature that supports
the assertion that currently marketed powdered gloves with lower powder
content reduce the risks presented by powdered gloves (Ref. 15). In
summary, FDA concludes that the risks of powder continue to be
unreasonable and substantial for currently marketed powdered gloves
despite lower powder content than previous generations of powdered
gloves.
    (Comment 6) Two comments oppose the proposed ban on powdered
patient examination gloves and powdered surgeon's gloves, because the
commenters believe a warning on the risks of powdered gloves is
sufficient to mitigate the risks posed by these devices.
    (Response 6) As described in Section IV of the proposed rule, FDA
has determined that no change in labeling could correct the risk of
illness or injury presented by the continued use of these devices.
Powdered gloves have additional or increased risks to health compared
to non-powdered gloves related to the spread of powder, and the fact
that powder-transported contaminants such as NRL allergens can become
aerosolized. Exposure to powder or latex allergens presents significant
risks to health care workers and patients when inhaled or when exposed
to internal tissue during oral, vaginal, gynecological, and rectal
exams. Although labeling can raise awareness of these risks, we
conclude that labeling cannot effectively mitigate these risks because
it cannot prohibit the spread of glove powder or powder-transported
contaminants. In addition, an important aspect of these devices is
their ability to affect persons other than the individual who decides
to wear or use them. For example, patients often do not know the type
of gloves being worn by the health care professional treating them, but
are still exposed to the potential dangers. Similarly, glove powder's
ability to aerosolize and carry NRL proteins exposes individuals to
harm via inhalation or surface contact. Thus, some of the risks posed
by glove powder can impact persons completely unaware or unassociated
with its employment and without the opportunity to consider the
devices' labeling. Because of this inherent quality, adequate
directions for use or warnings cannot be written that would provide
reasonable assurance of the safe and effective use of these devices for
all persons that might come in contact with them.
    Due to the ability of powder to affect people who would not have an
opportunity to read warning labels, and because potential warning
labels would raise awareness of the risks, but would not eliminate the
risks posed by glove powder, FDA has determined no label or warning can
correct the risks posed by these devices.
    (Comment 7) One comment opposes the proposed ban on powdered
patient examination gloves and powdered surgeon's gloves, because the
solvent used to remove powder during the manufacture of non-powdered
gloves may cause adverse reactions to the glove user.
    (Response 7) FDA is not aware of any report in the literature that
supports the assertion of widespread adverse reactions to solvent used
in the manufacturing process. Non-powdered patient examination and
surgeon's gloves require premarket notification (510(k)) submissions
prior to marketing. During the review of these submissions, FDA
evaluates the final finished glove, including manufacturing solvents
that are present on the final glove. FDA recommends that manufacturers
conduct and submit skin irritation and dermal sensitization studies in
these submissions to evaluate potential issues with components,
including manufacturing solvents (Ref. 1). Although individual
hypersensitivity reactions to different materials may occur, FDA has
been unable to find evidence in the literature of hypersensitivity to
typical glove manufacturing materials other than glove powder or NRL.
However, Palosuo, et al., reports that the use of hand sanitizers
containing isopropyl alcohol prior to donning gloves could cause
dermatitis reaction if the gloves are donned before the alcohol dries
(Ref. 16). The occurrence of this reaction is unrelated to the
manufacture of non-powdered gloves and unrelated to the use of non-
powdered gloves as an alternative to powdered gloves. Given the lack of
evidence of adverse reactions to solvents used in the manufacturing of
non-powdered gloves, and the established evidence demonstrating the
risks of powdered glove use, FDA continues to believe that powdered
gloves and glove powder meet the banning standard.
    (Comment 8) Several comments oppose the proposed ban on powdered
patient examination gloves and powdered surgeon's gloves due to the
expectation that users will ultimately have to pay more for medical
gloves once the ban is finalized, because the cost of non-powdered
gloves is currently higher than the cost of powdered gloves.
    (Response 8) We do not find any evidence to support the claims that

