Agency Information Collection Activities; Public Comment Request; Proposed Extension With Changes of a Currently Approved Collection; Evidence-Based Falls Prevention Program, 46064-46065 [2017-21179]
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46064
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
Dated: September 28, 2017.
William N. Parham, III
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–21248 Filed 10–2–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Public Comment Request;
Proposed Extension With Changes of
a Currently Approved Collection;
Evidence-Based Falls Prevention
Program
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
certain information by the agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal agencies are
required to publish a notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements relating to
ACL’s Evidence-Based Falls Prevention
Program. This notice solicits comments
on a proposed extension with minor
changes of a currently approved
collection.
DATES: Submit written or electronic
comments on the collection of
information by December 4, 2017.
ADDRESSES: Submit electronic
comments on the collection of
information to shannon.skowronski@
acl.hhs.gov. Submit written comments
on the collection of information to:
Shannon Skowronski, U.S. Department
of Health and Human Services:
Administration for Community Living,
Washington, DC 20201.
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.
‘‘Collection of information’’ is defined
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension or
update of an existing collection of
information, before submitting the
collection to OMB for approval. To
comply with this requirement, ACL is
publishing notice of the proposed
collection of information set forth in
this document.
With respect to the following
collection of information, ACL invites
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of ACL’s
functions, including whether the
information will have practical utility;
(2) the accuracy of ACL’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
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 and Further Continuing
Appropriations Act, 2015, Pub. L. 113–
235, Div. G., Title II, § 219(a); 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 and adults with disabilities
(including Tribal elders). The programs
also identify sustainable funding
mechanisms for these programs via the
resource center, promote the importance
of falls prevention strategies, and
provide public education about the risks
of falls and ways to prevent them.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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 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. In addition to nonsubstantive formatting edits, minor
changes are being proposed to 2 of the
5 currently approved tools, as indicated
below. All changes proposed are based
on feedback from a focus group that
included a sub-set of current grantees
and consultation with subject-matter
experts.
• On the Participant Information
Form:
1. Additional chronic conditions have
been added to the list of options
2. Question #11 (assessing the
frequency and impact of falls) has been
enhanced to include the location of the
fall(s) and further assess impact
3. Two questions have been added
(#15 and #16) to examine modifications
made to home and activity level
• On the Post-Program Survey:
1. Question #2 (assessing the
frequency and impact of falls) has been
enhanced to include the location of the
fall(s) and further assess impact
2. Questions #6 and #7 have been
modified slightly—removing references
to home modifications and activity
level. Home modifications and activity
level are now addressed in questions #8
and #9 instead.
Estimated Annualized Burden Hours
The proposed Falls Prevention Data
Collection Tools can be found at ACL’s
Web site 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.
E:\FR\FM\03OCN1.SGM
03OCN1
46065
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
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 ...............................
Local agency leaders ................
Semi-annual Performance Report .....................
Program Information Cover Sheet/Participant
Information Form/Attendance Log/Post Program Survey.
18 ................................
700 leaders .................
Twice a year .............................
Twice a year (one set per program).
8
.50
288
700
46 data entry staff ......
.50
700
.05
35
Local data entry staff ................
Local organization staff and
local database entry staff.
Program participants .................
Program participants .................
Host Organization Data Form ...........................
700 staff ......................
Once per program x 1400 programs.
1 ...............................................
Participant Information Form .............................
Post Program Survey ........................................
16,390 .........................
983 ..............................
1 ...............................................
1 ...............................................
.10
.10
1,639
983
Total Burden Hours ...........
............................................................................
.....................................
...................................................
................
4,345
Dated: September 20, 2017.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2017–21179 Filed 10–2–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5437]
Topical Dermatological Generic Drug
Products: Overcoming Barriers to
Development and Improving Patient
Access; Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Topical
Dermatological Generic Drug Products:
Overcoming Barriers to Development
and Improving Patient Access.’’ The
purpose of the public workshop is to
provide an overview of current
regulatory science initiatives related to
generic topical dermatological drug
products, solicit public input on
scientific barriers that may limit patient
access to such drug products, and
discuss approaches to overcome/address
any such barriers. FDA is seeking public
input from a variety of stakeholders,
including industry, academia, patient
advocates, and professional
associations.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
The public workshop will be
held on October 20, 2017, from 8:30
a.m. to 4:30 p.m., Eastern Standard
Time. Submit either electronic or
written comments on this public
workshop by November 20, 2017. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
DATES:
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
The public workshop will
be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Workingat
FDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 20, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 20, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
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Fmt 4703
Sfmt 4703
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–5437 for ‘‘Topical
Dermatological Generic Drug Products:
Overcoming Barriers to Development
and Improving Patient Access.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46064-46065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21179]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Public Comment Request;
Proposed Extension With Changes of a Currently Approved Collection;
Evidence-Based Falls Prevention Program
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
certain information by the agency. Under the Paperwork Reduction Act of
1995 (the PRA), Federal agencies are required to publish a notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on the
information collection requirements relating to ACL's Evidence-Based
Falls Prevention Program. This notice solicits comments on a proposed
extension with minor changes of a currently approved collection.
DATES: Submit written or electronic comments on the collection of
information by December 4, 2017.
ADDRESSES: Submit electronic comments on the collection of information
to shannon.skowronski@acl.hhs.gov. Submit written comments on the
collection of information to: Shannon Skowronski, U.S. Department of
Health and Human Services: Administration for Community Living,
Washington, DC 20201.
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.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension or update of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, ACL is publishing notice of the proposed
collection of information set forth in this document.
With respect to the following collection of information, ACL
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of ACL's functions, including
whether the information will have practical utility; (2) the accuracy
of ACL's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
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 and
Further Continuing Appropriations Act, 2015, Pub. L. 113-235, Div. G.,
Title II, Sec. 219(a); 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 and adults with disabilities (including
Tribal elders). The programs also identify sustainable funding
mechanisms for these programs via the 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 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. In
addition to non-substantive formatting edits, minor changes are being
proposed to 2 of the 5 currently approved tools, as indicated below.
All changes proposed are based on feedback from a focus group that
included a sub-set of current grantees and consultation with subject-
matter experts.
On the Participant Information Form:
1. Additional chronic conditions have been added to the list of
options
2. Question #11 (assessing the frequency and impact of falls) has
been enhanced to include the location of the fall(s) and further assess
impact
3. Two questions have been added (#15 and #16) to examine
modifications made to home and activity level
On the Post-Program Survey:
1. Question #2 (assessing the frequency and impact of falls) has
been enhanced to include the location of the fall(s) and further assess
impact
2. Questions #6 and #7 have been modified slightly--removing
references to home modifications and activity level. Home modifications
and activity level are now addressed in questions #8 and #9 instead.
Estimated Annualized Burden Hours
The proposed Falls Prevention Data Collection Tools can be found at
ACL's Web site 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.
[[Page 46065]]
----------------------------------------------------------------------------------------------------------------
Average
Number of time per Total
Type of respondent Form name Estimated number of responses per response 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....... 46 data entry staff..... Once per .50 700
program x 1400
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 983..................... 1.............. .10 983
Survey.
----------------------------------------------------------------------------------
Total Burden Hours....... ................ ........................ ............... ......... 4,345
----------------------------------------------------------------------------------------------------------------
Dated: September 20, 2017.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2017-21179 Filed 10-2-17; 8:45 am]
BILLING CODE 4154-01-P
