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 Opioid Call-back Surveys Form and Instruction	Unchanged
PRAMS Supplemental Modules Form and Instruction	Modified
PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules) Form and Instruction	Unchanged
0920-1273 Change Request_COVID and COVID vaccine supplements 07 28 2022v2.docx Justification for No Material/Nonsubstantive Change	2022-07-28
Appendix B Changes to SDOH questions cognitive testing.docx Supplementary Document	2022-03-30
Appendix A PRAMS_SDoH_testing report.pdf Supplementary Document	2022-03-30
0920-1273 Change Request_SDoH Supplement_03-30-2022.docx Justification for No Material/Nonsubstantive Change	2022-03-30
Web mode Change Request (0920-1273) 032222_v.2.docx Supplementary Document	2022-03-24
PRAMS SS-B_web mode_032222_v.2.docx Supporting Statement B	2022-03-24
PRAMS SS-A_web module_032222_v.2.docx Supporting Statement A	2022-03-24
Web module Change Request 0920-1273.docx Justification for No Material/Nonsubstantive Change	2021-09-23
0920-1273 Change Request Justification_6_07_21.docx Justification for No Material/Nonsubstantive Change	2021-06-22
Att 17-Field Testing Methodology.docx Supplementary Document	2019-06-20
Att 16-Opioid Call-Back Survey Alternate Methods.docx Supplementary Document	2019-06-20
Att 15-PRAMS Live Birth Sample Size by Jurisdiction.xlsx Supplementary Document	2019-06-20
Att 14-PRAMS IRB approval_19.docx Supplementary Document	2019-06-20
Att 5-PIDS Privacy Impact Assessment.pdf Supplementary Document	2019-06-20
Att 4-PRAMS Response Incentives and Rewards by State_rev_080118.docx Supplementary Document	2019-06-20
Att 3-PRAMS Questionnaire Development Process.docx Supplementary Document	2019-06-20
Att 2b_Response to Public Comments on 60 Day FRN.pdf Supplementary Document	2019-06-20
Att 2a-Published 60 Day FRN.pdf Supplementary Document	2019-06-20
Att 1c-PREEMIE ACT.pdf Supplementary Document	2019-06-20
Att 1b-SMART ACT.pdf Supplementary Document	2019-06-20
Att 1a-Section 301 of the Public Health Service Act (42 U.S.C. 241).docx Supplementary Document	2019-06-20

IC Document Collections

IC ID	Document Title	Status
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

OMB Control No: 0920-1273	ICR Reference No: 202207-0920-006
Status: Received in OIRA	Previous ICR Reference No: 202203-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1273-22HL
Title: 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: 07/28/2022

	Requested	Previously Approved
Expiration Date	11/30/2022	11/30/2022
Responses	149,094	117,594
Time Burden (Hours)	33,641	29,766
Cost Burden (Dollars)	825,520	730,438

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Abstract: 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).

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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
  

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:
	83 FR 44630	08/31/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 28817	06/20/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 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)	n/a, 0920-1273, n/a, n/a, n/a, n/a, 0920-1273, 0920-1273, 0920-1273, 0920-1273, n/a, n/a, n/a	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, n/a, n/a, 0920-1273, n/a, n/a	Family History of Breast and Ovarian Cancer Supplement ,   Prescription and Illicit Opioid Use Supplement ,   Disabilities Supplement ,   PRAMS Social Determinants of Health (SDOH) Supplemental Module ,   PRAMS COVID-19 Experience Supplemental Module (English or Spanish, mail or phone) ,   PRAMS COVID-19 Experience Supplemental Module (screenshots of web mode) ,   PRAMS COVID-19 Vaccine Supplemental Module (English or Spanish, mail or phone) ,   PRAMS COVID-19 Vaccine Supplemental Module (screenshots of web mode)

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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	149,094	117,594	0	31,500	0	0
Annual Time Burden (Hours)	33,641	29,766	0	3,875	0	0
Annual Cost Burden (Dollars)	825,520	730,438	0	95,082	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: COVID-19 information has been collected under the waiver for public health emergencies (PHE). CDC is submitting a Change Request to incorporate COVID-19 data collection into the PRAMS ICR and to ensure continuity in COVID-related data collection after the waiver expires,

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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? No

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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: 07/28/2022

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