Information Collection Request

[NCCDPHP] Pregnancy Risk Assessment Monitoring System (PRAMS)

ICR 202411-0920-014 · OMB 0920-1273 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
PRAMS Stillbirth Survey Form and Instruction Unchanged Repair queued
PRAMS Field Test Form and Instruction Unchanged Repair queued
PRAMS Call-back Surveys (with Opioid Call-back Survey Example) Form and Instruction Unchanged Repair queued
PRAMS Supplemental Modules Form and Instruction Unchanged Missing upstream
PRAMS Phase 8 and Phase 9 Questionnaires (Core Questions plus State-selected Standard Modules) Form and Instruction Unchanged Repair queued
OMB_Change Request_PRAMS 11-13-24.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-11-21 Repair queued
Att 17 - PRAMS Phase 9 Cognitive Testing Report.pdf Supplementary Document Uploaded 2023-05-25 Repair queued
0920-1273 Response to Terms of Clearance _05_23_2023.docx Justification for No Material/Nonsubstantive Change Uploaded 2023-05-25 Missing upstream
FINAL for signature - Stacey Y Brayboy_March of Dimes - CAPS 00264282_signed.docx Supplementary Document Uploaded 2023-05-25 Repair queued
Attachment 19a. Nonresponse Bias Assessment of 2020 and 2021 Data.docx Supplementary Document Uploaded 2024-11-21 Repair queued
Att 18 - PRAMS Phase 9 Field Testing Report.pdf Supplementary Document Uploaded 2023-03-22 Repair queued
Att 2f - PRAMS Phase 8 Web Mode Data Collection Metrics_03132023.docx Supplementary Document Uploaded 2023-03-22 Missing upstream
Att 16 Summary of Changes between Phase 8 and 9.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 15a - PRAMS Field Testing Methodology _03 13 2023 clean.docx Supplementary Document Uploaded 2023-03-22 Repair queued
Att 14 - PRAMS Live Birth Sample Size by Jurisdiction.xlsx Supplementary Document Uploaded 2022-11-29 Missing upstream
Att 13 - PRAMS IRB Approval_2022.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12j - Livebirth Web Introduction and Informed Consent - SPANISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12i - PRAMS Livebirth Web Introduction and Informed Consent - ENGLISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12h - Stillbirth Phone Introduction and Informed Consent_SPANISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12g - Stillbirth Phone Introduction and Informed Consent_ENGLISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12f - PRAMS Livebirth Phone Introduction and Informed Consent - SPANISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12e - PRAMS Livebirth Phone Introduction and Informed Consent - ENGLISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12d - Stillbirth Mail Introduction and Informed Consent - SPANISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12c - Stillbirth Mail Introduction and Informed Consent_ENGLISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12b - PRAMS Livebirth Mail Introduction and Informed Consent - SPANISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 12a - PRAMS Livebirth Mail Introduction and Informed Consent - ENGLISH.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 7 - PRAMS Livebirth Phase 8 and Phase 9 Questionnaire Topic Reference.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 6 - PIDS Privacy Impact Assessment.pdf Supplementary Document Uploaded 2022-11-29 Missing upstream
Att 5 - PRAMS Response Gifts and Incentives by Jurisdiction 03 13 2023 clean.docx Supplementary Document Uploaded 2023-03-22 Repair queued
Att 4 - PRAMS Questionnaire Development Process.docx Supplementary Document Uploaded 2022-11-29 Repair queued
Att 3b - Program Response to Comments 60 Day FRN.pdf Supplementary Document Uploaded 2022-11-29 Repair queued
Att 3a - Published 60 Day FRN.pdf Supplementary Document Uploaded 2022-11-29 Repair queued
Att 1c PREEMIE Reauthorization Act of 2018.pdf Supplementary Document Uploaded 2022-11-29 Repair queued
Att 1b Safe Motherhood and Infant Health Authorization.docx Supplementary Document Uploaded 2022-11-29 Available
Att 1a-Section 301 of the Public Health Service Act (42 U.S.C. 241).docx Supplementary Document Uploaded 2022-11-29 Repair queued
PRAMS SS-B_30 Day_11_13_2024_clean.docx Supporting Statement B Uploaded 2024-11-21 Repair queued
1273 PRAMS SSA 11_13_24_clean.docx Supporting Statement A Uploaded 2024-11-21 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
257195 Submission of Data File to CDC Instruction Unchanged
236591 PRAMS Stillbirth Survey Form and Instruction Unchanged
236590 PRAMS Field Test Form and Instruction Unchanged
236589 PRAMS Call-back Surveys (with Opioid Call-back Survey Example) Form and Instruction Unchanged
236588 PRAMS Supplemental Modules Form and Instruction Unchanged
236587 PRAMS Phase 8 and Phase 9 Questionnaires (Core Questions plus State-selected Standard Modules) Form and Instruction Unchanged
ICR Details
0920-1273 202411-0920-014
Received in OIRA 202305-0920-012
HHS/CDC 0920-1273
[NCCDPHP] Pregnancy Risk Assessment Monitoring System (PRAMS)
No material or nonsubstantive change to a currently approved collection   No
Regular 11/22/2024
  Requested Previously Approved
03/31/2026 03/31/2026
108,240 108,240
31,268 31,268
0 0

We request a non-substantive change to OMB control number 0920-1273 to 1) remove the current response threshold requirement so all jurisdiction data are available for release to internal and external researchers and 2) change release of PRAMS multi-jurisdiction data from previously documented proposal process to the PRAMS Automated Research File (ARF) process.

