Patient advocacy organizations with no patient registry and those with established patient registries that wish to be considered by the selection committee for the GRDR pilot project are encouraged to submit contact and background information about their organization and the rare disease(s) or condition(s) that they represent. The information provided should address the eligibility and selection criteria which will be the basis for selection. Refer to the Eligibility Criteria and Selection Criteria for further information.

Review

Submissions that meet the eligibility criteria and that provide responses to all sections of the selection criteria will be forwarded for further evaluation. Submissions that fail to meet the eligibility criteria or submissions that do not address all of the requested selection criteria will be considered incomplete and will not be forwarded for further evaluation.

Responses will reviewed by members of an external selection committee, comprised of leaders from advocacy, research and government. Review scores will be considered in the final determination and selection by ORDR.

Selection

To achieve maximum distribution of different rare diseases , the final selection process will consider the representation among various disease categories. In addition, an effort will be made to ensure that large and small patient organizations will be included, i.e., half from organizations that represent a rare disease with more than 2500 patient participants and half from organizations with less than 2500 patient participants (based on hard copy or the electronic contact list).

Based on the scores given by the review comittee, 24 groups will be selected by ORDR to participate in the pilot program. Twelve patient organizations without a registry will be selected for participation in the registry portion of the pilot program. Twelve patient organizations with previously established registries will be selected for participation in the repository portion of the pilot program. All groups will be notified by email with the outcome of their RFI submission. Organizations selected to participate will have their names will be posted on the ORDR website and the GRDR website. Information regarding future participation in the patient registry program or the repository program will also be provided to respondents at that time. I e