Authorization of Emergency Use of Certain Personal Respiratory Protection Devices; Availability, 38644-38648 [E9-18570]
Download as PDF
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
Joshua M. Sharfstein, MD
Principal Deputy Commissioner
Acting Commissioner
1 Centers
for Disease Control and Prevention
swabs, nasal swabs, throat swabs, dual nasopharyngeal swabs/throat swabs, nasal aspirates.
Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
4 FDA is authorizing the emergency use of the CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization
Panel for Respiratory Specimens (NPS, NS, TS, NPS/TS, NA) and Viral Culture (rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) as
described in the scope section of this letter (Section II). For ease of reference, this letter will use the term the ‘‘rRT-PCR Flu Panel
(NPS, NS, TS, NPS/TS, NA).’’
5 The cleared test for in vitro qualitative detection of human influenza viral RNA (The CDC rRT-PCR Flu Panel (IVD) 510(K)
080570) is not adequate because of the need to test additional types of samples during this emergency and it is not sufficiently available because of limited availability of certain reagents. No other criteria of issuance have been prescribed by regulation under section
564(c)(4) of the Act.
6 The CDC rRT-PCR Flu Panel (IVD) 510(K) 080570 is indicated for the in vitro qualitative detection of human influenza viral RNA
in nasopharyngeal swabs (NPS) and nasal swabs (NS) only.
7 All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret
the results from this procedure by a CDC instructor or designee prior to use. CDC Influenza Division will limit the distribution of this
device to those users who have successfully completed training provided by CDC instructors or designees. Use is limited to designated laboratories that are qualified to receive and use the CDC rRT-PCR Flu Panel (IVD) 510(K) 080570. See ‘‘Conditions of Authorization’’ below.
8 These requirements are waived only for the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) that is authorized for emergency
use. These requirements, and all other applicable statutory and regulatory requirements, continue to apply to the CDC rRT-PCR Flu
Panel (IVD) 510(K) 080570.
2 Nasopharyngeal
3 Memorandum,
Dated: June 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–18569 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0278]
Authorization of Emergency Use of
Certain Personal Respiratory
Protection Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the
Authorization), as amended, for certain
personal respiratory protection devices.1
FDA is issuing this Authorization under
the Federal Food, Drug, and Cosmetic
Act (the act), as requested by the Centers
for Disease Control and Prevention
(CDC). The Authorization contains,
among other things, conditions on the
emergency use of the authorized
personal respiratory protection devices.
The Authorization follows the
determination by the Acting Secretary of
the Department of Health and Human
1 The Authorization covers certain disposable
respirators certified by the National Institute for
Occupational Safety and Health (NIOSH), in
accordance with 42 CFR part 84, as non-powered
air-purifying particulate respirators with a
minimum filtration efficiency classification of N95
(certain disposable NIOSH certified N95
respirators).
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Services, Charles E. Johnson (the Acting
Secretary), that a public health
emergency exists involving Swine
Influenza A (now known as 2009 H1N1
Influenza A or 2009 H1N1 flu) that
affects, or has the significant potential to
affect, national security. On the basis of
such determination, the Acting
Secretary declared an emergency
justifying the authorization of the
emergency use of certain disposable
National Institute for Occupational
Safety and Health (NIOSH) certified N95
respirators, accompanied by emergency
use information subject to the terms of
any authorization issued under the act.
The Authorization, as amended, which
includes an explanation of the reasons
for its issuance, is reprinted in this
document. Elsewhere in this issue of the
Federal Register, FDA is announcing
the issuance of EUAs for certain
products from the neuraminidase class
of antivirals, zanamivir and oseltamivir
phosphate and the issuance of EUAs for
certain in vitro diagnostic devices.
DATES: The Authorization is effective as
of April 27, 2009.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats (HF–29), Food and Drug
Administration, 5600 Fishers Lane, rm.
14C–26, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the
Authorization may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT:
Boris Lushniak, Office of
Counterterrorism and Emerging Threats
(HF–29), Food and Drug
PO 00000
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Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4067.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the act (21 U.S.C.
