Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 53977 

speaker’s testimony during this open 

public hearing may be limited by time 

constraints. 

Comments: Submit either electronic 

or written comments by December 27, 

2010. Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. It 

is only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

If you need special accommodations 

due to a disability, contact Mary Gross 

or Dominic Chiapperino (see Contacts) 

at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Nicotine is the primary addictive 

substance in tobacco. NRT products are 

designed to help people stop smoking 

by supplying controlled amounts of 

purified nicotine to replace the nicotine 

derived from smoking. People who use 

NRT products instead of cigarettes 

during an attempt to quit smoking 

obtain nicotine to ease the symptoms 

associated with quitting, but 

significantly reduce their exposure to 

harmful chemicals present in tobacco 

products and tobacco smoke. NRT 

products are available over-the-counter 

(OTC) and by prescription. The labeling 

for all NRT products recommends that 

they be used for a short time only (up 

to 12 weeks) to relieve the acute 

withdrawal symptoms experienced 

when quitting smoking. Prescription 

NRT products are marketed under the 

brand name Nicotrol and are available 

as a nasal spray and oral inhaler. OTC 

NRT products include skin patches 

(transdermal nicotine patches, various 

brand names and generics), chewing 

gum (Nicorette and generics) and 

lozenges (Commit, Nicorette, and 

generics). 

FDA will explore the following topics 

during this public workshop: 

• What is known about the long-term 

safety of nicotine from animal studies? 

• What is known about the long-term 

safety of nicotine from human studies? 

• What evidence is there that longterm NRT helps people to sustain 

abstinence from smoking? 

• What evidence is there that longterm NRT helps people to sustain 

reduced smoking levels? 

• What evidence is there that using 

NRT to maintain reduced levels of 

smoking, rather than complete 

abstinence, yields clinical benefits? 

• What is known about dependence/ 

addiction to NRT products? 

• Does the route of administration/ 

speed of onset influence the addiction 

potential? 

• What factors mitigate against abuse/ 

addiction to NRT products and against 

initiation of NRT products by people 

who have never used tobacco products 

previously? 

FDA will post the agenda and 

additional workshop background 

material approximately 5 days before 

the workshop at: http://www.fda.gov/ 

Drugs/NewsEvents/ucm221185.htm. 

II. Transcripts 

Please be advised that approximately 

30 days after the public workshop, a 

transcript will be available. It will be 

accessible at http:// 

www.regulations.gov, and may be 

viewed at the Division of Dockets 

Management (see Comments). A 

transcript will also be available in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

Dated: August 27, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–21894 Filed 9–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1934– 

DR; Docket ID FEMA–2010–0002] 

Missouri; Amendment No. 1 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

State of Missouri (FEMA–1934–DR), 

dated August 17, 2010, and related 

determinations. 

DATES: Effective Date: August 26, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Recovery Directorate, 

Federal Emergency Management 

Agency, 500 C Street, SW., Washington, 

DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: The notice 

of a major disaster declaration for the 

State of Missouri is hereby amended to 

include the following areas among those 

areas determined to have been adversely 

affected by the event declared a major 

disaster by the President in his 

declaration of August 17, 2010. 

Knox, Linn, Marion, Monroe, Pike, Ralls, 

and Shelby Counties for Public Assistance. 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant. 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2010–21994 Filed 9–1–10; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1912– 

DR; Docket ID FEMA–2010–0002] 

Kentucky; Amendment No. 8 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

Commonwealth of Kentucky (FEMA– 

1912–DR), dated May 11, 2010, and 

related determinations. 

DATES: Effective Date: August 19, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Recovery Directorate, 

Federal Emergency Management 

Agency, 500 C Street, SW., Washington, 

DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) hereby gives notice that 

pursuant to the authority vested in the 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
53978 Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 

Administrator, under Executive Order 

12148, as amended, Terry L. Quarles, of 

FEMA is appointed to act as the Federal 

Coordinating Officer for this disaster. 

This action terminates the 

appointment of Douglas G. Mayne as 

Federal Coordinating Officer for this 

disaster. 

