Medical Monitoring Project

Forms and Documents

Document Name	Status
Form 2b Patient Short interview Form and Instruction	Modified
Form 2a Patients Standard Interview Form	Modified
Supporting_Statement_Part B.doc Supporting Statement B	2012-03-26
Attachment 14 MMP Protocol.pdf Supplementary Document	2012-03-26
Att_17 References.doc Supplementary Document	2012-03-26
Att_16 Formulas Used to Calculate RR.docx Supplementary Document	2012-03-26
Att_12 Summary of Changes 2 (2).docx Supplementary Document	2012-03-26
Att_10 Model Consent.doc Supplementary Document	2012-03-26
Att_8_Consultants.doc Supplementary Document	2012-03-26
Att_6_Assurance of Confidentiality.doc Supplementary Document	2012-03-26
Att_5 MMP Bibliography.docx Supplementary Document	2012-03-26
Att_4 minimum data set.docx Supplementary Document	2012-03-26
Attachment11_Model Scripts.doc Supplementary Document	2009-03-12
Supporting_Statement_Part A.doc Supporting Statement A	2012-03-26

IC Document Collections

IC ID	Document Title	Status
180569	Approaching Sampled Patients for Enrollment Instruction	Modified
180568	Providing Patient Lists for Medical Monitoring Project Patient Sampling Instruction	Modified
180566	Facility staff Providing Estimated Patient Loads Instruction	Modified
180565	Facility Staff Medical Record Abstraction Instruction	Modified
178498	Patient Short interview Form and Instruction	Modified
178497	Patients Standard Interview Form	Modified

ICR Details

OMB Control No: 0920-0740	ICR Reference No: 201203-0920-011
Status: Historical Active	Previous ICR Reference No: 201107-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Medical Monitoring Project
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/07/2012
	Date Received in OIRA: 03/29/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2015	36 Months From Approved	05/31/2012
Responses	20,126	0	20,045
Time Burden (Hours)	8,537	0	8,500
Cost Burden (Dollars)	0	0	0

---

Abstract: The Medical Monitoring Project (MMP) was designed to address the need for a national behavioral and clinical surveillance system for HIV-infected persons, as articulated in CDC's HIV Prevention Strategic Plan. The primary objective of MMP is to conduct behavioral and clinical surveillance among a probability sample of persons with HIV infection in the United States in order to assess prevalence of and trends in: 1) risk behaviors for HIV transmission, 2) HIV care and treatment, and 3) exposure to, use of, and impact of HIV prevention services. Through MMP, CDC works with state and local health departments to obtain HIV-related behavioral and clinical data through confidential interviews and medical record abstractions. MMP addresses the goal of strengthening the capacity nationwide to monitor the epidemic to better direct and evaluate prevention, care, and treatment efforts.

---

Authorizing Statute(s): PL: Pub.L. 111 - 241 301 Name of Law: Title III - General Powers and Duties of Public Health Service
  

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:
	77 FR 2066	01/13/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 17063	03/23/2012
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Patients Standard Interview	2a	2012 Standard Interview Questionnaire for Medical Monitoring Project (MMP)
Patient Short interview	2b	2012 Short Interview Questionnaire for Medical Monitoring Project (MMP)
Facility Staff Medical Record Abstraction
Facility staff Providing Estimated Patient Loads
Providing Patient Lists for Medical Monitoring Project Patient Sampling
Approaching Sampled Patients for Enrollment

---

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	20,126	20,045	0	81	0	0
Annual Time Burden (Hours)	8,537	8,500	0	37	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: Estimated annualized burden hours changed from 8,500 to 8,537 because an additional 62 patients will be sampled (total of 9400 patients from previously approved 9338 patients)

---

Annual Cost to Federal Government: $14,700,128

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? Yes

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: 03/29/2012

---