Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Evidence-Based Falls Prevention Program; OMB Control Number, 0985-0039, 4659-4660 [2018-02000]
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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Submission for OMB
Review; Public Comment Request;
Evidence-Based Falls Prevention
Program; OMB Control Number, 0985–
0039
Administration for Community
Living (ACL), HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living is announcing that
the proposed collection of information
listed above has been submitted to the
Office of Management and Budget
(OMB) for review and clearance as
required under section 506(c)(2)(A) of
the Paperwork Reduction Act of 1995.
This 30-Day notice collects comments
on the information collection
requirements related to ACL’s EvidenceBased Falls Prevention Program’s
Proposed Extension with Changes of a
Currently Approved Collection.
DATES: Submit written comments on the
collection of information by March 5,
2018.
SUMMARY:
Submit written comments
on the collection of information by:
(a) Email to: OIRA_submission@
omb.eop.gov, Attn: OMB Desk Officer
for ACL;
(b) fax to 202–395–5806, Attn: OMB
Desk Officer for ACL; or
(c) by mail to the Office of
Information and Regulatory Affairs,
OMB, New Executive Office Bldg., 725
17th St. NW, Rm. 10235, Washington,
DC 20503, Attn: OMB Desk Officer for
ACL.
FOR FURTHER INFORMATION CONTACT:
Shannon Skowronski at
shannon.skowronski@acl.hhs.gov or
202–795–7438.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
The Evidence-Based Falls Prevention
Programs is a cooperative agreement
financed through the Prevention and
Public Health Fund (PPHF), most
recently with FY 2017 PPHF funds. The
statutory authority for cooperative
agreements under the current program
announcement is contained in the
Public Health Service Act, 42 U.S.C.
300u–2 (Community Programs) and
300u–3 (Information Programs); and
Consolidated Appropriations Act, 2017,
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ADDRESSES:
VerDate Sep<11>2014
19:34 Jan 31, 2018
Jkt 244001
Public Law 115–31, Title II; and the
Patient Protection and Affordable Care
Act, 42 U.S.C. 300u–11 (Prevention and
Public Health Fund).
The Evidence-Based Falls Prevention
Programs support a national resource
center and award competitive grants to
implement evidence-based community
programs that have been proven to
reduce the incidence of falls for older
adults. The programs also identify
sustainable funding mechanisms for
these programs via the national resource
center, promote the importance of falls
prevention strategies, and provide
public education about the risks of falls
and ways to prevent them.
OMB approval of the existing set of
Falls Prevention data collection tools
(OMB Control Number, 0985–0039)
expires on 01/31/2018. This data
collection continues to be necessary for
monitoring program operations and
outcomes. ACL/AoA proposes to use the
following tools: (1) Semi-annual
performance reports to monitor grantee
progress; (2) a Host Organization Data
form to record the location of agencies
that sponsor programs that will allow
mapping of the delivery infrastructure;
and (3) a set of tools used to collect
information at each program completed
by the program leaders (Program
Information Cover Sheet and
Attendance Log), a Participant
Information Form completed by each
participant, and a Post Program Survey
to be completed by a random sample of
participants. ACL/AoA intends to
continue using an online data entry
system for the program and participant
survey data.
Comments in Response to the 60-Day
Federal Register Notice
As required by 5 CFR 1320.8(d), a 60Day notice was published in the Federal
Register on October 3, 3017, Volume 82,
Number 190, page 46064. Four emails
were received with comments. Based on
the comments, some minor
modifications were made to the
proposed survey instruments. In
addition to the public comments,
feedback on the current forms was
sought from the following:
• ACL Performance and Evaluation
subject matter experts
• CDC Injury Prevention Center subject
matter experts
• National Falls Prevention Resource
Center and falls prevention subject
matter experts
• Two grantee focus groups (with fewer
than 9 participants combined)
Based on this collective feedback, the
following modifications to the currently
approved forms are being proposed:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
4659
• On the Participant Information
Form:
1. Question #8 on currently approved
and proposed Participant Information
Form: Additional chronic conditions
have been added to the list of options:
Cancer; high blood pressure/
hypertension; osteoporosis; and
Parkinson’s Disease.
2. Question #8 on currently approved
and proposed Participant Information
Form: None (no chronic conditions) has
been removed from the list of options.
