Notice2025-23043
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 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
December 17, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Before submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below or any other aspect of the ICR.
Full Text
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<title>Federal Register, Volume 90 Issue 240 (Wednesday, December 17, 2025)</title>
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[Federal Register Volume 90, Number 240 (Wednesday, December 17, 2025)]
[Notices]
[Pages 58568-58569]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23043]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title:
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 requirement of the Paperwork Reduction
Act of 1995 for opportunity for public comment on proposed data
collection projects, HRSA announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Before submitting the ICR to OMB, HRSA seeks comments
from the public regarding the burden estimate below or any other aspect
of the ICR.
DATES: Comments on this ICR should be received no later than February
17, 2026.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#8afaebfaeff8fde5f8e1cae2f8f9eba4ede5fc"><span class="__cf_email__" data-cfemail="3e4e5f4e5b4c49514c557e564c4d5f10595148">[email protected]</span></a> or mail the HRSA
Information Collection Clearance Officer, Room 13N82, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email <a href="/cdn-cgi/l/email-protection#047465746176736b766f446c7677652a636b72"><span class="__cf_email__" data-cfemail="bacadbcadfc8cdd5c8d1fad2c8c9db94ddd5cc">[email protected]</span></a> or call Samantha Miller,
the HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
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 the 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.
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
this 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.
[[Page 58569]]
(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 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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RFB Form and Supporting Medical Documentation. 360 1 360 11.00 3,960
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. 2025-23043 Filed 12-16-25; 8:45 am]
BILLING CODE 4165-15-P
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