Proposed Data Collection Submitted for Public Comment and Recommendations, 29454-29456 [2020-10411]
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29454
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
born, and (3) 2–4 maternal dietary data
recalls. The data from IFPS III will be
used to: Fill research gaps on how
feeding behaviors, patterns, and
practices change over the first two years
of life and the health-related impacts;
inform multiple federal agency efforts
targeting maternal and infant and
birth to 24 months of age for the first
time in 2020–2025. CDC requests
approval of 5,051 annualized burden
hours for this collection. There is no
cost to respondents other than their
time.
toddler nutrition through work in
hospitals, with health care providers,
with early care and education providers,
and outreach to families and caregivers;
and provide context to policy level
documents such as the U.S. Dietary
Guidelines for Americans, which will
include pregnant women and children
ESTIMATED ANNUALIZED BURDEN HOURS
Total
annualized
burden hours
Form name
Pregnant/Postpartum Women ...........
Study Screener ................................
Study Consent ..................................
Prenatal Survey ................................
24-Hour Dietary Recall—Prenatal ....
Replicate 24-Hour Dietary Recall—
Prenatal.
Request for notification of child’s
birth.
Birth Screener ..................................
1-Month Survey ................................
2-Month Survey ................................
3-Month Survey ................................
24-Hour Dietary Recall—Month 3 ....
Replicate 24-Hour Dietary Recall—
Month 3.
4-Month Survey ................................
5-Month Survey ................................
6-Month Survey ................................
8-Month Survey ................................
10-Month Survey ..............................
12-Month Survey ..............................
15-Month Survey ..............................
18-Month Survey ..............................
21-Month Survey ..............................
24-Month Survey ..............................
7,477
4,711
4,239
2,756
269
1
1
1
1
1
3/60
5/60
20/60
24/60
24/60
125
131
471
367
36
4,239
1
2/60
47
4,103
3,693
3,575
3,460
2,249
219
1
1
1
1
1
1
2/60
20/60
15/60
15/60
24/60
24/60
46
410
298
288
300
29
3,350
3,243
3,139
3,038
2,941
2,847
2,756
2,668
2,582
2,500
1
1
1
1
1
1
1
1
1
1
15/60
15/60
15/60
15/60
20/60
15/60
15/60
15/60
15/60
15/60
279
270
262
253
327
237
230
222
215
208
...........................................................
........................
........................
........................
5,051
Total ...........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–10412 Filed 5–14–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0047]
Healthcare Infection Control Practices
Advisory Committee (HICPAC);
Cancellation of Meeting
Notice is hereby given of a change in
the meeting of the Healthcare Infection
Control Practices Advisory Committee
(HICPAC); [Docket No. CDC–2020–
0047]; May 15, 2020, 3:00 p.m. to 4:30
p.m., EDT, which was published in the
Federal Register on April 30, 2020,
VerDate Sep<11>2014
17:09 May 14, 2020
Volume 85, Number 84, pages 23965–
23966.
This meeting is being canceled in its
entirety.
Dated: May 11, 2020.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
KooWhang Chung, M.P.H., HICPAC,
Division of Healthcare Quality
Promotion, NCEZID, CDC, 1600 Clifton
Road NE, MS H16–3, Atlanta, Georgia
30329–4027; Telephone: 404–639–4000;
Email: hicpac@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2020–10417 Filed 5–14–20; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4163–18–P
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Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Respondents
Jkt 250001
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BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20ND; Docket No. CDC–2020–
0044]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
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Notice with comment period.
15MYN1
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
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 Investigation of SARS–CoV–2
Seroprevalence and Factors Associated
with Seropositivity in a Community
Setting. CDC will, at the request of state
and local health departments, collect
epidemiological data and blood samples
from households to determine the extent
of COVID–19 infection in communities
as determined by overall SARS–CoV–2
seroprevalence.
DATES: CDC must receive written
comments on or before July 14, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0044 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: omb@cdc.gov.
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
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
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
Investigation of SARS–CoV–2
Seroprevalence and Factors Associated
with Seropositivity in a Community
Setting—New—National Center for
Immunization and Respiratory Diseases
(NCIRD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
Immunization and Respiratory Diseases
(NCRID), Division of Viral Diseases
(DVD) requests approval for a new
information collection, ‘‘Investigation of
SARS–CoV–2 Seroprevalence and
Factors Associated with Seropositivity
in a Community Setting.’’ Coronavirus
disease 2019 (COVID–19), caused by the
severe acute respiratory syndrome
coronavirus 2 (SARS–CoV–2), was first
reported in Wuhan, Hubei Province,
China in late December 2019. On
February 26, 2020, CDC announced that
an infection with the novel coronavirus
had been confirmed ‘‘in a person who
reportedly did not have relevant travel
history or exposure to another known
patient with COVID–19,’’ making this
the first suspected United States (U.S.)
case of community transmission.
