Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule, 62306-62309 [2011-25858]
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62306
Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Rules and Regulations
2. Paperwork Reduction Act
This rule does not impose an
information collection burden under the
Paperwork Reduction Act.
3. Regulatory Flexibility Act
After considering the economic
impacts of this rule on small entities
under the Regulatory Flexibility Act, I
certify that this rule will not have a
significant economic impact on a
substantial number of small entities.
4. Unfunded Mandates Reform Act
Because this rule approves preexisting
requirements under state law and does
not impose any additional enforceable
duty beyond that required by state law,
it does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act.
5. Executive Order 13132: Federalism
Executive Order 13132 does not apply
to this rule because it will not have
federalism implications (i.e., substantial
direct effects on the State, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government) as described in
Executive Order 13132.
6. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Executive Order 13175 does not apply
to this rule because it will not have
tribal implications (i.e., substantial
direct effects on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes). As
stated previously, this action would
have no effect on the Indian country
within the State’s borders and EPA will
continue to implement and administer
the RCRA program in Indian country
within the State.
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7. Executive Order 13045: Protection of
Children From Environmental Health &
Safety Risks
This rule is not subject to Executive
Order 13045 because it is not
economically significant and it is not
based on health or safety risks.
8. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This rule is not subject to Executive
Order 13211 because it is not a
significant regulatory action as defined
in Executive Order 12866.
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9. National Technology Transfer
Advancement Act
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
EPA approves State programs as long
as they meet criteria required by RCRA,
so it would be inconsistent with
applicable law for EPA, in its review of
a State program, to require the use of
any particular voluntary consensus
standard in place of another standard
that meets the requirements of RCRA.
Thus, Section 12(d) of the National
Technology Transfer and Advance Act
does not apply to this rule.
42 CFR Part 110
10. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and Low
Income Populations
Because this rule addresses
authorizing pre-existing State rules and
imposes no additional requirements
beyond those imposed by State law and
there are no anticipated significant
adverse human health or environmental
effects, the rule is not subject to
Executive Order 12898.
11. Executive Order 12988
As required by section 3 of Executive
Order 12988 (61 FR 4729, February 7,
1996), in issuing this rule, EPA has
taken the necessary steps to eliminate
drafting errors and ambiguity, minimize
potential litigation, and provide a clear
legal standard for affected conduct.
12. Executive Order 12630: Evaluation
of Risk and Avoidance of Unanticipated
Takings
EPA has complied with Executive
Order 12630 (53 FR 8859, March 15,
1988) by examining the takings
implications of the rule in accordance
with the Attorney General’s
Supplemental Guidelines for the
Evaluation of Risk and Avoidance of
Unanticipated Takings issued under the
Executive Order.
List of Subjects in 40 CFR Part 271
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous materials transportation,
Hazardous waste, Indian lands,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements.
Authority: This notice is issued under the
authority of Sections 2002(a), 3006 and
7004(b) of the Solid Waste Disposal Act as
amended 42 U.S.C. 6912(a), 6926, 6974(b).
Dated: September 8, 2011.
Jared Blumenfeld,
Regional Administrator, Region 9.
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Countermeasures Injury
Compensation Program (CICP):
Administrative Implementation, Final
Rule
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Final rule; technical
amendments.
AGENCY:
This document adopts the
Countermeasures Injury Compensation
Program Administrative Implementation
Interim Final Rule as the final rule with
technical amendments. The Public
Readiness and Emergency Preparedness
Act (PREP Act) authorizes the Secretary
of Health and Human Services (the
Secretary) to establish the
Countermeasures Injury Compensation
Program (CICP or Program). The
Department of Health and Human
Services (HHS) is issuing this final rule
to adopt the administrative policies,
procedures, and requirements for the
CICP set out in the interim final rule,
which was published and effective on
October 15, 2010. This Program is
designed to provide benefits to certain
persons who sustain serious physical
injuries or death as a direct result of
administration or use of covered
countermeasures identified by the
Secretary in declarations issued under
the PREP Act. In addition, the Secretary
may provide death benefits to certain
survivors of individuals who died as the
direct result of such covered injuries or
their health complications. The
Secretary makes only minor technical
amendments to the interim final rule,
described below, and otherwise adopts
the regulation as published on October
15, 2010.
DATES: This rule is effective October 7,
2011.
FOR FURTHER INFORMATION CONTACT: Dr.
Vito Caserta, Director, Countermeasures
Injury Compensation Program,
Healthcare Systems Bureau, Health
Resources and Services Administration,
Parklawn Building, Room 11C–06, 5600
Fishers Lane, Rockville, MD 20857.
