[Federal Register Volume 88, Number 2 (Wednesday, January 4, 2023)]
[Notices]
[Pages 358-360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28573]


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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--
Extension

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 for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Prior to 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 March 6, 
2023.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Information Collection Clearance Officer, Room 14N39, 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 [email protected] or call Samantha Miller, 
the HRSA Information Collection Clearance Officer at (301) 443-1984.

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--Extension
    Abstract: This is a request for continued OMB approval of the 
information collection requirements for the Countermeasures Injury 
Compensation Program (CICP or Program). The CICP, within the Division

[[Page 359]]

of Injury Compensation Programs, Health Systems Bureau, HRSA, 
administers this compensation program as specified by the Public 
Readiness and Emergency Preparedness Act (PREP Act). CICP is requesting 
continued approval for this information collection which includes 
documents specified in the CICP's regulations (42 CFR part 110).
    The PREP Act created 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 their estates and/or to certain 
survivors. An individual who is an injured countermeasure recipient, 
the individual's legal representative, or the estate or survivor(s) of 
an injured countermeasure recipient is responsible for submitting the 
Request for Benefits (RFB) package, as well as the injured 
countermeasure recipient's medical records and supporting 
documentation. Individuals are able to 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 Documentation
    The RFB Form and supporting documentation initiate the CICP claims 
review process. They also serve as the CICP's mechanism for gathering 
required information about the requester, documenting the use or 
administration of a countermeasure, and obtaining medical information 
about the countermeasure recipient.
(2) Authorization for Use or Disclosure of Health Information Form
    The Authorization Form is completed by the requester 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 Documentation and Certification
    During the eligibility review, CICP provides requesters with the 
opportunity to supplement their RFB with additional medical records and 
supporting documentation before the Program makes a final decision. 
CICP asks requesters to complete and sign a form indicating whether 
they intend to submit additional documentation prior to the final 
determination of their case. After CICP makes a final decision on a 
case, there are no other opportunities for a requester to submit 
additional medical records or supporting documents.
(4) Benefits Package and Supporting 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 countermeasure 
recipient may also be eligible to receive payment for unreimbursed 
medical expenses and/or lost employment income accrued prior to the 
injured countermeasure recipient's death. These documents ask the 
requester to submit documentation of the countermeasure recipient's 
unreimbursed medical expenses and lost employment income. If death was 
the result of the administration or use of the countermeasure, certain 
survivor(s) of eligible deceased countermeasure recipients may be 
eligible to receive a death benefit, but not unreimbursed medical 
expenses or lost employment income benefits (42 CFR 110.33). These 
documents request additional information, such as a marriage license, 
from the requester to prove that they are a survivor of the deceased 
countermeasure recipient.
    The RFB that CICP sends to requesters who may be eligible for 
compensation includes certification forms and instructions outlining 
the supporting documentation needed to determine the type and amount of 
benefits. This documentation is required under 42 CFR 110.60-110.63 of 
CICP's implementing regulation to enable the Program to determine the 
type and amount of benefits the requester may be eligible to receive.
    Likely Respondents: Countermeasure claimants 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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                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
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Request for Benefits Form and                100               1             100          11.000        1,100.00
 Supporting Documentation.......
Authorization for Use or                     100               1             100           2.000          200.00
 Disclosure of Health
 Information Form...............
Additional Documentation and                  30               1              30           0.750           22.50
 Certification..................
Benefits Package and Supporting               30               1              30           0.125            3.75
 Documentation..................
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    Total.......................             260  ..............             260  ..............        1,326.25
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[[Page 360]]

    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. 2022-28573 Filed 1-3-23; 8:45 am]
BILLING CODE 4165-15-P