Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 78709 

during the meeting for public oral 

comments, which will be limited to 1 

minute for each individual and a total 

of 3 minutes per organization. 

VIII. Meeting Attendance 

The meeting is open to the public; 

however, attendance is limited to space 

available. Attendance will be 

determined on a first-come, first-served 

basis. 

Persons wishing to attend this 

meeting, which is located on Federal 

property, must e-mail the DFO to 

register in advance no later than 5 p.m. 

(e.s.t.), Wednesday, February 23, 2011. 

A confirmation will be sent to the 

requester(s) by return e-mail. 

The following personal information 

must be e-mailed to the DFO by the date 

and time above: 

• Name(s) of attendee(s). 

• Title(s). 

• Organization. 

• E-mail address(es). 

• Telephone number(s). 

IX. Security, Building, and Parking 

Guidelines 

The following are the security, 

building, and parking guidelines: 

• Persons attending the meeting 

including presenters must be registered 

and on the attendance list by the 

prescribed date. 

• Individuals who are not registered 

in advance will not be permitted to 

enter the building and will be unable to 

attend the meeting. 

• Attendees must present 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel before entering the 

building. 

• Security measures include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. 

• All persons entering the building 

must pass through a metal detector. 

• All items brought into CMS 

including personal items, such as 

laptops, cell phones, and palm pilots, 

are subject to physical inspection. 

• The public may enter the building 

30 to 45 minutes before the meeting 

convenes each day. 

• All visitors must be escorted in 

areas other than the lower and first-floor 

levels in the Central Building. 

• The main-entrance guards will 

issue parking permits and instructions 

upon arrival at the building. 

X. Special Accommodations 

Individuals requiring sign-language 

interpretation or other special 

accommodations must send a request 

for these services to the DFO by 5 p.m. 

(e.s.t.), Wednesday, February 23, 2011. 

XI. Panel Recommendations and 

Discussions 

The Panel’s recommendations at any 

APC Panel meeting generally are not 

final until they have been reviewed and 

approved by the Panel on the last day 

prior to final adjournment. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: December 2, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–31542 Filed 12–15–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Public Comment on the Draft Tribal 

Consultation Policy 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Notice. 

SUMMARY: 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. 

The Department of Health and Human 

Services (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, the Administration for 

Children and Families (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. ACF solicited membership for an 

ACF Tribal/Federal Workgroup to 

develop the initial draft policy. The 

Workgroup met August 23 and 24, 2010, 

in Washington, DC, and again in 

Minneapolis, Minnesota, on September 

16 and 17, 2010. The draft was reviewed 

by tribal leaders attending the ACF 

Tribal Consultation Session held in 

Washington, DC on September 29, 2010, 

and the Workgroup met again to address 

the comments heard at the Tribal 

Consultation Session. ACF will convene 

the Tribal/Federal Workgroup again to 

review and address the comments 

received from this publication. 

DATES: The deadline for receipt of 

comments is January 31, 2011. 

ADDRESSES: Comments made in 

response to this notice should be 

addressed to Lillian Sparks, 

Commissioner, Administration for 

Native Americans, 370 L’Enfant 

Promenade, SW., Mail Stop: Aerospace 

2—West, Washington, DC 20447. Delays 

may occur in mail delivery to Federal 

offices; therefore, a copy of comments 

should be faxed to (202) 690–7441. 

Comments will be available for 

inspection by members of the public at 

the Administration for Native 

Americans, 901 D Street, SW., 

Washington, DC 20447. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Sparks, Commissioner, 

Administration for Native Americans, 

(877) 922–9262. 


srobinson on DSKHWCL6B1PROD with NOTICES
78710 Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 

SUPPLEMENTARY INFORMATION: The draft 

Tribal Consultation Policy is provided 

below. 

Dated: December 7, 2010. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

U.S. Department of Health and Human 

Services 

Administration for Children and 

Families 

Tribal Consultation Policy 

1. Introduction 

On November 5, 2009, President 

Obama signed an Executive 

Memorandum reaffirming the 

government-to-government relationship 

between Indian Tribes and the Federal 

Government, and directing each 

executive department and agency to 

consult with Tribal Governments prior 

to taking actions that affect this 

population. The importance of 

consultation with Indian Tribes was 

affirmed through Presidential 

Memoranda in 1994, 2004, and 2009, 

and Executive Order 13175 in 2000. 