Phone calls can be directed to (855)
266–CICP (2427). This is a toll-free
number.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Background
[FR Doc. 2011–25899 Filed 10–6–11; 8:45 am]
BILLING CODE 6560–50–P
RIN 0906–AA83
This regulation adopts the interim
final rule that administratively
established the compensation program
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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Rules and Regulations
authorized by the Public Readiness and
Emergency Preparedness Act (the PREP
Act), which added new authorities
under sections 319F–3 and 319F–4 of
the Public Health Service Act, as
amended (PHS Act) (42 U.S.C. 247d–6d,
247d–6e). The PREP Act, which was
enacted as part of the Department of
Defense, Emergency Supplemental
Appropriations to Address Hurricanes
in the Gulf of Mexico, and Pandemic
Influenza Act of 2006 (Pub. L. 109–148)
on December 30, 2005, confers broad
liability protections to covered persons
and authorizes compensation to eligible
individuals who sustain serious
physical injuries or death as the direct
result of the administration or use of a
covered countermeasure for a disease,
condition, or threat that the Secretary of
Health and Human Services (the
Secretary) determines either constitutes
a current public health emergency or
may in the future constitute such an
emergency. This determination is
identified in a declaration issued by the
Secretary under the PREP Act.
Both the liability protections and the
compensation authorized under the
PREP Act are invoked by declarations
issued by the Secretary (hereinafter
PREP Act declarations or declarations)
(section 319F–3(b) of the PHS Act (42
U.S.C. 247d–6d(b)). Through the
issuance of such PREP Act declarations,
the Secretary makes a determination
that a disease, condition, or other threat
to health constitutes a public health
emergency, or that there is a credible
risk that the disease, condition, or threat
may in the future constitute such an
emergency.
The Secretary publishes all PREP Act
declarations, and amendments to such
declarations, in the Federal Register. In
addition, they are posted on the
Department’s Web site at https://
www.phe.gov/Preparedness/legal/
prepact/Pages/default.aspx and on the
Countermeasures Injury Compensation
Program’s (hereinafter ‘‘CICP’’ or
‘‘Program’’) Web site at https://
www.hrsa.gov/countermeasurescomp/.
As of September 2011, the Secretary had
published declarations with respect to
the following countermeasures: (1)
Pandemic influenza vaccines
(including, but not limited to the
influenza A H1N1 2009 monovalent
vaccine which will be referred to
hereafter as the 2009 H1N1 vaccine); (2)
anthrax countermeasures; (3) botulism
countermeasures; (4) the influenza
antiviral drugs Tamiflu® and Relenza®
when used for pandemic purposes; (5)
smallpox countermeasures; (6) acute
radiation syndrome countermeasures;
(7) pandemic influenza diagnostics,
personal respiratory devices, and
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respiratory support devices; and (8) the
influenza antiviral drug peramivir when
used to treat pandemic H1N1 2009
influenza (which will be referred to
hereafter as 2009 H1N1). Several of
these declarations have been amended,
some on multiple occasions.
In addition to establishing the PREP
Act’s liability protections for covered
persons, the PREP Act authorized the
Secretary to establish a program to
provide compensation to eligible
individuals for certain covered injuries
sustained as the direct result of the
administration or use of a covered
countermeasure identified in a PREP
Act declaration. The Secretary delegated
the authority to operate the
compensation program described in
section 319F–4 of the PHS Act (42
U.S.C. 247d–6e) to the Administrator of
the Health Resources and Services
Administration (HRSA) on November 8,
2006. Pursuant to this delegation of
authority, HRSA established and
administers the CICP.
Under the CICP, certain persons may
be eligible for benefits for covered
injuries sustained as a direct result of
the administration or use of covered
countermeasures. The PREP Act
stipulates that the CICP must follow,
with very limited exceptions, the
Smallpox Vaccine Injury Compensation
Program (SVICP) for eligibility and
compensation determinations (section
319F–4(b)(4) of the PHS Act (42 U.S.C.
247d–6e(b)(4)). In addition, the
elements of compensation are almost
identical to those available under the
SVICP (section 319F–4(b)(2) of the PHS
Act (42 U.S.C. 247d–6e(b)(2)). The
SVICP was established under the
Smallpox Emergency Personnel
Protection Act of 2003 (SEPPA) and its
implementing regulations are available
at 42 CFR part 102. Specifically, the
PREP Act provides that (with limited
exceptions) the CICP is to follow the
SEPPA, the SVICP regulations
implementing the SEPPA, and such
additional or alternate regulations as the
Secretary may promulgate for purposes
of this section (section 319F–4(b)(4) of
the PHS Act (42 U.S.C. 247d–6e(b)(4)).
The Secretary is issuing this final rule
under that authority.
On October 15, 2010, the Secretary
published an interim final rule
establishing the procedures and
requirements governing the CICP.
Although the interim final rule was
effective on the date of publication, the
Secretary sought public comments and
indicated that she might amend the
procedures and requirements described
in the interim final rule based on the
comments received. No public
comments were received on the interim
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final rule. On October 21, 2010, the
Secretary published minor corrections
to the interim final rule in the Federal
Register (75 FR 64955).
