Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments, 42080-42081 [E9-19985]
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42080
Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices
Reauthorization Act (CHIPRA). The
initial core measure set is required to be
posted for public comment by January 1,
2010. CHIPRA reauthorized the Child
Health Insurance Program (CHIP)
originally established in 1997, and in
Title IV of the law, added a number of
new provisions designed to improve
health care quality and outcomes for
children. AHRQ is working closely with
the Centers for Medicare and Medicaid
Services (CMS) in implementing these
provisions. For more information about
AHRQ’s role in carrying out the quality
provisions of CHIPRA, see https://
www.ahrg.gov/chip/chipraact.htm.
II. Agenda
On Thursday, September 17, 2009, the
Subcommittee meeting will convene at
8 a.m., with the call to order by the
Subcommittee Co-Chairs. The meeting
will review results of the second stage
of the Delphi Process of scoring
measures for validity, feasibility, and
importance, and proceed to select an
initial core set of children’s healthcare
quality measures to recommend to the
AHRQ National Advisory Committee
(NAC). This process was started in the
first subcommittee meeting, held July
22–23, 2009.
A more specific proposed agenda will
be available before the meeting from
Padmini Jagadish, Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850, (301) 427–1927, e-mail address
Padmini.Jagadish@ahrq.hhs.gov. The
final agenda, including the time for
public comment during the meeting,
will be available on the AHRQ Web site
at https://www.ahrg.gov/chip/
chipraact.htm no later than September
10, 2009. This AHRQ Web site links to
an email address that can be used to
submit comments on CHIPRA quality
measure development as the process of
identifying the initial core measure set
proceeds. Subcommittee meeting
minutes will be available within 21
business days after the meeting.
Dated: August 13, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–20020 Filed 8–19–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0374]
Educating the Public About Removal
of Essential-Use Designation for
Epinephrine; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Educating
the Public About Removal of EssentialUse Designation for Epinephrine.’’ The
currently approved over-the-counter
(OTC) epinephrine metered-dose
inhalers (MDIs) contain
chlorofluorocarbons (CFCs) and cannot
be marketed after December 31, 2011.
This 1-day public workshop is intended
to seek input from key stakeholders in
the asthma community, the
pharmaceutical industry, experts in
health care communication, and the
public on strategies to educate
consumers about the decision to remove
epinephrine MDIs from the market and
transition consumers to therapeutic
alternatives that do not contain CFCs or
other ozone-depleting substances
(ODSs). The agency encourages
individuals, patient advocates, industry,
consumer groups, health care
professionals, researchers, and other
interested persons to attend this public
workshop.
DATES: The public workshop will be
held on September 25, 2009, from 8:30
a.m. to 3 p.m. However, depending on
public participation, the meeting may be
extended or may end early. See section
III of this document for information on
how to register for the workshop.
Written or electronic comments must be
submitted by November 24, 2009.
ADDRESSES: The public workshop will
be held at FDA’s, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, 5630
Fishers Lane, rm. 1066, Rockville, MD
20852.
Submit written or electronic requests
to make a presentation to Faith Dugan
(see FOR FURTHER INFORMATION CONTACT).
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.regulations.gov. All
comments should be identified with the
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Faith Dugan, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6182, Silver Spring,
MD 20993–0002, 301–796–3446, FAX:
301–847–8752, e-mail:
Faith.Dugan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Montreal Protocol on
Substances that Deplete the Ozone
Layer (Montreal Protocol) and the Clean
Air Act,1 FDA, in consultation with the
Environmental Protection Agency, is
required to determine whether an FDAregulated product that releases an ODS
is an essential use of the ODS. Products
containing an ODS, such as CFCs, that
are not designated as essential uses
cannot be sold or distributed in the
United States. In the Federal Register of
November 19, 2008 (73 FR 69532) (the
final rule), we amended our regulation
on the use of ODSs in self-pressurized
containers to remove the essential-use
designation for MDIs containing
epinephrine. Epinephrine MDIs
containing an ODS cannot be marketed
after December 31, 2011. You may find
copies of the final rule on the Internet
at https://www.regulations.gov.
