Draft Policy on Conferring With Urban Indian Organizations, 43846-43849 [2012-18300]
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Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18232 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Food and Drug Administration
Pediatric Medical Devices Workshop;
Notice of Workshop
AGENCY:
Food and Drug Administration,
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ACTION:
Notice.
The Food and Drug Administration’s
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Development is announcing the
following workshop: FDA Pediatric
Medical Devices Workshop. This
meeting is intended to focus on
challenges in pediatric device
development—namely, business
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attendees will have an opportunity
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Date and Time: The meeting will be
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support.com/events/FDA_OOPD_
Pediatric_Medical_Devices_Workshop.
Please note that registration for the live
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The FDA Pediatric Medical Devices
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Dated: July 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18231 Filed 7–25–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Draft Policy on Conferring With Urban
Indian Organizations
Indian Health Service,
Department of Health and Human
Services.
ACTION: Notice, with a 45-day comment
period.
AGENCY:
This Notice sets forth the
Indian Health Service policy for
conferring with urban Indian
organizations and invites comments
within 45 days. In March 2010, the
Indian Health Care Improvement Act
was reauthorized and amended as part
of the Patient Protection and Affordable
Care Act, Public Law 111–148, as
amended by the Health Care and
Education Reconciliation Act (together,
the Affordable Care Act), Public Law
111–152. One of the changes made to
the IHCIA was to create a new
requirement that the IHS ‘‘confer’’ with
UIOs, to the maximum extent
practicable, in carrying out the Act as
defined by the Indian Health Care
Improvement Reauthorization and
Extension Act, as enacted and amended
by the Affordable Care Act.
DATES: We will consider all comments
received by September 10, 2012.
ADDRESSES: Submit comments by email
to Betty.Gould@ihs.gov; or by US mail
to: Ms. Betty Gould, Regulations Officer,
SUMMARY:
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Indian Health Service, 801 Thompson
Avenue, TMP Suite 450, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT: Ms.
Phyllis Wolfe, Director, Office of Urban
Indian Health Programs, Indian Health
Service, 801 Thompson Avenue, Suite
200, Rockville, Maryland 20852.
Telephone 301/443–4680 (This is not a
toll free number).
Policy on Conferring With Urban
Indian Organizations
5–26.1 Introduction
A. Purpose. Congress has specifically
declared that it is the policy of the
Nation ‘‘to ensure the highest possible
health status for Indians and urban
Indians.’’ 25 U.S.C. 1602(1). The U. S.
Department of Health and Human
Services (HHS) is committed to working
with Indian and urban Indian
communities to meet this policy. This
policy applies to the Indian Health
Service (IHS).
This Notice establishes the IHS policy
and procedures for conferring with
urban Indian organizations (UIOs). The
IHS will use this conferring policy to
ensure that the health care needs of the
urban Indian population are considered
at the local, Area, and national levels,
when implementing and carrying out
the Indian Health Care Improvement
Act (IHCIA).
B. Background. Urban Indian
organizations are a major provider of
health care to urban American Indians
and Alaska Natives (AI/AN) across the
country. When the IHCIA was enacted
into law in 1976, it identified the
authorities, responsibilities, and
functions of the IHS, the primary
Federal Agency charged with providing
health care to AI/AN. The IHCIA
included the authority for the IHS to
‘‘establish programs in urban centers to
make health services more accessible to
urban Indians’’ [Indian Health Care
Improvement Act, Title V, section 501,
Pub. L. 94–437, 90 Statute (Stat.) 1400,
1410 (1976), codified at 25 United States
Code (U.S.C.) 1651]. The IHS carries out
this authority through contracts with
and grants to UIOs. In March 2010, as
part of the Affordable Care Act,
Congress reauthorized and amended the
IHCIA. The reauthorization of the IHCIA
included a requirement that the IHS
‘‘confer,’’ to the maximum extent
practicable, with UIOs in carrying out
the IHCIA.
C. Policy. It is IHS policy to confer
with UIOs, to the maximum extent
practicable, whenever a ‘‘critical event
or issue,’’ as defined in this Notice,
arises in implementing or carrying out
the IHCIA.
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D. Requirement. The IHCIA, as
amended, includes four provisions that
require the IHS to confer with UIOs.
(1) Indian Health Care Improvement
Act, 25 U.S.C. 1660d(b). ‘‘The Secretary
shall ensure that the Service confers, to
the maximum extent practicable, with
urban Indian organizations in carrying
out this [Act].’’
