Agency Information Collection Activities; Submission for OMB Review; Comment Request; Redesign of Existing Data Collection; National Longitudinal Survey of Older Americans Act Participants (NLSOAAP), 7189-7191 [2018-03390]
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7189
Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
for the Approval of Respirators (SAF),
currently Version 9.
Respirator manufacturers are the
respondents (estimated to average 73
each year over the years 2017–2020).
Upon submission of the SAF, NIOSH
evaluates their applications for
approval. Respirator manufacturers
submit applications according to their
business needs, which depends upon
market conditions, technical advances,
and other factors that are not easy to
forecast. The best estimate for the
annual number of respondents is the
number from the most recent year for
which data exists, 73 in 2016, an
increase from 63 in 2014. Those 73
applicants submitted 542 applications
in 2016, providing the current best
estimate. A $200 fee is required for each
application. Respondents requesting
respirator approval or certain extensions
of approval are required to submit
additional fees for necessary testing and
evaluation as specified in 42 CFR parts
84.20–22, 84.66, 84.258 and 84.1102. In
2016, $2,662,329.00 was accepted.
Applicants are required to provide
test data that shows that the
manufacturer is capable of ensuring that
the respirator is capable of meeting the
specified requirements in 42 CFR part
84. The requirement for submitted test
data is likely to be satisfied by standard
testing performed by the manufacturer,
and is not required to follow the
relevant NIOSH Standard Test
Procedures. As additional testing is not
required, providing proof that an
adequate test has been performed is
limited to providing existing paperwork.
Manufacturers with current approvals
are subject to site audits by the Institute
or its agents. Audits may occur
periodically, typically every second
year, or because of a reported issue.
NIOSH completed 59 site audits from 92
respirator approval holders for the 2016
fiscal year. There is an average fee of
$8,833 for each audit to align with fee
collection provisions of the Independent
Offices Appropriations Act of 1952 (31
U.S.C. 9701), and OMB Circular A–25
Revised. There is no cost to respondents
other than the time to participate. The
total estimated burden hours are
118,435. Burden hours have increased
due to a moderate increase in the
estimated number of annual responses
per respondent.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Business or other for-profit .............................
Standard Application for the Approval of
Respirators.
Audit ...............................................................
Business or other for-profit .............................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–03385 Filed 2–16–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Redesign
of Existing Data Collection; National
Longitudinal Survey of Older
Americans Act Participants
(NLSOAAP)
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
that the proposed collection of
information listed below has been
submitted to the Office of Management
and Budget (OMB) for review and
clearance as required under the
Paperwork Reduction Act of 1995 (the
PRA). This 30-Day notice collects
comments on a proposed revision to an
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Jkt 244001
existing data collection related to the
National Survey of Older Americans Act
Participants (NSOAAP).
DATES: Submit written comments on the
collection of information by March 22,
2018.
ADDRESSES: Submit written comments
on the collection of information by fax
202–395–5806 or by email to OIRA_
submission@omb.eop.gov, Attn: OMB
Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT:
Heather Menne at 202–795–7733 or
Heather.Menne@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with Section 44 U.S.C.
3507, ACL has submitted the following
proposed collection of information to
OMB for review and clearance.
ACL is requesting approval for three
years for a redesign of an existing data
collection (OMB Control Number: 0985–
0023).
The National Longitudinal Survey of
Older Americans Act (OAA)
Participants (NLSOAAP) information
collection will include consumer
assessment surveys for the Congregate
and Home-delivered meal nutrition
programs; Case Management,
Homemaker, and Transportation
Services; and the National Family
Caregiver Support Program. This survey
builds on earlier national pilot studies
and surveys, as well as performance
PO 00000
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Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden
per response
(in hours)
73
7
229
59
1
24
measurement tools developed by ACL
grantees in the Performance Outcomes
Measures Project (POMP). Changes
identified as a result of these initiatives,
public comment, and the input from an
expert panel (i.e., comprised of
gerontologists, survey methodologists,
and OAA program experts), are
included in this proposed redesign of an
existing data collection. This
information will be used by ACL to
track performance outcome measures;
support budget requests; comply with
the GPRA Modernization Act of 2010
(GPRAMA) reporting requirements;
provide national benchmark
information; and inform program
development and management
initiatives.
