Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies, 36360-36363 [E7-12789]
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Federal Register / Vol. 72, No. 127 / Tuesday, July 3, 2007 / Rules and Regulations
Background
The final regulations published March
29, 2007, changed cross-references in 20
CFR 402.35(b)(2) from §§ 404.984(b),
410.610c(b) and 416.1484(b) to
§§ 404.985(c), 410.670c(b) and
416.1485(c), respectively. However, two
of the new cross-references,
§§ 404.985(c) and 416.1485(c) should
have been §§ 404.985(b) and
416.1485(b). In addition, we omitted
another set of corrections in the same
CFR section. The next-to-last sentence
incorrectly cites 20 CFR 404.984,
410.610, and 416.1484, which should
correctly read as 20 CFR 404.985(c),
410.670c, and 416.1485(c), respectively.
Need for Correction
As published, the final regulations
contained errors at 20 CFR 402.35(b)(2).
Therefore, we are changing the last two
sentences of that section to reflect
correct CFR citations and crossreferences.
(Catalog of Federal Domestic Assistance
Programs Nos. 96.001 Social Security—
Disability Insurance; 96.002 Social
Security—Retirement Insurance; 96.004
Social Security—Survivors Insurance and
96.006 Supplemental Security Income.)
Administrative practice and
procedure; Freedom of information.
Dated: June 27, 2007.
Paul Kryglik,
Acting SSA Regulations Officer.
Accordingly, part 402 of chapter III of
title 20 of the Code of Federal
Regulations is corrected by making the
following correcting amendments:
I
PART 402—AVAILABILITY OF
INFORMATION AND RECORDS TO
THE PUBLIC
1. The authority citation for part 402
continues to read as follows:
I
Authority: Secs. 205, 702(a)(5), and 1106 of
the Social Security Act; (42 U.S.C. 405,
902(a)(5), and 1306); 5 U.S.C. 552 and 552a;
8 U.S.C. 1360; 18 U.S.C. 1905; 26 U.S.C.
6103; 30 U.S.C. 923(b); 31 U.S.C. 9701; E.O.
12600, 52 FR 23781, 3 CFR, 1987 Comp., p.
235.
2. Section 402.35 is being corrected by
revising the second and third sentences
of paragraph (b)(2) to read as follows:
I
Publication.
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(b) * * *
(2) * * * They are binding on all
components of the Social Security
Administration, except with respect to
claims subject to the relitigation
procedures established in 20 CFR
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[FR Doc. E7–12828 Filed 7–2–07; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 2007N–0198 ]
Medical Devices; General Hospital and
Personal Use Devices; Classification
of the Filtering Facepiece Respirator
for Use by the General Public in Public
Health Medical Emergencies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
List of Subjects in 20 CFR Part 402
§ 402.35
404.985(c), 410.670c, and 416.1485(c).
For a description of Social Security
Acquiescence Rulings, see 20 CFR
404.985(b), 410.670c(b), and 416.1485(b)
of this title.
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Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is classifying the
filtering facepiece respirator for use by
the general public in public health
medical emergencies into class II
(special controls). The agency is
classifying these devices into class II
(special controls) in order to provide a
reasonable assurance of the safety and
effectiveness of these devices and is
specifying what those special controls
are.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of a guidance document
entitled, ‘‘Guidance for Industry and
Food and Drug Administration Staff;
Class II Special Controls Guidance
Document: Filtering Facepiece
Respirator for Use by the General Public
in Public Health Medical Emergencies.’’
This guidance document will serve as
one of the special controls, along with
certification of the respirator by the
National Institute for Occupational
Safety and Health (NIOSH) in
accordance with its regulations for nonpowered air-purifying particulate
respirators, found in 42 CFR part 84, as
specified in the classification regulation.
DATES: This rule is effective August 2,
2007. The classification was effective
May 8, 2007.
FOR FURTHER INFORMATION CONTACT:
Sheila A. Murphey, Center for Devices
and Radiological Health (HFZ–480),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3700.
SUPPLEMENTARY INFORMATION:
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I. What is the Background of this
Rulemaking?
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360c(f)(1)),
devices that were not in commercial
distribution before May 28, 1976, the
date of enactment of the Medical Device
Amendments of 1976 (the amendments),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless the device is
classified or reclassified into class I or
class II, or FDA issues an order finding
the device to be substantially
equivalent, in accordance with section
513(i) of the act, to a predicate device
that does not require premarket
approval. The agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the act
(21 U.S.C. 360(k)) and part 807 (21 CFR
part 807) of FDA’s regulations.