(2) Indian Health Care Improvement
Act, 25 U.S.C. 1602(5). ‘‘Congress
declares * * * that all actions under
this [Act] shall be carried out with
* * * conference with urban Indian
organizations, to implement this [Act].
* * *’’
(3) Indian Health Care Improvement
Act, 25 U.S.C. 1631(f). ‘‘The Secretary
shall * * * confer with urban Indian
organizations, in developing innovative
approaches to address all or part of the
total unmet need for construction of
health facilities. * * *’’
(4) Indian Health Care Improvement
Act, 25 U.S.C. 1665k(a)(2)(A)(vii).
‘‘Funding provided pursuant to [25
U.S.C. 1665k ‘‘fetal alcohol spectrum
disorders programs’’] shall be used
* * * to develop and implement * * *
in conferring with urban Indian
organizations, culturally sensitive
assessment and diagnostic tools
including * * * multidisciplinary fetal
alcohol spectrum disorder clinics for
use in Indian communities and urban
centers.’’
E. Authorities.
(1) Indian Health Care Improvement
Reauthorization and Extension Act, as
enacted and amended by the Patient
Protection and Affordable Care Act,
Public Law 111–148, § 10221, 124 Stat.
119, 935 (2010).
(2) Indian Health Care Improvement
Act, 25 U.S.C. 1601–1683, as amended,
including, §§ 1602(1), 1603(29), 1651,
1653(a).
(3) Office of Management and Budget
Circular A–19.
F. Definitions.
(1) Confer. The term ‘‘confer’’ means
to engage in an open and free exchange
of information and opinions that:
a. leads to mutual understanding and
comprehension, and
b. emphasizes trust, respect, and
shared responsibility.
(2) Conferring Activities. The term
‘‘conferring activities’’ means
implementing confer mechanisms, such
as face-to-face meetings,
teleconferences, and mailings, to solicit
comments and discuss critical events or
issues.
(3) Critical Event or Issue. A ‘‘critical
event or issue,’’ as used in this policy,
is an event or issue that significantly
affects one or more UIOs. Critical events
or issues are complex, have significant
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implications, and are time sensitive.
Examples of critical events or issues
include developing program regulations,
formulating the budget, allocating new
resources, and changing policy, as well
as public health or environmental
events. When necessary, it is within the
discretion of the Director, IHS, to make
the final determination as to whether or
not a specific event or issue qualifies as
a ‘‘critical event or issue,’’ as defined in
this policy.
(4) IHS Confer with UIOs Report. The
term ‘‘IHS Confer with UIOs Report’’
means an annual report to the Secretary,
HHS, describing ‘‘critical events or
issues’’ to UIOs arising in implementing
or carrying out the IHCIA.
(5) Urban Indian Organization. The
term ‘‘urban Indian organization’’ means
a nonprofit corporate body situated in
an urban center, governed by an urban
Indian controlled board of directors, and
providing for the maximum
participation of all interested Indian
groups and individuals, which body is
capable of legally cooperating with
other public and private entities for the
purpose of performing the activities
described in [25 U.S.C. 1653(a)]. 25
U.S.C. 1603(29).
5–26.2
Objectives
A. To formalize the IHS approach to
conferring with UIOs to ensure that
urban Indian health priorities and goals
are considered.
B. To establish a minimum set of
requirements and expectations with
respect to conferring for the three levels
of IHS management: Headquarters, Area
Offices, and Service Units.
C. To identify ‘‘critical events or
issues’’ arising in implementing or
carrying out the IHCIA for which
conferring with UIOs will be required
for the three levels of IHS management:
Headquarters, Area Offices, and Service
Units.
D. To identify ‘‘critical events or
issues’’ arising in implementing or
carrying out the IHCIA where
partnerships and the inclusion of UIOs
would complement consultation with
Indian Tribes.
E. To require conferring with UIOs on
proposed, new, and existing health
policies and programs that qualify as
‘‘critical events or issues’’ arising in
implementing or carrying out the IHCIA.
F. To promote and develop innovative
methods of involving UIOs in IHS
policy development and in the decisionmaking processes of the IHS.
G. To coordinate with the HHS
Divisions or Regional Offices; State
Agencies; to assist UIOs in
communicating their priorities.
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H. To charge and hold responsible all
levels of management within the IHS for
the implementation of this policy.
5–26.3 Roles
A. Headquarters. The Director, IHS, is
responsible for providing overall
guidance and direction to the Office of
Urban Indian Health Programs (OUIHP)
and ensuring that the IHS confers, to the
maximum extent practicable, with UIOs
in accordance with this policy.