The U.S. Department of Health and 

Human Services (HHS) and Indian 

Tribes share the goal of eliminating 

health and human service disparities of 

American Indians and Alaska Natives 

(AI/AN) and ensuring that access to 

critical health and human services is 

maximized. 

2. Purpose 

The Administration for Children and 

Families, as an Operating Division 

within the Department of Health and 

Human Services, hereby establishes a 

consultation policy with Federally 

recognized Indian Tribes in accordance 

with the HHS consultation policy. The 

purpose of the ACF tribal consultation 

policy is to build meaningful 

relationships with Federally recognized 

Tribes by engaging in open, continuous, 

and meaningful consultation. True 

consultation leads to information 

exchange, mutual understanding, and 

informed decision-making. 

This ACF Tribal Consultation Policy 

document was developed based upon: 

• Executive Order 13175, reaffirmed 

in 2009; 

• HHS Tribal Consultation Policy 

(established in 2005, and amended in 

2010); 

• Input from an ACF Tribal/Federal 

Workgroup convened to develop the 

ACF Draft Consultation Policy; 

• Input from Tribes to ensure a 

consultation policy that reflects the 

goals of all partners involved; and 

• Input of all of the programs and 

regions within ACF, many of which 

already consult with American Indians 

and Alaska Natives (AI/ANs). 

3. Background 

Since the formation of the Union, the 

United States (U.S.) has recognized 

Indian Tribes as sovereign nations. A 

unique nation-to-nation relationship 

exists between AI/AN Indian Tribes and 

the Federal Government. This 

relationship is grounded in the U.S. 

Constitution, numerous treaties, 

statutes, and executive orders, as well as 

political, legal, moral, and ethical 

principles. This relationship is derived 

from the political relationship that 

Tribes have with the Federal 

Government and is not based upon race. 

The Federal Government has enacted 

numerous regulations that establish and 

define a trust relationship with Indian 

Tribes. 

An integral element of this 

government-to-government relationship 

is that consultation occurs with Indian 

Tribes. This policy applies to all offices 

of ACF. Offices shall provide an 

opportunity for meaningful consultation 

between Tribes and ACF in policy 

development, as set forth in this policy. 

Executive Memorandum entitled 

‘‘Government-to-Government 

Relationship with Tribal Governments’’ 

reaffirmed this government-togovernment relationship with Indian 

Tribes on November 5, 2009. The 

implementation of this policy is in 

recognition of this special relationship. 

This special relationship is affirmed 

in statutes and various Presidential 

Executive Orders including, but not 

limited to: 

• Older Americans Act, Public Law 

89–73, as amended (42 U.S.C. 3001 et 

seq.); 

• Indian Self-Determination and 

Education Assistance Act, Public Law 

93–638, as amended (25 U.S.C. 450 et 

seq.); 

• Native American Programs Act, 

Public Law 93–644, as amended (42 

U.S.C. 2991 et seq.); 

• Indian Health Care Improvement 

Act, Public Law 94–437, as amended (25 

U.S.C. 1601 et seq.); 

• Personal Responsibility and Work 

Opportunity Reconciliation Act of 1996, 

Public Law 104–193 (42 U.S.C. 1305 et 

seq.); 

• Head Start for School Readiness Act 

of 2007, Public Law 110–134, as 

amended (42 U.S.C. 9801 et seq.); 

• Patient Protection and Affordable 

Care Act (PPACA), Public Law 111–148 

(42 U.S.C. 18001 et seq.); 

• Fostering Connections to Success 

and Increasing Adoptions Act of 2008, 

Public Law 110–351 (42 U.S.C. 1305 et 

seq.); 

• Presidential Executive 

Memorandum to the Heads of Executive 

Departments dated April 29, 1994; 

• Presidential Executive Order 13175, 

Consultation and Coordination with 

Indian Tribal Governments, November 

6, 2000; and 

• Presidential Memorandum, 

Government-to-Government 

Relationship with Tribal Governments, 

September 23, 2004 and November 5, 

2009. 

4. Tribal Sovereignty 

This policy does not waive any Tribal 

Governmental rights, including treaty 

rights, sovereign immunities or 

jurisdiction. Additionally, this policy 

does not diminish any rights or 

protections afforded other AI/AN 

persons or entities under Federal law. 

