Notice of Final Issuance on the Adoption of Administration for Native Americans (ANA) Program Policies and Procedures, 23769-23770 [2013-09330]
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Federal Register / Vol. 78, No. 77 / Monday, April 22, 2013 / Notices
for Medicare Beneficiaries Receiving
Implantable Cardioverter-Defibrillators
for Primary Prevention of Sudden
Cardiac Death; Use: CMS provides
coverage for implantable cardioverterdefibrillators (ICDs) for secondary
prevention of sudden cardiac death
based on extensive evidence showing
that use of ICDs among patients with a
certain set of physiologic conditions are
effective. Accordingly, CMS considers
coverage for ICDs reasonable and
necessary under Section 1862(a)(1)(A) of
the Social Security Act. However,
evidence for use of ICDs for primary
prevention of sudden cardiac death is
less compelling for certain patients.
To encourage responsible and
appropriate use of ICDs, CMS issued a
‘‘Decision Memo for Implantable
Defibrillators’’ on January 27, 2005,
indicating that ICDs will be covered for
primary prevention of sudden cardiac
death if the beneficiary is enrolled in
either an FDA-approved category B IDE
clinical trial (42 CFR 405.201), a trial
under the CMS Clinical Trial Policy
(NCD Manual § 310.1) or a qualifying
prospective data collection system
(either a practical clinical trial or
prospective systematic data collection,
which is sometimes referred to as a
registry). Form Number: CMS–10151
(OMB#: 0938–0967); Frequency:
Occasionally; Affected Public: Private
Sector; Business or other for-profits,
Not-for-profit institutions; Number of
Respondents: 1,702; Total Annual
Responses: 82; Total Annual Hours:
139,356. (For policy questions regarding
this collection contact JoAnna Baldwin
at 410–786–7205. For all other issues
call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by June 21, 2013:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
VerDate Mar<15>2010
17:03 Apr 19, 2013
Jkt 229001
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 17, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–09413 Filed 4–19–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Numbers: 93.581, 93.587, 93.612]
Notice of Final Issuance on the
Adoption of Administration for Native
Americans (ANA) Program Policies
and Procedures
Administration for Native
Americans (ANA), ACF, HHS.
ACTION: Issuance of Final Policy
Directive.
AGENCY:
The Administration for
Native Americans (ANA) is issuing final
interpretive rules, general statements of
policy and rules of agency organization,
procedure, or practice relating to the
following Funding Opportunity
Announcements (FOAs): Social and
Economic Development Strategies
(hereinafter referred to as SEDS),
SEDS—Native Asset Building Initiative
(hereinafter referred to as NABI),
Sustainable Employment and Economic
Development Strategies (hereinafter
referred to as SEEDS), Native Language
Preservation and Maintenance
(hereinafter referred to as Language
Preservation), Native Language
Preservation and Maintenance—Esther
Martinez Initiative (hereinafter referred
to as Language—EMI), and
Environmental Regulatory Enhancement
(hereinafter referred to as ERE). This
notice also provides information about
how ANA will administer these
programs.
SUMMARY:
The policies noted in the original
Notice of Public Comment (NOPC) are
effective immediately upon publication.
FOR FURTHER INFORMATION CONTACT:
Carmelia Strickland, Director, Division
of Program Operations, ANA (877) 922–
9262.
DATES:
PO 00000
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Sfmt 4703
23769
Section
814 of the Native Americans Programs
Act of 1974, as amended, requires ANA
to provide notice of its proposed
interpretive rules, general statements of
policy, and rules of agency organization,
procedure or practice. The proposed
clarifications, modifications, and new
text will appear in the six FY 2013
FOAs: SEDS, NABI, SEEDS, Language
Preservation, Language—EMI, and ERE.
ANA published a NOPC in the Federal
Register (78 FR 13062) on February 26,
2013, with proposed policy and
program clarifications, modifications,
and activities for the fiscal year (FY)
2013 FOAs. The public comment period
was open for 30 days.
For information on the changes ANA
is making, please refer to the NOPC at
the following link: https://www.federal
register.gov/articles/2013/02/26/201304383/request-for-public-comment-onthe-proposed-adoption-ofadministration-for-native-americansprogram.