3. Question #11 on currently
approved and proposed Participant
Information Form: Two sub-questions
have been added to assess the:
• Frequency of Falls (6b)
• Impact of Falls (6c)
4. Question #15 on the Participant
Information Form has been added to
examine home modifications
5. Question #16 on the Participant
Information Form has been added to
examine activity level
On the Post Program Survey:
1. Question #2 on the currently
approved and proposed Post Program
Survey: Two sub-questions have been
added to assess the:
• Frequency of Falls (6b)
• Impact of Falls (6c)
2. Question #4 on the currently
approved Post Program Survey (‘‘Has
this program reduced your fear of
falling?’’) has been removed.
3. Question #7 on currently approved
Post Program Survey and Question #6
on the proposed form: Removed ‘‘I plan
to continue exercising’’ from the list of
options. Activity level is now addressed
in Question #9.
4. Question #8 on currently approved
Post Program Survey and Question #7
on the proposed form: Removed ‘‘Did
exercises I learned in this program at
home’’ from the list of options. Activity
level is now addressed in Question #9
on the revised form.
5. Question #8 on currently approved
Post Program Survey and Question #7
on the proposed form: Removed ‘‘Made
changes in my home to reduce my risk
of falling (for example, secured rugs or
improved lighting)’’ from the list of
options. Home modifications are now
addressed in Question #8 in the revised
form.
6. Question #8 on the Participant
Information Form has been added to
examine home modifications
7. Question #9 on the Participant
Information Form has been added to
examine activity level
On the Program Information Cover
Sheet:
1. Question #6 has been revised to
improve clarity to read ‘‘Session 0/
Introductory Session’’.
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01FEN1
4660
Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices
2. Question #7 has been revised to
change wording to ‘‘Name of program
offered.’’
Estimated Annualized Burden Hours
The proposed Falls Prevention Data
Collection Tools can be found at ACL’s
Website at: https://www.acl.gov/aboutacl/public-input.
The total estimated burden is 4,345
hours per year. ACL/AoA estimates the
burden of this collection of information
as 288 hours for project staff, 1,435
hours for local agency staff, and 2,622
hours for individuals.
Average time
per response
(in hours)
Total burden
hours
(annual)
Type of respondent
Form name
Estimated number of
respondents
Number of responses
per respondent
Project staff .....................
Semi-annual Performance Report.
Program Information
Cover Sheet/Participant Information Form/
Attendance Log/Post
Program Survey.
18 ...................................
Twice a year ...................
700 leaders ....................
Twice a year (one set
per program).
.50
700
36 data entry staff ..........
.50
700
.05
35
Local agency leaders ......
8
288
Host Organization Data
Form.
700 staff .........................
Once per program ×
1,400 programs.
1 .....................................
16,390 ............................
1 .....................................
.10
1,639
Program participants .......
Participant Information
Form.
Post Program Survey .....
9,834 ..............................
1 .....................................
.10
983
Total Burden Hours ..
.........................................
.........................................
.........................................
..........................
4,345
Local data entry staff ......
Local organization staff
and local database
entry staff.
Program participants .......
Dated: January 26, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018–02000 Filed 1–31–18; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0001]
Best Practices in Modeling and
Simulation for Oncology Products;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA, the Agency, or
we) Center for Drug Evaluation and
Research (CDER), in co-sponsorship
with the International Society of
Pharmacometrics (ISoP), is announcing
a public workshop entitled ‘‘Best
Practices in Modeling and Simulation
for Oncology Products.’’ The purpose of
the meeting is to discuss ‘‘best
practices’’ in integrating
pharmacokinetic, pharmacodynamic,
efficacy, and safety data into models to
best inform oncology drug development,
evaluate disease- and mechanismspecific early endpoints to predict longterm efficacy, and discuss potential
regulatory implications of modelinformed decisions in drug
development. This workshop is also
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:34 Jan 31, 2018
Jkt 244001
being conducted to satisfy one of FDA’s
performance goals included in the sixth
reauthorization of the Prescription Drug
User Fee Act (PDUFA VI), part of the
FDA Reauthorization Act of 2017
(FDARA), to hold a series of workshops
related to model-informed drug
development (MIDD).