360bbb–3), as amended by the Project
BioShield Act of 2004 (Public Law 108–
276), allows FDA to strengthen the
public health protections against
biological, chemical, nuclear, and
radiological agents. Among other things,
section 564 of the act allows FDA to
authorize the use of an unapproved
medical product or an unapproved use
of an approved medical product during
a public health emergency that affects,
or has a significant potential to affect,
national security, and that involves
biological, chemical, radiological, or
nuclear agent or agents, or a specified
disease or condition that may be
attributable to such agent or agents.
With this EUA authority, FDA can help
assure that medical countermeasures
may be used in an emergency to
diagnose, treat, or prevent serious or
life-threatening diseases or conditions
caused by such agents, when there are
no adequate, approved, and available
alternatives.
Section 564(b)(1) of the act provides
that, before an EUA may be issued, the
Secretary must declare an emergency
justifying the authorization based on
one of the following grounds: ‘‘(A) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a specified biological, chemical,
radiological, or nuclear agent or agents;
(B) a determination by the Secretary of
Defense that there is a military
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces of attack with a specified
biological, chemical, radiological, or
nuclear agent or agents; or (C) a
determination by the Secretary of a
public health emergency under section
319 of the Public Health Service Act
that affects, or has a significant potential
to affect, national security, and that
involves a specified biological,
chemical, radiological, or nuclear agent
or agents, or a specified disease or
condition that may be attributable to
such agent or agents.’’
Once the Secretary has declared an
emergency justifying an authorization
under section 564 of the act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the act, FDA is required to
publish, in the Federal Register, a
notice of each authorization, and each
termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use in a declared
emergency. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
and 515 of the act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
Public Health Service Act (PHS Act) (42
U.S.C. 262). FDA may issue an EUA
only if, after consultation with the
National Institutes of Health and CDC
(to the extent feasible and appropriate
given the circumstances of the
emergency), FDA2 concludes: (1) That
an agent specified in a declaration of
emergency can cause a serious or life-
threatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that: (A) the
product may be effective in diagnosing,
treating, or preventing—(1) such disease
or condition; or (2) a serious or lifethreatening disease or condition caused
by a product authorized under Section
564, approved or cleared under this Act,
or licensed under Section 351 of the
PHS Act, for diagnosing, treating, or
preventing such a disease or condition
caused by such an agent; and (B) the
known and potential benefits of the
product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product; (3) that
there is no adequate, approved, and
available alternative to the product for
diagnosing, preventing, or treating such
disease or condition; and (4) that such
other criteria as the Secretary may by
regulation prescribe are satisfied.
No other criteria of issuance have
been prescribed by regulation under
section 564(c)(4) of the act. Because the
statute is self-executing, FDA does not
require regulations or guidance to
implement the EUA authority. However,
in the Federal Register of July 26, 2007
(72 FR 41083), FDA announced the
availability of a guidance entitled
‘‘Emergency Use Authorization of
Medical Products.’’ The guidance
provides more information for
stakeholders and the public about the
EUA authority and the agency’s process
for the consideration of EUA requests.
II. EUA Request for Certain Personal
Respiratory Protection Devices
On April 26, 2009, under section
564(b)(1)(C) of the act, the Acting
Secretary determined that a public
health emergency exists involving
38645
Swine Influenza A (now known as 2009
H1N1 Influenza A or 2009 H1N1 flu)
that affects, or has the significant
potential to affect, national security. On
April 26, 2009, under section 564(b) of
the act, and on the basis of such
determination, the Acting Secretary
declared an emergency justifying the
authorization of the emergency use of
certain disposable NIOSH certified N95
respirators, accompanied by emergency
use information subject to the terms of
any authorization issued under 21
U.S.C. 360bbb–3(a). Notice of the
determination and the declaration of the
Acting Secretary is published elsewhere
in this issue of the Federal Register. On
April 27, 2009, the CDC requested and
FDA issued an EUA for certain
disposable NIOSH certified N95
respirators, deployed from the Strategic
National Stockpile with certain written
information, including emergency use
instructions, which are authorized
under this EUA. On May 1, 2009, in
response to a CDC request to make
certain clarifications, FDA amended the
authorization letter and reissued the
Authorization letter in its entirety.
