Availability of Final Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns, 75273-75275 [2022-26664]
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75273
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
Hours per
respondent
Hourly wage and labor category
$20.88 Clerical Workers ..................................................................................
lotter on DSK11XQN23PROD with NOTICES1
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VerDate Sep<11>2014
17:36 Dec 07, 2022
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annual labor
costs
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367,176
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Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2022–26623 Filed 12–7–22; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2022–0070]
Availability of Final Guidelines for
Examining Unusual Patterns of Cancer
and Environmental Concerns
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: General notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) and the
Agency for Toxic Substances and
Disease Registry (ATSDR), located
within the Department of Health and
Human Services (HHS) announces the
availability of the final Guidelines for
Examining Unusual Patterns of Cancer
and Environmental Concerns (2022
Guidelines). The 2022 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). The updates
provide state, tribal, local, and territorial
health departments guidance for a
SUMMARY:
E:\FR\FM\08DEN1.SGM
08DEN1
75274
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
revised and expanded approach to
evaluating concerns about unusual
patterns of cancer in communities,
including those associated with local
environmental concerns. The 2022
Guidelines finalize the draft guidelines
issued on May 25, 2022.
DATES: The 2022 Guidelines are
available December 8, 2022.
FOR FURTHER INFORMATION CONTACT:
Amy Lavery, Centers for Disease Control
and Prevention, National Center for
Environmental Health, Division of
Environmental Health Science and
Practice, 4770 Buford Highway NE,
Mailstop F–60, Atlanta, GA 30341;
Telephone: 770–488–4024; Email:
CCGuidelines@cdc.gov.
SUPPLEMENTARY INFORMATION:
Background
CDC/ATSDR is announcing the
availability of final Guidelines for
Examining Unusual Patterns of Cancer
and Environmental Concerns (2022
Guidelines). The 2022 Guidelines are an
update to the 2013 guidelines,
Investigating Suspected Cancer Clusters
and Responding to Community
Concerns: Guidelines from CDC and the
Council of State and Territorial
Epidemiologists (2013 Guidelines).
CDC/ATSDR develops guidance for
state, tribal, local, and territorial (STLT)
health departments on how to respond
to cancer cluster concerns. The 2022
Guidelines are a 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.
In the 2022 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 potential
unusual patterns of cancer in
communities.
CDC/ATSDR developed the 2022
Guidelines using input from a variety of
sources, including STLT public health
agencies, subject matter experts from
academia and non-governmental
organizations, an internal CDC/ATSDR
steering committee, public comments
received from an announcement in the
Federal Register (84 FR 21786), 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
comprehensive literature review and
media scan and evaluated advances in
the field of environmental epidemiology
VerDate Sep<11>2014
17:36 Dec 07, 2022
Jkt 259001
(e.g., geospatial methods) and
community engagement strategies.
On May 25, 2022 CDC/ATSDR
published a notice in the Federal
Register announcing the availability of
the draft 2022 Guidelines (87 FR 31888).
The notice gave the public an
opportunity to submit comments by July
25, 2022. CDC/ATSDR received 46 sets
of comments from state health
departments, community members,
academicians, clinicians, cancer
registries, non-governmental
organizations, and private consultants
on behalf of trade associations (https://
www.regulations.gov/docket/CDC-20220070/comments). A summary of the
comments received and the
modifications CDC/ATSDR made to the
draft 2022 Guidelines after careful
consideration are below:
• Commenters stated the terms
‘‘cancer cluster’’ and ‘‘unusual patterns
of cancer’’ were used interchangeably
throughout the document without clear
definition of both terms.
Æ Response: CDC/ATSDR provided a
clear definition of both terms.
• Commenters noted that it was
unclear whether every proactive
evaluation must result in the criteria
assessment. Commenters questioned
how the criteria assessment differs from
the response from an incoming inquiry.
Æ Response: CDC/ATSDR added
language to clarify the response to both
proactive monitoring and incoming
inquiries and provided examples on
how to respond to unusual patterns of
cancer identified in the proactive
monitoring. CDC/ATSDR refined the
flow chart in Figure 1, which provides
a summary of the enhanced process for
evaluating patterns of cancer routinely
and evaluating community inquiries
about unusual patterns of cancer and
environmental concerns. CDC/ATSDR
also clarified the discussion on
proactive evaluation and routine
monitoring of cancer data, including
clarifying the need for collaboration
with other health agency programs to
determine the need for further
evaluation through the criteria
assessment.
• Commenters noted that the
discussion of challenges and limitations
was important to mention early in the
guidelines document, rather than in
later sections of the document.
Æ Response: CDC/ATSDR added
information on limitations and
challenges related to implementation of
the recommendations provided within
the guidelines early in the document
and then reinforced these limitations
later in the document.
• Several comments were focused on
clarifying phases and the intent of
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
various criteria, as well as the need for
examples to enhance clarity.
Æ Response: CDC/ATSDR made
editorial changes to improve clarity and
provided examples when possible, such
as including examples of specific
partners within a public health agency
to engage on unusual patterns of cancer.
