Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Countermeasures Injury Compensation Program-OMB No. 0915-0334-Extension, 17860-17861 [2023-06134]
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Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title:
Countermeasures Injury
Compensation Program—OMB No.
0915–0334—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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 April 24, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N39, 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 paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance
Officer, at (301) 594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
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
information collection requirements for
the Countermeasures Injury
Compensation Program (CICP or
Program). The CICP, within the Division
of Injury Compensation Programs,
Health Systems Bureau, HRSA,
administers this compensation program
as specified by the Public Readiness and
Emergency Preparedness Act (PREP
Act). CICP is requesting continued
approval for this information collection
which includes documents specified in
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SUMMARY:
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19:18 Mar 23, 2023
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the CICP’s regulations (42 CFR part
110).
The PREP Act created the CICP and
provides liability immunity to covered
persons for claims of loss caused by,
arising out of, relating to, or resulting
from the administration or use of
covered countermeasures for diseases,
threats, and conditions identified in
PREP Act declarations. The immunity
extended in the PREP Act encourages
the development, manufacture, testing,
distribution, and administration/use of
countermeasures (e.g., vaccine,
medication, device) when a disease,
health condition, or other threat to
health constitutes a public health
emergency, or there is a credible risk
that it may in the future constitute such
an emergency.
A 60-day notice was published in the
Federal Register on January 4, 2023,
vol. 88, No. 2; pp. 358. There were no
public comments.
Need and Proposed Use of the
Information: CICP provides
compensation to eligible individuals
who suffer serious injuries or death
directly caused by a covered
countermeasure administered or used
pursuant to a PREP Act Declaration or
to their estates and/or to certain
survivors. An individual who is an
injured countermeasure recipient, the
individual’s legal representative, or the
estate or survivor(s) of an injured
countermeasure recipient is responsible
for submitting the Request for Benefits
(RFB) package, as well as the injured
countermeasure recipient’s medical
records and supporting documentation.
Individuals are able to apply at any
time, but eligibility for compensation is
subject to meeting applicable filing
deadlines and other requirements.
To determine whether a requester is
eligible for Program benefits
(compensation) for a countermeasure
injury, CICP staff must review the RFB
package which includes the following:
(1) RFB Form and Supporting
Documentation
The RFB Form and supporting
documentation initiate 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 Authorization
Form is completed by the requester and
gives medical providers permission to
disclose the countermeasure recipient’s
health information via medical records
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Sfmt 4703
to CICP for the purpose of determining
eligibility for CICP benefits.
(3) Additional Documentation and
Certification
During the eligibility review, CICP
provides requesters with the
opportunity to supplement their RFB
with additional medical records and
supporting documentation before the
Program makes a final decision. 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 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 CICP sends to requesters
who may be eligible for compensation
includes certification forms and
instructions outlining the supporting
documentation needed to determine the
type and amount of benefits. This
documentation is required under 42
CFR 110.60–110.63 of CICP’s
implementing regulation to enable the
Program to determine the type and
amount of benefits the requester may be
eligible to receive.
Likely Respondents: Countermeasure
claimants are the most likely
respondents to this Federal Register
notice regarding the CICP information
collection request because 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,
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17861
Federal Register / Vol. 88, No. 57 / Friday, March 24, 2023 / Notices
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
respondents
Form name
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
RBF Form and Supporting Documentation .........................
Authorization Form ...............................................................
Additional Documentation and Certification .........................
Benefits Package and Supporting Documentation ..............
100
100
30
30
1
1
1
1
100
100
30
30
11.000
2.000
0.750
0.125
1,100.00
200.00
22.50
3.75
Total ..............................................................................
260
........................
260
........................
1,326.25
HRSA specifically 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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–06134 Filed 3–23–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0937–0198]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 23, 2023.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
SUMMARY:
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Number of
responses per
respondent
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FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0937–0198–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: Public Health
Service Policies on Research
Misconduct (42 CFR part 93).
Type of Collection: Extension.
OMB No: OS–0937–0198.
Abstract: The Office of Research
Integrity is requesting an extension on a
currently approved collection. The
purpose of the Institutional Assurance
and Annual Report on Possible Research
Misconduct form PHS–6349 is to
provide data on the amount of research
misconduct activity occurring in
institutions conducting PHS-supported
research. The purpose of the Assurance
of Compliance by Sub-Award Recipients
forms PHS–6315 is to establish an
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Fmt 4703
Sfmt 4703
assurance of compliance for a subawardee institution. Forms PHS 6349
and PHS–6315 are also used to provide
an annual assurance that the institution
has established and will follow
administrative policies and procedures
for responding to allegations of research
misconduct that comply with the Public
Health Service (PHS) Policies on
Research Misconduct (42 CFR part 93).