current prices of non-powdered gloves are significantly higher than
powdered gloves. As we stated in the preliminary regulatory impact
analysis (PRIA), extensive searches of glove distributor pricing
indicate that non-powdered gloves have become as affordable as powdered
gloves. Our searches also revealed that the market is saturated with
alternatives to powdered gloves, resulting in downward pressure on the
prices of non-powdered gloves. In addition, the share of powdered
medical gloves sales has been declining since at least 2000 while total
sales of all disposable medical gloves have increased (Ref. 17). We
would not expect this trend to be occurring without regulatory action
if users of disposable medical gloves faced significantly higher prices
for switching to non-powdered gloves. We therefore do not find it
necessary to update our analysis based on these comments.
    (Comment 9) We received one comment that disagrees with our
determination that the availability of examination and surgical gloves
would not be reduced.
    (Response 9) We do not find any evidence to support these claims.
As we stated in the PRIA, research shows only 7 percent of total sales
of examination and surgical gloves to medical workers were projected to
be from powdered gloves in 2010 (Ref. 17). Global Industry Analysts
(GIA) projected the share of powdered disposable medical gloves sales
to decrease to 2 percent in 2015, while total sales of all disposable
medical gloves continue to increase (Ref. 17). We would not expect this
trend to be occurring without regulatory action if there were a
reduction in the availability of disposable examination and surgical
gloves. We therefore do not find it necessary to update our analysis
based on these comments.
    (Comment 10) Commenters suggest there would be a loss in consumer
utility due to the preference some medical workers may have for
powdered gloves due to comfort and ease of use.
    (Response 10) We stated in the PRIA that the remaining 7 percent
continuing to use these powdered gloves may experience utility loss
from the removal of powdered gloves from the market (Ref. 17). The
potential loss in consumer utility would be due to the perceived loss
in comfort from powdered gloves users switching to non-powdered gloves.
However, as the GIA report shows, there has been a downward trend in
total sales of powdered gloves since at least the year 2000 while total
sales of all disposable medical gloves has increased (Ref. 17). We
would not expect this trend to be occurring without regulatory action
if the loss in consumer utility to current medical workers were
substantial. Korniewicz et al. reported no loss in consumer
satisfaction in a sample of operating room staff switching to non-
powdered surgical gloves (Ref. 4). We have not estimated this potential
burden, but the evidence described here suggests that any burden would
not be substantial. Further, even having considered that some degree of
consumer comfort may be lost by banning powdered gloves, FDA continues
to believe that this benefit is considerably outweighed by the numerous
risks posed by powdered gloves.
    (Comment 11) One comment opposes the proposed ban on powdered
patient examination gloves and powdered surgeon's gloves, because the
risks identified for powdered gloves are due to contaminants, such as
pesticides and herbicides, in the powder that would not be present if
the powder were manufactured in the United States.
    (Response 11) FDA disagrees with the assertion that contaminated
powder is the source of the risks identified for powdered gloves. FDA's
proposal to ban powdered gloves and glove powder is based on various
studies on the risks of powdered gloves due to the properties of the
powder itself. Powdered gloves have additional or increased risks to
health compared to non-powdered gloves. For example, powder on NRL
gloves can aerosolize latex allergens, resulting in sensitization to
latex and allergic reactions. Latex sensitization and allergic
reactions are unrelated to any potential presence of manufacturing
contaminants, such as pesticides and herbicides. Additional risks of
powdered gloves include severe airway inflammation, conjunctivitis,
dyspnea, as well as granuloma and adhesion formation when exposed to
internal tissue. FDA's assessment of the available literature and
information indicates that these risks are attributable to the powder
itself, as opposed to any potential presence of manufacturing
contaminants, such as pesticides and herbicides.
    In addition, the powder used on powdered gloves is required to
comply with FDA's Quality System regulation, which includes
requirements for quality and inspection for the final finished gloves
that protect against the introduction of contaminated devices into
commerce. Among other requirements, device manufacturers must establish
and maintain procedures to prevent contamination of equipment or
product by substances that could reasonably be expected to have an
adverse effect on product quality (21 CFR 820.70(e)). FDA's Quality
System regulation applies to gloves and glove powder sold in the United
States, regardless of the manufacturing location.

