Submission for OMB Review; Child Abuse and Neglect Background Checks for Child Care and Early Education Project (New Collection), 65360-65361 [2024-17723]
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ddrumheller on DSK120RN23PROD with NOTICES1
65360
Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices
and protections related to their
Medicare prescription drug benefits,
including the right to receive a written
explanation from the drug plan about
why a prescription drug is not covered.
Through delivery of this standardized
notice, a Part D plan sponsor’s network
pharmacies are in the best position to
inform enrollees at point of sale about
how to contact their Part D plan if the
prescription cannot be filled. Form
Number: CMS–10147 (OMB control
number: 0938–0975); Frequency: Yearly;
Affected Public: Private Sector, Business
or other for-profits, Not for-profits;
Number of Respondents: 72,900;
Number of Responses: 55,215,940; Total
Annual Hours: 919,898. (For policy
questions regarding this collection
contact Sabrina Edmonston at 410–786–
3209 or Sabrina.edmonston@
cms.hhs.gov).
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Service Level
Data Collection for Initial
Determinations and Appeals; Use: The
Part C and D Reporting Requirements, as
set forth in §§ 422.516(a) and 423.514(a),
provide CMS with the ability to collect
more granular data related to all plan
activities regarding adjudicating
requests for coverage and plan
procedures related to making service
utilization decisions. This includes
collecting more timely data with greater
frequency or closer in real-time. The
proposed data elements listed in the
Technical Specifications document in
this proposed PRA would provide key
data to CMS on the utilization of
benefits, enhance audit activities to
ensure plans are operating in
accordance with CMS guidelines, and
ensure appropriate access to covered
services and benefits.
CMS staff will use this information to
monitor health plans and to hold them
accountable for their performance. CMS
users include group managers, division
managers, branch managers, account
managers, and researchers. Health plans
can use this information to measure and
benchmark their performance. CMS
receives inquiries from the industry and
other interested stakeholders about
beneficiary access to the items, services,
and drugs, including service level data
for initial determinations and appeals,
and other factors pertaining to use of
government funds, as well the
performance of MA plans. Form
Number: CMS–10905 (OMB control
number: 0938-New); Frequency:
Quarterly; Affected Public: Private
Sector, Business or other for-profits, Not
for-profits and Federal Government
State, Local; Number of Respondents:
VerDate Sep<11>2014
19:21 Aug 08, 2024
Jkt 262001
728; Number of Responses: 2,912; Total
Annual Hours: 728. (For policy
questions regarding this collection
contact Sabrina Edmonston at 410–786–
3209 or sabrina.edmonston@
cms.hhs.gov).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–17773 Filed 8–8–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Child
Abuse and Neglect Background
Checks for Child Care and Early
Education Project (New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, Department of
Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Children and
Families (ACF) is proposing an
information collection activity for the
Child Abuse and Neglect Background
Checks for Child Care and Early
Education (CAN Checks for CCEE)
Project. The goal of the project is to
better understand how states and
territories use findings from CAN
registry background checks, as required
by the Child Care and Development
Block Grant Act of 2014 (CCDBG), to
make child care employment eligibility
determinations. The study will also be
used to understand state and territory
variation, facilitators, and challenges in
implementing CAN registry background
checks; and explore any resulting
within- or across-state/territory equity
implications.
SUMMARY:
Comments due within 30 days of
publication. The Office of Management
and Budget (OMB) must make a
decision about the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
DATES:
Written 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/
ADDRESSES:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review-Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing
OPREinfocollection@acf.hhs.gov. All
emailed requests should be identified by
the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The proposed
information collections for the CAN
Checks for CCEE Project is designed to
explore how states and territories
implement CAN registry background
checks for child care employment
eligibility decisions. While the CCDBG
Act of 2014 clearly describes procedures
and exclusionary criteria pertaining to
the use of criminal and sexual offender
registry background checks to inform
child care employment eligibility
decisions, requirements for the use of
CAN registry background checks are less
clear. The findings will be of interest to
ACF, and, in particular, to OPRE and
the Office of Child Care, who are
interested in the effective and equitable
implementation of CAN registry
background checks for prospective and
current child care staff. Findings will
also be of interest to Child Care and
Development Fund (CCDF) state/
territory lead agencies that oversee the
CCDF program in their states/territories
and the state/territory offices that
oversee early care and education. The
results of this study also have
implications for child care programs
and staff. Further, given the U.S.
