Request for Information on Guidance for the Specification of a Secure, Online Reporting System for Streamlining Programmatic, Fiscal, and Other Data From DHHS-Funded HIV Prevention, Treatment, and Care Services Grantees, 26013-26014 [2012-10591]
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Federal Register / Vol. 77, No. 85 / Wednesday, May 2, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Esther.Yoo@bioethics.gov in advance of
the meeting. The Commission will make
every effort to accommodate persons
who need special assistance.
Written comments will also be
accepted in advance of the meeting and
are especially welcome. Please address
written comments by email to
info@bioethics.gov, or by mail to the
following address: Public Commentary,
Presidential Commission for the Study
of Bioethical Issues, 1425 New York
Ave. NW., Suite C–100, Washington, DC
20005. Comments will be publicly
available, including any personally
identifiable or confidential business
information that they contain. Trade
secrets should not be submitted.
FOR FURTHER INFORMATION CONTACT:
Andrew D. Forsyth Ph.D. or Vera
Yakovchenko, MPH, Office of HIV/AIDS
and Infectious Disease Policy (OHAIDP),
(202) 205–6606.
SUPPLEMENTARY INFORMATION:
In July 2010, the White House
released the National HIV/AIDS Strategy
(NHAS) for the United States that
outlined four key goals: (1) Reduce the
number of people who become infected
with HIV; (2) increase access to care and
optimize health outcomes for people
living with HIV; (3) reduce HIV-related
health disparities; and (4) achieve a
more coordinated national response to
the HIV epidemic in the United States.1
Central to the latter goal were two
related directives. The first was to
Dated: April 23, 2012.
develop improved mechanisms to
Lisa M. Lee,
monitor, evaluate, and report on
Executive Director, Presidential Commission
progress toward achieving national
for the Study of Bioethical Issues.
goals. And the second was to simplify
[FR Doc. 2012–10513 Filed 5–1–12; 8:45 am]
grant administration activities by
BILLING CODE 4154–06–P
standardizing data collection and
reducing undue grantee reporting
requirements for federal HIV programs.
DEPARTMENT OF HEALTH AND
In December 2009, the White House
HUMAN SERVICES
also released its Open Government
Directive,2 which seeks to improve
Request for Information on Guidance
access to government data in a manner
for the Specification of a Secure,
that enhances transparency, fosters
Online Reporting System for
participation through the public’s
Streamlining Programmatic, Fiscal,
contribution of ideas and expertise to
and Other Data From DHHS-Funded
decision-making, and enhances
HIV Prevention, Treatment, and Care
collaboration through new partnerships
Services Grantees
within the federal government and
AGENCY: Office of the Assistant
between public and private institutions.
Secretary for Health, Office of the
Notwithstanding existing clearance
Secretary, Department of Health and
requirements or legitimate reasons to
Human Services.
protect information, the Directive
ACTION: Notice.
highlighted the need for the following:
(1) Timely and accessible online
SUMMARY: The Department of Health and
publication of government information;
Human Services (DHHS) is seeking to
(2) improved quality of government
identify interest and obtain information
information; (3) creation of a culture of
relevant to the design, deployment,
open government; and (4) establishment
operations, maintenance, and future
of a policy framework for Open
enhancement of a centralized, secure,
Government. The release of the
flexible data reporting system to
Directive was followed shortly
streamline the collection, processing,
thereafter by the DHHS Open
and sharing of programmatic, funding,
Government Plan,3 which seeks to build
and other data reported to DHHS
upon the White House’s emphasis on
Operating Divisions (OpDivs) by
transparency, collaboration, and
grantees funded to provide HIV
collaboration to ensure that the
prevention, treatment, and care services.
government works better for all
DATES: To be assured consideration,
Americans.
comments must be received at one of
An important contribution of the
the addresses provided below, no later
DHHS Open Government Plan is its
than 5 p.m. EST on May 17, 2012.
reference to new technological
ADDRESSES: Electronic responses are
developments that make it possible to
strongly preferred and may be addressed streamline the collection, sharing, and
to [HIVOpenData@hhs.gov]. Written
1 https://www.whitehouse.gov/administration/eop/
responses should be addressed to: U.S.
onap/nhas.
