Final Policy on Conferring With Urban Indian Organizations, 58359-58363 [2014-23005]
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Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring,
MD 20993–0002, 301–796–5732.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0447]
Internet/Social Media Platforms:
Correcting Independent Third-Party
Misinformation About Prescription
Drugs and Medical Devices; Draft
Guidance for Industry; Reopening of
the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice of
availability of the draft guidance
entitled ‘‘Internet/Social Media
Platforms: Correcting Independent
Third-Party Misinformation About
Prescription Drugs and Medical
Devices,’’ published in the Federal
Register of June 18, 2014. FDA is
reopening the comment period in
response to a request for additional time
and to allow interested persons more
time to submit comments.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
by October 29, 2014.
ADDRESSES: Submit electronic
comments to https://
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.
FOR FURTHER INFORMATION CONTACT:
Regarding human prescription drugs:
Julie Chronis, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993–0002, 301–796–1200.
Regarding human prescription
biological products: Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
Regarding animal prescription drugs:
Thomas Moskal, Center for Veterinary
Medicine (HFV–216), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9300.
Regarding medical devices for human
use: Deborah Wolf, Center for Devices
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SUMMARY:
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I. Background
In the Federal Register of June 18,
2014 (79 FR 34760), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Internet/Social Media
Platforms: Correcting Independent
Third-Party Misinformation About
Prescription Drugs and Medical
Devices.’’ In that document, FDA
requested comments on the draft
guidance, which responds to (among
other things) stakeholder requests for
specific guidance. The draft guidance
describes FDA’s current thinking on
how manufacturers, packers, and
distributors of prescription human and
animal drugs and medical devices for
human use, including biological
products, should respond, if they
choose to respond, to misinformation
related to a firm’s own FDA-approved or
cleared products when that information
is created or disseminated by
independent third parties. The draft
guidance also updates and clarifies
FDA’s policies on the correction of
misinformation created or disseminated
by independent third parties on the
Internet or through social media
platforms, regardless of whether that
misinformation appears on a firm’s own
forum, an independent third-party
forum, or a Web site. The draft guidance
represents FDA’s current thinking on
specific aspects of FDA’s evolving
consideration of social media platforms
and other Internet-related matters. FDA
actively continues to review, analyze,
and develop approaches to a variety of
topics related to the labeling and
advertising of medical products,
including the development of this and
other guidance addressing the use of
social media platforms and the Internet.
Interested persons were originally
given until September 16, 2014, to
submit comments on the draft guidance.
II. Request for Comments
Following publication of the June 18,
2014, notice, FDA received a request for
additional time to develop meaningful
and thoughtful comments, especially in
light of the concurrent comment period
with another draft guidance entitled
‘‘Internet/Social Media Platforms with
Character Space Limitations: Presenting
Risk and Benefit Information for
Prescription Drugs and Medical
Devices’’ published elsewhere in this
volume of the Federal Register.
FDA has considered the request and
will reopen the comment period for an
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58359
additional 30 days. The Agency believes
that an additional 30 days allows
adequate time for interested persons to
submit comments without significantly
delaying the Agency’s consideration of
these important issues.
III. How To Submit Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov.
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–23064 Filed 9–26–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Final Policy on Conferring With Urban
Indian Organizations
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
The Indian Health Service
(IHS or ‘‘the Agency’’) is issuing this
Notice to implement the final Policy for
conferring with Urban Indian
Organizations (UIOs). In March 2010,
the Indian Health Care Improvement
Act (IHCIA) 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 IHCIA.
DATES: This Policy will become effective
on October 29, 2014.
FOR FURTHER INFORMATION CONTACT:
Office of Management Services,
Management Policy and Internal Control
Staff, Indian Health Service, 801
Thompson Avenue, Suite 625A,
Rockville, Maryland 20852. Telephone
301/443–2650 (This is not a toll free
number).
SUMMARY:
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Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
The IHS
published a proposed draft Policy in a
notice in the Federal Register on July
26, 2012 (77 FR 43846). In response to
the notice, the Agency received thirtytwo comments on the draft Policy. All
comments were considered and
appropriate changes were made to the
policy. In addition, a Listening Session
was held on January 22, 2013, following
publication of a meeting notice in the
Federal Register (78 FR 2413).
SUPPLEMENTARY INFORMATION:
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Inspection of Public Comments
Comments are available for public
inspection at the following address:
Indian Health Service, Division of
Regulatory Affairs, 12300 Twinbrook
Parkway, TMP Suite 430, Rockville MD
20852, Monday through Friday of each
week from 8:30 a.m. to 4:00 p.m. To
schedule an appointment to view public
comments, phone 1–301–443–1116 (not
a toll free number).