Our Nation, under the law of the U.S. 

and in accordance with treaties, 

statutes, Executive Orders, and judicial 

decisions has recognized the right of 

Indian Tribes to self-government and 

self-determination. Indian Tribes 

exercise inherent sovereign powers over 

their members and territory. The U.S. 

continues to work with Indian Tribes on 

a government-to-government basis to 

address issues concerning tribal selfgovernment, tribal trust resources, tribal 

treaties and other rights. 

The constitutional relationship among 

sovereign governments is inherent in 

the very structure of the Constitution, 

and is formalized in and protected by 

Article I, Section 8. Self-determination 

and meaningful involvement for Indian 

Tribes in Federal decision-making 

through consultation in matters that 

affect Indian Tribes have been shown to 

result in improved program 

performance and positive outcomes for 

tribal communities. The involvement of 

Indian Tribes in the development of 

public health and human services 

policy allows for locally relevant and 

culturally appropriate approaches to 

public issues. 

Tribal self-government has been 

demonstrated to improve and 

perpetuate the government-togovernment relationship and strengthen 

tribal control over Federal funding that 

it receives, and its internal program 

management. 

5. Background on ACF 

ACF provides national leadership and 

direction to plan, manage, and 

coordinate the nationwide 

administration of comprehensive and 

supportive programs for vulnerable and 

at-risk children and families. ACF 

oversees and finances a broad range of 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 78711 

programs for children and families, 

including Native Americans, persons 

with developmental disabilities, 

refugees, and legal immigrants, to help 

them develop and grow toward a more 

independent, self-reliant life. These 

programs, carried out by State, county, 

city, and Tribal Governments, and 

public and private local agencies, are 

designed to promote stability, economic 

security, responsibility, and selfsufficiency. 

ACF coordinates development and 

implementation of family-centered 

strategies, policies, and linkages among 

its programs, and with other Federal, 

tribal and State programs serving 

children and families. ACF’s programs 

assist families in financial crisis, 

emphasizing short-term financial 

assistance, and education, training, and 

employment for the long term. Its 

programs for children and youth focus 

on those children and youth with 

special problems, including children of 

low-income families, abused and 

neglected children, those in institutions 

or requiring adoption or foster family 

services, runaway youth, children with 

disabilities, migrant children, and 

Native American children. ACF 

promotes the development of 

comprehensive and integrated 

community and home-based modes of 

service delivery where possible. The 

following offices are located in ACF: 

Æ Administration on Children, Youth, 

and Families (ACYF) 

■ Children’s Bureau (CB) 

■ Family and Youth Services Bureau 

(FYSB) 

Æ Administration on Developmental 

Disabilities (ADD) 

Æ Administration for Native Americans 

(ANA) 

Æ Office of Administration 

Æ Office of Community Services (OCS) 

Æ Office of Child Care (OCC) 

Æ Office of Child Support Enforcement 

(OCSE) 

Æ Office of Family Assistance (OFA) 

■ Temporary Assistance for Needy 

Families Bureau (TANF) 

Æ Office of Head Start (OHS) 

Æ Office of Human Services Emergency 

Preparedness and Response 

(OHSEPR) 

Æ Office of Legislative Affairs and 

Budget (OLAB) 

Æ Office of Planning, Research, and 

Evaluation (OPRE) 

Æ Office of Refugee Resettlement (ORR) 

Æ Office of Regional Operations (ORO) 

Æ President’s Committee for People 

with Intellectual Disabilities 

(PCPID), an advisory Committee to 

the President of the United States 

and Health and Human Services 

Secretary. 

In June 2010, ACF established the 

Native American Affairs Advisory 

Council (NAAAC). This Council will 

function as an internal agency work 

group to support the Assistant Secretary 

for Children and Families, the 

Commissioner of ANA, and all ACF 

program and regional offices that 

provide services to Native Americans. 

On behalf of the Assistant Secretary, 

Administration for Children and 

Families, the Commissioner of ANA is 

the Chair of the NAAAC and ANA is the 

lead office to coordinate the activities. 

One of the responsibilities of the 

Council is to facilitate the development 

of the ACF Tribal Consultation Policy, 

in conjunction with the Office of the 

Assistant Secretary for Children and 

Families. 

