[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72740-72741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-6180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Announcement of Potential Eligibility for Compensation Under 
Public Readiness and Emergency Preparedness Act Declaration and Filing 
Deadlines

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Notice.

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SUMMARY: This Notice provides notification that individuals who have 
been injured by pandemic, epidemic, or security countermeasures 
identified in a declaration issued by the Secretary pursuant to section 
319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d-
6d) have one (1) year from the time they receive the covered 
countermeasure to file requests for compensation for injuries directly 
resulting from administration or use of covered countermeasures under 
the Public Readiness and Emergency Preparedness Act (PREP Act).

DATES: This Notice is effective on December 21, 2007.

FOR FURTHER INFORMATION CONTACT: Healthcare Systems Bureau, Health 
Resources and Services Administration, Parklawn Building, Room 11C-26, 
5600 Fishers Lane, Rockville, Maryland 20857; toll-free telephone 
number 1-888-496-0338. Electronic inquiries should be sent via Tamara 
Overby at [email protected].

[[Page 72741]]


SUPPLEMENTARY INFORMATION: The PREP Act, which is a 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), was enacted on December 30, 2005, and confers 
broad liability protections on covered persons, as defined in section 
319F-3(i)(2) of the PHS Act, and compensation to individuals injured by 
the receipt of covered countermeasures, as defined in section 319F-
3(i)(1) of the PHS Act, in the event of designated public health 
emergencies. A covered countermeasure means: (A) A qualified pandemic 
or epidemic product (as defined in section 319F-3(i)(7) of the PHS 
Act); (B) a security countermeasure (as defined in section 319F-
2(c)(1)(B) of the PHS Act); or (C) a drug (as such term is defined in 
section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
321(g)(1)), biological product (as such term is defined by section 
351(i) of this Act), or device (as such term is defined by section 
201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) 
that is authorized for emergency use in accordance with section 564 of 
the Federal Food, Drug and Cosmetic Act.
    Passed primarily to address the pandemic influenza threat, the PREP 
Act provides liability protections after a Secretarial declaration of 
covered countermeasures for any disease or health condition that the 
Secretary views as constituting a public health emergency, either 
presently or in the future. Liability protections cover the 
manufacture, testing, development, distribution, or use of the 
designated covered countermeasure absent willful misconduct as defined 
in section 319F-3(c)(1) of the PHS Act. A Secretarial declaration 
specifies the categories of health threats or conditions for which 
countermeasures are recommended, the period liability protections are 
in effect, the population of individuals protected, and the geographic 
areas for which the protections are in effect.
    In addition to liability protections, the PREP Act provides the 
Secretary the authority, which was delegated by the Secretary on 
November 8, 2006 to the Administrator of the Health Resources and 
Services Administration, to compensate eligible individuals for covered 
injuries from a covered countermeasure.
    The first Declaration under the PREP Act was published in the 
Federal Register on February 1, 2007 (72 FR 4710). It designated the 
pandemic influenza A (H5N1) vaccine as a covered countermeasure, with 
an effective time period of December 1, 2006-February 28, 2010. As a 
result of this Declaration, individuals injured by this vaccine can 
file a request for compensation. Individuals have one (1) year from the 
time they receive the vaccine to apply for compensation. Currently, no 
funds have been appropriated to provide compensation. However, all 
potential claims must still be filed within the one (1) year limit.
    This Declaration specifies that the following individuals with 
covered injuries may be eligible to receive compensation under the PREP 
Act: (1) All persons who use a covered countermeasure or to whom such a 
covered countermeasure is administered as an Investigational New Drug 
in a human clinical trial conducted directly by the Federal Government, 
or pursuant to a contract, grant or cooperative agreement with the 
Federal Government; (2) all persons who use a covered countermeasure or 
to whom such a countermeasure is administered in a pre-pandemic phase; 
and/or (3) all persons who use a covered countermeasure, or to whom 
such a covered countermeasure is administered in a pandemic phase. The 
Pre-Pandemic Phase means the following stages, as defined in the 
National Strategy for Pandemic Influenza: Implementation Plan (Homeland 
Security Council, May 2006): (0) New Domestic Animal Outbreak in At-
Risk Country; (1) Suspected Human Outbreak Overseas; (2) Confirmed 
Human Outbreak Overseas; and (3) Widespread Human Outbreaks in Multiple 
Locations Overseas. The Pandemic Phase means the following stages, as 
defined in the National Strategy for Pandemic Influenza: Implementation 
Plan (Homeland Security Council, May 2006): (4) First Human Case in 
North America; and (5) Spread Throughout United States.
    Eligible individuals may be compensated for out-of-pocket medical 
expenses, lost employment income, and survivor death benefits. 
Reasonable and necessary medical items and services may be paid or 
reimbursed to treat a covered countermeasure-related injury of an 
eligible individual. The payments or reimbursements for services or 
benefits are secondary to other forms of coverage. The individual may 
receive compensation for loss of employment income incurred as a result 
of the covered countermeasure injury. The amount of compensation is 
based on income at the time of injury. Death benefits may be paid to 
certain survivors of covered countermeasures recipients who have died 
as a direct result of the covered countermeasure injury. Since HHS is 
payer of last resort, payments are reduced by those of other third 
party payers.
    Interested parties may obtain request packages that contain copies 
of all necessary forms and instructions by writing to the Healthcare 
Systems Bureau, Health Resources and Services Administration, Parklawn 
Building, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857, calling 
at 1-888-496-0338, or downloading them from the HRSA Web site at http://www.hrsa.gov/countermeasurescomp.
    Completed request packages must be postmarked by the U.S. Postal 
Service, a commercial carrier, or a private courier service. HRSA will 
not accept request packages electronically or by hand-delivery. The 
postmark date is used to determine whether the filing deadline of one 
year from receipt of the countermeasure has been met.

Paperwork Reduction Act of 1995

    HRSA will submit to the Office of Management and Budget (OMB) an 
Information Collection Request (ICR) for approval of the required 
forms.

    Dated: December 18, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. 07-6180 Filed 12-19-07; 1:36 pm]
BILLING CODE 4165-15-P