Submission for OMB Review; Identifying and Addressing Human Trafficking in Child Welfare Agencies (New Collection), 66567-66568 [2020-23160]
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Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Notices
calculating discrepancy rates since it
cannot be generalizable for all reporting
clinics.
Since information on potential data
errors is not available from nonvalidated clinics and CDC’s annual data
validation only represents a very small
proportion of clinics (7–10%) and
cycles (1% of total reported cycles),
correcting identified discrepancies in
the final dataset for a small subset of
cycles will not have any significant
effect on data quality or published
success rates. However, CDC took into
account comments that publishing
inaccurate data with known major
discrepancies can be misleading, even
in the presence of a footnote describing
data quality concerns. Therefore, if a
clinic is selected to participate in the
NASS data validation process (either
through stratified random sampling or
through targeted selection), does
participate, and major data
discrepancies are identified (e.g., lack of
supporting information for a significant
proportion of reported pregnancy
outcomes, inability to confirm a
significant proportion of reported live
births, underreporting a significant
proportion of cycles, etc.), a message
will be displayed in the ART Fertility
Clinic Success Rates Report for the
clinic as:
CDC conducts data validation of a sample
of reporting clinics to assess discrepancy
rates for key variables helping, in part, to
ensure clinics submit accurate data and to
identify any systematic problems. This clinic
was visited for validation of (insert: reporting
year) data and major data discrepancies were
identified. This clinic’s reported success rates
data are therefore not published in this
report and not included in aggregate national
data reports.
CDC may re-select this ART program
for data validation during the following
reporting year(s) to assess corrections of
identified data errors.
In addition, CDC will publish
information in the annual ART Fertility
Clinic Success Rates Report to identify
clinics that are selected by CDC to
participate in the NASS data validation
but decline to participate. (See 80 FR
51811 for further information
concerning external validation of clinic
data). If a clinic is selected to participate
in the NASS data validation process and
declines to participate, the following
message will be displayed in the ART
Fertility Clinic Success Rates Report for
the clinic as:
CDC conducts data validation of a sample
of reporting clinics to assess discrepancy
rates for key variables helping, in part, to
ensure clinics submit accurate data and to
identify any systematic problems. This clinic
was selected for validation of (insert:
VerDate Sep<11>2014
18:08 Oct 19, 2020
Jkt 253001
reporting year) data, but declined to
participate. This clinic’s reported data are
therefore not published in this report and not
included in aggregate national data reports.
CDC may re-select this ART program
for data validation during the following
reporting year(s). Participation in data
validation is integral to helping ensure
the accuracy of the required pregnancy
success rates reported to have been
achieved by clinics. Therefore,
displaying this message, as well as the
other messages outlined herein, is
important in providing the public with
the most accurate information.
For consistency, for all other clinics
that are selected to participate in the
NASS data validation and do
participate, the following footnote will
be added:
CDC conducts data validation of a sample
of reporting clinics to assess discrepancy
rates for key variables helping, in part, to
ensure clinics submit accurate data and to
identify any systematic problems. This clinic
was visited for validation of (insert: reporting
year) data and no systematic problems were
identified.
Any messages added to a clinic’s
success rates page in the ART Fertility
Clinic Success Rates Report will appear
only for the reporting year that the
clinic was selected for validation. These
enhanced processes and messages in the
annual ART Fertility Clinic Success
Rates Report will help to inform the
public if there are issues with data
quality, thereby increasing the
transparency and help ensure the
accuracy of the NASS data reporting.
For 2017 reporting year, CDC started
reporting cumulative success rates
which take into account successes over
all embryo transfers within 12-month
period from a single oocyte retrieval
and, therefore, span two reporting years
(83 FR 53253). Effective for data
validation conducted in calendar year
2021, data validation approach will be
aligned with ART reporting approach
and will also span two reporting years.
Data validation conducted in 2021 will
cover oocyte retrievals conducted in
reporting year 2018 and associated
embryo transfers that took place within
12-month period from oocyte retrievals
(reporting years 2018 and 2019). As a
result of this transition to a cumulative
approach in data validation and due to
impacts of the COVID–19 pandemic
(i.e., travel restrictions), no data
validations will be conducted in
calendar year 2020.
