Agency Information Collection Activities; Proposed Collection; Public Comment Request; State Plan for Independent Living Instrument and Instructions OMB Control Number 0985-0044, 39854-39855 [2019-17172]
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39854
Federal Register / Vol. 84, No. 155 / Monday, August 12, 2019 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Total number
of responses
per
respondent
Average
burden
hours per
response
Annual
burden
hours
Procedures for Requests from Tribal Lead Agencies to use Child Care and
Development Fund (CCDF) Funds for Construction or Major Renovation
of Child Care Facilities (for all tribes) ..........................................................
50
1
20
1000
Estimated Total Annual Burden
Hours: 1,000
FOR FURTHER INFORMATION CONTACT:
Authority: 42 U.S.C. 9858(c)(6)
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–17167 Filed 8–9–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; State Plan for
Independent Living Instrument and
Instructions OMB Control Number
0985–0044
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice.
This Proposed Revision of a Currently
Approved Collection (ICR Rev) solicits
comments on the information collection
requirements related to the State Plan
for Independent Living.
DATES: Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (EST) or
postmarked by October 11, 2019.
ADDRESSES: Submit electronic
comments on the information collection
request to: Peter Nye at peter.nye@
acl.hhs.gov. Submit written comments
on the collection of information to
Administration for Community Living,
Washington, DC 20201, Attention: Peter
Nye.
jspears on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:16 Aug 09, 2019
Jkt 247001
Peter Nye, Administration for
Community Living, Washington, DC
20201, (202) 795–7606, or peter.nye@
acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA, Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor,
including agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. The PRA
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, before submitting the
collection to OMB for approval. To
comply with this requirement, ACL is
publishing a notice of the proposed
collection of information set forth in
this document. With respect to the
following collection of information,
ACL invites comments on our burden
estimates or any other aspect of this
collection of information, including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
Legal authority for the State Plan for
Independent Living (SPIL) is contained
in Chapter 1 of Title VII of the
Rehabilitation Act of 1973, as amended
(the Act). Section 704 of the
Rehabilitation Act requires that, to be
eligible to receive financial assistance
under Chapter 1, ‘‘a State shall submit
to the Department, and obtain approval
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
of, a State plan containing such
provisions as the Department may
require.’’ ACL approval of the SPIL is
required for states to receive federal
funding for both the Independent Living
Services State grants and Centers for
Independent Living (CIL) programs.
Federal statute and regulations require
the collection of this information every
three years.
The SPIL is jointly developed by the
chairperson of the Statewide
Independent Living Council (SILC) and
not less than 51% of the directors of the
CILs, after receiving public input from
individuals throughout the State. ACL
reviews the SPIL for compliance with
the Rehabilitation Act and its applicable
regulations (Sec 704(a)(4); 45 CFR part
1329.17) and approves the SPIL. It
serves statewide as a primary planning
document that describe[s] strategies—
including how, and to whom, the state
will disburse what funds—for providing
independent living services and
designates the Designated State Entity.
The SPIL also assures that all IL
grantees in the state will comply with
the Act’s requirements. § 704(a)(5) of the
Act; 45 CFR 1329.17(a–b), citing sec.
704(m) of the Act. The SPIL Instrument
is the template for SPILs; the SPIL
Instructions explain the Instrument and
give tips about how to draft SPILs.
ACL is proposing this revision
because ACL and the technical
assistance provider have been revising
the Instrument and Instructions to
address changes to the Act that result
from the Workforce Innovation and
Opportunity Act of 2014, 29 U.S.C. 32,
and to increase the Instrument’s and
Instructions’ clarity, conciseness, and
precision. For example,
• The revised Instrument and
Instructions will reflect the core services
that WIOA requires.
• The revised Instructions will
explain the state matching requirement,
and the revised Instrument will specify
how to include the state match in the
financial plan.
• The revised Instrument and
Instructions will add legal basis and
certifications and DSE assurances and
SILC assurances.
E:\FR\FM\12AUN1.SGM
12AUN1
39855
Federal Register / Vol. 84, No. 155 / Monday, August 12, 2019 / Notices
• The Revised Instrument and
Instructions will include a chart for the
financial plan and a chart for the
existing centers that specifies what
counties they serve, what entities
oversee them, and what oversight
processes apply.
• The Revised Instrument will
include a signatures section.
These revisions were recommended
by the technical assistance provider and
analyzed by all the independent living
program officers who work directly with
SPILs.
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
Respondent/data
collection activity
Responses
per
respondent
Hours per
response
Annual
burden
hours
Statewide Independent Living Councils ..........................................................
56
1
240
13,440
Total ..........................................................................................................
56
1
240
13,440
Dated: August 6, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–17172 Filed 8–9–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–2290]
Determination That LEVITRA
(Vardenafil Hydrochloride) Tablets, 2.5
Milligrams Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that LEVITRA (vardenafil
hydrochloride) tablets, 2.5 milligrams
(mg), were not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Daniel J. Ritterbeck, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219,
Silver Spring, MD 20993–0002, 301–
796–4673, Daniel.Ritterbeck@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
SUMMARY:
jspears on DSK3GMQ082PROD with NOTICES
Number of
respondents
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
56 SILCs will respond to the
requirement for a SPIL every three
years. Each state’s SILC will take
approximately 240 hours to develop the
SPIL for a total of approximately 13,440
hours. This estimate is based on
program knowledge.