DATES: The public workshop will be
held on February 1, 2018, from 8 a.m.
to 5 p.m., Eastern Time. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503, B and C), Silver Spring, MD
20993–0002. Entrance for public
workshop participants (non-FDA
employees) is through Building 1 where
routine security procedures will be
performed. For parking and security
information, please refer to: https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Jeannette Dinin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2108,
Silver Spring, MD 20993–0002, 240–
402–4978, email: Jeannette.Dinin@
fda.hhs.gov; or Yvonne Knight, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2142,
Silver Spring, MD 20993–0002, 301–
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
796–2133, email: Yvonne.Knight@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under FDARA, FDA agreed, in
accordance with section I of the PDUFA
VI Performance Goals, Ensuring the
Effectiveness of the Human Drug
Review, part J, Enhancing Regulatory
Decision Tools to Support Drug
Development and Review, to convene a
series of workshops to identify best
practices for MIDD (https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM511438.pdf). FDA is conducting
this workshop as part of the MIDD
workshop series.
Over the past few decades, there has
been extensive investment in oncology
drug discovery and development.
Despite greater understanding of disease
biology and drug mechanisms of action,
further progress in model-informed
strategies is needed to continue
advancements in oncology drug
development. Innovations in clinical
trial design utilizing more informative
endpoints could help bring more
effective treatment options to cancer
patients faster by accelerating
development of effective new drugs and
reducing failure rates in expensive latephase development.
As more effective and complex
combination strategies and novel targets
for cancer treatment evolve, exploring
more informative and predictive
endpoints to assess treatment response
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Notices]
[Pages 4659-4660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02000]
[[Page 4659]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Submission for OMB
Review; Public Comment Request; Evidence-Based Falls Prevention
Program; OMB Control Number, 0985-0039
AGENCY: Administration for Community Living (ACL), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living is announcing that the
proposed collection of information listed above has been submitted to
the Office of Management and Budget (OMB) for review and clearance as
required under section 506(c)(2)(A) of the Paperwork Reduction Act of
1995. This 30-Day notice collects comments on the information
collection requirements related to ACL's Evidence-Based Falls
Prevention Program's Proposed Extension with Changes of a Currently
Approved Collection.
DATES: Submit written comments on the collection of information by
March 5, 2018.
ADDRESSES: Submit written comments on the collection of information by:
(a) Email to: [email protected], Attn: OMB Desk Officer
for ACL;
(b) fax to 202-395-5806, Attn: OMB Desk Officer for ACL; or
(c) by mail to the Office of Information and Regulatory Affairs,
OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235,
Washington, DC 20503, Attn: OMB Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT: Shannon Skowronski at
[email protected] or 202-795-7438.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
The Evidence-Based Falls Prevention Programs is a cooperative
agreement financed through the Prevention and Public Health Fund
(PPHF), most recently with FY 2017 PPHF funds. The statutory authority
for cooperative agreements under the current program announcement is
contained in the Public Health Service Act, 42 U.S.C. 300u-2 (Community
Programs) and 300u-3 (Information Programs); and Consolidated
Appropriations Act, 2017, Public Law 115-31, Title II; and the Patient
Protection and Affordable Care Act, 42 U.S.C. 300u-11 (Prevention and
Public Health Fund).
The Evidence-Based Falls Prevention Programs support a national
resource center and award competitive grants to implement evidence-
based community programs that have been proven to reduce the incidence
of falls for older adults. The programs also identify sustainable
funding mechanisms for these programs via the national resource center,
promote the importance of falls prevention strategies, and provide
public education about the risks of falls and ways to prevent them.
OMB approval of the existing set of Falls Prevention data
collection tools (OMB Control Number, 0985-0039) expires on 01/31/2018.
This data collection continues to be necessary for monitoring program
operations and outcomes. ACL/AoA proposes to use the following tools:
(1) Semi-annual performance reports to monitor grantee progress; (2) a
Host Organization Data form to record the location of agencies that
sponsor programs that will allow mapping of the delivery
infrastructure; and (3) a set of tools used to collect information at
each program completed by the program leaders (Program Information
Cover Sheet and Attendance Log), a Participant Information Form
completed by each participant, and a Post Program Survey to be
completed by a random sample of participants. ACL/AoA intends to
continue using an online data entry system for the program and
participant survey data.