D. Description of Comments on Scope of Ban and FDA Response

    FDA received several comments requesting revision of the scope of
the ban. The scope of the proposed ban includes powdered surgeon's
gloves, powdered patient examination gloves, and absorbable powder for
lubricating a surgeon's glove. The glove types include all powdered
patient examination and surgeon's gloves, including NRL and synthetic
latex gloves. In the following paragraphs, we discuss and respond to
comments requesting revision of the scope of the ban. We are finalizing
the ban without change to the scope, but clarifying that all powdered
patient examination gloves and powder surgical gloves are banned,
regardless of the material from which they are made.
    (Comment 12) Several comments identify risks that result from the
use of powdered and non-powdered NRL gloves. These comments request FDA
to extend the ban to all NRL gloves, both powdered and non-powdered.
    (Response 12) Unlike with powdered latex gloves, which have the
ability to aerosolize glove powder and carry allergenic proteins, FDA
believes the risk of allergic reaction to non-powdered NRL gloves,
which affects the user and patients in direct contact with the glove,
is adequately mitigated through already-required labeling that alerts
users to this risk. NRL gloves must include a statement to alert users
to the risk of allergic reactions caused by NRL (21 CFR 801.437).
Further, several studies have indicated that the use of non-powdered
NRL gloves reduces the risk of sensitization to allergenic NRL proteins
and the number of allergic reactions experienced by those who are
already sensitized (Refs. 18, 19, and 20). FDA believes that these
study results, when considered alongside the risk mitigation that
follows from FDA's required labeling for NRL products, demonstrates
that non-powdered latex gloves can be safely used with appropriate
caution for latex-sensitive patients and health care workers.
Therefore, FDA has determined not to ban the use of all NRL gloves.
    (Comment 13) Several comments raise the issue of life threatening
latex allergy events that result from various uses of NRL gloves
including food preparation and food service. Several of these comments
assert that the Agency should broaden the scope of the ban to cover all

NRL gloves for all uses including food preparation and food service.
    (Response 13) We have concluded that it is not appropriate to
address a proposal to ban gloves used for food preparation because
these gloves do not meet the definition of a device under section
201(h) of the FD&C Act and are thus not subject to section 516 of the
FD&C Act (21 U.S.C. 360f), which provides the statutory authority to
ban devices within FDA's authority to regulate such products.
    (Comment 14) One comment asserts that the ban on powdered gloves
should not apply to dental practice, because the risks are not
applicable to dental practice.
    (Response 14) FDA disagrees with the assertion that the risks of
powdered gloves are not applicable to dental practice. Dentists and
dental patients face the same risks as other medical practices in terms
of the potential for powder exposure to open cavities or open wounds,
and for powder, if used with NRL gloves, to carry protein allergens.
Several studies documenting the risks of powdered gloves in dental
practices have been conducted, including Saary, et al., which
identified that changing to low-protein and non-powdered NRL gloves
reduced NRL allergy in dental students (Ref. 18). In addition, Charous
et al., reported in 2000 that a dental office was able to reduce
airborne NRL antigen levels to undetectable levels with the exclusive
use of non-powdered NRL gloves, permitting a highly sensitized staff
member to continue to work there (Ref. 21). These studies, among others
(Refs. 13 and 22), indicate that the risks of powdered medical gloves
apply to dental practice. Therefore, FDA has determined that the scope
of the ban on powdered medical gloves should continue to include
powdered gloves used in dental practice.

