Agency Information Collection Activities: Proposed Collection: Public Comment Request, 58786-58788 [2014-23175]
Download as PDF
<![CDATA[
58786
Federal Register / Vol. 79, No. 189 / Tuesday, September 30, 2014 / Notices
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
OMB control number 0910–0695. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2014–23206 Filed 9–29–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2014–N–0345]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Drug Product Communications as
Used by the Food and Drug
Administration
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Data To Support Drug Product
Communications as Used by the Food
and Drug Administration—(OMB
Control Number 0910–0695)—Extension
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 30,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
SUMMARY:
Testing of communication messages
in advance of a communication
campaign provides an important role in
improving FDA communications as they
allow for an in-depth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. The methods
to be employed include individual indepth interviews, general public focus
group interviews, intercept interviews,
self-administered surveys, gatekeeper
surveys, and professional clinician
focus group interviews. The methods to
be used serve the narrowly defined need
for direct and informal opinion on a
specific topic and, as a qualitative
research tool, have two major purposes:
(1) To obtain information that is
useful for developing variables and
measures for formulating the basic
objectives of risk communication
campaigns; and
(2) To assess the potential
effectiveness of messages and materials
in reaching and successfully
communicating with their intended
audiences.
FDA will use these methods to test
and refine its ideas and to help develop
messages and other communications but
will generally conduct further research
before making important decisions, such
as adopting new policies and allocating
or redirecting significant resources to
support these policies.
FDA will use this mechanism to test
messages about regulated drug products
on a variety of subjects related to
consumer, patient, or health care
professional perceptions and about use
of drug products and related materials,
including but not limited to, direct-toconsumer prescription drug promotion,
physician labeling of prescription drugs,
Medication Guides, over-the-counter
drug labeling, emerging risk
communications, patient labeling,
online sale of medical products, and
consumer and professional education.
Annually, FDA projects about 45
communication studies using the
variety of test methods listed in this
document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
In the Federal Register of April 7,
2014 (79 FR 19096), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment; however, this comment did
not address the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Interviews/Surveys ...............................................................
1 There
19,822
1
Total annual
responses
Average
burden per
response
19,822
0.24 (14
minutes)
Total hours
4,757
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–23236 Filed 9–29–14; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
responses per
respondent
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration, HHS.
AGENCY:
18:09 Sep 29, 2014
Jkt 232001
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
SUMMARY:
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
VerDate Sep<11>2014
ACTION:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
E:\FR\FM\30SEN1.SGM
30SEN1
58787
Federal Register / Vol. 79, No. 189 / Tuesday, September 30, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than December 1, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Maternal, Infant and Early Childhood
Home Visiting (MIECHV) Program
Competitive Grant Final Report OMB
No. 0915–xxxx—New
Abstract: On March 23, 2010, the
President signed into law the Patient
Protection and Affordable Care Act (the
Act), Section 2951 of the Act amended
Title V of the Social Security Act by
adding a new section, 511, which
authorized the creation of the Maternal,
Infant and Early Childhood Home
Visiting Program (MIECHV) (https://
frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=111_cong_
bills&docid=f:h3590enr.txt.pdf, pages
216–225). The legislative authority of
this Act was extended by the Protecting
Access to Medicare Act of 2014 (Pub. L.
113–93). The Act responds to the
diverse needs of children and families
in communities at risk and provides an
unprecedented opportunity for
collaboration and partnership at the
federal, state, and community levels to
improve health and development
outcomes for at risk children through
evidence-based home visiting programs.
Under this program, competitive
funding has been awarded since June
2011 for Competitive Development
Grants and Competitive Expansion
Grants. Competitive Development
Grants were intended to support the
efforts of states and jurisdictions with
modest evidence-based home visiting
programs to expand the depth and scope
of these efforts, with the intent to
develop the infrastructure and capacity
needed to seek a Competitive Expansion
Grant in the future. Competitive
Expansion Grants were intended to
support the efforts of states and
jurisdictions that had already made
significant progress towards a high
quality home visiting program or
embedding their home visiting program
into a comprehensive, high-quality early
childhood system.
Since federal fiscal year 2011, 19
states have been awarded Competitive
Development Grants, and 26 states have
been awarded Competitive Expansion
Grants. These competitive grants are for
2 years (Development Grants) and 4
years (Expansion Grants), respectively.
