Proposed Data Collection Submitted for Public Comment and Recommendations, 34636-34637 [2020-12242]
Download as PDF
<![CDATA[
34636
Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
State, Territory, and New Mexico
County Officials.
State, Territory, and other officials ....
Monthly Vital Statistics Report .........
91
12
8/60
146
Annual Vital Statistics Occurrence
Report.
58
1
30/60
29
Total ...........................................
..........................................................
........................
........................
........................
175
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–12243 Filed 6–4–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[60Day–20–20OT; Docket No. CDC–2020–
0063]
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 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 ‘‘Mycoplasma genitalium
Treatment Failure Registry.’’ The
purpose of the collection is to determine
which second-line antibiotics are in use
for M. genitalium treatment failure and
monitor antibiotic resistance patterns
for treatment failure cases throughout
the United States.
DATES: CDC must receive written
comments on or before August 4, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0063 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
SUMMARY:
VerDate Sep<11>2014
18:21 Jun 04, 2020
Jkt 250001
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.
Centers for Disease Control and
Prevention
lotter on DSK9F5VC42PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondents
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 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,
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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
Mycoplasma genitalium Treatment
Failure Registry—New—National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), Division of STD
Prevention requests a three-year
approval of an information collection
request for the Mycoplasma genitalium
Treatment Failure Registry, which will
entail use of a standardized Case Report
Form.
The primary goal of this activity is to
establish a registry to monitor cases of
Mycoplasma genitalium (M. genitalium)
treatment failure in the United States.
The project objectives are as follows: (1)
Using existing clinical data, describe
demographic and behavioral factors
among patients with documented
Mycoplasma genitalium who fail
current CDC-recommended treatment.
(2) Using existing clinical data, describe
antibiotic regimens utilized among
patients with Mycoplasma genitalium
treatment failure, including
documentation of clinical and
microbiologic cure. (3) Using existing
laboratory specimens, monitor genetic
mutations associated with macrolide or
fluroquinolone antibiotic resistance.
Data captured on the standardized Case
Report Form will be analyzed to
determine outcomes from usage of
second-line antibiotic therapy for M.
E:\FR\FM\05JNN1.SGM
05JNN1
34637
Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices
gentialium. These data may inform
future CDC STD Treatment Guidelines.
There are an estimated 100
respondents (anticipated to report once
per year) who will be clinicians in
private and public health care settings.
The data collection is necessary as there
are no current national
clinically effective, as well as
determining antibiotic resistance
patterns of M. genitalium throughout the
US. There are no costs to respondents
other than their time. The estimated
annualized burden hours for this data
collection are 100 hours.
recommendations for patients who fail
current CDC-recommended therapy for
M. genitalium. Each case report form is
anticipated to take up to 60 minutes to
complete.
This data collection provides CDC
with information to determine which
second-line treatments are most
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Physician or Nurse Practitioner.
Number of
respondents
Form name
M. genitalium Treatment Failure Registry
Case Report Form.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–12242 Filed 6–4–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Generic Clearance for the
Comprehensive Child Welfare
Information System (CCWIS) Review
and Technical Assistance Process
(New Collection)
Children’s Bureau,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Children’s Bureau (CB),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing to establish a generic
clearance to collect information to
assess regulatory requirements of title
IV–E agencies’ Comprehensive Child
Welfare Information System (CCWIS)
SUMMARY:
Number
responses per
respondent
100
and ensure that the CCWIS is utilized
for purposes consistent with the
efficient, economical, and effective
administration of the title IV–B and IV–
E plans. The information collected is
intended to be used for review and
technical assistance processes.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Copies can also be obtained
by writing to the Administration for
Children and Families, Office of
Planning, Research, and Evaluation
(OPRE), 330 C Street SW, Washington,
DC 20201, Attn: ACF Reports Clearance
Officer. All requests, emailed or written,
should be identified by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: This initial request is to
establish an overarching generic for
CCWIS Review and Technical
Assistance (TA) information collections
and includes six initial TA tools for title
1
Average
burden per
response
(in hours)
Total
burden hours
1
100
IV–E agencies to self-assess their
conformity to CCWIS project and design
requirements at 45 CFR 1355.52–3. The
initial six TA tools include intake,
investigation, case management,
adoption, foster care and service
provider management, and
administration.
