In response to feedback from families, clinicians, and other stakeholders, the Committee simplified the process of nominating a condition for the RUSP. The new process is a two-step process that includes the completion of a Preliminary Nomination Form. After submission of the Preliminary Nomination Form, the Nomination and Prioritization (N&P) workgroup will review and provide feedback. The Designated Federal Official (DFO) will work directly with the Nominators on next steps.
As of May 31, 2024, all conditions nominated for inclusion on the Recommended Uniform Screening Panel must use the Committee’s updated condition preliminary Nomination Form, found in the Preliminary Nomination Form section of this page.
Additional resources
All conditions for consideration by the Committee for the Recommended Uniform Screening Panel (RUSP) (PDF - 94 KB) must be nominated.
The Committee encourages individuals and organizations to form multi-disciplinary teams to submit nominations for conditions to be considered for inclusion on the RUSP. Teams should include researchers and/or clinicians with expertise on the condition being nominated, advocacy and/or professional organizations with knowledge of issues relevant to newborn screening, and interested consumers/individuals. To apply, the lead nominator or proponent should submit a nomination package to the Committee’s Designated Federal Official (DFO) at [email protected].
Nominators are strongly encouraged to review the Nominate a Condition FAQs page before compiling a nomination package. The FAQs provide valuable information about the nomination process and specific components of the Nomination Form. If you have additional questions, please contact the Committee’s DFO at [email protected].
Step 1: Preliminary nomination
The Preliminary Nomination Form (PDF - 1 MB) provides the N&P workgroup with responses to the four basic requirements needed for a condition to be considered for review. Some of its sections are technical and require input from experts on the team.
The form’s major sections are:
- Section 1: Your Details
This section provides the contact information for the primary nominator. The full nomination package will request the contact information for the entire nominator team. - Section 2: Preliminary Nomination Questions
This section consists of four preliminary nomination questions and provides a section for up to three supportive reference URLs for each question. If the reference does not have a URL and requires an attachment, please email [email protected].- Question 1: Is there a newborn screening test available?
- Question 2: Is there an agreement about the case definition of the targeted condition and diagnostic confirmation after a positive newborn screen?
- Question 3: Is there a prospective population-based newborn screening project that has identified at least one infant with the condition?
- Question 4: Can identification of the targeted condition before clinical presentation allow provision of effective therapy and improve outcomes for screened infants?
Complete and save form and email to [email protected].
The Committee’s Nomination and Prioritization (N&P) Workgroup reviews the preliminary nomination form and verifies that the nomination meets the four basic requirements needed for a condition to be considered for review. The Designated Federal Official (DFO) will communicate the N&P’s findings to the Nominators.
Step 2: Full Nomination Package
Once the preliminary nomination form and supportive references for each section are verified by the N&P Workgroup. The DFO will inform the nominators whether to complete the full nomination package. The full nomination package should not be completed until notified.
In the Full Nomination Package (PDF - 105 KB), nominators are instructed to succinctly answer questions related to the nominated condition and to provide a citation(s) to the most relevant peer-reviewed publications for each response. Some of its sections are technical and require input from experts on the team.
Next steps
Nomination and Prioritization Workgroup
The N&P Workgroup reviews the full nomination package and compiles a summary for Committee consideration. The Committee decides if sufficient evidence is available, and votes to assign, or not assign, the nominated condition to the external Evidence-Based Review Group (ERG). Nominators whose conditions are not assigned to the ERG are provided with feedback.
Evidence-Based Review Group (ERG)
The external ERG completes a systematic evidence-based review, provides updates, and presents a final report to the Committee on assigned conditions. Past ERG reports can be found on the Previously Nominated Conditions page.
Committee Deliberations and Vote
The Committee discusses and deliberates on the evidence presented by the ERG. The Committee uses a decision matrix (PDF - 1 MB) and accompanying decision matrix guidance to guide their final decisions. Then the Committee votes to recommend or not recommend adding the nominated condition to the RUSP for consideration by the Secretary of Health and Human Services. Nominators whose conditions are not recommended for addition to the RUSP are provided with feedback.
Final Decision
The Secretary of Health and Human Services makes the final decision on whether to add, or not add, a recommended condition to the RUSP. Committee recommendations and the Secretary’s responses can be found on the Recommendations to HHS Secretary with Responses page.