30-day FRN 20260903 HIO OS-0955-0019

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0365 or via email at paige.ezernack@
hhs.gov.
SUPPLEMENTARY INFORMATION:

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I. Background
Under section 564 of the FD&C Act,
HHS has the ability to take certain steps
to help facilitate the availability of
medical countermeasures based on one
of four determinations under section
564(b): (1) A determination by the
Secretary of Homeland Security that
there is a domestic emergency, or a
significant potential for a domestic
emergency, involving a heightened risk
of attack with a, chemical, biological,
radiological, or nuclear (‘‘CBRN’’) agent
or agents; (2) the identification of a
material threat by the Secretary of the
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act 1 sufficient to affect national
security or the health and security of
U.S. citizens living abroad; (3) a
determination by the Secretary of
Defense [War] that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50, of attack
with (i) a CBRN agent or agents; or (ii)
an agent or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces; or (4) a
determination by the Secretary [of HHS]
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves a CBRN agent or agents, or a
disease or condition that may be
attributable to such agent or agents.
Based on any of these four
determinations, the Secretary of HHS
may declare that circumstances exist
that justify the issuance of emergency
use authorizations (EUAs), at which
point the Commissioner of the U.S.
Food and Drug Administration (FDA),
acting under delegated authority from
the Secretary of HHS, may issue an EUA
or EUAs authorizing the emergency use
of an unapproved medical product or an
unapproved use of an approved medical
product in certain emergency
circumstances, if the criteria for
1 42 U.S.C. 247d–6b, which states: ‘‘[t]he
Homeland Security Secretary, in consultation with
the Secretary and the heads of other agencies as
appropriate, shall on an ongoing basis—(i) assess
current and emerging threats of chemical,
biological, radiological, and nuclear agents; and (ii)
determine which of such agents present a material
threat against the United States population
sufficient to affect national security.’’

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issuance of an authorization under
section 564 of the FD&C Act are met.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

II. Determination by the Secretary of
War

[Document Identifier: OS–0955–0019]

On July 15, 2026 the Secretary of War
determined, pursuant to sec.
564(b)(1)(B) of the FD&C Act, that there
is a military emergency, or a significant
potential for a military emergency,
involving a heightened risk to U.S.
military forces of an attack with a
chemical, biological, radiological, or
nuclear agent or agents; or an attack by
an agent or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces (including
agents of military combat such as
firearms, projectiles, and explosive
devices). Injuries arising from these
attacks may cause U.S. military forces to
experience moderate to severe acute
pain and place them at risk of
developing life-threatening
hemodynamic instability, including
shock or respiratory distress.
III. Declaration of the Secretary of HHS
On August 31, 2026, on the basis of
the Secretary of War’s determination
that there is a military emergency or
significant potential for a military
emergency involving a heightened risk
to U.S. military forces of an attack with
an agent or agents that may cause, or are
otherwise associated with an
imminently life-threatening and specific
risk to those forces, I declared that
circumstances exist justifying the
authorization of emergency use of drugs
identified and supported by the DOW as
addressing an unmet military
operations-related medical need for use
to manage moderate to severe acute pain
in casualties caused by, or associated
with, an emergency involving
biological, chemical, radiological, or
nuclear agent or agents, or agents of
military combat, including firearms,
projectiles, and explosive devices, that
may cause, or may otherwise be
associated with, an imminently lifethreatening and specific risk to U.S.
military forces, subject to the terms of
any authorization issued under that
section.
Notice of any EUAs issued by the
FDA Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
Register as required under section 564
of the FD&C Act.
Robert F. Kennedy, Jr.,
Secretary, Health and Human Services.
[FR Doc. 2026–18008 Filed 9–2–26; 8:45 am]
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Agency Information Collection
Request. 30-Day Public Comment
Request
AGENCY: Office of the National

Coordinator for Health IT, Office of the
Secretary, HHS.
ACTION: Notice.
SUMMARY: In compliance with the

requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before October 5, 2026.
ADDRESSES: When commenting, please
reference the document identifier/OMB
control number OS–0955–0019 and title
of collection, ‘‘National Survey of
Health Information Exchange
Organizations (HIO)’’. You may send
your comments electronically to Wesley
Barker, [email protected].
FOR FURTHER INFORMATION CONTACT: To
obtain copies of supporting material for
the proposed collection(s) summarized
in this notice, please include the
document identifier OS–0955–0019 and
title of collection ‘‘National Survey of
Health Information Exchange
Organizations (HIO)’’ for reference, and
address inquiries to Wesley Barker,
[email protected].
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: National
Survey of Health Information Exchange
Organizations (HIO).
Type of Collection: Revision of a
previously approved collection.
OMB No. 0955–0019
Abstract: Electronic health
information exchange (HIE) was one of
three goals specified by Congress in the
2009 Health Information Technology for
Economic and Clinical Health (HITECH)
Act to ensure that the $30 billion federal

