Proposed Data Collection Submitted for Public Comment and Recommendations, 24005-24007 [2024-07289]
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<![CDATA[
24005
Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Cluster and outbreak case patients ..............
National Hypothesis Generating Questionnaire.
Foodborne Focus Questionnaire.
Animal Contact Focus Questionnaire.
Shigella Hypothesis Generating Questionnaire.
NARMS SIRI Questionnaire
Module 1.
Cluster and outbreak case patients ..............
Cluster and outbreak case patients ..............
Shigellosis case patients ..............................
Nontyphoidal Salmonella, STEC, Vibrio, or
Campylobacter case patients whose bacterial isolates have concerning antimicrobial resistance.
Nontyphoidal Salmonella (except Newport
strain), STEC, or Vibrio case patients
whose bacterial isolates have concerning
antimicrobial resistance.
Multidrug-resistant Salmonella Newport
case patients.
Campylobacter case patients whose bacterial isolates have concerning antimicrobial resistance.
Salmonella Typhi or Paratyphi case patients
whose bacterial isolates have concerning
antimicrobial resistance.
Total .......................................................
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. 2024–07287 Filed 4–4–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[60Day–24–0556; Docket No. CDC–2024–
0025]
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
SUMMARY:
VerDate Sep<11>2014
16:44 Apr 04, 2024
Jkt 262001
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
4,000
1
45/60
3,000
4,000
1
20/60
1,333
450
1
30 min
225
1500
1
45/60
1,125
305
1
15/60
77
NARMS SIRI Questionnaire
Module 2.
130
1
10/60
22
NARMS SIRI Questionnaire
Module 3.
NARMS SIRI Questionnaire
Module 4.
125
1
15/60
32
50
1
25/60
21
NARMS SIRI Questionnaire
Module 5.
50
1
20/60
17
........................
........................
........................
5,852
...............................................
collection project titled Assisted
Reproductive Technology (ART)
Program Reporting System. This study
is designed to collect information on
ART cycles to publish information on
pregnancy success rates as required
under Section 2(a) of the Federal Clinic
Success Rate and Certification Act
(FCSRCA).
CDC must receive written
comments on or before June 4, 2024.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0025 by either of the following methods:
b Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
b 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.
DATES:
Centers for Disease Control and
Prevention
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
Please note: Submit all comments through
the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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: 404–639–7118; 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;
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05APN1.SGM
05APN1
24006
Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
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
Assisted Reproductive Technology
(ART) Program Reporting System (OMB
Control No. 0920–0556, Exp. 12/31/
2024)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 102–493
(known as the Fertility Clinic Success
Rate and Certification Act of 1992
(FCSRCA), 42 U.S.C. 263a–1(a)) requires
that each assisted reproductive
technology (ART) program shall
annually report to the Secretary through
the Centers for Disease Control and
Prevention: (1) pregnancy success rates
achieved by such ART program; and (2)
the identity of each embryo laboratory
used by such ART program and whether
the laboratory is certified or has applied
for such certification under the Act. The
required information is currently
reported by ART programs to CDC as
specified in the Assisted Reproductive
Technology (ART) Program Reporting
System (OMB Control No. 0920–0556,
Exp. 12/31/2024). The current revision
seeks to revise burden hour estimates,
modify data elements collected,
implement a new process for sharing
Society for Assisted Reproductive
Technology (SART), the American
Society for Reproductive Medicine
(ASRM), and RESOLVE: the National
Infertility Association (a national,
nonprofit consumer organization), as
well as a variety of individuals with
expertise and interest in this field.
The estimated number of respondents
(ART programs or clinics) is 453, based
on the number of clinics that provided
information in 2021. This number is
lower than the previous number of
reporting clinics (456). The estimated
average number of responses (ART
cycles) per respondent is 913. The total
burden estimate is higher than the
previous approval due to an increase in
the utilization of ART in the United
States. Additionally, approximately 5–
10% of responding clinics will be
randomly selected each year to
participate in data validation and
quality control activities; an estimated
35 clinics will be selected to report
validation data on 70 cycles each on
average. Finally, respondents may
provide feedback to CDC about the
usability and utility of the reporting
system. The option to participate in the
feedback survey is presented to
respondents when they complete their
required data submission. Participation
in the feedback survey is voluntary and
is not required by the FCSRCA. CDC
estimates that 50% of ART programs
will participate in the feedback survey.
Due to this lower response rate and
reduced number of reporting clinics,
CDC estimates 203 clinics will respond
to voluntary feedback survey.
The collection of ART cycle
information allows CDC to publish
clinic-specific success rates annually as
specified by the FCSRCA and to provide
information needed by consumers. OMB
approval is requested for three years.