As authorized under the PREP Act,
the Secretary is herein adopting, as the
final rule, the interim final rule that was
effective on October 15, 2010 with
minor technical amendments.
Specifically, this final rule makes three
amendments to the interim final rule to
correct typographical errors and one
amendment for purposes of
clarification. First, the final rule amends
section 110.3(f)(1) (included in the
definition of a covered countermeasure)
by replacing the reference to
‘‘§ 110.3(aa)’’ with ‘‘§ 110.3(bb).’’ Second,
the final rule amends section 110.3(g)
(which includes the definition of a
covered injury) by replacing the
reference to ‘‘§ 110.20(b)’’ (concerning
covered injuries generally) with
‘‘§ 110.3(z)’’ (the definition of a serious
injury). Both of these amendments are
technical in nature and correct
typographical errors. Third, the final
rule amends section 110.42(f)
(concerning deadlines for filing Request
Forms based on the initial publication
of a Table of Injuries or on
modifications to an existing Table) by
moving ‘‘within one year after the
effective date of the establishment of, or
amendment to, the Table’’ from the end
of the sentence and inserting it at the
beginning of the sentence, immediately
following ‘‘In such circumstances,.’’ This
amendment also is technical in nature,
and clarifies that, within one year of the
effective date of the publication of a
new Table or of an amendment to an
existing Table, requesters who were
previously denied eligibility for benefits
must file a new Request Form, and
requesters who did not previously file a
Request Form must do so.
The Secretary is aware that the
preamble to the interim final rule
contained several errors in the crossreferences to certain paragraphs and
subparagraphs, similar to the first two
amendments to the regulatory text
described above. However, these errors
were entirely typographical in nature
and had no substantive implications, so
they are not addressed here.
Additionally, the Secretary notes that,
as permitted by the Privacy Act, the
individuals administering the National
Vaccine Injury Compensation Program
(VICP) and the CICP for the Department
may share records that are filed with
either of the programs. For instance, the
VICP and CICP may want to share
medical records of an individual who
applied to both programs.
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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Rules and Regulations
Justification for Waiver of Delayed
Effective Date
The Secretary has found that a delay
in the effective date of this final rule is
unnecessary because the amendments
made to the previous interim final rule
are merely corrections of typographical
errors and one clarification. Through the
enactment of the PREP Act, the
Secretary was authorized to establish
and administer the Program. Congress
authorized the Secretary to issue
regulations implementing the PREP Act
as the Secretary deems reasonable and
necessary. In accordance with that
statutory authority, the Secretary
established the procedures and
requirements to govern the Program,
and published them as an interim final
rule with a 60-day comment period. The
Department received no public
comments in response to the
publication of the interim final rule on
October 15, 2010 and with three minor
exceptions, the text of the interim final
rule is being adopted without change in
this final rule. A delay in the effective
date of this final rule, which adopts the
interim final rule with only minor
technical changes is unnecessary and
contrary to the public interest. It is
important for individuals requesting
Program benefits to know that the
procedures and requirements set out in
the interim final rule remain
unchanged.
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Economic and Regulatory Impact
Executive Order 12866 requires that
all regulations reflect consideration of
alternatives, of costs, of benefits, of
incentives, of equity and of available
information. Regulations must meet
certain standards, such as avoiding an
unnecessary burden. Regulations that
are ‘‘significant’’ because of cost, adverse
effects on the economy, inconsistency
with other agency actions, effects on the
budget, or novel legal or policy issues,
require special analysis.
In 2011, the President issued
Executive Order 13563, which
supplements and reaffirms Executive
Order 12866. Executive Order 13563
provides that, to the extent feasible and
permitted by law, the public shall be
provided with a meaningful opportunity
to comment through the Internet on any
proposed regulations, with at least a 60day comment period. In addition, to the
extent feasible and permitted by law,
agencies must provide timely on-line
access to both proposed and final rules
of the rulemaking docket on
regulations.gov, including relevant
scientific and technical findings, in an
open format that can be searched and
downloaded. Federal agencies must
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consider approaches to maintain the
freedom of choice and flexibility,
including disclosure of relevant
information to the public. Regulations
must be guided by objective scientific
evidence, easy to understand,
consistent, and written in plain
language. Furthermore, Federal agencies
must attempt to coordinate, simplify,
and harmonize regulations to reduce
costs and promote certainty for the
public. The interim final rule published
on October 15, 2010 satisfied these
requirements.
The Secretary has determined that
minimal resources are required to
implement the provisions included in
this regulation. Therefore, in accordance
with the Regulatory Flexibility Act
(RFA) of 1980, and the Small Business
Regulatory Enforcement Fairness Act of
1996, which amended the RFA, the
Secretary certifies that this final rule
will not have a significant impact on a
substantial number of small entities.
The Secretary has also determined
that this final rule does not meet the
criteria for a major rule as defined by
Executive Order 12866 and would have
no major effect on the economy or
Federal expenditures. The Secretary has
determined that this final rule is not a
‘‘major rule’’ within the meaning of the
statute providing for Congressional
Review of Agency Rulemaking, 5 U.S.C.
