[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.

[[Page 62308]]

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]
BILLING CODE 4165-15-P