III. Electronic Access
An electronic version of this
document and the full text of the
Authorization are available on the
Internet at https://www.regulations.gov.
IV. The Authorization
Having concluded that the criteria for
issuance of this Authorization under
section 564(c) of the act are met, FDA
has authorized the emergency use of
certain disposable NIOSH certified N95
respirators. The Authorization, as
amended and reissued in its entirety on
May 1, 2009, follows and provides an
explanation of the reasons for its
issuance, as required by section
564(h)(1) of the act:
Richard E. Besser, M.D.
Acting Director
Centers for Disease Control and Prevention
Clifton Building 1, Room 6430
1600 Clifton Road, NE MS C-12
Atlanta, GA 30333
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Dear Dr. Besser:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization
(EUA) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3), for the emergency
use of certain personal respiratory protection devices deployed from the Strategic National Stockpile, specifically certain disposable respirators certified by the National Institute for Occupational Safety and Health (NIOSH), in accordance with 42 CFR part
84, as non-powered air-purifying particulate respirators with a minimum filtration efficiency classification of N95.1,2
2 The Secretary has delegated his authority to
issue an EUA under section 564 of the act to the
Commissioner of Food and Drugs.
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of
Health and Human Services (HHS) determined that a public health emergency exists involving Swine Influenza A that affects, or
has a significant potential to affect, national security. Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb-3(b)), and on the
basis of such determination, the Secretary of HHS then on April 27 declared an emergency justifying the authorization of the
emergency use of certain personal respiratory protection devices, accompanied by emergency use information subject to the
terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(b)) are
met, I am authorizing the emergency use, by the general public,3 of certain N95 respirators to help reduce wearer exposure to
pathogenic biological airborne particulates during a public health medical emergency involving Swine Influenza A, subject to the
terms of this authorization.4
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of certain N95 respirators meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition;
(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain N95 respirators may be
effective in preventing influenza by reducing wearer exposure to pathogenic biological airborne particulates, and that the
known and potential benefits of certain N95 respirators, when used for the prevention of influenza, outweigh the known and
potential risks of such products; and
(3) there is no adequate, approved, and available alternative to the emergency use of certain N95 respirators in the prevention
of influenza.5,6
Therefore, I have concluded that the emergency use of certain N95 respirators for the prevention of influenza through reduced
wearer exposure to pathogenic biological airborne particulates meets the above statutory criteria for issuance of an authorization.
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use, by the general
public, of authorized N95 respirators to help reduce wearer exposure to pathogenic biological airborne particulates during a public
health medical emergency involving Swine Influenza A.
The authorized N95 respirators are as follows:
Manufacturer
Model
3M
8210
8000
9210
1860
1870
Moldex
2200
2212
2201
Moldex-Metrics
3000
3001
3002
3003
1730
Kimberley-Clark
mstockstill on DSKH9S0YB1PROD with NOTICES
Gerson
PFR95–170
PFR95–174
The above products, as deployed from the Strategic National Stockpile before or after the signing of this letter of authorization,
are authorized to be made available to recipients when accompanied by the following written information pertaining to the emergency use:
• Summary Fact Sheet for Disposable Respirators for Use During the Swine Flu Emergency, as attached7
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38647
In addition, they may be made available to recipients in the form (i.e., with the packaging and labeling) in which they are customarily sold for use, as long as they are accompanied by the above-mentioned Summary Fact Sheet.8
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of
authorized N95 respirators, when used to prevent influenza by reducing wearer exposure to pathogenic biological airborne particulates, outweigh the known and potential risks of such products.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is
reasonable to believe that the authorized N95 respirators may be effective for the prevention of influenza pursuant to section
564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the information supporting the conclusions
described in Section I above, and concludes that the authorized N95 respirators, when used for the prevention of influenza by reducing wearer exposure to pathogenic biological airborne particulates, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of authorized N95 respirators under this EUA must be consistent with, and may not exceed, the terms of this
letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of
HHS’s corresponding declaration under section 564(b)(1), the N95 respirators described above are authorized for use, by the
general public, to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency involving Swine Influenza A.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when
the EUA is revoked under section 564(g) of the Act.