ANA received one comment from a
Native non-profit organization. ANA
considered the comment received and
provides responses, clarifications, and
modifications in this final directive. The
following paragraph summarizes the
comment and our response:
SUPPLEMENTARY INFORMATION:
A. Comment and Response
Comment: ANA received one
comment in reference to ANA’s new
administrative policy focused on
conflict of interest standards that states
that staff employed through an ANAfunded project cannot also serve as a
member of the governing body for the
applicant organization. Therefore, staff
employed through an ANA-funded
project cannot also serve as a member of
the governing body for the applicant
organization. During the award
negotiation phase, ANA will ask the
prospective recipient to modify project
personnel if a proposed staff member is
also a member of the applicant
organization’s governing body. In
addition, there should be a separation of
duties from staff and the governing
bodies within an organization to ensure
the integrity of internal controls and to
minimize disruptions in the continuity
of operations.
The commenter stated that this policy
would have a negative impact on the
commenter’s organization’s ability to
implement a grant as it currently allows
two teachers to serve as members of the
school board, as required by their
bylaws. If this policy were
implemented, the applicant would not
have the ability to modify project
personnel to align with this policy due
to the extreme shortage of certified
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22APN1
23770
Federal Register / Vol. 78, No. 77 / Monday, April 22, 2013 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
teachers with requisite language
capabilities available to staff an ANA
grant. In addition, the commenter stated
that the by-laws are written so that
teacher members do not have decisionmaking authority regarding personnel
actions, nor to make financial decisions
that are of personal benefit, thus
insuring internal controls.
Response: ANA offers no change in
response to this comment. While ANA
is sympathetic to the commenter’s
concern, it is important that this policy
remains as written. Under the standard
terms and conditions for discretionary
HHS awards (Grants Policy Statement,
page II–7 at https://www.acf.hhs.gov/
grants/terms-and-conditions), grant
recipients are required to establish
safeguards to prevent employees,
consultants, members of governing
bodies, and others who may be involved
in grant-supported activities, from using
their positions for purposes that are, or
give the appearance of being, motivated
by a desire for private financial gain for
themselves or others, such as those with
whom they have family, business, or
other ties.
This has been a long-standing policy
of the Administration for Children and
Families. All prospective applicants are
required to submit the SF–424B
Assurances (Non-Construction) agreeing
to these terms and conditions at the
time of submission. ANA understands
this can cause challenges for applicants
but it is important that applicants are
reminded of the requirement to
establish safeguards that prohibit
employees from using their position for
a purpose that presents a conflict of
interest or the appearance of a conflict
of interest.
B. Funding Opportunity
Announcements
For information on the types of
projects funded by ANA, please refer to
ANA’s Web site for information on our
program areas and funding opportunity
announcements: https://
www.acf.hhs.gov/programs/ana.
Pre-publication information on ANA’s
FOAs is available at the HHS Forecast
Web site at https://www.acf.hhs.gov/
hhsgrantsforecast/.
Once published, the 2013 FOAs can
be accessed at: https://www.acf.hhs.gov/
grants/open/foa/office/ana or https://
www.acf.hhs.gov/grants/open/foa/.
Synopses and application forms will be
available on www.Grants.gov.
Lillian A. Sparks,
Commissioner, Administration for Native
Americans.
[FR Doc. 2013–09330 Filed 4–19–13; 8:45 am]
BILLING CODE 4184–34–P
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Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Establishment of the Discretionary
Advisory Committee on Heritable
Disorders in Newborns and Children
Health Resources and Services
Administration, HHS.
ACTION: Proposed Establishment of
Discretionary Advisory Committee on
Heritable Disorders in Newborns and
Children.
AGENCY:
The U.S. Department of
Health and Human Services announces
establishment of the Discretionary
Advisory Committee on Heritable
Disorders in Newborns and Children.
FOR FURTHER INFORMATION CONTACT: Debi
Sarkar, Public Health Analyst, Health
Resources and Services Administration,
Maternal and Child Health Bureau;
telephone: 301–443–1080; email:
dsarkar@hrsa.gov.
