Technical Support Document (TSD) For

Emissions Inventories for the Pittsburgh – Beaver Valley Pennsylvania

8 Hour Ozone Redesignation Request, Maintenance Plan, and,

State Implementation Plan (SIP) Base Year Inventory.

Submitted May 2007 by the Pennsylvania

Department of Environmental Protection

TSD Prepared May 2007 by

Janet C. Kremer

Air Quality Analysis Branch, 3AP22

U.S. Environmental Protection Agency, Region 3

1650 Arch Street

Philadelphia, Pennsylvania 19103

_________________/S/________________________

Reviewed by Walter Wilkie, Chief

Air Quality Analysis Branch (3AP22)

_____5/30/07______

Date Signed

Introduction

The purpose of this document is to provide a technical summary of the
Air Quality Analysis Branch’s (AQAB) review of the emissions
inventories submitted with the Pittsburgh – Beaver Valley,
Pennsylvania 8 Hour Ozone Redesignation Request, Maintenance Plan and
State Implementation Plan (SIP) Base Year Inventory by the Pennsylvania
Department of Environmental Protection (PADEP).  This review does not
determine the approvability of the Redesignation Request or Maintenance
Plan; but it does determine the approvability of the SIP Base Year
Inventory.  Emissions inventories in a redesignation request are used to
show permanent and enforceable emission reductions between the year the
area was designated as a  nonattainment area and the year the area came
into attainment.  In a maintenance plan, the emissions inventories are
used to reflect the emissions during the time the area came into
attainment and are then projected to show that the area will remain in
attainment.  A SIP Base Year Inventory is the starting point from which
other SIP inventories are derived as well as serving as the benchmark
for other SIP planning activities, such as the establishment of an
emissions reduction credit program.  The Pittsburgh – Beaver Valley
Area, which consists of Allegheny, Armstrong, Beaver, Butler, Fayette,
Washington, and Westmoreland Counties, was designated as an 8 hour ozone
nonattainment area with a Subpart 1 classification.  Subpart 1 area(s)
are required to submit SIP base year inventories to EPA by June 15,
2007.  PADEP has included this early submission of SIP base year with
the redesignation request and maintenance plan package and has requested
EPA’s approval.

Any questions pertaining to this technical summary should be directed to
Walter K. Wilkie, Chief, Air Quality Analysis Branch, at<PHONE_NUMBER> or
via email at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

II 	Emissions Inventories for Redesignation Request (Base Year
Inventory)

	In a redesignation request, emissions inventories are used to support
the States claim that the area has permanent and enforceable emissions
reductions.  In order to do this, the state should estimate the percent
reduction (from the year that was used to determine the design value for
designation and classification) achieved from federal and state control
measures; this is usually termed as the “base year” inventory. The
base year inventory contains VOC and NOx emissions for all source
categories, which includes point, area, onroad mobile, and nonroad
mobile for the ozone season.

	In the Pittsburgh - Beaver Valley redesignation request, the base year
used was 2002.  The Point Source data for 2002 is derived from the
Pennsylvania Air Information Management System (AIMS).  The AIMS
database is comprised of sources identified and inventoried by PADEP’s
regional and central offices through permitting, field inspections, and
surveys.  Surveys are conducted annually as facilities must submit
emission estimates for various operations, throughputs, work hours, as
well as process data, such as combustion unit data and fuel
characteristics. For its redesignation request, PADEP provided its 2002
actual summer weekday emissions for NOx and VOC at the facility level
and by Source Classification Codes (SCCs).  “Summer weekday
emissions” is defined by PADEP as an average day’s emissions for a
typical summer day during the ozone season.

	For the 2002 Nonpoint Source emissions, also known as “area
sources,” PADEP provided an inventory that contained estimations of
emissions by multiplying an emission factor by some known indicator or
activity level for each category at the county level.  These emissions
are typically calculated on an annual basis because the activity data
are generally only available on an annual basis.  PADEP further
converted these annual emissions to seasonal emissions, for ozone, the
summer season is defined as peak ozone season months of June, July, and
August.  Seasonal estimates were calculated using default monthly and
weekly profiles from EPA’s Emissions Modeling Clearing House (EMCH).
Nonpoint source estimates were provided by SCC.