Congress’ interest in prior exploratory
work on this topic, it may also be
informative to federal lawmakers.
CCDF lead agency staff that
participate in this information
collection will be asked to complete a
voluntary, one-time web-based survey.
The survey will focus on the practices
and policies related both to in-state/
territory and interstate CAN registry
checks, including what data they
request and receive, as well as how they
use it in making child care employment
eligibility decisions.
Respondents: Each state, territory, and
the District of Columbia will be invited
to complete one web-based survey.
Given that each agency may have
multiple staff members with relevant
knowledge of different survey topics
and no one staff member may possess
all of the knowledge to complete the
survey, CCDF Lead Agencies may have
multiple staff members work together to
complete the survey. For burden
estimates, we are assuming up to 3
respondents may work on the survey
E:\FR\FM\09AUN1.SGM
09AUN1
65361
Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices
per state/territory (up to 168 total
individuals). Only one survey will be
submitted for each state/territory.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
(total over
request
period)
Number of
responses per
respondent
(total over
request
period)
Avg. burden
per response
(in hours)
Total/annual
burden
(in hours)
Instrument 1: CCDF Lead Agency Survey ......................................................
168
1
* 0.75
126
* Note that this is the estimated time to complete the full survey, which could be completed by one individual or multiple individuals. Surveys
completed by multiple individuals will take less time for each individual to provide a response.
Authority: Research funding set-aside
authorized by the CCDBG Act of 2014
and funded by CCDF. Section
658O(a)(5) of CCDBG (as codified at 42
U.S.C. 9857 et seq) grants the Secretary
of HHS the authority to reserve up to 1⁄2
percent of the total Discretionary and
Mandatory CCDF funding ‘‘to conduct
research and demonstration activities,
as well as periodic external,
independent evaluations of the impact
of the program described by this
subchapter on increasing access to child
care services and improving the safety
and quality of child care services, using
scientifically valid research
methodologies, and to disseminate the
key findings of those evaluations widely
and on a timely basis.’’
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–17723 Filed 8–8–24; 8:45 am]
BILLING CODE 4184–23–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–0342]
Bacillus Calmette-GuérinUnresponsive Nonmuscle Invasive
Bladder Cancer: Developing Drug and
Biological Products for Treatment;
Revised Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Bacillus
Calmette-Guérin-Unresponsive
Nonmuscle Invasive Bladder Cancer:
Developing Drug and Biological
Products for Treatment.’’ The purpose of
this guidance is to assist sponsors in the
development of drug and biological
products for the treatment of patients
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:21 Aug 08, 2024
Jkt 262001
with bacillus Calmette-Guérin (BCG)unresponsive nonmuscle invasive
bladder cancer (NMIBC). This draft
guidance reflects proposed revisions to
the final guidance entitled ‘‘BCGUnresponsive Nonmuscle Invasive
Bladder Cancer: Developing Drugs and
Biologics for Treatment,’’ published in
February 2018, and incorporates
changes based on review experience as
well as the evolving landscape of drug
development in bladder cancer, as noted
by external experts.
