53976 Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 

ADDRESSES: The Fairfax at Embassy 

Row, 2100 Massachusetts Ave., NW., 

Washington, DC 20008. 

FOR FURTHER INFORMATION CONTACT: 

Lillian A. Sparks, Commissioner, 

Administration for Native Americans, at 

202–401–5590, by e-mail at 

Lillian.sparks@acf.hhs.gov or by mail at 

370 L’Enfant Promenade, SW., 2 West, 

Washington, DC 20447. 

SUPPLEMENTARY INFORMATION: On 

November 5, 2009, President Obama 

signed the ‘‘Memorandum for the Heads 

of Executive Departments and Agencies 

on Tribal Consultation.’’ The President 

stated that his Administration is 

committed to regular and meaningful 

consultation and collaboration with 

tribal officials in policy decisions that 

have tribal implications, including, as 

an initial step, through complete and 

consistent implementation of Executive 

Order 13175. 

The United States has a unique legal 

and political relationship with Indian 

tribal governments, established through 

and confirmed by the Constitution of 

the United States, treaties, statutes, 

executive orders, and judicial decisions. 

In recognition of that special 

relationship, pursuant to Executive 

Order 13175 of November 6, 2000, 

executive departments and agencies are 

charged with engaging in regular and 

meaningful consultation and 

collaboration with tribal officials in the 

development of Federal policies that 

have tribal implications, and are 

responsible for strengthening the 

government-to-government relationship 

between the United States and Indian 

tribes. 

HHS has taken its responsibility to 

comply with Executive Order 13175 

very seriously over the past decade; 

including the initial implementation of 

a Department-wide policy on tribal 

consultation and coordination in 1997, 

and through multiple evaluations and 

revisions of that policy, most recently in 

2008. Many HHS agencies have already 

developed their own agency-specific 

consultation policies that complement 

the Department-wide efforts. 

Since 2005, ACF has been working 

under the guidance of the HHS policy 

issued in 2005 and updated in 2008. 

Due to the various programs 

administered by ACF and the many 

requests from tribes for consultation for 

specific programs, as well as specific 

program mandates for tribal 

consultation, ACF has decided to create 

an ACF tribal consultation policy to 

help ACF program and regional offices 

better engage Federally Recognized 

Indian Tribes in the development or 

revision of policies, regulations and 

proposed legislation that impact 

American Indians. ACF firmly believes 

that to create a good policy, ACF needs 

input from tribes to ensure that ACF is 

meeting tribal needs and to establish a 

partnership that can carry into the 

future. 

Testimonies may be submitted no 

later than September 21, 2010, to: 

Lillian Sparks, Commissioner, 

Administration for Native Americans, 

370 L’Enfant Promenade, SW., 

Washington, DC 20447, 

anacommissioner@acf.hhs.gov. 

ACF assembled a Tribal/Federal 

Workgroup to develop a draft policy and 

is asking Tribal Leaders to read the draft 

policy that will be sent to them in a 

letter prior to the scheduled 

consultation date. At the consultation 

session planned for September 29, 2010, 

ACF is interested in receiving tribal 

feedback on the policy and in working 

with tribal representatives to further 

refine a policy that meets both ACF and 

tribal needs, and works towards 

solidifying the partnership between 

ACF and tribes. 

In addition to the tribal consultation 

session, ACF will be hosting a tribal 

resources day to provide information 

about ACF programs, funding 

opportunities and tools on how to use 

ACF funding to create comprehensive 

community programs. The resources 

day will take place on September 28, 

2010, at the same above address. ACF is 

encouraging tribes to send their tribal 

planning officers or comparable 

employee to attend the tribal resources 

day. 

Dated: August 26, 2010. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2010–21915 Filed 9–1–10; 8:45 am] 

BILLING CODE 4184–34–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0449] 

Risks and Benefits of Long-Term Use 

of Nicotine Replacement Therapy 

Products; 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), Center for Drug 

Evaluation and Research (CDER) is 

announcing a scientific workshop to 

solicit feedback on the risks and benefits 

associated with the long-term use of 

nicotine replacement therapy (NRT) 

products. NRT products facilitate 

smoking cessation by ameliorating the 

symptoms of nicotine withdrawal and 

are available as approved 

nonprescription and prescription drugs. 

No currently-approved NRT product is 

intended for use beyond 12 weeks to 

relieve the acute withdrawal symptoms 

experienced when quitting smoking. 

Date and Time: The public workshop 

will be held on October 26 and 27, 2010, 

from 8:30 a.m. to 5 p.m. 

Location: The workshop will be held 

at the Radisson Hotel, Reagan National 

Airport, 2020 Jefferson Davis Highway, 

Arlington, VA 22202, 703–920–8600, 

FAX: 703–920–2840. 

Contacts: Mary C. Gross, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6178, 

Silver Spring, MD 20993–0002, 301– 

796–3519, email: 

mary.gross@fda.hhs.gov; or Dominic 

Chiapperino, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 3134, Silver Spring, 

MD 20993–0002, 301–796–1183, email: 

dominic.chiapperino@fda.hhs.gov. 

Registration to Attend the Workshop 

and Requests to Participate in Open 

Public Hearing: If you wish to attend or 

testify for the open public hearing, 

please email your registration to 

NRTPublicMeeting@fda.hhs.gov by 

October 5, 2010. Those without email 

access may register by contacting one of 

the persons listed in the Contacts 

section of the document. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email address, and 

telephone number. Registration is free 

and will be on a first-come, first-served 

basis. Early registration is recommended 

because seating is limited. FDA may 

limit the number of participants from 

each organization as well as the total 

number of participants based on space 

limitations. Registrants will receive 

confirmation once they have been 

accepted for the workshop. Onsite 

registration on the day of the meeting 

will be based on space availability. If 

registration reaches maximum capacity, 

FDA will post a notice closing meeting 

registration for the workshop at: http:// 

www.fda.gov/Drugs/NewsEvents/ 

ucm221185.htm. 

An open public hearing will be held 

between 1:30 p.m. to 2:30 p.m. on 

October 27, 2010, during which speaker 

testimony will be accepted. We will try 

to accommodate all persons who wish 

to testify, however, the duration of each 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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