Epinephrine is a short-acting
adrenergic bronchodilator used in the
treatment of asthma. A new drug
application (NDA) for OTC epinephrine
MDIs was approved in 1956.
Epinephrine was designated as an
essential use in 1978 (43 FR 11301,
March 17, 1978). Epinephrine MDIs are
marketed OTC as PRIMATENE MIST
and as generic brands for certain retail
pharmacies. Epinephrine MDIs are the
only MDIs for treatment of asthma (or
any other disease) that are approved for
OTC use. Consumers do not need a
prescription from a health care provider
to purchase OTC epinephrine MDIs.
In removing the essential-use
designation for epinephrine, we applied
the criteria for removing an essentialuse designation in § 2.125(g)(2) (21 CFR
2.125(g)(2)). Under § 2.125(g)(2), an
essential-use designation can be
removed even though the active moiety
is not available in a non-CFC product if
it no longer meets the criteria specified
in § 2.125(f) for adding a new essential
use. The criteria in § 2.125(f)(1) are: ‘‘(i)
Substantial technical barriers exist to
formulating the product without ODSs;
1 Montreal Protocol on Substances that Deplete
the Ozone Layer, September 16, 1987, 26 I.L.M.
1541 (1987); 1990 Amendments to the Clean Air
Act, Public Law No. 101–549 (November 15, 1990).
E:\FR\FM\20AUN1.SGM
20AUN1
Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices
(ii) The product will provide an
unavailable important public health
benefit; and (iii) Use of the product does
not release cumulatively significant
amounts of ODSs into the atmosphere or
the release is warranted in view of the
unavailable important public health
benefit.’’
In a proposed rule published on
September 20, 2007 (72 FR 53711), we
proposed an effective date for removal
of the essential-use designation for OTC
epinephrine MDIs of December 31,
2010, and we solicited comments on
this proposed effective date. We
received a number of comments on the
effective date and on the related issue of
ensuring adequate time to transition
consumers who use OTC epinephrine
MDIs to non-CFC alternatives. After
considering the comments, we were
persuaded that December 31, 2011,
rather than December 31, 2010, as
proposed, is a more appropriate
effective date for this rule. The
December 31, 2011, date provides
additional time to disseminate
information about the transition to OTC
epinephrine MDI users and allows
consumers more time to transition to
appropriate non-CFC alternatives.
Although at least one manufacturer has
stated its intent to develop an OTC
epinephrine MDI without CFCs,2 there
is no assurance that the product will be
available by December 31, 2011. Thus,
we assume that OTC epinephrine MDI
users will need to transition to
therapeutic alternatives that contain a
different active moiety, such as
prescription albuterol MDIs.
sroberts on DSKD5P82C1PROD with NOTICES
II. Scope of Public Workshop
FDA is holding this public workshop
to obtain information about usage of
OTC epinephrine MDIs and to discuss
the best methods for disseminating
information to consumers who use these
MDIs about the need to transition to
alternative treatments for asthma. At the
public workshop, FDA will provide
relevant background information,
including a brief summary of the
Montreal Protocol, the Clean Air Act,
and the epinephrine final rule. FDA also
will present an update on the current
transition from CFC MDIs to non-CFC
alternatives and FDA’s related outreach
efforts. Presentations by patient
outreach experts and other stakeholders
will provide a framework for discussion
2 See Comment from Mr. Robert Sussman on
behalf of Armstrong Pharmaceuticals, Inc.,
submitted in response to the Proposed Rule on Use
of Ozone-Depleting Substances; Removal of
Essential-Use Designation (Epinephrine) at 1-2
(dated November 21, 2007) (Document ID FDA–
2007–N–0314–0032, available on the Internet at
https://www.regulations.gov).
