The National Children’s Study Program Office staff will determine whether referral to the Office of Management and Budget (OMB) is required for a given Supplemental Methodological Study proposal. If OMB referral is necessary, Program Office staff will inform the applicant and the applicant will provide the information necessary for OMB to consider approval. This includes, but is not limited to, a description of the study design, protocol, evaluation plan, and respondent burden hours. The Program Office will initiate the OMB referral, and will inform the applicant of the outcome. In general, OMB action, if indicated, is preferred to begin prior to IRB assessment. If OMB approval is indicated, it is required before information collection begins.