Department of Health and Human
2 https://www.whitehouse.gov/open/documents/
Services, Room 443–H, 200
open-government-directive.
Independence Ave. SW., Washington,
3 https://www.hhs.gov/open/plan/
DC 20201. Attention: HIV Open Data
opengovernmentplan/transparency/
dashboard.html.
Project.
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16:55 May 01, 2012
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26013
processing of programmatic and fiscal
data in a manner that facilitates greater
transparency, participation, and
collaboration, even in such critical and
sensitive areas as the DHHS investment
in HIV prevention, treatment, and care
services. At present, DHHS OpDivs that
fund these services use a mixture of
non-interoperable information
processing systems to collect
programmatic, fiscal, and other data
from grantees. Moreover, these systems
often utilize different indicators to
monitor the progress of HIV/AIDS
programs that vary in their
specifications (e.g., numerators,
denominators, time frames) and other
key parameters. As a result, many
required HIV/AIDS data elements are
inconsistent, impede evaluation and
monitoring of all relevant DHHS-funded
services, and add undue burden to HIV
services grantees charged with reporting
obligations often from multiple DHHS
OpDivs.
Under consideration at DHHS is the
design, deployment, operations,
maintenance, and future enhancement
of a centralized, secure, flexible data
reporting information system to compile
programmatic, funding, and other data
reported to DHHS OpDivs by grantees
funded to provide HIV prevention,
treatment, and care services. In effect,
DHHS is exploring the possibility of
establishing a single data reporting tool
for funders, grantees, and sub-grantees
that builds upon or shares many of the
features of the Health Resources and
Services Administration’s (HRSA) Ryan
White HIV/AIDS Services Report (RSR),
which is a secure, online, data
collection system for programmatic and
fiscal data. Similarly, such a system
might share features central to the
National Institutes of Health’s Electronic
Research Administration (ERA), which
offers a one-stop solution ‘‘to manage
the receipt, processing, review, award
and monitoring of over $30 billion in
research and non-research grants’’ (see
https://era.nih.gov). Moreover, such a
system would offer a secure data
solution that permits internal and
external access to data, eliminates
paper-based reporting, and streamlines
the process of data collection and
sharing in a manner that advances the
DHHS Open Government Plan.
The HIV Open Data Project
envisioned might offer several benefits,
such as: (1) Improve mechanisms to
monitor, evaluate, and report on
progress toward achieving NHAS goals;
(2) ensure more coordinated program
administration; (3) utilize a common
protocol for establishing patient
identifiers to protect confidentiality and
de-identify client data; (4) reduce
E:\FR\FM\02MYN1.SGM
02MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
26014
Federal Register / Vol. 77, No. 85 / Wednesday, May 2, 2012 / Notices
administrative and infrastructural costs
associated with reporting to or
maintaining independent data systems;
(5) streamline and standardize data
collection; (6) facilitate data sharing
among federal and non-federal partners;
(7) reduce bottlenecks and redundant
data entry to different data systems; (8)
integrate with electronic health record
systems; (9) improve accountability and
tracking of grantees with multiple
funding streams; (10) facilitate data
standardization and deployment of
common core indicators that could form
the basis of performance dashboards;
(11) identify services gaps and unmet
need; and (12) enhance transparency,
participation, and collaboration around
key public policy decisions relevant to
the DHHS investment in HIV
prevention, treatment, and care services.
Accordingly, this request for
information seeks public comment on
several key dimensions of such a
project, including but not limited to the
following:
1. In evaluating the feasibility of such
a centralized data system, what specific
steps would be critical to the design,
deployment, operations, maintenance,
and enhancement of such a system,
particularly in light of addressing
interoperability issues of existing data
systems operated by DHHS OpDivs that
support HIV prevention, treatment, or
care services (e.g., Centers for Medicare
and Medicaid Services, HRSA,
Substance Abuse and Mental Health
Services Administration, Indian Health
Service, Centers for Disease Control and
Prevention)?
2. What existing systems currently in
use to monitor health grants offer the
features desired and what are the
strengths and challenges of (a) designing
an entirely new online resource or (b)
adopting an existing resource (e.g.,
HRSA’s RSR or others)?
