42080 Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices 

1Montreal 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). 

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 http:// 

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 http://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. 

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 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 http://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 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 http://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; 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices 42081 

2See 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 

http://www.regulations.gov). 

(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. 

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 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 

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 http://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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