Comments in Response to the 60-Day Federal Register Notice
As required by 5 CFR 1320.8(d), a 60-Day notice was published in
the Federal Register on October 3, 3017, Volume 82, Number 190, page
46064. Four emails were received with comments. Based on the comments,
some minor modifications were made to the proposed survey instruments.
In addition to the public comments, feedback on the current forms was
sought from the following:
ACL Performance and Evaluation subject matter experts
CDC Injury Prevention Center subject matter experts
National Falls Prevention Resource Center and falls prevention
subject matter experts
Two grantee focus groups (with fewer than 9 participants
combined)
Based on this collective feedback, the following modifications to
the currently approved forms are being proposed:
On the Participant Information Form:
1. Question #8 on currently approved and proposed Participant
Information Form: Additional chronic conditions have been added to the
list of options: Cancer; high blood pressure/hypertension;
osteoporosis; and Parkinson's Disease.
2. Question #8 on currently approved and proposed Participant
Information Form: None (no chronic conditions) has been removed from
the list of options.
3. Question #11 on currently approved and proposed Participant
Information Form: Two sub-questions have been added to assess the:
Frequency of Falls (6b)
Impact of Falls (6c)
4. Question #15 on the Participant Information Form has been added
to examine home modifications
5. Question #16 on the Participant Information Form has been added
to examine activity level
On the Post Program Survey:
1. Question #2 on the currently approved and proposed Post Program
Survey: Two sub-questions have been added to assess the:
Frequency of Falls (6b)
Impact of Falls (6c)
2. Question #4 on the currently approved Post Program Survey (``Has
this program reduced your fear of falling?'') has been removed.
3. Question #7 on currently approved Post Program Survey and
Question #6 on the proposed form: Removed ``I plan to continue
exercising'' from the list of options. Activity level is now addressed
in Question #9.
4. Question #8 on currently approved Post Program Survey and
Question #7 on the proposed form: Removed ``Did exercises I learned in
this program at home'' from the list of options. Activity level is now
addressed in Question #9 on the revised form.
5. Question #8 on currently approved Post Program Survey and
Question #7 on the proposed form: Removed ``Made changes in my home to
reduce my risk of falling (for example, secured rugs or improved
lighting)'' from the list of options. Home modifications are now
addressed in Question #8 in the revised form.
6. Question #8 on the Participant Information Form has been added
to examine home modifications
7. Question #9 on the Participant Information Form has been added
to examine activity level
On the Program Information Cover Sheet:
1. Question #6 has been revised to improve clarity to read
``Session 0/Introductory Session''.
[[Page 4660]]
2. Question #7 has been revised to change wording to ``Name of
program offered.''
Estimated Annualized Burden Hours
The proposed Falls Prevention Data Collection Tools can be found at
ACL's Website at: https://www.acl.gov/about-acl/public-input.
The total estimated burden is 4,345 hours per year. ACL/AoA
estimates the burden of this collection of information as 288 hours for
project staff, 1,435 hours for local agency staff, and 2,622 hours for
individuals.
----------------------------------------------------------------------------------------------------------------
Estimated Number of Average time
Type of respondent Form name number of responses per per response Total burden
respondents respondent (in hours) hours (annual)
----------------------------------------------------------------------------------------------------------------
Project staff................ Semi-annual 18............. Twice a year... 8 288
Performance
Report.
Local agency leaders......... Program 700 leaders.... Twice a year .50 700
Information (one set per
Cover Sheet/ program).
Participant
Information
Form/
Attendance Log/
Post Program
Survey.
Local data entry staff....... 36 data entry Once per .50 700
staff. program x
1,400 programs.
Local organization staff and Host 700 staff...... 1.............. .05 35
local database entry staff. Organization
Data Form.
Program participants......... Participant 16,390......... 1.............. .10 1,639
Information
Form.
Program participants......... Post Program 9,834.......... 1.............. .10 983
Survey.
-------------------------------
Total Burden Hours....... ............... ............... ............... .............. 4,345
----------------------------------------------------------------------------------------------------------------
Dated: January 26, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018-02000 Filed 1-31-18; 8:45 am]
BILLING CODE 4154-01-P
