Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 39122-39123 [2015-16697]
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39122
Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
srobinson on DSK5SPTVN1PROD with NOTICES
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. The
proposal was received on March 23,
2015. Mr. Khan failed to respond within
the timeframe prescribed by regulation
and has, therefore, waived his
opportunity for a hearing and has
waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(a)(2)(B) of the FD&C Act,
under authority delegated to him (Staff
Manual Guide 1410.35), finds that Talib
Khan has been convicted of felonies
under Federal law for conduct relating
to the regulation of a drug product.
As a result of the foregoing finding,
Talib Khan is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 505, 512, or 802 of the FD&C
Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
(see DATES)(see section 201(dd),
306(c)(1)(B), and 306(c)(2)(A)(ii) of the
FD&C Act, (21 U.S.C. 321(dd),
335a(c)(1)(B), and 335a(c)(2)(A)(ii)). Any
person with an approved or pending
drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses the services of Talib Khan, in any
capacity during his debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Mr. Khan provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act (21 U.S.C. 335b(a)(7))). In
addition, FDA will not accept or review
any abbreviated new drug applications
from Talib Khan during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B))).
Any application by Mr. Khan for
special termination of debarment under
section 306(d)(4) of the FD&C Act (21
U.S.C. 335a(d)(4)) should be identified
with Docket No. FDA–2014–N–2103
and sent to the Division of Dockets
Management (see ADDRESSES). All
such submissions are to be filed in four
copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VerDate Sep<11>2014
18:49 Jul 07, 2015
Jkt 235001
Dated: June 25, 2015.
Douglas Stearn,
Director, Division of Compliance Policy,
Office of Enforcement, Office of Regulatory
Affairs.
[FR Doc. 2015–16664 Filed 7–7–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than August 7, 2015.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 594–4306.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Maternal, Infant, and Childhood Home
Visiting (Home Visiting) Program Fiscal
Year (FY) 2015, FY2016, FY2017 NonCompeting Continuation Annual
Progress Report for Formula Grant.
OMB No.: 0915–0355—Extension.
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting (Home
Visiting) Program, administered by the
Health Resources and Services
Administration (HRSA) in close
partnership with the Administration for
Children and Families (ACF), supports
voluntary, evidence-based home visiting
services during pregnancy and to
parents with young children up to
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
kindergarten entry. The purpose of this
formula grant program is to: support the
delivery of coordinated and
comprehensive voluntary early
childhood home visiting program
services and effective implementation of
high-quality evidence-based practices.
The fifty states, District of Columbia,
and 5 territories and nonprofit
organizations that would provide
services in jurisdictions that have not
directly applied for or been approved
for a grant are eligible for formula grants
and submit non-competing continuation
progress reports annually. There are 56
jurisdictions eligible for formula awards
and 56 formula awards are issued
annually.
Need and Proposed Use of the
Information: This information collection
is needed for eligible entities to report
progress under the Home Visiting
Program annually. On March 23, 2010,
the President signed into law the Patient
Protection and Affordable Care Act
(ACA). Section 2951 of the ACA
amended Title V of the Social Security
Act by adding a new section, 511, which
authorized the creation of the Home
Visiting Program (https://
frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=111_cong_
bills&docid=f:h3590enr.txt.pdf, pages
216–225). A portion of funding under
this program is awarded to participating
states and eligible jurisdictions by
formula. The purpose of formula
funding is to support the delivery of
coordinated and comprehensive
voluntary early childhood home visiting
program services and effective
implementation of high-quality
evidence-based practices.
The information collected will be
used to review grantee progress on
proposed project plans sufficient to
permit project officers to assess whether
the project is performing adequately to
achieve the goals and objectives that
were previously approved. This report
will also provide implementation plans
for the upcoming year, which project
officers can use to assess to whether the
plan is consistent with the grant as
approved, and will result in
implementation of a high-quality project
that will complement the home visiting
program as a whole. Progress Reports
are submitted to project officers through
the Electronic HandBooks (EHB).
Failure to collect this information
would result in the inability of the
project officers to exercise due diligence
in monitoring and overseeing the use of
grant funds in keeping with legislative,
policy, and programmatic requirements.
