Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories, 29456-29457 [2020-10461]
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29456
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
(in hours)
Form name
Household Participants .....................
Individual Questionnaire ...................
Household Questionnaire .................
Blood collection (no form) ................
4,000
1,680
4,000
1
1
1
20/60
15/60
10/60
1,333
420
667
Total ...........................................
...........................................................
........................
........................
........................
2,420
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–10411 Filed 5–14–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0051]
Request for Information Concerning
Personnel and the Retention of Next
Generation Sequencing Data in Clinical
and Public Health Laboratories
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with request for
comment.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the opening
of a docket to obtain public comment on
personnel performing bioinformatics
activities in clinical and public health
laboratories; storage and retention of
next generation sequencing (NGS) data
files; and maintenance of sequence
analysis software. The comments will be
used by the Clinical Laboratory
Improvement Advisory Committee
(CLIAC) for deliberation and possible
recommendations about future changes
to the Clinical Laboratory Improvement
Amendments of 1988 (CLIA)
regulations.
DATES: Written comments must be
received on or before July 14, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0051 by any of the following methods.
CDC does not accept public comment by
email.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Heather Stang, MS, MT,
Division of Laboratory Systems, Centers
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
for Disease Control and Prevention,
1600 Clifton Road NE, Mailstop V24–3,
Atlanta, GA 30329, Attn: Docket No.
CDC–2020–0051.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to https://www.regulations.gov,
including any personal information
provided. For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Heather Stang, MS, MT, Center for
Surveillance, Epidemiology and
Laboratory Services, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, Mailstop V24–3, Atlanta,
Georgia 30329–4018, telephone (800)
232–4636; email: dlsinquiries@cdc.gov.
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data about topics related to personnel
performing informatics activities, as
well as data storage and retention
practices related to the use of next
generation sequencing (NGS)
technology. In addition, CDC invites
comments specifically on the following
questions:
(1) What are the roles and
responsibilities for all personnel
performing bioinformatics or pathology/
laboratory informatics activities? What
training is considered essential for each
of the roles? What competencies are
considered essential for each of the
roles? What minimum educational
requirements (degrees or courses) are
required for each of the roles?
(2) What are the challenges for
recruitment and retention of
bioinformatics or pathology/laboratory
informatics personnel?
(3) What are examples of how NGS
data files are used in addition to
generating a clinical test result?
(4) What NGS data files should be
retained for quality assurance, repeat
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
analyses, or subsequent analyses? How
long should these NGS data files be
retained?
(5) What are the challenges and
approaches for laboratories to maintain
and utilize previous versions of
sequence analysis software?
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. Do not submit public
comments by email. 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/near duplicate examples of a
mass-mail campaign.
Background and Brief Description
Clinical laboratory testing technology
has advanced significantly since the
CLIA regulations were first
implemented approximately 30 years
ago. Next generation sequencing (NGS)
technologies provide the highthroughput capability to rapidly and
cost-effectively sequence large regions
and mixed populations of DNA and
RNA, when compared to traditional
sequencing methods. This technology
results in a significant increase in data
that requires specialized analysis to
derive a clinically meaningful result.
NGS has led to improvements in
diagnoses and patient care in many
areas of medicine that include medical
genetics, pediatrics, oncology, and
microbiology. In some instances, NGS
has led to life-saving diagnoses and
treatment pathways, not achievable
using other testing modalities. One
element that differentiates NGS from
most laboratory methodologies is its
E:\FR\FM\15MYN1.SGM
15MYN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
significant reliance on informatics to
achieve a meaningful and reportable
result. As a consequence, clinical
laboratories require personnel
knowledgeable in bioinformatics or
pathology/laboratory informatics to
design and manage the bioinformatics
analysis.
While CLIA regulations apply to
clinical NGS testing, there is a lack of
clarity regarding how the general CLIA
quality system and personnel
requirements should be specifically
implemented for the NGS
bioinformatics components. In April
2019, CLIAC made eight
recommendations regarding CLIA’s
application to NGS-based technologies.
