Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Blockchain and its Emerging Role in Health IT and Health-related Research”; Amendment, 45510-45511 [2016-16607]
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Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
FOR FURTHER INFORMATION CONTACT:
Edward Weinstein, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6382,
Silver Spring, MD 20993–0002, 301–
796–1400.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Bacterial Vaginosis: Developing Drugs
for Treatment.’’ The purpose of this
guidance is to assist sponsors in the
development of drugs for the treatment
of BV. This draft guidance helps define
enrollment criteria for BV trials and
recommends that such trials be
superiority trials. The draft guidance
reflects recent developments in
scientific information that pertain to
drugs being developed for the treatment
of BV, including the characterization of
the primary efficacy endpoint.
Issuance of this guidance fulfills a
portion of the requirements of Title VIII,
section 804, of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144), which requires
FDA to review and, as appropriate,
revise not fewer than three guidance
documents per year for the conduct of
clinical trials with respect to
antibacterial and antifungal drugs. In
1998, FDA published a draft guidance
entitled ‘‘Bacterial Vaginosis—
Developing Antimicrobial Drugs for
Treatment’’ (the 1998 draft guidance). In
a Federal Register notice dated August
7, 2013 (78 FR 48175), FDA announced
an initiative in the Center for Drug
Evaluation and Research involving the
review of draft guidance documents
issued before 2010 to determine their
status and to decide whether those
guidances should be withdrawn,
revised, or finalized with only minor
changes. In the August 7, 2013, Federal
Register notice, FDA announced that
the 1998 draft guidance, as well as other
draft guidances, was being withdrawn
(78 FR 48175). FDA is now issuing a
new draft guidance that revises the
recommendations in the 1998 draft
guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
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II. The Paperwork Reduction Act of
1995
This guidance refers to previously
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(44 U.S.C. 3501–3520). The collections
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314 have been approved under OMB
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0001, respectively.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16636 Filed 7–13–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology;
Announcement of Requirements and
Registration for ‘‘Blockchain and its
Emerging Role in Health IT and Healthrelated Research’’; Amendment
Office of the National
Coordinator for Health Information
Technology, HHS. Award Approving
Official: Karen DeSalvo, National
Coordinator for Health Information
Technology.
ACTION: Notice; Amendment.
AGENCY:
This document amends the
notice published in Federal Register,
Friday July 8, 2016, volume 81, pages
44639–44640. This notice updates and
extends the submission period to
August 8, 2016, limits an investigator or
co-investigator to one submission and
adds prize details. The ‘‘Use of
Blockchain in Health IT and Healthrelated Research’’ Ideation Challenge
solicits white papers on the topic of
Blockchain Technology and the
potential use in Health IT to address
privacy, security and scalability
challenges of managing electronic
health record and resources. Up to 15
winners will be awarded a cash prize
and up to 8 winners may be invited to
present their papers at an upcoming
industry-wide workshop co-hosted with
the National Institute of Standards and
Technology (NIST). The statutory
authority for this Challenge is section
105 of the America COMPETES
SUMMARY:
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Reauthorization Act of 2010 (Pub. L.
111–358).
DATES:
• Submission period begins: July 7,
2016.
• Submission period ends: August 8,
2016.
• Evaluation begins: August 9, 2016.
• Evaluation ends: August 19, 2016.
• Winners notified: August 22, 2016.
• Winners Announced: August 29,
2016.
• Winner Presentation: September
26–27, 2016.
FOR FURTHER INFORMATION CONTACT:
Debbie Bucci, debbie.bucci@hhs.gov
(preferred), (202) 690–0213.
SUPPLEMENTARY INFORMATION:
Subject of Challenge
A Blockchain is a data structure that
can be timed-stamped and signed using
a private key to prevent tampering.
There are generally three types of
Blockchain: Public, private and
consortium. Potential uses include:
• Digitally sign information,
• Computable enforcement of policies
and contracts (smart contracts),
• Management of Internet of Things
devices,
• Distributed encrypted storage, and
• Distributed trust.
This Ideation Challenge solicits White
Papers on the topic of Blockchain
Technology and the Potential for Its Use
in Health IT and/or Healthcare Related
Research Data. This nationwide call
may be addressed by an individual
investigator or an investigator team.
Interested parties should submit a White
Paper no longer than 10 pages
describing the proposed subject.
Investigators or co-investigators may
only participate in one submission. Up
to 15 of these submissions will be
selected as winners. The selection of a
White Paper may also result in an
invitation to present at an upcoming
industry-wide workshop on September
26th–27th, 2016, at NIST Headquarters
in Gaithersburg, MD.
