Agency Forms Undergoing Paperwork Reduction Act Review, 92935-92937 [2024-27468]
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Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
92935
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements]
Element
Inclusion criteria
Exclusion criteria
Key Question 2 .................................................
• Studies of adults
Æ Parallel or cross-over RCTs
D n ≥25/group *
Æ Nonrandomized comparative studies
D Must account for potential confounders.
D Dietary intake must be defined or
described prospectively.
D We will aim for a minimum of about
10 observational studies for each
specific intervention—CV event
pair (e.g., reduced saturated fat
and stroke). We will thus select the
largest observational studies within
each category.†.
D n ≥100/group.
Timing ................................................................
Key Question 1 .................................................
• Minimum intervention length: 4 weeks .........
• In cross-over studies, any change in outcome measure must exclude data from the
first week after end of any prior treatments
Key Question 2 .................................................
• Minimum follow-up
Æ If population has no CV risk factors: 10
years.
Æ If population has one or more CV risk
factors (or unselected general population): 5 years.
None.
Setting ................................................................
• General community settings, including nursing homes, assisted living facilities, etc.
• Hospital or other acute care settings.
• Institutionalized, confined settings (e.g.,
prisons)
Publication .........................................................
• English language
• Published in peer-reviewed journals.
* Minimum sample size may be altered depending on the number of eligible studies found.
† Applying this approach for the 2016 AHRQ report n-3 fatty acids and cardiovascular disease (https://doi.org/10.23970/AHRQEPCERTA223),
we included: for cardiac event outcomes, observational studies with at least 10,000 participants; for stroke outcomes, at least 3000 participants;
for arrhythmia outcomes, at least 2000 participants; congestive heart failure outcomes, at least 700 participants; and for peripheral vascular disease events and MACE outcomes, at least 500 participants. In all instances, if a study meets eligibility criteria for any outcome, we will extract all
outcomes of interest from that study; therefore, there will be multiple instances of studies being included for an outcome even though the study
might not have met study size criteria for that specific outcome.
CV = cardiovascular; CVD = cardiovascular disease; MUFA = mono-unsaturated fatty acids; PUFA = polyunsaturated fatty acids; c = cholesterol; LDL = low-density lipoprotein; IDL = intermediate-density lipoprotein; HDL high-density lipoprotein; TC—total cholesterol; Tg = Triglycerides/
Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major adverse cardiac (or cerebro) events; BMI = body mass index; KQ = key question; N =
number of participants.
Dated: November 19, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–27488 Filed 11–22–24; 8:45 am]
BILLING CODE 4160–90–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[30Day–25–0047]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Agency for
Toxic Substances and Disease Registry
VerDate Sep<11>2014
18:29 Nov 22, 2024
Jkt 265001
(ATSDR) has submitted the information
collection request titled ‘‘Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery’’ to the Office of Management
and Budget (OMB) for review and
approval. ATSDR previously published
a ‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on August
16, 2024, to obtain comments from the
public and affected agencies. ATSDR
did not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
ATSDR will accept all comments for
this proposed information collection
project. The Office of Management and
PO 00000
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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,
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25NON1
92936
Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(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
Generic Clearance for the Collection
of Qualitative Feedback on Agency
Service Delivery (OMB Control No.
0923–0047, Expiration Date 2/28/
2025)—Extension—Agency for Toxic
Substances and Disease Registry
(ATSDR).
Background and Brief Description
The information collection activity
provides a means to garner qualitative
customer and stakeholder feedback in
an efficient, timely manner, in
accordance with the Federal
government’s commitment to improving
service delivery. By qualitative feedback
we mean information that provides
useful insights on perceptions and
opinions, but are not statistical surveys
that yield quantitative results that can
be generalized to the population of
study.
This feedback will provide insights
into customer or stakeholder
perceptions, experiences, and
expectations, provide an early warning
of issues with service, or focus attention
on areas where communication, training
or changes in operations might improve
delivery of products or services. These
collections will allow for ongoing,
collaborative, and actionable
communications between the ATSDR
and its customers and stakeholders. It
will also allow feedback to contribute
directly to the improvement of program
management.
The solicitation of feedback will target
areas such as: timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the Agency’s services
will be unavailable.