Grantees of the competitive grant
program will need to complete final
reports in order to comply with HRSA
reporting requirements. Grantees that
were awarded Competitive
Development Grants during federal
fiscal year 2011 were eligible for
Competitive Expansion Grants in federal
fiscal year 2013. For this reason, some
grantees have been awarded up to two
Competitive Grants to date. Ten grantees
have both a Competitive Development
Grant and a Competitive Expansion
Grant. Additional funds are being made
available for Competitive Grants in
federal fiscal year 2015. Up to 35 grants
are anticipated to be awarded on March
1, 2015, with a project period equal to
2 years and 7 months. Grantees are
expected to use 2015 competitive grant
funds to provide ongoing support to
high-quality evidence-based home
visiting programs and for the
development and expansion of
evidence-based home visiting programs
funded, in whole or in part, by the
MIECHV program through increased
enrollment and retention of families
served. After Competitive Grant
issuance in 2015, some MIECHV
grantees may have up to three
competitive grants for which final
reports need to be submitted.
HRSA is collecting information from
MIECHV grantees that have received
competitive grant funds as part of the
Number of
respondents
Form name
MIECHV Competitive Grant Final Report—Fiscal Year
2011 and 2012 Development Grantees ...........................
VerDate Sep<11>2014
18:09 Sep 29, 2014
Jkt 232001
PO 00000
Frm 00063
Number of
responses
per
respondent
19
Fmt 4703
Sfmt 4703
agency’s final reporting requirements.
The final report will be completed by
grantees funded under the Competitive
Grant Program and submitted to HRSA
within 90 days of the project period end
date.
The burden estimates presented in the
table below are based on consultations
with a few states on the final reporting
requirements described in the
competitive grant guidance documents.
Need and Proposed Use of the
Information: Submission of a final
report is a reporting requirement under
the grant award. The final report will
enable assessment of program
effectiveness and impact on the health
and development of service recipients.
Each final report will be assessed to
measure and quantify the degree to
which each grantee was successful in
implementing the grant and ensuring
yearly program improvement. Data will
be extracted from final reports and
aggregated, using suitable analytic
approaches, to compare, contrast, and
identify successes, areas for
improvement, and promising practices
across the program. These findings will
be used to identify the accomplishments
of the MIECHV program, support
program or grantee improvement, and
craft or inform dissemination strategies.
Likely Respondents: MIECHV grantees
that have received a competitive (D89)
grant award.
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total
responses
1
E:\FR\FM\30SEN1.SGM
19
30SEN1
Average
burden
per response
(in hours)
25
Total
burden
hours
475
58788
Federal Register / Vol. 79, No. 189 / Tuesday, September 30, 2014 / Notices
Number of
respondents
Form name
Number of
responses
per
respondent
Total
responses
Average
burden
per response
(in hours)
Total
burden
hours
MIECHV Competitive Grant Final Report—Fiscal Year
2011, 2012, 2013, and 2014 Expansion Grantees ..........
MIECHV Competitive Grant Final Report—Fiscal Year
2015 Expansion Grantees ................................................
31
1
31
25
775
35
1
35
25
875
Total ..............................................................................
........................
........................
........................
........................
2125
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Dated: September 24, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–23175 Filed 9–29–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
SUMMARY:
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than December 1, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Health Professions Student Loan (HPSL)
Program and Nursing Student Loan
(NSL) Program Administrative
Requirements (Regulations and Policy).
OMB No. 0915–0047—Extension.
Abstract: The statutory authorities for
the Health Professions Student Loan
(HPSL) Program, as authorized by
Public Health Service (PHS) Act
sections 721–722 and 725–735, and the
Nursing Student Loan (NSL) Program, as
authorized by PHS Act sections 835–
842, contain a number of recordkeeping
and reporting requirements for
academic institutions and loan
applicants. The applicable regulations
for these programs under 42 CFR Part 57
details the various requirements (see
chart below).
Need and Proposed Use of the
Information: The requirements are
essential for assuring that borrowers are
aware of their rights and
responsibilities, academic institutions
have accurate records of the history and
status of each loan account in order to
pursue aggressive collection efforts to
reduce default rates, and that academic
institutions maintain adequate records
for audit and assessment purposes to
help the U.S. Department of Health and
Human Services safeguard federal funds
made through the Federal Capital
Contribution (FCC). Academic
institutions are free to use improved
information technology to manage the
information required by the regulations.
Likely Respondents: Financial Aid
Directors working at institutions
participating in the HPSL and NSL
Programs.
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
tkelley on DSK3SPTVN1PROD with NOTICES
RECORDKEEPING REQUIREMENTS
Number of
recordkeepers
Regulatory/section requirements
Hours per year
435
435
435
*477
*477
1.17
1.25
1.25
0.33
10
HPSL Program:
57.206(b)(2), Documentation of Cost of Attendance ...........................................................
57.208(a), Promissory Note .................................................................................................
57.210(b)(1)(i), Documentation of Entrance Interview .........................................................
57. 210(b)(1)(ii), Documentation of Exit Interview ...............................................................