This request for information is soliciting
comments from the public for more
information on topic areas mentioned in
two of the recommendations,
specifically, the qualifications of
personnel performing bioinformatics
activities; storage and retention of NGS
data files; and maintenance of sequence
analysis software. The April 2019
CLIAC summary is available in the
docket under the Supporting Materials
tab and at https://www.cdc.gov/cliac/
past-meetings.html.
The qualifications and responsibilities
of personnel performing the informatics
component of the testing process are not
addressed in the CLIA regulations. For
the purpose of this request for
information, the informatics component
of NGS includes the analysis of NGS
machine-generated data and subsequent
computational processes. Therefore,
CDC is asking the public to describe
different responsibilities of personnel
providing bioinformatics or pathology/
laboratory informatics expertise such as
validating and assuring that the
informatics pipeline meets documented
performance specifications.
CDC is also interested in learning the
skills, training, and education of
personnel who will fill bioinformatics
or pathology/laboratory informatics
positions, and how clinical and public
health laboratories can recruit and
retain personnel with these identified
skills.
Lastly, the NGS testing process
generates large amounts of data and
requires multiple file types. CLIA
regulations specify at 42 CFR
493.1105(a)(3) that all analytic systems
records must be kept for at least two
years, but the regulations do not specify
the types of data to be captured or the
retention time for a given data type. The
regulations do not address the capability
to access and reanalyze the data after
the test is performed. This capability
may require retention of the version of
software used in the original analysis.
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
CDC requests comment from the public
on this topic.
Dated: May 12, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2020–10461 Filed 5–14–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–19BHC]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled National
Evaluation of the DP18–1815
Cooperative Agreement Program:
Category A, Diabetes Management and
Type 2 Diabetes Prevention to the Office
of Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on July 5,
2019, to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
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Fmt 4703
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29457
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
National Evaluation of the DP18–1815
Cooperative Agreement Program:
Category A, Diabetes Management and
Type 2 Diabetes Prevention—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) Division of Diabetes
Translation (DDT) and Division for
Heart Disease and Stroke Prevention
(DHDSP) are submitting this new
information collection request (ICR) for
an evaluation of the recently launched
five-year Cooperative Agreement
program CDC–RFA–DP18–1815PPHF18:
Improving the Health of Americans
Through Prevention and Management of
Diabetes and Heart Disease and Stroke,
hereafter referred to as ‘‘1815’’. This
cooperative agreement funds all 50 State
Health Departments and the
Washington, DC health department
(hereafter referred to as ‘‘HD
recipients’’) to support investments in
implementing evidence-based strategies
to prevent and manage cardiovascular
disease (CVD) and diabetes in highburden populations/communities
within each state and the District of
Columbia. High burden populations/
communities are those affected
disproportionately by high blood
pressure, high blood cholesterol,
diabetes, or prediabetes due to
socioeconomic or other characteristics,
including access to care, poor quality of
care, or low income. The 1815 program
is a collaboration between DDT and
DHDSP and is structured into two
program categories aligning with each
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Notices]
[Pages 29456-29457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2020-0051]
Request for Information Concerning Personnel and the Retention of
Next Generation Sequencing Data in Clinical and Public Health
Laboratories
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with request for comment.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) announces the opening of
a docket to obtain public comment on personnel performing
bioinformatics activities in clinical and public health laboratories;
storage and retention of next generation sequencing (NGS) data files;
and maintenance of sequence analysis software. The comments will be
used by the Clinical Laboratory Improvement Advisory Committee (CLIAC)
for deliberation and possible recommendations about future changes to
the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
regulations.
DATES: Written comments must be received on or before July 14, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0051 by any of the following methods. CDC does not accept public
comment by email.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Heather Stang, MS, MT, Division of Laboratory
Systems, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, Mailstop V24-3, Atlanta, GA 30329, Attn: Docket No. CDC-2020-0051.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to https://www.regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Heather Stang, MS, MT, Center for
Surveillance, Epidemiology and Laboratory Services, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop V24-3, Atlanta,
Georgia 30329-4018, telephone (800) 232-4636; email:
[email protected].