(The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households in Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant.) 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2010–21900 Filed 9–1–10; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1925– 

DR; Docket ID FEMA–2010–0002] 

Kentucky; Amendment No. 5 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

Commonwealth of Kentucky (FEMA– 

1925–DR), dated July 23, 2010, and 

related determinations. 

DATES: Effective Date: August 19, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Recovery Directorate, 

Federal Emergency Management 

Agency, 500 C Street, SW., Washington, 

DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) hereby gives notice that 

pursuant to the authority vested in the 

Administrator, under Executive Order 

12148, as amended, Terry L. Quarles, of 

FEMA is appointed to act as the Federal 

Coordinating Officer for this disaster. 

This action terminates the 

appointment of Douglas G. Mayne as 

Federal Coordinating Officer for this 

disaster. 

(The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households in Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant.) 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2010–21901 Filed 9–1–10; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R1–ES–2010–N133;10120–1113– 

0000–C4] 

Endangered and Threatened Wildlife 

and Plants; 5-Year Status Reviews for 

Lomatium cookii (Cook’s Lomatium) 

and Limnanthes floccosa ssp. 

grandiflora (Large-flowered Woolly 

Meadowfoam) 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of initiation of reviews; 

request for information. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service, are initiating 5-year 

reviews for two plant species in Oregon 

under the Endangered Species Act of 

1973, as amended (Act). We request any 

new information on these species that 

may have a bearing on their 

classification as endangered. Based on 

the results of our 5-year reviews we will 

determine whether these species are 

properly classified under the Act. 

DATES: To ensure consideration in our 

reviews, we are requesting submission 

of new information no later than 

November 1, 2010. However, we will 

continue to accept new information 

about any listed species at any time. 

ADDRESSES: Submit information to: 

Field Supervisor, Attention: 5-Year 

Review, U.S. Fish and Wildlife Service, 

Oregon Fish and Wildlife Office, 2600 

SE 98th Avenue, Suite 100, Portland, 

OR 97266. Information can also be 

submitted by e-mail to: 

fw1or5yearreview@fws.gov. 

FOR FURTHER INFORMATION CONTACT: Jeff 

Dillon, U.S. Fish and Wildlife Service, 

Oregon Fish and Wildlife Office (see 

ADDRESSES), 503–231–6179. Individuals 

who are hearing impaired or speech 

impaired may call the Federal Relay 

Service at (800) 877–8337 for TTY 

assistance. 

SUPPLEMENTARY INFORMATION: 

I. Why do we conduct 5-year reviews? 

Under the Act (16 U.S.C. 1531 et seq.), 

we maintain Lists of Endangered and 

Threatened Wildlife and Plants (which 

we collectively refer to as the List) in 

the Code of Federal Regulations (CFR) at 

50 CFR 17.11 (for animals) and 17.12 

(for plants). Section 4(c)(2)(A) of the Act 

requires us to review each listed 

species’ status at least once every 5 

years. Then, under section 4(c)(2)(B), we 

determine whether to remove any 

species from the List (delist), to 

reclassify it from endangered to 

threatened, to reclassify it from 

threatened to endangered, or to 

conclude that the current listing is 

appropriate. Any change in Federal 

classification requires a separate 

rulemaking process. 

We use the following definitions, 

from 50 CFR 424.02, in our analysis of 

classification status: 

(A) Species includes any species or 

subspecies of fish, wildlife, or plant, 

and any distinct population segment of 

any species of vertebrate, that 

interbreeds when mature; 

(B) Endangered species means any 

species that is in danger of extinction 

throughout all or a significant portion of 

its range; and 

(C) Threatened species means any 

species that is likely to become an 

endangered species within the 

foreseeable future throughout all or a 

significant portion of its range. 

Our regulations at 50 CFR 424.21 

require that we publish a notice in the 

Federal Register announcing the species 

we are reviewing. 

II. What species are under review? 

This notice announces our active 

review of Lomatium cookii (Cook’s 

lomatium) and Limnanthes floccosa ssp. 

grandiflora (large-flowered woolly 

meadowfoam). These two plant species 

occur only in Oregon and were 

originally listed as endangered on 

November 7, 2002 (67 FR 68004). 

III. What information do we consider in 

the review? 

A 5-year review considers all new 

information available at the time of the 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1