Agency Information Collection Activities: Proposed Collection: Public Comment Request, 18863-18864 [2016-07319]
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18863
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
ACTION:
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
[FR Doc. 2016–07369 Filed 3–31–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–N–0471, FDA–
2012–N–0294]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Notice.
Food and Drug Administration,
HHS.
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB Control
number
Title of collection
Prescription Drug User Fee Cover Sheet; Form FDA 3397 ...................................................................................
Food Additives; Food Contact Substances Notification System .............................................................................
Dated: March 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07363 Filed 3–31–16; 8:45 am]
BILLING CODE 4164–01–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.
AGENCY:
ACTION:
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
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Comments on this ICR should be
received no later than May 31, 2016.
DATES:
VerDate Sep<11>2014
17:25 Mar 31, 2016
Jkt 238001
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, 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 Program Funding
Opportunity Announcement for
Formula Grant Awards OMB No. 0906–
xxxx—New.
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting (Federal
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. Formula grant
awards support Federal Home Visiting
Program grantees in meeting statutory
and programmatic objectives for
ADDRESSES:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
0910–0297
0910–0495
Date
approval
expires
3/31/2019
3/31/2019
implementing high quality home
visiting programs and coordinating with
comprehensive statewide early
childhood systems. All fifty states, the
District of Columbia, five territories, and
nonprofit organizations that would
provide services in jurisdictions that
have not directly applied for or been
approved for a grant are eligible to
receive formula grant awards. There are
currently 56 entities with formula grant
awards.
Need and Proposed Use of the
Information: This information collection
is requested for eligible entities to
submit applications in response to
annual formula Funding Opportunity
Announcements (FOA) beginning in
Fiscal Year (FY) 2017.
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 Federal Home Visiting
Program. A portion of funding under
this program is awarded to participating
states and eligible jurisdictions using a
funding formula. Formula funding is the
main funding mechanism used by
HRSA to provide support to eligible
entities for the provision of voluntary
high-quality home visiting services to
families living in at-risk communities.
The information collected will be
used to provide guidance to eligible
entities on how to prepare and submit
applications in response to annual
E:\FR\FM\01APN1.SGM
01APN1
18864
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
FOAs beginning in FY 2017. The
application will provide project plans
and budgets for upcoming years. This
information will permit federal staff to
assess whether the proposed activities
align with statutory and programmatic
requirements and objectives and will
result in the implementation of a highquality project. Applications in
response to annual FOAs are submitted
via Grants.gov.
Failure to collect this information
would result in the inability of HRSA to
collect information necessary for the
determination of the responsiveness and
quality of applications and would
subject the government to undue risk in
awarding formula funds under the
Federal Home Visiting Program.
Applicants will be required to submit
several types of information in addition
to the SF–424 Forms which are
included under a separate Information
Collection Request. These types of
information include: (1) Project
Abstract, (2) Project Narrative, (3)
Budget Justification, (4) ProgramSpecific Forms and Tables, and (5)
Attachments.
Likely Respondents: Eligible entities
under the Social Security Act, Title V,
Section 511(c) (42 U.S.C., Section
711(c)), as added by Section 2951 of the
ACA (Pub. L. 111–148).
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
Number of
respondents
Form name
Number of
responses per
respondent
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
Average
burden per
response
(in hours)
Total burden
hours
Federal Home Visiting Program Formula Funding Opportunity Announcement ........................................................
56
1
56
80
4,480
Total ..............................................................................
56
1
56
80
4,480
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.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–07319 Filed 3–31–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Advisory Committee on Heritable
Disorders in Newborns and Children;
Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463, codified at 5 U.S.C.
App.), notice is hereby given of the
following meeting:
Name: Advisory Committee on
Heritable Disorders in Newborns and
Children.
Dates and Times: May 9, 2016, 9:00
a.m. to 5:00 p.m. (Meeting time is
VerDate Sep<11>2014
17:25 Mar 31, 2016
Jkt 238001
tentative.) May 10, 2016, 9:00 a.m. to
3:00 p.m. (Meeting time is tentative.)
Place: Webcast and In-Person, Fishers
Lane Conference Center, Terrace Level,
5635 Fishers Lane, Rockville, MD
20852.
Status: The meeting will be open to
the public with attendance limited to
space availability. Participants also have
the option of viewing the meeting via
webcast. Whether attending in-person or
via webcast, all participants must
register for the meeting. The registration
link will be made available at https://
www.hrsa.gov/advisorycommittees/
mchbadvisory/heritabledisorders/. The
registration deadline is Friday, April 29,
2016, 11:59 p.m. Eastern Time.
