Agency Information Collection Activities: Proposed Collection: Public Comment Request, 53811-53812 [2015-22545]
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Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
second edition SE FAQ guidance. Based
on the comments received on the
September 2011 draft guidance and the
March 2015 final guidance, we are now
issuing the second edition FAQ final
guidance.
The second edition FAQ guidance
describes FDA’s current thinking on
whether and when a change to a tobacco
product’s label, product quantity in the
package, additives, or specifications
renders that product a ‘‘new tobacco
product’’ subject to premarket review. It
explains that a manufacturer may
submit streamlined SE reports for
certain modifications to labels and
changes to product quantity. The
guidance also explains FDA’s plans and
processes for review of the streamlined
SE reports. Finally, this guidance
responds to several questions that have
been raised about the SE process more
generally.
The guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved information collections. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
sections 905(j) and 910 of the FD&C Act
(21 U.S.C. 387e(j) and 387j,
respectively), as amended by the
Tobacco Control Act (Pub. L. 111–31),
have been approved under OMB control
number 0910–0673; the collections of
information in 21 CFR part 25 have been
approved under OMB control number
0910–0322.
III. Comments
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document.
Received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to
the docket at https://
VerDate Sep<11>2014
17:18 Sep 04, 2015
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C. Information Identifying the Person
Submitting the Comment
Please note that your name, contact
information, and other information
identifying you will be posted on https://
www.regulations.gov if you include that
information in the body of your
comments. For electronic comments
submitted to https://
www.regulations.gov, FDA will post the
body of your comment on https://
www.regulations.gov along with your
state/province and country (if
provided), the name of your
representative (if any), and the category
identifying you (e.g., individual,
consumer, academic, industry). For
written submissions submitted to the
Division of Dockets Management, FDA
will post the body of your comments on
https://www.regulations.gov, but you can
put your name and/or contact
information on a separate cover sheet
and not in the body of your comments.
IV. Electronic Access
A. General Information About
Submitting Comments
B. Public Availability of Comments
www.regulations.gov. As a matter of
Agency practice, FDA generally does
not post comments submitted by
individuals in their individual capacity
on https://www.regulations.gov. This is
determined by information indicating
that the submission is written by an
individual, for example, the comment is
identified with the category ‘‘Individual
Consumer’’ under the field titled
‘‘Category (Required),’’ on the ‘‘Your
Information’’ page on https://
www.regulations.gov. For this
document, however, FDA will not be
following this general practice. Instead,
FDA will post on https://
www.regulations.gov comments to this
docket that have been submitted by
individuals in their individual capacity.
If you wish to submit any information
under a claim of confidentiality, please
refer to 21 CFR 10.20.
Persons with access to the Internet
may obtain an electronic version of the
guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: August 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22494 Filed 9–4–15; 8:45 am]
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53811
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
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 November 9, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, 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:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Performance Measurement Information
System.
OMB No. 0906–xxxx—New
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting Program
(MIECHV), administered by HRSA in
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. States and Tribal
entities are eligible to receive funding
from the MIECHV Program and have the
flexibility to tailor the program to serve
the specific needs of their communities.
SUMMARY:
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53812
Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
Need and Proposed Use of the
Information: HRSA will use the
proposed information to demonstrate
program accountability and
continuously monitor and provide
oversight to Home Visiting Program
grantees. The information will also be
used to provide quality improvement
guidance and technical assistance to
grantees and help inform the
development of early childhood systems
at the national, state, and local level.
HRSA is seeking to collect demographic,
service utilization, and select clinical
indicators for participants enrolled in
home visiting services. In addition,
HRSA will collect a set of standardized
performance and outcome indicators
that correspond with the statutorily
identified benchmark areas.
Demographic, Service Utilization, and
Clinical Indicators Data
These data will describe the
population served by the MIECHV
Program, including the unduplicated
count of the number of participants and
participant groups by primary insurance
coverage. These data will provide other
socio-demographic characteristics of
program participants and their
utilization of services, such as program
retention. Additionally, these data will
describe several select clinical
indicators of program participants, such
as the percent of eligible participants
who deliver their child preterm. This
information will be collected from
participants once, at enrollment in
home visiting services and aggregated
and reported to HRSA by state/territory
grantees once annually.
Performance and Outcome Benchmark
Data
These data constitute a discrete set of
standardized performance and outcome
indicators that correspond with the
statutorily identified benchmark areas.
These data will provide aggregate totals,
percentages, and rates for performance
and outcome indicators that are salient
to the MIECHV Program, home visiting
services more generally, and the at-risk
populations served. These data will be
collected from participants based on the
appropriate measurement period
defined for each measure and aggregated
and reported to HRSA by state/territory
grantees once annually.
