Clinic Context Matters Study

Forms and Documents

Document Name	Status
Consent and Interview Form	Modified
CHANGE_REQUEST_201408-0920-1058_April.docx Justification for No Material/Nonsubstantive Change	2016-05-06
SS_Part A clean.docx Supporting Statement A	2016-05-06
IRB Approval .pdf Supplementary Document	2014-12-15
SS_Part B clean.doc Supporting Statement B	2016-05-06
Att 5_Public Comment.docx Supplementary Document	2014-11-20
Att 2 60 Day FRN.pdf Supplementary Document	2014-11-20
Att 1_Auth Legislation.docx Supplementary Document	2014-11-20

IC Document Collections

IC ID	Document Title	Status
214247	Consent and Interview Form	Modified

ICR Details

OMB Control No: 0920-1058	ICR Reference No: 201605-0920-002
Status: Historical Active	Previous ICR Reference No: 201411-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 14ARJ
Title: Clinic Context Matters Study
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: 05/09/2016
	Date Received in OIRA: 05/06/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	03/31/2018	03/31/2018
Responses	200	0	175
Time Burden (Hours)	100	0	88
Cost Burden (Dollars)	0	0	0

---

Abstract: The daily use of specific antiretroviral medications by persons without HIV infection, but at high risk exposure, has been shown to be a safe and effective HIV prevention method. The FDA approved Truvada® for preexposure prophylaxis (PrEP) in July 2012 and Public Health Services has issued clinical practice guidelines for its use. CDC requests approval to collect data to be used to conduct research about clinician knowledge, attitudes, and practices related to PrEP over the period of its initial introduction in their clinics. The knowledge will be used to refine measurement instruments and methods, develop training and educational resources and tools for use by CDC-funded partners, and other organizations supporting delivery of PrEP in clinical settings. This change request is to change two of the clinic sites and add a few more respondents with minimal change in burden.

---

Authorizing Statute(s): US Code: 42 USC 301 Name of Law: 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:
	79 FR 46827	08/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 68885	11/19/2014
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Consent and Interview	none	Survey

---

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	200	175	0	25	0	0
Annual Time Burden (Hours)	100	88	0	12	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: This request is for a minor increase in respondents, from 175 to 200, and changing two of the clinic sites to other cities. There is a minor change in burden from 88 to 100 hours.

---

Annual Cost to Federal Government: $34,700

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 05/06/2016

---