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
   US Code: 42 USC 247b-12 Name of Law: Safe Motherhood and Infant Health
  
None

Not associated with rulemaking

  87 FR 39837 07/05/2022
87 FR 69024 11/17/2022
Yes

6
IC Title Form No. Form Name
PRAMS Call-back Surveys (with Opioid Call-back Survey Example) n/a, n/a PRAMS Opioid Call-back Survey (English) ,   PRAMS Opioid Call-back Survey (Spanish)
PRAMS Field Test None PRAMS Field Testing Questionnaire (English and Spanish)
PRAMS Phase 8 and Phase 9 Questionnaires (Core Questions plus State-selected Standard Modules) None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None, None PRAMS Phase 8 Web Survey - MD ,   PRAMS Phase 8 Web Survey - PR ,   PRAMS Phase 8 Web Survey - SC ,   PRAMS Phase 8 Web Survey - VA ,   PRAMS Phase 8 Web Survey - WY ,   PRAMS Livebirth Phase 8 Core Mail Questionnaire (English) ,   PRAMS Livebirth Phase 8 Core Mail Questionnaire (Spanish) ,   PRAMS Livebirth Phase 8 Core Phone Questionnaire (English) ,   PRAMS Livebirth Phase 8 Core Phone Questionnaire (English) ,   PRAMS Livebirth Phase 9 Core Mail Questionnaire (English) ,   PRAMS Livebirth Phase 9 Core Mail Questionnaire (Spanish) ,   PRAMS Livebirth Phase 9 Core Phone Questionnaire (English) ,   PRAMS Livebirth Phase 9 Core Phone Questionnaire (Spanish) ,   PRAMS Livebirth Phase 9 Core Web Questionnaire (English) ,   PRAMS Livebirth Phase 9 Core Web Questionnaire (Spanish) ,   PRAMS Livebirth Phase 8 Standard Mail Modules (English) ,   PRAMS Livebirth Phase 8 Standard Mail Modules (Spanish) ,   PRAMS Livebirth Phase 8 Standard Phone Module (English) ,   PRAMS Livebirth Phase 8 Standard Phone Module (Spanish) ,   PRAMS Livebirth Phase 9 Standard Mail Questionnaire (English) ,   PRAMS Livebirth Phase 9 Standard Mail Questionnaire (Spanish) ,   PRAMS Livebirth Phase 9 Standard Phone Questionnaire (English) ,   PRAMS Livebirth Phase 9 Standard Phone Questionnaire (Spanish) ,   PRAMS Livebirth Phase 9 Standard Web Module (English) ,   PRAMS Livebirth Phase 9 Standard Web Module (Spanish)
PRAMS Stillbirth Survey None, None, None, None PRAMS Stillbirth Mail Questionnaire (English) ,   PRAMS Stillbirth Mail Questionnaire (Spanish) ,   PRAMS Stillbirth Phone Questionnaire (English) ,   PRAMS Stillbirth Phone Questionnaire (Spanish)
PRAMS Supplemental Modules None, None, None, None, None, None, None, None, None, None, None, None PRAMS Social Determinants of Health Supplement (mail and phone) ,   PRAMS Social Determinants of Health Supplement (web mode) ,   PRAMS COVID-19 Vaccine Supplement (mail and phone) ,   PRAMS COVID-19 Vaccine Supplement (web mode) ,   PRAMS COVID-19 Experience Supplement (mail and phone) ,   PRAMS COVID-19 Experience Supplement (web mode) ,   PRAMS Opioid Use Supplement (mail and phone) ,   PRAMS Opioid Use Supplement (web mode) ,   PRAMS Marijuana Use Supplement (mail and phone) ,   PRAMS Marijuana Use Supplement (web mode) ,   PRAMS Disabilities Supplement (mail and phone) ,   PRAMS Disabilities Supplement (web mode)
Submission of Data File to CDC

  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 108,240 108,240 0 0 0 0
Annual Time Burden (Hours) 31,268 31,268 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
CDC will continue to use the approved Phase 8 questionnaires until April 2023, when the Phase 9 questionnaires will be implemented with changes in content that are described in an attachment to the ICR. Five states are currently implementing a web-based mode of data collection which will be made available as an option for all states in Phase 9. CDC has added a new IC to account for the burden to states of preparing and submitting an aggregate data file. There are minor changes to the estimated number of respondents for the core PRAMS survey, an expected increase in the use of supplemental modules, and updated estimates for field testing. Additional information collection needed to monitor COVID-19 vaccination and experiences was formally incorporated in 2022 and will continue. The net result is a modest decrease in total estimated annualized burden of 2,373 hours. In addition, note that the change in the total cost burden appears to be very large. However, the change in total cost burden is associated with the change in accounting method. In the past, CDC reported the cost burden for each IC as the wage-equivalents that appear in Section 12.B of the supporting statement. Consistent with the rest of HHS, CDC is now reporting the total from Section 13 in the "burden cost" field for each IC. Section 13 covers nonwage costs (e.g., equipment). As such, costs associated with these ICs are now "zero."

$7,025,000
Yes Part B of Supporting Statement
    No
    No
No
No
No
Yes
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.
11/22/2024