Section 513(f)(2) of the act provides
that any person who submits a
premarket notification under section
510(k) of the act for a device that has not
previously been classified may, within
30 days after receiving an order
classifying the device in class III under
section 513(f)(1) of the act, request FDA
to classify the device under the criteria
set forth in section 513(a)(1) of the act.
FDA shall, within 60 days of receiving
such a request, classify the device by
written order. This classification shall
be the initial classification of the device
type. Within 30 days after the issuance
of an order classifying the device, FDA
must publish a notice in the Federal
Register announcing such classification
(section 513(f)(2) of the act).
In accordance with section 513(f)(1) of
the act, FDA issued an order on August
30, 2006, classifying the two 3M
filtering facepiece respirators intended
for use by the general public in public
health medical emergencies (designated
at that time as the 3MTM N95 Home
Respirator with Fluid Resistance and
3MTM N95 Home Respirator) in class III,
because each device was not
substantially equivalent to a device that
was introduced or delivered for
introduction into interstate commerce
for commercial distribution before May
28, 1976, or a device that was
subsequently reclassified into class I or
class II. On October 3, 2006, 3M Inc.
submitted a petition requesting initial
classification of these devices under
section 513(f) (2) of the act. The
manufacturer recommended that the
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devices be classified into class II (Ref.
1). In response to FDA requests for
additional information, 3M
supplemented its petition on March 22,
2007.
In accordance with section 513(f) (2)
of the act, FDA reviewed the petition in
order to classify the devices under the
criteria for classification set forth in
513(a)(1) of the act. Devices are to be
classified into class II 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 reasonable
assurance of the safety and effectiveness
of the device for its intended use. After
review of the information submitted in
the petition and its supplements, FDA
determined that the 3MTM filtering
facepiece respirator devices, now
known as the 3MTM 8612F Respirator
for Use by the General Public in Public
Health Medical Emergencies and 3MTM
8670F Respirator for Use by the General
Public in Public Health Medical
Emergencies can be classified into class
II with the establishment of special
controls. FDA believes that special
controls, in addition to general controls,
are adequate to provide reasonable
assurance of the safety and effectiveness
of the device and that there is sufficient
information to establish special controls
to provide such assurance.
The device is assigned the generic
name ‘‘Filtering Facepiece Respirator for
use by the General Public in Public
Health Medical Emergencies’’ and is
identified as a device that is a
disposable half-facepiece non-powered
air-purifying particulate respirator
intended for use to cover the nose and
mouth of the wearer to help reduce
wearer exposure to pathogenic
biological airborne particulates during a
public health medical emergency. The
device is made of polymeric materials
and is intended to fit closely to the face
and to function by filtering particulate
material.
FDA believes that special controls are
needed to help address the following
issues affecting the safety and
effectiveness of the filtering facepiece
respirator for use by the general public
in public health medical emergencies.
A. Assuring Filtration and Breathability
For this type of respirator to reduce
wearer exposure to pathogenic
biological airborne particulates, it must
be made of filter material that is highly
efficient in filtering such particles. At
the same time, because this type of
device depends on the wearer’s normal
respiration to draw ambient air through
the respirator materials and into the
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lungs, the respirator material must also
permit adequate respiration.
B. Assuring Proper Fit
The device must fit closely to the
wearer’s face without any gaps that
would allow air to reach the wearer’s
respiratory tract without passing
through the filter material. Otherwise,
improper fit of the respirator could
result in inhalation of pathogenic
biological airborne particulates carried
in air that passes around the sides of the
device.
C. Avoiding Adverse Skin Reaction
Reducing wearer exposure to
pathogenic biological airborne
particulates requires that the device be
properly fitted to the face. If the
respirator material in contact with the
skin is not biocompatible, it may cause
adverse reactions such as redness,
pruritus, and skin irritation.
D. Assuring Proper Use
While a filtering facepiece respirator
for use by the general public in public
health medical emergencies can help to
reduce wearer exposure to pathogenic
biological airborne particulates in a
public health medical emergency where
there is a serious risk from such
exposure, these devices do not provide
complete protection against infection.
