2020-12244. 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 Colorectal Cancer Control Program (CRCCP) Monitoring Activities. CDC is requesting a revision to OMB No. 0920-1074 to include a redesigned survey, a redesigned clinic-level data collection instrument, and a new quarterly awardee-level program update survey.

DATES:

CDC must receive written comments on or before August 4, 2020.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2020-0064 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; 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

Colorectal Cancer Control Program (CRCCP) Monitoring Activities (OMB Control No. 0920-1074, Exp. 7/31/2020)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC)

Background and Brief Description

CDC is requesting a revision to Colorectal Cancer Control Program (CRCCP) Monitoring Activities (OMB Control No. 0920-1074). Based on feedback from awardees and internal subject matter experts, CDC proposes use of a revised annual grantee survey instrument (renamed, Annual Awardee Survey), a revised clinic-level data collection instrument, and a new awardee-level quarterly program update. The number of respondents will also increase from 30 to 35 awardees. Total estimated annualized burden will increase. OMB approval is requested for three years.

Colorectal cancer (CRC) is the second leading cause of death from cancer in the United States among cancers that affect both men and women. There is substantial evidence that CRC screening reduces the incidence of and death from the disease. Screening for CRC can detect disease early when treatment is more effective, and prevent cancer by finding and removing precancerous polyps. Of individuals diagnosed with early stage CRC, more than 90% live five or more years. Despite strong evidence supporting screening, only 68.8% of adults currently report being up-to-date with CRC screening as recommended by the U.S. Preventive Services Task Force, with more than 22 million age-eligible adults estimated to be untested. To reduce CRC morbidity, mortality, and associated costs, use of CRC screening tests must be increased among age-eligible adults with the lowest CRC screening rates.

The purpose of the Colorectal Cancer Control Program (CRCCP) is to partner with health systems and their individual primary care clinics to implement EBIs to increase CRC screening among defined populations of adults ages 50-75 that have CRC screening rates lower than the national, regional, or local rate. The previous cooperative agreement supporting the CRCCP (DP15-1502) funded 30 awardees that are state governments or bona-fide agents, universities, and tribal organizations. All 30 recipients received Component 1 funding, which required recipients to partner with health systems and their primary care clinics to implement at least two of four priority evidence-based interventions (EBIs) described in The Guide to Community Preventive Services as well as other supporting strategies. In addition, six recipients received Component 2 funding to provide clinical screening and follow-up services for a limited number of individuals aged 50-64 in the program's priority population who are asymptomatic, at average risk for CRC, have inadequate or no health insurance for CRC screening, and are low income.

In 2020, CDC issued a new funding opportunity, Public Health and Health System Partnerships to Increase Colorectal Cancer Screening in Clinical Settings (DP20-2002), a five-year cooperative agreement to increase CRC screening among defined populations of adults ages 50-75 that have CRC screening rates lower than the national, regional, or local rate. Similar to DP15-1502, DP20-2002 funds recipients to partner with health systems and their primary care clinics to implement multiple EBIs, partner with organizations to support implementation of EBIs in those clinics, and collect high-quality clinic-level data when a clinic is recruited to participate (baseline) and annually thereafter to monitor EBI implementation and assess screening rate changes. DP20-2002 eliminates Component 2 funding to provide direct clinical service delivery. However, DP20-2002 requires recipients to conduct a formal capacity/readiness assessment of potential clinics to implement EBIs, use assessment findings to select appropriate EBIs for implementation, and provide clinics with limited financial resources to support follow-up colonoscopies for under- and uninsured patients after an abnormal CRC screening test.

CDC proposes three information collections—a revised Annual Awardee Survey, a revised Clinic-Level Data Collection Instrument, and a new awardee-level Quarterly Program Update—to reflect the strategies and objectives detailed in DP20-2002.

The previous Annual Awardee Survey assessed: (1) Program management, (2) health information technology, (3) partnerships, (4) data use, (5) training and technical assistance (TA), (6) clinic service delivery. The revised instrument no longer includes questions related to clinic service delivery since these pertained solely to Component 2, which is no longer funded under DP20-2002. In addition, many program management questions were eliminated and will now be gathered via the Quarterly Program Update on a quarterly basis to better inform CDC TA. Several data use questions were eliminated as they did not yield meaningful data to inform CDC TA during the previous funding cycle.

The previous Clinic-level Data Collection instrument assessed: (1) Health system and clinic characteristics, (2) EBI and supporting activities implementation within clinics; (3) monitoring and quality improvement activities, and (4)CRC screening rates. The revised instrument was reorganized (e.g., sections merged, variables moved to new sections) for increased efficiency and to improve overall data quality. In addition, wording and responses for many variables and their response options have undergone minor revisions to better capture awardees' partnerships with both health systems and clinics, and appropriate capture of baseline and annual variables. The revised instrument gathers information to assess health system and clinic characteristics; program reach; CRC screening practices and outcomes; clinics' quality improvement and monitoring activities; EBI implementation, and additional factors that affect EBI implementation over time.

The new Quarterly Program Update will collect standardized awardee-level information on aspects of program management, including (1) quarterly program expenditures, (2) current staff vacancies, (3) program successes and challenges, and (4) current TA needs. This information collection will provide CDC staff rapid reporting of programmatic information to inform their efforts to provide awardees with tailored TA.

Redesigned data elements will enable CDC to better gauge progress in meeting CRCCP program goals and monitor implementation activities, evaluate outcomes, and identify awardee TA needs. In addition, data collected will inform program improvement and help identify successful activities that need to be maintained, replicated, or expanded.

OMB approval is requested for three years. The number of awardees will increase from 30 awardees in DP15-1502 to 35 awardees in DP20-2002, and the number of clinic partners is expected to increase from 12 to 24 per awardee. Therefore, the total estimated annualized burden hours have increased from 204 to 663 hours.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hr)	Total burden (in hr)
CRCCP Awardees	CRCCP Annual Awardee Survey	35	1	15/60	9
	CRCCP Clinic-level Information Collection Instrument	35	24	43/60	602
	CRCCP Quarterly Program Update	35	4	22/60	52
Total					663

Jeffrey M. Zirger,

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