2019-04011. 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 Study on Disparities in Distress Screening among Lung and Ovarian Cancer Survivors. The goal of this study is to understand the processes, facilitators, and barriers related to implementing distress screening in 50 healthcare facilities.

DATES:

CDC must receive written comments on or before May 6, 2019.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2019-0006 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

Study on Disparities in Distress Screening Among Lung and Ovarian Cancer—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC)

Background and Brief Description

Within the cancer treatment community, interest in the psychosocial impacts of cancer diagnosis and treatment is increasing. These psychosocial impacts are wide ranging and include not only anxiety related to the illness and treatment side effects such as pain, fatigue and cognition, but also stress related to nonmedical issues such as family relationships, financial hardship, social stressors (e.g. transportation), and stigmatization. There is growing evidence that addressing the psychosocial stresses of cancer survivors increases both their longevity and quality of life.

The 2016 Institute of Medicine (currently, National Academies of Sciences, Engineering, and Medicine) ovarian cancer report, funded by CDC, calls for increased study of the psychosocial needs of ovarian cancer survivors, recognizing the high rates of depression, anxiety, and distress. Up to 60% of lung cancer survivors also experience high levels of distress. Both ovarian and lung cancer patients have relatively low 5-year survival rates (45% and 17%, respectively). Therefore, CDC believes that it is imperative to develop a greater understanding about the types of psychosocial services they receive during their course of treatment and follow-up care.

CDC proposes a new information collection to examine the extent to which disparities exist in distress screening and follow-up among cancer treatment facilities and programs across the country. The study will include 50 healthcare facilities. From these facilities, we will request electronic health records (EHR) of 2,000 lung and ovarian cancer survivors. Data elements collected will include patient demographic information, cancer diagnosis and treatment, experience with distress screening and follow-up care, and medical service utilization. Patient names, addresses, birth dates and Social Security Numbers will not be collected.

Staff from twelve of the 50 participating healthcare facilities will be invited to participate in an interview and focus group to provide contextual understanding about facilitators and barriers to distress screening and follow-up processes. This is a one-time data collection. Results of this study will provide CDC's National Comprehensive Cancer Control Program (NCCCP) with information to assist with the development of information, resources, technical assistance, and future evidence-based interventions to improve the quality of life of lung and ovarian cancer survivors. Summative findings will be used to evaluate the need to help with policy, systems, or environmental changes that may enhance the landscape of quality of life services for cancer survivors in communities at large. OMB approval is requested for one year. The total estimated annualized burden hours are 512.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Quantitative:
Healthcare Professionals (POC)	Survey	50	1	20/60	17
IT Staff	EMR data	50	1	7.5	375
Qualitative:
Healthcare Professionals	Key Informant Interview	12	1	1	12
	Focus Groups	72	1	1.5	108
Total					512

Jeffrey M. Zirger,

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