Summary and Discussion of Comments
Received
The Agency received thirty-two
comments on the draft Policy. All
comments were considered and
appropriate changes were made to the
policy. Fifteen of the comments were in
support of the Policy as it was written.
Numerous comments addressed topics
that would require no change to the
Policy; however, some comments did
raise critical issues that may require
additional conferring activities. It is
expected that the confer process may
result in the need to update this policy
from time to time.
Several commenters recommended
that UIOs confer with the respective
Area Offices rather than with Service
Units. The Policy identifies a conferring
role to be available at every level of IHS,
including both Area Offices and Service
Units, if applicable. UIOs are not
limited or required to confer at any
specific level. IHS will conduct special
trainings and provide technical
assistance for the Service Units, if
necessary.
One commenter recommended that
application of the Federal Advisory
Committee Act (FACA) be clarified. The
policy is updated to clarify the
applicability of FACA when federal
advisory groups are convened for the
purpose of generating consensus
recommendations, and the
inapplicability of the
‘‘intergovernmental’’ exemption. In the
event questions arise regarding
application of FACA, the following was
added at the end of the FACA section
in the Policy: ‘‘For questions regarding
the applicability of FACA, please
contact the Director, IHS Division of
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Regulatory Affairs, Office of
Management Services.’’
Several commenters were concerned
about the authority in the draft Policy
for the Director, IHS, and the Director,
Office of Urban Indian Health Programs,
to determine when to confer, and
expressed objection to the proposal to
require conference between the IHS and
UIOs upon the occurrence of a critical
event as determined by IHS, and further
commented that either party should be
able to identify a critical event. In
response to the comments, IHS removed
the subject language from the final
Policy. Consistent with the IHCIA, the
Policy requires IHS to confer, to the
maximum extent practicable, on any
critical event or issue, which is defined
broadly as ‘‘an event or issue that
significantly affects one or more UIOs.’’
Section 5–26.4(A) provides that a
critical event or issue may be identified
by IHS and/or UIOs. Subsection (A)(2)
was amended to further clarify that the
identification of a critical event or issue
is intended to be a collaborative one.
Several commenters suggested that
the provisions that were developed by
the ‘‘conferring policy’’ workgroup
established in 2010 be incorporated into
the Policy. While, IHS is not required to
adopt any recommendations of a
workgroup or committee, it was
determined that the ‘‘conferring policy’’
workgroup was convened in a manner
that may not have complied with the
requirements of the FACA. Therefore,
although IHS considered the
workgroup’s discussion and
recommendation to the same extent it
considered all other recommendations
received on this issue, federal staff
developed a draft policy based on the
statute and all comments received to
that point, and published the draft in
the Federal Register for comment. Many
of the points raised in the discussion of
the workgroup actually are consistent
with the draft policy and were raised
and responded to in the comments that
were subsequently received. Some
issues raised by the workgroup, but not
included in the final policy, may require
further conferring with UIOs.
One commenter expressed concern
regarding violation of trust
responsibility. The IHCIA defines
‘‘confer’’ to mean ‘‘to engage in an open
and free exchange of information and
opinions that—(1) leads to mutual
understanding and comprehension; and
(2) emphasizes trust, respect, and shared
responsibility.’’ 25 U.S.C. § 1660d(a).
IHS believes this will be accomplished
through the various confer mechanisms
that will be conducted in response to a
critical event or issue.
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A few commenters suggested that it
was the intent of the IHCIA that the IHS
confers only with UIOs funded by the
IHS under the IHCIA. Similarly, another
commenter suggested the definition of a
UIO be inclusive to ensure adequate
input and participation from the
nonprofit organizations providing
services to Tribal members living away
from the reservation. The Policy is
inclusive of all UIOs that meet the
IHCIA definition of UIO, 25 U.S.C.
1603(29), which is not limited, per the
statute, to organizations that are
receiving funding from the IHS under
the IHCIA. In practice, UIOs funded by
the IHS under the IHCIA will have
opportunities to raise issues specific to
their relationship with IHS during the
confer process and can also continue to
approach IHS directly regarding such
specific concerns, without relying on
the conferring process set out in this
policy.
