(a) The Act authorizes three forms of benefits to, or on behalf of, requesters determined to be eligible by the Secretary:

(b) In general, the benefits paid under the Program, are secondary to any obligation of any third-party payer to provide or pay for such benefits. The benefits available under the CICP usually will be paid only after the requester has in good faith attempted to obtain all other available coverage from all third-party payers with an obligation to pay for or provide such benefits (e.g., medical insurance for medical services or items, workers' compensation program(s) for lost employment income). However, as provided in § 110.84, the Secretary has the discretion to pay benefits under this Program before a potential third-party payer makes a determination on the availability of similar benefits and has the right to later pursue a claim against any third-party payer with a legal or contractual obligation to pay for, or provide, such benefits.

(a) Act or PHS Act means the Public Health Service Act, as amended.

(b) Alternative calculation means the calculation used in § 110.82(c) of this part for the death benefit available to dependents younger than 18 years old at the time of payment.

(c) Approval means a decision by the Secretary or her designee that the requester is eligible for benefits under the Program.

(d) Benefits means payments and/or compensation for reasonable and necessary medical expenses or provision of services described in § 110.31, lost employment income described in § 110.32, and/or payment to certain survivors of death benefits described in § 110.33.

(e)

(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

(g) Covered Injury means death, or a serious injury as described in § 110.3(z), and determined by the Secretary in accordance with § 110.20 of this part to be:

(h) Declaration means a recommendation issued by the Secretary under section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d(b)), for the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, following her determination that a specific disease, condition, or threat represents a public health emergency or a credible risk of a future public health emergency.

(i) Dependent means, for purposes of lost employment income benefits, a person whom the Internal Revenue Service would consider to be the injured countermeasure recipient's dependent at the time the covered injury was sustained. For purposes of survivor death benefits, dependent means a person whom the Internal Revenue Service would consider to be the deceased injured countermeasure recipient's dependent at the time the covered injury was sustained, and who is younger than the age of 18 at the time of filing the Request Form.

(j) Disapproval means a decision by the Secretary that the individual requesting benefits is not eligible to receive benefits under the Program for the specified injury that is the basis of the Request for Benefits.

(k) Effective period of the declaration means the time span specified in a declaration, or as amended by the Secretary.

(l) Federal Employees' Compensation Act (FECA) Program means the workers' compensation benefits program for civilian officers and employees of the Federal Government established under 5 U.S.C. 8101 et seq. as amended, and implemented by the United States Department of Labor in regulations codified at 20 CFR part 10, as amended.

(m) Healthcare provider means an individual licensed, certified, or registered by an appropriate authority and who is qualified and authorized to provide health care services, such as diagnosing and treating physical or mental health conditions, prescribing medications, and providing primary and/or specialty care.

(n) Injured countermeasure recipient means an individual:

(o) Lacks legal capacity means legally incompetent to receive payment(s) of benefits, as determined under applicable law.

(p) Medical records means documentation associated with primary care, hospital in-patient and out-patient care, specialty consultations, and diagnostic testing and results.

(q) Payer of last resort means that the Program pays benefits secondary to all other public and private third-party payers who have an obligation to pay for such benefits.

(r) Program means the Countermeasures Injury Compensation Program (CICP).

(s) PREP Act means the Public Readiness and Emergency Preparedness Act, codified as sections 319F-3 and 319F-4 of the PHS Act (42 U.S.C. 247d-6d, 42 U.S.C. 247d-6e).

(t) Public Safety Officers' Benefits (PSOB) Program means the Program established under Subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.), as amended, and implemented by the United States Department of Justice in regulations codified at 28 CFR part 32, as amended.

(u) Representative (legal or personal) means someone other than the person for whom Program benefits are sought, and who is authorized to file the Request Package on the requester's behalf pursuant to § 110.44.

(v) Requester means an injured countermeasure recipient, or survivor, or the estate of a deceased injured countermeasure recipient (through the executor or administrator of the estate) who files a Request Package for Program benefits, or on whose behalf a Request Package is filed, under this part.

(w) Request Form or Request for Benefits Form means the document designated by the Secretary for applying for Program benefits under this part.

(x) Request Package means the Request Form, all documentation submitted by, or on behalf of, the requester, and all documentation obtained by the Secretary as authorized by, or on behalf of, the requester for determinations of Program eligibility and benefits under this part.

(y) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority conferred on the Secretary under the PREP Act has been delegated.

(z) Serious injury means serious physical injury. Physical biochemical alterations leading to physical changes and serious functional abnormalities at the cellular or tissue level in any bodily function may, in certain circumstances, be considered serious injuries. As a general matter, only injuries that warranted hospitalization (whether or not the person was actually hospitalized) or injuries that led to a significant loss of function or disability (whether or not hospitalization was warranted) will be considered serious injuries.

