Information Collection Request

Pregnancy Risk Assessment Monitoring System (PRAMS)

ICR 202203-0920-012 · OMB 0920-1273 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
PRAMS Stillbirth Survey Form and Instruction Unchanged Missing upstream
PRAMS Field Test Form and Instruction Unchanged Repair queued
PRAMS Opioid Call-back Surveys Form and Instruction Unchanged Repair queued
PRAMS Supplemental Modules Form and Instruction Modified Repair queued
PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules) Form and Instruction Unchanged Repair queued
Appendix B Changes to SDOH questions cognitive testing.docx Supplementary Document Uploaded 2022-03-30 Repair queued
Appendix A PRAMS_SDoH_testing report.pdf Supplementary Document Uploaded 2022-03-30 Repair queued
0920-1273 Change Request_SDoH Supplement_03-30-2022.docx Justification for No Material/Nonsubstantive Change Uploaded 2022-03-30 Repair queued
Web mode Change Request (0920-1273) 032222_v.2.docx Supplementary Document Uploaded 2022-03-24 Repair queued
PRAMS SS-B_web mode_032222_v.2.docx Supporting Statement B Uploaded 2022-03-24 Repair queued
PRAMS SS-A_web module_032222_v.2.docx Supporting Statement A Uploaded 2022-03-24 Missing upstream
Web module Change Request 0920-1273.docx Justification for No Material/Nonsubstantive Change Uploaded 2021-09-23 Missing upstream
0920-1273 Change Request Justification_6_07_21.docx Justification for No Material/Nonsubstantive Change Uploaded 2021-06-22 Repair queued
Att 17-Field Testing Methodology.docx Supplementary Document Uploaded 2019-06-20 Missing upstream
Att 16-Opioid Call-Back Survey Alternate Methods.docx Supplementary Document Uploaded 2019-06-20 Repair queued
Att 15-PRAMS Live Birth Sample Size by Jurisdiction.xlsx Supplementary Document Uploaded 2019-06-20 Repair queued
Att 14-PRAMS IRB approval_19.docx Supplementary Document Uploaded 2019-06-20 Repair queued
Att 5-PIDS Privacy Impact Assessment.pdf Supplementary Document Uploaded 2019-06-20 Repair queued
Att 4-PRAMS Response Incentives and Rewards by State_rev_080118.docx Supplementary Document Uploaded 2019-06-20 Missing upstream
Att 3-PRAMS Questionnaire Development Process.docx Supplementary Document Uploaded 2019-06-20 Missing upstream
Att 2b_Response to Public Comments on 60 Day FRN.pdf Supplementary Document Uploaded 2019-06-20 Repair queued
Att 2a-Published 60 Day FRN.pdf Supplementary Document Uploaded 2019-06-20 Repair queued
Att 1c-PREEMIE ACT.pdf Supplementary Document Uploaded 2019-06-20 Repair queued
Att 1b-SMART ACT.pdf Supplementary Document Uploaded 2019-06-20 Repair queued
Att 1a-Section 301 of the Public Health Service Act (42 U.S.C. 241).docx Supplementary Document Uploaded 2019-06-20 Missing upstream
IC Document Collections
IC IDCollectionTypeStatusForm
236591 PRAMS Stillbirth Survey Form and Instruction Unchanged
236590 PRAMS Field Test Form and Instruction Unchanged
236589 PRAMS Opioid Call-back Surveys Form and Instruction Unchanged
236588 PRAMS Supplemental Modules Form and Instruction Modified
236587 PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules) Form and Instruction Unchanged
ICR Details
0920-1273 202203-0920-012
Received in OIRA 202109-0920-010
HHS/CDC 0920-1273-22DX
Pregnancy Risk Assessment Monitoring System (PRAMS)
No material or nonsubstantive change to a currently approved collection   No
Regular 03/31/2022
  Requested Previously Approved
11/30/2022 11/30/2022
117,594 117,594
29,766 29,766
730,438 730,438

