Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices 42079 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost for this two year 

project. The annual cost to the Federal 

Government is estimated to be $10.3 

million. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

[$ thousands] 

Cost component Total cost Annualized 

cost 

Project Development ....................................................................................................................................................... $3,099 $1,550 

Data Collection Activities ................................................................................................................................................. 7,230 3,615 

Data Processing and Analysis ......................................................................................................................................... 7,230 3,615 

Project Management ........................................................................................................................................................ 2,066 1,033 

Overhead ......................................................................................................................................................................... 1,033 517 

Total .......................................................................................................................................................................... $20,658 $10,329 

Note: Components may not sum to Total 

due to rounding. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research, quality 

improvement and information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 13, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–20021 Filed 8–19–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting of the AHRQ National 

Advisory Council for Healthcare 

Research and Quality Subcommittee 

on Quality Measures for Children’s 

Healthcare in Medicaid and Children’s 

Health Insurance Programs 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

SUMMARY: In accordance with section 

10(a) of the Federal Advisory Committee 

Act, 5 U.S.C. App. 2, this notice 

announces a meeting of the National 

Advisory Council for Healthcare 

Research and Quality Subcommittee on 

Quality Measures for Children’s 

Healthcare in Medicaid and Children’s 

Health Insurance Programs (CHIP). 

DATES: The meeting will be held on 

Thursday, September 17, 2009, from 8 

a.m. to 5 p.m. and Friday, September 18, 

2009 from 8 a.m. to 12 p.m. 

ADDRESSES: Holiday Inn Capitol, 550 C 

Street, SW., Washington, DC 20024. 

FOR FURTHER INFORMATION CONTACT: 

Padmini Jagadish, Public Health Analyst 

at the Agency for Healthcare Research 

and Quality, 540 Gaither Road, 

Rockville, Maryland 20850, (301) 427– 

1927. For press-related information, 

please contact Karen Migdail at (301) 

427–1855. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact Mr. 

Michael Chew, Director, Office of Equal 

Employment Opportunity Program, 

Program Support Center, on (301) 443– 

1144, no later than August 31, 2009. 

SUPPLEMENTARY INFORMATION: 

I. Purpose 

The National Advisory Council for 

Healthcare Research and Quality was 

established in accordance with Section 

921 (now Section 931) of the Public 

Health Service Act, 42 U.S.C. 299c. In 

accordance with its statutory mandate, 

the Council is to advise the Secretary of 

the Department of Health and Human 

Services and the Director, Agency for 

Healthcare Research and Quality 

(AHRQ), on matters related to actions of 

AHRQ to enhance the quality, and 

improve the outcomes, of health care 

services; improve access to such 

services through scientific research; and 

promote improvements in clinical 

practice and in the organization, 

financing, and delivery of health care 

services. 

The Council is composed of members 

of the public, appointed by the 

Secretary, and Federal ex-officio 

members. 

AHRQ’s National Advisory Council 

on Healthcare Research and Quality 

(NAC) has established a Subcommittee 

on Quality Measures for Children’s 

Healthcare in Medicaid and Children’s 

Health Insurance Programs (CHIP). The 

Subcommittee was created to provide 

advice to the NAC for consideration and 

transmission to AHRQ as AHRQ 

undertakes responsibilities in the 

identification of an initial core quality 

measure set for use by Medicaid and 

CHIP programs for children’s 

healthcare. A roster of the 

Subcommittee members is available at 

http://www.ahrg.gov/chip/ 

chipraact.htm. The first meeting of the 

subcommittee took place on July 22 and 

23, 2009. The September meeting is the 

second working meeting that will be 

held as a part of this effort. 

The identification of an initial core 

measure set for public comment is 

required under Public Law 111–3, the 

Child Health Insurance Program 


sroberts on DSKD5P82C1PROD with NOTICES
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] 

BILLING CODE 4160–90–M 

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