	The Nonroad Mobile Source 2002 inventory was prepared with EPA’s
NONROAD2005 model.  NONROAD estimates fuel consumption and emissions of
total hydrocarbons, carbon monoxide, nitrogen oxides, sulfur dioxide,
and particulate matter for all nonroad mobile source categories except
for aircraft, locomotives, and commercial marine vessels.  PADEP
provided emission estimates for locomotive engines and aircraft
emissions separately.  For locomotive engine emissions, PADEP projected
emissions from a 1999 survey using national fuel consumption information
and EPA emission and conversion factors.  Emissions from commercial
aircraft emissions were estimated using the EPA’s Emissions and
Dispersion Modeling System (EDMS).  Commercial aircraft operations were
modeled directly by EDMS for Pittsburgh International Airport and a
small amount from Arnold Palmer Regional Airport.  Small aircraft
emissions were calculated by using small airport operation statistics,
which can be found at ww.airnav.com.  All Nonroad mobile source
emissions were provided by SCC and classification.

	The Onroad Mobile Source 2002 emissions inventory was developed using
the most current version of EPA’s highway mobile source emissions
model MOBILE 6.2. PADEP also used PPSUITE, an enhanced version of the
Post Processor for Air Quality software systems used for previous
inventory and conformity submissions in Pennsylvania.  Traffic data
source and fleet data inputs were supplied by the 2002 PENNDOT Roadway
Management System.  PADEP provided Mobile6.2 input and output files for
review as a part of their redesignation request.  Mobile emissions
values were given in units of tons per summer day and were provided by
SCC.

AQAB staff reviewed the files and the emission results provided by PADEP
and found them to be reasonable for use in this redesignation request.

III.	Emissions Inventories for Maintenance Plan

2004 Attainment Year Inventory and Maintenance Plan Base Year Inventory

As stated earlier, emissions inventories are used to show emission
reductions for the area between the year of designation to nonattainment
and the year of attainment.  The inventory used for the year of
attainment is called the Attainment Year Inventory and also is referred
to as the Maintenance Plan Base Year Inventory.  This inventory is used
as the basis for the projected inventories that are used to show the
area will remain in attainment.  This section will discuss the 2004
Attainment Year Inventory that was used in the Pittsburgh - Beaver
Valley Redesignation Request and Maintenance Plan submitted by PADEP.

PADEP compiled an actual 2004 Point Source inventory for the Pittsburgh
- Beaver Valley Redesignation Request and Maintenance Plan.  The 2004
point source inventory contained point source emissions derived from the
Pennsylvania Air Information Management System (AIMS).  As previously
discussed, AIMS houses all point source data compiled by various
programs (permitting, enforcement, etc.).  For its redesignation
request, PADEP provided its 2004 actual summer weekday emissions for NOx
and VOC at the facility level and by Source Classification Codes (SCCs).
 “Summer weekday emissions” is defined by PADEP as an average
day’s emissions for a typical summer day during the ozone season.

For the 2004 Nonpoint Source emissions, PADEP provided a projected
inventory from the 2002 inventory.  The factors used for the temporal
allocation of projections were provided by the Mid-Atlantic Regional Air
Management Association (MARAMA).  The factors were from EPA’s Sparse
Matrix Operator Kernel Emissions (SMOKE) v2.2 input files.  Data from
2004 area sources is a linear interpolation of between the 2002 base
year and the 2009 projected inventory.  Emissions were provided by SCC
and units were in tons per summer day.

	The 2004 emissions for Nonroad Mobile Source emissions were estimated
using the EPA NONROAD2005 model.  The NONROAD model estimates emissions
of total hydrocarbons, carbon monoxide, nitrogen oxides, sulfur dioxide,
and particulate matter for diesel, gasoline, liquefied petroleum
gasoline and compressed natural gas-fueled nonroad equipment categories.
 Locomotives and aircraft were developed separately by PADEP.  Just as
with the 2002 nonroad inventory, for locomotive emissions in 2004, PADEP
projected emissions from a 1999 survey using national fuel consumption
information and EPA emission and conversion factors.  For commercial
aircraft emissions, PADEP estimated emissions by growing the 2002
emissions modeled in EDMS using operations projection in the Federal
Aviation Administration’s APO Terminal Area Forecast Detailed Report.
Nonroad mobile source emissions were provided by SCC and classification
and were given in units of tons per summer day.