The members of the Council are the 

ACF program and regional offices that 

have Native American constituents or 

work with Native American 

communities. These offices include the 

Administration on Children, Youth, and 

Families (Children’s Bureau, and the 

Family and Youth Services Bureau); the 

Administration on Developmental 

Disabilities; the Administration for 

Native Americans; the Office of Child 

Care; the Office of Child Support 

Enforcement; the Office of Community 

Services; the Office of Family 

Assistance (Tribal Temporary 

Assistance for Needy Families [Tribal 

TANF]); the Office of Head Start; the 

Office of Planning, Research, and 

Evaluation; and the Office of Regional 

Operations. The following Regions will 

be represented: Region I, Region II, 

Region IV, Region V, Region VI, Region 

VII, Region VIII, Region IX, and Region 

X. 

6. Consultation Principles 

Consultation is an enhanced form of 

communication that emphasizes trust, 

respect, and shared responsibility. It is 

an open and free exchange of 

information and opinion among parties, 

which leads to mutual understanding 

and comprehension. Consultation is 

integral to a deliberative process that 

results in effective collaboration and 

informed decision-making with the 

ultimate goal of reaching consensus on 

issues. 

The ACF policy is to conduct timely 

communication and meaningful 

consultation with Tribes wherein 

elected officials and other authorized 

representatives of the Tribal 

Governments have an opportunity to 

provide meaningful and timely input 

prior to a legislative proposal, new rule 

adoption, or other policy change that 

ACF determines may significantly affect 

Indian Tribes, or where one or more 

Tribes has communicated that such 

action will significantly affect one or 

more Indian Tribes. An action is 

considered to significantly affect Tribes 

if it has substantial direct effects on one 

or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

7. Consultation Parties 

Consultation parties are: 

A. The ACF Assistant Secretary, ACF 

Deputy Assistant Secretaries, ACF 

Central Office Principals, or their 

designee, and 

B. Tribal President, Tribal Chair, or 

Tribal Governor, or an elected or 

appointed Tribal Leader, or their 

authorized representative(s). 

Each party will identify their authorized 

representatives with delegated 

authorities to negotiate on their behalf. 

8. Consultation Process 

A. Consultation is initiated when 

either the ACF or a Tribe(s) makes a 

written request for a consultation to 

discuss issue(s) concerning a legislative 

proposal, new rule adoption, or other 

policy change that ACF determines may 

significantly affect the Tribe(s). 

B. A consultation request by a Tribe 

should: 

1. Identify the subject issue(s) for 

resolution. 

2. Identify the applicable program(s), 

policy, rule, regulation, statute, and 

authorizing legislation. 

3. Identify the related concerns such 

as State-tribal relations, related 

programs, complexity, time constraints, 

funding and budget implications. 

4. Identify the affected and potentially 

affected Indian Tribe(s). 

ACF will acknowledge receipt of the 

tribal consultation request within 14 

calendar days after receipt of the letter. 

C. Proper notice of the tribal 

consultation and the level of 

consultation, as determined by ACF, 

shall be communicated to all affected 

and all potentially affected Indian 

Tribes within 45 calendar days after 

receipt of the tribal request. Appropriate 

forms of notice include a ‘‘Dear Tribal 

Leader Letter’’ signed by the Assistant 

Secretary, broadcast e-mail, Federal 

Register (FR), and other outlets. 

D. The following are Levels of 

Consultation: Consultation will occur 

through a combination of one or more 

levels of consultation, defined below, 

and will include additional actions and 

participants as determined by the 

parties. 


srobinson on DSKHWCL6B1PROD with NOTICES
78712 Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 

1. Meeting(s): One or more meetings 

with affected and potentially affected 

Indian Tribes to discuss all pertinent 

issues related to the legislative proposal, 

new rule adoption, or other policy 

change that ACF determines may 

significantly affect the Tribe(s) using a 

single purpose meeting, or a national or 

regional forum, if appropriate, when the 

consultation is determined to include 

all Tribes. Meetings can be face-to-face 

or by teleconference call. 

2. Correspondence: Written 

communications exchanged between 

ACF and the Indian Tribe(s) that 

provide affected and potentially affected 

Indian Tribes an opportunity to identify 

concerns, potential impacts, proposed 

alternatives or flexibilities, and provide 

ACF with the opportunity to identify 

resources and other considerations 

relevant to the issue(s) raised. All 

correspondence will identify the 

manner in which tribal comments will 

be solicited. 

3. Federal Register: When one or 

more meetings are not practicable, 

notices in the Federal Register will 

represent the level of consultation to 

solicit comment from Tribes about 

concerns, potential impacts, proposed 

alternatives or flexibilities. Such notices 

will include clear and explicit 

instructions for the submission of 

comments that provide adequate time 

for tribal responses. 