III. Current Good Manufacturing Practice
I am waiving current good manufacturing practice requirements with respect to the authorized N95 respirators that are used in accordance with this emergency use authorization.
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
CDC
A. CDC will ensure that the state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.
B. CDC will make available to state and/or local health authority(ies) through appropriate means the authorized Summary Fact
Sheet, as attached.
C. CDC will make available to the public through appropriate means, including through internet posting, general instructions for
use to assist with donning the respirators. These instructions will be categorized, or adjusted as necessary, to account for any
differences related to the following different respirator designs: molded/cone, folded, and duckbill respirators.
State and/or Local Public Health Authority(ies)
D. The appropriate state and/or local public health authorities will make available through appropriate means the authorized Summary Fact Sheet, as attached.
E. The appropriate state and/or local public health authority(ies) will ensure that authorized N95 respirators are distributed to recipients in accordance with applicable state and local laws and/or in accordance with the public health and medical emergency
response of the Authority Having Jurisdiction to deliver, distribute, or dispense the covered countermeasures, and their officials,
agents, employees, contractors, or volunteers following a declaration of an emergency.
CDC and State and/or Local Public Health Authority(ies)
F. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized N95 respirators that is consistent with, and does not exceed, the terms of
this letter of authorization.
mstockstill on DSKH9S0YB1PROD with NOTICES
The emergency use of authorized N95 respirators as described in this letter of authorization must comply with the conditions
above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
Acting Commissioner of Food and Drugs
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
1 The specific products covered are listed below, in Section II (scope of authorization). For purposes of this document, we will refer
to the devices covered by this authorization as ‘‘certain N95 respirators.’’ Only respirators that have passed specific testing by NIOSH
may be labeled as NIOSH-certified. Each NIOSH-certified respirator (also called a filtering facepiece) bears a rating which refers to
its certified level of filtration efficiency: for example, N95 signifies that the respirator filters at least 95% of airborne particles (and is
not resistant to oil). 42 CFR 84.170. For more information on disposable NIOSH-certified respirators, see https://www.cdc.gov/niosh/
npptl/topics/respirators/disp_part/.
2 FDA has cleared four models of disposable N95 respirators for use by the general public in public health medical emergencies,
such as influenza pandemic: 3M Respirators 8612F and 8670F, and Pasture Pharma Respirators F550G and A520G. See 21 CFR
880.6260 (product code NZJ) and https://www.fda.gov/cdrh/ode/guidance/1626.pdf. These four models of N95 respirators are already
FDA-cleared for a use contemplated by this letter of authorization.
3 For purposes of this letter of authorization, the term ‘‘general public’’ is broad and includes people performing work-related duties.
This authorization affects only requirements applicable under the Federal Food, Drug, and Cosmetic Act. If respirators are used for
people performing work-related duties, employers must comply with the Occupational Safety and Health Administration (OSHA) Respiratory Protection Standard, 29 CFR 1910.134, found at www.OSHA.gov.
4 FDA is authorizing the emergency use of certain N95 respirators as described in the scope section of this letter (Section II).
5 As described in footnote 2, FDA has cleared four models of N95 respirators for use by the general public in public health medical
emergencies, such as influenza pandemic. A shortage of FDA-cleared respirators is nonetheless expected for the following reasons:
not all of the four cleared models have been marketed extensively to date, and in fact two such models were only recently cleared by
FDA; the respirators are disposable, and so one user is expected to use multiple respirators over a span of time; and, to ensure
proper fit, each user may need to try on various sizes and models of respirators before selecting one for use. There are also some
models of N95 respirators that are cleared by FDA for use in certain workplace settings. However, under the circumstances of this
emergency, shortage of supplies of these models is expected.
6 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
7 This Summary Fact Sheet contains, among other information, known and potential risks of use, including risks to children as a result of breathing difficulties and improper fit.