E. Description of Other Specific Comments and FDA Response

    Many comments made specific remarks requesting clarification or
revision to the proposed rule. In the following paragraphs, we discuss
and respond to such specific comments.
    (Comment 15) A number of comments request extension of the
effective date of the ban. The proposed rule included a proposed
effective date of 30 days after publication of the final rule for all
devices, including those already in commercial distribution. The
comments suggest a range of effective dates of 90 days to 18 months
after publication of the final rule and assert that a longer transition
period is necessary to allow existing inventory to flow through the
supply chain to providers and patients.
    (Response 15) FDA is not extending the effective date of the ban
for devices already in commercial distribution. We have concluded that
powdered surgeon's gloves, powdered patient examination gloves, and
absorbable powder for lubricating a surgeon's glove present an
unreasonable and substantial risk of illness or injury and that the
risk cannot be corrected or eliminated by labeling or a change in
labeling. The continued marketing of these devices beyond the 30 day
effective date would allow for the continued sale and purchase of
devices that FDA has determined present an unreasonable and substantial
risk to patients and health care workers. Therefore, FDA does not
believe that it is in the best interest of the public health to extend
the effective date for devices already in commercial distribution. In
order to minimize the risk of continued exposure of health care workers
and patients to these devices, the effective date for devices remains
30 days after the date of publication of this final rule.
    (Comment 16) One comment requests that FDA not extend the effective
date of the ban to allow companies to deplete their inventory of the
devices.
    (Response 16) As described in the response to comment 15, FDA
agrees that it is in the best interest of the public health to not
extend the effective date of the ban for devices already in commercial
distribution. Therefore, the effective date of the ban for devices
already in commercial distribution remains at 30 days after the date of
publication of the final rule.
    (Comment 17) A few comments request recommendations on the means of
disposal or recycling of powdered gloves.
    (Response 17) FDA recommends that unused inventories of powdered
medical gloves remaining at domestic manufacturing and distribution
locations be disposed of in accordance with standard industry
practices. Unused supplies at hospitals, outpatient centers, clinics,
medical and dental offices, other service delivery points (nursing
homes, etc.), and in the possession of end users, will need to be
disposed of according to established procedures of the local
community's solid waste management system. Established procedures for
these materials typically involve disposal in landfills or
incineration. FDA has concluded that this final rule will not have a
significant impact on the human environment. (See Section VII. Analysis
of Environmental Impact.)
    (Comment 18) One comment requests clarification on whether after
the effective date of the ban the Agency will permit a manufacturer to
export powdered medical gloves that are already physically located at
distribution centers in the United States.
    (Response 18) After the effective date of this final rule,
manufacturers will not be allowed to import powdered medical gloves.
However, while powdered medical gloves will be banned in the United
States on the effective date of this final rule, manufacturers may
export existing inventory of powdered gloves to a foreign country if
the device complies with the laws of that country and has valid
marketing authorization by the appropriate authority, as described in
section 802 of the FD&C Act (21 U.S.C. 382)). If eligible for export
under section 802 of the FD&C Act, a device intended for export will
not be deemed adulterated or misbranded if it
    (A) accords to the specifications of the foreign purchaser,
    (B) is not in conflict with the laws of the country to which it is
intended for export,
    (C) is labeled on the outside of the shipping package that it is
intended for export, and
    (D) is not sold or offered for sale in domestic commerce.

V. Effective Date

    This rule is effective January 18, 2017. The effective date of this
rule applies to devices already in commercial distribution and those
already sold to the ultimate user, as well as to devices that would be
sold or distributed in the future. All powdered surgeon's gloves,
powdered patient examination gloves, and absorbable powder for
lubricating a surgeon's gloves must be removed from the market upon the
effective date of this final rule. Section 501(g) of the FD&C Act (21
U.S.C. 351(g)) deems a device to be adulterated if it is a banned
device.