E. Reporting of Outcome: All national 

and regional consultation meetings and 

recommended actions shall be recorded 

and made available to Indian Tribes. 

ACF program offices will provide a 

detailed report on their consultation 

sessions, which summarizes the 

discussions, specific recommendations, 

and responses and solicits tribal 

feedback on the consultation process, 

within forty-five (45) calendar days of 

the conclusion of the consultation 

process. The ACF report will be 

available on the program offices’ Web 

sites. 

Once the consultation process is 

complete and a proposed policy is 

approved and issued, the final policy 

must be broadly distributed to all Indian 

Tribes and it will be independently 

posted on the ACF webpage and also 

linked to several appropriate tribal and 

inter-tribal organization Web sites. 

F. Meaningful Outcomes: The 

consultation process and activities 

conducted within the scope of the ACF 

policy should result in a meaningful 

outcome for both ACF and Tribes. 

Before any final policy decisions are 

adopted, the proposed outcome of a 

consultation shall be widely publicized 

and circulated for review and comment 

to affected Indian Tribes, inter-tribal 

organizations, and within HHS. 

Good faith implementation of ACF 

programs and a cooperative working 

relationship with Tribes in support of 

ACF programs is the primary 

meaningful outcome. ACF will work 

with States to emphasize the importance 

of providing progam services and 

funding on an equitable basis to tribal 

members. 

ACF shall facilitate meaningful 

consultations and outcomes between 

Tribe(s) and one or more States 

administering ACF programs, shall 

measure State performance in serving 

tribal populations, report the outcome of 

its efforts to affected Tribes, and shall 

make a good faith effort to ensure all 

parties fully comply with ACF program 

requirements. 

G. Waivers and Elevation of Issue(s): 

The intent of this policy is to provide 

increased ability to address issues 

impacting Indian Tribes. ACF will, to 

the extent practicable and permitted by 

law, utilize flexible approaches to 

enable Tribes to achieve established 

ACF program objectives, including 

consideration of waivers of statutory 

and regulatory requirements and other 

alternatives that preserve the 

prerogatives and authority of Indian 

Tribes. 

In cases where a Tribe(s) is not 

satisfied with the resolution of an issue 

or issues after consultation with the 

program office, a Tribe(s), consistent 

with the government-to-government 

relationship, may elevate an issue of 

importance to the Assistant Secretary of 

ACF. If the Tribe is still not satisfied 

with the resolution of an issue after 

consultation with the Assistant 

Secretary of ACF, a Tribe(s), consistent 

with the government-to-government 

relationship, may elevate an issue of 

importance to the Department, through 

the Office of Intergovernmental Affairs 

(IGA), for decision. 

9. ACF Consultation and 

Communication Responsibilities 

ACF will conduct an annual agencywide tribal consultation each year, in 

addition to the tribal consultations 

required by several ACF program 

offices. The following will guide ACF’s 

coordination of the various sessions. 

The NAAAC will work with the 

program offices to coordinate ACF 

required consultations, on required 

topics and in required regions, to 

maximize the time and resources of 

Indian Tribes and program offices. 

A. ACF Annual Tribal Consultation 

Session 

1. ACF will hold, at a minimum, an 

agency-wide annual tribal consultation 

session to discuss ACF programs and 

policies impacting tribal programs. 

ANA, working through NAAAC, will be 

the lead agency to coordinate the annual 

tribal consultation session. 

2. Every ACF program office 

Principal, or their designee, will be 

required to participate in the annual 

ACF tribal consultation. 

3. NAAAC will coordinate with the 

program offices to prepare and 

disseminate a written report within 

forty-five (45) calendar days of the 

annual ACF tribal consultation. 

4. ACF will post this report on its 

Web site. 

5. The annual ACF tribal consultation 

session will not supplant any tribal 

consultation sessions that are required 

by law to be conducted by ACF program 

offices. 

B. Special Statutory Consultation 

Requirements 

1. The following ACF Offices have 

programs that require consultation with 

Indian Tribes in accordance with their 

authorizing statutes. 

• Office of Head Start 

• Children’s Bureau 

• Family and Youth Services Bureau 

2. ACF program offices will conduct 

tribal consultation sessions that are 

required by law, including in 

conjunction with the Annual ACF 

Tribal Consultation Session. 

