Agency Information Collection Activities: Proposed Collection: Comment Request; Information Collection Request Title: Countermeasures Injury Compensation Program, 33954-33956 [2019-15007]
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33954
Federal Register / Vol. 84, No. 136 / Tuesday, July 16, 2019 / Notices
information to Docket No. FDA–2008–
D–0150. The labeling submission
should reference the submission to the
docket. We estimate that no more than
one submission to the docket will be
made annually from one company, and
that each submission will take
approximately 10 hours to prepare and
submit. Recommendations for the
CLINICAL STUDIES section of the Full
Prescribing Information of the labeling
are covered by FDA regulations at
§§ 201.56 and 201.57 (21 CFR 201.56
and 201.57) and require such labeling.
The information collection associated
with these regulations is approved
under OMB control number 0910–0572.
2. Section VI.B of the guidance
requests that the format of the
cardiovascular outcome claim submitted
to FDA in a prior approval supplement
include the following information:
• A statement that the submission is
a cardiovascular outcome claim
supplement, with reference to the
guidance and related Docket No. FDA–
2008–D–0150
• Applicable FDA forms (e.g., 356h,
3397)
• Detailed table of contents
• Revised labeling to include:
Æ Draft revised labeling conforming to
the requirements in §§ 201.56 and
201.57, and
Æ Marked-up copy of the latest
approved labeling, showing all
additions and deletions, with
annotations of where supporting data (if
applicable) are located in the
submission.
We estimate that on average, 4
cardiovascular outcome claim
supplements will be submitted annually
from 4 different companies, and that
each supplement will take
approximately 20 hours to prepare and
submit. The guidance also recommends
that other labeling changes (e.g., the
addition of adverse event data) should
be minimized and provided in separate
supplements, and that the revision of
labeling to conform to §§ 201.56 and
201.57 may require substantial revision
to the ADVERSE REACTIONS or other
labeling sections.
3. Section VI.C of the guidance states
that applicants are encouraged to
include the following statement in the
drug’s promotional materials:
• ‘‘[DRUGNAME] reduces blood
pressure, which reduces the risk of fatal
and nonfatal cardiovascular events,
primarily strokes and myocardial
infarctions. Controlling high blood
pressure should be part of
comprehensive cardiovascular risk
management, including, as appropriate,
lipid control, diabetes management,
antithrombotic therapy, smoking
cessation, exercise, and limited sodium
intake. Many patients will require more
than one drug to achieve blood pressure
goals.’’
The inclusion of this statement in the
promotional materials for the drug is
exempt from OMB review under 5 CFR
1320.3(c)(2).
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Total hours
Submission to Docket No. FDA–2008–D–0150 ..................
Cardiovascular Outcome Claim Supplement Submission ...
1
4
1
1
1
4
10
20
10
80
Total .....................................................................................
........................
........................
........................
........................
90
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate for the information
collection reflects an overall increase of
burden. This increase corresponds to an
increase in submissions we have
received over the last few years.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[OMB No. 0915–0334—Extension]
[FR Doc. 2019–15101 Filed 7–15–19; 8:45 am]
BILLING CODE 4164–01–P
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request; Information
Collection Request Title:
Countermeasures Injury
Compensation Program
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
SUMMARY:
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Hours per
response
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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
paperwork@hrsa.gov 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 paperwork@hrsa.gov
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
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Federal Register / Vol. 84, No. 136 / Tuesday, July 16, 2019 / Notices
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
Number of
respondents
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Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
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
11.00
1,100.00
100
30
30
1
1
1
100
30
30
2.00
.75
.13
200.00
22.50
3.75
Total ..............................................................................
260
........................
260
........................
1,326.25
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33956
Federal Register / Vol. 84, No. 136 / Tuesday, July 16, 2019 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[OMHA–1902–N]
Medicare Program; Administrative Law
Judge Hearing Program for Medicare
Claim and Entitlement Appeals;
Quarterly Listing of Program
Issuances—April Through June 2019
Office of Medicare Hearings
and Appeals (OMHA), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists the
OMHA Case Processing Manual (OCPM)
instructions that were published from
April through June 2019. This manual
standardizes the day-to-day procedures
for carrying out adjudicative functions,
in accordance with applicable statutes,
regulations, and OMHA directives, and
gives OMHA staff direction for
processing appeals at the OMHA level
of adjudication.
FOR FURTHER INFORMATION CONTACT:
Jason Green, by telephone at (571) 777–
2723, or by email at jason.green@
hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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I. Background
The Office of Medicare Hearings and
Appeals (OMHA), a staff division within
the Office of the Secretary within the
U.S. Department of Health and Human
Services (HHS), administers the
nationwide Administrative Law Judge
hearing program for Medicare claim;
organization, coverage, and at-risk
determination; and entitlement appeals
under sections 1869, 1155,
1876(c)(5)(B), 1852(g)(5), and 1860D–
4(h) of the Social Security Act (the Act).