This proposed collection is a revision
that will replace the currently approved
version (OMB Control Number: 0985–
0023) by transitioning from a crosssectional survey to a longitudinal
survey. The current National Survey of
Older Americans Act Participants
(NSOAAP), an exclusively crosssectional survey, can transition to a
longitudinal information collection
component by establishing a baseline
cohort and conducting follow-up
interviews with that cohort at specified
time intervals. A baseline cohort can be
selected in the same manner as in prior
cycles of the cross-sectional NSOAAP.
E:\FR\FM\20FEN1.SGM
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7190
Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
Area Agencies on Aging (AAAs) would
be selected with a probability
proportional to their size, with some
large AAAs sampled with certainty.
Random samples of clients within
each selected AAA will be sampled
from the agencies’ client lists. However,
in a change from current procedures, the
target sample size would be increased
from current standards (n = 6000) to
account for attrition of individuals over
time. For the duration of the
longitudinal cohort analysis, the same
sample of AAAs and clients should be
maintained to preserve the longitudinal
nature of the study. Three strategies are
key for transforming the current survey
into a longitudinal study, while
preserving the ability to produce
nationally representative cross-sectional
estimates of client characteristics at
each wave. The three strategies include:
(1) A higher initial sample size (n =
6600), (2) an intensive operational
campaign to keep track of respondents
over time, and (3) limiting the number
of waves for each cohort study (e.g.,
three waves are proposed).
Comments in Response to the 60 Day
Federal Register Notice
A 60-Day notice was published in the
Federal Register in Vol. 82, No. 185,
Pages 44800–44802, on September 26,
2017 announcing that ACL was
requesting approval of a proposed
redesign of an existing data collection
extension with modifications of a
currently approved data collection. ACL
received comments from sixty-four (64)
organizations and 15 individuals about
the Redesigned National Survey of
Older Americans Act Participants
(NSOAAP). ACL reviewed all of the
comments. Two (2) of the comments
were deemed not relevant. The first
referenced other data collections and
not the NSOAAP (i.e., Census), and the
other was commentary without
reference to the NSOAAP.
The majority of the comments that
ACL received requested improved
methodology for collecting gender
identity (e.g., adding questions to
understand gender identity/transgender
status). ACL plans to conduct cognitive
testing of questions in the redesigned
information collection tool, including
the gender question, to determine
whether the questions are interpreted as
intended. Based on the cognitive testing
of the information collection tool, ACL
will determine whether additional
changes are necessary. Other public
comments supported the: (a)
Longitudinal methodology; (b)
collection of data on sexual orientation;
(c) inclusion of a rotating module on
discrimination; and (d) limiting of
burden on the Area Agencies on Aging
(AAAs). Because these comments were
in support of the proposed information
collection, no response is needed.
Burden Estimates
Descriptions of previous National
Surveys of OAA Participants can be
found under the section on Performance
Outcomes on ACL’s website at: https://
www.acl.gov/programs/performanceolder-americans-act-programs. Copies
of the survey instruments and data from
previous National Surveys of OAA
Participants can be found and queried
using the AGing Integrated Database
(AGID) at https://agid.acl.gov/. The
proposed revisions for the National
Survey of Older Americans Act
Participants may be found on the ACL
website at: https://www.acl.gov/aboutacl/public-input.
The estimated average hour burden
per respondent for the Redesigned
NSOAAP will change from the 0.80
hour estimate in 2017 to 0.71 hours.
This decrease is due to the proposed
change of Area Agencies on Aging only
providing client lists once at the start of
the three years of data collection
(compared to annually in the current
cross-sectional data collection). ACL
estimates the burden of this revised
collection of information as follows:
TABLE—ESTIMATED ANNUALIZED BURDEN HOURS
Responses
per
respondent
Average
hours per
response
250
4,400
1 ..................
1 ..................
4.0 ...............
.6667 ...........
1,000
2,933
2,200
1 ..................
.6667 ...........
1,467
0
4,200
0 ..................
1 ..................
0 ..................
.6667 ...........
0
2,800
2,100
1 ..................
.6667 ...........
1,400
Area Agency on Aging: Respondent selection process .......................................