3. Individual Program Consultation 

Responsibilities 

(a) Each individual program office 

will meet with Indian Tribes and AI/AN 

grantees regarding programmatic 

concerns at the request of the Indian 

Tribe or AI/AN grantee. 

(b) An official staff contact will be 

designated as responsible for the initial 

coordination and facilitation of the 

program office interaction with Tribes 

and Native American organizations and 

to serve as the program single point of 

contact for interaction with offices and 

workgroups within HHS on AI/AN 

issues. 

(c) ACF program offices will 

acknowledge requests for consultation 

within fourteen (14) calendar days of 

receipt of the request. 

(d) ACF program offices will 

acknowledge and report on unresolved 

issues with the Tribe in a timely 

manner. ACF program offices will 

acknowledge issues within fourteen (14) 

calendar days after the consultation. 

(e) Feedback will be provided by ACF 

program offices to Tribes on the 


srobinson on DSKHWCL6B1PROD with NOTICES
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resolution of issues for which 

consultation has been requested within 

forty-five (45) calendar days of the 

consultation. 

(f) ACF program offices will ensure 

intra-agency coordination with Regional 

Offices to facilitate communication and 

outreach on consultations held in the 

Region. Regional Offices will facilitate 

State participation as appropriate. 

(g) ACF program offices will provide 

assistance to States in their efforts to 

develop policies and plans to ensure 

consultation with Indian Tribes. 

(h) ACF program offices will provide 

a written report on the consultations, 

which summarizes the discussions, 

recommendations, and responses, 

within forty-five (45) calendar days of 

the last consultation. 

4. HHS Tribal Consultations 

(a) ACF will participate in the Annual 

Budget Consultation Session and 

Annual Regional Tribal Consultations. 

10. ACF Performance and 

Accountability 

A. Implementation of this policy shall 

be made part of the Annual Performance 

Plan for ACF Senior Management as a 

critical performance element, in those 

offices where there are specific tribal 

activities. 

B. ACF program offices will design 

indicators to ensure accountability 

among program managers, central office 

and regional offices staff, and various 

partners in carrying out the HHS and 

ACF tribal consultation policies. 

C. ACF will ensure that all personnel 

working with Tribes receive appropriate 

training on consultation, this policy, 

and working with Tribal Governments. 

D. As part of the Department’s annual 

measurement of the level of satisfaction 

of Indian Tribes with the consultation 

process and the activities conducted 

under this policy, Indian Tribes’ 

satisfaction with ACF will be recorded 

and evaluated to determine whether the 

intended results were achieved and to 

solicit recommendations for 

improvement from Tribes. 

11. ACF–Tribal Conflict Resolution 

In compliance with the HHS 

Consultation Policy, each Operating 

Division shall develop a conflict 

resolution process. The following shall 

serve as the ACF tribal conflict 

resolution process until further defined. 

Should an impasse arise between ACF 

and a Tribe(s) concerning ACF 

compliance with consultation policy, a 

Tribe may invoke the conflict resolution 

process by filing a written notice of 

conflict resolution. Using the timelines 

under Section 8B, ACF will initiate the 

conflict resolution process. As 

determined by the Assistant Secretary, 

authorized tribal representatives shall 

meet with the Assistant Secretary for 

Children and Families, and/or a Deputy 

Assistant Secretary, and/or the 

Commissioner for the Administration 

for Native Americans and/or the ACF 

Regional Administrator(s) for the 

regional offices that provide services to 

the affected Tribes. The goal is to 

accomplish the following: 

A. Clarify all aspects of the issue(s) at 

an impasse; 

B. Explore the alternative position(s) 

available to resolve the impasse; 

C. Establish language about the 

issue(s) that the parties can accept on 

the record; 

D. Create acceptance of recommended 

actions; and 

E. Facilitate coordination of 

resolution(s) for parties. 

12. Workgroups and Advisory 

Committees 

A. To maximize the expertise and 

knowledge of individuals working in 

tribal communities, ACF may convene 

Tribal/Federal Workgroups (TFWG) to 

develop and discuss agency-wide 

policies that impact Indian Tribes, prior 

to formal tribal consultation sessions on 

the policies. 

B. The TFWG will work in accordance 

with the HHS policy on tribal 

workgroups and will follow procedures 

to ensure compliance with the Federal 

Advisory Committee Act (FACA). 

Groups with membership composed of 

Federal, State employees, or elected 

officials of a Federally recognized 

Indian Tribe are exempt from FACA. 