Objective
The goal of this Ideation Challenge is
to solicit White Papers that investigate
the relationship between Blockchain
technology and its use in Health IT and/
or Health Related research. The paper
should discuss the cryptography and
underlying fundamentals of Blockchain
technology, examine how the use of
Blockchain can advance industry
interoperability needs expressed in the
ONC’s Shared Nationwide
Interoperability Roadmap, as well as for
Patient Centered Outcomes Research
(PCOR), the Precision Medicine
E:\FR\FM\14JYN1.SGM
14JYN1
Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
Initiative (PMI), delivery system reform,
and other health care delivery needs, as
well as provide recommendations for
Blockchain’s implementation. In
addition to a monetary award, winners
may also have the opportunity to
present their White Papers at an
industry-wide ‘‘Blockchain & Healthcare
Workshop’’ co-hosted by ONC and
NIST.
Submission Requirements
The white paper must:
• Be no longer than ten (10) pages;
• Address whether there is a place in
health IT and/or healthcare related
research for the technology;
• Describe the value of Blockchain to
the health-care system;
• Identify potential gaps in standards
created and/or resolved by the use of
Blockchain;
• Discuss the effectiveness of
Blockchain to function in the ‘‘real
world.’’ This discussion may include
information regarding meeting privacy
and security standards, implementation
and potential performance issues, and
cost implications. Risk analysis and
mitigation would be appropriate to
include here as well; and
• Discuss how Blockchain links to the
stated objectives in the Nationwide
Interoperability Roadmap, PCOR, PMI,
delivery system reform, and other
national health care delivery priorities.
How To Enter
Challenge participants will submit
their submission on the challenge Web
site [https://
www.cccinnovationcenter.com/
challenges/block-chain-challenge].
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Eligibility Rules for Participating in the
Challenge
To be eligible to win a prize under
this Challenge, an individual or entity:
1. Shall have registered to participate
in the Challenge under the rules
promulgated by the Office of the
National Coordinator for Health
Information Technology.
2. Shall have complied with all the
stated requirements of the Blockchain
and Its Emerging Role in Healthcare and
Health-related Research Challenge.
3. In the case of a private entity, shall
be incorporated in and maintain a
primary place of business in the United
States, and in the case of an individual,
whether participating singly or in a
group, shall be a citizen or permanent
resident of the United States.
4. May not be a Federal entity or
Federal employee acting within the
scope of their employment.
5. Shall not be an HHS employee
working on their applications or
VerDate Sep<11>2014
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Jkt 238001
Submissions during assigned duty
hours.
6. Shall not be an employee of the
Office of the National Coordinator for
Health Information Technology.
7. Federal grantees may not use
Federal funds to develop COMPETES
Act challenge applications unless
consistent with the purpose of their
grant award.
8. Federal contractors may not use
Federal funds from a contract to develop
COMPETES Act challenge applications
or to fund efforts in support of a
COMPETES Act challenge Submission.
9. An individual or entity shall not be
deemed ineligible because the
individual or entity used Federal
facilities or consulted with Federal
employees during a Challenge if the
facilities and employees are made
available to all individuals and entities
participating in the Challenge on an
equitable basis.
10. Submissions must not display
HHS’ or ONC’s logos or official seals
and must not claim endorsement.
11. Accuracy—A white paper
submission may be disqualified if it
provides inaccurate or incomplete
information.
Registration Process for Participants
To register for this Challenge,
participants can access https://
www.challenge.gov and search for
‘‘Blockchain and Its Emerging Role in
Healthcare and Health-related
Research.’’
Prize
• 12–15 white papers will be awarded
a cash prize in the range of $ 1,500–
5,000,
• Up to 8 winners may be given the
opportunity to present their paper at a
Blockchain & Healthcare Workshop
Hosted at NIST,
• Inclusion of the white papers in the
Blockchain workshop proceedings.
Payment of the Prize
Prize will be paid by contractor.
Basis Upon Which Winner Will Be
Selected
The judging panel will rate each
submission based upon:
• Potential of the overall concept to
help foster transformative change in the
culture of health IT,
• Viability of the proposed
recommendations,
• Innovativeness of the approach,
• Potential for achieving the
objectives of ONC.
Additional Information
General Conditions: ONC reserves the
right to cancel, suspend, and/or modify
PO 00000
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Sfmt 9990
45511
the Challenge, or any part of it, for any
reason, at ONC’s sole discretion.
Intellectual Property: Each participant
retains title and full ownership in and
to their Submission. Participants
expressly reserve all intellectual
property rights not expressly granted
under the challenge agreement. By
participating in the Challenge, each
entrant hereby irrevocably grants to the
Government a limited, non-exclusive,
royalty-free, perpetual, worldwide
license and right to reproduce,
publically perform, publically display,
and use the Submission to the extent
necessary to administer the challenge,
and to publically perform and
publically display the Submission,
including, without limitation, for
advertising and promotional purposes
relating to the Challenge. This may also
include displaying the results of the
Challenge on a public Web site or
during a public presentation.