Grantees are required to provide a
performance narrative with the
following sections: project identifier
E:\FR\FM\08JYN1.SGM
08JYN1
39123
Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
information, accomplishments and
barriers, home visiting program goals
and objectives, update on the home
visiting program promising approach,
implementation of the home visiting
program in targeted at-risk
communities, progress toward meeting
legislatively-mandated reporting on
benchmark areas, home visiting quality
improvement efforts, and updates on the
administration of the home visiting
program.
In the event a new Funding
Opportunity Announcement is issued
annually for the formula grant program,
the application for new grant funds may
take the place of completion of a noncompeting continuation progress report.
Likely Respondents: Grantees with
Home Visiting Formula Awards
Awarded in Federal FYs 2013—2017.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
Number of
respondents
Form name
Number of responses per
respondent
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden—
Hours: The burden estimates presented
in the table below are based on
consultations with a few states on the
guidance. Grantees receive a new
formula grant annually and are expected
to report on progress annually, so the
expectation is that grantees would
submit non-competing continuation
progress reports four times between
federal fiscal years 2015 and 2018. Only
seven grantees are currently
implementing a promising approach
and require an annual update on the
promising approach.
Total
responses
Hours per
response
Total burden
hours
Formula Grant Award ..........................................................
56
4
224
42
9408
Total ..............................................................................
56
4
224
42
9408
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–16697 Filed 7–7–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Clinical and Preventive
Services; Division of Behavioral
Health; Domestic Violence Prevention
Initiative
Announcement Type: New —Limited
Competition
Funding Announcement Number:
HHS–2015–IHS–DVPI–0001
Catalog of Federal Domestic Assistance
Number (CFDA): 93.933
srobinson on DSK5SPTVN1PROD with NOTICES
Key Dates
Application Deadline Date: September
8, 2015
Review Date: September 14–18, 2015
Earliest Anticipated Start Date:
September 30, 2015
Signed Tribal Resolutions Due Date:
September 11, 2015
Proof of Non-Profit Status Due Date:
September 8, 2015
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS), an
agency which is part of the Department
of Health and Human Services (HHS), is
accepting applications for a five-year
funding cycle, to continue the planning,
VerDate Sep<11>2014
18:49 Jul 07, 2015
Jkt 235001
development, and implementation of
the Domestic Violence Prevention
Initiative (Short Title: DVPI). This
program was first established by the
Omnibus Appropriations Act of 2009,
Public Law 111–8, 123 Stat. 524, 735,
and continued in the annual
appropriations acts since that time. This
program is authorized under the
authority of 25 U.S.C. 13, the Snyder
Act, and the Indian Health Care
Improvement Act, 25 U.S.C. 1601–1683.
The amounts made available for the
DVPI shall be allocated at the discretion
of the Director, IHS and shall remain
available until expended. IHS utilizes a
national funding formula developed in
consultation with Tribes and the
National Tribal Advisory Committee
(NTAC) on behavioral health, as well as
conferring with urban Indian health
programs (UIHPs). The funding formula
provides the allocation methodology for
each IHS Service Area. This program is
described in the Catalog of Federal
Domestic Assistance under 93.933.
Background
From August 2010–August 2015, IHS
funded 65 IHS, Tribal, Tribal
organizations, and UIHPs that
participated in a nationally coordinated
five-year demonstration pilot project to
expand outreach and increase
awareness of domestic and sexual
violence and provide victim advocacy,
intervention, case coordination, policy
development, community response
teams, and community and school
education programs. The DVPI promotes
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
the development of evidence-based and
practice-based models that represent
culturally appropriate prevention and
treatment approaches to domestic and
sexual violence from a communitydriven context. For a complete listing of
demonstration pilot projects, please
visit www.ihs.gov/dvpi/pilotprojects.
Purpose
The primary purpose of this grant
program is to accomplish the DVPI goals
listed below:
1. Build Tribal, UIHP, and Federal
capacity to provide coordinated
community responses to American
Indian/Alaska Native (AI/AN) victims of
domestic and sexual violence.
2. Increase access to domestic and
sexual violence prevention, advocacy,
crisis intervention, and behavioral
health services for AI/AN victims and
their families.
3. Promote trauma-informed services
for AI/AN victims of domestic and
sexual violence and their families.