The IHS has the responsibility to
engage in an open and free exchange of
information and opinions with UIOs
that leads to mutual understanding and
comprehension; and emphasizes trust,
respect, and shared responsibility
whenever a ‘‘critical event or issue,’’ as
defined in this policy, arises in
implementing or carrying out the IHCIA.
When necessary, it is within the
discretion of the Director, IHS, to make
the final determination as to whether or
not a specific event or issue qualifies as
a ‘‘critical event or issue,’’ as defined in
this policy.
The Director, OUIHP, is responsible
for monitoring compliance with this
policy, including submissions to the
OUIHP conferring email address:
urbanconfer@ihs.gov. The Director,
OUIHP, will ensure that all levels of the
IHS conduct regular official conferring
sessions that are publicized through
correspondence or, when necessary,
Federal Register Notices (FRN), and
receive conferring reports. The Director,
OUIHP, will also receive and
acknowledge receipt of written
correspondence from UIOs describing
potential ‘‘critical events or issues’’
arising in implementing or carrying out
the IHCIA, the affected UIO(s), and the
proposed conferring activity. Where
applicable, OUIHP will notify all
affected UIOs through a ‘‘Dear Urban
Indian Health Organization Director
Letter’’ and broadcast emails, and, if
necessary, through the Federal Register,
if the IHS will undertake any conferring
activity. The notice will identify the
issue, the method for conferring, and the
timeline for the conferring activity. The
Director, OUIHP, is responsible for
preparing and submitting the annual
IHS Confer with UIOs Report.
All IHS Headquarters Office Directors
will provide leadership to identify
potential ‘‘critical events or issues’’
arising in implementing or carrying out
the IHCIA for which conferring with
UIOs will be recommended to the
Director, OUIHP, and assist the OUIHP
in completion of the annual IHS Confer
with UIOs Report, when necessary.
B. Area Offices. The Area Director is
responsible for regional administration,
management, evaluation, contract and
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grant monitoring, and funding
responsibilities for the IHCIA Title
V-funded UIOs located in their Areas.
The Area Director will provide the
support and assistance to ensure that
IHS confers, in accordance with this
policy, with UIOs at the Area level. The
Area Director will conduct regular
official conferring sessions through biannual meetings and other conferring
activities with UIOs. The Area Director
will ensure that the Director, OUIHP, is
informed of the Area conferring
activities and outcomes for inclusion in
the Annual IHS Confer with UIOs
Report.
C. Service Units. The Service Unit
Chief Executive Officer (CEO) is
responsible for ensuring compliance
with this policy by conferring with UIOs
that are located in the Service Unit. The
CEO shall provide the Service Unit
conferring activities and results or
outcomes through the Area Urban
Coordinator, to the Area Director, who
will report them to the OUIHP.
5–26.4 Confer Management
A. Identification of Conferring
Activities. A potential ‘‘critical event or
issue’’ arising in implementing or
carrying out the IHCIA may be
identified by either the IHS and/or
UIOs.
(1) If a potential ‘‘critical event or
issue’’ is identified by a UIO, written
correspondence must be submitted to
the Director, OUIHP, (with a copy to the
appropriate Area Director) describing
the event or issue, the affected UIO(s),
and the proposed conferring activity.
The Director, OUIHP, shall acknowledge
receipt of the request within 15 business
days. IHS will consider whether or not
to confer with affected/potentially
affected UIOs in response to this
request.
(2) The Director, OUIHP, shall
determine whether or not a specific
event or issue arising in implementing
or carrying out the IHCIA qualifies as a
‘‘critical event or issue,’’ as defined in
this policy. The Director, OUIHP, shall
provide an official response indicating
the reason(s) why conferring will or will
not be conducted. If the Director,
OUIHP, determines that a ‘‘critical event
or issue’’ has arisen in implementing or
carrying out the IHCIA, the Director,
OUIHP, shall, in the official response,
identify the conferring activity that has
been selected and the timeline for the
activity. In addition, if the Director,
OUIHP, determines that a ‘‘critical event
or issue’’ has arisen in implementing or
carrying out the IHCIA, the IHS will
issue notices to all affected/potentially
affected UIOs through correspondence
such as a ‘‘Dear Urban Indian Health
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Organization Director Letter’’ and
broadcast emails, as well as through a
FRN, if applicable. Communication will
identify the ‘‘critical events or issues’’ to
be discussed, as well as the mechanism
for conferring. When necessary, it is
within the discretion of the Director,
IHS, to make the final determination as
to whether or not a specific event or
issue qualifies as a ‘‘critical event or
issue,’’ as defined in this policy.
