Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program OMB No. 0915-0334-Extension, 322-323 [2019-28367]
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Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Notices
protocol, product characterization and
relevant manufacturing data.
Description of Respondents: A
sponsor, applicant, or manufacturer of a
drug or biologic product that FDA
regulates under the Federal Food, Drug,
and Cosmetic Act or section 351 of the
Public Health Service Act (42 U.S.C.
262) requesting special protocol
assessment.
Burden Estimate: Table 1 provides an
estimate of the annual reporting burden
for notifications for a carcinogenicity
protocol and requests for a special
protocol assessment.
Notification for a Carcinogenicity
Protocol: Based on the number of
notifications for carcinogenicity
protocols and the number of
carcinogenicity protocols currently
submitted to CDER and CBER, CDER
estimates that it will receive
approximately 188 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 105
sponsors. CBER estimates that it will
receive approximately one notification
of an intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately one
sponsor. The hours per response, which
is the estimated number of hours that a
sponsor would spend preparing the
notification and background
information to be submitted in
accordance with the guidance, is
estimated to be approximately 8 hours.
Requests for Special Protocol
Assessment: Based on the number of
requests for special protocol assessment
currently submitted to CDER and CBER,
CDER estimates that it will receive
approximately 108 requests for special
protocol assessment per year from
approximately 105 sponsors. CBER
estimates that it will receive
approximately eight requests from
approximately eight sponsors. The
hours per response is the estimated
number of hours that a respondent
would spend preparing the information
to be submitted with a request for
special protocol assessment, including
the time it takes to gather and copy
questions to be posed to the Agency
regarding the protocol and data,
assumptions, and information needed to
permit an adequate evaluation of the
protocol. Based on our experience with
these submissions, we estimate
approximately 15 hours on average
would be needed per response.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Total annual
responses
Average
burden per
response
Total hours
Notification for Carcinogenicity Protocols ............................
Requests for Special Protocol Assessment Reports ...........
106
113
1.78
1.66
189
116
8
15
1,510
1,740
Total ..............................................................................
........................
........................
305
........................
3,250
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection reflects an
adjustment in burden by 608 hours. We
attribute this adjustment to an increase
in the number of submissions we
received over the last few years.
Dated: December 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–28408 Filed 1–2–20; 8:45 am]
BILLING CODE 4164–01–P
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 OMB No.
0915–0334—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
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
SUMMARY:
VerDate Sep<11>2014
17:29 Jan 02, 2020
Jkt 250001
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 OIRA_
submission@omb.eop.gov 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
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
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
PO 00000
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Sfmt 4703
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 declaration.
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.
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03JAN1
323
Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Notices
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
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 ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Total burden
hours
Request for Benefits Form and Supporting Documentation
Authorization for Use or Disclosure of Health Information
Form .................................................................................
Additional Documentation and Certification .........................
Benefits Package and Supporting Documentation ..............
100
1
100
11
1,100
100
30
30
1
1
1
100
30
30
2
.75
.125
200
22.5
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]
BILLING CODE 4165–15–P
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Average
burden per
response
(in hours)
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]]>Agencies
[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 322-323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28367]
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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 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.
SUPPLEMENTARY INFORMATION:
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
declaration.
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
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 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
Certification..................
Benefits Package and Supporting 30 1 30 .125 3.75
Documentation..................
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Total....................... 260 .............. 260 .............. 1,326.25
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-28367 Filed 1-2-20; 8:45 am]
BILLING CODE 4165-15-P
