Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal, Infant, and Early Childhood Home Visiting Program Cost Reporting Pilot Study, 62511-62512 [2016-21734]
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Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
microbiological laboratory technologist
would work an average of 76.5 hours
annually (153 infants × 0.5 hours per
infant = 76.5 hours) to prepare and
analyze fecal samples taken from infants
in the controlled study. All estimates
are shown in table 2. Therefore, a total
of 156 additional annual burden hours
(3 + 38.25 + 38.25 + 76.5 = 156) are
estimated to account for the information
collection burden resulting from the
need to conduct a controlled study in
order to gather data to substantiate a
new structure/function claim, or a
structure/function claim that lacks
sufficient prior evidence, for a total of
166 total annual hours (156 + 10 = 166)
for the upkeep and generation of
information used to substantiate
structure/function claims. Including the
one-time burden of 160 hours
annualized over 3 years (160/3 = 53.3),
the total annual record keeping burden
is 219.3 hours (166 + 53.3 = 219.3).
There are no estimated capital costs or
operating and maintenance costs
associated with this information
collection.
TABLE 1—ESTIMATED ONE-TIME HOURLY RECORDKEEPING BURDEN
Number of
respondents
Recordkeeping activity
First year
frequency of
recordkeeping
Total records
Hours per
record
Total hours
First Year Hourly Burden
Assembling Records Related to Substantiation of Existing
Structure/Function Claims ................................................
10
1
10
16
160
Total First Year Only Recordkeeping Burden ..............
........................
........................
........................
........................
*160
TABLE 2—RECORDKEEPING BURDEN
Annual
frequency of
recordkeeping
Number of
respondents
Recordkeeping activity
Total records
Hours per record
Total hours
Recurring Hourly Burden
*Annualized Recordkeeping Burden from Table 1
Maintaining Records Related to Substantiation of
Structure/Function Claims.
Controlled Study—Principal Investigator ..............
Controlled Study—Sample Collector ....................
Controlled Study—Nurse/Heath Care Professional.
Controlled Study—Lab Tech ................................
10
10
1
1
5.3
10
1 ....................................
1 ....................................
53.3
10
1
1
1
1
153
153
1
153
153
3 ....................................
0.25 (15 minutes) .........
0.25 (15 minutes) .........
3
38.25
38.25
1
153
153
0.5 (30 minutes) ...........
76.5
Total Recordkeeping Burden ........................
........................
........................
........................
.......................................
219.3
Before the proposed information
collection provisions contained in this
draft guidance become effective, we will
publish a notice in the Federal Register
announcing OMB’s decision to approve,
modify, or disapprove the proposed
information collection provisions. 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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
IV. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and are
available for viewing by interested
VerDate Sep<11>2014
17:11 Sep 08, 2016
Jkt 238001
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov.
1. Moro, G., F. Mosca, V. Miniello, et al.,
‘‘Effects of a New Mixture of Prebiotics
on Faecal Flora and Stools in Term
Infants.’’ Acta Paediatrica, 2003.
Supplement September 1991(441): pp.
77–79.
2. Boehm, G., M. Lidestri, P. Casetta,, et al.,
‘‘Supplementation of a Bovine Milk
Formula with an Oligosaccharide
Mixture Increases Counts of Faecal
Bifidobacteria in Preterm Infants.’’
Archives of Disease in Childhood Fetal
and Neonatal Edition, 2002. 86(3): pp.
F178–181.
3. Pickering, L.K., D.M. Granoff, J.R.
Erickson, et al., ‘‘Modulation of the
Immune System by Human Milk and
Infant Formula Containing Nucleotides.’’
Pediatrics, 1998. 101(2): pp. 242–249.
Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21725 Filed 9–8–16; 8:45 am]
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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; Maternal, Infant, and Early
Childhood Home Visiting Program
Cost Reporting Pilot Study
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, 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
SUMMARY:
E:\FR\FM\09SEN1.SGM
09SEN1
62512
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than October 11, 2016.
ADDRESSES: Submit your comments,
including the ICR 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) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Maternal, Infant, and Early Childhood
Home Visiting Program Cost Reporting
Pilot Study
OMB No. 0906–xxxx—NEW
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting Program
(Federal Home Visiting Program),
administered by HRSA in partnership
with the Administration for Children
and Families, supports voluntary,
evidence-based home visiting services
during pregnancy and to parents with
young children up to kindergarten
entry. States, Tribal entities, and certain
nonprofit organizations are eligible to
receive funding from the Federal Home
Visiting Program and have the flexibility
to tailor the program to serve the
specific needs of their communities.
Funding recipients may subaward grant
funds to organizations, otherwise
known as Local Implementing Agencies
(LIAs), in order to provide services to
eligible families in at-risk communities.