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16:07 Aug 19, 2009
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about OTC use of epinephrine and how
best to educate epinephrine users about
the phase-out and therapeutic
alternatives. The input from the public
workshop will help FDA in developing
further outreach and education
campaigns to assist consumers in the
transition away from OTC epinephrine
MDIs.
A. Objectives of the Workshop
The workshop objectives are as
follows:
1. Provide an overview of the
regulatory framework for the transition
and FDA’s current outreach activities.
2. Discuss what is known about
current OTC epinephrine MDI usage
and the demand for OTC epinephrine
MDIs.
3. Discuss the therapeutic alternatives
to OTC epinephrine MDIs.
4. Discuss how best to educate
consumers who use OTC epinephrine
MDIs about the phase-out and
therapeutic alternatives.
B. Issues for Comment
FDA is interested in obtaining public
comment on the following issues
relating to the transition from OTC
epinephrine MDIs to therapeutic
alternatives that do not contain ozonedepleting substances:
1. What is known about current OTC
epinephrine MDI usage? Who uses them
and under what circumstances?
2. What sales data are available and
what do they indicate about use of OTC
epinephrine MDIs?
3. What treatment alternatives are
available for consumers who must
switch from OTC epinephrine MDIs?
4. What are effective outreach
strategies for informing consumers who
use OTC epinephrine MDIs about the
transition?
5. What other education efforts should
FDA undertake to effect an orderly
transition?
III. Registration
Interested parties are encouraged to
register early because space is limited
and seating will be on a first-come, firstserved basis. There is no fee to attend
the public workshop. If you would like
to make an oral presentation during the
open public session of the workshop,
you must register and provide an
abstract of your presentation by close of
business on September 11, 2009. To
register to attend or speak at the public
workshop, submit your name, title,
business affiliation (if applicable),
address, telephone and fax numbers,
and e-mail address to Faith Dugan (see
FOR FURTHER INFORMATION CONTACT).
FDA has included questions for
PO 00000
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Sfmt 4703
42081
comment in section II of this document.
You may identify by number each
question you wish to address in your
presentation and the approximate time
requested for your presentation. FDA
will do its best to accommodate requests
to speak. Individuals and organizations
with common interests are urged to
consolidate or coordinate their
presentations and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin. Persons registered to make an
oral presentation should check in at the
registration table at 8 a.m.
If you need special accommodations
due to a disability, please contact Faith
Dugan (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance.
IV. Comments
Regardless of attendance at the public
workshop, interested persons may
submit written or electronic comments
to the Division of Dockets Management
(see ADDRESSES). Submit a single copy
of electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments should be identified
with the docket number found in
brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
V. Transcripts
Transcripts of the public workshop
may be requested in writing from the
Freedom of Information Office (HFI–35),
Food and Drug Administration, 5600
Fishers Lane, rm. 6–30, Rockville, MD
20857, approximately 45 working days
after the public workshop at a cost of 10
cents per page. A transcript of the
public workshop will be available on
the Internet at https://www.regulations.
gov.
Dated: August 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19985 Filed 8–19–09; 8:45 am]
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Agencies
[Federal Register Volume 74, Number 160 (Thursday, August 20, 2009)]
[Notices]
[Pages 42080-42081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0374]
Educating the Public About Removal of Essential-Use Designation
for Epinephrine; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Educating the Public About Removal of Essential-Use
Designation for Epinephrine.'' The currently approved over-the-counter
(OTC) epinephrine metered-dose inhalers (MDIs) contain
chlorofluorocarbons (CFCs) and cannot be marketed after December 31,
2011. This 1-day public workshop is intended to seek input from key
stakeholders in the asthma community, the pharmaceutical industry,
experts in health care communication, and the public on strategies to
educate consumers about the decision to remove epinephrine MDIs from
the market and transition consumers to therapeutic alternatives that do
not contain CFCs or other ozone-depleting substances (ODSs). The agency
encourages individuals, patient advocates, industry, consumer groups,
health care professionals, researchers, and other interested persons to
attend this public workshop.