ATSDR will only submit a collection
for approval under this Generic
Clearance if it meets the following
conditions:
• The collections are voluntary;
• The collections are low-burden for
respondents (based on considerations of
total burden hours, total number of
respondents, or burden-hours per
respondent) and are low-cost for both
the respondents and the Federal
Government;
• The collections are
noncontroversial and do not raise issues
of concern to other Federal agencies;
• Any collection is targeted to the
solicitation of opinions from
respondents who have experience with
the program or may have experience
with the program in the near future;
• Personally identifiable information
(PII) is collected only to the extent
necessary and is not retained;
• Information gathered is intended to
be used only internally for general
service improvement and program
management purposes and is not
intended for release outside of the
agency (if released, the agency must
indicate the qualitative nature of the
information);
• Information gathered will not be
used for the purpose of substantially
Estimated Annualized Burden Hours
Number of
respondents
Type of collection
khammond on DSK9W7S144PROD with NOTICES
informing influential policy decisions;
and
• Information gathered will yield
qualitative information; the collections
will not be designed or expected to
yield statistically reliable results or used
as though the results are generalizable to
the population of study.
Feedback collected under this Generic
Clearance provides useful information,
but it does not yield data that can be
generalized to the overall population.
This type of Generic Clearance for
qualitative information will not be used
for quantitative information collections
that are designed to yield reliably
actionable results, such as monitoring
trends over time or documenting
program performance. Such data uses
require more rigorous designs that
address: (1) the target population to
which generalizations will be made; (2)
the sampling frame; (3) the sample
design (including stratification and
clustering); (4) the precision
requirements or power calculations that
justify the proposed sample size; (5) the
expected response rate; (6) the methods
for assessing potential nonresponse bias;
(7) the protocols for data collection; and
(8) any testing procedures that were or
will be undertaken prior to fielding the
study. Depending on the degree of
influence the results are likely to have,
such collections may still be eligible for
submission for other generic
mechanisms that are designed to yield
quantitative results. As a general matter,
information collections will not result
in any new system of records containing
privacy information and will not ask
questions of a sensitive nature, such as
sexual behavior and attitudes, religious
beliefs, and other matters that are
commonly considered private.
This is an Extension of the previously
approved collection. The respondents
are Individuals and Households;
Businesses and Organizations; and
State, Local, or Tribal Government.
ATSDR requests OMB approval for an
estimated 7,075 annualized burden
hours. There is no cost to respondents
other than their time.
Small discussion groups ..............................................................................................................
Request for customer comment cards/complaint forms/post-conference or training surveys ....
Focus groups of customers, potential customers, delivery partners, or other stakeholders ......
Qualitative customer satisfaction surveys or interviews ..............................................................
Usability testing/in-person observation testing ............................................................................
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300
1,500
2,000
3,000
1,500
25NON1
Annual
frequency per
response
1
1
1
1
1
Hours per
response
90/60
15/60
2
30/60
30/60
Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
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. 2024–27468 Filed 11–22–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–25–1255; Docket No. CDC–2024–
0096]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 Emergency
Cruise Ship Outbreak Investigations
(CSOIs). The Vessel Sanitation Program
(VSP) conducts CSOIs in response to
acute gastroenteritis (AGE) outbreaks on
cruise ships within the VSP’s
jurisdiction.
DATES: CDC must receive written
comments on or before January 24,
2025.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0096 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
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SUMMARY:
VerDate Sep<11>2014
18:29 Nov 22, 2024
Jkt 265001
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;
telephone: 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 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
Emergency Cruise Ship Outbreak
Investigations (CSOIs (OMB Control No.
0920–1255, Exp. 3/31/2025)—
Extension—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Established in 1975 as a cooperative
activity with the cruise ship industry,
the Centers for Disease Control and
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92937
Prevention (CDC) Vessel Sanitation
Program (VSP) develops and
implements comprehensive operational
public health programs to minimize the
risk of gastrointestinal illness. VSP
coordinates and conducts public health
inspections, ongoing surveillance of
gastrointestinal illness, and outbreak
investigations on cruise ships.
Under the authority of the Public
Health Service Act (42 U.S.C. 264 and
269), VSP is requesting a three-year
Extension Information Collection
Request (ICR) for an existing Generic
Clearance. This ICR will provide for the
quick turnaround necessary to conduct
emergency Cruise Ship Outbreak
Investigations (CSOIs) in response to
acute gastroenteritis (AGE) outbreaks.
CSOIs are used to determine causative
agents and their sources, modes of
transmission, or risk factors. VSP’s
jurisdiction includes passenger vessels
carrying 13 or more people sailing from
foreign ports and within 15 days of
arriving at a U.S. port.
VSP uses its syndromic surveillance
system called the Maritime Illness and
Death Reporting System (MIDRS) (OMB
Control No. 0920–1260, expiration date
03/31/2026) to collect aggregate data
about the number of people onboard
ships in VSP’s jurisdiction who are
experiencing AGE symptoms. When the
levels of illness meet VSP’s alert
threshold (i.e., at least 2% in either the
passenger or crew populations), a
special report is made to VSP via
MIDRS and VSP provides
environmental health and
epidemiologic assistance. VSP considers
an outbreak to be ≥3% of reportable
AGE cases in either passenger or crew
populations.