CDC requests approval for 297,352
annual burden hours. There are no costs
to respondents other than their time.
data externally, and to extend OMB
approval for a period of three years. The
revised total burden estimate is higher
than the previous approval, due to an
increase in the utilization of ART in the
United States and the number of
reported cycles. Data elements collected
will be modified to remove five data
elements no longer needed and add one
new data element to reflect current
clinical practice. The average estimated
burden for reporting information related
to each cycle is not anticipated to
change from the time burden previously
approved (43 minutes). Data will be
made available in the National Center
for Health Statistics Research Data
Center to increase accessibility of
Assisted Reproductive Technology
(ART) Program Reporting System data
for secondary epidemiological analyses.
The currently approved program
reporting system, also known as the
National ART Surveillance System
(NASS), collects information about all
ART cycles initiated by ART programs
in the United States. The start of an ART
cycle is considered when a woman
begins taking medication to stimulate
egg production or begins monitoring
with the intent of having embryos
transferred. For each cycle, CDC collects
information about the pregnancy
outcome, as well as several data
elements deemed by experts in the field
to be important to explain variability in
success rates across ART programs and
individuals.
Each ART program reports its annual
ART cycle data to CDC in midDecember. The annual data reporting
consists of information about all ART
cycles that were initiated in the
previous calendar year. For example,
ART programs that submit their data in
mid-December 2021 will include all
ART cycles that were initiated between
January 1, 2020, and December 31, 2020.
Data elements and definitions
currently in use reflect CDC’s prior
consultations with representatives of the
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
ART Program/Clinic ......................................
NASS Reporting Form ..........
Data Validation .....................
Feedback Survey ..................
453
35
203
913
70
1
43/60
23/60
2/60
296,406
939
7
Total .......................................................
...............................................
........................
........................
........................
297,352
VerDate Sep<11>2014
16:44 Apr 04, 2024
Jkt 262001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\05APN1.SGM
05APN1
Federal Register / Vol. 89, No. 67 / Friday, April 5, 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. 2024–07289 Filed 4–4–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–24–24EG; Docket No. CDC–2024–
0024]
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 proposed information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Documenting
outcomes associated with Persistent Tic
Disorders (including Tourette
Syndrome) in Children, Adolescents,
and Young Adults through Surveillance.
This study will collect data on the
public health impact of persistent tic
disorders from children and adolescents
with tic disorders and their parents, as
well as young adults with tic disorders.
DATES: CDC must receive written
comments on or before June 4, 2024.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0024 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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:44 Apr 04, 2024
Jkt 262001
Please note: Submit all comments through
the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to the
address listed above.
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;
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.
FOR FURTHER INFORMATION CONTACT:
Proposed Project
Documenting outcomes associated
with Persistent Tic Disorders (including
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
24007
Tourette Syndrome) in Children,
Adolescents, and Young Adults through
Surveillance—New—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
There are an estimated 1.4 million
people in the U.S. affected by persistent
tic disorders (PTD), including Tourette
syndrome (TS). To support people with
these conditions, the impact of PTD/TS
must be understood. Although some
data on the impact of PTD/TS on social
relationships and education are
available, other potential outcomes
associated with PTD/TS have not been
well-documented; including associated
costs, suicidality, health care transition,
and the prevalence of co-occurring
disorders and how co-occurring
disorders modify these outcomes.
Limited data are available on how these
outcomes may differ among subpopulations (e.g., by sex, race/ethnicity,
age group, and geography [e.g., urban/
rural]).
This data collection aims to document
priority outcomes including costs (e.g.,
education level, employment,
healthcare beyond those available in
claims data), prevalence of suicidality
risk, transition to adult healthcare, and
the prevalence of co-occurring
conditions and how they modify these
outcomes among children and
adolescents (4–17 years) and young
adults (18–26 years) with PTD/TS. Data
will be collected once from a participant
(i.e., individuals with PTD/TS and/or
their caregiver), via a survey, and a
clinical assessment of tic symptoms. All
questions for the Tic Impact
Surveillance Survey, the survey created
for this surveillance project, were
selected from national surveys or
previously validated measures. This
will allow us to compare estimates from
the Tic Impact Surveillance Survey to
external prevalence estimates for the
same health indicators in US children,
adolescents, and young adults in the
general population and to previously
published findings. Data will be used to
inform where resources for families and
healthcare providers (e.g., professional
trainings) are most needed to support
people with PTD/TS and their families
and to address health inequities among
the population.
CDC requests OMB approval for an
estimated 401 annual burden hours.
There is no cost to respondents other
than their time to participate.
