[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Rules and Regulations]
[Pages 62306-62309]
From the Federal Register Online via the Government Publishing 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
[[Page 62307]]
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 http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx and on the Countermeasures Injury
Compensation Program's (hereinafter ``CICP'' or ``Program'') Web site
at http://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:
[[Page 62309]]
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]
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