[NCCDPHP] Pregnancy Risk Assessment Monitoring System (PRAMS)

Forms and Documents

Document Name	Status
PRAMS Stillbirth Survey Form and Instruction	Unchanged
PRAMS Field Test Form and Instruction	Unchanged
PRAMS Call-back Surveys (with Opioid Call-back Survey Example) Form and Instruction	Unchanged
PRAMS Supplemental Modules Form and Instruction	Unchanged
PRAMS Phase 8 and Phase 9 Questionnaires (Core Questions plus State-selected Standard Modules) Form and Instruction	Unchanged
OMB_Change Request_PRAMS 11-13-24.docx Justification for No Material/Nonsubstantive Change	2024-11-21
Att 17 - PRAMS Phase 9 Cognitive Testing Report.pdf Supplementary Document	2023-05-25
0920-1273 Response to Terms of Clearance _05_23_2023.docx Justification for No Material/Nonsubstantive Change	2023-05-25
FINAL for signature - Stacey Y Brayboy_March of Dimes - CAPS 00264282_signed.docx Supplementary Document	2023-05-25
Attachment 19a. Nonresponse Bias Assessment of 2020 and 2021 Data.docx Supplementary Document	2024-11-21
Att 18 - PRAMS Phase 9 Field Testing Report.pdf Supplementary Document	2023-03-22
Att 2f - PRAMS Phase 8 Web Mode Data Collection Metrics_03132023.docx Supplementary Document	2023-03-22
Att 16 Summary of Changes between Phase 8 and 9.docx Supplementary Document	2022-11-29
Att 15a - PRAMS Field Testing Methodology _03 13 2023 clean.docx Supplementary Document	2023-03-22
Att 14 - PRAMS Live Birth Sample Size by Jurisdiction.xlsx Supplementary Document	2022-11-29
Att 13 - PRAMS IRB Approval_2022.docx Supplementary Document	2022-11-29
Att 12j - Livebirth Web Introduction and Informed Consent - SPANISH.docx Supplementary Document	2022-11-29
Att 12i - PRAMS Livebirth Web Introduction and Informed Consent - ENGLISH.docx Supplementary Document	2022-11-29
Att 12h - Stillbirth Phone Introduction and Informed Consent_SPANISH.docx Supplementary Document	2022-11-29
Att 12g - Stillbirth Phone Introduction and Informed Consent_ENGLISH.docx Supplementary Document	2022-11-29
Att 12f - PRAMS Livebirth Phone Introduction and Informed Consent - SPANISH.docx Supplementary Document	2022-11-29
Att 12e - PRAMS Livebirth Phone Introduction and Informed Consent - ENGLISH.docx Supplementary Document	2022-11-29
Att 12d - Stillbirth Mail Introduction and Informed Consent - SPANISH.docx Supplementary Document	2022-11-29
Att 12c - Stillbirth Mail Introduction and Informed Consent_ENGLISH.docx Supplementary Document	2022-11-29
Att 12b - PRAMS Livebirth Mail Introduction and Informed Consent - SPANISH.docx Supplementary Document	2022-11-29
Att 12a - PRAMS Livebirth Mail Introduction and Informed Consent - ENGLISH.docx Supplementary Document	2022-11-29
Att 7 - PRAMS Livebirth Phase 8 and Phase 9 Questionnaire Topic Reference.docx Supplementary Document	2022-11-29
Att 6 - PIDS Privacy Impact Assessment.pdf Supplementary Document	2022-11-29
Att 5 - PRAMS Response Gifts and Incentives by Jurisdiction 03 13 2023 clean.docx Supplementary Document	2023-03-22
Att 4 - PRAMS Questionnaire Development Process.docx Supplementary Document	2022-11-29
Att 3b - Program Response to Comments 60 Day FRN.pdf Supplementary Document	2022-11-29
Att 3a - Published 60 Day FRN.pdf Supplementary Document	2022-11-29
Att 1c PREEMIE Reauthorization Act of 2018.pdf Supplementary Document	2022-11-29
Att 1b Safe Motherhood and Infant Health Authorization.docx Supplementary Document	2022-11-29
Att 1a-Section 301 of the Public Health Service Act (42 U.S.C. 241).docx Supplementary Document	2022-11-29
PRAMS SS-B_30 Day_11_13_2024_clean.docx Supporting Statement B	2024-11-21
1273 PRAMS SSA 11_13_24_clean.docx Supporting Statement A	2024-11-21

IC Document Collections

IC ID	Document Title	Status
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

OMB Control No: 0920-1273	ICR Reference No: 202411-0920-014
Status: Received in OIRA	Previous ICR Reference No: 202305-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1273
Title: [NCCDPHP] Pregnancy Risk Assessment Monitoring System (PRAMS)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/22/2024

	Requested	Previously Approved
Expiration Date	03/31/2026	03/31/2026
Responses	108,240	108,240
Time Burden (Hours)	31,268	31,268
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 39837	07/05/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 69024	11/17/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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."

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Annual Cost to Federal Government: $7,025,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 11/22/2024

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