801, and that this final rule also
comports with the 2011 supplemental
requirements of Executive Order 13563.
Unfunded Mandates Reform Act of
1995: The Secretary has determined that
this final rule will not have effects on
State, local, and tribal governments and
on the private sector such as to require
consultation under the Unfunded
Mandates Reform Act of 1995.
Federalism Impact Statement: The
Secretary has also reviewed this rule in
accordance with Executive Order 13132
regarding federalism, and has
determined that it does not have
‘‘federalism implications.’’ The rule does
not ‘‘have substantial direct effects on
the states, or on the relationship
between the national government and
the states, or on the distribution of
power and responsibilities among the
various levels of government.’’
Impact on Family Well-Being: This
final rule will not adversely affect the
following elements of family well-being.
Family safety, family stability, marital
commitment; parental rights in the
education, nurture and supervision of
their children; family functioning,
disposable income or poverty; or the
behavior and personal responsibility of
youth, as determined under section
654(c) of the Treasury and General
Government Appropriations Act of
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1999. In fact, this final rule may have a
positive impact on the disposable
income and poverty elements of family
well-being to the extent that injured
persons, their families or survivors
receive, or are helped by, medical, lost
employment income, and/or death
benefits paid under this part without
imposing a corresponding burden on
them.
Impact of the New Rule: In this final
rule, the Secretary adopts the
administrative procedures and
requirements applicable to requesters
filing for benefits under the Program, as
established in the interim final rule.
This final rule will have the effect of
enabling certain eligible individuals
who sustained covered injuries as the
direct result of receiving a covered
countermeasure under the Secretary’s
declaration, to receive benefits under
the Program. In the event that an
otherwise eligible injured
countermeasure recipient has died, his
or her estate and/or survivors may be
entitled to certain benefits.
Paperwork Reduction Act of 1995:
The information collection requirements
remain unchanged.
List of Subjects in 42 CFR Part 110
Benefits, Biologics, Compensation,
Immunization, Public health, Pandemic,
Countermeasures, Pandemic influenza,
2009 H1N1 vaccine, Influenza
antivirals, Tamiflu®, Relenza®,
Peramivir, Pandemic influenza
diagnostics, Personal respiratory
devices, N–95 filtering facepiece
respirators, Respiratory support devices,
Ventilators, Anthrax, Smallpox,
Botulism, Acute radiation syndrome.
Dated: September 27, 2011.
Mary Wakefield,
Administrator, Health Resources and Services
Administration.
Approved: September 27, 2011.
Kathleen Sebelius,
Secretary.
For the reasons stated in the
preamble, the Secretary adopts the
interim final rule adding 42 CFR part
110, published at 75 FR 63656 on
Friday, October 15, 2010, as a final rule
with the following amendments:
PART 110—COUNTERMEASURES
INJURY COMPENSATION PROGRAM
1. The authority section for part 110
continues to read as follows:
■
Authority: 42 U.S.C. 247d–6e.
2. Amend § 110.3 by revising
paragraphs (f) introductory text, (f)(1)
and (g) introductory text to read as
follows:
■
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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Rules and Regulations
§ 110.3
Definitions.
ACTION:
*
*
*
*
(f) Covered Countermeasure means
the term that is defined in section 319F–
3(i)(1) of the PHS Act and described in
a declaration issued under section
319F–3(b) of the PHS Act (42 U.S.C.
247d–6d(i)(I), (b)). To be a covered
countermeasure for purposes of this
part, the countermeasure must have
been administered or used pursuant to
the terms of a declaration, or in a good
faith belief of such; and
(1) Administered or used within a
State (as defined in § 110.3(bb)), or
otherwise in the territory of the United
States; or
*
*
*
*
*
(g) Covered Injury means death, or a
serious injury as described in § 110.3(z),
and determined by the Secretary in
accordance with § 110.20 of this part to
be:
*
*
*
*
*
■ 3. Amend § 110.42 by revising
paragraph (f) to read as follows:
Regulatory Flexibility Act
Final rule.
*
§ 110.42
Forms.
Deadlines for filing Request
*
*
*
*
*
(f) Request Forms (or amendments to
Request Forms) based on initial
publication of a Table of Injuries or
modifications to an existing Table. The
Secretary may publish a new Table (or
Tables) by amendment(s) to subpart K of
this part. The effect of such a new Table
or amendment may enable a requester
who previously could not establish a
Table injury to do so. In such
circumstances, within one year after the
effective date of the establishment of, or
amendment to, the Table, the requester
must file a new Request Form if one was
previously submitted and eligibility was
denied or if one was not previously
submitted. If the Secretary has not made
a determination, she will automatically
review any pending Request Forms in
light of the new or amended Table(s).