8 In a work setting, OSHA requirements also apply (see note 3 of this letter).
Dated: June 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–18570 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0276]
Authorizations of Emergency Use of
Certain Antiviral Drugs—Zanamivir and
Oseltamivir Phosphate; Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
issuance of two Emergency Use
Authorizations (EUAs) (the
Authorizations) for certain products
from the neuraminidase class of
antivirals—Zanamivir and oseltamivir
phosphate. FDA is issuing the
Authorizations under the Federal Food,
Drug, and Cosmetic Act (the act), as
requested by the Centers for Disease
Control and Prevention (CDC). The
Authorizations contain, among other
things, conditions on the emergency use
of the authorized zanamivir and
oseltamivir phosphate products. The
Authorizations follow the determination
by the Acting Secretary of the
Department of Health and Human
Services, Charles E. Johnson (the Acting
Secretary), that a public health
emergency exists involving Swine
Influenza A (now known as 2009 H1N1
Influenza A or 2009 H1N1 flu) that
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16:07 Aug 03, 2009
Jkt 217001
affects, or has the significant potential to
affect, national security. On the basis of
such determination, the Acting
Secretary declared an emergency
justifying the authorization of the
emergency use of certain products from
the neuraminidase class of antivirals—
Zanamivir and oseltamivir phosphate,
accompanied by emergency use
information subject to the terms of any
authorization issued under the act. The
Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
issuance of EUAs for certain in vitro
diagnostic devices and the issuance of
an EUA for certain personal respiratory
protection devices.
DATES: The Authorizations are effective
as of April 27, 2009.
Submit written requests for
single copies of the EUAs to the Office
of Counterterrorism and Emerging
Threats (HF–29), Food and Drug
Administration, 5600 Fishers Lane, rm.
14C–26, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the
Authorization(s) may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the Authorizations.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Boris Lushniak, Office of
Counterterrorism and Emerging Threats
(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4067.
SUPPLEMENTARY INFORMATION:
PO 00000
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I. Background
Section 564 of the act (21 U.S.C.
360bbb–3), as amended by the Project
BioShield Act of 2004 (Public Law 108–
276), allows FDA to strengthen the
public health protections against
biological, chemical, nuclear, and
radiological agents. Among other things,
section 564 of the act allows FDA to
authorize the use of an unapproved
medical product or an unapproved use
of an approved medical product during
a public health emergency that affects,
or has a significant potential to affect,
national security, and that involves
biological, chemical, radiological, or
nuclear agent or agents, or a specified
disease or condition that may be
attributable to such agent or agents.
With this EUA authority, FDA can help
assure that medical countermeasures
may be used in an emergency to
diagnose, treat, or prevent serious or
life-threatening diseases or conditions
caused by such agents, when there are
no adequate, approved, and available
alternatives.
Section 564(b)(1) of the act provides
that, before an EUA may be issued, the
Secretary must declare an emergency
justifying the authorization based on
one of the following grounds: ‘‘(A) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a specified biological, chemical,
radiological, or nuclear agent or agents;
(B) a determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
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Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38644-38648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18570]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0278]
Authorization of Emergency Use of Certain Personal Respiratory
Protection Devices; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization),
as amended, for certain personal respiratory protection devices.\1\ FDA
is issuing this Authorization under the Federal Food, Drug, and
Cosmetic Act (the act), as requested by the Centers for Disease Control
and Prevention (CDC). The Authorization contains, among other things,
conditions on the emergency use of the authorized personal respiratory
protection devices. The Authorization follows the determination by the
Acting Secretary of the Department of Health and Human Services,
Charles E. Johnson (the Acting Secretary), that a public health
emergency exists involving Swine Influenza A (now known as 2009 H1N1
Influenza A or 2009 H1N1 flu) that affects, or has the significant
potential to affect, national security. On the basis of such
determination, the Acting Secretary declared an emergency justifying
the authorization of the emergency use of certain disposable National
Institute for Occupational Safety and Health (NIOSH) certified N95
respirators, accompanied by emergency use information subject to the
terms of any authorization issued under the act. The Authorization, as
amended, which includes an explanation of the reasons for its issuance,
is reprinted in this document. Elsewhere in this issue of the Federal
Register, FDA is announcing the issuance of EUAs for certain products
from the neuraminidase class of antivirals, zanamivir and oseltamivir
phosphate and the issuance of EUAs for certain in vitro diagnostic
devices.