3. What are the greatest challenges
encountered in reporting data (describe
your reporting obligations, if applicable)
and what specific solutions have DHHS
grantees implemented to streamline
divergent, non-interoperable reporting
systems?
4. And what data would prove most
useful for different stakeholders to
receive from such a centralized system?
5. What costs, benefits, and risks need
to be given careful consideration in
development of such a resource? What
are the estimated costs and return on
investment of each component?
6. What technological resources and
expertise would be needed to design,
deploy, operate, maintain, and enhance
such a system and what extant models
exist for achieving the goal of a secure
VerDate Mar<15>2010
16:55 May 01, 2012
Jkt 226001
electronic resource capable of achieving
the benefits noted above?
7. What system architecture do you
recommend for the project, particularly
considering the government’s desire to
keep the project simple and streamlined
(i.e. using as few different software
packages and tools as possible)? What
architecture, expertise, and other
components are indispensible to the
success of the design, deployment,
operations, maintenance, and
enhancement of such a system?
8. What would a phased
implementation plan consist of? If a
modular or phased approach is
recommended, what is a realistic
timeframe for the completion of the
project?
9. What additional information not
specifically addressed elsewhere in this
RFI that would be important for the
government to bear in mind in
developing such a system?
Dated: April 25, 2012.
Ronald O. Valdiserri,
Deputy Assistant Secretary for Health
(Infectious Diseases), Office of HIV/AIDS and
Infectious Disease Policy.
[FR Doc. 2012–10591 Filed 5–1–12; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Prospective Grant of Exclusive
License: P4 Peptide From
Streptococcus Pneumoniae
Technology Transfer Office,
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
This is a notice in accordance
with 35 U.S.C. 209(e) and 37 CFR
404.7(a)(1)(i) that the Centers for Disease
Control and Prevention (CDC),
Technology Transfer Office, Department
of Health and Human Services (DHHS),
is contemplating the grant of a
worldwide, exclusive license (excluding
the nonexclusively licensed field of use
entitled ‘‘Use of P4 as either a carrier
and/or immunoenhancer in a
polysaccharide vaccine conjugate for
prevention of Streptococcus pneumonia
infection in humans’’) to practice the
inventions embodied in the patent
application referred to below to Viper
Therapeutics, having a place of business
in Atlanta, Georgia. The patent rights in
these inventions have been assigned to
the government of the United States of
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 9990
America. The patent(s) to be licensed
are:
‘‘U.S. Patent 7,919,104 entitled
‘‘Functional Epitopes of Streptococcus
Pneumoniae PsaA Antigen and Uses
Thereof,’’ filed 7/18/2008, claiming priority
to U.S. Provisional Patent Application No.
60/682,495, filed 5/19/2005, and all related
continuing and foreign patents/patent
applications for the technology family. CDC
Technology ID No. I–030–04.
Status: Issued.
Priority Date: 5/19/2005.
Issue Date: 4/5/2011.
The prospective exclusive license will
be royalty-bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7.
Technology
This technology consists of a P4
peptide which contains functional
epitopes of the PsaA protein of
Streptococcus pneumoniae. This
technology also includes an antibody
that can bind to the epitopes of the
defined peptides. The technology is a
complete kit that includes two vaccines
comprised of two separate peptides, a
pharmaceutical carrier for each vaccine,
methods of using the peptides and
antibodies, and diagnostic kits
comprising a P4 peptide.
Requests for a copy of this
patent, inquiries, comments, and other
materials relating to the contemplated
license should be directed to Donald
Prather, J.D., Ph.D., Technology
Licensing and Marketing Specialist,
Technology Transfer Office, Centers for
Disease Control and Prevention (CDC),
4770 Buford Highway, Mailstop K–79,
Atlanta, GA 30341, Telephone: (770)
488–8612; Facsimile: (770) 488–8615.