*
*
*
*
*
[FR Doc. 2011–25858 Filed 10–6–11; 8:45 am]
BILLING CODE 4165–15–P
FEDERAL COMMUNICATIONS
COMMISSION
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47 CFR Chapter I
[PS Docket No. 06–229; WT Docket 06–150;
WP Docket 07–100; FCC 11–113]
Implementing a Nationwide,
Broadband, Interoperable Public
Safety Network in the 700 MHz Band
Federal Communications
Commission.
AGENCY:
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In this document, the
Commission considered a request for
declaratory ruling filed by the City of
Charlotte, North Carolina, seeking
guidance on the scope of permissible
operations under section 337 of the
Communications Act as undertaken by
state, local and other governmental
entities in the public safety broadband
spectrum of the 700 MHz band. The
Commission dismissed the request, but
clarified that a reasonably broad
interpretation of the definition of
‘‘public safety services’’ under section
337 of the Act would allow some of the
uses proposed by Charlotte and other
commenters.
SUMMARY:
DATES:
62309
Effective October 7, 2011.
FOR FURTHER INFORMATION CONTACT:
Jennifer Manner, Federal
Communications Commission, Public
Safety and Homeland Security Bureau,
445 12th Street, SW., Room 7–C761,
Washington, DC 20554. Telephone:
(202)–418–3619, e-mail:
jennifer.manner@fcc.gov.
This Fourth Report and Order does
not promulgate any ‘‘rule’’ as that term
is defined in the Regulatory Flexibility
Act, 5 U.S.C. 601(2) et. seq., so the
Commission is not required to prepare
a Final Regulatory Flexibility Analysis
at this stage of this proceeding.
Paperwork Reduction Act Analysis
The Fourth Report and Order contains
no new or modified information
collection requirements subject to the
Paperwork Reduction Act of 1995
(PRA), Public Law 104–13. The
Commission shall send a copy of the
Fourth Report and Order in a report to
be sent to Congress and the Government
Accountability Office pursuant to the
Congressional Review Act, see 5 U.S.C.
801(a)(1)(A).
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 2011–26023 Filed 10–6–11; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF COMMERCE
This is a
summary of the Commission’s Fourth
Report and Order, FCC 11–113, adopted
July 20, 2011, and released July 21,
2011. The Fourth Report and Order is
available at https://transition.fcc.gov/
Daily_Releases/Daily_Business/2011/
db0721/FCC–11–113A1.pdf.
National Oceanic and Atmospheric
Administration
Summary of Fourth Report and Order
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; Coastal
Migratory Pelagic Resources of the
Gulf of Mexico and South Atlantic;
Closure
SUPPLEMENTARY INFORMATION:
The Commission considered a request
for declaratory ruling filed by the City
of Charlotte, North Carolina (Charlotte),
requesting that the Commission clarify
that ‘‘[t]erritories, possessions, states,
counties, towns or similar State or local
governmental entities that qualify as 700
MHz lessees/users have as their sole or
principal purpose the protection of the
safety of life, health and property and
are permitted to use 700 MHz
broadband spectrum for activities
conducted by their personnel including,
but not limited to, activities of police,
fire and medical emergency first
responders.’’ The Commission
determined that the plain language of
section 337 of the Communications Act
does not support this broad
presumption, and it accordingly
dismissed Charlotte’s request. The
Commission clarified, however, that
there is sufficient flexibility within
section 337 to encompass many of the
state and local government uses of the
spectrum contemplated by Charlotte
and by other commenters.
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50 CFR Part 622
[Docket No. 001005281–0369–02]
RIN 0648–XA753
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS closes the northern
Florida west coast subzone to the
commercial harvest of king mackerel in
or from the exclusive economic zone
(EEZ). This closure is necessary to
protect the Gulf king mackerel resource.
DATES: This rule is effective 12:01 a.m.,
local time, October 7, 2011, until 12:01
a.m., local time, July 1, 2012, unless
changed by further notice in the Federal
Register.
FOR FURTHER INFORMATION CONTACT:
Susan Gerhart, telephone: 727–824–
5305, or e-mail:
susan.gerhart@noaa.gov.
SUMMARY:
The
fishery for coastal migratory pelagic fish
SUPPLEMENTARY INFORMATION:
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[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Rules and Regulations]
[Pages 62306-62309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25858]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 110
RIN 0906-AA83
Countermeasures Injury Compensation Program (CICP):
Administrative Implementation, Final Rule
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: This document adopts the Countermeasures Injury Compensation
Program Administrative Implementation Interim Final Rule as the final
rule with technical amendments. The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes the Secretary of Health and
Human Services (the Secretary) to establish the Countermeasures Injury
Compensation Program (CICP or Program). The Department of Health and
Human Services (HHS) is issuing this final rule to adopt the
administrative policies, procedures, and requirements for the CICP set
out in the interim final rule, which was published and effective on
October 15, 2010. This Program is designed to provide benefits to
certain persons who sustain serious physical injuries or death as a
direct result of administration or use of covered countermeasures
identified by the Secretary in declarations issued under the PREP Act.
