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 National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Monitoring Activities. Proposed study is designed to collect information about implementation, including delivery of screening and follow-up clinical services, and outcomes of the NBCCEDP.

DATES:

CDC must receive written comments on or before September 24, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0074 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: 404-639-7570; 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;

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

National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Monitoring Activities—(OMB Control No. 0920-1046, Exp. 11/30/2021)—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 of the information collection with the OMB Control Number 0920-1046, titled “National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Monitoring Activities.” In the previous OMB approval period, information collection consisted of an annual NBCCEDP survey and clinic-level data collection. In the next OMB approval period, information collection will consist of a revised NBCCEDP survey, revised clinic-level data collection, new quarterly program update, new service delivery projection worksheet, and the addition of previously approved minimum data elements (MDEs; OMB Control No. 0920-0571, Exp. 11/30/2021) to increase efficiency. The number of respondents will remain the same and the total estimated annualized burden will increase from 683 to 1,216.

Breast and cervical cancers are prevalent among U.S. women. In 2017, the U.S. experienced 250,520 new cases and 42,000 deaths as a result of breast cancer, as well as 12,831 new cases and 4,207 deaths as a result of cervical cancer. Evidence shows that deaths from both breast and cervical cancers can be avoided by increasing screening services—mammography and PAP tests—among women. However, screening is typically underutilized among women who are under- or uninsured, have no regular source of healthcare, or who recently immigrated to the U.S. As a longstanding priority within chronic disease prevention, CDC focuses on increasing access to these cancer screenings, particularly among women who may be at increased risk.

To improve access to cancer screening, Congress passed the Breast and Cervical Cancer Mortality Prevention Act of 1990 (Pub. L. 106-354), which directed CDC to create the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). The NBCCEDP currently provides funding to 70 awardees under “Cancer Prevention and Control Programs for State, Territorial, and Tribal Organizations (DP17-1701).” NBCCEDP awardees include states or their bona fide agents; U.S. territories; and tribes or tribal organizations. The purpose of NBCCEDP is to increase breast and cervical cancer screening rates among women residing within defined geographical locations (as determined by the funded program) who are at or below 250% of the federal poverty level; aged 40-64 years for breast cancer services, and aged 21-64 years for cervical cancer services; and under- or uninsured.

In 2022, CDC will issue a new Notice of Funding Opportunity (DP22-2202) to continue this mission. Consistent with programmatic changes, the information collection plan has also been redesigned to update existing, and add new data collection instruments, and to integrate the previously approved MDEs into this single approval package to increase efficiency of information collection for the NBCCEDP. This revised information collection will allow CDC to provide routine monitoring feedback to awardees based on their data submissions, tailor technical assistance (TA) as needed, support program planning, and assess program outcomes.

CDC proposes five forms of information collection. First, the NBCCEDP survey will be submitted to CDC annually and collects information to monitor awardees' TA needs, external funding sources, partnerships, EBI implementation, and COVID-19 impact. Minor revisions to survey questions and formatting reflect the program under DP22-2202. Second, clinic-level data will be submitted to CDC at baseline and annually for all partnering health system clinic sites—an estimated six clinics per awardee for breast cancer data and six clinics per awardee for cervical cancer data. Clinic-level data allow CDC to assess health system, clinic, and patient population characteristics; monitoring and quality improvement activities; EBI implementation; and baseline or annual screening rates. Minor revisions were made to variable wording, formatting (e.g., split or combined variables), and response options to improve data quality. Third, quarterly program updates will be submitted to CDC four times per year to monitor award spending, service delivery, staff vacancies, program challenges and successes, and TA needs. This is a new information collection. Fourth, the service delivery projection worksheet will be submitted to CDC annually to provide an estimate of the number of women served for breast and cervical cancer. Fifth, the minimum data elements (MDEs) will be submitted to CDC twice per year to monitor patient demographics; breast and cervical cancer screening, diagnosis, and treatment; timeliness of services; and patient navigation. This information collection was previously approved (OMB No. 0920-0571, exp. 03/30/2022) and incorporated into this approval package for increased efficiency for NBCCEDP information collection efforts.

The proposed information collections will allow CDC to gauge progress in meeting NBCCEDP program goals and monitor implementation activities, evaluate outcomes, and identify awardee TA needs. In addition, findings will inform program improvement and help identify successful activities that need to be maintained, replicated, or expanded.

OMB approval is requested for three years. CDC requests approval for an estimated 1,216 annual burden hours. Participation is required for NBCCEDP awardees. There are no costs to respondents other than their time.