Even when used correctly and
consistently, a filtering facepiece
respirator does not eliminate all
respiratory exposure, and for many
pathogens that may be transmitted
through airborne particulates,
transmission via other routes is also
possible. (Because filtering facepiece
respirators for use by the general public
in public health medical emergencies
have not been tested against specific
microorganisms, the extent of protection
to be expected against specific
pathogens is not known and would vary
with particular conditions in any event.)
The respirator should always be used
in conjunction with other infection
control and respiratory protection
measures. In addition, because the
outside of the respirator may be
contaminated with infectious materials
during normal use, proper handling and
disposal is important to avoid the
respirator itself becoming a vector of
transmission of infectious agents.
Further, failure of the user to assure
proper fit of the respirator could result
in exposure to pathogenic biological
airborne particles. Certain populations
such as children will be unlikely to
achieve a proper fit because respirators
are designed and sized for adults.
For users with certain underlying
cardiac, pulmonary or related medical
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conditions, achieving the fit necessary
to help reduce their exposure to
pathogenic biological airborne
particulates may exacerbate their
underlying medical conditions raising a
concern about their safe use for these
populations.
Finally, these respirators have not
been established to be safe or effective
if reused, and use of a single respirator
by multiple users may result in the
respirator itself becoming a vector of
transmission.
To address these issues, the class II
special controls guidance document
provides recommendations for labeling
and for information to be provided to
meet premarket notification (510(k))
submission requirements for the device,
including recommendations for fit
testing and biocompatibility testing. In
addition, this classification regulation
specifies another special control,
certification of the respirator by NIOSH
as a non-powered air-purifying
particulate respirator with a minimum
filtration efficiency classification of
N95, in accordance with 42 CFR part 84.
The respirators that were the subject of
the initial classification order described
in this document and that are the initial
legal predicate devices for this new
device classification were certified by
NIOSH under these requirements, as
revised as of October 1, 2006. FDA’s
determination that NIOSH certification
is an appropriate special control to help
assure the safety and effectiveness of the
respirator for its intended use under this
classification rests on the assurance of
filtration efficiency and breathability
provided by NIOSH certification under
these requirements, as effective on May
8, 2007, the date of FDA’s classification
order. Should NIOSH revise the
requirements for certification in the
future, FDA will evaluate whether
certification under such revised NIOSH
regulations is an appropriate special
control for devices within this
classification and may revise FDA’s
regulation using appropriate
procedures.
FDA believes that these special
controls, designated in this rule, in
addition to general controls, address the
issues identified previously and provide
reasonable assurance of the safety and
effectiveness of the device type. Thus,
on May 8, 2007, FDA issued an order to
the petitioner classifying the device type
into class II. FDA is codifying this
classification at 21 CFR 880.6260.
Following the effective date of the
final classification rule, manufacturers
will need to demonstrate NIOSH
certification of any filtering facepiece
respirator for use by the general public
in public health medical emergencies,
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Federal Register / Vol. 72, No. 127 / Tuesday, July 3, 2007 / Rules and Regulations
as set forth in 21 CFR 880.6260(b)(1),
and address the issues covered in the
special controls guidance. With respect
to the issues addressed only in the
special control guidance, however, the
manufacturer need only show that its
device meets the recommendations of
the guidance or in some other way
provides equivalent assurance of safety
and effectiveness.
Section 510(m) of the act provides
that FDA may exempt a class II device
from the premarket notification
requirements under section 510(k) of the
act, if FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. For filtering
facepiece respirators for use by the
general public in public health medical
emergencies, however, FDA has
determined that premarket review of fit
performance data, labeling, and other
requirements as outlined in 21 CFR
807.87, is necessary to provide
reasonable assurance that acceptable
levels of performance for both safety
and effectiveness will be addressed
before marketing clearance. Thus,
persons who intend to market this type
of device must submit to FDA a
premarket notification, prior to
marketing the device type.
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II. What is the Environmental Impact of
This Rule?
The agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Thus, neither
an environmental assessment nor an
environmental impact statement is
required.
III. What is the Economic Impact of
This Rule?
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies 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). The agency
believes that this final rule is not a
significant regulatory action as defined
by the Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
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entities. Because classification of this
device into class II will relieve
manufacturers of the cost of complying
with the premarket approval
requirements of section 515 of the act
(21 U.S.C. 360e), and may permit small
potential competitors to enter the
marketplace by lowering their costs, the
agency certifies that the final rule will
not have a significant economic impact
on a substantial number of small
entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘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 $122
million, using the most current (2005)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1–year
expenditure that would meet or exceed
this amount.
