[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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