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

• Published date: 16 July 2019
• Citation: 84 FR 33954
• Pages: 33954-33956
• FR Document: 2019-15007
• Section: Notices
• Issuer: Health and Human Services Department,Health Resources and Services Administration,Health And Human Services Department,Health Resources And Services Administration

Federal Register, Volume 84 Issue 136 (Tuesday, July 16, 2019)

[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