VI. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety,

and other advantages; distributive impacts; and equity). We have
developed a comprehensive Economic Analysis of Impacts that assesses
the impacts of the final rule. We believe that this final rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule imposes no new burdens, we certify that the
final rule will not have a significant economic impact on a substantial
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    The final rule prohibits marketing of powdered surgeon's gloves,
powdered patient examination gloves, and absorbable powder for
lubricating surgeon's gloves. The rule does not cover or include
powdered radiographic gloves.
    The final rule is expected to provide a positive net benefit
(estimated benefits minus estimated costs) to society. Banning powdered
glove products is not expected to impose any costs to society.
Extensive searches of glove distributor pricing indicate that
improvements to non-powdered gloves have made these products as
affordable as powdered gloves. The ban is expected to reduce the
adverse events associated with using powdered gloves. The Agency
estimates maximum total annual net benefits to range between $26.8
million and $31.8 million. The present discounted value of the
estimated benefits over 10 years ranges from $228.9 million to $270.8
million at a 3 percent discount rate and from $188.5 million to $223
million at a 7 percent discount rate.
    FDA has examined the economic implications of the rule as required
by the Regulatory Flexibility Act. If a rule will have a significant
economic impact on a substantial number of small entities, the
Regulatory Flexibility Act requires us to analyze regulatory options
that would lessen the economic effect of the rule on small entities.
This rule will not impose any new burdens on small entities, and thus
will not impose a significant economic impact on a substantial number
of small entities.
    The full discussion of the economic impacts of the rule, which
includes a list of changes made in the final regulatory impact
analysis, in accordance with Executive Order 12866, Executive Order
13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform
Act is available at https://www.regulations.gov under the docket number
(FDA-2015-N-5017) for this rule and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm# (Ref. 23).

VII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental effects of
this final rule and of possible alternative actions. In doing so, the
Agency focused on the environmental impacts of its action as a result
of disposal of unused powdered surgeon's gloves, powdered patient
examination gloves, and absorbable powder for lubricating a surgeon's
glove that will need to be handled after the rule is finalized.
    The environmental assessment (EA) considered each of the
alternatives in terms of the need to provide maximum reasonable
protection of human health without resulting in a significant impact on
the environment. The EA considered environmental impacts related to
landfill and incineration of solid waste at municipal solid waste (MSW)
facilities nationwide. The selected action, if finalized, will result
in an initial batch disposal of unused powdered surgeon's gloves,
powdered patient examination gloves, and absorbable powder for
lubricating a surgeon's glove from user facilities to MSW facilities
nationwide, followed by a rapid decrease in the rate of disposal of
these devices, as supplies are depleted. The selected action does not
change the ultimate disposition of these devices but expedites their
rate of disposal and ceases future production. Overall, given the
limited number of powdered surgeon's gloves, powdered patient
examination gloves, and absorbable powder for lubricating a surgeon's
glove, currently in commercial distribution, the selected action is
expected to have no significant impact on MSW and landfill facilities
and the environment in affected communities.
    The Agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The Agency's finding of
no significant impact and the evidence supporting that finding,
contained in an EA, may be seen in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday (Ref.
24).

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
FDA is not required to seek clearance by Office of Management and
Budget under the Paperwork Reduction Act of 1995.

IX. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

X. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. ``Guidance for Industry and FDA Staff: Medical Glove Guidance
Manual,'' January 22, 2008, available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM428191.pdf.
2. ``ASTM D6124 Standard Test Method for Residual Powder on Medical
Gloves,'' 2011, available at: http://www.astm.org/Standards/D6124.htm.
3. Cote, S.J., M.D. Fisher, J.N. Kheir, et al., ``Ease of donning
commercially available latex examination gloves,'' Journal of
Biomedical Matererials Research, 43(3):331-337, 1998, available at:
http://