(aa) Standard calculation means the calculation used in § 110.82(b) of this part for the death benefit available to all eligible survivors (other than surviving dependents younger than the age of 18 who do not fit the definition of “child” under § 110.3(e)).

(bb) State means any State of the United States of America, the District of Columbia, United States territories, commonwealths, and possessions, the Republic of the Marshall Islands, the Republic of Palau, and the Federated States of Micronesia.

(cc) Survivor means a person meeting the requirements of § 110.11 with respect to a deceased injured countermeasure recipient who died as a direct result of a covered injury.

(dd) Table or Table of Injuries means a Table of Covered Countermeasure Injuries to be included under Subpart K of this part, including the definitions and requirements set out therein.

(ee) Third-party payer means the United States (other than for payments of benefits under this Program) or any other third party, including but not limited to, any State or local governmental entity, private insurance carrier, or employer, any public or private entity with a legal or contractual obligation to pay for or provide benefits. The Program is the payer of last resort.

(a) The following requesters may, as determined by the Secretary, be eligible to receive benefits from this Program:

(b) If a countermeasure recipient dies, his or her survivor(s) and/or the executor or administrator of his or her estate may file a new Request Package (or Request Package(s)) or amend a previously filed Request Package. A new Request Package may be filed whether or not a Request Package was previously submitted by, or on behalf of, the deceased injured countermeasure recipient, but must be filed within the filing deadlines described in § 110.42. Amendments to previously filed Request Packages and the filing deadlines for such amendments are described in § 110.46.

(c) The benefits available to different categories of requesters are described in § 110.30.

(a) Survivors of injured countermeasure recipients who died as the direct result of a covered injury. If the Secretary determines that an injured countermeasure recipient died as the direct result of a covered injury (or injuries), his or her survivor(s) may be eligible for death benefits.

(b) Survivors who may be eligible to receive benefits and the order of priority for benefits.

(a) General. Only serious injuries, as described in § 110.3(z), or deaths are covered under the Program. In order to be eligible for benefits under the Program, a requester must submit documentation showing that a covered injury, as described in § 110.3(g), was sustained as the direct result of the administration or use of a covered countermeasure pursuant to the terms of a declaration under section 319F-3(b) of the PHS Act (including administration or use during the effective period of the declaration) or as the direct result of the administration or use of a covered countermeasure in a good faith belief that it was administered or used pursuant to the terms of a declaration (including administration or use during the effective period of the declaration). A requester can establish that a covered injury was sustained by demonstrating to the Secretary that a Table injury occurred, as described in paragraph (c) of this section. In the alternative, a requester can establish that an injury was actually caused by a covered countermeasure, as described in paragraph (d) of this section. The Secretary may obtain the opinions of qualified medical experts in making determinations concerning covered injuries.

(b) Table injuries. A Table lists and explains injuries that, based on compelling, reliable, valid, medical and scientific evidence, are presumed to be caused by a covered countermeasure, and the time periods in which the onset (i.e., first sign or symptom) of these injuries must occur after administration or use of the covered countermeasures. If an injury occurred within the listed time periods, and at the level of severity required, there is a rebuttable presumption that the covered countermeasure was the cause of the injury. A Table is accompanied by Qualifications and Aids to Interpretation which provide an explanation of the injuries listed on a Table. A requester may establish that a covered injury occurred by demonstrating that the countermeasure recipient sustained an injury listed on a Table, within the time interval defined by the Table's Definitions and Requirements. In such circumstances, the requester need not demonstrate the cause of the injury because the Secretary will presume, only for purposes of making determinations under this Subpart, that the injury was the direct result of the administration or use of a covered countermeasure. Even if the Table requirements are satisfied, however, an injury will not be considered a covered injury if the Secretary determines, based on her review of the evidence, that a source other than the countermeasure more likely caused the injury. In such circumstances, the Table presumption of causation will be rebutted.

(c) Injuries for which causation must be shown (non-Table injuries). If an injury is not included on a Table or if the injury does not meet the requirements set out for an injury that is listed on a Table (e.g., the first sign or symptom of the injury did not occur within the time interval specified on the Table), the requester must demonstrate that the injury occurred as the direct result of the administration or use of a covered countermeasure. Such proof must be based on compelling, reliable, valid, medical and scientific evidence. Temporal association between receipt of the countermeasure and onset of the injury is not sufficient by itself to prove that the countermeasure caused the injury.

(d) Injuries resulting from the underlying condition for which the countermeasure was administered or used. An injury sustained as the direct result of the covered condition or disease for which the countermeasure was administered or used, and not as the direct result of the administration or use of the covered countermeasure, is not a covered injury (e.g., if the covered countermeasure is ineffective in treating or preventing the underlying condition or disease).