Two commenters urged the IHS to
consider coordination with the IHS
Tribal Consultation Policy and
Executive Order 13175. The
commenters suggested that UIO matters
could have Tribal implications that may
trigger consultation and, therefore,
Tribal governments should be included
as a required party in the confer process
with UIOs. The Policy published in this
Federal Register notice addresses IHS’s
responsibility to confer with UIOs under
the IHCIA. The IHS Urban Confer Policy
does not change the Tribal Consultation
Policy. IHS will continue to follow the
Tribal Consultation Policy for
consulting Indian Tribes on matters that
will significantly affect Tribes. For
issues of interest to both Tribes and
UIOs, both policies will apply.
Final Policy, With Revisions
Incorporated in Response to Above
Comments
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 United States Code (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 Policy establishes the Indian
Health Service (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
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Indian population are considered at the
local, Area, and national levels, when
implementing and carrying out the
Indian Health Care Improvement Act
(IHCIA or Act).
B. Background. Urban Indian
organizations are a major provider of
health care to urban AI/ANs 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 American Indians and
Alaska Natives (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,
Public Law No. (Pub. L. No.) 94–437, 90
Statute (Stat.) 1400, 1410 (1976),
codified at 25 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 Policy, arises in
implementing or carrying out the IHCIA.
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 . . .
[t]o develop and implement . . . in
conference with urban Indian
organizations, culturally sensitive
assessment and diagnostic tools
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including dysmorphology clinics and
multidisciplinary fetal alcohol spectrum
disorders clinics for use in Indian
communities and urban centers.’’
E. Authorities.
(1) Indian Health Care Improvement
Act, 25 U.S.C. §§ 1601–1683, as
amended, including, §§ 1602(1),
1603(29), 1651, 1653(a), 1660d.
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. 25 U.S.C.
§ 1660d(a).
(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.
(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
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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 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.
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 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 identifying
critical events or issues arising in
implementing or carrying out the IHCIA.
Such correspondence should identify
the critical events or issue, the affected
UIO(s), and the proposed conferring
activity. After receiving such
correspondence, or upon identification
of a critical event or issue by IHS, all
affected UIOs will be notified through a
‘‘Dear Urban Indian Organization
Letter’’ and broadcast emails, and, if
necessary, through the Federal Register,
when IHS will undertake conferring
activity. The notice will identify the
issue, the method for conferring, and the
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timeline for the conferring activity. The
Director, OUIHP, is responsible for
preparing the annual IHS Confer with
Urban Indian Organizations 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
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 official conferring sessions
through meetings or conferring actions
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, if
applicable. The CEO shall provide the
Service Unit conferring activities and
results or outcomes reports 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, IHS, (with a copy to the
appropriate Area Director) describing
the event or issue, the affected UIO(s),
and the proposed conferring activity.
The IHS shall acknowledge receipt of
the request within 60 business days.
(2) Within 60 business days of
acknowledging the request, IHS shall
provide an official response to all
affected/potentially affected UIO(s),
identifying the conferring activity that
has been selected and the timeline for
the activity. In addition, if IHS itself
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 Organization Letter’’ and
broadcast emails, as well as through a
FRN, if necessary. The communication
will identify the critical events or issues
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to be discussed, as well as the
mechanism for conferring.
B. Conferring Activity. The IHS will
conduct official conferring activities
that shall be publicized, both through
correspondence such as a ‘‘Dear Urban
Indian Organization Letter’’ and
broadcast emails, and, if necessary,
through a FRN. The notices will include
information such as the mechanism,
dates, and locations of the conferring
activity, the agenda, and any critical
events or issues that will be discussed.
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/Webinars
(3) Regular or special program level
conferring sessions
(4) Conferences or meetings, such as
the annual 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).
(7) Federal Register Notices with
request for comment.
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.
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.
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F. Annual IHS Confer With UIOs
Report to HHS. The IHS shall prepare
and submit the annual IHS Confer with
UIOs Report to the Secretary, HHS,
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.
The report shall include a description
of each 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 activity, 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), 5 U.S.C. App. § 1–16, 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 consensus 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 capacities, UIOs do not
meet the requirements of the ‘‘intergovernmental’’ exemption. Accordingly,
any conferring activities that qualify as
an advisory committee under the FACA
that is convened for the purpose of
developing consensus recommendations
will be required to comply with the
procedures set out in FACA. For
questions regarding the applicability of
FACA, please contact the Director, IHS
Division of Regulatory Affairs, Office of
Management Services.