Service Recipients (i.e., Case Management; Congregate Nutrition; Home-delivered Nutrition; Homemaker; Transportation).
National Family Caregiver Support Program Clients ...........................................
0
4,000
0 ..................
1 ..................
0 ..................
.6667 ...........
0
2,667
2,000
1 ..................
.6667 ...........
1,333
Total ...............................................................................................................
19,150
Varies ..........
.710 (weighted mean).
13,600
Number of
respondents
Respondent/data collection activity
Annual burden
hours
Baseline
Area Agency on Aging: Respondent selection process .......................................
Service Recipients (i.e., Case Management; Congregate Nutrition; Home-delivered Nutrition; Homemaker; Transportation).
National Family Caregiver Support Program Clients ...........................................
Year 2
Area Agency on Aging: Respondent selection process .......................................
Service Recipients (i.e., Case Management; Congregate Nutrition; Home-delivered Nutrition; Homemaker; Transportation).
National Family Caregiver Support Program Clients ...........................................
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Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
Dated: February 13, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018–03390 Filed 2–16–18; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–1891]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PORTRAZZA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for PORTRAZZA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 23, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 20, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: 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 April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. 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.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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17:55 Feb 16, 2018
Jkt 244001
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
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–
2016–E–1891 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; PORTRAZZA.’’
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
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7191
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
E:\FR\FM\20FEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7189-7191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03390]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Redesign of Existing Data Collection; National
Longitudinal Survey of Older Americans Act Participants (NLSOAAP)
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing
that the proposed collection of information listed below has been
submitted to the Office of Management and Budget (OMB) for review and
clearance as required under the Paperwork Reduction Act of 1995 (the
PRA). This 30-Day notice collects comments on a proposed revision to an
existing data collection related to the National Survey of Older
Americans Act Participants (NSOAAP).
DATES: Submit written comments on the collection of information by
March 22, 2018.
ADDRESSES: Submit written comments on the collection of information by
fax 202-395-5806 or by email to [email protected], Attn: OMB
Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT: Heather Menne at 202-795-7733 or
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with Section 44 U.S.C. 3507,
ACL has submitted the following proposed collection of information to
OMB for review and clearance.
ACL is requesting approval for three years for a redesign of an
existing data collection (OMB Control Number: 0985-0023).
The National Longitudinal Survey of Older Americans Act (OAA)
Participants (NLSOAAP) information collection will include consumer
assessment surveys for the Congregate and Home-delivered meal nutrition
programs; Case Management, Homemaker, and Transportation Services; and
the National Family Caregiver Support Program. This survey builds on
earlier national pilot studies and surveys, as well as performance
measurement tools developed by ACL grantees in the Performance Outcomes
Measures Project (POMP). Changes identified as a result of these
initiatives, public comment, and the input from an expert panel (i.e.,
comprised of gerontologists, survey methodologists, and OAA program
experts), are included in this proposed redesign of an existing data
collection. This information will be used by ACL to track performance
outcome measures; support budget requests; comply with the GPRA
Modernization Act of 2010 (GPRAMA) reporting requirements; provide
national benchmark information; and inform program development and
management initiatives.
This proposed collection is a revision that will replace the
currently approved version (OMB Control Number: 0985-0023) by
transitioning from a cross-sectional survey to a longitudinal survey.
The current National Survey of Older Americans Act Participants
(NSOAAP), an exclusively cross-sectional survey, can transition to a
longitudinal information collection component by establishing a
baseline cohort and conducting follow-up interviews with that cohort at
specified time intervals. A baseline cohort can be selected in the same
manner as in prior cycles of the cross-sectional NSOAAP.
[[Page 7190]]
Area Agencies on Aging (AAAs) would be selected with a probability
proportional to their size, with some large AAAs sampled with
certainty.
Random samples of clients within each selected AAA will be sampled
from the agencies' client lists. However, in a change from current
procedures, the target sample size would be increased from current
standards (n = 6000) to account for attrition of individuals over time.
