Agency Information Collection Activities; Proposed Collection; Public Comment Request; State Grants for Assistive Technology Program State Plan for Assistive Technology; [OMB# 0985-0048], 26522-26523 [2021-10239]
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26522
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
Dated: May 11, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–10260 Filed 5–13–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
[OMB No. 0985–0048]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; State Grants for
Assistive Technology Program State
Plan for Assistive Technology;
[OMB# 0985–0048]
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living is announcing that
the proposed collection of information
listed above has been submitted to the
Office of Management and Budget
(OMB) for review and clearance as
required under section 506(c)(2)(A) of
the Paperwork Reduction Act of 1995.
This 30-Day notice collects comments
on the information collection
requirements related to the proposed
renewal for the information collection
requirements related to State Grants for
Assistive Technology Program State
Plan for Assistive Technology.
DATES: Submit written comments on the
collection of information by June 14,
2021.
SUMMARY:
Submit written comments
and recommendations for the proposed
information collection within 30 days of
publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find the information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function. By mail to
the Office of Information and Regulatory
Affairs, OMB, New Executive Office
Bldg., 725 17th St. NW, Rm. 10235,
Washington, DC 20503, Attn: OMB Desk
Officer for ACL.
FOR FURTHER INFORMATION CONTACT:
Robert Groenendaal, Assistive
Technology Program Manager, Center
for Innovation and Partnership in the
Office of Interagency Innovation
Administration for Community Living,
330 C Street SW, Washington, DC
20201, Phone: 202–795–7356, Email:
Robert.Groenendaal@acl.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. ACL is requesting
approval for the renewal of a data
collection associated with the State
Grants for Assistive Technology
Program, State Plan for Assistive
Technology.
The information collected through
this data collection instrument is
necessary for ACL and states to comply
with Sections 4 and 7 of the Assistive
Technology Act of 1998, as amended
(AT Act). ACL is requesting a renewal
of the state plan data collection
instrument (OMB No. 0985–0048).
Section 4 of the AT Act authorizes
grants to public agencies in the 50 states
and the District of Columbia, Puerto
Rico, the Virgin Islands, Guam,
American Samoa, and the
Commonwealth of the Northern
Marianas (states and outlying areas).
With these funds, the 56 states and
outlying areas operate ‘‘Statewide AT
Programs’’ that conduct activities to
increase access to and acquisition of
assistive technology (AT) for
individuals with disabilities and older
Americans.
Divided into two comprehensive
activity categories: ‘‘State-level
Activities’’ and ‘‘State Leadership
Activities,’’ according to Section 4 of the
AT Act, as a condition of receiving a
grant to support their Statewide AT
Programs, the 56 states and outlying
areas must provide to ACL: (1)
Applications and (2) annual progress
reports on their activities.
Applications: The application
required of states and outlying areas is
a three-year State Plan for Assistive
Technology (State Plan for AT or State
Plan) (OMB No. 0985–0048). The
content of the State Plan for AT is based
on the requirements in Section 4(d) of
the AT Act.
Annual Reports: In addition to
submitting a State Plan, every three
years, states and outlying areas are
required to submit annual progress
reports on their activities. The data
required in that progress report is
specified in Section 4(f) of the AT Act
(OMB No. 0985–0042).
National aggregation of data related to
conducting required state-level and state
leadership activities is necessary for the
Government Performance and Results
Modernization Act of 2010 (GPRAMA)
(Pub. L. 111–352), as well as an Annual
Report to Congress (see ‘‘Section 7
Requirements Necessitating Collection’’
below). Therefore, this data collection
instrument provides a way for all 56
SUPPLEMENTARY INFORMATION:
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Fmt 4703
Sfmt 4703
grantees—50 U.S. states, DC, Puerto
Rico, the U.S. Virgin Islands, Guam,
American Samoa, and the
Commonwealth of the Northern Mariana
Islands to collect and report data on
their activities in a consistent manner,
including a uniform survey to be given
to consumers. This uniform survey is
included as part of the Assistive
Technology Annual Performance Report
(APR) data collection package (OMB No.
0985–0042).
Section 7(d) of the AT Act requires
that ACL submit to Congress an annual
report on the activities conducted under
the Act and an analysis of the progress
of the states and outlying areas in
meeting measurable goals. This report
must include a compilation and
summary of the data collected under
Section 4(f). In order to make this
possible, states and outlying areas must
provide their data uniformly. This data
collection instrument was developed to
ensure that all 56 states and outlying
areas report data in a consistent manner
in alignment with the requirements of
Section 4(f).
As stated above, ACL will use the
information collected via this
instrument to:
(1) Complete the annual report to
Congress required by the AT Act;
(2) Comply with reporting
requirements under the Government
Performance and Results Modernization
Act of 2010 (GPRAMA) (Pub. L. 111–
352); and
(3) Assess the progress of states and
outlying areas regarding measurable
goals.