Applications for a license filed in
response to this notice will be treated as
objections to the grant of the
contemplated license. Only written
comments and/or applications for a
license which are received by CDC
within thirty days of this notice will be
considered. Comments and objections
submitted in response to this notice will
not be made available for public
inspection, and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
ADDRESSES:
Dated: April 23, 2012.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2012–10547 Filed 5–1–12; 8:45 am]
BILLING CODE 4163–18–P
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02MYN1
Agencies
[Federal Register Volume 77, Number 85 (Wednesday, May 2, 2012)]
[Notices]
[Pages 26013-26014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10591]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information on Guidance for the Specification of a
Secure, Online Reporting System for Streamlining Programmatic, Fiscal,
and Other Data From DHHS-Funded HIV Prevention, Treatment, and Care
Services Grantees
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (DHHS) is seeking
to identify interest and obtain information relevant to the design,
deployment, operations, maintenance, and future enhancement of a
centralized, secure, flexible data reporting system to streamline the
collection, processing, and sharing of programmatic, funding, and other
data reported to DHHS Operating Divisions (OpDivs) by grantees funded
to provide HIV prevention, treatment, and care services.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. EST on May 17, 2012.
ADDRESSES: Electronic responses are strongly preferred and may be
addressed to [HIVOpenData@hhs.gov]. Written responses should be
addressed to: U.S. Department of Health and Human Services, Room 443-H,
200 Independence Ave. SW., Washington, DC 20201. Attention: HIV Open
Data Project.
FOR FURTHER INFORMATION CONTACT: Andrew D. Forsyth Ph.D. or Vera
Yakovchenko, MPH, Office of HIV/AIDS and Infectious Disease Policy
(OHAIDP), (202) 205-6606.
SUPPLEMENTARY INFORMATION:
In July 2010, the White House released the National HIV/AIDS
Strategy (NHAS) for the United States that outlined four key goals: (1)
Reduce the number of people who become infected with HIV; (2) increase
access to care and optimize health outcomes for people living with HIV;
(3) reduce HIV-related health disparities; and (4) achieve a more
coordinated national response to the HIV epidemic in the United
States.\1\ Central to the latter goal were two related directives. The
first was to develop improved mechanisms to monitor, evaluate, and
report on progress toward achieving national goals. And the second was
to simplify grant administration activities by standardizing data
collection and reducing undue grantee reporting requirements for
federal HIV programs.
---------------------------------------------------------------------------
\1\ https://www.whitehouse.gov/administration/eop/onap/nhas.
---------------------------------------------------------------------------
In December 2009, the White House also released its Open Government
Directive,\2\ which seeks to improve access to government data in a
manner that enhances transparency, fosters participation through the
public's contribution of ideas and expertise to decision-making, and
enhances collaboration through new partnerships within the federal
government and between public and private institutions. Notwithstanding
existing clearance requirements or legitimate reasons to protect
information, the Directive highlighted the need for the following: (1)
Timely and accessible online publication of government information; (2)
improved quality of government information; (3) creation of a culture
of open government; and (4) establishment of a policy framework for
Open Government. The release of the Directive was followed shortly
thereafter by the DHHS Open Government Plan,\3\ which seeks to build
upon the White House's emphasis on transparency, collaboration, and
collaboration to ensure that the government works better for all
Americans.
---------------------------------------------------------------------------
\2\ https://www.whitehouse.gov/open/documents/open-government-directive.
\3\ https://www.hhs.gov/open/plan/opengovernmentplan/transparency/dashboard.html.
---------------------------------------------------------------------------
An important contribution of the DHHS Open Government Plan is its
reference to new technological developments that make it possible to
streamline the collection, sharing, and processing of programmatic and
fiscal data in a manner that facilitates greater transparency,
participation, and collaboration, even in such critical and sensitive
areas as the DHHS investment in HIV prevention, treatment, and care
services. At present, DHHS OpDivs that fund these services use a
mixture of non-interoperable information processing systems to collect
programmatic, fiscal, and other data from grantees. Moreover, these
systems often utilize different indicators to monitor the progress of
HIV/AIDS programs that vary in their specifications (e.g., numerators,
denominators, time frames) and other key parameters. As a result, many
required HIV/AIDS data elements are inconsistent, impede evaluation and
monitoring of all relevant DHHS-funded services, and add undue burden
to HIV services grantees charged with reporting obligations often from
multiple DHHS OpDivs.
