Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program OMB No. 0915-0334-Extension

Federal Register, Volume 85 Issue 2 (Friday, January 3, 2020)
[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Pages 322-323]
From the Federal Register Online via the Government Publishing Office []
[FR Doc No: 2019-28367]
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Countermeasures Injury
Compensation Program OMB No. 0915-0334--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
SUMMARY: In compliance with of 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. OMB may act on HRSA's ICR only after the 30
day comment period for this Notice has closed.
DATES: Comments on this ICR should be received no later than February
3, 2020.
ADDRESSES: Submit your comments, including the Information Collection
Request 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 Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
    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 (DICP), 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 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
    A 60-day notice was published in the Federal Register on July 16,
2019, vol. 84, No. 136; pp. 33954-55. There were no public comments.
    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.
[[Page 323]]
    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 requester completes the Authorization Form and permits medical
providers to disclose the countermeasure recipient's health information
via medical records to the CICP for determining eligibility for CICP
(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 Annualized Burden--Hours
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
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
Benefits Package and Supporting               30               1              30            .125            3.75
    Total.......................             260  ..............             260  ..............        1,326.25
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-28367 Filed 1-2-20; 8:45 am]