Purpose: The Advisory Committee on
Heritable Disorders in Newborns and
Children (Committee), as authorized by
Public Health Service Act, title XI,
section 1111 (42 U.S.C. 300b–10), as
amended by the Newborn Screening
Saves Lives Reauthorization Act of 2014
(Pub. L. 113–240), was established to
advise the Secretary of the Department
of Health and Human Services about the
development of newborn screening
activities, technologies, policies,
guidelines, and programs for effectively
reducing morbidity and mortality in
newborns and children having, or at risk
for, heritable disorders. In addition, the
Committee’s recommendations
regarding additional conditions/
heritable disorders for screening that
have been adopted by the Secretary are
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
included in the Recommended Uniform
Screening Panel (RUSP) and constitute
part of the comprehensive guidelines
supported by the Health Resources and
Services Administration. Pursuant to
section 2713 of the Public Health
Service Act, codified at 42 U.S.C.
300gg–13, non-grandfathered health
plans and group and individual health
insurance issuers are required to cover
evidence-informed care and screenings
included in the HRSA-supported
comprehensive guidelines without
charging a co-payment, co-insurance, or
deductible for plan years (in the
individual market, policy years)
beginning on or after the date that is 1
year from the Secretary’s adoption of the
condition for screening.
Agenda: The Committee will hear
presentations and discussions on topics
including newborn screening long-term
follow-up, the Newborn Sequencing in
Genomic Medicine and Public Health
projects, screening for lysosomal storage
disorders, and prenatal education
regarding newborn screening
bloodspots. The Committee will also
review draft reports from the Pilot Study
and Cost Analysis workgroups and hear
updates from the Committee’s
subcommittees on Laboratory Standards
and Procedures, Follow-up and
Treatment, and Education and Training
Tentatively, the Committee is expected
to review and/or vote on whether or not
the nominated condition
Guanidinoacetate Methyltransferase
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18863-18864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07319]
-----------------------------------------------------------------------
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 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 ICR should be received no later than May 31,
2016.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N-39, 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 Program Funding Opportunity Announcement for
Formula Grant Awards OMB No. 0906-xxxx--New.
Abstract: The Maternal, Infant, and Early Childhood Home Visiting
(Federal 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. Formula grant awards
support Federal Home Visiting Program grantees in meeting statutory and
programmatic objectives for implementing high quality home visiting
programs and coordinating with comprehensive statewide early childhood
systems. All fifty states, the District of Columbia, five territories,
and nonprofit organizations that would provide services in
jurisdictions that have not directly applied for or been approved for a
grant are eligible to receive formula grant awards. There are currently
56 entities with formula grant awards.
Need and Proposed Use of the Information: This information
collection is requested for eligible entities to submit applications in
response to annual formula Funding Opportunity Announcements (FOA)
beginning in Fiscal Year (FY) 2017.
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 Federal Home Visiting
Program. A portion of funding under this program is awarded to
participating states and eligible jurisdictions using a funding
formula. Formula funding is the main funding mechanism used by HRSA to
provide support to eligible entities for the provision of voluntary
high-quality home visiting services to families living in at-risk
communities.
The information collected will be used to provide guidance to
eligible entities on how to prepare and submit applications in response
to annual
[[Page 18864]]
FOAs beginning in FY 2017. The application will provide project plans
and budgets for upcoming years. This information will permit federal
staff to assess whether the proposed activities align with statutory
and programmatic requirements and objectives and will result in the
implementation of a high-quality project. Applications in response to
annual FOAs are submitted via Grants.gov.
Failure to collect this information would result in the inability
of HRSA to collect information necessary for the determination of the
responsiveness and quality of applications and would subject the
government to undue risk in awarding formula funds under the Federal
Home Visiting Program. Applicants will be required to submit several
types of information in addition to the SF-424 Forms which are included
under a separate Information Collection Request. These types of
information include: (1) Project Abstract, (2) Project Narrative, (3)
Budget Justification, (4) Program-Specific Forms and Tables, and (5)
Attachments.
Likely Respondents: Eligible entities under the Social Security
Act, Title V, Section 511(c) (42 U.S.C., Section 711(c)), as added by
Section 2951 of the ACA (Pub. L. 111-148).
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)
----------------------------------------------------------------------------------------------------------------
Federal Home Visiting Program 56 1 56 80 4,480
Formula Funding Opportunity
Announcement...................
-------------------------------------------------------------------------------
Total....................... 56 1 56 80 4,480
----------------------------------------------------------------------------------------------------------------
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.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-07319 Filed 3-31-16; 8:45 am]
BILLING CODE 4165-15-P
