[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43215-43216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. 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 the HRSA Information Collection Clearance Officer at (301) 443-
1984.

DATES: Comments on this ICR should be received no later than August 30, 
2016.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Reports Clearance Officer, 14N39, 5600 Fishers Lane, Rockville, MD 
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 the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Countermeasures Injury 
Compensation Program.
    OMB No. 0915-0334--Extension.
    Abstract: This is an extension request for OMB approval of the 
information collection requirements for the Countermeasures Injury 
Compensation Program (CICP or Program). CICP, within the Division of 
Injury Compensation Programs (DICP), Healthcare Systems Bureau, HRSA, 
administers the compensation program specified by the Public Readiness 
and Emergency Preparedness Act of 2005 (PREP Act). 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. A declaration is issued by the Secretary of the 
Department of Health and Humans 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 Program benefits 
(compensation) for the injury, CICP must review the Request for 
Benefits Package, which includes the Request for Benefits Form and 
Authorization for

[[Page 43216]]

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 also 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. Continued approval is 
requested for the required information collection via the Request for 
Benefits Package (RFB) and for continued use of CICP's mechanisms of 
medical documentation and supporting documentation collection. During 
the eligibility review, CICP provides requesters with the opportunity 
to supplement their Requests for Benefits with additional medical 
records and supporting documentation before a final Program decision is 
made. 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. In addition, approval is requested 
for the continued use of a benefits documentation package that 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 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: Members of the public who believe they have 
sustained serious physical injuries or deaths as the direct result of 
the administration or use of a covered countermeasure for a disease, 
condition, or threat that the Secretary determines either constitutes a 
current public health emergency, or there is a credible risk that the 
disease, condition, or threat may in the future constitute such an 
emergency. Persons who may be eligible to receive benefits from the 
CICP are:
    (1) Injured countermeasure recipients, as described in Sec.  
110.3(n).
    (2) Survivors, as described in Sec. Sec.  110.3(cc) and 110.11.
    (3) Estates of deceased injured countermeasure recipients, as 
described in Sec.  110.10(a)(3).
    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 Information Collection Request are summarized in the table below.
    The annual estimate of burden is as follows:

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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           1,100
 Supporting Documentation.......
Authorization for Use or                     100               1             100               2             200
 Disclosure of Health
 Information Form...............
Additional Documentation and                  30               1              30             .75            22.5
 Certification..................
Benefits Package and Supporting               30               1              30            .125            3.75
 Documentation..................
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    Total.......................             100  ..............             100  ..............        1,326.25
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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.

    HRSA especially 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.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-15710 Filed 6-30-16; 8:45 am]
 BILLING CODE 4165-15-P