(a) Benefits available to injured countermeasure recipients. A requester who is an injured countermeasure recipient may be eligible to receive either medical benefits or benefits for lost employment income, or both.

(b) Benefits available to survivors. A requester who is an eligible survivor of a deceased injured countermeasure recipient may be eligible to receive a death benefit if the death was caused by the covered injury or its health complications.

(c) Benefits available to estates of deceased injured countermeasure recipients. The estate of an otherwise eligible deceased injured countermeasure recipient may be eligible to receive medical benefits or benefits for lost employment income, or both, if such benefits were accrued during the deceased countermeasure recipient's lifetime, or at the time of death, as a result of a covered injury or its health complications, but have not yet been paid in full by the Program. Such medical benefits and benefits for lost employment income may be available regardless of the cause of death. The estate of the deceased injured countermeasure recipient may not receive a death benefit. Death benefits are only available to certain survivors.

(a) Injured countermeasure recipients may receive payments or reimbursements for medical services and items that the Secretary determines to be reasonable and necessary to diagnose or treat a covered injury, or to diagnose, treat, or prevent the health complications of a covered injury. The Secretary may pay for such medical services and items in an effort to cure, counteract, or minimize the effects of any covered injury, or any health complication of a covered injury, or to give relief, reduce the degree or the period of disability, or aid in lessening the amount of benefits to a requester (e.g., a surgical procedure that lessens the amount of time and expense for the treatment of a covered injury). The Secretary may make such payments or reimbursements if reasonable and necessary medical services and items have already been provided or if they are likely to be needed in the future. In making determinations about which medical services and items are reasonable and necessary, the Secretary may consider whether those medical services and items were prescribed or recommended by a healthcare provider, and may consider whether the applicable service or item is within the standard of care for that condition.

(b) To receive medical benefits for the health complications of a covered injury, a requester must demonstrate that the complications are the direct result of the covered injury. Examples of health complications include, but are not limited to, ill-effects that stem from the covered injury, an adverse reaction to a prescribed medication or as a result of a diagnostic test used in connection with a covered injury, or a complication of a surgical procedure used to treat a covered injury.

(c) The calculation of medical benefits available under this Program is described in § 110.80. Although there are no caps on medical benefits, the Secretary may limit payments to the amounts that she determines are reasonable for services and items considered reasonable and necessary. All payment or reimbursement for medical services and items is secondary to any obligation of any third-party payer to pay for or provide such services or items to the requester. As provided in § 110.84, the Secretary retains the right to recover medical benefits paid by the Program to requesters if third-party payers are obligated to provide those benefits. Requesters are expected to make good faith efforts to pursue medical benefits and services from their primary payers. The Secretary reserves the right to disapprove medical benefits if the requester fails to do so.

(d) The Secretary may make payments of medical benefits or reimbursements of medical expenses described in this section to the estate of a deceased injured countermeasure recipient as long as such payments or expenses were accrued during the deceased injured countermeasure recipient's lifetime, or at the time of death, as the result of the covered injury or its health complications, and were not paid in full by the Program before the deceased injured countermeasure recipient died.

(a) Requesters who are determined to be eligible for Program benefits as injured countermeasure recipients may be able to receive benefits for loss of employment income incurred as a result of a covered injury (or its health complications, as described in § 110.31(b)). Compensation for lost wages is paid as a percentage of the amount of employment income earned at the time of injury and lost as the result of the covered injury or its health complications. The period of time requested for lost employment income benefits must be supported by the severity of the covered injury as demonstrated by the medical and employment records.

(b) The method and amount of benefits for lost employment income are described in § 110.81. Benefits for lost employment income will be adjusted if there are fewer than ten days of lost employment income. Pursuant to law, and as described in § 110.81, benefits provided for lost employment income may also be adjusted for annual and lifetime caps. Payment of benefits for lost employment income is secondary to any obligation of any third-party payer to pay for lost employment income or to provide disability or retirement benefits to the requester. It is the obligation of requesters to follow all specified procedures to apply for and acquire third-party benefits. The Secretary has the discretion to disapprove lost employment income benefits if the requester fails to do so. As provided in § 110.84, the Secretary reserves the right to recover lost employment income benefits paid by the Program to requesters if third-party payers are obligated to provide those benefits.

(c) The Secretary does not require an individual to use paid leave (e.g., sick leave or vacation leave) for lost work days. However, if an individual uses paid leave for lost work days, the Secretary will not consider those days to be days of lost employment income unless the individual reimburses the employer for the paid leave taken and the employer restores the leave that was used. This puts the individual back in the same position as if he or she had not used paid leave for the lost work days.

