Pregnancy Risk Assessment Monitoring System (PRAMS)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
PRAMS Stillbirth Phone Questionnaire (Spanish)	Form and Instruction	Unchanged	Available
PRAMS Stillbirth Phone Questionnaire (English)	Form and Instruction	Unchanged	Available
PRAMS Stillbirth Mail Questionnaire (Spanish)	Form and Instruction	Unchanged	Available
PRAMS Stillbirth Mail Questionnaire (English)	Form and Instruction	Unchanged	Available
PRAMS Stillbirth Survey	Form and Instruction	Unchanged	Repair queued
PRAMS Field Testing	Form and Instruction	Unchanged	Available
PRAMS Field Test	Form and Instruction	Unchanged	Repair queued
PRAMS Opioid Call-back Survey (Spanish)	Form and Instruction	Unchanged	Available
PRAMS Opioid Call-back Survey (English)	Form and Instruction	Unchanged	Available
PRAMS Opioid Call-back Surveys	Form and Instruction	Unchanged	Repair queued
Form 0920-1273 PRAMS Social Determinants of Health (SDOH) Supplemental Module	Form and Instruction	Modified	Available
Disabilities Supplement	Form and Instruction	Modified	Available
Prescription and Illicit Opioid Use Supplement	Form and Instruction	Modified	Available
Family History of Breast and Ovarian Cancer Supplement	Form and Instruction	Modified	Available
PRAMS Supplemental Modules	Form and Instruction	Modified	Repair queued
Form 0920-1273 Wyoming PRAMS Grantee Web Questionnaire	Form	Unchanged	Available
Form 0920-1273 Virginia PRAMS Grantee Web Questionnaire	Form	Unchanged	Available
Form 0920-1273 South Carolina PRAMS Grantee Web Questionnaire	Form	Unchanged	Repair queued
Form 0920-1273 Puerto Rico PRAMS Grantee Web Questionnaire	Form	Unchanged	Available
Form 0920-1273 Maryland PRAMS Grantee Web Questionnaire	Form	Unchanged	Available
PRAMS Livebirth Standard Phase 8 Phone Modules (Spanish)	Form and Instruction	Unchanged	Repair queued
PRAMS Livebirth Standard Phase 8 Phone Modules (English)	Form and Instruction	Unchanged	Available
PRAMS Livebirth Standard Phase 8 Mail Modules (Spanish)	Form and Instruction	Unchanged	Available
PRAMS Livebirth Standard Phase 8 Mail Modules (English)	Form and Instruction	Unchanged	Available
PRAMS Livebirth Core Phase 8 Phone Questionnaire (Spanish)	Form and Instruction	Unchanged	Available
PRAMS Livebirth Core Phase 8 Phone Questionnaire (English)	Form and Instruction	Unchanged	Available
PRAMS Livebirth Core Phase 8 Mail Questionnaire (Spanish)	Form and Instruction	Unchanged	Available
PRAMS Livebirth Core Phase 8 Mail Questionnaire (English)	Form and Instruction	Unchanged	Available
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	Repair queued
Web module Change Request 0920-1273.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-09-23	Repair queued
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	Repair queued
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	Repair queued
Att 3-PRAMS Questionnaire Development Process.docx	Supplementary Document	Uploaded 2019-06-20	Repair queued
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	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
236591	PRAMS Stillbirth Survey	Form and Instruction	Unchanged	PRAMS Stillbirth Phone Questionnaire (Spanish)
236591	PRAMS Stillbirth Survey	Form and Instruction	Unchanged	PRAMS Stillbirth Phone Questionnaire (English)
236591	PRAMS Stillbirth Survey	Form and Instruction	Unchanged	PRAMS Stillbirth Mail Questionnaire (Spanish)
236591	PRAMS Stillbirth Survey	Form and Instruction	Unchanged	PRAMS Stillbirth Mail Questionnaire (English)
236591	PRAMS Stillbirth Survey	Form and Instruction	Unchanged
236590	PRAMS Field Test	Form and Instruction	Unchanged	PRAMS Field Testing
236590	PRAMS Field Test	Form and Instruction	Unchanged
236589	PRAMS Opioid Call-back Surveys	Form and Instruction	Unchanged	PRAMS Opioid Call-back Survey (Spanish)
236589	PRAMS Opioid Call-back Surveys	Form and Instruction	Unchanged	PRAMS Opioid Call-back Survey (English)
236589	PRAMS Opioid Call-back Surveys	Form and Instruction	Unchanged
236588	PRAMS Supplemental Modules	Form and Instruction	Modified	PRAMS Social Determinants of Health (SDOH) Supplemental Module
236588	PRAMS Supplemental Modules	Form and Instruction	Modified	Disabilities Supplement
236588	PRAMS Supplemental Modules	Form and Instruction	Modified	Prescription and Illicit Opioid Use Supplement
236588	PRAMS Supplemental Modules	Form and Instruction	Modified	Family History of Breast and Ovarian Cancer Supplement
236588	PRAMS Supplemental Modules	Form and Instruction	Modified
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form	Unchanged	Wyoming PRAMS Grantee Web Questionnaire
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form	Unchanged	Virginia PRAMS Grantee Web Questionnaire
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form	Unchanged	South Carolina PRAMS Grantee Web Questionnaire
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form	Unchanged	Puerto Rico PRAMS Grantee Web Questionnaire
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form	Unchanged	Maryland PRAMS Grantee Web Questionnaire
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Standard Phase 8 Phone Modules (Spanish)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Standard Phase 8 Phone Modules (English)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Standard Phase 8 Mail Modules (Spanish)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Standard Phase 8 Mail Modules (English)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Core Phase 8 Phone Questionnaire (Spanish)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Core Phase 8 Phone Questionnaire (English)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Core Phase 8 Mail Questionnaire (Spanish)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged	PRAMS Livebirth Core Phase 8 Mail Questionnaire (English)
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Form and Instruction	Unchanged
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	Other-Reference Material: Phase 8 Core and Standard Questions, b	Unchanged

ICR Details

OMB Control No: 0920-1273	ICR Reference No: 202203-0920-012
Status: Historical Active	Previous ICR Reference No: 202109-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1273-22DX
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/29/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/31/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	11/30/2022	11/30/2022
Responses	117,594	0	117,594
Time Burden (Hours)	29,766	0	29,766
Cost Burden (Dollars)	730,438	0	730,438

---

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).

---

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

---

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

---

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

---

Number of Information Collection (IC) in this ICR: 5

table that charts list of burden

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

---

ICR Summary of Burden

table that charts list of burden

	Total Approved	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

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:

---

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

---

Common Form ICR:  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:

(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: 03/31/2022

---