In addition, the Secretary may provide death benefits to certain
survivors of individuals who died as the direct result of such covered
injuries or their health complications. The Secretary makes only minor
technical amendments to the interim final rule, described below, and
otherwise adopts the regulation as published on October 15, 2010.
DATES: This rule is effective October 7, 2011.
FOR FURTHER INFORMATION CONTACT: Dr. Vito Caserta, Director,
Countermeasures Injury Compensation Program, Healthcare Systems Bureau,
Health Resources and Services Administration, Parklawn Building, Room
11C-06, 5600 Fishers Lane, Rockville, MD 20857. Phone calls can be
directed to (855) 266-CICP (2427). This is a toll-free number.
SUPPLEMENTARY INFORMATION:
Background
This regulation adopts the interim final rule that administratively
established the compensation program
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authorized by the Public Readiness and Emergency Preparedness Act (the
PREP Act), which added new authorities under sections 319F-3 and 319F-4
of the Public Health Service Act, as amended (PHS Act) (42 U.S.C. 247d-
6d, 247d-6e). The PREP Act, which was enacted as part of the Department
of Defense, Emergency Supplemental Appropriations to Address Hurricanes
in the Gulf of Mexico, and Pandemic Influenza Act of 2006 (Pub. L. 109-
148) on December 30, 2005, confers broad liability protections to
covered persons and authorizes compensation to eligible individuals who
sustain serious physical injuries or death as the direct result of the
administration or use of a covered countermeasure for a disease,
condition, or threat that the Secretary of Health and Human Services
(the Secretary) determines either constitutes a current public health
emergency or may in the future constitute such an emergency. This
determination is identified in a declaration issued by the Secretary
under the PREP Act.
Both the liability protections and the compensation authorized
under the PREP Act are invoked by declarations issued by the Secretary
(hereinafter PREP Act declarations or declarations) (section 319F-3(b)
of the PHS Act (42 U.S.C. 247d-6d(b)). Through the issuance of such
PREP Act declarations, the Secretary makes a determination that a
disease, condition, or other threat to health constitutes a public
health emergency, or that there is a credible risk that the disease,
condition, or threat may in the future constitute such an emergency.
The Secretary publishes all PREP Act declarations, and amendments
to such declarations, in the Federal Register. In addition, they are
posted on the Department's Web site at https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx and on the Countermeasures Injury
Compensation Program's (hereinafter ``CICP'' or ``Program'') Web site
at https://www.hrsa.gov/countermeasurescomp/. As of September 2011, the
Secretary had published declarations with respect to the following
countermeasures: (1) Pandemic influenza vaccines (including, but not
limited to the influenza A H1N1 2009 monovalent vaccine which will be
referred to hereafter as the 2009 H1N1 vaccine); (2) anthrax
countermeasures; (3) botulism countermeasures; (4) the influenza
antiviral drugs Tamiflu[supreg] and Relenza[supreg] when used for
pandemic purposes; (5) smallpox countermeasures; (6) acute radiation
syndrome countermeasures; (7) pandemic influenza diagnostics, personal
respiratory devices, and respiratory support devices; and (8) the
influenza antiviral drug peramivir when used to treat pandemic H1N1
2009 influenza (which will be referred to hereafter as 2009 H1N1).
Several of these declarations have been amended, some on multiple
occasions.
In addition to establishing the PREP Act's liability protections
for covered persons, the PREP Act authorized the Secretary to establish
a program to provide compensation to eligible individuals for certain
covered injuries sustained as the direct result of the administration
or use of a covered countermeasure identified in a PREP Act
declaration. The Secretary delegated the authority to operate the
compensation program described in section 319F-4 of the PHS Act (42
U.S.C. 247d-6e) to the Administrator of the Health Resources and
Services Administration (HRSA) on November 8, 2006. Pursuant to this
delegation of authority, HRSA established and administers the CICP.
Under the CICP, certain persons may be eligible for benefits for
covered injuries sustained as a direct result of the administration or
use of covered countermeasures. The PREP Act stipulates that the CICP
must follow, with very limited exceptions, the Smallpox Vaccine Injury
Compensation Program (SVICP) for eligibility and compensation
determinations (section 319F-4(b)(4) of the PHS Act (42 U.S.C. 247d-
6e(b)(4)). In addition, the elements of compensation are almost
identical to those available under the SVICP (section 319F-4(b)(2) of
the PHS Act (42 U.S.C. 247d-6e(b)(2)). The SVICP was established under
the Smallpox Emergency Personnel Protection Act of 2003 (SEPPA) and its
implementing regulations are available at 42 CFR part 102.
Specifically, the PREP Act provides that (with limited exceptions) the
CICP is to follow the SEPPA, the SVICP regulations implementing the
SEPPA, and such additional or alternate regulations as the Secretary
may promulgate for purposes of this section (section 319F-4(b)(4) of
the PHS Act (42 U.S.C. 247d-6e(b)(4)). The Secretary is issuing this
final rule under that authority.