	The Onroad Mobile Source 2004 emissions inventory was developed using
the most current version of EPA’s highway mobile source emissions
model MOBILE 6.2.  In addition, PADEP uses a MOBILE pre- and post-
processing software package, PPSUITE, to process and compile
Pennsylvania’s highway data.  PPSUITE has been used in previous
inventory and conformity submittals from Pennsylvania.  Traffic data
source and fleet data inputs were supplied by the 2002 PENNDOT Roadway
Management System.  PADEP provided sample Mobile6.2 input and output
files for review.  Mobile emissions values were given in units of tons
per summer day and were provided by SCC.

AQAB staff reviewed the files and emission results and believes them to
be reasonable for use in the maintenance plan.

2009 and 2018 Projection Emission Inventories

Projection inventories are used to show that the area will remain in
attainment.  Projection inventories for the years 2009 and 2018 were
used for the Pittsburgh - Beaver Valley Maintenance Plan.  Inventories
were developed for all emission sources for both years.

PADEP used projection inventories for point and nonpoint sources
prepared by MACTEC Federal Programs, Inc., for the Mid-Atlantic Regional
Air Management Association (MARAMA).  MACTEC’s projected inventories
were from 2002, not 2004. PADEP’s 2004 inventory was not available at
the time of MACTEC’s work.

The Point Source emissions for 2009 and 2018 were projected, for both
EGUs and non EGUs, using growth factors from EPA’s Economic Growth and
Analysis System, Version 5.0 (EGAS 5.0) and the Department of Energy’s
Annual Energy Outlook 2005 fuel consumption forecasts.  In addition, for
non-EGUs, state-supplied population, employment and other emission
projection data were also applied to account for changes in economic
activity.  Then, control factors were applied to account for future
emission reductions from on-the-books (OTB) control regulations and
on-the-way (OTW) control regulations.

	The Nonpoint Source emissions for 2009 and 2018 were projected using
growth factors to account for population and economic activity.  Then,
as with point sources, control factors were used to account for future
emission reductions from on-the-books (OTB) control regulations and
on-the-way (OTW) control regulations.

For the 2009 and 2018 Nonroad Mobile Source inventories, PADEP used
EPA’s NONROAD2005 model to generate these future inventories.  The
NONROAD model allows for the calculation of past year, present year, and
future year inventories (up to the year 2050) to be generated.  Growth
for locomotives came from the Association of American Railroads and
compared well with EGAS; and, commercial aircraft growth was estimated
from the Federal Aviation Administration’s APO Terminal Area Forecast
Detailed Report.

The 2009 and 2018 Onroad Mobile Source inventories were generated using
EPA’s MOBILE6.2.  In addition, PADEP used a PENNDOT study completed in
2005, “Statistical Evaluation of Projected Traffic Growth, Traffic
Growth Forecasting System:  Final Report, March 14, 2005” that
provided information used to forecast traffic volumes.  Growth rates for
vehicle miles traveled (VMT), and four functional road classifications
in each Pennsylvania county:  urban interstate, urban non-interstate,
rural interstate, and rural non-interstate were incorporated with
traffic data and socioeconomic forecasts which is inputted in PPSUITE to
calculate VMT and speeds; the output is then run in MOBILE6.2 to
calculate emissions.

AQAB staff reviewed the procedures, and found them to be reasonable for
development of these inventories.

IV.	2002 SIP Base Year Inventory

	The SIP base year inventory is the primary inventory from which other
inventories (3-year cycle inventories, reasonable further progress
inventories, modeling inventories) are derived.  The Clean Air Act calls
for State, local, and Tribal agencies to ensure that the base year
inventory is comprehensive, accurate, and current for all actual
emissions.  The base year inventory includes emissions estimates from
stationary point and nonpoint sources, onroad mobile sources, and
nonroad mobile sources.  For the 8-hour ozone NAAQS, the pollutants to
be inventoried are VOC, NOx and CO (carbon monoxide).  For the 8-hour
ozone NAAQS, VOC, NOx and CO emissions should be reported as actual
annual and actual summer weekday emissions (defined as an average
day’s emissions for a typical summer day during the ozone season).
PADEP’s base year inventory is for 2002.  A significant amount of
documentation is required for these SIP base year estimates which PADEP
has provided.

