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