PO 00000
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66567
Dated: October 15, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2020–23188 Filed 10–19–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Identifying and Addressing Human
Trafficking in Child Welfare Agencies
(New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) within the
U.S. Department of Health and Human
Services (HHS) is proposing to collect
data on child welfare agencies’ efforts to
identify human trafficking and
subsequent service delivery. The goal of
the study is to better understand child
welfare practice in screening for human
trafficking, and the degree to which
screening is related to subsequent
referrals for, access to, and delivery of
specialized services for children
identified as trafficking victims or at
high risk of trafficking.
DATES: Comments due within 30 days of
publication. 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.
SUPPLEMENTARY INFORMATION:
Description: ACF is proposing data
collection as part of the study,
‘‘Identifying and Addressing Human
Trafficking in Child Welfare Agencies,’’
exploring child welfare practice in
screening for human trafficking, and the
relationship between screening and
specialized services.
Primary data collection includes
semi-structured qualitative interviews
SUMMARY:
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20OCN1
66568
Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Notices
with state and local human trafficking
coordinators (or comparable staff
members with greatest knowledge about
human trafficking efforts); small group
interviews with casework supervisors;
and case narrative interviews with
caseworkers.
The interviews will be conducted by
telephone (25 state agencies) and inperson (up to 8 local agencies or
offices). Interview questions will be
focused on how agencies select, train
on, and implement screening for human
trafficking, the details of screening
protocols, and variations in
implementation. Questions will also
address the availability of specialized
services for children identified as
trafficking victims or at high risk of
trafficking, agency steps based on
Number of
respondents
(total over
request
period)
Instrument
State Human Trafficking Coordinator Telephone Interview
Guide ................................................................................
Local Human Trafficking Coordinator Interview Guide ........
Casework Supervisor Group Interview Guide .....................
Caseworker Case Narrative Interview Guide ......................
Estimated Total Annual Burden
Hours: 79.
Authority: Section 476(a)(1–2) (42 U.S.C.
676) of the Social Security Act Part E—
Federal Payments for Foster Care and
Adoption Assistance.
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–23160 Filed 10–19–20; 8:45 am]
BILLING CODE 4184–25–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1058]
Keith Komar: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Keith Komar for a period of 5 years from
importing or offering for import any
drug into the United States. FDA bases
this order on a finding that Mr. Komar
was convicted of one felony count
under Federal law for mail fraud. The
factual basis supporting Mr. Komar’s
conviction, as described below, is
conduct relating to the importation into
the United States of a drug or controlled
substance. Mr. Komar was given notice
of the proposed debarment and was
given an opportunity to request a
hearing to show why he should not be
debarred. As of 30 days after receipt of
the notice (July 22, 2020), Mr. Komar
had not responded. Mr. Komar’s failure
SUMMARY:
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18:08 Oct 19, 2020
Jkt 253001
Number of
responses per
respondent
(total over
request
period)
25
8
40
48
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
debarment of an individual from
importing or offering for import any
drug into the United States if FDA finds,
as required by section 306(b)(3)(C) of the
FD&C Act, that the individual has been
convicted of a felony for conduct
relating to the importation into the
United States of any drug or controlled
substance. On November 7, 2019, Mr.
Komar was convicted, as defined in
section 306(l)(1) of the FD&C Act, in the
U.S. District Court for the Western
District of Pennsylvania, when the court
entered judgment against him for the
felony offense of mail fraud in violation
of 18 U.S.C. 1341.
FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows: As contained in count 3 of the
Frm 00036
Fmt 4703
Sfmt 4703
Annual Burden Estimates
Data collection is expected to take
place over two years.
Average
burden per
response
(in hours)
1
1
1
1
to respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable October
20, 2020.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
positive or suspected screening, and the
process for initiating specialized
services.
Respondents: State and local human
trafficking coordinators, casework
supervisors, and caseworkers.
1.5
1.5
1.5
1
Total burden
(in hours)
37.5
12
60
48
Annual burden
(in hours)
19
6
30
24
indictment in Mr. Komar’s case, filed on
November 29, 2017, to which Mr.
