Notice2026-05274
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program-OMB No. 0915-0334-Revision
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 18, 2026
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. No comments were submitted during the first public review of this ICR. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Full Text
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<title>Federal Register, Volume 91 Issue 52 (Wednesday, March 18, 2026)</title>
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[Federal Register Volume 91, Number 52 (Wednesday, March 18, 2026)]
[Notices]
[Pages 13042-13043]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05274]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Countermeasures Injury
Compensation Program--OMB No. 0915-0334--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. No comments were
submitted during the first public review of this ICR. OMB will accept
further comments from the public during the review and approval period.
OMB may act on HRSA's ICR only after the 30-day comment period for this
notice has closed.
DATES: Comments on this ICR should be received no later than April 17,
2026.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the HRSA
Information Collection Clearance Officer, at <a href="/cdn-cgi/l/email-protection#7d0d1c0d180f0a120f163d150f0e1c531a120b"><span class="__cf_email__" data-cfemail="106071607562677f627b50786263713e777f66">[email protected]</span></a> or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Countermeasures Injury
Compensation Program--OMB No. 0915-0334--Revision.
Abstract: This is a request for continued OMB approval of the
information collection requirements for the Countermeasures Injury
Compensation Program (CICP or Program).
This request includes revisions to improve the efficiency of the
information collection process and the quality of the information
collected. The revisions streamline questions on the information
collection documents and update CICP contact information. HRSA
administers CICP in accordance with the Public Readiness and Emergency
Preparedness Act (PREP Act) and CICP regulations at 42 CFR part 110.
CICP is requesting continued approval for this information collection,
which includes documents specified in CICP's regulations (42 CFR part
110).
The PREP Act authorized the establishment of CICP and provides
liability immunity to covered persons for claims of loss caused by,
arising out of, relating to, or resulting from the administration or
use of covered countermeasures for diseases, threats, and conditions
identified in PREP Act declarations. The immunity extended in the PREP
Act encourages the development, manufacture, testing, distribution, and
administration/use of countermeasures (e.g., vaccine, medication,
device) when a disease, health condition, or other threat to health
constitutes a public health emergency, or there is a credible risk that
it may in the future constitute such an emergency. A 60-day notice
published in the Federal Register on December 17, 2025, vol. 90, No.
240; pp. 58568. There were no public comments.
Need and Proposed Use of the Information: CICP provides
compensation to eligible individuals who suffer serious injuries or
death directly caused by a covered countermeasure administered or used
pursuant to a PREP Act Declaration or to their estates and/or to
certain survivors. An individual who is an injured countermeasure
recipient, the estate or survivor(s) of a deceased injured
countermeasure recipient, or their representative is responsible for
submitting the Request for Benefits (RFB) package, as well as the
injured countermeasure recipient's medical records and supporting
documentation. Individuals can apply at any time, but eligibility for
compensation is subject to meeting applicable filing deadlines and
other requirements.
To determine whether a requester is eligible for Program benefits
(compensation) for a countermeasure injury, CICP staff must review the
RFB package, which includes the following:
(1) RFB Form and Supporting Medical Documentation: Submission of
the RFB form and supporting medical documentation initiate the CICP
claims review process. CICP assesses the RFB form and supporting
medical documentation to gather required information about the
requester, document the use or administration of a countermeasure, and
obtain medical information about the countermeasure recipient.
(2) Authorization for Use or Disclosure of Health Information Form
(Authorization Form): The requester or representative, if applicable,
completes the Authorization Form and gives medical providers permission
to disclose the countermeasure recipient's health information via
medical records to CICP for the purpose of determining eligibility for
CICP benefits.
(3) Additional Medical Documentation and Certification: During the
eligibility review, CICP provides requesters with the opportunity to
supplement their RFB package with additional medical records and
supporting documentation before the Program makes a final decision.
CICP may ask requesters and/or representatives to complete and sign a
form indicating whether they intend to submit additional required
documentation before the final determination of their case. After CICP
makes a final decision on a case, there are no other opportunities for
a requester or representative to submit additional medical records or
supporting documents.
(4) Supporting Benefits Documentation: A requester who is an
injured countermeasure recipient may be eligible to receive benefits
for unreimbursed medical expenses and/or lost employment income. The
estate of a deceased injured countermeasure recipient may also be
eligible to receive payment for unreimbursed medical expenses and/or
lost employment income accrued before the injured countermeasure
recipient's death. Requesters seeking such benefits must submit
documentation of the injured countermeasure recipient's unreimbursed
medical expenses and lost employment income. If the administration or
use of a covered countermeasure directly caused an individual's death,
certain of the individual's survivors may be eligible to receive a
death benefit, but not unreimbursed medical expenses or lost
[[Page 13043]]
employment income benefits (42 CFR 110.33). Survivors or their
representatives must submit additional information, such as a marriage
license, to prove that they are a survivor of the deceased
countermeasure recipient.
The RFB package instructions outline the supporting documentation
needed to determine the type and amount of benefits. This documentation
is required under 42 CFR 110.60-110.63 to enable the Program to
determine the type and amount of benefits the requester may be eligible
to receive.
Likely Respondents: Countermeasure recipients, their estates,
survivors, and/or their representatives, are the most likely
respondents to this Federal Register notice regarding the CICP
information collection request because CICP reviews and, if eligible,
compensates countermeasure recipient injury claims.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
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Average
Number of Number of Total burden per Total
Document name respondents responses per responses response burden
respondent (in hours) hours
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Request for Benefits Form and Supporting 360 1 360 11.00 3,960
Medical Documentation........................
Authorization for Use or Disclosure of Health 360 1 360 2.00 720
Information Form (Authorization Form)........
Additional Medical Documentation and 324 1 324 0.75 243
Certification................................
Supporting Benefits Documentation............. 30 1 30 10.00 300
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Total..................................... 1,074 .............. 1,074 ........... 5,223
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HRSA specifically requests comments on: (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2026-05274 Filed 3-17-26; 8:45 am]
BILLING CODE 4165-15-P
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