[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60708-60710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21168]


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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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
has submitted an Information Collection Request (ICR) to the Office of 
Management and Budget (OMB) for review and approval. Comments submitted 
during the first public review of this ICR will be provided to OMB. OMB 
will accept further comments from the public during the review and 
approval period.

DATES: Comments on this ICR should be received within 30 days of this 
notice.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at [email protected] or call (301) 443-
1984.

[[Page 60709]]


SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Countermeasures Injury 
Compensation Program OMB No. 0915-0334--Extension.
    Abstract: This is a request for an extension of OMB approval of the 
information collection requirements for the Countermeasures Injury 
Compensation Program (CICP). The CICP, within the Health Resources and 
Services Administration (HRSA), administers the compensation program 
specified by the Public Readiness and Emergency Preparedness Act of 
2005 (PREP Act). 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 (all of these parties may be 
``requesters''). A declaration is issued by the Secretary of the 
Department of Health and Human Services (Secretary). 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. In addition, the Secretary, through a declaration, 
may recommend and encourage the development, manufacturing, 
distribution, dispensing, and administration or use of one or more 
covered countermeasures to treat, prevent, or diagnose the disease, 
condition, or threat specified in the declaration.
    To determine whether a requester is eligible for CICP benefits 
(compensation) for the injury, the CICP must review the Request for 
Benefits Package, which includes the Request for Benefits Form and 
Authorization for Use or Disclosure of Health Information Form(s), as 
well as the injured countermeasure recipient's medical records 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 be eligible to receive medical benefits and/or benefits 
for lost employment income accrued prior to the injured countermeasure 
recipient's death. If death was the result of the administration or use 
of the countermeasure, certain survivor(s) of deceased eligible 
countermeasure recipients may be eligible to receive a death benefit, 
but not unreimbursed medical expenses or lost employment income 
benefits. 42 CFR 110.33. The death benefit is calculated using either 
the ``standard calculation'' or the ``alternative calculation.'' The 
``standard calculation'' is based on the death benefit available under 
the Public Safety Officers' Benefits (PSOB) Program. 42 CFR 110.82(b). 
The ``alternative calculation'' is based on the deceased countermeasure 
recipient's income and is only available to the recipient's 
dependent(s) younger than age 18 at the time of the countermeasure 
recipient's death. 42 CFR 110.82(c).
    Approval is requested for the required continued information 
collection via the Request for Benefits Package and for the continued 
use of CICP's mechanisms for obtaining medical documentation and 
supporting documentation collection. During the eligibility review, the 
CICP provides requesters with the opportunity to supplement their 
Request for Benefits with additional medical records and supporting 
documentation before a final determination is made. 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.
    Approval is requested for the continued use of the benefits 
documentation package that the CICP sends to requesters who may be 
eligible for compensation, which includes certification forms and 
instructions outlining the documentation needed to determine the types 
and amounts of benefits. This documentation is required under 42 CFR 
110.61-110.63 of the CICP's implementing regulation to enable the CICP 
to determine the types and amounts of benefits the requester may be 
eligible to receive.
    Need and Proposed Use of the Information: The information collected 
from requesters provides data and documentation that is needed for the 
CICP to determine: (1) The requester's eligibility to receive benefits; 
and (2) if applicable, the type and amount of benefits that may be 
awarded.
    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
                                                  Number of    responses      Total      burden per     Total
                   Form name                     respondents      per       responses     response      burden
                                                               respondent                (in hours)     hours
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Request for Benefits Form and Supporting                 100            1          100           11         1100
 Documentation.................................
Authorization for Use or Disclosure of Health            100            1          100            2          200
 Information Form..............................
Additional Documentation and Certification.....           30            1           30          .75         22.5
Benefits Package and Supporting Documentation..           30            1           30         .125         3.75
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    Total......................................        * 100  ...........          100  ...........      1326.25
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* The number 100 represents an estimate of individuals applying for Program benefits. The 4 documents are
  required of the same 100 individuals or subset of the 100 individuals.



[[Page 60710]]

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-21168 Filed 9-1-16; 8:45 am]
BILLING CODE 4165-15-P