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]

Download as PDF 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. VerDate Mar<15>2010 16:55 May 01, 2012 Jkt 226001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 E:\FR\FM\02MYN1.SGM 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
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