2018-09914. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Medical Monitoring Project (MMP) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on [insert August 22, 2017] to obtain comments from the public and affected agencies. CDC received 1 comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Medical Monitoring Project (MMP)—(OMB No. 0920-0740 Exp: 6/30/2018)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention (DHAP) requests a revision of the currently approved Information Collection Request: “Medical Monitoring Project” expiring June 30, 2018. This data collection addresses the need for national estimates of access to and utilization of HIV-related medical care and services, the quality of HIV-related ambulatory care, and HIV-related behaviors and clinical outcomes.

For the proposed project, the same data collection methods will be used as for the currently approved project. Data would be collected from a probability sample of HIV-diagnosed adults in the U.S. who consent to an interview and abstraction of their medical records. As for the currently approved project, de-identified information would also be extracted from HIV case surveillance records for a dataset, referred to as the minimum dataset, which is used to assess non-response bias, for quality control, to improve the ability of MMP to monitor ongoing care and treatment of HIV-infected persons, and to make inferences from the MMP sample to HIV-diagnosed persons nationally. No other Federal agency collects such nationally representative population-based information from HIV-diagnosed adults. The data are expected to have significant implications for policy, program development, and resource allocation at the state/local and national levels.

The changes proposed in this request update the data collection system to meet prevailing information needs and enhance the value of MMP data, while remaining within the scope of the currently approved project purpose. The result is a 11% reduction in burden, or a reduction of 786 total burden hours annually. Specifically, the removal of three unfunded project areas reduces the number of interviews conducted and the number of persons for whom healthcare facility staff will be asked for contact information, assistance with approaching for participation, and pulling medical records.

Changes were made that did not affect the burden, listed below:

• Sampled persons found to have resided in a non-funded project area on the date of sampling will be considered ineligible for the project, because non-funded project areas were deemed ineligible in the first stage of sampling.
• Tracking data reports will no longer be sent to CDC, as this information is no longer needed.
• The average token of appreciation for participants has been increased from $25 to $50.
• Non-substantive changes have been made to recruitment materials to decrease the reading comprehension level, simplify and standardize procedures, and incorporate a user-friendly eligibility checklist.
• Changes have been made to the respondent consent form to decrease the reading comprehension level and clarify whom participants should contact for different concerns.
• Forty-three data elements were removed from the minimum data set and thirty-seven data elements were added. Because these data elements are extracted from the HIV surveillance system from which they are sampled, these changes do not affect the burden of the project.
• Revisions to the interview questionnaire were made to improve coherence, boost the efficiency of the data collection, and increase the relevance and value of the information. Based on an evaluation of the currently approved MMP interview instrument 118 questions were added to the interview form and 221 questions were removed. However, the average amount of time to complete the interview did not change.
• Thirty-nine data elements were removed from the MRA data structure because they were not found to be useful. No new elements were added. Because the medical records are abstracted by MMP staff, these changes do not affect the burden of the project.

This proposed data collection would supplement the National HIV Surveillance System (NHSS, OMB Control No. 0920-0573, Exp. 6/30/2019) in 23 selected state and local health departments, which collect information on persons diagnosed with, living with, and dying from HIV infection and AIDS.

Through their participation, respondents will help to improve programs to prevent HIV infection as well as services for those who already have HIV. The total burden hours are 6,354 hours. The participation of respondents is voluntary. There is no cost to the respondents other than their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average hours per response
Sampled, Eligible HIV-Infected Persons	Interview Questionnaire (att 8a)	7,760	1	45/60
Facility office staff looking up contact information	Look up contact information	1,940	1	2/60
Facility office staff approaching sampled persons for enrollment	Approach persons for enrollment	970	1	5/60
Facility office staff pulling medical records	Pull medical records	7,760	1	3/60

Jeffrey M. Zirger,

Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.