www.ncbi.nlm.nih.gov/pubmed/9730072.
4. Korniewicz, D.M., M.M. El-Masri, J.M. Broyles, et al., ``A
laboratory-based study to assess the performance of surgical
gloves,'' AORN Journal, 77(4):772-779, 2003, available at: http://www.ncbi.nlm.nih.gov/pubmed/12705733.
5. Kerr, L.N., M.P. Chaput, L.D. Cash, et al., ``Assessment of the
durability of medical examination gloves,'' Journal of Occupational
and Environmental Hygiene, 1(9):607-612, 2004, available at: http://www.ncbi.nlm.nih.gov/pubmed/15559332.
6. Fisher, M.D., V.R. Reddy, F.M. Williams, et al., ``Biomechanical
performance of powder-free examination gloves,'' The Journal of
Emergency Medicine, 17(6):1011-1018, 1999, available at: http://www.ncbi.nlm.nih.gov/pubmed/10595890.
7. Korniewicz, D.M., M. El-Masri, J.M. Broyles, et al.,
``Performance of latex and nonlatex medical examination gloves
during simulated use,'' American Journal of Infection Control,
30(2):133-138, 2002. available at: http://www.ncbi.nlm.nih.gov/pubmed/11944004.
8. Patel, H.B., G.J. Fleming, and F.J. Burke, ``Puncture resistance
and stiffness of nitrile and latex dental examination gloves,''
British Dental Journal, 196(11):695-700; discussion 685; quiz 707,
2004, available at: http://www.ncbi.nlm.nih.gov/pubmed/15192735.
9. Rego, A. and L. Roley, ``In-use barrier integrity of gloves:
latex and nitrile superior to vinyl,'' American Journal of Infection
Control, 27(5):405-410, 1999, available at: http://www.ncbi.nlm.nih.gov/pubmed/10511487.
10. Sawyer, J. and A. Bennett, ``Comparing the level of dexterity
offered by latex and nitrile SafeSkin gloves,'' Annals of
Occupational Hygiene, 50(3):289-296, 2006, available at: http://www.ncbi.nlm.nih.gov/pubmed/16357028.
11. ASTM, ``ASTM D3577-01a Standard Specification for Rubber
Surgical Gloves,'' 2001.
12. ASTM, ``ASTM D3578-01a Standard Specification for Rubber
Examination Gloves,'' 2001.
13. Zarra, T. and T. Lambrianidis, ``Skin reactions amongst Greek
endodontists: a national questionnaire survey,'' International
Endodontic Journal, 48(4):390-398, 2015, available at: http://www.ncbi.nlm.nih.gov/pubmed/24889504.
14. Aghaee, A., H. Parsa, M. Nassiri Asl, et al., ``Comparison of
the Effects of Powdered and Powder-free Surgical Gloves on
Postlaparotomy Peritoneal Adhesions in Rats,'' Iranian Red Crescent
Medical Journal, 15(5):442-443, 2013, available at: http://www.ncbi.nlm.nih.gov/pubmed/24349737.
15. Bensefa-Colas, L., M. Telle-Lamberton, S. Faye, et al.,
``Occupational contact urticaria: lessons from the French National
Network for Occupational Disease Vigilance and Prevention (RNV3P),''
British Journal of Dermatology, 173(6):1453-1461, 2015, available
at: http://www.ncbi.nlm.nih.gov/pubmed/26212252.
16. Palosuo, T., I. Antoniadou, F. Gottrup, et al., ``Latex medical
gloves: time for a reappraisal,'' International Archives of Allergy
and Immunology, 156(3):234-246, 2011, available at: http://www.ncbi.nlm.nih.gov/pubmed/21720169.
17. GIA, Global Industry Analysts, Inc., ``Disposable Medical
Gloves: A Global Strategic Business Report,'' 2008.
18. Saary, M.J., A. Kanani, H. Alghadeer, et al., ``Changes in rates
of natural rubber latex sensitivity among dental school students and
staff members after changes in latex gloves,'' Journal of Allergy
and Clinical Immunology, 109(1):131-135, 2002, available at: http://www.ncbi.nlm.nih.gov/pubmed/11799379.
19. Tarlo, S.M., A. Easty, K. Eubanks, et al., ``Outcomes of a
natural rubber latex control program in an Ontario teaching
hospital,'' Journal of Allergy and Clinical Immunology, 108(4):628-
633, 2001, available at: http://www.ncbi.nlm.nih.gov/pubmed/11590392.
20. Allmers, H., J. Schmengler, and C. Skudlik, ``Primary prevention
of natural rubber latex allergy in the German health care system
through education and intervention,'' Journal of Allergy and
Clinical Immunology, 110(2):318-323, 2002, available at: http://www.ncbi.nlm.nih.gov/pubmed/12170275.
21. Charous, B.L., P.J. Schuenemann, and M.C. Swanson, ``Passive
dispersion of latex aeroallergen in a healthcare facility,'' Annals
of Allergy, Asthma and Immunology, 85(4):285-290, 2000, available
at: http://www.ncbi.nlm.nih.gov/pubmed/11061471.
22. Dave, J., M.H. Wilcox, and M. Kellett, ``Glove powder:
implications for infection control,'' Journal of Hospital Infection,
42(4):283-285, 1999, available at: http://www.ncbi.nlm.nih.gov/pubmed/10467541.
23. ``Final Regulatory Impact Analysis, Final Regulatory Flexibility
Analysis, and Final Unfunded Mandates Reform Act Analysis for Banned
Devices; Proposal to Ban Powdered Surgeon's Gloves, Powdered Patient
Examination Gloves, and Absorbable Powder for Lubricating a
Surgeon's Glove,'' available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.
24. FDA, ``Finding of No Significant Impact (FONSI) and
Environmental Analysis for Banned Devices; Proposal to Ban Powdered
Surgeon's Gloves, Powdered Patient Examination Gloves, and
Absorbable Powder for Lubricating a Surgeon's Glove.''

