71538 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices 

Dated: November 18, 2005. 

Betsey Dunaway, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E5–6671 Filed 11–28–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Breast and Cervical Cancer Early 

Detection and Control Advisory 

Committee 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following committee 

meeting: 

Name: Breast and Cervical Cancer 

Early Detection and Control Advisory 

Committee (BCCEDCAC). 

Times and Dates: 8:30 a.m.–5 p.m., 

December 6, 2005. 8:30 a.m.–1 p.m., 

December 7, 2005. 

Place: Embassy Suites Hotel, 

Centennial Olympic Park, 267 Marietta 

Street, Atlanta, Georgia 30313. 

Phone: 1–404–223–2300. 

Status: Open to the public, limited 

only by the space available. 

Purpose: The committee is charged 

with advising the Secretary, Department 

of Health and Human Services, and the 

Director, CDC, regarding the early 

detection and control of breast and 

cervical cancer. The committee makes 

recommendations regarding national 

program goals and objectives; 

implementation strategies; and program 

priorities including surveillance, 

epidemiologic investigations, education 

and training, information dissemination, 

professional interactions and 

collaborations, and policy. 

Matters to be Discussed: The agenda 

will include discussion and review of 

the vision for National Cancer 

Prevention and Control Program; 

strategies for Performance-Based 

Funding; Case Management; update of 

expert panel meetings; HPV Testing and 

the Breast and Cervical Program; and 

HPV Vaccine update. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Debra Younginer, Executive Secretary, 

BCCEDCAC, Division of Cancer 

Prevention and Control, National Center 

for Chronic Disease Prevention and 

Health Promotion, CDC, 4770 Buford 

Highway, Mailstop K–57, Chamblee, 

Georgia 30316, Telephone: 770–488–

1074. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control. 

[FR Doc. 05–23425 Filed 11–28–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0374] 

Nonprescription Drugs Advisory 

Committee and Pulmonary-Allergy 

Drugs Advisory Committee; Notice of 

Meeting and Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: 

Nonprescription Drugs Advisory 

Committee and the Pulmonary-Allergy 

Drugs Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 24, 2006, from 8 a.m. 

to 5 p.m. Interested persons and 

organizations may submit written or 

electronic comments until January 6, 

2006, to the Division of Dockets 

Management (see Addresses). 

Addresses: Electronic comments 

should be submitted to http:// 

www.fda.gov/dockets/ecomments. 

Select ‘‘2005N–0374 Use of OzoneDepleting Substance: Essential-Use 

Determination of Over-the-Counter 

(OTC) Epinephrine Metered Dose 

Inhalers’’ and follow the prompts to 

submit your statement. Written 

comments should be submitted to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Location: Holiday Inn Select 

Bethesda, The Ballrooms, 8120 

Wisconsin Ave., Bethesda, MD. The 

hotel telephone number is 301–652–

2000. 

Contact Person: Darrell Lyons, Center 

for Drug Evaluation and Research (HFD 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, (301–827–7001, FAX: 301–

827–6776, e-mail: lyonsd@cder.fda.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area) codes 3014512541 or 3014512545. 

Please call the Information Line for up 

to date information on this meeting. 

Agenda: The committee will discuss 

the continued need for the designation 

of OTC epinephrine-metered dose 

inhalers for the treatment of asthma as 

an essential use of ozone-depleting 

substances (ODSs) under § 2.125 (21 

CFR 2.125). ODSs are substances that 

deplete the stratospheric ozone, which 

include chlorofluorocarbons (CFCs). 

Once released, CFCs rise to the 

stratosphere. In the stratosphere, CFCs 

are gradually broken down by strong 

ultraviolet light, and they release 

chlorine atoms that then deplete 

stratospheric ozone. Depletion of 

stratospheric ozone by CFCs and other 

ODSs leads to higher ultraviolet B 

radiation levels, which in turn increase 

skin cancers and cataracts, as well as 

cause other significant environmental 

damage. 

FDA is soliciting comments and data 

to support or refute an essential-use 

designation for OTC epinephrine 

metered-dose inhaler (MDI) drug 

products. These products include the 

only OTC drug available in an MDI 

dosage form for the treatment of asthma. 