C. ACF retains the right to meet with 

various representatives of organizations 

on an individual basis. 

D. For policies that impact more than 

Federally recognized Indian Tribes, ACF 

will develop forums to provide 

opportunities for input and dialogue for 

State-recognized Tribes; Native 

American organizations, including 

Native Hawaiians and Native American 

Pacific Islanders; urban Indian centers; 

tribally controlled community colleges 

and universities; Alaska Region 

Corporations; and others as defined in 

program office guidance. 

E. Program offices may still convene 

their individual working groups to work 

on program specific policies. Program 

offices will ensure that these working 

groups operate within the FACA 

guidelines and requirements. 

13. Definitions 

A. Agency—Any authority of the 

United States that is an ‘‘agency’’ under 

44 U.S.C. 3502(1) other than those 

considered to be independent regulatory 

agencies, as defined in 44 U.S.C. 

3502(5). 

B. Communication—The exchange of 

ideas, messages, or information by 

speech, signals, writing, or other means. 

C. Consortia of Tribes—Two or more 

Federally recognized Indian Tribes. 

D. Consultation—An enhanced form 

of communication, which emphasizes 

trust, respect, and shared responsibility. 

It is an open and free exchange of 

information and opinion among parties, 

which leads to mutual understanding 

and comprehension. Consultation is 

integral to a deliberative process, which 

results in effective collaboration and 

informed decision-making with the 

ultimate goal of reaching consensus on 

issues. 

E. Coordination and Collaboration— 

Working and communicating together in 

a meaningful government-togovernment effort to create a positive 

outcome. 

F. Deliberative Process Privilege— 

Privilege exempting the government 

from disclosure of government-agency 

materials containing opinions, 

recommendations, and other 

communications that are part of the 

decision-making process within the 

agency. 

G. Executive Order—An order issued 

by the government’s executive on the 

basis of authority specifically granted to 

the Executive Branch (as by the U.S. 

Constitution or a Congressional Act). 

H. Federally Recognized Tribal 

Governments—Indian Tribes with 

whom the Federal Government 

maintains an official government-togovernment relationship; usually 

established by a Federal treaty, statute, 

executive order, court order, or a 

Federal Administrative Action. The 

Bureau of Indian Affairs (BIA) maintains 

and regularly publishes the list of 

Federally recognized Indian Tribes. 

I. Indian Organization—Any group, 

association, partnership, corporation, or 

legal entity owned or controlled by 

Indians, or a majority whose members 

are Indians. 

J. Indian Tribe—Any Indian Tribe, 

band, nation, or other organized group 

or community, including any Alaska 

Native village, or regional or village 

corporation as defined in or established 

pursuant to the Alaska Native Claims 

Settlement Act (85 Stat. 688) [43 U.S.C. 

1601 et seq.], which is recognized as 

eligible for the special programs and 

services provided by the United States 

to Indians because of their status as 

Indians [25 U.S.C. Sec 450b(e)]. 

K. Indian—A person who is a member 

of an Indian Tribe [25 U.S.C. 450b(d)]. 

Throughout this policy, Indian is 


srobinson on DSKHWCL6B1PROD with NOTICES
78714 Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 

synonymous with American Indian/ 

Alaska Native. 

L. Native American (NA)—Broadly 

describes the people considered 

indigenous to North America. 

M. Native American Affairs Advisory 

Council (NAAAC)—An internal agency 

work group to support the Assistant 

Secretary for Children and Families, the 

Commissioner of the Administration for 

Native Americans, and all ACF program 

and regional offices that provide 

services to Native Americans. 

N. Native Hawaiian—Any individual 

whose ancestors were natives of the 

area, which consists of the Hawaiian 

Islands prior to 1778 (42 U.S.C. 3057k). 

O. Inter-Tribal Organization—A 

nongovernmental body organized and 

operated to represent the interests of a 

group of individuals considered 

indigenous to North American 

countries. Organizations that represent 

the interests of individuals do not fall 

under the intergovernmental committee 

exemption to FACA found in 2 U.S.C. 

Sec 1534. Therefore, the Department is 

required to adhere to FACA if 

representatives of those organizations 

are included on advisory committees or 

workgroups. 

P. Non-Recognized Tribe—Any Tribe 

with whom the Federal Government 

does not maintain a government-togovernment relationship, and to which 

the Federal Government does not 

recognize a trust responsibility. 