Under consideration at DHHS is the design, deployment, operations,
maintenance, and future enhancement of a centralized, secure, flexible
data reporting information system to compile programmatic, funding, and
other data reported to DHHS OpDivs by grantees funded to provide HIV
prevention, treatment, and care services. In effect, DHHS is exploring
the possibility of establishing a single data reporting tool for
funders, grantees, and sub-grantees that builds upon or shares many of
the features of the Health Resources and Services Administration's
(HRSA) Ryan White HIV/AIDS Services Report (RSR), which is a secure,
online, data collection system for programmatic and fiscal data.
Similarly, such a system might share features central to the National
Institutes of Health's Electronic Research Administration (ERA), which
offers a one-stop solution ``to manage the receipt, processing, review,
award and monitoring of over $30 billion in research and non-research
grants'' (see https://era.nih.gov). Moreover, such a system would offer
a secure data solution that permits internal and external access to
data, eliminates paper-based reporting, and streamlines the process of
data collection and sharing in a manner that advances the DHHS Open
Government Plan.
The HIV Open Data Project envisioned might offer several benefits,
such as: (1) Improve mechanisms to monitor, evaluate, and report on
progress toward achieving NHAS goals; (2) ensure more coordinated
program administration; (3) utilize a common protocol for establishing
patient identifiers to protect confidentiality and de-identify client
data; (4) reduce
[[Page 26014]]
administrative and infrastructural costs associated with reporting to
or maintaining independent data systems; (5) streamline and standardize
data collection; (6) facilitate data sharing among federal and non-
federal partners; (7) reduce bottlenecks and redundant data entry to
different data systems; (8) integrate with electronic health record
systems; (9) improve accountability and tracking of grantees with
multiple funding streams; (10) facilitate data standardization and
deployment of common core indicators that could form the basis of
performance dashboards; (11) identify services gaps and unmet need; and
(12) enhance transparency, participation, and collaboration around key
public policy decisions relevant to the DHHS investment in HIV
prevention, treatment, and care services.
Accordingly, this request for information seeks public comment on
several key dimensions of such a project, including but not limited to
the following:
1. In evaluating the feasibility of such a centralized data system,
what specific steps would be critical to the design, deployment,
operations, maintenance, and enhancement of such a system, particularly
in light of addressing interoperability issues of existing data systems
operated by DHHS OpDivs that support HIV prevention, treatment, or care
services (e.g., Centers for Medicare and Medicaid Services, HRSA,
Substance Abuse and Mental Health Services Administration, Indian
Health Service, Centers for Disease Control and Prevention)?
2. What existing systems currently in use to monitor health grants
offer the features desired and what are the strengths and challenges of
(a) designing an entirely new online resource or (b) adopting an
existing resource (e.g., HRSA's RSR or others)?
3. What are the greatest challenges encountered in reporting data
(describe your reporting obligations, if applicable) and what specific
solutions have DHHS grantees implemented to streamline divergent, non-
interoperable reporting systems?
4. And what data would prove most useful for different stakeholders
to receive from such a centralized system?
5. What costs, benefits, and risks need to be given careful
consideration in development of such a resource? What are the estimated
costs and return on investment of each component?
6. What technological resources and expertise would be needed to
design, deploy, operate, maintain, and enhance such a system and what
extant models exist for achieving the goal of a secure electronic
resource capable of achieving the benefits noted above?
7. What system architecture do you recommend for the project,
particularly considering the government's desire to keep the project
simple and streamlined (i.e. using as few different software packages
and tools as possible)? What architecture, expertise, and other
components are indispensible to the success of the design, deployment,
operations, maintenance, and enhancement of such a system?
8. What would a phased implementation plan consist of? If a modular
or phased approach is recommended, what is a realistic timeframe for
the completion of the project?
9. What additional information not specifically addressed elsewhere
in this RFI that would be important for the government to bear in mind
in developing such a system?
Dated: April 25, 2012.
Ronald O. Valdiserri,
Deputy Assistant Secretary for Health (Infectious Diseases), Office of
HIV/AIDS and Infectious Disease Policy.
[FR Doc. 2012-10591 Filed 5-1-12; 8:45 am]
BILLING CODE 4150-28-P