(d) The Secretary may pay benefits for lost employment income to the estate of a deceased injured countermeasure recipient as long as such benefits were accrued during the deceased injured countermeasure recipient's lifetime as the result of a covered injury or its health complications, and were not paid in full by the Program before the deceased injured countermeasure recipient died. However, no such lost employment income may be paid after the receipt, by the survivor or survivors of a deceased injured countermeasure recipient, of death benefits under § 110.82.

(a) Eligible survivors may be able to receive a death benefit under this Program if the Secretary determines that an otherwise eligible countermeasure recipient sustained a covered injury and died as a direct result of the injury or its health complications. The method and amount of death benefits are described in § 110.82. As provided in § 110.84, the Secretary retains the right to recover death benefits paid by the Program if third-party payers are obligated to provide those benefits. There are two different calculations for death benefits: the standard calculation and the alternative calculation.

(b) The standard calculation, described in § 110.82(b), is based upon the death benefit available under the PSOB Program and is available to all eligible survivors with one exception (surviving dependents younger than the age of 18 who do not fit the definition of “child” under § 110.3(e)). In the event that death benefits were paid under the PSOB Program with respect to the deceased injured countermeasure recipient, no death benefits may be paid under the standard calculation. In addition, death benefits under this standard calculation are secondary to disability benefits under the PSOB Program. If a disability benefit was paid under the PSOB Program, the amount of that disability benefit would be deducted from benefits payable under the standard calculation.

(c) The alternative calculation, described in § 110.82(c), is based on the injured countermeasure recipient's employment income at the time of the covered injury. Payment under this calculation is only available to surviving dependents who are younger than the age of 18 at the time of payment. The legal guardian(s) of such surviving dependents must select the death benefit as calculated under this alternative calculation before it will be paid. Annual and lifetime caps may apply. The payment of a death benefit as calculated under this alternative calculation is secondary to other benefits paid or payable with respect to the deceased injured countermeasure recipient, namely:

(a) Copies of all necessary forms and instructions will be available:

(b) Before reviewing a Request for Benefits, the Secretary will assign a case number to the Request for Benefits and so inform the requester (or his or her representative) in writing. All correspondence to the requester (or his or her representative) about a specific Request for Benefits will be referenced by this case number.

(a) General. All Request Forms (or Letters of Intent, described in paragraph (b) of this section) must be filed within one year of the date of the administration or use of a covered countermeasure that is alleged to have caused the injury. If no previous Request Form (or Letter of Intent) has been filed, this deadline also applies to survivor(s) of an injured countermeasure recipient who is deceased, and to the executor or administrator of his or her estate. If a Request Form (or Letter of Intent) was previously filed, § 110.46 describes amendments to Request Packages.

(b) Letters of Intent. Until Request Forms and Instructions are available, requesters must file a Letter of Intent to File, in order to establish that their Requests for Benefits are timely filed within the one-year deadline. Directions for submitting a Letter of Intent (to file) are available on the Program's Web site at http://www.hrsa.gov/countermeasurescomp/ or by calling 1-888-ASK-HRSA. Even once Request Forms are available, the Secretary has the discretion to accept Letters of Intent (to file) for purposes of meeting the filing deadline. However, when Request Forms and Instructions are available, all requesters who have submitted Letters of Intent must still file Request Forms as soon as possible.

(c) Determination of proper filing. The filing date is the date the Request Form (or Letter of Intent) is postmarked. A legibly dated receipt from a commercial carrier, a private courier service, or the U.S. Postal Service will be considered equivalent to a postmark. If and when Request Forms are accepted electronically, the filing date is the date the Request Form is submitted electronically. A Request Form will not be considered filed unless it has been completed (to the fullest extent possible) and signed by the requester or his or her personal or legal representative. After filing a Request Form within the governing filing deadline, a requester must update the Request Package to reflect new information as it becomes available (e.g., copies of medical records generated after the initial submission of the Request Package).

(d) Request Forms not filed within the one-year deadline. If the Secretary determines that a Request Form or Letter of Intent was not filed within the governing filing deadline set out in this section, the Request Form (or Letter of Intent) will not be processed and the requester will not be eligible for benefits under this Program.

(e) Constructive receipt. The Secretary reserves the right to consider a legal claim filed with the Federal Government (e.g., a Federal Tort Claims Act claim or a petition with the National Vaccine Injury Compensation Program) concerning an alleged injury resulting from the administration or use of a covered countermeasure to be a filing of a Request Form or Letter of Intent for purposes of determining the filing date under this Program. The date of such constructive filing will be the official filing date of the action, i.e., when all applicable requirements for proper filing in that forum have been met.

(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).

(a) Documentation for eligibility determinations. A requester will satisfy the filing deadline as long as the signed Request Form is completed (to the fullest extent possible) and submitted within the governing filing deadline described in § 110.42. The Secretary generally will not begin review of a requester's eligibility until all the documentation necessary to make this determination has been submitted.