B. Conferring Activity. The IHS will
conduct regular, official conferring
sessions through bi-annual meetings.
The bi-annual meetings shall be
publicized, both through
correspondence such as a ‘‘Dear Urban
Indian Health Program Director Letter’’
and broadcast emails, and, if necessary,
through a FRN. The notices will include
information such as the dates and
locations of the conferring sessions, the
agenda, and any ‘‘critical events or
issues’’ that will be discussed. In
addition to the bi-annual meetings,
other conferring activities may occur
throughout the year. In the event that a
confer activity will be conducted, the
degree and extent of the conferring and
the mechanism for conferring shall
depend upon several factors, including:
(1) the nature of the ‘‘critical event or
issue,’’
(2) the number of potentially affected
UIOs, and
(3) the most cost effective and
efficient conferring mechanism, based
on the nature of the ‘‘critical event or
issue’’ and the number of potentially
affected UIOs.
C. Confer Mechanisms. The IHS will
consider the following confer
mechanisms as options that provide the
opportunity for an open and free
exchange of information and opinions
that lead to mutual understanding and
comprehension and emphasize trust,
respect, and shared responsibility:
(1) Mailings
(2) Teleconferences
(3) Regular or special program level
conferring sessions
(4) Annual meetings, such as the
annual Spring Urban Indian Health
Leadership Conference
(5) Opportunities for comment,
including submissions to
urbanconfer@ihs.gov
(6) Face-to-face meetings, including
meetings conducted at the Area Office
level or at the national-level Indian
health system meetings that include the
IHS, Tribes, and UIO(s).
D. Contract- and Grant-Specific
Issues. A UIO may request to meet oneon-one with an IHS representative to
confer on issues specific to that UIO and
its contract and grant awards from the
IHS.
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E. Unresolved Issues. Upon the
completion of any of the conferring
activities in this section, the IHS will
document and follow-up on any
unresolved issue(s) that would benefit
from the ongoing involvement of the
affected UIO(s). Documentation of the
conferring process and outcomes will be
maintained by the OUIHP and the Area
Office(s) in which the affected UIO(s)
are located.
F. Annual IHS Confer with UIOs
Report to HHS. As part of the annual
IHS Confer with UIOs Report to the
Secretary, HHS, the IHS shall prepare
and submit an annual report describing
‘‘critical events or issues’’ arising in
implementing or carrying out the IHCIA,
related conferring activities, and the
results and outcomes of conferring with
UIOs.
(1) The report shall address:
Development of the urban Indian health
program budget; development and
implementation of urban Indian health
program regulations and policies; and
public health or environmental health
critical events impacting UIOs.
(2) The report shall include a
description of the ‘‘critical event or
issue(s)’’ that was the subject of
conferring, a description of the process
that was used, a discussion of the
recommendations that resulted from the
conferring meeting(s), a list of any
follow-up action items, a timeline for
addressing these items, and a discussion
of the level of satisfaction with the
conferring process.
G. Conflict Resolution.
(1) The intent of this policy is to
promote mutual understanding and
comprehension, and to emphasize trust,
respect, and shared responsibility
between the IHS and UIOs.
(2) However, the IHS and UIOs may
not always agree. Where such
disagreement occurs, nothing in this
policy creates a right of action against
the IHS or the HHS for failure to comply
with this policy.
5–26.5 Federal Advisory Committee
Act
The Federal Advisory Committee Act
(FACA) may apply to conferring
activities. The FACA is implicated
when an Agency establishes, manages,
or controls a group that includes one or
more participants who are not Federal
employees for the purpose of obtaining
the group’s advice or recommendations
on Agency issues or policies. The FACA
imposes several procedural
requirements on Federal Agencies that
convene advisory committees. Although
FACA may not apply to groups
consisting solely of Tribal leaders
serving on the group in their official
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capacities, UIOs do not meet the
requirements of the ‘‘Tribal leader’’
exemption. Accordingly, any conferring
activities that qualify as an advisory
committee under the FACA will be
required to comply with the procedures
set out in FACA.
5–26.6
Deliberative Process Privilege
Nothing in this policy waives the
Government’s deliberative process
privilege. Examples of the government’s
deliberative process privilege are as
follows:
(1) When the Secretary, HHS, is
specifically requested by a member or
members of Congress to respond to or
report on proposed legislation, the
development of such responses and of
related policy is a part of the Executive
Branch’s deliberative process privilege
and should remain confidential.
(2) In specified instances, when
Congress requires the HHS to work with
UIOs on the development of
recommendations that may require
legislation, such as reports,
recommendations, or other products
that are developed independent of a
Department position, the development
of which is governed by Office of
Management and Budget Circular A–19.