In the case of Pittsburgh - Beaver Valley, it was designated as an 8
hour ozone nonattainment area with a Subpart 1 classification.  Subpart
1 area(s) are required to submit SIP base year inventories to EPA by
June 15, 2007.  PADEP elected to include this early submission of the
SIP base year with its redesignation request and maintenance plan
package and has requested EPA’s approval.

	PADEP’s methodologies concerning the generation of point, nonpoint,
onroad mobile and nonroad mobile emissions for the SIP base year are the
same as for the 2002 base year redesignation request.  However, EPA
guidance required, in addition to the NOx and VOC summer day emissions,
annual emissions for NOx and VOCs.  Further, the EPA guidance required
annual and summer day estimates for CO.

	PADEP also applied rule effectiveness and rule penetration for its 2002
8-hour ozone SIP base year inventories.  Rule effectiveness reflects the
actual ability of a regulatory program to achieve the emission
reductions required by regulation (or perhaps voluntarily adopted).  In
the 2005, EPA developed recommendations to revise EPA’s existing rule
effectiveness guidance; due to the fact that PADEP’s inventory was
developed prior to the issuance of the new rule effectiveness policy,
EPA’s previous policy was followed, which assumed an 80% rule
effectiveness for applicable sources unless otherwise specified.  Rule
penetration is an estimate of percentage of emissions in a source
category that are emitted at facilities subject to the requirements of a
rule.  PADEP applied rule penetration for its nonpoint sources at 60%.

AQAB staff reviewed the results, procedures, and methodologies for the
SIP base year, and found them to be approvable.  The following table
summarizes PADEP’s 2002 SIP Base Year for Pittsburgh - Beaver Valley.

Pittsburgh 2002 SIP Base Year

 	VOC Emissions	NOx Emissions	CO Emissions

Source Type	Tons/yr	Tons/day	Tons/yr	Tons/day	Tons/year	Tons/day

Point Sources	6134.0	16.5	92842.2	250.4	50966.0	134.5

Nonpoint Sources 	40162.6	100.3	33052.2	11.5	33052.2	61.6

Onroad Mobile Sources	29285.5	86.4	493445.8	173.9	493445.8	630.1

Nonroad Mobile Sources	15193.1	51.5	174583.3	86.1	174583.3	1105.6

TOTAL Emissions	90775.2	254.7	793923.5	521.9	752047.3	1931.8

 “Emissions Inventory Guidance for Implementation of Ozone and
Particulate Matter National Ambient Air Quality Standards (NAAQS) and
Regional Haze Regulations” EPA-454/R-05-001, August 2005


[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Page 10429]
[FR Doc No: 2011-4116]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending February 12, 2011

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under subpart
B (formerly subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2011-0024.
    Date Filed: February 9, 2011.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: March 2, 2011.
    Description: Application of Marceco, Ltd requesting a certificate
of public convenience and necessity authorizing interstate charter air
transportation.
    Docket Number: DOT-OST-2011-0026.
    Date Filed: February 9, 2011.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: March 2, 2011.
    Description:
    Application of 2106701 Ontario Inc. DBA NovaJet requesting an
exemption and a foreign air carrier permit to engage in non-scheduled
charter flights in foreign air transportation of persons, property and
mail: (1) Between any points in Canada and any points in the United
States; (2) between any point or points in the United States and any
point or points in a third country or countries, provided that, except
with respect to cargo charters, such services constitutes part of a
continuous operations, with or without a change of aircraft, that
includes service to Canada for the purpose of carrying local traffic
between Canada and the United States; and (3) other charter operations.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2011-4116 Filed 2-23-11; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40061-40063]
[FR Doc No: 2021-15891]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-Z-0025]

Medical Devices; Class I Surgeon's and Patient Examination Gloves

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

ACTION: Final order, determination.