5–26.6 Summary
This policy considers a wide range of
needs and unique characteristics in
crafting these guidelines; therefore, it is
important for the IHS urban confer
E:\FR\FM\29SEN1.SGM
29SEN1
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Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
policy to remain dynamic and be
responsive to changing circumstances
that affect UIOs. It is expected that the
confer process may result in the need to
update the policy from time to time.
5–26.7 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: September 22, 2014.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2014–23005 Filed 9–26–14; 8:45 am]
BILLING CODE 4160–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request; A Generic
Submission for Formative Research,
Pre-Testing, Stakeholder Measures
and Advocate Forms at NCI
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
SUMMARY:
NCI’s authorized programs. It is
beneficial for NCI, through the OAR, to
pretest strategies, concepts, activities
and materials while they are under
development. Additionally,
administrative forms are a necessary
part of collecting demographic
information and areas of interest for
advocates. Pre-testing, or formative
evaluation, helps ensure that the
products and services developed by NCI
have the greatest capacity of being
received, understood, and accepted by
their target audiences. Since OAR is
responsible for matching advocates to
NCI programs and initiatives across the
cancer continuum, it is necessary to
measure the satisfaction of both internal
and external stakeholders with this
collaboration. This customer satisfaction
research helps ensure the relevance,
utility, and appropriateness of the many
initiatives and products that OAR and
NCI produce. The OAR will use a
variety of qualitative (focus groups,
interviews) and quantitative (paper,
phone, in-person, and web surveys)
methodologies to conduct this research,
allowing NCI to: 1) Understand
characteristics (attitudes, beliefs, and
behaviors) of the intended target
audience and use this information in the
development of effective strategies,
concepts, activities; 2) use a feedback
loop to help refine, revise, and enhance
OAR’s efforts—ensuring that they have
the greatest relevance, utility,
appropriateness, and impact for/to
target audiences; and 3) expend limited
program resource dollars wisely and
effectively. The anticipated individual
respondents will consist of: Adult
cancer research advocates, members of
the public, health care professionals,
and organizational representatives.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,025.
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on July 18, 2014
(Volume 79, P. 42023) and allowed 60days for public comment. There were no
comments received.
Direct comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Kelley Landy, Acting Director
of the Office of Advocacy Relations
(OAR), NCI, NIH, 31 Center Drive, Bldg.
31, Room 10A28, MSC 2580, Bethesda,
MD 20892, call non-toll-free number
301–594–3194, or email your request,
including your address, to kelley.landy@
nih.gov. Formal requests for additional
plans and instruments must be
requested in writing.
Proposed Collection: A Generic
Submission for Formative Research, Pretesting, Stakeholder Measures and
Advocate Forms at NCI, 0925–0641,
Revision, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The Office of Advocacy
Relations (OAR) disseminates cancerrelated information to a variety of
stakeholders, seeks input and feedback,
and facilitates collaboration to advance
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Individuals .........................................
tkelley on DSK3SPTVN1PROD with NOTICES
Respondent type
Self-Administered Questionnaires ....
Individual In-Depth Interviews ..........
Focus Group Interviews ...................
VerDate Sep<11>2014
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response
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75
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(minutes/hour)
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]]>Agencies
[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Pages 58359-58363]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23005]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Final Policy on Conferring With Urban Indian Organizations
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Indian Health Service (IHS or ``the Agency'') is issuing
this Notice to implement the final Policy for conferring with Urban
Indian Organizations (UIOs). In March 2010, the Indian Health Care
Improvement Act (IHCIA) 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
IHCIA.
DATES: This Policy will become effective on October 29, 2014.
FOR FURTHER INFORMATION CONTACT: Office of Management Services,
Management Policy and Internal Control Staff, Indian Health Service,
801 Thompson Avenue, Suite 625A, Rockville, Maryland 20852. Telephone
301/443-2650 (This is not a toll free number).
[[Page 58360]]
SUPPLEMENTARY INFORMATION: The IHS published a proposed draft Policy in
a notice in the Federal Register on July 26, 2012 (77 FR 43846). In
response to the notice, the Agency received thirty-two comments on the
draft Policy. All comments were considered and appropriate changes were
made to the policy. In addition, a Listening Session was held on
January 22, 2013, following publication of a meeting notice in the
Federal Register (78 FR 2413).
Inspection of Public Comments
Comments are available for public inspection at the following
address: Indian Health Service, Division of Regulatory Affairs, 12300
Twinbrook Parkway, TMP Suite 430, Rockville MD 20852, Monday through
Friday of each week from 8:30 a.m. to 4:00 p.m. To schedule an
appointment to view public comments, phone 1-301-443-1116 (not a toll
free number).