IV. Does This Final Rule Have
Federalism Implications?
FDA has 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, the
agency has concluded 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.
V. How Does This Rule Comply with
the Paperwork Reduction Act of 1995?
This final rule contains no new
information collection provisions but
refers to NIOSH regulations in 42 CFR
part 84 that contain information
collection provisions that have been
reviewed and approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520), under OMB
Control No. 0920–0109. Based on
information from NIOSH regarding
submissions for respirator certification
received in the past 3 years, FDA
concludes that specification of NIOSH
certification as a special control will not
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result in the collection of any additional
information by NIOSH not already
covered by NIOSH’s burden estimates.
This final rule also designates a
guidance document as a special control.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
announcing the availability of that
guidance document, ‘‘Class II Special
Controls Guidance Document: Filtering
Facepiece Respirators for Use by the
General Public in Public Health Medical
Emergencies,’’ which contains a
Paperwork Reduction Act analysis for
that guidance.
VI. What References are on Display?
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Petition from 3M.
2. 42 CFR part 84, as revised as of October
1, 2006.
List of Subjects in 21 CFR part 880
Medical devices.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 880 is
amended as follows:
PART 880—GENERAL HOSPITAL AND
PERSONAL USE DEVICES
1. The authority citation for 21 CFR
part 880 continues to read as follows:
I
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 880.6260 is added to
subpart G to read as follows:
I
§ 880.6260 Filtering facepiece respirator
for use by the general public in public
health medical emergencies.
(a) Identification. A filtering facepiece
respirator for use by the general public
in public health medical emergencies is
a device that is a disposable halffacepiece non-powered air-purifying
particulate respirator intended for use to
cover the nose and mouth of the wearer
to help reduce wearer exposure to
pathogenic biological airborne
particulates during a public health
medical emergency. The device is made
of polymeric materials and is intended
to fit closely to the face and to function
by filtering particulate material.
(b) Classification. Class II (special
controls). The special controls are:
(1) Certification by the National
Institute for Occupational Safety and
Health (NIOSH) as a non-powered air-
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Federal Register / Vol. 72, No. 127 / Tuesday, July 3, 2007 / Rules and Regulations
purifying particulate respirator with a
minimum filtration efficiency
classification of N95, in accordance
with 42 CFR part 84.
(2) The FDA guidance document
entitled: ‘‘Guidance for Industry and
Food and Drug Administration Staff;
Class II Special Controls Guidance
Document: Filtering Facepiece
Respirator for use by the General Public
in Public Health Medical Emergencies.’’
See § 880.1(e) for information on
obtaining a copy of this guidance
document.
Dated: June 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–12789 Filed 7–2–07; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2006–0510; FRL–8334–4]
RIN 2060–AO46
Amendments to National Emission
Standards for Hazardous Air Pollutants
for Primary Copper Smelting and
Secondary Copper Smelting Area
Sources
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
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AGENCY:
SUMMARY: EPA is taking direct final
action to amend the national emission
standards for primary copper smelting
area sources and secondary copper
smelting area sources published on
January 23, 2007. The amendments to
the national emission standards for
primary copper smelting area sources
clarify when plants must exhaust gases
to a control device and what control
devices may be used for this
requirement; numbering errors are also
corrected. The amendments to the
national emission standards for
secondary copper smelting area sources
clarify the date which defines a new
copper smelter and correct a crossreferencing error.
DATES: This direct final rule is effective
on October 1, 2007 without further
notice, unless EPA receives adverse
comment by August 2, 2007. If the
effective date is delayed, timely notice
will be published in the Federal
Register. If we receive adverse
comment, we will publish a timely
withdrawal in the Federal Register
informing the public that some or all of
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the amendments in this rule will not
take effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2006–0510 by one of the following
methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• E-mail: a-and-r-docket@epa.gov.
• Fax: (202) 566–1741.
• Mail: National Emission Standards
for Hazardous Air Pollutants for Four
Area Source Categories Docket,
Environmental Protection Agency,
Mailcode: 6102T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
Please include a total of two copies.