SUPPLEMENTARY INFORMATION: Under the
Public Health Service Act (PHS), 42
U.S.C. 217a, the Secretary of Health and
Human Services directed that the
Discretionary Advisory Committee on
Heritable Disorders in Newborns and
Children shall be established within the
Department of Health and Human
Services (HHS). To comply with the
authorizing directive and guidelines
under the Federal Advisory Committee
Act (FACA), a charter will be filed with
the Committee Management Secretariat
in the General Services Administration
(GSA), the appropriate committees in
the Senate and U.S. House of
Representatives, and the Library of
Congress to establish the Committee as
a discretionary federal advisory
committee.
Objectives and Scope of Activities.
The purpose of the Discretionary
Advisory Committee on Heritable
Disorders in Newborns and Children
(DACHDNC) is to advise the Secretary of
Health and Human Services about
aspects of newborn and childhood
screening and technical information for
the development of policies and
priorities that will enhance the ability of
the state and local health agencies to
provide for newborn and child
screening, counseling and health care
services for newborns and children
having, or at risk for, heritable
disorders. The DACHDNC will review
and report regularly on newborn and
childhood screening practices,
recommend improvements for newborn
and childhood screening programs, as
well as fulfill the list of requirements
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
stated in the original authorizing
legislation.
Membership and Designation. The
Committee shall consist of up to fifteen
(15) voting members, including the
Chair. The members of the Committee
shall be appointed by the Secretary or
his/her designee. Membership will be
composed of the Chair, Special
Government Employees (SGEs), and
federal ex-officio members. Federal exofficio members shall include the
Administrator of the Health Resources
and Services Administration; the
Directors of the Centers for Disease
Control and Prevention; the National
Institutes of Health; the Agency for
Healthcare Research and Quality; and
the Commissioner of the Food and Drug
Administration—or their designees. The
Chair and other members shall be (a)
medical, technical, public health or
scientific professionals with special
expertise in the field of heritable
disorders or in providing screening,
counseling, testing, or specialty services
for newborns and children at risk for
heritable disorders; (b) experts in ethics
and heritable disorders who have
worked and published material in the
area of public health and genetic
conditions; and (c) members from the
public sector who have expertise, either
professional or personal, about or
concerning heritable disorders in order
to achieve a fairly balanced
membership.
Administrative Management and
Support. HHS will provide funding and
administrative support for the
Committee to the extent permitted by
law within existing appropriations.
Management and oversight for support
services provided to the Committee will
be the responsibility of the Health
Resources and Services Administration
(HRSA), Maternal and Child Health
Bureau (MCHB).
A copy of the Committee charter will
be made available through access to the
FACA database, maintained by the GSA
Committee Management Secretariat, or
from the designated contacts. The Web
site for the FACA database is https://
fido.gov/facadatabase/.
Authority: The Discretionary Advisory
Committee on Heritable Disorders in
Newborns and Children is authorized in
accordance with the Public Health Service
Act (PHS), 42 U.S.C. 222 [217a]: Advisory
councils or committees. The Committee is
governed by provisions of Public Law 92–
463, as amended, (5 U.S.C. App.), which sets
forth standards for the formation and use of
advisory committees.
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Agencies
[Federal Register Volume 78, Number 77 (Monday, April 22, 2013)]
[Notices]
[Pages 23769-23770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09330]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[CFDA Numbers: 93.581, 93.587, 93.612]
Notice of Final Issuance on the Adoption of Administration for
Native Americans (ANA) Program Policies and Procedures
AGENCY: Administration for Native Americans (ANA), ACF, HHS.
ACTION: Issuance of Final Policy Directive.
-----------------------------------------------------------------------
SUMMARY: The Administration for Native Americans (ANA) is issuing final
interpretive rules, general statements of policy and rules of agency
organization, procedure, or practice relating to the following Funding
Opportunity Announcements (FOAs): Social and Economic Development
Strategies (hereinafter referred to as SEDS), SEDS--Native Asset
Building Initiative (hereinafter referred to as NABI), Sustainable
Employment and Economic Development Strategies (hereinafter referred to
as SEEDS), Native Language Preservation and Maintenance (hereinafter
referred to as Language Preservation), Native Language Preservation and
Maintenance--Esther Martinez Initiative (hereinafter referred to as
Language--EMI), and Environmental Regulatory Enhancement (hereinafter
referred to as ERE). This notice also provides information about how
ANA will administer these programs.
