Network Epidemiology of Syphilis Transmission (NEST)

Forms and Documents

Document Name	Status
Smartphone Survey - Study Participant Form and Instruction	New
NEST Survey - Study Participant Form and Instruction	New
NEST Data Elements - Site Data Manager Form and Instruction	New
Screener Form and Instruction	New
Att 3b_Data elements summary and source_11092018.docx Supplementary Document	2018-12-07
CDC Syphilis SSB_11092018.docx Supporting Statement B	2018-12-07
CDC Syphilis SSA_11092018.doc Supporting Statement A	2018-12-07
OSU IRB approval_July 2018.pdf Supplementary Document	2018-09-07
Baltimore_IRB approval letter.pdf Supplementary Document	2018-09-07
Att 10 PIA NEST.pdf Supplementary Document	2018-09-07
Att 8_Non research determination.pdf Supplementary Document	2018-09-07
Att 7_Project Personnel.doc Supplementary Document	2018-09-07
Att 6_Consent Form_11092018.doc Supplementary Document	2018-12-07
Att 2A_Public Comments.pdf Supplementary Document	2018-09-07
Att 1_Public Health Service Act.pdf Supplementary Document	2018-09-07

IC Document Collections

IC ID	Document Title	Status
232949	Smartphone Survey - Study Participant Form and Instruction	New
232948	NEST Survey - Study Participant Form and Instruction	New
232947	NEST Data Elements - Site Data Manager Form and Instruction	New
232946	Screener Form and Instruction	New

ICR Details

OMB Control No: 0920-1248	ICR Reference No: 201808-0920-013
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18MY
Title: Network Epidemiology of Syphilis Transmission (NEST)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/07/2018
	Date Received in OIRA: 09/25/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved
Responses	41,955	0	0
Time Burden (Hours)	6,828	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The Network Epidemiology of Syphilis Transmission (NEST) study will help inform methodologies for the collection of complex sexual network data among men who have sex with men (MSM) who are at high risk for syphilis in the United States. NEST will help to address knowledge gaps in the epidemiology of syphilis among this population of individuals.

---

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA
  

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 9318	03/05/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 45452	09/07/2018
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Screener	NA	Eligibility Screener
NEST Data Elements - Site Data Manager	NA	NEST Data Elements Summary and Source 07DEC2018
NEST Survey - Study Participant	NA	NEST - Questionnaire and Data Elements
Smartphone Survey - Study Participant	NA	NEST - Smartphone Survey 07DEC2018

---

ICR Summary 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	41,955	0	0	41,955	0	0
Annual Time Burden (Hours)	6,828	0	0	6,828	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: Submission of 0920-18MY - Network Epidemiology of Syphilis Transmission (NEST) is a New ICR.

---

Annual Cost to Federal Government: $2,724,241

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? Uncollected

---

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: 09/25/2018

---