Q. Policies that have Tribal 

Implications—Refers to regulations, 

legislation, and other policy statements 

or actions that have substantial direct 

effects on one or more Indian Tribes, on 

the relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

R. Public Participation—When the 

public is notified of a proposed or actual 

action, and is provided meaningful 

opportunities to participate in the 

policy development process. 

S. Reservation—Lands reserved with 

the Federal Government for tribal use 

and are usually held in trust by the 

Federal Government or within certain 

defined boundaries. 

T. Self Government—Government in 

which the people who are most directly 

affected by the decisions make 

decisions. 

U. Sovereignty—The ultimate source 

of political power from which all 

specific political powers are derived. 

V. State Recognized Tribes—Tribes 

that maintain a special relationship with 

the State government and whose lands 

and rights are usually recognized by the 

State. State recognized Tribes may or 

may not be Federally recognized. 

W. Substantial Direct Compliance 

Costs—Those costs incurred directly 

from implementation of changes 

necessary to meet the requirements of a 

Federal regulation. Because of the large 

variation in Tribes, ‘‘substantial costs’’ is 

also variable by Indian Tribe. Each 

Indian Tribe and the Secretary shall 

mutually determine the level of costs 

that represent ‘‘substantial costs’’ in the 

context of the Indian Tribe’s resource 

base. 

X. To the Extent Practicable and 

Permitted by Law—Refers to situations 

where the opportunity for consultation 

is limited because of constraints of time, 

budget, legal authority, etc. 

Y. Treaty—A legally binding and 

written agreement that affirms the 

government-to-government relationship 

between two or more nations. 

Z. Tribal Government—An American 

Indian or Alaska Native Tribe, band, 

nation, pueblo, village or community 

that the Secretary of the Interior 

acknowledges to exist as an Indian Tribe 

pursuant to the Federally recognized 

Indian Tribe List Act of 1994, (25 U.S.C. 

479a). 

AA. Tribal Officials—Elected or duly 

appointed officials of Indian Tribes or 

authorized inter-tribal organizations. 

BB. Tribal Organization—The 

recognized governing body of any 

Indian Tribe; any legally established 

organization of American Indians and 

Alaska Natives which is controlled, 

sanctioned, or chartered by such 

governing body or which is 

democratically elected by the adult 

members of the community to be served 

by such organization and which 

includes the maximum participation of 

Indian Tribe members in all phases of 

its activities (25 U.S.C. 450b). 

CC. Tribal Resolution—A formal 

expression of the opinion or will of an 

official tribal governing body which is 

adopted by vote of the tribal governing 

body. 

DD. Tribal Self-Governance—The 

governmental actions of Tribes 

exercising self-government and selfdetermination. 

14. Acronyms 

ACF Administration for Children and 

Families 

AI/AN American Indian/Alaska Native 

AI/AN/NA American Indian/Alaska Native/ 

Native American 

ANA Administration for Native Americans 

BIA Bureau of Indian Affairs 

Division Staff Division and/or Operating 

Division 

EO Executive Order 

FACA Federal Advisory Committee Act 

FR Federal Register 

HHS U.S. Department of Health and Human 

Services 

NAAAC Native American Affairs Advisory 

Council 

OPDIV Operating Divisions of HHS 

SPOC Single Point of Contact 

TFWG Tribal/Federal Workgroup 

U.S. United States 

U.S.C. United States Code 

15. Policy Review 

ACF shall review, and if necessary 

revise, its Tribal Consultation Policy no 

less than every 2 years. Should ACF 

determine that the policy requires 

revision, the Tribal/Federal Workgroup 

will be convened to develop the 

revisions. 

16. Retention of Executive Branch 

Authorities 

Nothing in this policy waives the 

Government’s deliberative process 

privilege, including when the 

Department is specifically requested by 

Members of Congress to respond to or 

report on proposed legislation. The 

development of such responses and 

related policy documents is a part of the 

deliberative process by the Executive 

Branch and should remain confidential. 

Nothing in the Policy creates a right 

of action against the Department for 

failure to comply with this Policy nor 

creates any right, substantive or 

procedural, enforceable at law by a 

party against the United States, its 

agencies, or any individual. 

17. Effective Date 

This policy is effective on the date of 

signature by the Assistant Secretary for 

Children and Families and shall apply 

to all ACF Program Offices. 

[FR Doc. 2010–31465 Filed 12–15–10; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2001–E–0027] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ANGIOMAX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ANGIOMAX and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 


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