(b) Documentation for benefits determinations. Although the Secretary will accept documentation required to make benefits determinations (i.e., calculate benefits available, if any) at the time the Request Form is filed or any time thereafter, requesters need not submit such documentation until they have been notified that the Secretary has determined eligibility. The Secretary will not generally begin review of the benefits available to a requester until the documentation necessary to make a benefits determination has been submitted.

(a) Generally. Persons other than a requester (e.g., a lawyer, guardian, family member, friend) may file a Request Package on a requester's behalf as his or her legal or personal representative. A requester need not use the services of a lawyer to apply for benefits under this Program. A legal representative, or a personal representative (who does not need to be a lawyer) is only required, as described in this section, for requesters who are minors or adults who lack legal capacity to receive payment of benefits. In the event that a legal or personal representative files on behalf of a requester, the representative will be bound by the obligations and documentation requirements that apply to the requester (e.g., if a requester is required to submit employment records, the representative must file the requester's employment records). The representative must also satisfy the requirements specific to representatives set out in this part. If a requester has a representative, the Program will generally direct all communications to the representative. However, the Secretary reserves the right of the Program to contact the requester directly if necessary, and to conduct a follow-up survey to determine the ability of the Program to meet requesters' needs.

(b) Legal or personal representatives of legally competent adults. A requester who is a legally competent adult may use a legal or personal representative to submit a Request Package on his or her behalf. In such circumstances, the requester must indicate on the Request Form that he or she is authorizing the representative to seek benefits under this Program on his or her behalf.

(c) Legal or personal representatives of minors and adults who lack legal capacity to receive payment of benefits. A requester who is a minor or an adult who lacks legal capacity to receive payment of benefits must use a legal or personal representative to apply for benefits under this Program on his or her behalf. In such circumstances, the representative must indicate, in the place provided on the Request Form, that the requester is a minor or an adult who lacks legal capacity to receive payment of benefits and that the representative is filing on behalf of the requester. In addition, before the requester will be paid by the Program, the representative must submit the documentation described in § 110.63. A minor who is emancipated, as determined by a court of competent jurisdiction, does not need a legal or personal representative to file a Request Form or Request Package on his or her behalf.

(d) No payment or reimbursement for legal or personal representatives' fees or costs. The Act does not authorize the Secretary to pay for, or reimburse, any fees or costs associated with the requester's use of the services of a legal or personal representative under this Program, including those of an attorney.

(a) Generally. All requesters may amend their documentation concerning eligibility up to the time the Secretary has made an eligibility determination. Requesters are expected to submit additional medical records as they become available. Requesters also may amend their information or documentation concerning the calculation of benefits until the Secretary has made a benefits determination. Once an eligibility determination has been made, the Secretary will not accept additional documentation concerning eligibility, except as described in paragraphs (b) and (c) of this section. Once a benefits determination has been made, the Secretary will not accept additional documentation regarding the type or amount of benefits for that covered injury, except as described in paragraphs (b) and (c) of this section.

(b) Requesters who are survivors. If an injured countermeasure recipient submitted a Request Form within the filing deadline, but subsequently dies, or the executor or administrator timely filed on behalf of the estate, the survivor(s) may amend the previously filed Request Package at any time by filing a new Request Form in order to be considered for death benefits. Such an amendment can be filed regardless of whether the Secretary made an eligibility determination or paid benefits with respect to the deceased injured countermeasure recipient's Request Package. However, a survivor filing an amendment to a previously filed Request Package may only be eligible for benefits if the previously filed Request Package was filed within the governing filing deadline. All documentation that has already been submitted with respect to the deceased injured countermeasure recipient will be considered part of the survivor requester's Request Package, and he or she is not required to resubmit such documentation. Survivor requesters must also file an amendment to a Request Package if there is a change in the order of priority of survivors, as described in § 110.11.

(c) Requests in which the benefits are sought for the estate of a deceased injured countermeasure recipient. If an injured countermeasure recipient submitted a Request Form within the filing deadline, but subsequently dies before all due benefits are paid by the Program, the executor or administrator of his or her estate may amend his or her Request Package at any time in order for the estate to be considered for benefits. This opportunity to amend applies also if the Request Form was timely filed by a survivor. Such an amendment can be filed regardless of whether the Secretary made an eligibility determination or paid benefits with respect to the deceased injured countermeasure recipient's Request Package. However, the executor or administrator of the deceased injured countermeasure recipient's estate filing an amendment to a previously filed Request Package may only be eligible to receive benefits on behalf of the estate if the previously filed Request Package was filed within the governing deadline. All documentation that has already been submitted with respect to the deceased injured countermeasure recipient will be considered part of that person's Request Package, and the executor or administrator of the estate is not required to resubmit such documentation.