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\1\ The Authorization covers certain disposable respirators
certified by the National Institute for Occupational Safety and
Health (NIOSH), in accordance with 42 CFR part 84, as non-powered
air-purifying particulate respirators with a minimum filtration
efficiency classification of N95 (certain disposable NIOSH certified
N95 respirators).
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DATES: The Authorization is effective as of April 27, 2009.
ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats (HF-29), Food and Drug
Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your request or include a fax number to which the
Authorization may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT: Boris Lushniak, Office of
Counterterrorism and Emerging Threats (HF-29), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the act (21 U.S.C. 360bbb-3), as amended by the
Project BioShield Act of 2004 (Public Law 108-276), allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product during a
public health emergency that affects, or has a significant potential to
affect, national security, and that involves biological, chemical,
radiological, or nuclear agent or agents, or a specified disease or
condition that may be attributable to such agent or agents. With this
EUA authority, FDA can help assure that medical countermeasures may be
used in an emergency to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by such agents, when there
are no adequate, approved, and available alternatives.
Section 564(b)(1) of the act provides that, before an EUA may be
issued, the Secretary must declare an emergency justifying the
authorization based on one of the following grounds: ``(A) a
determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a specified
biological, chemical, radiological, or nuclear agent or agents; (B) a
determination by the Secretary of Defense that there is a military
[[Page 38645]]
emergency, or a significant potential for a military emergency,
involving a heightened risk to United States military forces of attack
with a specified biological, chemical, radiological, or nuclear agent
or agents; or (C) a determination by the Secretary of a public health
emergency under section 319 of the Public Health Service Act that
affects, or has a significant potential to affect, national security,
and that involves a specified biological, chemical, radiological, or
nuclear agent or agents, or a specified disease or condition that may
be attributable to such agent or agents.''
Once the Secretary has declared an emergency justifying an
authorization under section 564 of the act, FDA may authorize the
emergency use of a drug, device, or biological product if the agency
concludes that the statutory criteria are satisfied. Under section
564(h)(1) of the act, FDA is required to publish, in the Federal
Register, a notice of each authorization, and each termination or
revocation of an authorization, and an explanation of the reasons for
the action. Section 564 of the act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in a declared emergency. Products appropriate
for emergency use may include products and uses that are not approved,
cleared, or licensed under sections 505, 510(k), and 515 of the act (21
U.S.C. 355, 360(k), and 360e) or section 351 of the Public Health
Service Act (PHS Act) (42 U.S.C. 262). FDA may issue an EUA only if,
after consultation with the National Institutes of Health and CDC (to
the extent feasible and appropriate given the circumstances of the
emergency), FDA\2\ concludes: (1) That an agent specified in a
declaration of emergency can cause a serious or life-threatening
disease or condition; (2) that, based on the totality of scientific
evidence available to FDA, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to believe
that: (A) the product may be effective in diagnosing, treating, or
preventing--(1) such disease or condition; or (2) a serious or life-
threatening disease or condition caused by a product authorized under
Section 564, approved or cleared under this Act, or licensed under
Section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
the Secretary may by regulation prescribe are satisfied.
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\2\ The Secretary has delegated his authority to issue an EUA
under section 564 of the act to the Commissioner of Food and Drugs.
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No other criteria of issuance have been prescribed by regulation
under section 564(c)(4) of the act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement
the EUA authority. However, in the Federal Register of July 26, 2007
(72 FR 41083), FDA announced the availability of a guidance entitled
``Emergency Use Authorization of Medical Products.'' The guidance
provides more information for stakeholders and the public about the EUA
authority and the agency's process for the consideration of EUA
requests.
II. EUA Request for Certain Personal Respiratory Protection Devices
On April 26, 2009, under section 564(b)(1)(C) of the act, the
Acting Secretary determined that a public health emergency exists
involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009
H1N1 flu) that affects, or has the significant potential to affect,
national security. On April 26, 2009, under section 564(b) of the act,
and on the basis of such determination, the Acting Secretary declared
an emergency justifying the authorization of the emergency use of
certain disposable NIOSH certified N95 respirators, accompanied by
emergency use information subject to the terms of any authorization
issued under 21 U.S.C. 360bbb-3(a). Notice of the determination and the
declaration of the Acting Secretary is published elsewhere in this
issue of the Federal Register. On April 27, 2009, the CDC requested and
FDA issued an EUA for certain disposable NIOSH certified N95
respirators, deployed from the Strategic National Stockpile with
certain written information, including emergency use instructions,
which are authorized under this EUA. On May 1, 2009, in response to a
CDC request to make certain clarifications, FDA amended the
authorization letter and reissued the Authorization letter in its
entirety.