CDC/ATSDR endeavored to improve
clarity with respect to certain
components of the criteria. For example,
CDC/ATSDR changed step 8 of the
criteria from ‘‘Is there known biologic
plausibility of the cancer(s) of concern
with suspected environmental
contaminants in terms of disease
etiology?’’ to ‘‘Is there a plausible
pathway of exposure between the
suspected environmental contaminants
and the cancer(s) of concern in terms of
disease etiology?’’ This change allowed
for a clearer depiction of the intent of
step 8 of the criteria.
• Some commenters raised the issue
of how frequent and regular routine
monitoring of cancer may place
additional burdens on public health
agency resources.
Æ Response: 50% of states reported
through the STLT survey that they
already conduct routine monitoring of
cancer incidence data. However, CDC/
ATSDR acknowledged, within the 2022
Guidelines, that resource limitations
may impact the frequency with which
routine monitoring can be carried out.
CDC’s National Environmental Public
Health Tracking Program (https://
www.cdc.gov/nceh/tracking/
default.htm) worked with state cancer
registries and tracking partners to make
three- and five-year rates more readily
available, to reduce the burden on states
with respect to monitoring.
• Commenters suggested that
providing more references would be
helpful.
Æ Response: CDC/ATSDR added
additional references throughout the
2022 Guidelines.
• Commenters noted that more
guidance and instructions are needed on
the use of the Cancer Inquiry intake
form.
Æ Response: CDC/ATSDR is
developing an instructions document
for STLT public health agencies to use
as a supplement to the Cancer Inquiry
intake form.
• Commenters noted that more details
and resources were needed on use of the
standardized incidence ration, such as
specific minimum thresholds.
Æ Response: CDC/ATSDR is
developing additional education and
resource tools and will post on the
National Center for Environmental
Health’s Health Studies website once
available.
E:\FR\FM\08DEN1.SGM
08DEN1
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
For more information about the
process of updating the 2022
Guidelines, please visit https://
www.cdc.gov/nceh/cancer-environment/
index.html.
Availability of the Final 2022
Guideline: The Final 2022 Guidelines
can be found in the Supporting &
Related Materials tab of this docket
found on the Federal eRulemaking
Portal: https://www.regulations.gov,
identified by Docket No. CDC–2022–
0070.
Angela K. Oliver,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2022–26664 Filed 12–7–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–0187 [Formerly
Docket No. 2000D–1267]]
Recommendations To Reduce the Risk
of Transfusion-Transmitted Malaria;
Guidance for Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance entitled ‘‘Recommendations to
Reduce the Risk of TransfusionTransmitted Malaria.’’ The guidance
document provides blood
establishments that collect blood and
blood components with FDA’s
recommendations to reduce the risk of
transfusion-transmitted malaria (TTM).
The recommendations contained in the
guidance apply to the collection of
Whole Blood and blood components,
except Source Plasma. The guidance
announced in this notice supersedes the
guidance entitled ‘‘Revised
Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria;
Guidance for Industry’’ dated April
2020.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on December 8, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
lotter on DSK11XQN23PROD with NOTICES1
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
17:36 Dec 07, 2022
Jkt 259001
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2000–D–0187 for ‘‘Recommendations to
Reduce the Risk of TransfusionTransmitted Malaria; Guidance for
Industry.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
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Frm 00060
Fmt 4703
Sfmt 4703
75275
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Jessica Gillum, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a final guidance entitled
‘‘Recommendations to Reduce the Risk
of Transfusion-Transmitted Malaria;
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75273-75275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26664]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0070]
Availability of Final 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: General notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) and the
Agency for Toxic Substances and Disease Registry (ATSDR), located
within the Department of Health and Human Services (HHS) announces the
availability of the final Guidelines for Examining Unusual Patterns of
Cancer and Environmental Concerns (2022 Guidelines). The 2022
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). The updates provide state, tribal, local, and
territorial health departments guidance for a
[[Page 75274]]
revised and expanded approach to evaluating concerns about unusual
patterns of cancer in communities, including those associated with
local environmental concerns. The 2022 Guidelines finalize the draft
guidelines issued on May 25, 2022.
DATES: The 2022 Guidelines are available December 8, 2022.
FOR FURTHER INFORMATION CONTACT: Amy Lavery, Centers for Disease
Control and Prevention, National Center for Environmental Health,
Division of Environmental Health Science and Practice, 4770 Buford
Highway NE, Mailstop F-60, Atlanta, GA 30341; Telephone: 770-488-4024;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background
CDC/ATSDR is announcing the availability of final Guidelines for
Examining Unusual Patterns of Cancer and Environmental Concerns (2022
Guidelines). The 2022 Guidelines are an update to the 2013 guidelines,
Investigating Suspected Cancer Clusters and Responding to Community
Concerns: Guidelines from CDC and the Council of State and Territorial
Epidemiologists (2013 Guidelines). CDC/ATSDR develops guidance for
state, tribal, local, and territorial (STLT) health departments on how
to respond to cancer cluster concerns. The 2022 Guidelines are a 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.
