Proposed Data Collection Submitted for Public Comment and Recommendations, 71364-71365 [2023-22779]
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71364
Federal Register / Vol. 88, No. 198 / Monday, October 16, 2023 / Notices
years of age. FMB&M–IFPS III will be a
longitudinal study of pregnant women
and their new baby for two years.
Throughout the study planning period,
CDC engaged with subject matter
experts from multiple Federal agencies
including the National Institutes of
Health (NIH), the U.S. Department of
Agriculture (USDA), and the Food and
Drug Administration (FDA) to ensure
that FMB&M–IFPS III applies lessons
learned from previous studies and
represents the priorities and needs of
numerous stakeholders. The new study
design is based on updated
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 ............................................
[FR Doc. 2023–22780 Filed 10–13–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–24–1316; Docket No. CDC–2023–
0084]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
The Centers for Disease
Control and Prevention (CDC), as part of
SUMMARY:
VerDate Sep<11>2014
17:03 Oct 13, 2023
Jkt 262001
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 continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Aerosols from
Harmful Algal Blooms: Exposures and
Health Effects in Highly Exposed
Populations. The goal of this study is to
conduct exploratory analyses of the
relationships between HAB-related
biomonitoring data, environmental data,
and symptom reporting.
CDC must receive written
comments on or before December 15,
2023.
DATES:
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
You may submit comments,
identified by Docket No. CDC–2023–
0084 by either of the following methods:
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
recalls. CDC estimates that 7,477
pregnant women, ages 18–49, must be
screened in order to obtain complete
data on 2,500 study participants. The
goal is to recruit equal proportions of
non-Hispanic white, non-Hispanic
black, and Hispanic participants. An
OMB Extension is requested for one
year. CDC requests OMB approval for an
estimated 5,051 annualized burden
hours. Participation is voluntary, and
there are no costs to respondents other
than their time.
Estimated Annualized Burden Hours
Number of
respondents
Type of respondents
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
ddrumheller on DSK120RN23PROD with NOTICES1
methodology and questions, and
recruitment of a new cohort of study
participants.
CDC will collect information about
mother’s intentions, behaviors, feeding
decisions, and practices from pregnancy
through their child’s first two years of
life and how these change; child health
outcomes; and emerging issues related
to infant and toddler feeding practices.
Data will be collected using web-based
surveys at multiple time points. This
includes: (1) a prenatal survey; (2) 14
follow-up surveys after the baby is born;
and (3) 2–4 maternal dietary data
2,492
1,570
1,413
919
90
1,413
1,368
1,231
1,192
1,153
750
73
1,117
1,081
1,046
1,013
980
949
919
889
861
833
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Average
burden per
response
(in hours)
3/60
5/60
20/60
24/60
24/60
2/60
2/60
20/60
15/60
15/60
24/60
24/60
15/60
15/60
15/60
15/60
20/60
15/60
15/60
15/60
15/60
15/60
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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
H21–8, Atlanta, Georgia 30329;
E:\FR\FM\16OCN1.SGM
16OCN1
71365
Federal Register / Vol. 88, No. 198 / Monday, October 16, 2023 / Notices
Telephone: 404–639–7570; Email: omb@
cdc.gov.
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;
SUPPLEMENTARY INFORMATION:
reporting. CDC anticipates this research
to be hypothesis generating, and not
necessarily generalizable to participants
with similar exposures in the same
population or to the public more
generally.
HABs and associated environmental
impacts (e.g., geographic and temporal
extent, composition, toxin production)
are difficult, if not impossible to predict
and track. This project was developed in
response to community health concerns
reported during a severe cyanobacterial
bloom in 2018. Since then, there have
not been any significant blooms, and
CDC has been unable to implement the
study. As such, during the first three
years of approval for this data
collection, CDC was unable to align the
physical occurrence of a specific type of
HAB, a cyanobacterial bloom, of
significant magnitude with government
approvals and resource commitments.
The program requests an Extension of
OMB approval to allow us to implement
the study during the next substantial
HAB that occurs in Florida whether it
comprises cyanobacteria, marine
microalgae, or seaweed.
The total number of respondents is
486, which is unchanged from the
previously approved number of
respondents. The total estimated
annualized time burden is 1,273 hours.
Participation is voluntary and there are
no costs to respondents other than their
time.
3. Enhance the quality, utility, and
clarity of the information to be
collected;
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; and
5. Assess information collection costs.
Proposed Project
Aerosols from Harmful Algal Blooms:
Exposures and Health Effects in Highly
Exposed Populations (OMB Control No.