III. Electronic Access
An electronic version of this document and the full text of the
Authorization are available on the Internet at https://www.regulations.gov.
IV. The Authorization
Having concluded that the criteria for issuance of this
Authorization under section 564(c) of the act are met, FDA has
authorized the emergency use of certain disposable NIOSH certified N95
respirators. The Authorization, as amended and reissued in its entirety
on May 1, 2009, follows and provides an explanation of the reasons for
its issuance, as required by section 564(h)(1) of the act:
Richard E. Besser, M.D.
Acting Director
Centers for Disease Control and Prevention
Clifton Building 1, Room 6430
1600 Clifton Road, NE MS C-12
Atlanta, GA 30333
Dear Dr. Besser:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) pursuant to section 564 of the Federal Food, Drug, and
Cosmetic Act (the Act) (21 U.S.C. Sec. 360bbb-3), for the emergency use of certain personal respiratory protection devices deployed from the Strategic National Stockpile, specifically
certain disposable respirators certified by the National Institute for Occupational Safety and Health (NIOSH), in accordance with 42 CFR part 84, as non-powered air-purifying particulate
respirators with a minimum filtration efficiency classification of N95.\1,2\
[[Page 38646]]
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec. 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that a
public health emergency exists involving Swine Influenza A that affects, or has a significant potential to affect, national security. Pursuant to section 564(b) of the Act (21 U.S.C. Sec.
360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then on April 27 declared an emergency justifying the authorization of the emergency use of certain personal
respiratory protection devices, accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. Sec. 360bbb-3(a).
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec. 360bbb-3(b)) are met, I am authorizing the emergency use, by the
general public,\3\ of certain N95 respirators to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency involving Swine Influenza
A, subject to the terms of this authorization.\4\
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of certain N95 respirators meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
(1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition;
(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain N95 respirators may be effective in preventing influenza by reducing wearer
exposure to pathogenic biological airborne particulates, and that the known and potential benefits of certain N95 respirators, when used for the prevention of influenza, outweigh the
known and potential risks of such products; and
(3) there is no adequate, approved, and available alternative to the emergency use of certain N95 respirators in the prevention of influenza.\5,6\
Therefore, I have concluded that the emergency use of certain N95 respirators for the prevention of influenza through reduced wearer exposure to pathogenic biological airborne particulates
meets the above statutory criteria for issuance of an authorization.
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use, by the general public, of authorized N95 respirators to help reduce
wearer exposure to pathogenic biological airborne particulates during a public health medical emergency involving Swine Influenza A.
The authorized N95 respirators are as follows:
----------------------------------------------------------------------------------------------------------------
Manufacturer Model
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3M 8210
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8000
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9210
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1860
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1870
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Moldex 2200
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2212
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2201
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Moldex-Metrics 3000
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3001
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3002
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3003
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Gerson 1730
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Kimberley-Clark PFR95-170
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PFR95-174
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The above products, as deployed from the Strategic National Stockpile before or after the signing of this letter of authorization, are authorized to be made available to recipients when
accompanied by the following written information pertaining to the emergency use:
Summary Fact Sheet for Disposable Respirators for Use During the Swine Flu Emergency, as attached\7\
[[Page 38647]]
In addition, they may be made available to recipients in the form (i.e., with the packaging and labeling) in which they are customarily sold for use, as long as they are accompanied by the
above-mentioned Summary Fact Sheet.\8\
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized N95 respirators, when used to prevent
influenza by reducing wearer exposure to pathogenic biological airborne particulates, outweigh the known and potential risks of such products.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized N95 respirators
may be effective for the prevention of influenza pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the information supporting the
conclusions described in Section I above, and concludes that the authorized N95 respirators, when used for the prevention of influenza by reducing wearer exposure to pathogenic biological
airborne particulates, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of authorized N95 respirators under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization
set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under section 564(b)(1)(C) described above and the Secretary of
HHS's corresponding declaration under section 564(b)(1), the N95 respirators described above are authorized for use, by the general public, to help reduce wearer exposure to pathogenic
biological airborne particulates during a public health medical emergency involving Swine Influenza A.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Current Good Manufacturing Practice
I am waiving current good manufacturing practice requirements with respect to the authorized N95 respirators that are used in accordance with this emergency use authorization.