Komar pleaded guilty, on or about
December 7, 2015, Mr. Komar, for the
purpose of executing a scheme and
artifice to defraud, and in attempting to
do so, knowingly caused the U.S. mail
to deliver from Mumbai, India, a parcel
containing misbranded drugs.
Specifically, the parcel contained 30
tablets of the unapproved new
prescription drug bicalutamide and 30
gelcaps of the unapproved new
prescription drug isotretinoin. These
drugs were misbranded because, as
contained in the indictment in Mr.
Komar’s case, they were dispensed to
consumers without a valid prescription
from a practitioner licensed by law to
administer such drugs, and they did not
contain labeling bearing adequate
directions for use. As detailed in facts
contained in counts 1, 2, and 4 of Mr.
Komar’s indictment (facts which Mr.
Komar acknowledged responsibility for
in his plea agreement), Mr. Komar was
part of a criminal conspiracy. As part of
this criminal conspiracy, Mr. Komar’s
intent was to fraudulently import this
misbranded bicalutamide and
isotretinoin and sell them in interstate
commerce to customers of Mr. Komar’s
websites. On these websites Mr. Komar
made a number of false statements to
potential customers, such as that he
provided ‘‘high quality, safe, and
approved medications meeting or
exceeding the U.S. FDA standard.’’ In
addition, Mr. Komar later did in fact
cause the introduction and delivery for
introduction of misbranded drugs
(bicalutamide and isotretinoin) into
interstate commerce with the intent to
defraud and mislead by selling these
unapproved new prescription drugs to a
E:\FR\FM\20OCN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Notices]
[Pages 66567-66568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23160]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Identifying and Addressing Human
Trafficking in Child Welfare Agencies (New Collection)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) within the
U.S. Department of Health and Human Services (HHS) is proposing to
collect data on child welfare agencies' efforts to identify human
trafficking and subsequent service delivery. The goal of the study is
to better understand child welfare practice in screening for human
trafficking, and the degree to which screening is related to subsequent
referrals for, access to, and delivery of specialized services for
children identified as trafficking victims or at high risk of
trafficking.
DATES: Comments due within 30 days of publication. 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.
SUPPLEMENTARY INFORMATION:
Description: ACF is proposing data collection as part of the study,
``Identifying and Addressing Human Trafficking in Child Welfare
Agencies,'' exploring child welfare practice in screening for human
trafficking, and the relationship between screening and specialized
services.
Primary data collection includes semi-structured qualitative
interviews
[[Page 66568]]
with state and local human trafficking coordinators (or comparable
staff members with greatest knowledge about human trafficking efforts);
small group interviews with casework supervisors; and case narrative
interviews with caseworkers.
The interviews will be conducted by telephone (25 state agencies)
and in-person (up to 8 local agencies or offices). Interview questions
will be focused on how agencies select, train on, and implement
screening for human trafficking, the details of screening protocols,
and variations in implementation. Questions will also address the
availability of specialized services for children identified as
trafficking victims or at high risk of trafficking, agency steps based
on positive or suspected screening, and the process for initiating
specialized services.
Respondents: State and local human trafficking coordinators,
casework supervisors, and caseworkers.
Annual Burden Estimates
Data collection is expected to take place over two years.
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per
respondents respondent Average burden Total burden Annual burden
Instrument (total over (total over per response (in hours) (in hours)
request request (in hours)
period) period)
----------------------------------------------------------------------------------------------------------------
State Human Trafficking 25 1 1.5 37.5 19
Coordinator Telephone Interview
Guide..........................
Local Human Trafficking 8 1 1.5 12 6
Coordinator Interview Guide....
Casework Supervisor Group 40 1 1.5 60 30
Interview Guide................
Caseworker Case Narrative 48 1 1 48 24
Interview Guide................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 79.
Authority: Section 476(a)(1-2) (42 U.S.C. 676) of the Social
Security Act Part E--Federal Payments for Foster Care and Adoption
Assistance.
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-23160 Filed 10-19-20; 8:45 am]
BILLING CODE 4184-25-P
