Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Medical Monitoring Project (MMP). The purpose of this data collection is to describe the health-related behaviors, experiences and needs of adults diagnosed with HIV in the United States. Data will be used to guide national and local HIV-related service organization and delivery, and monitor receipt of HIV treatment and prevention services and clinical outcomes.

DATES:

CDC must receive written comments on or before May 11, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0028 by any of the following methods:

• Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. 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;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. 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 submissions of responses.

5. Assess information collection costs.

Proposed Project

Medical Monitoring Project (MMP) (OMB Control No. 0920-0740, Exp. 6/30/2021)—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” which expires June 30, 2021. 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, deidentified 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 10% reduction in burden, or a reduction of 647 total burden hours annually. The reduction in burden was a result of revisions to the interview questionnaire that were made to improve coherence, boost the efficiency of the data collection, and increase the relevance and value of the information, which decreased the time of interview from 45 minutes to 40 minutes.

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

• Non-substantive changes have been made to the respondent consent form to decrease the reading comprehension level and make the form more visual.
• Nine data elements were removed from, and three data elements were added to the Minimum Dataset. 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.
• Seven data elements were added to the medical record abstraction data elements to collect information on SARS-CoV-2 (COVID-19) testing. 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. 11/30/2022) in 23 selected state and local health departments, which collect information on persons diagnosed with, living with, and dying from HIV infection and AIDS. The participation of respondents is voluntary. There is no cost to the respondents other than their time. Through their participation, respondents will help to improve programs to prevent HIV infection as well as services for those who already have HIV. Total estimated annual burden requested is 5,707 hours.