• Hand Delivery: EPA Docket Center,
Public Reading Room, EPA West, Room
3334, 1301 Constitution Ave., NW,
Washington, DC 20460. Such deliveries
are only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OAR–2006–
0510. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or e-mail. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an e-mail
comment directly to EPA without going
through www.regulations.gov, your email address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the www.regulations.gov
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36363
index. Although listed in the index,
some information is not publicly
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in
www.regulations.gov or in hard copy at
the National Emission Standards for
Hazardous Air Pollutants for Four Area
Source Categories Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the Air Docket is (202) 566–
1742.
Ms.
Sharon Nizich, Sector Policies and
Programs Division, Office of Air Quality
Planning and Standards (D243–02),
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711, telephone number: (919) 541–
2825; fax number: (919) 541–3207; email address: nizich.sharon@epa.gov.
FOR FURTHER INFORMATION CONTACT:
The
information presented in this preamble
is organized as follows:
SUPPLEMENTARY INFORMATION:
I. Why is EPA using a direct final rule?
II. Does this action apply to me?
III. Where can I get a copy of this document?
IV. What should I consider as I prepare my
comments to EPA?
V. What are the changes to the NESHAP for
primary copper smelting and secondary
copper smelting area source?
A. NEHSAP for Primary Copper Smelting
Area Sources
B. NESHAP for Secondary Copper
Smelting Area Sources
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer
Advancement Act
J. Executive Order 12898: Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations
K. Congressional Review Act
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[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Rules and Regulations]
[Pages 36360-36363]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12789]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 2007N-0198 ]
Medical Devices; General Hospital and Personal Use Devices;
Classification of the Filtering Facepiece Respirator for Use by the
General Public in Public Health Medical Emergencies
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
filtering facepiece respirator for use by the general public in public
health medical emergencies into class II (special controls). The agency
is classifying these devices into class II (special controls) in order
to provide a reasonable assurance of the safety and effectiveness of
these devices and is specifying what those special controls are.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a guidance document entitled, ``Guidance for
Industry and Food and Drug Administration Staff; Class II Special
Controls Guidance Document: Filtering Facepiece Respirator for Use by
the General Public in Public Health Medical Emergencies.'' This
guidance document will serve as one of the special controls, along with
certification of the respirator by the National Institute for
Occupational Safety and Health (NIOSH) in accordance with its
regulations for non-powered air-purifying particulate respirators,
found in 42 CFR part 84, as specified in the classification regulation.
DATES: This rule is effective August 2, 2007. The classification was
effective May 8, 2007.
FOR FURTHER INFORMATION CONTACT: Sheila A. Murphey, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3700.
SUPPLEMENTARY INFORMATION:
I. What is the Background of this Rulemaking?
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in
commercial distribution before May 28, 1976, the date of enactment of
the Medical Device Amendments of 1976 (the amendments), generally
referred to as postamendments devices, are classified automatically by
statute into class III without any FDA rulemaking process. These
devices remain in class III and require premarket approval, unless the
device is classified or reclassified into class I or class II, or FDA
issues an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the act, to a predicate device that
does not require premarket approval. The agency determines whether new
devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) of the act for a device
that has not previously been classified may, within 30 days after
receiving an order classifying the device in class III under section
513(f)(1) of the act, request FDA to classify the device under the
criteria set forth in section 513(a)(1) of the act. FDA shall, within
60 days of receiving such a request, classify the device by written
order. This classification shall be the initial classification of the
device type. Within 30 days after the issuance of an order classifying
the device, FDA must publish a notice in the Federal Register
announcing such classification (section 513(f)(2) of the act).
In accordance with section 513(f)(1) of the act, FDA issued an
order on August 30, 2006, classifying the two 3M filtering facepiece
respirators intended for use by the general public in public health
medical emergencies (designated at that time as the 3M\TM\ N95 Home
Respirator with Fluid Resistance and 3M\TM\ N95 Home Respirator) in
class III, because each device was not substantially equivalent to a
device that was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976, or
a device that was subsequently reclassified into class I or class II.
On October 3, 2006, 3M Inc. submitted a petition requesting initial
classification of these devices under section 513(f) (2) of the act.
The manufacturer recommended that the
[[Page 36361]]
devices be classified into class II (Ref. 1). In response to FDA
requests for additional information, 3M supplemented its petition on
March 22, 2007.