List of Subjects

21 CFR Parts 878 and 880

    Medical devices.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
878, 880, and 895 are amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

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

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

0
2. Amend Sec.  878.4460 by revising the section heading and paragraph
(a) to read as follows:

Sec.  878.4460  Non-powdered surgeon's glove.

    (a) Identification. A non-powdered surgeon's glove is a device
intended to be worn on the hands of operating room personnel to protect
a surgical wound from contamination. A non-powdered surgeon's glove
does not incorporate powder for purposes other than manufacturing. The
final finished glove includes only residual powder from manufacturing.
* * * * *

Sec.  878.4480   [Removed]

0
3. Remove Sec.  878.4480.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
4. The authority citation for part 880 continues to read as follows:

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

0
5. Amend Sec.  880.6250 by revising the section heading and paragraph
(a) to read as follows:

Sec.  880.6250   Non-powdered patient examination glove.

    (a) Identification. A non-powdered patient examination glove is a
disposable device intended for medical purposes that is worn on the
examiner's hand or finger to prevent contamination between patient and
examiner. A non-powdered patient examination glove does not incorporate
powder for purposes other than manufacturing. The final finished glove
includes only residual powder from manufacturing.
* * * * *

PART 895--BANNED DEVICES

0
6. The authority citation for part 895 continues to read as follows:

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.

0
7. Add Sec.  895.102 to read as follows:

Sec.  895.102   Powdered surgeon's glove.

    (a) Identification. A powdered surgeon's glove is a device intended
to be worn on the hands of operating room personnel to protect a
surgical wound from contamination. A powdered surgeon's glove
incorporates powder for purposes other than manufacturing.
    (b) [Reserved]

0
8. Add Sec.  895.103 to read as follows:

Sec.  895.103   Powdered patient examination glove.

