[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Pages 31888-31889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2022-0070]


Draft Guidelines for Examining Unusual Patterns of Cancer and 
Environmental Concerns

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), within 
the Department of Health and Human Services (HHS), announces the 
opening of a docket to obtain comment on the Draft Guidelines for 
Examining Unusual Patterns of Cancer and Environmental Concerns (2022 
Draft Guidelines). The 2022 Draft Guidelines provide updates to the 
2013 publication, Investigating Suspected Cancer Clusters and 
Responding to Community Concerns: Guidelines from the CDC and the 
Council of State and Territorial Epidemiologists (CSTE) (2013 
Guidelines). The updates provide state, tribal, local, and territorial 
health departments guidance for a revised and expanded approach to 
evaluating concerns about unusual patterns of cancer in communities, 
including those associated with local environmental concerns. The 2022 
Draft Guidelines provide recommendations only; compliance with these 
recommendations is voluntary.

DATES: Written comments must be received on or before July 25, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0070, by either of the methods listed below.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Environmental Health Science and 
Practice, National Center for Environmental Health, Centers for Disease 
Control and Prevention, Attn: Docket No. CDC-2022-0070, 4770 Buford 
Highway NE, Mailstop S-106-6, Atlanta, GA 30341.
    Instructions: All submissions received must include the agency name 
and docket number. All relevant comments, including any personal 
information provided will be posted without change to http://regulations.gov. Do not submit comments by email. CDC does not accept 
comments by email. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Alisha Etheredge, Centers for Disease 
Control and Prevention, National Center for Environmental Health, 
Division of Environmental Health Science and Practice, 4770 Buford 
Highway NE, Mailstop S-106-6, Atlanta, GA 30341; Telephone: 770-488-
4024; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data related to the 2022 
Draft Guidelines. In addition, CDC invites comments specifically on the 
following:
    1. Please comment on the strengths and limitations of the enhanced 
approach for routine, proactive evaluation of cancer patterns.
    2. Please comment on the strengths and limitations of the 
recommendations for enhancing communications and engagement with 
communities.
    3. Please comment on the strengths and limitations of the enhanced 
phased approach for responding to community inquiries.
    4. Please comment on the strengths and limitations of the new 
criteria for suggesting continued assessment of a report of an unusual 
pattern of cancer and addressing environmental concerns.
    5. Please comment on the strengths and limitations of the revised 
definition of a cancer cluster.
    6. Please comment on the strengths of the 2022 Draft Guidelines and 
provide suggestions to address weaknesses.
    7. Please comment on whether the language in the 2022 Draft 
Guidelines is sufficiently clear for both the general public and state, 
tribal, local, and territorial public health agency staff, in terms of 
comprehension of the investigative process and recommendations.
    8. Please provide any additional comments about the document.
    CDC will carefully consider all comments submitted in preparation 
of the final Guidelines for Examining Unusual Patterns of Cancer and 
Environmental Concerns and may revise the final document as 
appropriate.
    Please note that comments received, including attachments and other 
supporting materials, are part of the public record and are subject to 
public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your 
comment or supporting materials that you consider confidential or 
inappropriate for public disclosure. If you include your name, contact 
information, or other information that identifies you in the body of 
your comments, that information will be on public display. CDC will 
review all submissions and may choose to redact or withhold submissions 
containing private or proprietary information such as Social Security 
numbers, medical information, inappropriate language, or duplicate or 
near duplicate examples of a mass-mail campaign. Do not submit comments 
by email. CDC does not accept comment by email.

[[Page 31889]]