OMHA ensures that Medicare
beneficiaries and the providers and
suppliers that furnish items or services
to Medicare beneficiaries, as well as
Medicare Advantage organizations
(MAOs), Medicaid State agencies, and
applicable plans, have a fair and
impartial forum to address
disagreements with Medicare coverage
and payment determinations made by
Medicare contractors, MAOs, or Part D
plan sponsors (PDPSs), and
determinations related to Medicare
eligibility and entitlement, Part B late
enrollment penalty, and income-related
monthly adjustment amounts (IRMAA)
made by the Social Security
Administration (SSA).
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The Medicare claim, organization
determination, coverage determination,
and at-risk determination appeals
processes consist of four levels of
administrative review, and a fifth level
of review with the Federal district
courts after administrative remedies
under HHS regulations have been
exhausted. The first two levels of review
are administered by the Centers for
Medicare & Medicaid Services (CMS)
and conducted by Medicare contractors
for claim appeals, by MAOs and an
Independent Review Entity (IRE) for
Part C organization determination
appeals, or by PDPSs and an IRE for Part
D coverage determination and at-risk
determination appeals. The third level
of review is administered by OMHA and
conducted by Administrative Law
Judges and attorney adjudicators. The
fourth level of review is administered by
the HHS Departmental Appeals Board
(DAB) and conducted by the Medicare
Appeals Council (Council). In addition,
OMHA and the DAB administer the
second and third levels of appeal,
respectively, for Medicare eligibility,
entitlement, Part B late enrollment
penalty, and IRMAA reconsiderations
made by SSA; a fourth level of review
with the Federal district courts is
available after administrative remedies
within SSA and HHS have been
exhausted.
Sections 1869, 1155, 1876(c)(5)(B),
1852(g)(5), and 1860D–4(h) of the Act
are implemented through the
regulations at 42 CFR part 405 subparts
I and J; part 417, subpart Q; part 422,
subpart M; part 423, subparts M and U;
and part 478, subpart B. As noted above,
OMHA administers the nationwide
Administrative Law Judge hearing
program in accordance with these
statutes and applicable regulations. To
help ensure nationwide consistency in
that effort, OMHA established a manual,
the OCPM. Through the OCPM, the
OMHA Chief Administrative Law Judge
establishes the day-to-day procedures
for carrying out adjudicative functions,
in accordance with applicable statutes,
regulations, and OMHA directives. The
OCPM provides direction for processing
appeals at the OMHA level of
adjudication for Medicare Part A and B
claims; Part C organization
determinations; Part D coverage
determinations and at-risk
determinations; and SSA eligibility and
entitlement, Part B late enrollment
penalty, and IRMAA determinations.
Section 1871(c) of the Act requires
that the Secretary publish a list of all
Medicare manual instructions,
interpretive rules, statements of policy,
and guidelines of general applicability
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not issued as regulations at least every
three months in the Federal Register.
II. Format for the Quarterly Issuance
Notices
This quarterly notice provides the
specific updates to the OCPM that have
occurred in the three-month period of
April through June 2019. A hyperlink to
the available chapters on the OMHA
website is provided below. The OMHA
website contains the most current, upto-date chapters and revisions to
chapters, and will be available earlier
than we publish our quarterly notice.
We believe the OMHA website provides
more timely access to the current OCPM
chapters for those involved in the
Medicare claim; organization, coverage,
and at-risk determination; and
entitlement appeals processes. We also
believe the website offers the public a
more convenient tool for real time
access to current OCPM provisions. In
addition, OMHA has a listserv to which
the public can subscribe to receive
notification of certain updates to the
OMHA website, including when new or
revised OCPM chapters are posted. If
accessing the OMHA website proves to
be difficult, the contact person listed
above can provide the information.
III. How To Use the Notice
This notice lists the OCPM chapters
and subjects published during the
quarter covered by the notice so the
reader may determine whether any are
of particular interest. The OCPM can be
accessed at https://www.hhs.gov/about/
agencies/omha/the-appeals-process/
case-processing-manual/.
IV. OCPM Releases for April Through
June 2019
The OCPM is used by OMHA
adjudicators and staff to administer the
OMHA program. It offers day-to-day
operating instructions, policies, and
procedures based on statutes and
regulations, and OMHA directives.
The following is a list and description
of OCPM provisions that were issued or
revised in the three-month period of
April through June 2019. This
information is available on our website
at https://www.hhs.gov/about/agencies/
omha/the-appeals-process/caseprocessing-manual/.
OCPM Chapter 11: Procedural Review
and Determinations
This newly issued chapter describes
how to conduct a procedural review of
an appeal, and how to resolve any
identified procedural defects. The
procedural review is required to ensure
that a request for hearing or review of
dismissal meets jurisdictional and filing
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
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..................
-------------------------------------------------------------------------------
Total....................... 260 .............. 260 .............. 1,326.25
----------------------------------------------------------------------------------------------------------------
[[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