DATES: The public workshop will be held on September 25, 2009, from
8:30 a.m. to 3 p.m. However, depending on public participation, the
meeting may be extended or may end early. See section III of this
document for information on how to register for the workshop. Written
or electronic comments must be submitted by November 24, 2009.
ADDRESSES: The public workshop will be held at FDA's, Center for Drug
Evaluation and Research Advisory Committee Conference Room, 5630
Fishers Lane, rm. 1066, Rockville, MD 20852.
Submit written or electronic requests to make a presentation to
Faith Dugan (see FOR FURTHER INFORMATION CONTACT). Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://www.regulations.gov. All comments
should be identified with the docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Faith Dugan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6182, Silver Spring, MD 20993-0002, 301-
796-3446, FAX: 301-847-8752, e-mail: Faith.Dugan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Montreal Protocol on Substances that Deplete the Ozone
Layer (Montreal Protocol) and the Clean Air Act,\1\ FDA, in
consultation with the Environmental Protection Agency, is required to
determine whether an FDA-regulated product that releases an ODS is an
essential use of the ODS. Products containing an ODS, such as CFCs,
that are not designated as essential uses cannot be sold or distributed
in the United States. In the Federal Register of November 19, 2008 (73
FR 69532) (the final rule), we amended our regulation on the use of
ODSs in self-pressurized containers to remove the essential-use
designation for MDIs containing epinephrine. Epinephrine MDIs
containing an ODS cannot be marketed after December 31, 2011. You may
find copies of the final rule on the Internet at https://www.regulations.gov.
---------------------------------------------------------------------------
\1\ Montreal Protocol on Substances that Deplete the Ozone
Layer, September 16, 1987, 26 I.L.M. 1541 (1987); 1990 Amendments to
the Clean Air Act, Public Law No. 101-549 (November 15, 1990).
---------------------------------------------------------------------------
Epinephrine is a short-acting adrenergic bronchodilator used in the
treatment of asthma. A new drug application (NDA) for OTC epinephrine
MDIs was approved in 1956. Epinephrine was designated as an essential
use in 1978 (43 FR 11301, March 17, 1978). Epinephrine MDIs are
marketed OTC as PRIMATENE MIST and as generic brands for certain retail
pharmacies. Epinephrine MDIs are the only MDIs for treatment of asthma
(or any other disease) that are approved for OTC use. Consumers do not
need a prescription from a health care provider to purchase OTC
epinephrine MDIs.
In removing the essential-use designation for epinephrine, we
applied the criteria for removing an essential-use designation in Sec.
2.125(g)(2) (21 CFR 2.125(g)(2)). Under Sec. 2.125(g)(2), an
essential-use designation can be removed even though the active moiety
is not available in a non-CFC product if it no longer meets the
criteria specified in Sec. 2.125(f) for adding a new essential use.
The criteria in Sec. 2.125(f)(1) are: ``(i) Substantial technical
barriers exist to formulating the product without ODSs;
[[Page 42081]]
(ii) The product will provide an unavailable important public health
benefit; and (iii) Use of the product does not release cumulatively
significant amounts of ODSs into the atmosphere or the release is
warranted in view of the unavailable important public health benefit.''
In a proposed rule published on September 20, 2007 (72 FR 53711),
we proposed an effective date for removal of the essential-use
designation for OTC epinephrine MDIs of December 31, 2010, and we
solicited comments on this proposed effective date. We received a
number of comments on the effective date and on the related issue of
ensuring adequate time to transition consumers who use OTC epinephrine
MDIs to non-CFC alternatives. After considering the comments, we were
persuaded that December 31, 2011, rather than December 31, 2010, as
proposed, is a more appropriate effective date for this rule. The
December 31, 2011, date provides additional time to disseminate
information about the transition to OTC epinephrine MDI users and
allows consumers more time to transition to appropriate non-CFC
alternatives. Although at least one manufacturer has stated its intent
to develop an OTC epinephrine MDI without CFCs,\2\ there is no
assurance that the product will be available by December 31, 2011.