Dated: July 20, 2012.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2012–18300 Filed 7–25–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institute of Mental Health;
Notice of Meeting
Accommodations Statement
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a conference call/
Webinar meeting of the Interagency
Autism Coordinating Committee (IACC).
The IACC Full Committee will be
having an open meeting conference call/
Webinar on Friday, July 27, 2012. The
committee will discuss and vote on the
establishment of subcommittees, as well
as discuss future IACC activities and
public comments that were received at
the July 10, 2012 IACC meeting. The
meeting will be accessible by Webinar
and conference call.
Name of Committee: Interagency Autism
Coordinating Committee (IACC).
Type of meeting: Open Meeting Conference
Call and Webinar.
Date: July 27, 2012.
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Time: 10:00 a.m. to 2:00 p.m. *Eastern
Time*—Approximate end time.
Agenda: The committee will discuss and
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and discuss future IACC activities and public
comments that were received at the July 10,
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Place: Webinar and conference call only;
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Webinar Access: https://
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Conference Call: Dial: 800–857–7423
Access code: 8875622.
Cost: The conference call and Webinar is
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Contact Person: Ms. Lina Perez, Office of
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Schedule subject to change.
Information about the IACC and a
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Dated: July 20, 2012.
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Name of Committee: Environmental Health
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Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: July 20, 2012.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–18195 Filed 7–25–12; 8:45 am]
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[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43846-43849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18300]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Draft Policy on Conferring With Urban Indian Organizations
AGENCY: Indian Health Service, Department of Health and Human Services.
ACTION: Notice, with a 45-day comment period.
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SUMMARY: This Notice sets forth the Indian Health Service policy for
conferring with urban Indian organizations and invites comments within
45 days. In March 2010, the Indian Health Care Improvement Act was
reauthorized and amended as part of the Patient Protection and
Affordable Care Act, Public Law 111-148, as amended by the Health Care
and Education Reconciliation Act (together, the Affordable Care Act),
Public Law 111-152. One of the changes made to the IHCIA was to create
a new requirement that the IHS ``confer'' with UIOs, to the maximum
extent practicable, in carrying out the Act as defined by the Indian
Health Care Improvement Reauthorization and Extension Act, as enacted
and amended by the Affordable Care Act.
DATES: We will consider all comments received by September 10, 2012.
ADDRESSES: Submit comments by email to Betty.Gould@ihs.gov; or by US
mail to: Ms. Betty Gould, Regulations Officer, Indian Health Service,
801 Thompson Avenue, TMP Suite 450, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ms. Phyllis Wolfe, Director, Office of
Urban Indian Health Programs, Indian Health Service, 801 Thompson
Avenue, Suite 200, Rockville, Maryland 20852. Telephone 301/443-4680
(This is not a toll free number).
Policy on Conferring With Urban Indian Organizations
5-26.1 Introduction
A. Purpose. Congress has specifically declared that it is the
policy of the Nation ``to ensure the highest possible health status for
Indians and urban Indians.'' 25 U.S.C. 1602(1). The U. S. Department of
Health and Human Services (HHS) is committed to working with Indian and
urban Indian communities to meet this policy. This policy applies to
the Indian Health Service (IHS).
This Notice establishes the IHS policy and procedures for
conferring with urban Indian organizations (UIOs). The IHS will use
this conferring policy to ensure that the health care needs of the
urban Indian population are considered at the local, Area, and national
levels, when implementing and carrying out the Indian Health Care
Improvement Act (IHCIA).
B. Background. Urban Indian organizations are a major provider of
health care to urban American Indians and Alaska Natives (AI/AN) across
the country. When the IHCIA was enacted into law in 1976, it identified
the authorities, responsibilities, and functions of the IHS, the
primary Federal Agency charged with providing health care to AI/AN. The
IHCIA included the authority for the IHS to ``establish programs in
urban centers to make health services more accessible to urban
Indians'' [Indian Health Care Improvement Act, Title V, section 501,
Pub. L. 94-437, 90 Statute (Stat.) 1400, 1410 (1976), codified at 25
United States Code (U.S.C.) 1651]. The IHS carries out this authority
through contracts with and grants to UIOs. In March 2010, as part of
the Affordable Care Act, Congress reauthorized and amended the IHCIA.
The reauthorization of the IHCIA included a requirement that the IHS
``confer,'' to the maximum extent practicable, with UIOs in carrying
out the IHCIA.
