[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33954-33956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[OMB No. 0915-0334--Extension]


Agency Information Collection Activities: Proposed Collection: 
Comment Request; Information Collection Request Title: Countermeasures 
Injury Compensation Program

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 September 
16, 2019.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 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 Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title, below, 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

[[Page 33955]]

information collection requirements for the Countermeasures Injury 
Compensation Program (CICP or Program). The CICP, within the Division 
of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, 
administers this compensation program as specified by the Public 
Readiness and Emergency Preparedness Act of 2005 (PREP Act).
    The Secretary of the Department of HHS (Secretary) can issue a PREP 
Act declaration. When issued, the purpose of a declaration is to 
identify a disease, health condition, or a threat to health that is 
currently, or may in the future constitute, a public health emergency. 
The Secretary's declaration may recommend and encourage the 
development, manufacturing, distribution, dispensing, and 
administration or use of one or more covered countermeasures (e.g., 
anthrax vaccine) to treat, prevent, or diagnose the disease, condition, 
or threat specified in the declaration.
    Need and Proposed Use of the Information: The CICP provides 
compensation to eligible individuals who suffer serious injuries 
directly caused by a covered countermeasure administered or used 
pursuant to a PREP Act Declaration or to their estates and/or to 
certain survivors.
    To determine whether a requester is eligible for Program benefits 
(compensation) for a countermeasure injury, the CICP staff must review 
the Request for Benefits Package (RFB) that includes the following:
    (1) Request for Benefits Form and Supporting Documentation: The 
Request for Benefits Form and supporting documentation initiates 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 requestor completes the Authorization Form 
and gives medical providers permission to disclose the countermeasure 
recipient's health information via medical records to the CICP for 
determining eligibility for CICP benefits.
    (3) Additional Documentation and Certification: During the 
eligibility review, the CICP provides requesters with the opportunity 
to supplement their RFB with additional medical records and supporting 
documentation before the Program makes a final decision. The 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 the 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 the CICP sends to requesters who may be eligible for 
compensation includes certification forms and instructions outlining 
the supporting documentation needed to determine the types and amounts 
of benefits. This documentation is required under 42 CFR 110.60-110.63 
of the CICP's implementing regulation to enable the Program to 
determine the types and amounts of benefits the requester may be 
eligible to receive.
    Likely Respondents: Countermeasure recipients are the most likely 
respondents to this Federal Register notice regarding the CICP 
information collection request because the 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 Annual 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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Request for Benefits Form and                100               1             100           11.00        1,100.00
 Supporting Documentation.......
Authorization for Use or                     100               1             100            2.00          200.00
 Disclosure of Health
 Information Form...............
Additional Documentation and                  30               1              30             .75           22.50
 Certification..................
Benefits Package and Supporting               30               1              30             .13            3.75
 Documentation..................
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    Total.......................             260  ..............             260  ..............        1,326.25
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[[Page 33956]]

Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-15007 Filed 7-15-19; 8:45 am]
BILLING CODE 4165-15-P