57.215(a) & (d), Program Records .......................................................................................
VerDate Sep<11>2014
18:09 Sep 29, 2014
Jkt 232001
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
E:\FR\FM\30SEN1.SGM
30SEN1
Total burden
hours
509
544
544
157
4,770
]]>Agencies
[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Notices]
[Pages 58786-58788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23175]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and
[[Page 58787]]
Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments
from the public regarding the burden estimate, below, or any other
aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
no later than December 1, 2014.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Maternal, Infant and Early
Childhood Home Visiting (MIECHV) Program Competitive Grant Final Report
OMB No. 0915-xxxx--New
Abstract: On March 23, 2010, the President signed into law the
Patient Protection and Affordable Care Act (the Act), Section 2951 of
the Act amended Title V of the Social Security Act by adding a new
section, 511, which authorized the creation of the Maternal, Infant and
Early Childhood Home Visiting Program (MIECHV) (https://
frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=111congbills&docid=f:h3590enr.txt.pd
f, pages 216-225). The legislative authority of this Act was extended
by the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93). The
Act responds to the diverse needs of children and families in
communities at risk and provides an unprecedented opportunity for
collaboration and partnership at the federal, state, and community
levels to improve health and development outcomes for at risk children
through evidence-based home visiting programs.
Under this program, competitive funding has been awarded since June
2011 for Competitive Development Grants and Competitive Expansion
Grants. Competitive Development Grants were intended to support the
efforts of states and jurisdictions with modest evidence-based home
visiting programs to expand the depth and scope of these efforts, with
the intent to develop the infrastructure and capacity needed to seek a
Competitive Expansion Grant in the future. Competitive Expansion Grants
were intended to support the efforts of states and jurisdictions that
had already made significant progress towards a high quality home
visiting program or embedding their home visiting program into a
comprehensive, high-quality early childhood system.
Since federal fiscal year 2011, 19 states have been awarded
Competitive Development Grants, and 26 states have been awarded
Competitive Expansion Grants. These competitive grants are for 2 years
(Development Grants) and 4 years (Expansion Grants), respectively.
Grantees of the competitive grant program will need to complete final
reports in order to comply with HRSA reporting requirements. Grantees
that were awarded Competitive Development Grants during federal fiscal
year 2011 were eligible for Competitive Expansion Grants in federal
fiscal year 2013. For this reason, some grantees have been awarded up
to two Competitive Grants to date. Ten grantees have both a Competitive
Development Grant and a Competitive Expansion Grant. Additional funds
are being made available for Competitive Grants in federal fiscal year
2015. Up to 35 grants are anticipated to be awarded on March 1, 2015,
with a project period equal to 2 years and 7 months. Grantees are
expected to use 2015 competitive grant funds to provide ongoing support
to high-quality evidence-based home visiting programs and for the
development and expansion of evidence-based home visiting programs
funded, in whole or in part, by the MIECHV program through increased
enrollment and retention of families served. After Competitive Grant
issuance in 2015, some MIECHV grantees may have up to three competitive
grants for which final reports need to be submitted.
HRSA is collecting information from MIECHV grantees that have
received competitive grant funds as part of the agency's final
reporting requirements. The final report will be completed by grantees
funded under the Competitive Grant Program and submitted to HRSA within
90 days of the project period end date.
The burden estimates presented in the table below are based on
consultations with a few states on the final reporting requirements
described in the competitive grant guidance documents.
Need and Proposed Use of the Information: Submission of a final
report is a reporting requirement under the grant award. The final
report will enable assessment of program effectiveness and impact on
the health and development of service recipients. Each final report
will be assessed to measure and quantify the degree to which each
grantee was successful in implementing the grant and ensuring yearly
program improvement. Data will be extracted from final reports and
aggregated, using suitable analytic approaches, to compare, contrast,
and identify successes, areas for improvement, and promising practices
across the program. These findings will be used to identify the
accomplishments of the MIECHV program, support program or grantee
improvement, and craft or inform dissemination strategies.
Likely Respondents: MIECHV grantees that have received a
competitive (D89) grant award.
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 Information Collection Request are summarized in the table below.
Total Estimated Annualized burden hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
MIECHV Competitive Grant Final 19 1 19 25 475
Report--Fiscal Year 2011 and
2012 Development Grantees......
[[Page 58788]]
MIECHV Competitive Grant Final 31 1 31 25 775
Report--Fiscal Year 2011, 2012,
2013, and 2014 Expansion
Grantees.......................
MIECHV Competitive Grant Final 35 1 35 25 875
Report--Fiscal Year 2015
Expansion Grantees.............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2125
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Dated: September 24, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-23175 Filed 9-29-14; 8:45 am]
BILLING CODE 4165-15-P