C. Policy. It is IHS policy to confer with UIOs, to the maximum
extent practicable, whenever a ``critical event or issue,'' as defined
in this Notice, arises in implementing or carrying out the IHCIA.
[[Page 43847]]
D. Requirement. The IHCIA, as amended, includes four provisions
that require the IHS to confer with UIOs.
(1) Indian Health Care Improvement Act, 25 U.S.C. 1660d(b). ``The
Secretary shall ensure that the Service confers, to the maximum extent
practicable, with urban Indian organizations in carrying out this
[Act].''
(2) Indian Health Care Improvement Act, 25 U.S.C. 1602(5).
``Congress declares * * * that all actions under this [Act] shall be
carried out with * * * conference with urban Indian organizations, to
implement this [Act]. * * *''
(3) Indian Health Care Improvement Act, 25 U.S.C. 1631(f). ``The
Secretary shall * * * confer with urban Indian organizations, in
developing innovative approaches to address all or part of the total
unmet need for construction of health facilities. * * *''
(4) Indian Health Care Improvement Act, 25 U.S.C.
1665k(a)(2)(A)(vii). ``Funding provided pursuant to [25 U.S.C. 1665k
``fetal alcohol spectrum disorders programs''] shall be used * * * to
develop and implement * * * in conferring with urban Indian
organizations, culturally sensitive assessment and diagnostic tools
including * * * multidisciplinary fetal alcohol spectrum disorder
clinics for use in Indian communities and urban centers.''
E. Authorities.
(1) Indian Health Care Improvement Reauthorization and Extension
Act, as enacted and amended by the Patient Protection and Affordable
Care Act, Public Law 111-148, Sec. 10221, 124 Stat. 119, 935 (2010).
(2) Indian Health Care Improvement Act, 25 U.S.C. 1601-1683, as
amended, including, Sec. Sec. 1602(1), 1603(29), 1651, 1653(a).
(3) Office of Management and Budget Circular A-19.
F. Definitions.
(1) Confer. The term ``confer'' means to engage in an open and free
exchange of information and opinions that:
a. leads to mutual understanding and comprehension, and
b. emphasizes trust, respect, and shared responsibility.
(2) Conferring Activities. The term ``conferring activities'' means
implementing confer mechanisms, such as face-to-face meetings,
teleconferences, and mailings, to solicit comments and discuss critical
events or issues.
(3) Critical Event or Issue. A ``critical event or issue,'' as used
in this policy, is an event or issue that significantly affects one or
more UIOs. Critical events or issues are complex, have significant
implications, and are time sensitive. Examples of critical events or
issues include developing program regulations, formulating the budget,
allocating new resources, and changing policy, as well as public health
or environmental events. When necessary, it is within the discretion of
the Director, IHS, to make the final determination as to whether or not
a specific event or issue qualifies as a ``critical event or issue,''
as defined in this policy.
(4) IHS Confer with UIOs Report. The term ``IHS Confer with UIOs
Report'' means an annual report to the Secretary, HHS, describing
``critical events or issues'' to UIOs arising in implementing or
carrying out the IHCIA.
(5) Urban Indian Organization. The term ``urban Indian
organization'' means a nonprofit corporate body situated in an urban
center, governed by an urban Indian controlled board of directors, and
providing for the maximum participation of all interested Indian groups
and individuals, which body is capable of legally cooperating with
other public and private entities for the purpose of performing the
activities described in [25 U.S.C. 1653(a)]. 25 U.S.C. 1603(29).
5-26.2 Objectives
A. To formalize the IHS approach to conferring with UIOs to ensure
that urban Indian health priorities and goals are considered.
B. To establish a minimum set of requirements and expectations with
respect to conferring for the three levels of IHS management:
Headquarters, Area Offices, and Service Units.
C. To identify ``critical events or issues'' arising in
implementing or carrying out the IHCIA for which conferring with UIOs
will be required for the three levels of IHS management: Headquarters,
Area Offices, and Service Units.
D. To identify ``critical events or issues'' arising in
implementing or carrying out the IHCIA where partnerships and the
inclusion of UIOs would complement consultation with Indian Tribes.
E. To require conferring with UIOs on proposed, new, and existing
health policies and programs that qualify as ``critical events or
issues'' arising in implementing or carrying out the IHCIA.
F. To promote and develop innovative methods of involving UIOs in
IHS policy development and in the decision-making processes of the IHS.
G. To coordinate with the HHS Divisions or Regional Offices; State
Agencies; to assist UIOs in communicating their priorities.
H. To charge and hold responsible all levels of management within
the IHS for the implementation of this policy.