This information will be used to
demonstrate accountability with
legislative and programmatic
requirements. It will also be used to
monitor and provide continued
oversight for grantee performance and to
target technical assistance resources to
grantees. In the future, it is anticipated
the MIECHV funding decisions may be
allocated based on grantee performance,
including on benchmark performance
areas.
Likely Respondents: Home Visiting
Program grantees.
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
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Form 1:
Demographic, Service Utilization, and Clinical Indicators Data ....................................................................
Performance and Outcome Benchmark Data ..............
56
56
1
1
56
56
650
200
36,400
11,200
Total .......................................................................
56
........................
56
........................
47,600
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jackie Painter,
Director, Division of the Executive Secretariat.
ACTION:
[FR Doc. 2015–22545 Filed 9–4–15; 8:45 am]
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Indian Health Service
[OMB NO. 0917–0028]
Request for Public Comment: 30-Day
Proposed Information Collection:
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions
Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
Public Law (Pub. L.) 104–13 [44 United
States Code (U.S.C.) section
3507(a)(1)(D)], the Indian Health Service
SUMMARY:
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(IHS) is submitting to the Office of
Management and Budget (OMB) a
request for an extension of a previously
approved collection of information
titled, ‘‘Addendum to Declaration for
Federal Employment, Child Care and
Indian Child Care Worker Positions,’’
Office of Management and Budget
(OMB) Control Number 0917–0028,
which expires November 30, 2015.
This previously approved information
collection project was last published in
the Federal Register (80 FR 43100) on
July 21, 2015, and allowed 60 days for
public comment, as required by 44
U.S.C. 3506(c)(2)(A). The IHS received
no comments regarding this collection.
The purpose of this notice is to solicit
public comments on specific aspects of
the proposed information collection,
which are to be submitted directly to
OMB for a 30 day period.
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]]>Agencies
[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53811-53812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22545]
-----------------------------------------------------------------------
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 Information Collection Request must be received
no later than November 9, 2015.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10C-03, 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: The Maternal, Infant, and
Early Childhood Home Visiting Program Performance Measurement
Information System.
OMB No. 0906-xxxx--New
Abstract: The Maternal, Infant, and Early Childhood Home Visiting
Program (MIECHV), administered by HRSA in 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. States and Tribal
entities are eligible to receive funding from the MIECHV Program and
have the flexibility to tailor the program to serve the specific needs
of their communities.
[[Page 53812]]
Need and Proposed Use of the Information: HRSA will use the
proposed information to demonstrate program accountability and
continuously monitor and provide oversight to Home Visiting Program
grantees. The information will also be used to provide quality
improvement guidance and technical assistance to grantees and help
inform the development of early childhood systems at the national,
state, and local level. HRSA is seeking to collect demographic, service
utilization, and select clinical indicators for participants enrolled
in home visiting services. In addition, HRSA will collect a set of
standardized performance and outcome indicators that correspond with
the statutorily identified benchmark areas.
Demographic, Service Utilization, and Clinical Indicators Data
These data will describe the population served by the MIECHV
Program, including the unduplicated count of the number of participants
and participant groups by primary insurance coverage. These data will
provide other socio-demographic characteristics of program participants
and their utilization of services, such as program retention.
Additionally, these data will describe several select clinical
indicators of program participants, such as the percent of eligible
participants who deliver their child preterm. This information will be
collected from participants once, at enrollment in home visiting
services and aggregated and reported to HRSA by state/territory
grantees once annually.
Performance and Outcome Benchmark Data
These data constitute a discrete set of standardized performance
and outcome indicators that correspond with the statutorily identified
benchmark areas. These data will provide aggregate totals, percentages,
and rates for performance and outcome indicators that are salient to
the MIECHV Program, home visiting services more generally, and the at-
risk populations served. These data will be collected from participants
based on the appropriate measurement period defined for each measure
and aggregated and reported to HRSA by state/territory grantees once
annually.
This information will be used to demonstrate accountability with
legislative and programmatic requirements. It will also be used to
monitor and provide continued oversight for grantee performance and to
target technical assistance resources to grantees. In the future, it is
anticipated the MIECHV funding decisions may be allocated based on
grantee performance, including on benchmark performance areas.
Likely Respondents: Home Visiting Program grantees.
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)
----------------------------------------------------------------------------------------------------------------
Form 1:
Demographic, Service 56 1 56 650 36,400
Utilization, and Clinical
Indicators Data............
Performance and Outcome 56 1 56 200 11,200
Benchmark Data.............
-------------------------------------------------------------------------------
Total................... 56 .............. 56 .............. 47,600
----------------------------------------------------------------------------------------------------------------
HHS 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. 2015-22545 Filed 9-4-15; 8:45 am]
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