    (a) Identification. A powdered patient examination glove is a
disposable device intended for medical purposes that is worn on the
examiner's hand or finger to prevent contamination between patient and
examiner. A powdered patient examination glove incorporates powder for
purposes other than manufacturing.
    (b) [Reserved]

0
9. Add Sec.  895.104 to read as follows:

Sec.  895.104  Absorbable powder for lubricating a surgeon's glove.

    Absorbable powder for lubricating a surgeon's glove is a powder
made from cornstarch that meets the specifications for absorbable
powder in the United States Pharmacopeia (U.S.P.) and that is intended
to be used to lubricate the surgeon's hand before putting on a
surgeon's glove. The device is absorbable through biological
degradation.

    Dated: December 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30382 Filed 12-16-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 21, 2009 (Volume 74, Number 181)]
[Proposed Rules]
[Page 48028-48030]
[DOCID:fr21se09-15]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0870; Directorate Identifier 2009-CE-049-AD]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de
Aeron[aacute]utica S.A. (EMBRAER) Model EMB-500 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as: It has been found the possibility of elevator mass
balance fasteners becoming slack under certain conditions. The loose of
at least two fasteners may lead to an unbalance condition, which may
induce flutter on airplane elevators.
    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by November 5,
2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0870;
Directorate Identifier 2009-CE-049-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC),
which is the aviation authority for Brazil, has issued AD No.: 2009-09-
01, dated September 3, 2009 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    It has been found the possibility of elevator mass balance
fasteners becoming slack under certain conditions. The loose of at
least two fasteners may lead to an unbalance condition, which may
induce flutter on airplane elevators.

The MCAI requires replacement of the nuts of the right and left
elevators mass balance fasteners. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Embraer--Empresa Brasileira de Aeronautica S.A. has issued Phenom
by Embraer Service Bulletin No. 500-55-0001, dated July 24, 2009. The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 25 products of U.S.
registry. We also estimate that it would take about 4 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $80 per work-hour. Required parts would cost
about $150 per product. Where the service information lists required
parts costs that are covered under warranty, we have assumed that there
will be no charge for these costs. As we do not control warranty
coverage for affected parties, some parties may incur costs higher than
estimated here.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $11,750, or $470 per product.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Empresa Brasileira de Aeron[aacute]utica S.A. (EMBRAER): Docket No.
FAA-2009-0870; Directorate Identifier 2009-CE-049-AD.

Comments Due Date

    (a) We must receive comments by November 5, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to EMB-500 airplanes, serial numbers
50000005, 50000006, 50000008 through 50000036, 50000038 through
50000041, 50000043 through 50000046, 50000048, and 50000053,
certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    It has been found the possibility of elevator mass balance
fasteners becoming slack under certain conditions. The loss of at
least two fasteners may lead to an unbalance condition, which may
induce flutter on airplane elevators.

The MCAI requires replacement of the nuts of the right and left
elevators mass balance fasteners.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within the next 30 days after the effective date of this AD,
replace the nuts of the right-hand (RH) and left-hand (LH)
elevators' mass balance fasteners with new ones of self-locking type
bearing part number (P/N) MS21043-4. Do the replacements following
Phenom by Embraer Service Bulletin No. 500-55-0001, dated July 24,
2009.
    (2) As of 30 days after the effective date of this AD, only
install self-locking type nuts, P/N MS21043-4, on the RH and LH
elevators mass balance fasteners.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective

actions are considered FAA-approved if they are approved by the
State of Design Authority (or their delegated agent). You are
required to assure the product is airworthy before it is returned to
service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC) Brazilian Airworthiness Directive
AD No.: 2009-09-01, dated September 3, 2009, and Phenom by Embraer
Service Bulletin No. 500-55-0001, dated July 24, 2009, for related
information.

    Issued in Kansas City, Missouri, on September 15, 2009.

Scott A. Horn,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-22642 Filed 9-18-09; 8:45 am]

BILLING CODE 4910-13-P