(a) In order to determine whether an injured countermeasure recipient sustained a covered injury, a requester must arrange for his or her medical providers to submit to the Program the following medical records, as defined in § 110.3(p):

(b) A requester may submit additional medical documentation that he or she believes will support the Request Package. Although generally not required if a Table injury was sustained, a requester may introduce additional medical documentation or scientific evidence in order to establish that an injury was caused by a covered countermeasure. Letters from treating physicians may be submitted as additional evidence, but may not substitute for the medical documentation required in paragraph (a) of this section.

(c) If certain medical records listed in paragraph (a) of this section are unavailable to the Program after the requester has made reasonable efforts to facilitate the records being sent to the Program, the requester must submit a statement describing the reasons for the records' unavailability and the efforts he or she has made to arrange for the health care providers to submit them. The Secretary has the discretion to accept this statement in place of the unavailable medical records. In this circumstance, the Secretary may attempt to obtain the records on the requester's behalf.

(d) In certain circumstances, the Secretary may require additional records to make a determination that a covered injury was sustained (e.g., medical records more than one year prior to the date of administration or use of the covered countermeasure) or may determine that certain records described in paragraph (a) of this section are not necessary for an eligibility determination.

(e) Although the Secretary prefers to receive medical records directly from healthcare providers, she has the discretion to accept them from the requester.

(a) An injured countermeasure recipient (or his or her legal or personal representative) must submit all of the following documentation in order for the Secretary to make a determination of eligibility:

(b) In certain circumstances, some of the above documentation may not be required, or additional documentation may be required, in which case the Secretary will so notify the requester. For example, the Secretary may require records sufficient to demonstrate that the injured countermeasure recipient was administered or used a covered countermeasure in accordance with the provisions of a Secretarial declaration, or in the good faith belief that it was so administered or used, if she is unable to determine this from the records submitted. In order to meet the specifications of a declaration, some individuals will need to show that the activity giving rise to the injury (i.e., administration or use of the covered countermeasure) was authorized in accordance with the public health and medical response of the Authority Having Jurisdiction, as defined in the pertinent declaration, to prescribe, administer, deliver, distribute or dispense the covered countermeasure following a declaration of an emergency, as defined in the pertinent declaration. For purposes of this part, this requirement can be satisfied by showing that the covered countermeasure was administered or used following the declaration of an emergency, as defined in the pertinent declaration, by an Authority Having Jurisdiction, as defined in the pertinent declaration either:

(a) A requester who is a survivor under § 110.11 must submit the following documentation in order for a determination of eligibility for a death benefit to be made:

(b) [Reserved]

(a) The executor or administrator of the estate of a deceased injured countermeasure recipient must submit the following documentation in order for a determination of eligibility for benefits to the estate to be made:

(b) [Reserved]

(a) A requester determined by the Secretary to be eligible for Program benefits and who seeks payment or reimbursement for medical services or items must provide the following, in addition to the documentation submitted under subpart F of this part:

(b) [Reserved]

(a) A requester determined by the Secretary to be eligible for Program benefits and who seeks benefits for lost employment income must provide, in addition to the documentation submitted under subpart F of this part, documentation describing:

(b) [Reserved]

(a) A requester determined by the Secretary to be an eligible survivor and who seeks a death benefit under § 110.82(b) (the standard calculation) must provide, in addition to the documentation submitted under subpart F of this part, a written certification informing the Secretary whether a disability or death benefit was paid or payable under the PSOB Program with respect to the deceased injured countermeasure recipient. If such benefit was provided, the requester must submit documentation showing the amount of the benefit paid by the PSOB Program. If the deceased injured countermeasure recipient was covered under the PSOB and no such benefit was, or will be provided, the certification must explain whether any survivors are eligible for a death benefit under the PSOB Program and, if so, whether a death benefit may be paid or payable under the PSOB Program.

(b) The legal guardian seeking a death benefit under § 110.82(c) (the alternative calculation) on behalf of a dependent younger than the age of 18 determined by the Secretary to be an eligible survivor must provide, in addition to the documentation submitted under Subpart F of this part, the following:

(a) For an eligible requester who is a minor:

(b) For an eligible requester who is an adult who lacks legal capacity to receive payment of benefits:

(a) The requester or his or her representative submitted a completed and signed Request Form within the governing filing deadline; and

(b) The requester meets the eligibility requirements set out in this part (including a determination that a covered injury was sustained); and

(c) The requester is entitled to receive benefits from the Program. In making this determination, the Secretary will decide the type(s) and amounts of benefits that will be paid to the requester.

