Notice2022-11237
Draft Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns
Primary source
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Published
May 25, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 101 (Wednesday, May 25, 2022)</title>
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[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Pages 31888-31889]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> 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 <a href="http://regulations.gov">http://regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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: <a href="/cdn-cgi/l/email-protection#094a4a4e7c606d6c6560676c7a496a6d6a276e667f"><span class="__cf_email__" data-cfemail="4b08080c3e222f2e2722252e380b282f28652c243d">[email protected]</span></a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
(<a href="https://cdn.ymaws.com/www.cste.org/resource/resmgr/environmentalhealth/CSTE_Cancer_Cluster_Guidelin.pdf">https://cdn.ymaws.com/www.cste.org/resource/resmgr/environmentalhealth/CSTE_Cancer_Cluster_Guidelin.pdf</a>) and STLT Survey
and Focus Group Report (<a href="https://www.cdc.gov/nceh/clusters/survey-report.html">https://www.cdc.gov/nceh/clusters/survey-report.html</a>) have been developed or are in the process of being
developed and will be published on the CDC Cancer Clusters website
(<a href="https://www.cdc.gov/nceh/clusters/guidelines.htm">https://www.cdc.gov/nceh/clusters/guidelines.htm</a>) 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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 (<a href="https://ephtracking.cdc.gov/">https://ephtracking.cdc.gov/</a>). 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:
<bullet> 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;
<bullet> Revising the definition of a cancer cluster;
<bullet> Including specific and standardized approaches to better
engage community members;
<bullet> Explaining how to use a standardized template to better
document the nature and extent of cancer and environmental concerns;
and
<bullet> 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 <a href="https://www.cdc.gov/nceh/clusters/guidelines.htm">https://www.cdc.gov/nceh/clusters/guidelines.htm</a>.
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
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