5-26.3 Roles
A. Headquarters. The Director, IHS, is responsible for providing
overall guidance and direction to the Office of Urban Indian Health
Programs (OUIHP) and ensuring that the IHS confers, to the maximum
extent practicable, with UIOs in accordance with this policy.
The IHS has the responsibility to engage in an open and free
exchange of information and opinions with UIOs that leads to mutual
understanding and comprehension; and emphasizes trust, respect, and
shared responsibility whenever a ``critical event or issue,'' as
defined in this policy, arises in implementing or carrying out the
IHCIA. When necessary, it is within the discretion of the Director,
IHS, to make the final determination as to whether or not a specific
event or issue qualifies as a ``critical event or issue,'' as defined
in this policy.
The Director, OUIHP, is responsible for monitoring compliance with
this policy, including submissions to the OUIHP conferring email
address: urbanconfer@ihs.gov. The Director, OUIHP, will ensure that all
levels of the IHS conduct regular official conferring sessions that are
publicized through correspondence or, when necessary, Federal Register
Notices (FRN), and receive conferring reports. The Director, OUIHP,
will also receive and acknowledge receipt of written correspondence
from UIOs describing potential ``critical events or issues'' arising in
implementing or carrying out the IHCIA, the affected UIO(s), and the
proposed conferring activity. Where applicable, OUIHP will notify all
affected UIOs through a ``Dear Urban Indian Health Organization
Director Letter'' and broadcast emails, and, if necessary, through the
Federal Register, if the IHS will undertake any conferring activity.
The notice will identify the issue, the method for conferring, and the
timeline for the conferring activity. The Director, OUIHP, is
responsible for preparing and submitting the annual IHS Confer with
UIOs Report.
All IHS Headquarters Office Directors will provide leadership to
identify potential ``critical events or issues'' arising in
implementing or carrying out the IHCIA for which conferring with UIOs
will be recommended to the Director, OUIHP, and assist the OUIHP in
completion of the annual IHS Confer with UIOs Report, when necessary.
B. Area Offices. The Area Director is responsible for regional
administration, management, evaluation, contract and
[[Page 43848]]
grant monitoring, and funding responsibilities for the IHCIA Title V-
funded UIOs located in their Areas. The Area Director will provide the
support and assistance to ensure that IHS confers, in accordance with
this policy, with UIOs at the Area level. The Area Director will
conduct regular official conferring sessions through bi-annual meetings
and other conferring activities with UIOs. The Area Director will
ensure that the Director, OUIHP, is informed of the Area conferring
activities and outcomes for inclusion in the Annual IHS Confer with
UIOs Report.
C. Service Units. The Service Unit Chief Executive Officer (CEO) is
responsible for ensuring compliance with this policy by conferring with
UIOs that are located in the Service Unit. The CEO shall provide the
Service Unit conferring activities and results or outcomes through the
Area Urban Coordinator, to the Area Director, who will report them to
the OUIHP.
5-26.4 Confer Management
A. Identification of Conferring Activities. A potential ``critical
event or issue'' arising in implementing or carrying out the IHCIA may
be identified by either the IHS and/or UIOs.
(1) If a potential ``critical event or issue'' is identified by a
UIO, written correspondence must be submitted to the Director, OUIHP,
(with a copy to the appropriate Area Director) describing the event or
issue, the affected UIO(s), and the proposed conferring activity. The
Director, OUIHP, shall acknowledge receipt of the request within 15
business days. IHS will consider whether or not to confer with
affected/potentially affected UIOs in response to this request.
(2) The Director, OUIHP, shall determine whether or not a specific
event or issue arising in implementing or carrying out the IHCIA
qualifies as a ``critical event or issue,'' as defined in this policy.
The Director, OUIHP, shall provide an official response indicating the
reason(s) why conferring will or will not be conducted. If the
Director, OUIHP, determines that a ``critical event or issue'' has
arisen in implementing or carrying out the IHCIA, the Director, OUIHP,
shall, in the official response, identify the conferring activity that
has been selected and the timeline for the activity. In addition, if
the Director, OUIHP, determines that a ``critical event or issue'' has
arisen in implementing or carrying out the IHCIA, the IHS will issue
notices to all affected/potentially affected UIOs through
correspondence such as a ``Dear Urban Indian Health Organization
Director Letter'' and broadcast emails, as well as through a FRN, if
applicable. Communication will identify the ``critical events or
issues'' to be discussed, as well as the mechanism for conferring. When
necessary, it is within the discretion of the Director, IHS, to make
the final determination as to whether or not a specific event or issue
qualifies as a ``critical event or issue,'' as defined in this policy.