Research misconduct is defined as
receipt of an allegation of research
misconduct and/or the conduct of an
inquiry and/or investigation into such
allegations. These data enable the ORI to
monitor institutional compliance with
the PHS regulation.
There were minor revisions made on
forms PHS–6349 and PHS–6315. The
revisions will not alter the data
collection.
Need and Proposed Use: The
information is needed to fulfill section
493 of the Public Health Service Act (42
U.S.C. 289b), which requires assurances
from institutions that apply for financial
assistance under the Public Health
Service Act for any project or program
that involves the conduct of biomedical
or behavioral research. In addition, the
information is also required to fulfill the
assurance and annual reporting
requirements of 42 CFR part 93. ORI
uses the information to monitor
institutional compliance with the
regulation. Lastly, the information may
be used to respond to congressional
requests for information to prevent
misuse of Federal funds and to protect
the public interest.
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]]>Agencies
[Federal Register Volume 88, Number 57 (Friday, March 24, 2023)]
[Notices]
[Pages 17860-17861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06134]
[[Page 17860]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title:
Countermeasures Injury Compensation Program--OMB No. 0915-0334--
Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
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 April 24,
2023.
ADDRESSES: Submit your comments to [email protected] or by mail to the
HRSA Information Collection Clearance Officer, Room 14N39, 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 Samantha Miller,
the HRSA Information Collection Clearance Officer, at (301) 594-4394.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title 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
information collection requirements for the Countermeasures Injury
Compensation Program (CICP or Program). The CICP, within the Division
of Injury Compensation Programs, Health Systems Bureau, HRSA,
administers this compensation program as specified by the Public
Readiness and Emergency Preparedness Act (PREP Act). CICP is requesting
continued approval for this information collection which includes
documents specified in the CICP's regulations (42 CFR part 110).
The PREP Act created the CICP and provides liability immunity to
covered persons for claims of loss caused by, arising out of, relating
to, or resulting from the administration or use of covered
countermeasures for diseases, threats, and conditions identified in
PREP Act declarations. The immunity extended in the PREP Act encourages
the development, manufacture, testing, distribution, and
administration/use of countermeasures (e.g., vaccine, medication,
device) when a disease, health condition, or other threat to health
constitutes a public health emergency, or there is a credible risk that
it may in the future constitute such an emergency.
A 60-day notice was published in the Federal Register on January 4,
2023, vol. 88, No. 2; pp. 358. There were no public comments.
Need and Proposed Use of the Information: CICP provides
compensation to eligible individuals who suffer serious injuries or
death directly caused by a covered countermeasure administered or used
pursuant to a PREP Act Declaration or to their estates and/or to
certain survivors. An individual who is an injured countermeasure
recipient, the individual's legal representative, or the estate or
survivor(s) of an injured countermeasure recipient is responsible for
submitting the Request for Benefits (RFB) package, as well as the
injured countermeasure recipient's medical records and supporting
documentation. Individuals are able to apply at any time, but
eligibility for compensation is subject to meeting applicable filing
deadlines and other requirements.
To determine whether a requester is eligible for Program benefits
(compensation) for a countermeasure injury, CICP staff must review the
RFB package which includes the following:
(1) RFB Form and Supporting Documentation
The RFB Form and supporting documentation initiate 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 Authorization Form is completed by the
requester and gives medical providers permission to disclose the
countermeasure recipient's health information via medical records to
CICP for the purpose of determining eligibility for CICP benefits.
(3) Additional Documentation and Certification
During the eligibility review, CICP provides requesters with the
opportunity to supplement their RFB with additional medical records and
supporting documentation before the Program makes a final decision.
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 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 CICP sends to requesters who may be eligible for
compensation includes certification forms and instructions outlining
the supporting documentation needed to determine the type and amount of
benefits. This documentation is required under 42 CFR 110.60-110.63 of
CICP's implementing regulation to enable the Program to determine the
type and amount of benefits the requester may be eligible to receive.
Likely Respondents: Countermeasure claimants are the most likely
respondents to this Federal Register notice regarding the CICP
information collection request because 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,
[[Page 17861]]
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
RBF Form and Supporting 100 1 100 11.000 1,100.00
Documentation..................
Authorization Form.............. 100 1 100 2.000 200.00
Additional Documentation and 30 1 30 0.750 22.50
Certification..................
Benefits Package and Supporting 30 1 30 0.125 3.75
Documentation..................
-------------------------------------------------------------------------------
Total....................... 260 .............. 260 .............. 1,326.25
----------------------------------------------------------------------------------------------------------------
HRSA specifically 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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-06134 Filed 3-23-23; 8:45 am]
BILLING CODE 4165-15-P