Background

    CDC/ATSDR develops guidance for state, tribal, local, and 
territorial (STLT) public health departments on how to respond to 
cancer cluster concerns. The current 2013 Guidelines provide a 
rationale and tool to assist STLT public health agencies in applying a 
systematic approach when responding to inquiries about suspected 
unusual patterns of cancer in residential or community settings. Since 
publication of the 2013 Guidelines, there have been technical and 
scientific advancements in areas such as data availability and analytic 
and geospatial methods.
    In the 2022 Draft Guidelines, CDC/ATSDR has updated and expanded 
the 2013 Guidelines to provide STLT public health agencies and other 
interested parties with access to information about current scientific 
tools and approaches to assess and respond to unusual patterns of 
cancer in communities. CDC/ATSDR plans to update the evidence base to 
include final reports associated with several of the inputs gathered to 
inform the 2022 Draft Guidelines.
    CDC/ATSDR developed the 2022 Draft Guidelines using input from a 
variety of stakeholders including STLT public health agencies, subject 
matter experts from academia and non-governmental organizations, an 
internal CDC/ATSDR steering committee, public comments received from a 
previous announcement in the Federal Register (84 FR 21786, Docket No. 
CDC-2019-0045), and focus groups conducted with community members and 
organizations that have been involved with cancer concerns in their 
communities. CDC/ATSDR also gathered input from a literature review and 
media scan and evaluated advances in the field of environmental 
epidemiology (e.g., geospatial methods) and community engagement 
strategies. An Environmental Media Scan Report, CSTE Workgroup Report 
(https://cdn.ymaws.com/www.cste.org/resource/resmgr/environmentalhealth/CSTE_Cancer_Cluster_Guidelin.pdf) and STLT Survey 
and Focus Group Report (https://www.cdc.gov/nceh/clusters/survey-report.html) have been developed or are in the process of being 
developed and will be published on the CDC Cancer Clusters website 
(https://www.cdc.gov/nceh/clusters/guidelines.htm) once available.
    As a result of these inputs, key themes emerged:
    1. The need for enhanced and improved engagement with communities;
    2. The need to deemphasize reliance on statistical significance so 
that statistical significance is not the deciding factor when 
evaluating the criteria to address cancer rates and environmental 
concerns;
    3. The need for routine, proactive evaluation of cancer data; and
    4. The need for tools and templates for standardized information 
collection and data evaluation.
    The 2022 Draft Guidelines address each of these themes in the 
following ways.
     Theme 1: Throughout the 2022 Draft Guidelines, the 
importance of communication and community engagement are addressed. 
Additionally, a section and one of the new recommended phases are 
devoted to communicating with and engaging communities, including 
identification of a community point of contact. These parts of the 
guidelines highlight and reinforce the need for establishing clear and 
ongoing communication channels about activities and challenges 
associated with the evaluation of unusual patterns of cancer and 
environmental concerns.
     Theme 2: The four-step approach to evaluate patterns of 
cancer and identify factors of concern to the community recommended in 
the 2013 Guidelines has been replaced with ten new criteria to clarify 
additional efforts that may be required. Statistical significance of 
the estimates for cancer rates is one among these criteria; however, 
the 2022 Draft Guidelines recommend that statistical significance alone 
should not be the deciding factor when evaluating the patterns of 
cancer. Further assessment and suggested actions are provided to 
include consideration of health equity and environmental justice issues 
when responding to community inquiries.
     Theme 3: The 2022 Draft Guidelines propose an approach for 
identifying and investigating unusual patterns of cancer as part of 
routine surveillance activities. The updates introduce a new section 
encouraging proactive evaluation of cancer registry data on a routine 
basis to monitor cancer trends and identify unusual patterns. The 2022 
Draft Guidelines also suggest that state health officials conduct 
routine monitoring of cancer data in an area of concern in situations 
when the criteria do not suggest further action at that time.
     Theme 4: New standardized data collection templates are 
provided to assist with the uniform collection of information during an 
inquiry from the community. Data collected and electronically 
transmitted will also enable CDC/ATSDR to have a clearer understanding 
of types of cancer and environmental concerns nationally.
    Other tools and resources included providing guidance regarding how 
to evaluate the new criteria. For example, decision trees are included 
to assist with understanding the new phases, the flow of activities, 
and reinforcing the proactive approach for routine evaluation of cancer 
surveillance data. A new tool for evaluating standardized incidence 
ratios (SIR) is also described. The SIR is a ratio of the number of 
observed cancer cases in the study population compared to the number 
that would be expected if the study population experienced the same 
cancer rates as a selected reference population (typically the state as 
a whole is used as a reference population). This tool will be available 
on the National Environmental Public Health Tracking Network (https://ephtracking.cdc.gov/). It will provide SIR estimates by county to 
enable review of cancer data by the public and STLT partners.
    In addition to these updates, other proposed changes in the 2022 
Draft Guidelines include the following:
     Changing the name of the guidelines to reflect 
consideration of environmental concerns as a factor when investigating 
a community inquiry about unusual patterns of cancer;
     Revising the definition of a cancer cluster;
     Including specific and standardized approaches to better 
engage community members;
     Explaining how to use a standardized template to better 
document the nature and extent of cancer and environmental concerns; 
and
     Enhanced appendices describing statistical and geospatial 
methods supporting the evaluation of unusual patterns of cancer.
    For more information about the process of developing the 2022 Draft 
Guidelines, please visit https://www.cdc.gov/nceh/clusters/guidelines.htm.

Supporting and Related Material in the Docket

    The 2022 Draft Guidelines can be found in the Supporting Materials 
tab of this docket.

Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-11237 Filed 5-24-22; 8:45 am]
BILLING CODE 4163-18-P