DATES: Submit either electronic or
written comments on the draft guidance
by October 8, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–0342 for ‘‘BCG-Unresponsive
Nonmuscle Invasive Bladder Cancer:
Developing Drug and Biological
Products for Treatment.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65360-65361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17723]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Child Abuse and Neglect Background
Checks for Child Care and Early Education Project (New Collection)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Planning, Research, and Evaluation (OPRE),
Administration for Children and Families (ACF) is proposing an
information collection activity for the Child Abuse and Neglect
Background Checks for Child Care and Early Education (CAN Checks for
CCEE) Project. The goal of the project is to better understand how
states and territories use findings from CAN registry background
checks, as required by the Child Care and Development Block Grant Act
of 2014 (CCDBG), to make child care employment eligibility
determinations. The study will also be used to understand state and
territory variation, facilitators, and challenges in implementing CAN
registry background checks; and explore any resulting within- or
across-state/territory equity implications.
DATES: Comments due within 30 days of publication. The Office of
Management and Budget (OMB) must make a decision about the collection
of information between 30 and 60 days after publication of this
document in the Federal Register. Therefore, a comment is best assured
of having its full effect if OMB receives it within 30 days of
publication.
ADDRESSES: Written 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. You can
also obtain copies of the proposed collection of information by
emailing [email protected]. All emailed requests should be
identified by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The proposed information collections for the CAN
Checks for CCEE Project is designed to explore how states and
territories implement CAN registry background checks for child care
employment eligibility decisions. While the CCDBG Act of 2014 clearly
describes procedures and exclusionary criteria pertaining to the use of
criminal and sexual offender registry background checks to inform child
care employment eligibility decisions, requirements for the use of CAN
registry background checks are less clear. The findings will be of
interest to ACF, and, in particular, to OPRE and the Office of Child
Care, who are interested in the effective and equitable implementation
of CAN registry background checks for prospective and current child
care staff. Findings will also be of interest to Child Care and
Development Fund (CCDF) state/territory lead agencies that oversee the
CCDF program in their states/territories and the state/territory
offices that oversee early care and education. The results of this
study also have implications for child care programs and staff.
Further, given the U.S. Congress' interest in prior exploratory work on
this topic, it may also be informative to federal lawmakers.
CCDF lead agency staff that participate in this information
collection will be asked to complete a voluntary, one-time web-based
survey. The survey will focus on the practices and policies related
both to in-state/territory and interstate CAN registry checks,
including what data they request and receive, as well as how they use
it in making child care employment eligibility decisions.
Respondents: Each state, territory, and the District of Columbia
will be invited to complete one web-based survey. Given that each
agency may have multiple staff members with relevant knowledge of
different survey topics and no one staff member may possess all of the
knowledge to complete the survey, CCDF Lead Agencies may have multiple
staff members work together to complete the survey. For burden
estimates, we are assuming up to 3 respondents may work on the survey
[[Page 65361]]
per state/territory (up to 168 total individuals). Only one survey will
be submitted for each state/territory.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per
respondents respondent Avg. burden per Total/annual
Instrument (total over (total over response (in burden (in
request request hours) hours)
period) period)
----------------------------------------------------------------------------------------------------------------
Instrument 1: CCDF Lead Agency Survey....... 168 1 * 0.75 126
----------------------------------------------------------------------------------------------------------------
* Note that this is the estimated time to complete the full survey, which could be completed by one individual
or multiple individuals. Surveys completed by multiple individuals will take less time for each individual to
provide a response.
Authority: Research funding set-aside authorized by the CCDBG Act
of 2014 and funded by CCDF. Section 658O(a)(5) of CCDBG (as codified at
42 U.S.C. 9857 et seq) grants the Secretary of HHS the authority to
reserve up to \1/2\ percent of the total Discretionary and Mandatory
CCDF funding ``to conduct research and demonstration activities, as
well as periodic external, independent evaluations of the impact of the
program described by this subchapter on increasing access to child care
services and improving the safety and quality of child care services,
using scientifically valid research methodologies, and to disseminate
the key findings of those evaluations widely and on a timely basis.''
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-17723 Filed 8-8-24; 8:45 am]
BILLING CODE 4184-23-P
