2021-07839. 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 SimpleReport Mobile Application. SimpleReport is a free web-based application that provides an easy way to manage the testing workflow, to record results for rapid point of care COVID tests, to report the results to the appropriate public health department on behalf of the testing site, and to comply with existing requirements.

DATES:

CDC must receive written comments on or before June 15, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0038 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: [phone]; Email: [e-mail].

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;

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; and

5. Assess information collection costs.

Proposed Project

SimpleReport Mobile Application—New—Office of Science (OS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

SimpleReport is a free web-based application that provides an easy way to manage the testing workflow, to record results for rapid point of care COVID tests, to report the results to the appropriate public health department on behalf of the testing site, and to comply with existing requirements. The data collected through this application is crucial for public health departments to take action during the current health crisis. Currently, many point of care tests are reported on paper, on fax, or are not reported at all.

SimpleReport will help public health departments get faster, better data and help them:

• Do contact tracing and case investigation faster with positive cases
• Identify outbreaks in the community faster
• Calculate percent positivity for testing continuously

SimpleReport will allow the user, after the administration of a test, to load in patient data, data about the facility, and data about the testing device. The user can then use the application as a part of their testing workflow to manage their work. Information submitted to the application will be sent to the appropriate State, Local, Territorial, or Tribal Public Health Department. The Health Department, as appropriate, may share the anonymized data with CDC for public health purposes.

CDC requests OMB approval for an estimated 379,600 annual burden hours. There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Average number of responses per respondent	Average burden per response (hours)	Total burden (hours)
Testing Facility Users	SimpleReport Use—User Training	10,000	1	10/60	1,600
Testing Facility Users	SimpleReport Use—Inputting Patient Data and Test Result Reporting	10,000	1	6/60	1,000
Testing Facility Users	SimpleReport Use—Repeated Tests on Existing Users	10,000	12	6/60	12,000
Testing Facility Users	Long-Term Program—User Training	250,000	1	10/60	40,000
Testing Facility Users	Long-Term Program—Inputting Patient Data and Test Result Reporting	250,000	1	6/60	25,000
Testing Facility Users	Long-Term Program—Repeated Tests on Existing Users	250,000	12	6/60	300,000
Total					379,600

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.