VerDate Sep<11>2014
17:16 Aug 09, 2019
Jkt 247001
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg, are the subject of NDA
021400, held by Bayer HealthCare
Pharmaceuticals, Inc., and initially
approved on August 19, 2003. LEVITRA
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
is a phosphodiesterase 5 (PDE5)
inhibitor indicated for the treatment of
erectile dysfunction. LEVITRA
(vardenafil hydrochloride) tablets, 2.5
mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
In a letter dated March 22, 2018,
Bayer HealthCare Pharmaceuticals, Inc.,
notified FDA that LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, were
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Alembic Pharmaceuticals Limited
submitted a citizen petition received on
May 9, 2019 (Docket No. FDA–2019–P–
2290), under 21 CFR 10.30, requesting
that the Agency determine whether
LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg, were withdrawn from
sale for safety or effectiveness reasons
and permit the filing of abbreviated new
drug applications (ANDAs) referencing
LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of LEVITRA
(vardenafil hydrochloride) tablets, 2.5
mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Notices]
[Pages 39854-39855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17172]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Public Comment Request; State Plan for Independent Living Instrument
and Instructions OMB Control Number 0985-0044
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
information listed above. Under the Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to publish a notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice.
This Proposed Revision of a Currently Approved Collection (ICR Rev)
solicits comments on the information collection requirements related to
the State Plan for Independent Living.
DATES: Comments on the collection of information must be submitted
electronically by 11:59 p.m. (EST) or postmarked by October 11, 2019.
ADDRESSES: Submit electronic comments on the information collection
request to: Peter Nye at [email protected]. Submit written comments
on the collection of information to Administration for Community
Living, Washington, DC 20201, Attention: Peter Nye.
FOR FURTHER INFORMATION CONTACT: Peter Nye, Administration for
Community Living, Washington, DC 20201, (202) 795-7606, or
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA, Federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor, including agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. The PRA requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, ACL is publishing a notice of the proposed collection of
information set forth in this document. With respect to the following
collection of information, ACL invites comments on our burden estimates
or any other aspect of this collection of information, including:
(1) Whether the proposed collection of information is necessary for
the proper performance of ACL's functions, including whether the
information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used to determine burden estimates;
(3) ways to enhance the quality, utility, and clarity of the
information to be collected; and
(4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques when appropriate, and other forms of information technology.
Legal authority for the State Plan for Independent Living (SPIL) is
contained in Chapter 1 of Title VII of the Rehabilitation Act of 1973,
as amended (the Act). Section 704 of the Rehabilitation Act requires
that, to be eligible to receive financial assistance under Chapter 1,
``a State shall submit to the Department, and obtain approval of, a
State plan containing such provisions as the Department may require.''
ACL approval of the SPIL is required for states to receive federal
funding for both the Independent Living Services State grants and
Centers for Independent Living (CIL) programs. Federal statute and
regulations require the collection of this information every three
years.
The SPIL is jointly developed by the chairperson of the Statewide
Independent Living Council (SILC) and not less than 51% of the
directors of the CILs, after receiving public input from individuals
throughout the State. ACL reviews the SPIL for compliance with the
Rehabilitation Act and its applicable regulations (Sec 704(a)(4); 45
CFR part 1329.17) and approves the SPIL. It serves statewide as a
primary planning document that describe[s] strategies--including how,
and to whom, the state will disburse what funds--for providing
independent living services and designates the Designated State Entity.
The SPIL also assures that all IL grantees in the state will comply
with the Act's requirements. Sec. 704(a)(5) of the Act; 45 CFR
1329.17(a-b), citing sec. 704(m) of the Act. The SPIL Instrument is the
template for SPILs; the SPIL Instructions explain the Instrument and
give tips about how to draft SPILs.
ACL is proposing this revision because ACL and the technical
assistance provider have been revising the Instrument and Instructions
to address changes to the Act that result from the Workforce Innovation
and Opportunity Act of 2014, 29 U.S.C. 32, and to increase the
Instrument's and Instructions' clarity, conciseness, and precision. For
example,
The revised Instrument and Instructions will reflect the
core services that WIOA requires.
The revised Instructions will explain the state matching
requirement, and the revised Instrument will specify how to include the
state match in the financial plan.
The revised Instrument and Instructions will add legal
basis and certifications and DSE assurances and SILC assurances.
[[Page 39855]]
The Revised Instrument and Instructions will include a
chart for the financial plan and a chart for the existing centers that
specifies what counties they serve, what entities oversee them, and
what oversight processes apply.
The Revised Instrument will include a signatures section.
These revisions were recommended by the technical assistance
provider and analyzed by all the independent living program officers
who work directly with SPILs.
The proposed data collection tools may be found on the ACL website
for review at https://www.acl.gov/about-acl/public-input.
Estimated Program Burden: ACL estimates the burden associated with
this collection of information as follows: 56 SILCs will respond to the
requirement for a SPIL every three years. Each state's SILC will take
approximately 240 hours to develop the SPIL for a total of
approximately 13,440 hours. This estimate is based on program
knowledge.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Statewide Independent Living Councils........... 56 1 240 13,440
---------------------------------------------------------------
Total....................................... 56 1 240 13,440
----------------------------------------------------------------------------------------------------------------
Dated: August 6, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019-17172 Filed 8-9-19; 8:45 am]
BILLING CODE 4154-01-P