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
CDC
A. CDC will ensure that the state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.
B. CDC will make available to state and/or local health authority(ies) through appropriate means the authorized Summary Fact Sheet, as attached.
C. CDC will make available to the public through appropriate means, including through internet posting, general instructions for use to assist with donning the respirators. These
instructions will be categorized, or adjusted as necessary, to account for any differences related to the following different respirator designs: molded/cone, folded, and duckbill
respirators.
State and/or Local Public Health Authority(ies)
D. The appropriate state and/or local public health authorities will make available through appropriate means the authorized Summary Fact Sheet, as attached.
E. The appropriate state and/or local public health authority(ies) will ensure that authorized N95 respirators are distributed to recipients in accordance with applicable state and local
laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to deliver, distribute, or dispense the covered countermeasures, and
their officials, agents, employees, contractors, or volunteers following a declaration of an emergency.
CDC and State and/or Local Public Health Authority(ies)
F. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized N95
respirators that is consistent with, and does not exceed, the terms of this letter of authorization.
The emergency use of authorized N95 respirators as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
Acting Commissioner of Food and Drugs
[[Page 38648]]
\1\ The specific products covered are listed below, in Section II (scope of authorization). For purposes of this document, we will refer to the devices covered by this authorization as
``certain N95 respirators.'' Only respirators that have passed specific testing by NIOSH may be labeled as NIOSH-certified. Each NIOSH-certified respirator (also called a filtering
facepiece) bears a rating which refers to its certified level of filtration efficiency: for example, N95 signifies that the respirator filters at least 95% of airborne particles (and is not
resistant to oil). 42 CFR 84.170. For more information on disposable NIOSH-certified respirators, see https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/.
\2\ FDA has cleared four models of disposable N95 respirators for use by the general public in public health medical emergencies, such as influenza pandemic: 3M Respirators 8612F and 8670F,
and Pasture Pharma Respirators F550G and A520G. See 21 CFR 880.6260 (product code NZJ) and https://www.fda.gov/cdrh/ode/guidance/1626.pdf. These four models of N95 respirators are already FDA-
cleared for a use contemplated by this letter of authorization.
\3\ For purposes of this letter of authorization, the term ``general public'' is broad and includes people performing work-related duties. This authorization affects only requirements
applicable under the Federal Food, Drug, and Cosmetic Act. If respirators are used for people performing work-related duties, employers must comply with the Occupational Safety and Health
Administration (OSHA) Respiratory Protection Standard, 29 CFR 1910.134, found at www.OSHA.gov.
\4\ FDA is authorizing the emergency use of certain N95 respirators as described in the scope section of this letter (Section II).
\5\ As described in footnote 2, FDA has cleared four models of N95 respirators for use by the general public in public health medical emergencies, such as influenza pandemic. A shortage of FDA-
cleared respirators is nonetheless expected for the following reasons: not all of the four cleared models have been marketed extensively to date, and in fact two such models were only
recently cleared by FDA; the respirators are disposable, and so one user is expected to use multiple respirators over a span of time; and, to ensure proper fit, each user may need to try on
various sizes and models of respirators before selecting one for use. There are also some models of N95 respirators that are cleared by FDA for use in certain workplace settings. However,
under the circumstances of this emergency, shortage of supplies of these models is expected.
\6\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\7\ This Summary Fact Sheet contains, among other information, known and potential risks of use, including risks to children as a result of breathing difficulties and improper fit.
\8\ In a work setting, OSHA requirements also apply (see note 3 of this letter).
Dated: June 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-18570 Filed 8-3-09; 8:45 am]
BILLING CODE 4160-01-S