(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).

[75 FR 63675, Oct. 15, 2010, as amended at 76 FR 62309, Oct. 7, 2011]