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

SUMMARY: The Department of Health and Human Services (HHS or ``the
Department'') issued a Notice in the Federal Register of January 15,
2021, (``the January 15 notice'') which identified seven types of
reserved class I devices that the Department had determined no longer
require premarket notification. The Department and the Food and Drug
Administration (FDA or ``the Agency'') issued a Notice in the Federal
Register of April 16, 2021 (``the April 16 notice'') explaining the
basis for our current view that the seven types of reserved class I
devices identified in the January 15 notice require a premarket
notification, and explaining why the reasoning supporting the prior
determination was unsound. HHS and FDA sought comment on the matters
discussed in the April 16 notice, and have considered the comments that
were submitted to the docket. HHS and FDA are issuing this final order
and determination that the seven types of class I surgeon's gloves and
patient examination gloves listed in the January 15 notice are reserved
class I devices for which a premarket notification is required.

DATES: Compliance date: All devices subject to this order shall comply
with the order no later than August 25, 2021.

ADDRESSES: For access to the docket to read background documents or the
electronic and-written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1660, Silver Spring, MD 20993,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background Regarding Section 510(l) of the FD&C Act

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. The Medical
Device Amendments of 1976 (``1976 amendments'') (Pub. L. 94-295), and
the Safe Medical Devices Act of 1990 (Pub. L. 101-629), require FDA to
classify devices into class I (``general controls'') if there is
information showing that the general controls of the FD&C Act are
sufficient to assure safety and effectiveness; into class II (``special
controls''), if general controls, by themselves, are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide such
assurance; and into class III (premarket approval), if there is
insufficient information to support classifying a device into class I
or class II and the device is a life sustaining or life supporting
device, or is for a use which is of substantial importance in
preventing impairment of human health, or presents a potential
unreasonable risk of illness or injury.
    Unless a device is exempt from premarket notification, section
510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing
regulations, part 807 of Title 21 of the Code of Federal Regulations
(CFR), require persons who intend to market a new device to submit a
premarket notification (510(k)) demonstrating the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the FD&C Act to a legally marketed device for which premarket approval
is not required. Section 510(l)(1) of the FD&C Act, added to the
statute by the Food and Drug Administration Modernization Act of 1997
(FDAMA), provides that a 510(k) is not required for a class I device,
except for any class I device intended for a use that is of substantial
importance in preventing impairment of human health, or any class I
device that presents a potential unreasonable risk of illness or
injury. FDA refers to these as the ``reserved criteria'' and to class I
devices subject to 510(k) as ``class I reserved devices.'' Thus, class
I devices are exempt from the 510(k) requirements except for class I
device types that meet the reserved criteria under section 510(l)(1).
    As discussed in the April 16 notice, since 2017, FDA has evaluated
which devices meet the reserved criteria several times. See 86 FR 20167
at 20168. Each time, FDA has made its determinations available to the
public through publication in the Federal Register. See 63 FR 5387, 63
FR 63222, 65 FR 2296, 82 FR 17841, 84 FR 71794. In 1998, after FDAMA
was enacted, FDA evaluated all class I devices in interstate commerce
at that time, and published a notice in the Federal Register
containing: (1) A list of device types that FDA believed met the
reserved criteria and thus would remain subject to premarket
notification and (2) a list of device types that FDA believed did not
meet these criteria and thus would be exempt from such requirements.
See 63 FR 5387. Although devices that did not meet the reserved
criteria became exempt on February 19, 1998, FDA also issued proposed
and final rules amending the applicable classification regulations for
these devices, as well as for five device types that FDA had exempted
prior to FDAMA that, post-FDAMA, FDA determined meet the reserved
criteria. See 63 FR 63222, 65 FR 2296.
    On December 13, 2016, the 21st Century Cures Act (Cures Act)
amended section 510(l) of the FD&C Act, reorganizing section 510(l)
into paragraphs 510(l)(1) and (2). Section 510(l)(2) of the FD&C Act
requires FDA to identify at least once every 5 years, through
publication in the Federal Register, any type of class I device that
the Agency determines no longer requires a report under section 510(k)
of the FD&C Act to provide reasonable assurance of safety and
effectiveness.

Section 510(l)(2) of the FD&C Act further provides that, upon
publication of the Agency's determination in the Federal Register,
these devices shall be exempt from 510(k), and the classification
regulation applicable to each such type of device shall be deemed
amended to incorporate such exemption. Accordingly, in 2017, FDA
published in a notice in the Federal Register a list of class I device
types that it has determined no longer meet the reserved criteria and
are thus exempt from 510(k) (82 FR 17841). In 2019, FDA amended the
classification regulations to reflect its exemption determinations.