On October 15, 2010, the Secretary published an interim final rule
establishing the procedures and requirements governing the CICP.
Although the interim final rule was effective on the date of
publication, the Secretary sought public comments and indicated that
she might amend the procedures and requirements described in the
interim final rule based on the comments received. No public comments
were received on the interim final rule. On October 21, 2010, the
Secretary published minor corrections to the interim final rule in the
Federal Register (75 FR 64955).
As authorized under the PREP Act, the Secretary is herein adopting,
as the final rule, the interim final rule that was effective on October
15, 2010 with minor technical amendments. Specifically, this final rule
makes three amendments to the interim final rule to correct
typographical errors and one amendment for purposes of clarification.
First, the final rule amends section 110.3(f)(1) (included in the
definition of a covered countermeasure) by replacing the reference to
``Sec. 110.3(aa)'' with ``Sec. 110.3(bb).'' Second, the final rule
amends section 110.3(g) (which includes the definition of a covered
injury) by replacing the reference to ``Sec. 110.20(b)'' (concerning
covered injuries generally) with ``Sec. 110.3(z)'' (the definition of
a serious injury). Both of these amendments are technical in nature and
correct typographical errors. Third, the final rule amends section
110.42(f) (concerning deadlines for filing Request Forms based on the
initial publication of a Table of Injuries or on modifications to an
existing Table) by moving ``within one year after the effective date of
the establishment of, or amendment to, the Table'' from the end of the
sentence and inserting it at the beginning of the sentence, immediately
following ``In such circumstances,.'' This amendment also is technical
in nature, and clarifies that, within one year of the effective date of
the publication of a new Table or of an amendment to an existing Table,
requesters who were previously denied eligibility for benefits must
file a new Request Form, and requesters who did not previously file a
Request Form must do so.
The Secretary is aware that the preamble to the interim final rule
contained several errors in the cross-references to certain paragraphs
and subparagraphs, similar to the first two amendments to the
regulatory text described above. However, these errors were entirely
typographical in nature and had no substantive implications, so they
are not addressed here.
Additionally, the Secretary notes that, as permitted by the Privacy
Act, the individuals administering the National Vaccine Injury
Compensation Program (VICP) and the CICP for the Department may share
records that are filed with either of the programs. For instance, the
VICP and CICP may want to share medical records of an individual who
applied to both programs.
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Justification for Waiver of Delayed Effective Date
The Secretary has found that a delay in the effective date of this
final rule is unnecessary because the amendments made to the previous
interim final rule are merely corrections of typographical errors and
one clarification. Through the enactment of the PREP Act, the Secretary
was authorized to establish and administer the Program. Congress
authorized the Secretary to issue regulations implementing the PREP Act
as the Secretary deems reasonable and necessary. In accordance with
that statutory authority, the Secretary established the procedures and
requirements to govern the Program, and published them as an interim
final rule with a 60-day comment period. The Department received no
public comments in response to the publication of the interim final
rule on October 15, 2010 and with three minor exceptions, the text of
the interim final rule is being adopted without change in this final
rule. A delay in the effective date of this final rule, which adopts
the interim final rule with only minor technical changes is unnecessary
and contrary to the public interest. It is important for individuals
requesting Program benefits to know that the procedures and
requirements set out in the interim final rule remain unchanged.
Economic and Regulatory Impact
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, of costs, of benefits, of incentives, of
equity and of available information. Regulations must meet certain
standards, such as avoiding an unnecessary burden. Regulations that are
``significant'' because of cost, adverse effects on the economy,
inconsistency with other agency actions, effects on the budget, or
novel legal or policy issues, require special analysis.
In 2011, the President issued Executive Order 13563, which
supplements and reaffirms Executive Order 12866. Executive Order 13563
provides that, to the extent feasible and permitted by law, the public
shall be provided with a meaningful opportunity to comment through the
Internet on any proposed regulations, with at least a 60-day comment
period. In addition, to the extent feasible and permitted by law,
agencies must provide timely on-line access to both proposed and final
rules of the rulemaking docket on regulations.gov, including relevant
scientific and technical findings, in an open format that can be
searched and downloaded. Federal agencies must consider approaches to
maintain the freedom of choice and flexibility, including disclosure of
relevant information to the public. Regulations must be guided by
objective scientific evidence, easy to understand, consistent, and
written in plain language. Furthermore, Federal agencies must attempt
to coordinate, simplify, and harmonize regulations to reduce costs and
promote certainty for the public. The interim final rule published on
October 15, 2010 satisfied these requirements.
The Secretary has determined that minimal resources are required to
implement the provisions included in this regulation. Therefore, in
accordance with the Regulatory Flexibility Act (RFA) of 1980, and the
Small Business Regulatory Enforcement Fairness Act of 1996, which
amended the RFA, the Secretary certifies that this final rule will not
have a significant impact on a substantial number of small entities.