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data about topics
related to personnel performing informatics activities, as well as data
storage and retention practices related to the use of next generation
sequencing (NGS) technology. In addition, CDC invites comments
specifically on the following questions:
(1) What are the roles and responsibilities for all personnel
performing bioinformatics or pathology/laboratory informatics
activities? What training is considered essential for each of the
roles? What competencies are considered essential for each of the
roles? What minimum educational requirements (degrees or courses) are
required for each of the roles?
(2) What are the challenges for recruitment and retention of
bioinformatics or pathology/laboratory informatics personnel?
(3) What are examples of how NGS data files are used in addition to
generating a clinical test result?
(4) What NGS data files should be retained for quality assurance,
repeat analyses, or subsequent analyses? How long should these NGS data
files be retained?
(5) What are the challenges and approaches for laboratories to
maintain and utilize previous versions of sequence analysis software?
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. Do not
submit public comments by email. 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/near duplicate
examples of a mass-mail campaign.
Background and Brief Description
Clinical laboratory testing technology has advanced significantly
since the CLIA regulations were first implemented approximately 30
years ago. Next generation sequencing (NGS) technologies provide the
high-throughput capability to rapidly and cost-effectively sequence
large regions and mixed populations of DNA and RNA, when compared to
traditional sequencing methods. This technology results in a
significant increase in data that requires specialized analysis to
derive a clinically meaningful result. NGS has led to improvements in
diagnoses and patient care in many areas of medicine that include
medical genetics, pediatrics, oncology, and microbiology. In some
instances, NGS has led to life-saving diagnoses and treatment pathways,
not achievable using other testing modalities. One element that
differentiates NGS from most laboratory methodologies is its
[[Page 29457]]
significant reliance on informatics to achieve a meaningful and
reportable result. As a consequence, clinical laboratories require
personnel knowledgeable in bioinformatics or pathology/laboratory
informatics to design and manage the bioinformatics analysis.
While CLIA regulations apply to clinical NGS testing, there is a
lack of clarity regarding how the general CLIA quality system and
personnel requirements should be specifically implemented for the NGS
bioinformatics components. In April 2019, CLIAC made eight
recommendations regarding CLIA's application to NGS-based technologies.
This request for information is soliciting comments from the public for
more information on topic areas mentioned in two of the
recommendations, specifically, the qualifications of personnel
performing bioinformatics activities; storage and retention of NGS data
files; and maintenance of sequence analysis software. The April 2019
CLIAC summary is available in the docket under the Supporting Materials
tab and at https://www.cdc.gov/cliac/past-meetings.html.
The qualifications and responsibilities of personnel performing the
informatics component of the testing process are not addressed in the
CLIA regulations. For the purpose of this request for information, the
informatics component of NGS includes the analysis of NGS machine-
generated data and subsequent computational processes. Therefore, CDC
is asking the public to describe different responsibilities of
personnel providing bioinformatics or pathology/laboratory informatics
expertise such as validating and assuring that the informatics pipeline
meets documented performance specifications.
CDC is also interested in learning the skills, training, and
education of personnel who will fill bioinformatics or pathology/
laboratory informatics positions, and how clinical and public health
laboratories can recruit and retain personnel with these identified
skills.
Lastly, the NGS testing process generates large amounts of data and
requires multiple file types. CLIA regulations specify at 42 CFR
493.1105(a)(3) that all analytic systems records must be kept for at
least two years, but the regulations do not specify the types of data
to be captured or the retention time for a given data type. The
regulations do not address the capability to access and reanalyze the
data after the test is performed. This capability may require retention
of the version of software used in the original analysis. CDC requests
comment from the public on this topic.
Dated: May 12, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2020-10461 Filed 5-14-20; 8:45 am]
BILLING CODE 4163-18-P