When a cruise ship has an AGE
outbreak, VSP often must deploy a
response team to meet the ship in port
within 24 hours of reaching the
outbreak threshold. In some cases, the
response team must board the ship
before its U.S. arrival and sail back to
the U.S. port of disembarkation to
conduct a more detailed and
comprehensive epidemiologic and
environmental health evaluation of the
outbreak.
VSP can ascertain a causative agent,
sources of exposure, modes of
transmission, and risk factors by
gathering the following types of
information from both the affected and
(seemingly) unaffected populations:
• Demographic information,
• Pre-embarkation travel information,
• Symptoms, including type, onset,
duration,
• Contact with people who were sick
or their body fluids,
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]]>Agencies
[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92935-92937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27468]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-25-0047]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Agency
for Toxic Substances and Disease Registry (ATSDR) has submitted the
information collection request titled ``Generic Clearance for the
Collection of Qualitative Feedback on Agency Service Delivery'' to the
Office of Management and Budget (OMB) for review and approval. ATSDR
previously published a ``Proposed Data Collection Submitted for Public
Comment and Recommendations'' notice on August 16, 2024, to obtain
comments from the public and affected agencies. ATSDR did not receive
comments related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
ATSDR 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,
[[Page 92936]]
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses; and
(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
Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery (OMB Control No. 0923-0047, Expiration Date 2/
28/2025)--Extension--Agency for Toxic Substances and Disease Registry
(ATSDR).
Background and Brief Description
The information collection activity provides a means to garner
qualitative customer and stakeholder feedback in an efficient, timely
manner, in accordance with the Federal government's commitment to
improving service delivery. By qualitative feedback we mean information
that provides useful insights on perceptions and opinions, but are not
statistical surveys that yield quantitative results that can be
generalized to the population of study.
This feedback will provide insights into customer or stakeholder
perceptions, experiences, and expectations, provide an early warning of
issues with service, or focus attention on areas where communication,
training or changes in operations might improve delivery of products or
services. These collections will allow for ongoing, collaborative, and
actionable communications between the ATSDR and its customers and
stakeholders. It will also allow feedback to contribute directly to the
improvement of program management.
The solicitation of feedback will target areas such as: timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the Agency's services will be unavailable.
ATSDR will only submit a collection for approval under this Generic
Clearance if it meets the following conditions:
The collections are voluntary;
The collections are low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government;
The collections are noncontroversial and do not raise
issues of concern to other Federal agencies;
Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
Information gathered is intended to be used only
internally for general service improvement and program management
purposes and is not intended for release outside of the agency (if
released, the agency must indicate the qualitative nature of the
information);
Information gathered will not be used for the purpose of
substantially informing influential policy decisions; and
Information gathered will yield qualitative information;
the collections will not be designed or expected to yield statistically
reliable results or used as though the results are generalizable to the
population of study.
Feedback collected under this Generic Clearance provides useful
information, but it does not yield data that can be generalized to the
overall population. This type of Generic Clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: (1) the target
population to which generalizations will be made; (2) the sampling
frame; (3) the sample design (including stratification and clustering);
(4) the precision requirements or power calculations that justify the
proposed sample size; (5) the expected response rate; (6) the methods
for assessing potential nonresponse bias; (7) the protocols for data
collection; and (8) any testing procedures that were or will be
undertaken prior to fielding the study. Depending on the degree of
influence the results are likely to have, such collections may still be
eligible for submission for other generic mechanisms that are designed
to yield quantitative results. As a general matter, information
collections will not result in any new system of records containing
privacy information and will not ask questions of a sensitive nature,
such as sexual behavior and attitudes, religious beliefs, and other
matters that are commonly considered private.
This is an Extension of the previously approved collection. The
respondents are Individuals and Households; Businesses and
Organizations; and State, Local, or Tribal Government. ATSDR requests
OMB approval for an estimated 7,075 annualized burden hours. There is
no cost to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Annual
Type of collection Number of frequency per Hours per
respondents response response
----------------------------------------------------------------------------------------------------------------
Small discussion groups......................................... 300 1 90/60
Request for customer comment cards/complaint forms/post- 1,500 1 15/60
conference or training surveys.................................
Focus groups of customers, potential customers, delivery 2,000 1 2
partners, or other stakeholders................................
Qualitative customer satisfaction surveys or interviews......... 3,000 1 30/60
Usability testing/in-person observation testing................. 1,500 1 30/60
----------------------------------------------------------------------------------------------------------------
[[Page 92937]]
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. 2024-27468 Filed 11-22-24; 8:45 am]
BILLING CODE 4163-18-P