The OTC epinephrine MDIs use CFCs as 

propellants. The OTC indication is ‘‘for 

temporary relief of shortness of breath, 

tightness of chest, and wheezing due to 

bronchial asthma.’’ In some instances, 

use of this product early during an 

asthma attack could avert a serious or 

life-threatening worsening of the attack. 

There are currently a limited number of 

marketed OTC drug products containing 

epinephrine in a MDI dosage form. 

According to § 2.125(f)(1), the 

following are criteria for continued ODS 

essential-use designation: 

(1) Substantial technical barriers exist 

to formulating the product without 

ODSs; 

(2) The product will provide an 

otherwise unavailable important public 

health benefit; and 

(3) Use of the product does not release 

cumulative significant amounts of ODSs 

into the atmosphere or the release is 

warranted in view of the high 

Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices 71539 

probability of an unavailable important 

public health benefit. 

Under section 610 of the Clean Air 

Act (42 U.S.C. 7671(i)), MDIs that are 

not the subject of an essential-use 

designation cannot be legally 

distributed in interstate commerce. 

We particularly encourage comments 

on the second criterion in § 2.125(f)(i) 

regarding the public health benefit 

derived from the availability of these 

products in the OTC setting. 

Information that may aid in the 

Committee’s discussion of essential use 

includes: 

• Who currently uses OTC 

epinephrine MDIs? 

• How many of these MDIs are used 

annually? 

• What are the alternatives if these 

products are no longer available? 

• From literature sources, what is the 

value of use of the product to the users, 

and why do they use it? 

• What established treatment 

guidelines recommend the use of OTC 

epinephrine? 

• How many people with asthma do 

not have ready access to prescription 

medication through healthcare 

professionals? 

The background material will become 

available no later than the day before 

the meeting and will be posted under 

the Nonprescription Drugs Advisory 

Committee (NDAC) and the Pulmonary 

Drugs Advisory Committee (PADAC) on 

FDA’s website at http://www.fda.gov/ 

ohrms/dockets/ac/acmenu.htm. (Click 

on the year 2006 and scroll down to 

NDAC or PADAC). 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. Written 

comments should be submitted by close 

of business January 6, 2006, to the 

Division of Dockets Management (see 

Addresses). Oral presentations from the 

public will be scheduled between 

approximately 1 p.m. and 2 p.m. Time 

allotted for each presentation may be 

limited. Those desiring to make formal 

oral presentations should notify the 

contact person by close of business 

January 6, 2006, and submit a brief 

statement of the general nature of the 

information they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Darrell Lyons 

(see Contact Person) at least 7 days in 

advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: November 17, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–23372 Filed 11–28–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Vaccines and 

Related Biological Products Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on December 14, 2005, from 9 a.m. 

to 4:30 p.m. and on December 15, 2005, 

from 9 a.m. to 4:30 p.m. 

Location: Holiday Inn Select, 8120 

Wisconsin Ave., Bethesda, MD. 

Contact Person: Christine Walsh or 

Denise Royster, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512391. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On December 14, 2005, the 

committee will hear presentations and 

make recommendations on the safety 

and efficacy of a rotavirus vaccine 

manufactured by Merck. On December 

15, 2005, the committee will hear 

presentations and make 

recommendations on the safety and 

efficacy of ZOSTAVAX (zoster vaccine 

live (Oka/Merck)) manufactured by 

Merck. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person by December 7, 2005. Oral 

presentations from the public will be 

scheduled between approximately 1:15 

p.m. and 1:45 p.m. on December 14, 

2005, and from approximately 1:30 p.m. 

and 2 p.m. on December 15, 2005. Time 

allotted for each presentation may be 

limited. Those desiring to make formal 

oral presentations should notify the 

contact person before December 7, 2005, 

and submit a brief statement of the 

general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Christine 

Walsh or Denise Royster at least 7 days 

in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: November 17, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–23373 Filed 11–28–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: Notice and request for 

comments. 

SUMMARY: The Federal Emergency 

Management Agency, as part of its