In accordance with section 513(f) (2) of the act, FDA reviewed the
petition in order to classify the devices under the criteria for
classification set forth in 513(a)(1) of the act. Devices are to be
classified into class II 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 reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition and its supplements, FDA
determined that the 3M\TM\ filtering facepiece respirator devices, now
known as the 3M\TM\ 8612F Respirator for Use by the General Public in
Public Health Medical Emergencies and 3M\TM\ 8670F Respirator for Use
by the General Public in Public Health Medical Emergencies can be
classified into class II with the establishment of special controls.
FDA believes that special controls, in addition to general controls,
are adequate to provide reasonable assurance of the safety and
effectiveness of the device and that there is sufficient information to
establish special controls to provide such assurance.
The device is assigned the generic name ``Filtering Facepiece
Respirator for use by the General Public in Public Health Medical
Emergencies'' and is identified as a device that is a disposable half-
facepiece non-powered air-purifying particulate respirator intended for
use to cover the nose and mouth of the wearer to help reduce wearer
exposure to pathogenic biological airborne particulates during a public
health medical emergency. The device is made of polymeric materials and
is intended to fit closely to the face and to function by filtering
particulate material.
FDA believes that special controls are needed to help address the
following issues affecting the safety and effectiveness of the
filtering facepiece respirator for use by the general public in public
health medical emergencies.
A. Assuring Filtration and Breathability
For this type of respirator to reduce wearer exposure to pathogenic
biological airborne particulates, it must be made of filter material
that is highly efficient in filtering such particles. At the same time,
because this type of device depends on the wearer's normal respiration
to draw ambient air through the respirator materials and into the
lungs, the respirator material must also permit adequate respiration.
B. Assuring Proper Fit
The device must fit closely to the wearer's face without any gaps
that would allow air to reach the wearer's respiratory tract without
passing through the filter material. Otherwise, improper fit of the
respirator could result in inhalation of pathogenic biological airborne
particulates carried in air that passes around the sides of the device.
C. Avoiding Adverse Skin Reaction
Reducing wearer exposure to pathogenic biological airborne
particulates requires that the device be properly fitted to the face.
If the respirator material in contact with the skin is not
biocompatible, it may cause adverse reactions such as redness,
pruritus, and skin irritation.
D. Assuring Proper Use
While a filtering facepiece respirator for use by the general
public in public health medical emergencies can help to reduce wearer
exposure to pathogenic biological airborne particulates in a public
health medical emergency where there is a serious risk from such
exposure, these devices do not provide complete protection against
infection. Even when used correctly and consistently, a filtering
facepiece respirator does not eliminate all respiratory exposure, and
for many pathogens that may be transmitted through airborne
particulates, transmission via other routes is also possible. (Because
filtering facepiece respirators for use by the general public in public
health medical emergencies have not been tested against specific
microorganisms, the extent of protection to be expected against
specific pathogens is not known and would vary with particular
conditions in any event.)
The respirator should always be used in conjunction with other
infection control and respiratory protection measures. In addition,
because the outside of the respirator may be contaminated with
infectious materials during normal use, proper handling and disposal is
important to avoid the respirator itself becoming a vector of
transmission of infectious agents.
Further, failure of the user to assure proper fit of the respirator
could result in exposure to pathogenic biological airborne particles.
Certain populations such as children will be unlikely to achieve a
proper fit because respirators are designed and sized for adults.
For users with certain underlying cardiac, pulmonary or related
medical conditions, achieving the fit necessary to help reduce their
exposure to pathogenic biological airborne particulates may exacerbate
their underlying medical conditions raising a concern about their safe
use for these populations.
Finally, these respirators have not been established to be safe or
effective if reused, and use of a single respirator by multiple users
may result in the respirator itself becoming a vector of transmission.
To address these issues, the class II special controls guidance
document provides recommendations for labeling and for information to
be provided to meet premarket notification (510(k)) submission
requirements for the device, including recommendations for fit testing
and biocompatibility testing. In addition, this classification
regulation specifies another special control, certification of the
respirator by NIOSH as a non-powered air-purifying particulate
respirator with a minimum filtration efficiency classification of N95,
in accordance with 42 CFR part 84. The respirators that were the
subject of the initial classification order described in this document
and that are the initial legal predicate devices for this new device
classification were certified by NIOSH under these requirements, as
revised as of October 1, 2006. FDA's determination that NIOSH
certification is an appropriate special control to help assure the
safety and effectiveness of the respirator for its intended use under
this classification rests on the assurance of filtration efficiency and
breathability provided by NIOSH certification under these requirements,
as effective on May 8, 2007, the date of FDA's classification order.