In the future, ACF will submit under
this generic clearance mechanism
additional TA tools for title IV–E
agencies to self-assess design, data
quality, usability, reporting, data
exchanges, external systems, eligibility,
finance, Child Welfare Contributing
Agencies, and other tools, as needed, to
assess new child welfare programs and
modern system architecture.
The CCWIS requirements at 45 CFR
1355.55 require the review, assessment,
and inspection of the planning, design,
development, installation, operation,
and maintenance of each CCWIS project
on a continuing basis. The Advance
Planning Document regulations at 45
CFR 95.621 require periodic reviews of
state and local agency methods and
practices to insure that information
systems, including CCWIS, are utilized
for purposes consistent with proper and
efficient administration.
Respondents: Title IV–E agencies
under the Social Security Act.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
lotter on DSK9F5VC42PROD with NOTICES
Instrument
CCWIS Self-Assessment—Intake ....................................................................
CCWIS Self-Assessment—Investigation .........................................................
CCWIS Self-Assessment—Case Management ...............................................
CCWIS Self-Assessment—Adoption ...............................................................
CCWIS Self-Assessment—Foster Care and Service Provider Management
CCWIS Self-Assessment—Administration .......................................................
Future Tools to be developed .........................................................................
VerDate Sep<11>2014
18:21 Jun 04, 2020
Jkt 250001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Total
number of
responses per
respondent
55
55
55
55
55
55
55
E:\FR\FM\05JNN1.SGM
1
1
1
1
1
1
10
05JNN1
Average
burden hours
per response
10
10
10
10
10
10
12
Total
burden hours
550
550
550
550
550
550
6,600
]]>Agencies
[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34636-34637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12242]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-20OT; Docket No. CDC-2020-0063]
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 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 ``Mycoplasma genitalium Treatment
Failure Registry.'' The purpose of the collection is to determine which
second-line antibiotics are in use for M. genitalium treatment failure
and monitor antibiotic resistance patterns for treatment failure cases
throughout the United States.
DATES: CDC must receive written comments on or before August 4, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0063 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
Mycoplasma genitalium Treatment Failure Registry--New--National
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), Division of
STD Prevention requests a three-year approval of an information
collection request for the Mycoplasma genitalium Treatment Failure
Registry, which will entail use of a standardized Case Report Form.
The primary goal of this activity is to establish a registry to
monitor cases of Mycoplasma genitalium (M. genitalium) treatment
failure in the United States. The project objectives are as follows:
(1) Using existing clinical data, describe demographic and behavioral
factors among patients with documented Mycoplasma genitalium who fail
current CDC-recommended treatment. (2) Using existing clinical data,
describe antibiotic regimens utilized among patients with Mycoplasma
genitalium treatment failure, including documentation of clinical and
microbiologic cure. (3) Using existing laboratory specimens, monitor
genetic mutations associated with macrolide or fluroquinolone
antibiotic resistance. Data captured on the standardized Case Report
Form will be analyzed to determine outcomes from usage of second-line
antibiotic therapy for M.
[[Page 34637]]
gentialium. These data may inform future CDC STD Treatment Guidelines.
There are an estimated 100 respondents (anticipated to report once
per year) who will be clinicians in private and public health care
settings. The data collection is necessary as there are no current
national recommendations for patients who fail current CDC-recommended
therapy for M. genitalium. Each case report form is anticipated to take
up to 60 minutes to complete.
This data collection provides CDC with information to determine
which second-line treatments are most clinically effective, as well as
determining antibiotic resistance patterns of M. genitalium throughout
the US. There are no costs to respondents other than their time. The
estimated annualized burden hours for this data collection are 100
hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Physician or Nurse M. genitalium 100 1 1 100
Practitioner. Treatment
Failure
Registry Case
Report Form.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-12242 Filed 6-4-20; 8:45 am]
BILLING CODE 4163-18-P
