07-6180. 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 [e-mail].

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.