Proposed Information Collection Activity; Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Review and Technical Assistance Process (New Collection), 34637-34638 [2020-12125]
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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
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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
34638
Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices
Estimated Total Annual Burden
Hours: 9,900.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
(Authority: 5 U.S.C. 301; 42 U.S.C. 470, 620
et seq., 622(b), 629b(a), 652(b), 654A, 670 et
seq., 671(a), 1302, and 1396a(a))
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–12125 Filed 6–4–20; 8:45 am]
BILLING CODE 4184–25–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1301]
Q3C(R8) Recommendations for the
Permitted Daily Exposures for Three
Solvents—2-Methyltetrahydrofuran,
Cyclopentyl Methyl Ether, and TertButyl Alcohol—According to the
Maintenance Procedures for the
Guidance Q3C Impurities: Residual
Solvents; International Council for
Harmonisation; Draft Guidance for
Industry; Availability
Correction
In notice document 2020–11280,
appearing on pages 31785 through
31786 in the issue of Wednesday, May
27, 2020 make the following correction.
On page 31785, in the first column, on
the last line, ‘‘July 26, 2024’’ should
read ‘‘July 27, 2020’’.
lotter on DSK9F5VC42PROD with NOTICES
[FR Doc. C1–2020–11280 Filed 6–4–20; 8:45 am]
BILLING CODE 1300–01–D
VerDate Sep<11>2014
18:21 Jun 04, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1335]
Authorization of Emergency Use of
Certain Medical Devices During
COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance and reissuance of Emergency
Use Authorizations (EUAs) (the
Authorizations) for certain medical
devices related to the coronavirus
disease 2019 (COVID–19) public health
emergency. FDA has issued, and in
some cases reissued, the Authorizations
listed in this document under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). These Authorizations
contain, among other things, conditions
on the emergency use of the authorized
products. The Authorizations follow the
February 4, 2020, determination by
Secretary of Health and Human Services
(HHS) that there is a public health
emergency that has significant potential
to affect national security or the health
and security of U.S. citizens living
abroad, which involves the virus that
causes COVID–19, and the subsequent
declarations on February 4, 2020, March
2, 2020, and March 24, 2020, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
diagnosis of the virus that causes
COVID–19, personal respiratory
protective devices, and medical devices,
including alternative products used as
medical devices, respectively, subject to
the terms of any authorization issued
under the FD&C Act. These
Authorizations, which include an
explanation of the reasons for issuance
and reissuance, are listed in this
document and are available on FDA’s
website at the links indicated in this
document.
SUMMARY:
These Authorizations are
effective on their date of issuance.
ADDRESSES: Submit written requests for
single copies of the EUAs to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
DATES:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
section for electronic access to the
Authorizations.
FOR FURTHER INFORMATION CONTACT:
Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4332, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen the public health protections
against biological, chemical,
radiological, or nuclear agent or agents.
Among other things, section 564 of the
FD&C Act allows FDA to authorize the
use of an unapproved medical product
or an unapproved use of an approved
medical product in certain situations.
With this EUA authority, FDA can help
ensure that medical countermeasures
may be used in emergencies to diagnose,
treat, or prevent serious or lifethreatening diseases or conditions
caused by a biological, chemical,
radiological, or nuclear agent or agents
when there are no adequate, approved,
and available alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50, U.S.
Code, of attack with (i) a biological,
chemical, radiological, or nuclear agent
or agents; or (ii) an agent or agents that
may cause, or are otherwise associated
with, an imminently life-threatening
and specific risk to U.S. military
forces; 1 (3) a determination by the
Secretary of HHS that there is a public
health emergency, or a significant
potential for a public health emergency,
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34637-34638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12125]
-----------------------------------------------------------------------
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)
AGENCY: Children's Bureau, Administration for Children and Families,
HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: 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) 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
[email protected]. 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 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 Average burden
Instrument Total number of responses hours per Total burden
of respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
CCWIS Self-Assessment--Intake................... 55 1 10 550
CCWIS Self-Assessment--Investigation............ 55 1 10 550
CCWIS Self-Assessment--Case Management.......... 55 1 10 550
CCWIS Self-Assessment--Adoption................. 55 1 10 550
CCWIS Self-Assessment--Foster Care and Service 55 1 10 550
Provider Management............................
CCWIS Self-Assessment--Administration........... 55 1 10 550
Future Tools to be developed.................... 55 10 12 6,600
----------------------------------------------------------------------------------------------------------------
[[Page 34638]]
Estimated Total Annual Burden Hours: 9,900.
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
(Authority: 5 U.S.C. 301; 42 U.S.C. 470, 620 et seq., 622(b),
629b(a), 652(b), 654A, 670 et seq., 671(a), 1302, and 1396a(a))
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-12125 Filed 6-4-20; 8:45 am]
BILLING CODE 4184-25-P