Representation, Warranties and
Indemnification
By entering the Challenge, each
applicant represents, warrants and
covenants as follows:
(a) Participant is the sole author,
creator, and owner of the Submission;
(b) The Submission is not the subject
of any actual or threatened litigation or
claim;
(c) The Submission does not and will
not violate or infringe upon the
intellectual property rights, privacy
rights, publicity rights, or other legal
rights of any third party.
Participants must indemnify, defend,
and hold harmless the Federal
Government from and against all third
party claims, actions, or proceedings of
any kind and from any and all damages,
liabilities, costs, and expenses relating
to or arising from participant’s
Submission or any breach or alleged
breach of any of the representations,
warranties, and covenants of participant
hereunder. The Federal sponsors reserve
the right to disqualify any Submission
that, in their discretion, deems to violate
these Official Rules, Terms &
Conditions.
Authority: 15 U.S.C. 3719.
Karen DeSalvo, MD., M.P.H., M.Sc.
National Coordinator for Health Information
Technology.
[FR Doc. 2016–16607 Filed 7–13–16; 8:45 am]
BILLING CODE 4150–45–P
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]]>Agencies
[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45510-45511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16607]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator for Health Information
Technology; Announcement of Requirements and Registration for
``Blockchain and its Emerging Role in Health IT and Health-related
Research''; Amendment
AGENCY: Office of the National Coordinator for Health Information
Technology, HHS. Award Approving Official: Karen DeSalvo, National
Coordinator for Health Information Technology.
ACTION: Notice; Amendment.
-----------------------------------------------------------------------
SUMMARY: This document amends the notice published in Federal Register,
Friday July 8, 2016, volume 81, pages 44639-44640. This notice updates
and extends the submission period to August 8, 2016, limits an
investigator or co-investigator to one submission and adds prize
details. The ``Use of Blockchain in Health IT and Health-related
Research'' Ideation Challenge solicits white papers on the topic of
Blockchain Technology and the potential use in Health IT to address
privacy, security and scalability challenges of managing electronic
health record and resources. Up to 15 winners will be awarded a cash
prize and up to 8 winners may be invited to present their papers at an
upcoming industry-wide workshop co-hosted with the National Institute
of Standards and Technology (NIST). The statutory authority for this
Challenge is section 105 of the America COMPETES Reauthorization Act of
2010 (Pub. L. 111-358).
DATES:
Submission period begins: July 7, 2016.
Submission period ends: August 8, 2016.
Evaluation begins: August 9, 2016.
Evaluation ends: August 19, 2016.
Winners notified: August 22, 2016.
Winners Announced: August 29, 2016.
Winner Presentation: September 26-27, 2016.
FOR FURTHER INFORMATION CONTACT: Debbie Bucci, debbie.bucci@hhs.gov
(preferred), (202) 690-0213.
SUPPLEMENTARY INFORMATION:
Subject of Challenge
A Blockchain is a data structure that can be timed-stamped and
signed using a private key to prevent tampering. There are generally
three types of Blockchain: Public, private and consortium. Potential
uses include:
Digitally sign information,
Computable enforcement of policies and contracts (smart
contracts),
Management of Internet of Things devices,
Distributed encrypted storage, and
Distributed trust.
This Ideation Challenge solicits White Papers on the topic of
Blockchain Technology and the Potential for Its Use in Health IT and/or
Healthcare Related Research Data. This nationwide call may be addressed
by an individual investigator or an investigator team. Interested
parties should submit a White Paper no longer than 10 pages describing
the proposed subject. Investigators or co-investigators may only
participate in one submission. Up to 15 of these submissions will be
selected as winners. The selection of a White Paper may also result in
an invitation to present at an upcoming industry-wide workshop on
September 26th-27th, 2016, at NIST Headquarters in Gaithersburg, MD.
Objective
The goal of this Ideation Challenge is to solicit White Papers that
investigate the relationship between Blockchain technology and its use
in Health IT and/or Health Related research. The paper should discuss
the cryptography and underlying fundamentals of Blockchain technology,
examine how the use of Blockchain can advance industry interoperability
needs expressed in the ONC's Shared Nationwide Interoperability
Roadmap, as well as for Patient Centered Outcomes Research (PCOR), the
Precision Medicine
[[Page 45511]]
Initiative (PMI), delivery system reform, and other health care
delivery needs, as well as provide recommendations for Blockchain's
implementation. In addition to a monetary award, winners may also have
the opportunity to present their White Papers at an industry-wide
``Blockchain & Healthcare Workshop'' co-hosted by ONC and NIST.