Data collected from the grantees will
provide a national description of
activities funded under the AT Act to
increase the access to and acquisition of
AT devices and services through
statewide AT programs for individuals
with disabilities. Data collected from
grantees will also provide information
for usage by Congress, the Department,
and the public. In addition, ACL will
use this data to inform program
management, monitoring, and technical
assistance efforts. States will be able to
use the data for internal management
and program improvement.
Comments in Response to the 60-Day
Federal Register Notice
A notice published in the Federal
Register on February 25, 2021 in FR 86
pg. 11545–11546. There were no public
comments received during the 60-day
FRN comment period.
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
E:\FR\FM\14MYN1.SGM
14MYN1
26523
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
Respondent/data collection activity
Number of
respondents
Responses
per
respondent
Hours per
response
Annual
burden hours
State Plan for Assistive Technology ................................................................
56
1
73.0
4,088
Dated: May 11, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2021–10239 Filed 5–13–21; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2047]
Rick Shepard: 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 Rick
Shepard 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. Shepard
was convicted of one felony count
under Federal law for conspiracy to
import and introduce misbranded drugs
into interstate commerce. The factual
basis supporting Mr. Shepard’s
conviction is conduct relating to the
importation into the United States of a
drug or controlled substance. Mr.
Shepard 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
February 14, 2021 (30 days after receipt
of the notice), Mr. Shepard had not
responded. His failure to respond and
request a hearing constitutes a waiver of
his right to a hearing concerning this
matter.
SUMMARY:
DATES:
This order is applicable May 14,
2021.
Submit applications for
termination of debarment to the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, or at https://
www.regulations.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa (ELEM–4029), Division
of Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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 the FDA
finds, as required by section 306(b)(3)(C)
of the FD&C, 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 September 14, 2020, Mr.
Shepard was convicted, as defined in
section 306(l)(1) of the FD&C Act, in the
U.S. District Court for the District of
Kansas, when the court entered
judgment against him for the offense of
‘‘Conspiracy to Import and Introducing
Misbranded Drugs into Interstate
Commerce, a Class D Felony’’ in
violation of 18 U.S.C. 371.
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 the Plea
Agreement in Mr. Shepard’s case, filed
on January 27, 2020, Mr. Shepard
owned, controlled, and operated Epic
Products, LLC (Epic), a Kansas Limited
Liability Company, from approximately
October 2013 until at least April 2018.
Epic was engaged in wholesaling of
products under the labeled name
‘‘Euphoric’’ that were marketed as ‘‘allnatural, herbal supplements for male
enhancement.’’ Euphoric’s label made
no mention of tadalafil and sildenafil
citrate. However, Mr. Shepard knew that
Euphoric contained tadalafil and
sildenafil citrate because he imported
these drugs, repacked them, and sold
them under the Euphoric label.
Specifically, Mr. Shepard purchased in
bulk from suppliers in China capsules
containing tadalafil and sildenafil
citrate that he had delivered to mail and
packing stores on the east coast before
forwarding them to his address in
Kansas.
Sildenafil citrate is the active
ingredient in Pfizer, Inc.’s FDAapproved erectile dysfunction drug,
VIAGRA. Likewise, tadalafil is the
active ingredient in Eli Lilly &
Company’s FDA-approved erectile
dysfunction drug, CIALIS. Once Mr.
Shepard received the bulk capsules, he
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Fmt 4703
Sfmt 4703
repackaged them and applied his
Euphoric label. Mr. Shepard then sold
these capsules in novelty stores in
Kansas, Missouri, and Colorado.
Throughout this entire scheme, Mr.
Shepard did not possess a valid
wholesale drug distribution license, a
valid pharmacy license, or a license to
prescribe prescription drugs. Finally,
from January 2012 to September 2017,
Mr. Shepard deposited $1.8 million into
his business account.
As a result of this conviction, FDA
sent Mr. Shepard, by certified mail on
December 21, 2020, a notice proposing
to debar him for a 5-year period from
importing or offering for import any
drug into the United States. The
proposal was based on a finding, under
section 306(b)(3)(C) of the FD&C Act,
that Mr. Shepard’s felony conviction for
one felony count under Federal law, for
the offense of ‘‘Conspiracy to Import
And Introducing Misbranded Drugs into
Interstate Commerce, a Class D Felony,’’
was for conduct relating to the
importation into the United States of
any drug or controlled substance
because he illegally imported,
repackaged, and introduced misbranded
tadalafil and sildenafil capsules into
interstate commerce.
In proposing a debarment period,
FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C
Act that it considered applicable to Mr.
Shepard’s offense and concluded that
this felony offense warranted the
imposition of a 5-year period of
debarment. The proposal informed Mr.
Shepard of the proposed debarment and
offered him an opportunity to request a
hearing, providing him 30 days from the
date of receipt of the letter in which to
file the request, and advised him that
failure to request a hearing constituted
a waiver of the opportunity for a hearing
and of any contentions concerning this
action. Mr. Shepard received the
proposal and notice of opportunity for
a hearing on January 15, 2021. He failed
to request a hearing within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26522-26523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
[OMB No. 0985-0048]
Agency Information Collection Activities; Proposed Collection;
Public Comment Request; State Grants for Assistive Technology Program
State Plan for Assistive Technology; [OMB# 0985-0048]
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living is announcing that the
proposed collection of information listed above has been submitted to
the Office of Management and Budget (OMB) for review and clearance as
required under section 506(c)(2)(A) of the Paperwork Reduction Act of
1995. This 30-Day notice collects comments on the information
collection requirements related to the proposed renewal for the
information collection requirements related to State Grants for
Assistive Technology Program State Plan for Assistive Technology.