CDC in collaboration with the Council for State and Territorial Epidemiologists sub-contracted or cognitive and field testing of the SDOH supplement that was completed from December 2021 through January 2022. The sub-contractor coordinated with two local pediatric clinics to identify eligible cognitive and field test participants. The participants for cognitive and field testing consisted of women who delivered a live born infant and who were ≤12 months postpartum. Both practices had large, diverse patient populations. The testing emphasis included obtaining data on the phrasing of the timeframe, and the use of Likert-scale responses. Testing was conducted in two phases--cognitive testing followed by field testing. Cognitive testing was conducted to assess respondents’ ability to understand standardized terminology and ensure the survey questions capture the scientific intent to ensure validity and appropriateness of proposed supplement. Cognitive testing methodology utilizes respondent narratives, which are collected using verbal probing techniques. Cognitive testing was conducted with 9 persons. Testing was conducted using all four questionnaire versions: English mail and phone, and Spanish mail and phone. Phone surveys were read to participants, while mail surveys were printed and given to participants to be filled out on their own, answering at their pace. For more details on the cognitive testing and field-testing methodology, please see the full report titled ‘Cognitive and Field Testing Evaluation of the Pregnancy Risk Assessment Monitoring System (PRAMS), Social Determinants of Health Supplement’ (Appendix A).

PL: Pub.L. 109 - 450 3 Name of Law: PREEMIE Act
   US Code: 42 USC 301 Name of Law: Public Health Service Act: Research and Investigations
  
None

Not associated with rulemaking

  83 FR 44630 08/31/2018
84 FR 28817 06/20/2019
Yes

5
IC Title Form No. Form Name
PRAMS Field Test n/a PRAMS Field Testing
PRAMS Opioid Call-back Surveys n/a, n/a PRAMS Opioid Call-back Survey (English) ,   PRAMS Opioid Call-back Survey (Spanish)
PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules) 0920-1273, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, 0920-1273, 0920-1273, 0920-1273, 0920-1273 PRAMS Livebirth Core Phase 8 Mail Questionnaire (English) ,   PRAMS Livebirth Core Phase 8 Mail Questionnaire (Spanish) ,   PRAMS Livebirth Core Phase 8 Phone Questionnaire (English) ,   PRAMS Livebirth Core Phase 8 Phone Questionnaire (Spanish) ,   PRAMS Livebirth Standard Phase 8 Mail Modules (English) ,   PRAMS Livebirth Standard Phase 8 Mail Modules (Spanish) ,   PRAMS Livebirth Standard Phase 8 Phone Modules (English) ,   PRAMS Livebirth Standard Phase 8 Phone Modules (Spanish) ,   Maryland PRAMS Grantee Web Questionnaire ,   Puerto Rico PRAMS Grantee Web Questionnaire ,   South Carolina PRAMS Grantee Web Questionnaire ,   Virginia PRAMS Grantee Web Questionnaire ,   Wyoming PRAMS Grantee Web Questionnaire
PRAMS Stillbirth Survey n/a, n/a, n/a, n/a PRAMS Stillbirth Mail Questionnaire (English) ,   PRAMS Stillbirth Mail Questionnaire (Spanish) ,   PRAMS Stillbirth Phone Questionnaire (English) ,   PRAMS Stillbirth Phone Questionnaire (Spanish)
PRAMS Supplemental Modules n/a, n/a, n/a, 0920-1273 Family History of Breast and Ovarian Cancer Supplement ,   Prescription and Illicit Opioid Use Supplement ,   Disabilities Supplement ,   PRAMS Social Determinants of Health (SDOH) Supplemental Module

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 117,594 117,594 0 0 0 0
Annual Time Burden (Hours) 29,766 29,766 0 0 0 0
Annual Cost Burden (Dollars) 730,438 730,438 0 0 0 0
No
No

$7,025,000
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Thelma Sims 4046394771

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
03/31/2022