Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 39122-39123 [2015-16697]

Download as PDF 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]


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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
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