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Federal Register / Vol. 91, No. 170 / Thursday, September 3, 2026 / Notices
investment in certified electronic health
records (EHRs) resulted in higherquality, lower-cost care. Subsequent
legislation and regulations have
continued to prioritize the sharing of
data electronically across EHRs and
other health information systems.
Within the Department of Health and
Human Services, the Office of the
National Coordinator for Health IT
(hereafter ONC) is responsible for
coordinating across the federal
government, industry, and the health
care community to achieve nationwide
interoperability of electronic health
information exchange. Health
information exchange organizations
(HIOs) play a pivotal role facilitating
health information exchange across
disparate providers, labs, pharmacies,
public health departments, and others.
This information collection request will
gather data from HIOs across the nation
through the administration of a survey
of HIOs to generate the most current
national statistics and associated
actionable insights to inform policy
efforts. The timely collection of national
data from our survey will assess current
capabilities of HIOs to support effective
electronic information sharing within
the U.S. health care system and further
aims to achieve nationwide
interoperability.

Since prior to HITECH there has been
ongoing assessment of trends in the
capabilities of HIOs to support clinical
exchange through nationwide surveys of
HIOs. These prior surveys and studies
have collected data on organizational
structure, financial viability, geographic
coverage, scope of services,
implementation and use of standards,
perceptions of information blocking,
support for public health exchange, and
participation in networks and the
Technical Exchange Framework and
Common Agreement (TEFCA).
Continuing the ongoing data collection
will be critical to construct a current
and comprehensive picture of HIOs’ role
in facilitating exchange and ensuring
rapid access to important health care
data and information when it matters
most, including vital data to address
public health emergencies.
The survey will collect data on HIO
capabilities to support electronic health
information exchange, their maturity,
and challenges they face. There are five
key areas that require assessment: (1)
adoption of technical standards; (2)
perceptions related to information
blocking; (3) network-to-network
connectivity and TEFCA; (4) public
health data exchange; and (5)
organizational demographics, including
technical capabilities offered by HIOs

and the challenges they face in
supporting electronic health
information exchange.
The survey is being revised
(previously approved in 2022 and 2024;
OMB Control No: 0955–0019) to reflect
progress made and ongoing efforts in
areas including public health, TEFCA,
and information blocking to ensure
alignment with current priorities such
as improving public health
interoperability and Make Health Tech
Great Again. These updates were
developed in consultation with subject
matter experts (SMEs) to improve the
relevance, clarity, and usefulness of the
data collected in all five key areas of the
survey. For example, certain questions
with low response rates and have lower
relevance to current priorities have been
removed or reorganized. Some question
and response wording have also been
updated to ensure consistency with
current policy efforts. For example, in
the TEFCA section, the list of Qualified
Health Information Networks (QHINs)
have been updated to reflect the current
list. These changes are intended to
reduce respondent burden and improve
overall data quality while maintaining
continuity with prior surveys where
appropriate.
This is a 3-year request for OMB
approval.

ANNUALIZED BURDEN HOUR TABLE
Number of
respondents

Number of
responses per
respondent

Average
burden per
response

Total burden
hours

U.S. based public and private HIOs ........................

85

1

1.0

85

..................................................................................

......................

........................

....................

85

Forms
(If necessary)

Respondents
(if necessary)

HIO Survey ......................
Total .........................

Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Christopher Reyes,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2026–18060 Filed 9–2–26; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a

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meeting of the National Advisory
Mental Health Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting
website (https://videocast.nih.gov/).
Registration is not required to access the
videocast.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential

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trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: September 14–15, 2026.
Closed: September 14, 2026, 1:00 p.m. to
4:30 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Address: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rooms 1255/65, Rockville, MD
20852.
Meeting Format: In Person and Virtual
Meeting.
Open: September 15, 2026, 10:00 a.m. to
1:30 p.m.

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