DATES: The policies noted in the original Notice of Public Comment
(NOPC) are effective immediately upon publication.
FOR FURTHER INFORMATION CONTACT: Carmelia Strickland, Director,
Division of Program Operations, ANA (877) 922-9262.
SUPPLEMENTARY INFORMATION: Section 814 of the Native Americans Programs
Act of 1974, as amended, requires ANA to provide notice of its proposed
interpretive rules, general statements of policy, and rules of agency
organization, procedure or practice. The proposed clarifications,
modifications, and new text will appear in the six FY 2013 FOAs: SEDS,
NABI, SEEDS, Language Preservation, Language--EMI, and ERE. ANA
published a NOPC in the Federal Register (78 FR 13062) on February 26,
2013, with proposed policy and program clarifications, modifications,
and activities for the fiscal year (FY) 2013 FOAs. The public comment
period was open for 30 days.
For information on the changes ANA is making, please refer to the
NOPC at the following link: https://www.federalregister.gov/articles/2013/02/26/2013-04383/request-for-public-comment-on-the-proposed-adoption-of-administration-for-native-americans-program.
ANA received one comment from a Native non-profit organization. ANA
considered the comment received and provides responses, clarifications,
and modifications in this final directive. The following paragraph
summarizes the comment and our response:
A. Comment and Response
Comment: ANA received one comment in reference to ANA's new
administrative policy focused on conflict of interest standards that
states that staff employed through an ANA-funded project cannot also
serve as a member of the governing body for the applicant organization.
Therefore, staff employed through an ANA-funded project cannot also
serve as a member of the governing body for the applicant organization.
During the award negotiation phase, ANA will ask the prospective
recipient to modify project personnel if a proposed staff member is
also a member of the applicant organization's governing body. In
addition, there should be a separation of duties from staff and the
governing bodies within an organization to ensure the integrity of
internal controls and to minimize disruptions in the continuity of
operations.
The commenter stated that this policy would have a negative impact
on the commenter's organization's ability to implement a grant as it
currently allows two teachers to serve as members of the school board,
as required by their bylaws. If this policy were implemented, the
applicant would not have the ability to modify project personnel to
align with this policy due to the extreme shortage of certified
[[Page 23770]]
teachers with requisite language capabilities available to staff an ANA
grant. In addition, the commenter stated that the by-laws are written
so that teacher members do not have decision-making authority regarding
personnel actions, nor to make financial decisions that are of personal
benefit, thus insuring internal controls.
Response: ANA offers no change in response to this comment. While
ANA is sympathetic to the commenter's concern, it is important that
this policy remains as written. Under the standard terms and conditions
for discretionary HHS awards (Grants Policy Statement, page II-7 at
https://www.acf.hhs.gov/grants/terms-and-conditions), grant recipients
are required to establish safeguards to prevent employees, consultants,
members of governing bodies, and others who may be involved in grant-
supported activities, from using their positions for purposes that are,
or give the appearance of being, motivated by a desire for private
financial gain for themselves or others, such as those with whom they
have family, business, or other ties.
This has been a long-standing policy of the Administration for
Children and Families. All prospective applicants are required to
submit the SF-424B Assurances (Non-Construction) agreeing to these
terms and conditions at the time of submission. ANA understands this
can cause challenges for applicants but it is important that applicants
are reminded of the requirement to establish safeguards that prohibit
employees from using their position for a purpose that presents a
conflict of interest or the appearance of a conflict of interest.
B. Funding Opportunity Announcements
For information on the types of projects funded by ANA, please
refer to ANA's Web site for information on our program areas and
funding opportunity announcements: https://www.acf.hhs.gov/programs/ana.
Pre-publication information on ANA's FOAs is available at the HHS
Forecast Web site at https://www.acf.hhs.gov/hhsgrantsforecast/.
Once published, the 2013 FOAs can be accessed at: https://www.acf.hhs.gov/grants/open/foa/office/ana or https://www.acf.hhs.gov/grants/open/foa/. Synopses and application forms will be available on
www.Grants.gov.
Lillian A. Sparks,
Commissioner, Administration for Native Americans.
[FR Doc. 2013-09330 Filed 4-19-13; 8:45 am]
BILLING CODE 4184-34-P