(a) Eligibility determinations. When the Secretary determines that there is sufficient documentation in the Request Package to evaluate a requester's eligibility, she will begin the review to determine whether the requester is eligible for Program benefits. If the Secretary determines that the requester is not eligible, the Secretary will inform the requester (or his or her representative) in writing of the disapproval, and the right to reconsideration of the determination, as described in subpart J.

(b) Benefits determinations. If the Secretary determines that the requester is eligible for benefits, she will, after receiving adequate documentation from the requester for a benefits determination, either calculate the amount and types of benefits, as described in subpart I of this part, or request additional documentation in order to calculate the benefits that can be paid (e.g., an Explanation of Benefits from the requester's health insurance company, if none was submitted). As provided in subpart J, requesters have the right to reconsideration of the Secretary's determination of the category and amount of benefits payable under the Program.

(c) Additional documentation required. At any time after a Request Form has been filed, the Secretary may ask a requester to supplement or amend the Request Package by providing additional information or documentation.

(a) If the Secretary determines that a requester is not eligible for payments under the Program, the Secretary will disapprove the Request for Benefits and provide the requester, or his or her representative, with written notice of the basis for the disapproval, and the right to reconsideration of the determination, as provided in § 110.90.

(b) The Secretary may disapprove a Request for Benefits even before the requester has submitted all the required documentation (e.g., the Secretary may determine that a requester did not meet the filing deadline, or that a covered countermeasure was not used or administered).

(c) The Secretary may re-open a disapproved Request for Benefits on her own accord should medical or scientific evidence later become available to justify a re-determination of the disapproval of eligibility or payments. In extraordinary circumstances, to be determined at the Secretary's discretion, she may re-open a disapproved Request for Benefits even after the requester has exercised the right to reconsideration and the disapproval determination has been upheld in accordance with the procedures set out in § 110.90.

(a) Primary calculation. Benefits under this section may be paid for days of work lost as a result of a covered injury or its health complications if the injured countermeasure recipient lost employment income for the lost work days as reasonable based on the degree of injury or disability. As stated in § 110.32(c), days for which an individual used paid leave will be considered days of work for which employment income was received and, therefore, would not qualify for lost employment income benefits. However, if the injured countermeasure recipient reimburses the employer for the paid leave taken and the employer restores the leave that was used, the individual may be eligible for lost employment income benefits for those days;

(b) Adjustment for inflation. Benefits for lost employment income paid under the Program that represent future lost employment income will be adjusted annually to account for inflation.

(c) Limitations on benefits paid. The Secretary will reduce the benefits calculated under paragraphs (a) and (b) of this section according to the limitations described in this paragraph (c):

(d) Reductions for other coverage. From the amount of benefits calculated under paragraphs (a), (b), and (c) of this section, the Secretary will make reductions:

(a) General.

(b) Standard calculation of death benefits.

(c) Alternative calculation of death benefits available to surviving dependents younger than the age of 18. If a deceased countermeasure recipient had at least one dependent who is younger than the age of 18 (and will be younger than the age of 18 at the time of the payment), the legal guardian(s) of all such dependents may request benefits under the alternative calculation described in this paragraph. To receive such a benefit, the legal guardian, on behalf of all such dependents for whom he or she is the legal guardian, must file a selection to receive benefits under the alternative calculation, as described in paragraph (c)(1) of this section, and the Secretary must approve such selection. If multiple dependents have different legal guardians, each legal guardian is responsible for requesting benefits under the standard calculation or for filing a selection for a death benefit under the alternative calculation. If a single dependent has more than one legal guardian, one legal guardian may file the selection. Payments made under the alternative calculation will be made to the legal guardian(s) of all of the dependents on behalf of all of those dependents until they reach the age of 18.

(a) The Secretary determines the mechanism of payment of Program benefits. She may choose to pay any benefits under this Program through lump-sum payments. If the Secretary determines that there is a reasonable likelihood that the payments of medical benefits, benefits for lost employment income, or death benefits paid under the alternative calculation (described in § 110.82(c)) will be required for a period in excess of one year from the date the Secretary determines the requester is eligible for such benefits, payments may be made through a lump-sum payment, the purchase of an annuity or medical insurance policy, establishment of a trust (including a U.S. grantor reversionary trust) or execution of an appropriate structured settlement agreement, at the Secretary's discretion. Payments, annuities, policies, or agreements must be actuarially determined to have a value equal to the present value of the projected total amount of benefits that the requester is eligible to receive under §§ 110.80, 110.81, and 110.82. Lump sum payments will be made through an electronic funds transfer to an account of the requester.