Need and Proposed Use of the
Information: This information collection
is requested to conduct a pilot study to
test the reliability of a standardized cost
reporting tool for the provision of
evidence-based home visiting services.
The information collected will be used
to: Test the reliability and feasibility of
implementing a proposed set of
standardized cost metrics and
organizational characteristics across
various contexts; estimate preliminary
total costs for implementing evidencebased home visiting services, including
ranges, and; further refine cost metrics
and the cost reporting tool based on
feedback received through the pilot
study. Proposed standard cost metrics
have been developed based on a review
of the existing literature for measures of
home visiting costs, as well as from
ongoing discussions with developers of
evidence-based home visiting models.
HRSA received comments from one
respondent during the public comment
period which estimated the hourly
burden per response to be 16 hours. The
estimated burden has been revised to
reflect this feedback. Further, the
commenter expressed an interest in
using the tool to analyze the cost-benefit
and overall value of home visiting
programs. While the cost reporting tool
may be useful in collecting information
that will lead to additional cost-benefit
analyses, those analyses are outside the
scope of the current project. A full
response to the comments can be
accessed in Part A of the Supporting
Statement.
Likely Respondents: Organizations,
including LIAs providing evidencebased home visiting services through
the Federal Home Visiting Program.
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
Number of
respondents
Form name
Number of
responses
per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Cost Elements Table ...........................................................
Organizational Characteristics Table ...................................
90
90
1
1
90
90
15.5
0.5
1,395
45
Total ..............................................................................
1 90
........................
90
........................
1,440
1 The
same 90 individuals complete the Cost Elements Table and the Organizational Characteristics Table.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–21734 Filed 9–8–16; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4165–15–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; Small Rural Hospital
Transitions Project
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA submitted
SUMMARY:
VerDate Sep<11>2014
17:11 Sep 08, 2016
Jkt 238001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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 October 11, 2016.
ADDRESSES: Submit your comments,
including the ICR 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
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62511-62512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21734]
-----------------------------------------------------------------------
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; Maternal, Infant, and
Early Childhood Home Visiting Program Cost Reporting Pilot Study
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, 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
[[Page 62512]]
the public during the review and approval period.
DATES: Comments on this ICR should be received no later than October
11, 2016.
ADDRESSES: Submit your comments, including the ICR 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) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Maternal, Infant, and Early
Childhood Home Visiting Program Cost Reporting Pilot Study
OMB No. 0906-xxxx--NEW
Abstract: The Maternal, Infant, and Early Childhood Home Visiting
Program (Federal Home Visiting Program), administered by HRSA in
partnership with the Administration for Children and Families, supports
voluntary, evidence-based home visiting services during pregnancy and
to parents with young children up to kindergarten entry. States, Tribal
entities, and certain nonprofit organizations are eligible to receive
funding from the Federal Home Visiting Program and have the flexibility
to tailor the program to serve the specific needs of their communities.
Funding recipients may subaward grant funds to organizations, otherwise
known as Local Implementing Agencies (LIAs), in order to provide
services to eligible families in at-risk communities.
Need and Proposed Use of the Information: This information
collection is requested to conduct a pilot study to test the
reliability of a standardized cost reporting tool for the provision of
evidence-based home visiting services. The information collected will
be used to: Test the reliability and feasibility of implementing a
proposed set of standardized cost metrics and organizational
characteristics across various contexts; estimate preliminary total
costs for implementing evidence-based home visiting services, including
ranges, and; further refine cost metrics and the cost reporting tool
based on feedback received through the pilot study. Proposed standard
cost metrics have been developed based on a review of the existing
literature for measures of home visiting costs, as well as from ongoing
discussions with developers of evidence-based home visiting models.
HRSA received comments from one respondent during the public
comment period which estimated the hourly burden per response to be 16
hours. The estimated burden has been revised to reflect this feedback.
Further, the commenter expressed an interest in using the tool to
analyze the cost-benefit and overall value of home visiting programs.
While the cost reporting tool may be useful in collecting information
that will lead to additional cost-benefit analyses, those analyses are
outside the scope of the current project. A full response to the
comments can be accessed in Part A of the Supporting Statement.
Likely Respondents: Organizations, including LIAs providing
evidence-based home visiting services through the Federal Home Visiting
Program.
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Cost Elements Table............. 90 1 90 15.5 1,395
Organizational Characteristics 90 1 90 0.5 45
Table..........................
-------------------------------------------------------------------------------
Total....................... \1\ 90 .............. 90 .............. 1,440
----------------------------------------------------------------------------------------------------------------
\1\ The same 90 individuals complete the Cost Elements Table and the Organizational Characteristics Table.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-21734 Filed 9-8-16; 8:45 am]
BILLING CODE 4165-15-P