Summary and Discussion of Comments Received
The Agency received thirty-two comments on the draft Policy. All
comments were considered and appropriate changes were made to the
policy. Fifteen of the comments were in support of the Policy as it was
written. Numerous comments addressed topics that would require no
change to the Policy; however, some comments did raise critical issues
that may require additional conferring activities. It is expected that
the confer process may result in the need to update this policy from
time to time.
Several commenters recommended that UIOs confer with the respective
Area Offices rather than with Service Units. The Policy identifies a
conferring role to be available at every level of IHS, including both
Area Offices and Service Units, if applicable. UIOs are not limited or
required to confer at any specific level. IHS will conduct special
trainings and provide technical assistance for the Service Units, if
necessary.
One commenter recommended that application of the Federal Advisory
Committee Act (FACA) be clarified. The policy is updated to clarify the
applicability of FACA when federal advisory groups are convened for the
purpose of generating consensus recommendations, and the
inapplicability of the ``intergovernmental'' exemption. In the event
questions arise regarding application of FACA, the following was added
at the end of the FACA section in the Policy: ``For questions regarding
the applicability of FACA, please contact the Director, IHS Division of
Regulatory Affairs, Office of Management Services.''
Several commenters were concerned about the authority in the draft
Policy for the Director, IHS, and the Director, Office of Urban Indian
Health Programs, to determine when to confer, and expressed objection
to the proposal to require conference between the IHS and UIOs upon the
occurrence of a critical event as determined by IHS, and further
commented that either party should be able to identify a critical
event. In response to the comments, IHS removed the subject language
from the final Policy. Consistent with the IHCIA, the Policy requires
IHS to confer, to the maximum extent practicable, on any critical event
or issue, which is defined broadly as ``an event or issue that
significantly affects one or more UIOs.'' Section 5-26.4(A) provides
that a critical event or issue may be identified by IHS and/or UIOs.
Subsection (A)(2) was amended to further clarify that the
identification of a critical event or issue is intended to be a
collaborative one.
Several commenters suggested that the provisions that were
developed by the ``conferring policy'' workgroup established in 2010 be
incorporated into the Policy. While, IHS is not required to adopt any
recommendations of a workgroup or committee, it was determined that the
``conferring policy'' workgroup was convened in a manner that may not
have complied with the requirements of the FACA. Therefore, although
IHS considered the workgroup's discussion and recommendation to the
same extent it considered all other recommendations received on this
issue, federal staff developed a draft policy based on the statute and
all comments received to that point, and published the draft in the
Federal Register for comment. Many of the points raised in the
discussion of the workgroup actually are consistent with the draft
policy and were raised and responded to in the comments that were
subsequently received. Some issues raised by the workgroup, but not
included in the final policy, may require further conferring with UIOs.
One commenter expressed concern regarding violation of trust
responsibility. The IHCIA defines ``confer'' to mean ``to engage in an
open and free exchange of information and opinions that--(1) leads to
mutual understanding and comprehension; and (2) emphasizes trust,
respect, and shared responsibility.'' 25 U.S.C. Sec. 1660d(a). IHS
believes this will be accomplished through the various confer
mechanisms that will be conducted in response to a critical event or
issue.
A few commenters suggested that it was the intent of the IHCIA that
the IHS confers only with UIOs funded by the IHS under the IHCIA.
Similarly, another commenter suggested the definition of a UIO be
inclusive to ensure adequate input and participation from the nonprofit
organizations providing services to Tribal members living away from the
reservation. The Policy is inclusive of all UIOs that meet the IHCIA
definition of UIO, 25 U.S.C. 1603(29), which is not limited, per the
statute, to organizations that are receiving funding from the IHS under
the IHCIA. In practice, UIOs funded by the IHS under the IHCIA will
have opportunities to raise issues specific to their relationship with
IHS during the confer process and can also continue to approach IHS
directly regarding such specific concerns, without relying on the
conferring process set out in this policy.
Two commenters urged the IHS to consider coordination with the IHS
Tribal Consultation Policy and Executive Order 13175. The commenters
suggested that UIO matters could have Tribal implications that may
trigger consultation and, therefore, Tribal governments should be
included as a required party in the confer process with UIOs. The
Policy published in this Federal Register notice addresses IHS's
responsibility to confer with UIOs under the IHCIA. The IHS Urban
Confer Policy does not change the Tribal Consultation Policy. IHS will
continue to follow the Tribal Consultation Policy for consulting Indian
Tribes on matters that will significantly affect Tribes. For issues of
interest to both Tribes and UIOs, both policies will apply.
