[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8100-8101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-19MM; Docket No. CDC-2019-0006]


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.

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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: 404-639-7570; Email: 
[email protected].

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

[[Page 8101]]

requested for one year. The total estimated annualized burden hours are 
512.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
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Quantitative:
    Healthcare Professionals    Survey..........              50               1           20/60              17
     (POC).
    IT Staff..................  EMR data........              50               1             7.5             375
Qualitative:
    Healthcare Professionals..  Key Informant                 12               1               1              12
                                 Interview.
                                Focus Groups....              72               1             1.5             108
                                                 ---------------------------------------------------------------
        Total.................  ................  ..............  ..............  ..............             512
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-04011 Filed 3-5-19; 8:45 am]
BILLING CODE 4163-18-P