The Secretary has also determined that this final rule does not
meet the criteria for a major rule as defined by Executive Order 12866
and would have no major effect on the economy or Federal expenditures.
The Secretary has determined that this final rule is not a ``major
rule'' within the meaning of the statute providing for Congressional
Review of Agency Rulemaking, 5 U.S.C. 801, and that this final rule
also comports with the 2011 supplemental requirements of Executive
Order 13563.
Unfunded Mandates Reform Act of 1995: The Secretary has determined
that this final rule will not have effects on State, local, and tribal
governments and on the private sector such as to require consultation
under the Unfunded Mandates Reform Act of 1995.
Federalism Impact Statement: The Secretary has also reviewed this
rule in accordance with Executive Order 13132 regarding federalism, and
has determined that it does not have ``federalism implications.'' The
rule does not ``have substantial direct effects on the states, or on
the relationship between the national government and the states, or on
the distribution of power and responsibilities among the various levels
of government.''
Impact on Family Well-Being: This final rule will not adversely
affect the following elements of family well-being. Family safety,
family stability, marital commitment; parental rights in the education,
nurture and supervision of their children; family functioning,
disposable income or poverty; or the behavior and personal
responsibility of youth, as determined under section 654(c) of the
Treasury and General Government Appropriations Act of 1999. In fact,
this final rule may have a positive impact on the disposable income and
poverty elements of family well-being to the extent that injured
persons, their families or survivors receive, or are helped by,
medical, lost employment income, and/or death benefits paid under this
part without imposing a corresponding burden on them.
Impact of the New Rule: In this final rule, the Secretary adopts
the administrative procedures and requirements applicable to requesters
filing for benefits under the Program, as established in the interim
final rule. This final rule will have the effect of enabling certain
eligible individuals who sustained covered injuries as the direct
result of receiving a covered countermeasure under the Secretary's
declaration, to receive benefits under the Program. In the event that
an otherwise eligible injured countermeasure recipient has died, his or
her estate and/or survivors may be entitled to certain benefits.
Paperwork Reduction Act of 1995: The information collection
requirements remain unchanged.
List of Subjects in 42 CFR Part 110
Benefits, Biologics, Compensation, Immunization, Public health,
Pandemic, Countermeasures, Pandemic influenza, 2009 H1N1 vaccine,
Influenza antivirals, Tamiflu[reg], Relenza[reg], Peramivir, Pandemic
influenza diagnostics, Personal respiratory devices, N-95 filtering
facepiece respirators, Respiratory support devices, Ventilators,
Anthrax, Smallpox, Botulism, Acute radiation syndrome.
Dated: September 27, 2011.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
Approved: September 27, 2011.
Kathleen Sebelius,
Secretary.
For the reasons stated in the preamble, the Secretary adopts the
interim final rule adding 42 CFR part 110, published at 75 FR 63656 on
Friday, October 15, 2010, as a final rule with the following
amendments:
PART 110--COUNTERMEASURES INJURY COMPENSATION PROGRAM
0
1. The authority section for part 110 continues to read as follows:
Authority: 42 U.S.C. 247d-6e.
0
2. Amend Sec. 110.3 by revising paragraphs (f) introductory text,
(f)(1) and (g) introductory text to read as follows:
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Sec. 110.3 Definitions.
* * * * *
(f) Covered Countermeasure means the term that is defined in
section 319F-3(i)(1) of the PHS Act and described in a declaration
issued under section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d(i)(I),
(b)). To be a covered countermeasure for purposes of this part, the
countermeasure must have been administered or used pursuant to the
terms of a declaration, or in a good faith belief of such; and
(1) Administered or used within a State (as defined in Sec.
110.3(bb)), or otherwise in the territory of the United States; or
* * * * *
(g) Covered Injury means death, or a serious injury as described in
Sec. 110.3(z), and determined by the Secretary in accordance with
Sec. 110.20 of this part to be:
* * * * *
0
3. Amend Sec. 110.42 by revising paragraph (f) to read as follows:
Sec. 110.42 Deadlines for filing Request Forms.
* * * * *
(f) Request Forms (or amendments to Request Forms) based on initial
publication of a Table of Injuries or modifications to an existing
Table. The Secretary may publish a new Table (or Tables) by
amendment(s) to subpart K of this part. The effect of such a new Table
or amendment may enable a requester who previously could not establish
a Table injury to do so. In such circumstances, within one year after
the effective date of the establishment of, or amendment to, the Table,
the requester must file a new Request Form if one was previously
submitted and eligibility was denied or if one was not previously
submitted. If the Secretary has not made a determination, she will
automatically review any pending Request Forms in light of the new or
amended Table(s).
* * * * *
[FR Doc. 2011-25858 Filed 10-6-11; 8:45 am]
BILLING CODE 4165-15-P
