As of January 1, 2022, all conditions nominated for inclusion on the Recommended Uniform Screening Panel must use the Committee’s updated condition Nomination Form, found in the Nomination Package Components section of this page.
On This Page
- Condition Nomination Review Process
- Nominate a Condition FAQs
- Key Questions Considered by the Committee
- Sample Questions Addressed in an Evidence-Based Review
- Committee Approach to Evaluating the Condition Review Report (Decision Matrix)
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@example.com.
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 firstname.lastname@example.org.
Nomination Package Components
Cover letter by the lead nominator that identifies all multi-disciplinary team members and their organizational affiliation(s), if applicable;
Letters of support (from multi-disciplinary team members), if applicable;
Completed Conflict of Interest Disclosure Forms (PDF - 62 KB) * from all team members;
Responses to the Nomination Form (PDF - 2 MB) **; and
Supporting data and scientific/clinical references to substantiate all responses to Nomination Form questions.
*A potential or actual conflict of interest exists when commitments and obligations are likely to be compromised by the nominator(s)'s other material interests or relationships (especially economic), particularly if those interests or commitments are not disclosed.
**This form uses dynamic Adobe Acrobat features that may not be compatible with assistive technology. Individuals using assistive technology can use the standard version of the nomination form (PDF - 246 KB) instead.
Nomination Form Sections
The Nomination Form is the main part of the nomination package. Some of its sections are technical and require input from experts on the team. The form’s major sections are:
- Condition and Treatment Information
This section gives an overview and case definition of the condition, screening, and treatment.
- Evidence-Based Information
This section gives evidence about the screening process and includes data from laboratory screening, confirmatory testing, and pilot studies.
- Key Reports
This section includes reports and references that support the nomination.
Nomination and Prioritization Workgroup
The Committee's Nomination and Prioritization (N&P) Workgroup reviews the completed nomination package to ensure it meets the following core requirements:
- Validation of the laboratory test
- Widely available confirmatory testing with a sensitive and specific diagnostic test
- A prospective population based pilot study
The N&P Workgroup 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 - 202 KB) 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.
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.
Note: Individuals using assistive technology may not be able to fully access information in these files. For assistance, please email HRSAAccessibility@hrsa.gov.