Should NIOSH revise the requirements for certification in the future,
FDA will evaluate whether certification under such revised NIOSH
regulations is an appropriate special control for devices within this
classification and may revise FDA's regulation using appropriate
procedures.
FDA believes that these special controls, designated in this rule,
in addition to general controls, address the issues identified
previously and provide reasonable assurance of the safety and
effectiveness of the device type. Thus, on May 8, 2007, FDA issued an
order to the petitioner classifying the device type into class II. FDA
is codifying this classification at 21 CFR 880.6260.
Following the effective date of the final classification rule,
manufacturers will need to demonstrate NIOSH certification of any
filtering facepiece respirator for use by the general public in public
health medical emergencies,
[[Page 36362]]
as set forth in 21 CFR 880.6260(b)(1), and address the issues covered
in the special controls guidance. With respect to the issues addressed
only in the special control guidance, however, the manufacturer need
only show that its device meets the recommendations of the guidance or
in some other way provides equivalent assurance of safety and
effectiveness.
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the act, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For filtering facepiece respirators for
use by the general public in public health medical emergencies,
however, FDA has determined that premarket review of fit performance
data, labeling, and other requirements as outlined in 21 CFR 807.87, is
necessary to provide reasonable assurance that acceptable levels of
performance for both safety and effectiveness will be addressed before
marketing clearance. Thus, persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device type.
II. What is the Environmental Impact of This Rule?
The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Thus, neither an environmental
assessment nor an environmental impact statement is required.
III. What is the Economic Impact of This Rule?
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies 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). The agency believes that
this final rule is not a significant regulatory action as defined by
the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because classification of this device into class II
will relieve manufacturers of the cost of complying with the premarket
approval requirements of section 515 of the act (21 U.S.C. 360e), and
may permit small potential competitors to enter the marketplace by
lowering their costs, the agency certifies that the final rule will not
have a significant economic impact on a substantial number of small
entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``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 $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
IV. Does This Final Rule Have Federalism Implications?
FDA has 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, the agency has concluded
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.
V. How Does This Rule Comply with the Paperwork Reduction Act of 1995?
This final rule contains no new information collection provisions
but refers to NIOSH regulations in 42 CFR part 84 that contain
information collection provisions that have been reviewed and approved
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520), under OMB Control No.
0920-0109. Based on information from NIOSH regarding submissions for
respirator certification received in the past 3 years, FDA concludes
that specification of NIOSH certification as a special control will not
result in the collection of any additional information by NIOSH not
already covered by NIOSH's burden estimates. This final rule also
designates a guidance document as a special control. Elsewhere in this
issue of the Federal Register, FDA is publishing a notice announcing
the availability of that guidance document, ``Class II Special Controls
Guidance Document: Filtering Facepiece Respirators for Use by the
General Public in Public Health Medical Emergencies,'' which contains a
Paperwork Reduction Act analysis for that guidance.
VI. What References are on Display?
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from 3M.
2. 42 CFR part 84, as revised as of October 1, 2006.
List of Subjects in 21 CFR part 880
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
880 is amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
1. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 880.6260 is added to subpart G to read as follows:
Sec. 880.6260 Filtering facepiece respirator for use by the general
public in public health medical emergencies.
(a) Identification. A filtering facepiece respirator for use by the
general public in public health medical emergencies is a device that is
a disposable half-facepiece non-powered air-purifying particulate
respirator intended for use to cover the nose and mouth of the wearer
to help reduce wearer exposure to pathogenic biological airborne
particulates during a public health medical emergency. The device is
made of polymeric materials and is intended to fit closely to the face
and to function by filtering particulate material.
(b) Classification. Class II (special controls). The special
controls are:
(1) Certification by the National Institute for Occupational Safety
and Health (NIOSH) as a non-powered air-
[[Page 36363]]
purifying particulate respirator with a minimum filtration efficiency
classification of N95, in accordance with 42 CFR part 84.
(2) The FDA guidance document entitled: ``Guidance for Industry and
Food and Drug Administration Staff; Class II Special Controls Guidance
Document: Filtering Facepiece Respirator for use by the General Public
in Public Health Medical Emergencies.'' See Sec. 880.1(e) for
information on obtaining a copy of this guidance document.
Dated: June 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-12789 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S