Submission Requirements
The white paper must:
Be no longer than ten (10) pages;
Address whether there is a place in health IT and/or
healthcare related research for the technology;
Describe the value of Blockchain to the health-care
system;
Identify potential gaps in standards created and/or
resolved by the use of Blockchain;
Discuss the effectiveness of Blockchain to function in the
``real world.'' This discussion may include information regarding
meeting privacy and security standards, implementation and potential
performance issues, and cost implications. Risk analysis and mitigation
would be appropriate to include here as well; and
Discuss how Blockchain links to the stated objectives in
the Nationwide Interoperability Roadmap, PCOR, PMI, delivery system
reform, and other national health care delivery priorities.
How To Enter
Challenge participants will submit their submission on the
challenge Web site [https://www.cccinnovationcenter.com/challenges/block-chain-challenge].
Eligibility Rules for Participating in the Challenge
To be eligible to win a prize under this Challenge, an individual
or entity:
1. Shall have registered to participate in the Challenge under the
rules promulgated by the Office of the National Coordinator for Health
Information Technology.
2. Shall have complied with all the stated requirements of the
Blockchain and Its Emerging Role in Healthcare and Health-related
Research Challenge.
3. In the case of a private entity, shall be incorporated in and
maintain a primary place of business in the United States, and in the
case of an individual, whether participating singly or in a group,
shall be a citizen or permanent resident of the United States.
4. May not be a Federal entity or Federal employee acting within
the scope of their employment.
5. Shall not be an HHS employee working on their applications or
Submissions during assigned duty hours.
6. Shall not be an employee of the Office of the National
Coordinator for Health Information Technology.
7. Federal grantees may not use Federal funds to develop COMPETES
Act challenge applications unless consistent with the purpose of their
grant award.
8. Federal contractors may not use Federal funds from a contract to
develop COMPETES Act challenge applications or to fund efforts in
support of a COMPETES Act challenge Submission.
9. An individual or entity shall not be deemed ineligible because
the individual or entity used Federal facilities or consulted with
Federal employees during a Challenge if the facilities and employees
are made available to all individuals and entities participating in the
Challenge on an equitable basis.
10. Submissions must not display HHS' or ONC's logos or official
seals and must not claim endorsement.
11. Accuracy--A white paper submission may be disqualified if it
provides inaccurate or incomplete information.
Registration Process for Participants
To register for this Challenge, participants can access https://www.challenge.gov and search for ``Blockchain and Its Emerging Role in
Healthcare and Health-related Research.''
Prize
12-15 white papers will be awarded a cash prize in the
range of $ 1,500-5,000,
Up to 8 winners may be given the opportunity to present
their paper at a Blockchain & Healthcare Workshop Hosted at NIST,
Inclusion of the white papers in the Blockchain workshop
proceedings.
Payment of the Prize
Prize will be paid by contractor.
Basis Upon Which Winner Will Be Selected
The judging panel will rate each submission based upon:
Potential of the overall concept to help foster
transformative change in the culture of health IT,
Viability of the proposed recommendations,
Innovativeness of the approach,
Potential for achieving the objectives of ONC.
Additional Information
General Conditions: ONC reserves the right to cancel, suspend, and/
or modify the Challenge, or any part of it, for any reason, at ONC's
sole discretion.
Intellectual Property: Each participant retains title and full
ownership in and to their Submission. Participants expressly reserve
all intellectual property rights not expressly granted under the
challenge agreement. By participating in the Challenge, each entrant
hereby irrevocably grants to the Government a limited, non-exclusive,
royalty-free, perpetual, worldwide license and right to reproduce,
publically perform, publically display, and use the Submission to the
extent necessary to administer the challenge, and to publically perform
and publically display the Submission, including, without limitation,
for advertising and promotional purposes relating to the Challenge.
This may also include displaying the results of the Challenge on a
public Web site or during a public presentation.
Representation, Warranties and Indemnification
By entering the Challenge, each applicant represents, warrants and
covenants as follows:
(a) Participant is the sole author, creator, and owner of the
Submission;
(b) The Submission is not the subject of any actual or threatened
litigation or claim;
(c) The Submission does not and will not violate or infringe upon
the intellectual property rights, privacy rights, publicity rights, or
other legal rights of any third party.
Participants must indemnify, defend, and hold harmless the Federal
Government from and against all third party claims, actions, or
proceedings of any kind and from any and all damages, liabilities,
costs, and expenses relating to or arising from participant's
Submission or any breach or alleged breach of any of the
representations, warranties, and covenants of participant hereunder.
The Federal sponsors reserve the right to disqualify any Submission
that, in their discretion, deems to violate these Official Rules, Terms
& Conditions.
Authority: 15 U.S.C. 3719.
Karen DeSalvo, MD., M.P.H., M.Sc.
National Coordinator for Health Information Technology.
[FR Doc. 2016-16607 Filed 7-13-16; 8:45 am]
BILLING CODE 4150-45-P