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29455
We propose to conduct an
investigation to (1) determine the extent
of infection in communities as
determined by overall SARS–CoV–2
seroprevalence; and (2) determine
factors associated with SARS–CoV–2
seropositivity among persons residing in
areas with evidence of community
transmission. The data collected under
this information collection request (ICR)
will be used immediately by CDC’s
emergency COVID–19 response at the
national level, and by state and local
health departments, to understand the
cumulative incidence in a given
population within their jurisdiction. A
cross-sectional household survey design
will be used to measure SARS–CoV–2
seroprevalence at one or more time
points in ≥1 U.S. areas with evidence of
community transmission of SARS–CoV–
2. Areas with existing population-based
surveillance platforms with welldefined catchment areas will be
preferentially selected. The
investigation population will consist of
all persons residing in selected
households from selected defined
geographic areas, according to the
sampling framework. CDC and health
departments alike will use this
seroprevalence data to prioritize the
allocation of resources and response
efforts.
CDC will collect epidemiological
information in the form of a
standardized questionnaire which will
capture information on household
characteristics, age, sex, race, ethnicity,
exposures, underlying medical
conditions and symptoms consistent
with COVID–19 infection that occurred
prior to the survey. One respondent in
each household (an adult who knows all
residents of the household) will provide
responses for the household
questionnaire. The household
questionnaire will capture information
on household characteristics and
document all household members,
whether they are present at the time of
the visit or not. Blood samples will be
collected by trained phlebotomists from
all individuals in the household and
tested for antibodies to SARS–CoV–2
using an enzyme-linked immunosorbent
assay with confirmatory
microneutralization testing as needed.
Investigations will be conducted at a
total of four sites throughout the
clearance period. There are no costs to
respondents other than their time to
participate. The total estimated
annualized burden hours requested for
this collection is 2,420.
E:\FR\FM\15MYN1.SGM
15MYN1
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
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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
]]>Agencies
[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Notices]
[Pages 29454-29456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-20ND; Docket No. CDC-2020-0044]
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.
-----------------------------------------------------------------------
[[Page 29455]]
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 Investigation of SARS-CoV-2
Seroprevalence and Factors Associated with Seropositivity in a
Community Setting. CDC will, at the request of state and local health
departments, collect epidemiological data and blood samples from
households to determine the extent of COVID-19 infection in communities
as determined by overall SARS-CoV-2 seroprevalence.
DATES: CDC must receive written comments on or before July 14, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0044 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
Investigation of SARS-CoV-2 Seroprevalence and Factors Associated
with Seropositivity in a Community Setting--New--National Center for
Immunization and Respiratory Diseases (NCIRD), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), National
Center for Immunization and Respiratory Diseases (NCRID), Division of
Viral Diseases (DVD) requests approval for a new information
collection, ``Investigation of SARS-CoV-2 Seroprevalence and Factors
Associated with Seropositivity in a Community Setting.'' Coronavirus
disease 2019 (COVID-19), caused by the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), was first reported in Wuhan, Hubei
Province, China in late December 2019. On February 26, 2020, CDC
announced that an infection with the novel coronavirus had been
confirmed ``in a person who reportedly did not have relevant travel
history or exposure to another known patient with COVID-19,'' making
this the first suspected United States (U.S.) case of community
transmission.
We propose to conduct an investigation to (1) determine the extent
of infection in communities as determined by overall SARS-CoV-2
seroprevalence; and (2) determine factors associated with SARS-CoV-2
seropositivity among persons residing in areas with evidence of
community transmission. The data collected under this information
collection request (ICR) will be used immediately by CDC's emergency
COVID-19 response at the national level, and by state and local health
departments, to understand the cumulative incidence in a given
population within their jurisdiction. A cross-sectional household
survey design will be used to measure SARS-CoV-2 seroprevalence at one
or more time points in >=1 U.S. areas with evidence of community
transmission of SARS-CoV-2. Areas with existing population-based
surveillance platforms with well-defined catchment areas will be
preferentially selected. The investigation population will consist of
all persons residing in selected households from selected defined
geographic areas, according to the sampling framework. CDC and health
departments alike will use this seroprevalence data to prioritize the
allocation of resources and response efforts.
CDC will collect epidemiological information in the form of a
standardized questionnaire which will capture information on household
characteristics, age, sex, race, ethnicity, exposures, underlying
medical conditions and symptoms consistent with COVID-19 infection that
occurred prior to the survey. One respondent in each household (an
adult who knows all residents of the household) will provide responses
for the household questionnaire. The household questionnaire will
capture information on household characteristics and document all
household members, whether they are present at the time of the visit or
not. Blood samples will be collected by trained phlebotomists from all
individuals in the household and tested for antibodies to SARS-CoV-2
using an enzyme-linked immunosorbent assay with confirmatory
microneutralization testing as needed. Investigations will be conducted
at a total of four sites throughout the clearance period. There are no
costs to respondents other than their time to participate. The total
estimated annualized burden hours requested for this collection is
2,420.
[[Page 29456]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Household Participants........ Individual 4,000 1 20/60 1,333
Questionnaire.
Household 1,680 1 15/60 420
Questionnaire.
Blood collection 4,000 1 10/60 667
(no form).
---------------------------------------------------------------------------------
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