4. Offer healthcare provider and
community education on domestic and
sexual violence.
5. Respond to the healthcare needs of
AI/AN victims of domestic and sexual
violence.
6. Incorporate culturally appropriate
practices and/or faith-based services for
AI/AN victims of domestic and sexual
violence.
To accomplish the DVPI goals, IHS
invites applicants to address one of the
Purpose Areas below:
E:\FR\FM\08JYN1.SGM
08JYN1
]]>Agencies
[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Notices]
[Pages 39122-39123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16697]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than August 7,
2015.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 594-
4306.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Maternal, Infant, and
Childhood Home Visiting (Home Visiting) Program Fiscal Year (FY) 2015,
FY2016, FY2017 Non-Competing Continuation Annual Progress Report for
Formula Grant.
OMB No.: 0915-0355--Extension.
Abstract: The Maternal, Infant, and Early Childhood Home Visiting
(Home Visiting) Program, administered by the Health Resources and
Services Administration (HRSA) in close partnership with the
Administration for Children and Families (ACF), supports voluntary,
evidence-based home visiting services during pregnancy and to parents
with young children up to kindergarten entry. The purpose of this
formula grant program is to: support the delivery of coordinated and
comprehensive voluntary early childhood home visiting program services
and effective implementation of high-quality evidence-based practices.
The fifty states, District of Columbia, and 5 territories and nonprofit
organizations that would provide services in jurisdictions that have
not directly applied for or been approved for a grant are eligible for
formula grants and submit non-competing continuation progress reports
annually. There are 56 jurisdictions eligible for formula awards and 56
formula awards are issued annually.
Need and Proposed Use of the Information: This information
collection is needed for eligible entities to report progress under the
Home Visiting Program annually. On March 23, 2010, the President signed
into law the Patient Protection and Affordable Care Act (ACA). Section
2951 of the ACA amended Title V of the Social Security Act by adding a
new section, 511, which authorized the creation of the Home Visiting
Program (https://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h3590enr.txt.pdf, pages 216-
225). A portion of funding under this program is awarded to
participating states and eligible jurisdictions by formula. The purpose
of formula funding is to support the delivery of coordinated and
comprehensive voluntary early childhood home visiting program services
and effective implementation of high-quality evidence-based practices.
The information collected will be used to review grantee progress
on proposed project plans sufficient to permit project officers to
assess whether the project is performing adequately to achieve the
goals and objectives that were previously approved. This report will
also provide implementation plans for the upcoming year, which project
officers can use to assess to whether the plan is consistent with the
grant as approved, and will result in implementation of a high-quality
project that will complement the home visiting program as a whole.
Progress Reports are submitted to project officers through the
Electronic HandBooks (EHB). Failure to collect this information would
result in the inability of the project officers to exercise due
diligence in monitoring and overseeing the use of grant funds in
keeping with legislative, policy, and programmatic requirements.
Grantees are required to provide a performance narrative with the
following sections: project identifier
[[Page 39123]]
information, accomplishments and barriers, home visiting program goals
and objectives, update on the home visiting program promising approach,
implementation of the home visiting program in targeted at-risk
communities, progress toward meeting legislatively-mandated reporting
on benchmark areas, home visiting quality improvement efforts, and
updates on the administration of the home visiting program.
In the event a new Funding Opportunity Announcement is issued
annually for the formula grant program, the application for new grant
funds may take the place of completion of a non-competing continuation
progress report.
Likely Respondents: Grantees with Home Visiting Formula Awards
Awarded in Federal FYs 2013--2017.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours: The burden estimates
presented in the table below are based on consultations with a few
states on the guidance. Grantees receive a new formula grant annually
and are expected to report on progress annually, so the expectation is
that grantees would submit non-competing continuation progress reports
four times between federal fiscal years 2015 and 2018. Only seven
grantees are currently implementing a promising approach and require an
annual update on the promising approach.
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Total Hours per Total burden
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Formula Grant Award............. 56 4 224 42 9408
-------------------------------------------------------------------------------
Total....................... 56 4 224 42 9408
----------------------------------------------------------------------------------------------------------------
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-16697 Filed 7-7-15; 8:45 am]
BILLING CODE 4165-15-P