For the duration of the longitudinal cohort analysis, the same sample
of AAAs and clients should be maintained to preserve the longitudinal
nature of the study. Three strategies are key for transforming the
current survey into a longitudinal study, while preserving the ability
to produce nationally representative cross-sectional estimates of
client characteristics at each wave. The three strategies include: (1)
A higher initial sample size (n = 6600), (2) an intensive operational
campaign to keep track of respondents over time, and (3) limiting the
number of waves for each cohort study (e.g., three waves are proposed).
Comments in Response to the 60 Day Federal Register Notice
A 60-Day notice was published in the Federal Register in Vol. 82,
No. 185, Pages 44800-44802, on September 26, 2017 announcing that ACL
was requesting approval of a proposed redesign of an existing data
collection extension with modifications of a currently approved data
collection. ACL received comments from sixty-four (64) organizations
and 15 individuals about the Redesigned National Survey of Older
Americans Act Participants (NSOAAP). ACL reviewed all of the comments.
Two (2) of the comments were deemed not relevant. The first referenced
other data collections and not the NSOAAP (i.e., Census), and the other
was commentary without reference to the NSOAAP.
The majority of the comments that ACL received requested improved
methodology for collecting gender identity (e.g., adding questions to
understand gender identity/transgender status). ACL plans to conduct
cognitive testing of questions in the redesigned information collection
tool, including the gender question, to determine whether the questions
are interpreted as intended. Based on the cognitive testing of the
information collection tool, ACL will determine whether additional
changes are necessary. Other public comments supported the: (a)
Longitudinal methodology; (b) collection of data on sexual orientation;
(c) inclusion of a rotating module on discrimination; and (d) limiting
of burden on the Area Agencies on Aging (AAAs). Because these comments
were in support of the proposed information collection, no response is
needed.
Burden Estimates
Descriptions of previous National Surveys of OAA Participants can
be found under the section on Performance Outcomes on ACL's website at:
https://www.acl.gov/programs/performance-older-americans-act-programs.
Copies of the survey instruments and data from previous National
Surveys of OAA Participants can be found and queried using the AGing
Integrated Database (AGID) at https://agid.acl.gov/. The proposed
revisions for the National Survey of Older Americans Act Participants
may be found on the ACL website at: https://www.acl.gov/about-acl/public-input.
The estimated average hour burden per respondent for the Redesigned
NSOAAP will change from the 0.80 hour estimate in 2017 to 0.71 hours.
This decrease is due to the proposed change of Area Agencies on Aging
only providing client lists once at the start of the three years of
data collection (compared to annually in the current cross-sectional
data collection). ACL estimates the burden of this revised collection
of information as follows:
Table--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Respondent/data collection Number of Responses per Average hours per Annual burden
activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Baseline
----------------------------------------------------------------------------------------------------------------
Area Agency on Aging: Respondent 250 1.................... 4.0.................. 1,000
selection process.
Service Recipients (i.e., Case 4,400 1.................... .6667................ 2,933
Management; Congregate Nutrition;
Home-delivered Nutrition;
Homemaker; Transportation).
National Family Caregiver Support 2,200 1.................... .6667................ 1,467
Program Clients.
----------------------------------------------------------------------------------------------------------------
Year 2
----------------------------------------------------------------------------------------------------------------
Area Agency on Aging: Respondent 0 0.................... 0.................... 0
selection process.
Service Recipients (i.e., Case 4,200 1.................... .6667................ 2,800
Management; Congregate Nutrition;
Home-delivered Nutrition;
Homemaker; Transportation).
National Family Caregiver Support 2,100 1.................... .6667................ 1,400
Program Clients.
----------------------------------------------------------------------------------------------------------------
Year 3
----------------------------------------------------------------------------------------------------------------
Area Agency on Aging: Respondent 0 0.................... 0.................... 0
selection process.
Service Recipients (i.e., Case 4,000 1.................... .6667................ 2,667
Management; Congregate Nutrition;
Home-delivered Nutrition;
Homemaker; Transportation).
National Family Caregiver Support 2,000 1.................... .6667................ 1,333
Program Clients.
-----------------------------------------------------------------------------
Total......................... 19,150 Varies............... .710 (weighted mean). 13,600
----------------------------------------------------------------------------------------------------------------
[[Page 7191]]
Dated: February 13, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018-03390 Filed 2-16-18; 8:45 am]
BILLING CODE 4154-01-P
