Notice2023-06134
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Countermeasures Injury Compensation Program-OMB No. 0915-0334-Extension
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 24, 2023
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 57 (Friday, March 24, 2023)</title>
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[Federal Register Volume 88, Number 57 (Friday, March 24, 2023)]
[Notices]
[Pages 17860-17861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06134]
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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 April 24,
2023.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#88f8e9f8edfaffe7fae3c8e0fafbe9a6efe7fe"><span class="__cf_email__" data-cfemail="512130213423263e233a11392322307f363e27">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#730312031601041c0118331b0100125d141c05"><span class="__cf_email__" data-cfemail="1c6c7d6c796e6b736e775c746e6f7d327b736a">[email protected]</span></a> or call Samantha Miller,
the HRSA Information Collection Clearance Officer, at (301) 594-4394.
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
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.
A 60-day notice was published in the Federal Register on January 4,
2023, vol. 88, No. 2; pp. 358. 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 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
(Authorization 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,
[[Page 17861]]
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 burden
Form name respondents responses per responses response (in hours
respondent hours)
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RBF Form and Supporting 100 1 100 11.000 1,100.00
Documentation..................
Authorization Form.............. 100 1 100 2.000 200.00
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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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. 2023-06134 Filed 3-23-23; 8:45 am]
BILLING CODE 4165-15-P
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