Final Policy, With Revisions Incorporated in Response to Above Comments
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 United States Code (U.S.C.) Sec.
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 Policy establishes the Indian Health Service (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
[[Page 58361]]
Indian population are considered at the local, Area, and national
levels, when implementing and carrying out the Indian Health Care
Improvement Act (IHCIA or Act).
B. Background. Urban Indian organizations are a major provider of
health care to urban AI/ANs 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 American Indians and Alaska
Natives (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, Public Law No. (Pub. L. No.) 94-437, 90 Statute
(Stat.) 1400, 1410 (1976), codified at 25 U.S.C. Sec. 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 Policy, arises in implementing or carrying out the IHCIA.
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. Sec. 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. Sec. 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. Sec. 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. Sec.
1665k(a)(2)(A)(vii). ``Funding provided pursuant to [25 U.S.C. Sec.
1665k ``fetal alcohol spectrum disorders programs''] shall be used . .
. [t]o develop and implement . . . in conference with urban Indian
organizations, culturally sensitive assessment and diagnostic tools
including dysmorphology clinics and multidisciplinary fetal alcohol
spectrum disorders clinics for use in Indian communities and urban
centers.''
E. Authorities.
(1) Indian Health Care Improvement Act, 25 U.S.C. Sec. Sec. 1601-
1683, as amended, including, Sec. Sec. 1602(1), 1603(29), 1651,
1653(a), 1660d.
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. 25 U.S.C.
Sec. 1660d(a).
(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.
(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 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.
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 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 identifying critical events or issues arising in implementing or
carrying out the IHCIA. Such correspondence should identify the
critical events or issue, the affected UIO(s), and the proposed
conferring activity. After receiving such correspondence, or upon
identification of a critical event or issue by IHS, all affected UIOs
will be notified through a ``Dear Urban Indian Organization Letter''
and broadcast emails, and, if necessary, through the Federal Register,
when IHS will undertake conferring activity. The notice will identify
the issue, the method for conferring, and the
[[Page 58362]]
timeline for the conferring activity. The Director, OUIHP, is
responsible for preparing the annual IHS Confer with Urban Indian
Organizations 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 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 official
conferring sessions through meetings or conferring actions 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, if applicable. The CEO shall
provide the Service Unit conferring activities and results or outcomes
reports 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, IHS, (with a
copy to the appropriate Area Director) describing the event or issue,
the affected UIO(s), and the proposed conferring activity. The IHS
shall acknowledge receipt of the request within 60 business days.
(2) Within 60 business days of acknowledging the request, IHS shall
provide an official response to all affected/potentially affected
UIO(s), identifying the conferring activity that has been selected and
the timeline for the activity. In addition, if IHS itself 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
Organization Letter'' and broadcast emails, as well as through a FRN,
if necessary. The communication will identify the critical events or
issues to be discussed, as well as the mechanism for conferring.
B. Conferring Activity. The IHS will conduct official conferring
activities that shall be publicized, both through correspondence such
as a ``Dear Urban Indian Organization Letter'' and broadcast emails,
and, if necessary, through a FRN. The notices will include information
such as the mechanism, dates, and locations of the conferring activity,
the agenda, and any critical events or issues that will be discussed.
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/Webinars
(3) Regular or special program level conferring sessions
(4) Conferences or meetings, such as the annual 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).
(7) Federal Register Notices with request for comment.
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. The IHS shall prepare
and submit the annual IHS Confer with UIOs Report to the Secretary,
HHS, 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.
The report shall include a description of each 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 activity, 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), 5 U.S.C. App. Sec. 1-
16, 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 consensus 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 capacities, UIOs do not meet the requirements
of the ``inter-governmental'' exemption. Accordingly, any conferring
activities that qualify as an advisory committee under the FACA that is
convened for the purpose of developing consensus recommendations will
be required to comply with the procedures set out in FACA. For
questions regarding the applicability of FACA, please contact the
Director, IHS Division of Regulatory Affairs, Office of Management
Services.
5-26.6 Summary
This policy considers a wide range of needs and unique
characteristics in crafting these guidelines; therefore, it is
important for the IHS urban confer
[[Page 58363]]
policy to remain dynamic and be responsive to changing circumstances
that affect UIOs. It is expected that the confer process may result in
the need to update the policy from time to time.
5-26.7 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: September 22, 2014.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2014-23005 Filed 9-26-14; 8:45 am]
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