DATES: Submit written comments on the collection of information by June
14, 2021.
ADDRESSES: Submit written comments and recommendations for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find the information collection by selecting ``Currently under 30-
day Review--Open for Public Comments'' or by using the search function.
By mail to the Office of Information and Regulatory Affairs, OMB, New
Executive Office Bldg., 725 17th St. NW, Rm. 10235, Washington, DC
20503, Attn: OMB Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT: Robert Groenendaal, Assistive
Technology Program Manager, Center for Innovation and Partnership in
the Office of Interagency Innovation Administration for Community
Living, 330 C Street SW, Washington, DC 20201, Phone: 202-795-7356,
Email: [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has
submitted the following proposed collection of information to OMB for
review and clearance. ACL is requesting approval for the renewal of a
data collection associated with the State Grants for Assistive
Technology Program, State Plan for Assistive Technology.
The information collected through this data collection instrument
is necessary for ACL and states to comply with Sections 4 and 7 of the
Assistive Technology Act of 1998, as amended (AT Act). ACL is
requesting a renewal of the state plan data collection instrument (OMB
No. 0985-0048). Section 4 of the AT Act authorizes grants to public
agencies in the 50 states and the District of Columbia, Puerto Rico,
the Virgin Islands, Guam, American Samoa, and the Commonwealth of the
Northern Marianas (states and outlying areas). With these funds, the 56
states and outlying areas operate ``Statewide AT Programs'' that
conduct activities to increase access to and acquisition of assistive
technology (AT) for individuals with disabilities and older Americans.
Divided into two comprehensive activity categories: ``State-level
Activities'' and ``State Leadership Activities,'' according to Section
4 of the AT Act, as a condition of receiving a grant to support their
Statewide AT Programs, the 56 states and outlying areas must provide to
ACL: (1) Applications and (2) annual progress reports on their
activities.
Applications: The application required of states and outlying areas
is a three-year State Plan for Assistive Technology (State Plan for AT
or State Plan) (OMB No. 0985-0048). The content of the State Plan for
AT is based on the requirements in Section 4(d) of the AT Act.
Annual Reports: In addition to submitting a State Plan, every three
years, states and outlying areas are required to submit annual progress
reports on their activities. The data required in that progress report
is specified in Section 4(f) of the AT Act (OMB No. 0985-0042).
National aggregation of data related to conducting required state-
level and state leadership activities is necessary for the Government
Performance and Results Modernization Act of 2010 (GPRAMA) (Pub. L.
111-352), as well as an Annual Report to Congress (see ``Section 7
Requirements Necessitating Collection'' below). Therefore, this data
collection instrument provides a way for all 56 grantees--50 U.S.
states, DC, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern Mariana Islands to collect and
report data on their activities in a consistent manner, including a
uniform survey to be given to consumers. This uniform survey is
included as part of the Assistive Technology Annual Performance Report
(APR) data collection package (OMB No. 0985-0042).
Section 7(d) of the AT Act requires that ACL submit to Congress an
annual report on the activities conducted under the Act and an analysis
of the progress of the states and outlying areas in meeting measurable
goals. This report must include a compilation and summary of the data
collected under Section 4(f). In order to make this possible, states
and outlying areas must provide their data uniformly. This data
collection instrument was developed to ensure that all 56 states and
outlying areas report data in a consistent manner in alignment with the
requirements of Section 4(f).
As stated above, ACL will use the information collected via this
instrument to:
(1) Complete the annual report to Congress required by the AT Act;
(2) Comply with reporting requirements under the Government
Performance and Results Modernization Act of 2010 (GPRAMA) (Pub. L.
111-352); and
(3) Assess the progress of states and outlying areas regarding
measurable goals.
Data collected from the grantees will provide a national
description of activities funded under the AT Act to increase the
access to and acquisition of AT devices and services through statewide
AT programs for individuals with disabilities. Data collected from
grantees will also provide information for usage by Congress, the
Department, and the public. In addition, ACL will use this data to
inform program management, monitoring, and technical assistance
efforts. States will be able to use the data for internal management
and program improvement.
Comments in Response to the 60-Day Federal Register Notice
A notice published in the Federal Register on February 25, 2021 in
FR 86 pg. 11545-11546. There were no public comments received during
the 60-day FRN comment period.
Estimated Program Burden: ACL estimates the burden associated with
this collection of information as follows:
[[Page 26523]]
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
State Plan for Assistive Technology......... 56 1 73.0 4,088
----------------------------------------------------------------------------------------------------------------
Dated: May 11, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary for Aging.
[FR Doc. 2021-10239 Filed 5-13-21; 8:45 am]
BILLING CODE 4154-01-P