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Pages 24005-24007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07289]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-0556; Docket No. CDC-2024-0025]
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 Assisted Reproductive Technology (ART) Program Reporting System.
This study is designed to collect information on ART cycles to publish
information on pregnancy success rates as required under Section 2(a)
of the Federal Clinic Success Rate and Certification Act (FCSRCA).
DATES: CDC must receive written comments on or before June 4, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0025 by either of the following methods:
[squ] Federal eRulemaking Portal: www.regulations.gov. Follow the
instructions for submitting comments.
[squ] 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; Telephone: 404-639-7118;
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;
[[Page 24006]]
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
Assisted Reproductive Technology (ART) Program Reporting System
(OMB Control No. 0920-0556, Exp. 12/31/2024)--Revision--National Center
for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 102-493 (known as the Fertility Clinic
Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-
1(a)) requires that each assisted reproductive technology (ART) program
shall annually report to the Secretary through the Centers for Disease
Control and Prevention: (1) pregnancy success rates achieved by such
ART program; and (2) the identity of each embryo laboratory used by
such ART program and whether the laboratory is certified or has applied
for such certification under the Act. The required information is
currently reported by ART programs to CDC as specified in the Assisted
Reproductive Technology (ART) Program Reporting System (OMB Control No.
0920-0556, Exp. 12/31/2024). The current revision seeks to revise
burden hour estimates, modify data elements collected, implement a new
process for sharing data externally, and to extend OMB approval for a
period of three years. The revised total burden estimate is higher than
the previous approval, due to an increase in the utilization of ART in
the United States and the number of reported cycles. Data elements
collected will be modified to remove five data elements no longer
needed and add one new data element to reflect current clinical
practice. The average estimated burden for reporting information
related to each cycle is not anticipated to change from the time burden
previously approved (43 minutes). Data will be made available in the
National Center for Health Statistics Research Data Center to increase
accessibility of Assisted Reproductive Technology (ART) Program
Reporting System data for secondary epidemiological analyses.
The currently approved program reporting system, also known as the
National ART Surveillance System (NASS), collects information about all
ART cycles initiated by ART programs in the United States. The start of
an ART cycle is considered when a woman begins taking medication to
stimulate egg production or begins monitoring with the intent of having
embryos transferred. For each cycle, CDC collects information about the
pregnancy outcome, as well as several data elements deemed by experts
in the field to be important to explain variability in success rates
across ART programs and individuals.
Each ART program reports its annual ART cycle data to CDC in mid-
December. The annual data reporting consists of information about all
ART cycles that were initiated in the previous calendar year. For
example, ART programs that submit their data in mid-December 2021 will
include all ART cycles that were initiated between January 1, 2020, and
December 31, 2020.
Data elements and definitions currently in use reflect CDC's prior
consultations with representatives of the Society for Assisted
Reproductive Technology (SART), the American Society for Reproductive
Medicine (ASRM), and RESOLVE: the National Infertility Association (a
national, nonprofit consumer organization), as well as a variety of
individuals with expertise and interest in this field.
The estimated number of respondents (ART programs or clinics) is
453, based on the number of clinics that provided information in 2021.
This number is lower than the previous number of reporting clinics
(456). The estimated average number of responses (ART cycles) per
respondent is 913. The total burden estimate is higher than the
previous approval due to an increase in the utilization of ART in the
United States. Additionally, approximately 5-10% of responding clinics
will be randomly selected each year to participate in data validation
and quality control activities; an estimated 35 clinics will be
selected to report validation data on 70 cycles each on average.
Finally, respondents may provide feedback to CDC about the usability
and utility of the reporting system. The option to participate in the
feedback survey is presented to respondents when they complete their
required data submission. Participation in the feedback survey is
voluntary and is not required by the FCSRCA. CDC estimates that 50% of
ART programs will participate in the feedback survey. Due to this lower
response rate and reduced number of reporting clinics, CDC estimates
203 clinics will respond to voluntary feedback survey.
The collection of ART cycle information allows CDC to publish
clinic-specific success rates annually as specified by the FCSRCA and
to provide information needed by consumers. OMB approval is requested
for three years. CDC requests approval for 297,352 annual burden hours.
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)
----------------------------------------------------------------------------------------------------------------
ART Program/Clinic............ NASS Reporting 453 913 43/60 296,406
Form.
Data Validation. 35 70 23/60 939
Feedback Survey. 203 1 2/60 7
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 297,352
----------------------------------------------------------------------------------------------------------------
[[Page 24007]]
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. 2024-07289 Filed 4-4-24; 8:45 am]
BILLING CODE 4163-18-P