Thus, we assume that OTC epinephrine MDI users will need to transition
to therapeutic alternatives that contain a different active moiety,
such as prescription albuterol MDIs.
---------------------------------------------------------------------------
\2\ See Comment from Mr. Robert Sussman on behalf of Armstrong
Pharmaceuticals, Inc., submitted in response to the Proposed Rule on
Use of Ozone-Depleting Substances; Removal of Essential-Use
Designation (Epinephrine) at 1-2 (dated November 21, 2007) (Document
ID FDA-2007-N-0314-0032, available on the Internet at https://www.regulations.gov).
---------------------------------------------------------------------------
II. Scope of Public Workshop
FDA is holding this public workshop to obtain information about
usage of OTC epinephrine MDIs and to discuss the best methods for
disseminating information to consumers who use these MDIs about the
need to transition to alternative treatments for asthma. At the public
workshop, FDA will provide relevant background information, including a
brief summary of the Montreal Protocol, the Clean Air Act, and the
epinephrine final rule. FDA also will present an update on the current
transition from CFC MDIs to non-CFC alternatives and FDA's related
outreach efforts. Presentations by patient outreach experts and other
stakeholders will provide a framework for discussion about OTC use of
epinephrine and how best to educate epinephrine users about the phase-
out and therapeutic alternatives. The input from the public workshop
will help FDA in developing further outreach and education campaigns to
assist consumers in the transition away from OTC epinephrine MDIs.
A. Objectives of the Workshop
The workshop objectives are as follows:
1. Provide an overview of the regulatory framework for the
transition and FDA's current outreach activities.
2. Discuss what is known about current OTC epinephrine MDI usage
and the demand for OTC epinephrine MDIs.
3. Discuss the therapeutic alternatives to OTC epinephrine MDIs.
4. Discuss how best to educate consumers who use OTC epinephrine
MDIs about the phase-out and therapeutic alternatives.
B. Issues for Comment
FDA is interested in obtaining public comment on the following
issues relating to the transition from OTC epinephrine MDIs to
therapeutic alternatives that do not contain ozone-depleting
substances:
1. What is known about current OTC epinephrine MDI usage? Who uses
them and under what circumstances?
2. What sales data are available and what do they indicate about
use of OTC epinephrine MDIs?
3. What treatment alternatives are available for consumers who must
switch from OTC epinephrine MDIs?
4. What are effective outreach strategies for informing consumers
who use OTC epinephrine MDIs about the transition?
5. What other education efforts should FDA undertake to effect an
orderly transition?
III. Registration
Interested parties are encouraged to register early because space
is limited and seating will be on a first-come, first-served basis.
There is no fee to attend the public workshop. If you would like to
make an oral presentation during the open public session of the
workshop, you must register and provide an abstract of your
presentation by close of business on September 11, 2009. To register to
attend or speak at the public workshop, submit your name, title,
business affiliation (if applicable), address, telephone and fax
numbers, and e-mail address to Faith Dugan (see FOR FURTHER INFORMATION
CONTACT). FDA has included questions for comment in section II of this
document. You may identify by number each question you wish to address
in your presentation and the approximate time requested for your
presentation. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and to request time for a
joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin. Persons registered to make an oral presentation
should check in at the registration table at 8 a.m.
If you need special accommodations due to a disability, please
contact Faith Dugan (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.
IV. Comments
Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
V. Transcripts
Transcripts of the public workshop may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 45 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.regulations.gov.
Dated: August 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19985 Filed 8-19-09; 8:45 am]
BILLING CODE 4160-01-S