II. Criteria for Exemption From Section 510(k) of the FD&C Act

    Section 510(l)(1) of the FD&C Act provides that a class I device is
not exempt from the premarket notification requirements of section
510(k) of the FD&C Act if the device is intended for a use that is of
substantial importance in preventing impairment of human health, or it
presents a potential unreasonable risk of illness or injury. As
explained in the April 16 notice, section 510(l)(2) of the FD&C Act
directs FDA to identify which class I devices that FDA previously
determined meet the reserved criteria no longer meet these criteria, in
which case a 510(k) is no longer required to provide reasonable
assurance of safety and effectiveness. FDA has explained that in
determining whether either of these criteria are met, the Agency
considers, for example, its experience in reviewing premarket
notifications for each device, focusing on the risk inherent with the
device and the disease being treated or diagnosed (e.g., devices with
rapidly evolving technology or expansions of intended uses). See 63 FR
5387, 82 FR 17841. The Agency also considers the history of adverse
event reports under the medical device reporting program for these
devices, as well as their history of product recalls. Id.
    As discussed in the April 16 notice, the January 15 notice (86 FR
4088) neither discussed the reserved criteria nor explained how HHS
came to determine that the gloves no longer meet the reserved criteria;
i.e., that the gloves are not intended for a use that is of substantial
importance in preventing impairment of human health, or do not present
a potential unreasonable risk of illness or injury. The January 15
notice contained no mention of or cite to this statutory standard, nor
an explanation as to why it was left out. The April 16 notice discussed
other procedural and substantive deficiencies in the January 15 notice
that contributed to HHS's and FDA's decision to reverse the
determinations made in that notice. For example, the January 15 notice
relied solely upon adverse event reports in the Manufacturer and User
Facility Device Experience (MAUDE) as its basis for determining the
products to be exempt from 510(k), and then only adverse event reports
for a very narrow period of time. While adverse event reports are a
valuable source of information, the reports have limitations, including
the potential submission of incomplete, inaccurate, untimely,
unverified, or biased data. In addition, the incidence or prevalence of
an event cannot be determined from adverse event reports alone, due to
underreporting of events, inaccuracies in reports, lack of verification
that the device caused the reported event, and lack of information
about frequency of device use. Adverse event data is not adequate on
its own for assessing safety, let alone whether to determine a device
to be exempt from 510(k).

III. Final Order Regarding Surgeon's Gloves and Patient Examination
Gloves and Premarket Notification

    In the April 16 notice, HHS and FDA announced our view that
surgeon's gloves and patient examination gloves meet the reserved
criteria, and sought comment on this determination. HHS and FDA
received eight comments on that notice, all of which were supportive of
the determination that surgeon's gloves and patient examination gloves
meet the reserved criteria and are properly subject to premarket
notification.
    As discussed in the April 16 notice, because of their importance in
preventing impairment of human health, FDA has long considered
surgeon's and patient examination gloves to meet the reserved criteria
under section 510(l) and to be subject to the 510(k) requirement. See
63 FR 5387, 63 FR 63222, 65 FR 2296. In 2017 and 2019, FDA evaluated
all class I reserved devices to determine whether they continued to
meet the reserved criteria. See 82 FR 17841, 84 FR 71794. FDA
specifically evaluated the seven device types at issue based on its
experiences with 510(k) submissions for the gloves, the risk inherent
to the devices and the diseases they prevent, and other relevant
considerations and determined that surgeon's gloves and patient
examination gloves met the reserved criteria and therefore remained
subject to premarket notification.
    HHS and FDA continue to believe that these gloves are of
substantial importance in preventing impairment of human health or
present a potential unreasonable risk of illness or injury and thus are
subject to the reporting requirement under section 510(k) of the FD&C
Act. Based on the risks inherent to surgeon's gloves and patient
examination gloves and the diseases being prevented, FDA's experience
with these devices, and other relevant considerations, HHS and FDA have
determined that gloves with the product codes LYY, LYZ, OIG, OPC, OPH,
LZC, and OPA are intended for uses which are of substantial importance
in preventing impairment of human health or present a potential
unreasonable risk of illness or injury, and thus a report is required
under section 510(k) of the FD&C Act. Surgeon's gloves and patient
examination gloves are generally intended to prevent contamination and
the spread of pathogens, and can be the key barrier protecting against
spreading infection (Refs. 1-3). See 21 CFR 878.4460 and 880.6250. As
set forth in the April 16 notice, surgeon's gloves prevent against
contamination in the operating room (Refs. 4 and 5), medical gloves
protect against occupational exposure, for example, to chemotherapy
drugs (Refs. 6 and 7), and these gloves play an important role in
protecting the public. Review under section 510(k) is necessary to
provide reasonable assurance of their safety and effectiveness,
including by helping to assure that the identified gloves are durable
and impermeable, among other things.
    Based on this evaluation and considering the comments submitted,
HHS and FDA have made a final determination that surgeon's gloves and
patient examination gloves meet the reserved criteria and therefore are
subject to premarket notification.