In the 2022 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 potential unusual patterns of
cancer in communities.
CDC/ATSDR developed the 2022 Guidelines using input from a variety
of sources, including STLT public health agencies, subject matter
experts from academia and non-governmental organizations, an internal
CDC/ATSDR steering committee, public comments received from an
announcement in the Federal Register (84 FR 21786), 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 comprehensive literature review and media scan
and evaluated advances in the field of environmental epidemiology
(e.g., geospatial methods) and community engagement strategies.
On May 25, 2022 CDC/ATSDR published a notice in the Federal
Register announcing the availability of the draft 2022 Guidelines (87
FR 31888). The notice gave the public an opportunity to submit comments
by July 25, 2022. CDC/ATSDR received 46 sets of comments from state
health departments, community members, academicians, clinicians, cancer
registries, non-governmental organizations, and private consultants on
behalf of trade associations (https://www.regulations.gov/docket/CDC-2022-0070/comments). A summary of the comments received and the
modifications CDC/ATSDR made to the draft 2022 Guidelines after careful
consideration are below:
Commenters stated the terms ``cancer cluster'' and
``unusual patterns of cancer'' were used interchangeably throughout the
document without clear definition of both terms.
[cir] Response: CDC/ATSDR provided a clear definition of both
terms.
Commenters noted that it was unclear whether every
proactive evaluation must result in the criteria assessment. Commenters
questioned how the criteria assessment differs from the response from
an incoming inquiry.
[cir] Response: CDC/ATSDR added language to clarify the response to
both proactive monitoring and incoming inquiries and provided examples
on how to respond to unusual patterns of cancer identified in the
proactive monitoring. CDC/ATSDR refined the flow chart in Figure 1,
which provides a summary of the enhanced process for evaluating
patterns of cancer routinely and evaluating community inquiries about
unusual patterns of cancer and environmental concerns. CDC/ATSDR also
clarified the discussion on proactive evaluation and routine monitoring
of cancer data, including clarifying the need for collaboration with
other health agency programs to determine the need for further
evaluation through the criteria assessment.
Commenters noted that the discussion of challenges and
limitations was important to mention early in the guidelines document,
rather than in later sections of the document.
[cir] Response: CDC/ATSDR added information on limitations and
challenges related to implementation of the recommendations provided
within the guidelines early in the document and then reinforced these
limitations later in the document.
Several comments were focused on clarifying phases and the
intent of various criteria, as well as the need for examples to enhance
clarity.
[cir] Response: CDC/ATSDR made editorial changes to improve clarity
and provided examples when possible, such as including examples of
specific partners within a public health agency to engage on unusual
patterns of cancer.
CDC/ATSDR endeavored to improve clarity with respect to certain
components of the criteria. For example, CDC/ATSDR changed step 8 of
the criteria from ``Is there known biologic plausibility of the
cancer(s) of concern with suspected environmental contaminants in terms
of disease etiology?'' to ``Is there a plausible pathway of exposure
between the suspected environmental contaminants and the cancer(s) of
concern in terms of disease etiology?'' This change allowed for a
clearer depiction of the intent of step 8 of the criteria.
Some commenters raised the issue of how frequent and
regular routine monitoring of cancer may place additional burdens on
public health agency resources.
[cir] Response: 50% of states reported through the STLT survey that
they already conduct routine monitoring of cancer incidence data.
However, CDC/ATSDR acknowledged, within the 2022 Guidelines, that
resource limitations may impact the frequency with which routine
monitoring can be carried out. CDC's National Environmental Public
Health Tracking Program (https://www.cdc.gov/nceh/tracking/default.htm)
worked with state cancer registries and tracking partners to make
three- and five-year rates more readily available, to reduce the burden
on states with respect to monitoring.
Commenters suggested that providing more references would
be helpful.
[cir] Response: CDC/ATSDR added additional references throughout
the 2022 Guidelines.
Commenters noted that more guidance and instructions are
needed on the use of the Cancer Inquiry intake form.
[cir] Response: CDC/ATSDR is developing an instructions document
for STLT public health agencies to use as a supplement to the Cancer
Inquiry intake form.
Commenters noted that more details and resources were
needed on use of the standardized incidence ration, such as specific
minimum thresholds.
[cir] Response: CDC/ATSDR is developing additional education and
resource tools and will post on the National Center for Environmental
Health's Health Studies website once available.
[[Page 75275]]
For more information about the process of updating the 2022
Guidelines, please visit https://www.cdc.gov/nceh/cancer-environment/.
Availability of the Final 2022 Guideline: The Final 2022 Guidelines
can be found in the Supporting & Related Materials tab of this docket
found on the Federal eRulemaking Portal: https://www.regulations.gov,
identified by Docket No. CDC-2022-0070.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-26664 Filed 12-7-22; 8:45 am]
BILLING CODE 4163-18-P