0920–1316, Exp. 1/31/2024)—
Extension—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Human exposures to HAB toxins
(harmful algal blooms, or HABS,
include marine microalgae; marine
macroalgae, such as seaweeds; and
cyanobacteria, also called blue-green
algae) have been reported to produce a
variety of health effects, including
respiratory irritation and liver and
kidney damage. The goal of this study
is to conduct exploratory analyses of the
relationships between biomonitoring
data, environmental data, and symptom
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden
per response
(in hours)
Total burden
(in hours)
Form name
Interested community members .......
Eligible study respondents ................
Eligible study respondents ................
Eligible study respondents ................
Eligible study respondents ................
Screening/baseline Survey ..............
Symptom Survey ..............................
Record of Time Spent Outdoors ......
Provide blood specimen ...................
Provide specimens (urine, nasal
swabs, lung function test).
Be outfitted with personal air sampler.
Provide fish (if respondent went
fishing and caught fish).
84
67
67
67
67
1
10
5
3
10
15/60
15/60
10/60
15/60
1
21
167
56
51
670
67
5
45/60
252
67
5
10/60
56
...........................................................
........................
........................
........................
1,273
Eligible study respondents ................
Eligible study respondents ................
Total ...........................................
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
respondents
Type of respondents
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–22779 Filed 10–13–23; 8:45 am]
BILLING CODE 4163–18–P
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PO 00000
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]]>Agencies
[Federal Register Volume 88, Number 198 (Monday, October 16, 2023)]
[Notices]
[Pages 71364-71365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22779]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-1316; Docket No. CDC-2023-0084]
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.
-----------------------------------------------------------------------
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 continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Aerosols from Harmful Algal Blooms: Exposures and Health Effects
in Highly Exposed Populations. The goal of this study is to conduct
exploratory analyses of the relationships between HAB-related
biomonitoring data, environmental data, and symptom reporting.
DATES: CDC must receive written comments on or before December 15,
2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0084 by either of the following methods:
Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.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 H21-8, Atlanta, Georgia 30329;
[[Page 71365]]
Telephone: 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;
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; and
5. Assess information collection costs.
Proposed Project
Aerosols from Harmful Algal Blooms: Exposures and Health Effects in
Highly Exposed Populations (OMB Control No. 0920-1316, Exp. 1/31/
2024)--Extension--National Center for Environmental Health (NCEH),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Human exposures to HAB toxins (harmful algal blooms, or HABS,
include marine microalgae; marine macroalgae, such as seaweeds; and
cyanobacteria, also called blue-green algae) have been reported to
produce a variety of health effects, including respiratory irritation
and liver and kidney damage. The goal of this study is to conduct
exploratory analyses of the relationships between biomonitoring data,
environmental data, and symptom reporting. CDC anticipates this
research to be hypothesis generating, and not necessarily generalizable
to participants with similar exposures in the same population or to the
public more generally.
HABs and associated environmental impacts (e.g., geographic and
temporal extent, composition, toxin production) are difficult, if not
impossible to predict and track. This project was developed in response
to community health concerns reported during a severe cyanobacterial
bloom in 2018. Since then, there have not been any significant blooms,
and CDC has been unable to implement the study. As such, during the
first three years of approval for this data collection, CDC was unable
to align the physical occurrence of a specific type of HAB, a
cyanobacterial bloom, of significant magnitude with government
approvals and resource commitments. The program requests an Extension
of OMB approval to allow us to implement the study during the next
substantial HAB that occurs in Florida whether it comprises
cyanobacteria, marine microalgae, or seaweed.
The total number of respondents is 486, which is unchanged from the
previously approved number of respondents. The total estimated
annualized time burden is 1,273 hours. Participation is voluntary and
there are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Interested community members.. Screening/ 84 1 15/60 21
baseline Survey.
Eligible study respondents.... Symptom Survey.. 67 10 15/60 167
Eligible study respondents.... Record of Time 67 5 10/60 56
Spent Outdoors.
Eligible study respondents.... Provide blood 67 3 15/60 51
specimen.
Eligible study respondents.... Provide 67 10 1 670
specimens
(urine, nasal
swabs, lung
function test).
Eligible study respondents.... Be outfitted 67 5 45/60 252
with personal
air sampler.
Eligible study respondents.... Provide fish (if 67 5 10/60 56
respondent went
fishing and
caught fish).
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 1,273
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-22779 Filed 10-13-23; 8:45 am]
BILLING CODE 4163-18-P