IV. Further Information for Regulated Entities

    The gloves discussed in this notice are reserved, and as such, a
510(k) is required for them. In general, FDA evaluates the dimensional
and physical properties of the gloves, and nonclinical data regarding
barrier performance, biocompatibility, and residual powders, among
other information, to support the safety and effectiveness of the
gloves for their intended use. FDA also evaluates the indications for
use and labeling to ensure the devices are appropriately labeled,
consistent with their intended use. For any gloves that are
distributed--including any gloves that are presented for import--after
the compliance date of this order without premarket review, the Agency
will consider and take appropriate enforcement action, taking into
account the enforcement policy in its Guidance for Industry,
``Enforcement Policy for

Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-
19) Public Health Emergency; Guidance for Industry and Food and Drug
Administration Staff'' (Ref. 8).

V. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. *Centers for Disease Control. ``Perspectives in Disease
Prevention and Health Promotion Update: Universal Precautions for
Prevention of Transmission of Human Immunodeficiency Virus,
Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care
Settings.'' Morbidity and Mortality Weekly Report 1988; 37(25):377-
388.
2. World Health Organization. Glove Use Information Leaflet. 2009.
https://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf.
3. *Collins, A.S. ``Preventing Health Care-Associated Infections.''
In: Hughes, R.G., editor. Patient Safety and Quality: An Evidence-
Based Handbook for Nurses. Rockville (MD): Agency for Healthcare
Research and Quality (US); 2008 April. Chapter 41. https://www.ncbi.nlm.nih.gov/books/NBK2683/pdf/Bookshelf_NBK2683.pdf.
4. Alexander, J. Wesley, Joseph S. Solomkin, and Michael J. Edwards
(2011). ``Updated Recommendations for Control of Surgical Site
Infections,'' Annals of Surgery, 253(6):1082-1093.
5. Sugarbaker, P.H. (2018). ``Increased Safety of Surgical Glove
Application: The Under/Over Method'' Annals of the Royal College of
Surgeons of England, 100(4):339-340.
6. Landeck, L., E. Gonzalez, and O.M. Koch. ``Handling Chemotherapy
Drugs--Do Medical Gloves Really Protect?'' International Journal of
Cancer. 2015 October 15;137(8):1800-5. doi: 10.1002/ijc.29058. Epub
2014 July 22. PMID: 24978061
7. Nalin, M., G. Hug, E. Boeckmans, C. Machon, et al. ``Permeation
Measurement of 27 Chemotherapy Drugs After Simulated Dynamic Testing
on 15 Surgical And Examination Gloves: A Knowledge Update.'' Journal
of Oncology Pharmacy Practice. 2020 Aug 26:1078155220950423. doi:
10.1177/1078155220950423. Epub ahead of print. PMID: 32847481.
8. *FDA Guidance, ``Enforcement Policy for Gown, Other Apparel, and
Gloves During the Coronavirus Disease (COVID-19) Public Health
Emergency, Guidance for Industry and Food and Drug Administration
Staff,'' March 25, 2020, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health.

    Dated: July 12, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.

    Dated: July 21, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-15891 Filed 7-23-21; 8:45 am]
BILLING CODE 4164-01-P