B. Conferring Activity. The IHS will conduct regular, official
conferring sessions through bi-annual meetings. The bi-annual meetings
shall be publicized, both through correspondence such as a ``Dear Urban
Indian Health Program Director Letter'' and broadcast emails, and, if
necessary, through a FRN. The notices will include information such as
the dates and locations of the conferring sessions, the agenda, and any
``critical events or issues'' that will be discussed. In addition to
the bi-annual meetings, other conferring activities may occur
throughout the year. In the event that a confer activity will be
conducted, the degree and extent of the conferring and the mechanism
for conferring shall depend upon several factors, including:
(1) the nature of the ``critical event or issue,''
(2) the number of potentially affected UIOs, and
(3) the most cost effective and efficient conferring mechanism,
based on the nature of the ``critical event or issue'' and the number
of potentially affected UIOs.
C. Confer Mechanisms. The IHS will consider the following confer
mechanisms as options that provide the opportunity for an open and free
exchange of information and opinions that lead to mutual understanding
and comprehension and emphasize trust, respect, and shared
responsibility:
(1) Mailings
(2) Teleconferences
(3) Regular or special program level conferring sessions
(4) Annual meetings, such as the annual Spring Urban Indian Health
Leadership Conference
(5) Opportunities for comment, including submissions to
urbanconfer@ihs.gov
(6) Face-to-face meetings, including meetings conducted at the Area
Office level or at the national-level Indian health system meetings
that include the IHS, Tribes, and UIO(s).
D. Contract- and Grant-Specific Issues. A UIO may request to meet
one-on-one with an IHS representative to confer on issues specific to
that UIO and its contract and grant awards from the IHS.
E. Unresolved Issues. Upon the completion of any of the conferring
activities in this section, the IHS will document and follow-up on any
unresolved issue(s) that would benefit from the ongoing involvement of
the affected UIO(s). Documentation of the conferring process and
outcomes will be maintained by the OUIHP and the Area Office(s) in
which the affected UIO(s) are located.
F. Annual IHS Confer with UIOs Report to HHS. As part of the annual
IHS Confer with UIOs Report to the Secretary, HHS, the IHS shall
prepare and submit an annual report describing ``critical events or
issues'' arising in implementing or carrying out the IHCIA, related
conferring activities, and the results and outcomes of conferring with
UIOs.
(1) The report shall address: Development of the urban Indian
health program budget; development and implementation of urban Indian
health program regulations and policies; and public health or
environmental health critical events impacting UIOs.
(2) The report shall include a description of the ``critical event
or issue(s)'' that was the subject of conferring, a description of the
process that was used, a discussion of the recommendations that
resulted from the conferring meeting(s), a list of any follow-up action
items, a timeline for addressing these items, and a discussion of the
level of satisfaction with the conferring process.
G. Conflict Resolution.
(1) The intent of this policy is to promote mutual understanding
and comprehension, and to emphasize trust, respect, and shared
responsibility between the IHS and UIOs.
(2) However, the IHS and UIOs may not always agree. Where such
disagreement occurs, nothing in this policy creates a right of action
against the IHS or the HHS for failure to comply with this policy.
5-26.5 Federal Advisory Committee Act
The Federal Advisory Committee Act (FACA) may apply to conferring
activities. The FACA is implicated when an Agency establishes, manages,
or controls a group that includes one or more participants who are not
Federal employees for the purpose of obtaining the group's advice or
recommendations on Agency issues or policies. The FACA imposes several
procedural requirements on Federal Agencies that convene advisory
committees. Although FACA may not apply to groups consisting solely of
Tribal leaders serving on the group in their official
[[Page 43849]]
capacities, UIOs do not meet the requirements of the ``Tribal leader''
exemption. Accordingly, any conferring activities that qualify as an
advisory committee under the FACA will be required to comply with the
procedures set out in FACA.
5-26.6 Deliberative Process Privilege
Nothing in this policy waives the Government's deliberative process
privilege. Examples of the government's deliberative process privilege
are as follows:
(1) When the Secretary, HHS, is specifically requested by a member
or members of Congress to respond to or report on proposed legislation,
the development of such responses and of related policy is a part of
the Executive Branch's deliberative process privilege and should remain
confidential.
(2) In specified instances, when Congress requires the HHS to work
with UIOs on the development of recommendations that may require
legislation, such as reports, recommendations, or other products that
are developed independent of a Department position, the development of
which is governed by Office of Management and Budget Circular A-19.
Dated: July 20, 2012.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2012-18300 Filed 7-25-12; 8:45 am]
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