(b) If the requester is a minor, the payment will be made on the minor's behalf to the account of the legal guardian of the estate or property of the minor. In accepting such payments, the legal guardian of a minor requester is obligated to use the funds for the benefit of the minor and to take any actions necessary to comply with State law requirements pertaining to such payments. If the requester is an adult who lacks the legal capacity to receive payment(s), the legal guardian must establish a guardianship or conservatorship of the estate account with court oversight, in accordance with State law, and payment will be made to that account. Documentation of guardianship (or conservatorship) is required for requesters who are minors or adults who lack legal capacity unless the Secretary waives this requirement for good cause.

(c) The Secretary has the discretion to make interim payments of benefits under this Program, even before a final determination as to the type(s) and total amount of benefits that will be paid. Interim payments will be made only in exceptional cases. The Secretary may, for example, make an interim payment of medical benefits that have been calculated before a final determination on benefits for lost employment income is completed, or of past medical benefits that have been calculated before a final calculation of future medical benefits is completed. The Secretary may make an interim payment even before a final eligibility or benefits determination is made (e.g., if a piece of documentation has not been obtained because a person with a severe countermeasure-related injury is hospitalized, but all other documentation is consistent with the requester meeting the eligibility requirements). If such a requester's documentation is incomplete, the requester must submit the required documentation within the time-frame determined by the Secretary. The requester must agree that he or she will be obligated to repay the Secretary such benefits in the event that a Program payment is later determined to be incorrect. Any payments made on an interim basis will not entitle a requester to seek reconsideration of the Secretary's decision on these benefits until the Secretary makes a final benefits determination.

(a) Right of reconsideration. A requester has the right to seek reconsideration of the Secretary's determination that he or she is not eligible for Program benefits. In addition, a requester who asserts that the amount of the benefits paid (or the fact that certain benefits were not paid or payable) is incorrect may also seek reconsideration. A requester may not seek reconsideration of the Secretary's decision as to the mechanism of payment. Requests for reconsideration must be in writing, describe the reason(s) why the decision should be reconsidered, and be postmarked within 60 calendar days of the date of the Secretary's decision on the Request for Benefits. Because no new documentation will be considered in the reconsideration process, the reconsideration request may not include or refer to any documentation that was not before the Secretary at the time of her determination.

(b) Letters seeking reconsideration. A requester, or his or her representative, may send the letter seeking reconsideration through the U.S. Postal Service, commercial carrier, or a private courier service. The Secretary will not accept reconsideration requests delivered by hand. Electronic submissions of letters seeking reconsideration are not currently accepted, but may be accepted in the future. The Program will publish a notice if an electronic method becomes available. Letters sent through the U.S. Postal Service, commercial carrier or private courier service must be sent to the Associate Administrator, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12-105, Rockville, Maryland 20857.

(c) Reconsideration process. When the Associate Administrator of the Healthcare Systems Bureau (the Associate Administrator), receives a request for reconsideration, a qualified panel, independent of the Program, will be convened to review the Secretary's determination. The panel will base its recommendation on the documentation before the Secretary when the determination was made. The panel will perform its own review and make its own findings, which will be submitted to the Associate Administrator. The Associate Administrator will then review the panel's recommendation(s) and make a final determination, which will be sent to the requester (or his or her representative). This will be the Secretary's final action on the request for reconsideration and will be considered the Secretary's final determination on the request for Program benefits with regard to the injury that is the subject of that Request Package. Requesters may not seek review of a decision made on reconsideration.

(d) Effect of reconsideration on amending a Request Package. As stated in § 110.46, a Request Package cannot be amended after exhaustion of the reconsideration process, except for amendments by survivors seeking death benefits or executors or administrators on behalf of an estate.

(a) Under section 319F-4(b)(4) of the PHS Act (42 U.S.C. 247d-6e(b)(4)) (referencing section 262 of the PHS Act (42 U.S.C. 239a)), no judicial review of the Secretary's actions concerning eligibility and benefits determinations under this part (including, but not limited to, determinations concerning eligibility, the type or amount of benefits, and the method of payment of benefits) is permitted. In addition, no further administrative review of such actions are permitted unless the President specifically directs otherwise.

(b) Under section 319F-4(b)(5)(c) of the PHS Act (42 U.S.C. 247d-6e(b)(5)(c)), no judicial review of the Secretary's actions in establishing or amending a Table (or Tables) for purposes of this part (which include, but are not limited to, identifying injuries on a Table (or choosing not to identify injuries on a Table), establishing time-frames or definitions for Table injuries, and amending a Table) is permitted.

(a) Pandemic influenza countermeasures injury table.

(b) Qualifications and aids to interpretation (table definitions and requirements). The following definitions and requirements shall apply to the Table set forth in paragraph (a) of this section and only apply for purposes of this subpart.

(c) Smallpox countermeasures injury table.

(d) Qualifications and aids to interpretation (table definitions and requirements). The following definitions and requirements shall apply to the Table set forth in paragraph (c) of this section and only apply for purposes of this subpart.