Agency Information Collection Activities; Proposed Collection; Comment Request; Data Collection Materials for the Annual Performance Reporting of the Administration for Community Living's American Indian, Alaskan Natives and Native Hawaiian Programs, 7379-7381 [2019-03847]
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Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
Zika virus disease and Zika virus
congenital infection are nationally
notifiable conditions for which the
Council of State and Territorial
Epidemiologists (CSTE) has established
interim case definitions. All 50 states,
the District of Columbia, and Puerto
Rico, the U.S. Virgin Islands, American
Samoa, Guam, and the Northern
Mariana Islands currently participate in
reporting of arboviral diseases through
ArboNET. However, ArboNET does not
capture all the information needed to
provide timely situational awareness in
the context of the ongoing public health
response. In particular, ArboNET
collects limited data on pregnancy,
pregnancy and birth outcomes, and
congenital infections, all of which are
necessary for informing ongoing
response efforts.
As part of the public health response
to the Zika virus disease outbreak, CDC
will conduct supplemental surveillance
of antenatal diagnostic testing and
clinical outcomes among pregnant
women with laboratory evidence of Zika
virus or unspecified flavivirus infection
and their infants through the U.S. Zika
increase, and sexual transmission from
male travelers to their sex partners in
the United States will likely continue to
occur. In addition, mosquito-borne local
transmission may occur in states where
Aedes species mosquitoes are present.
In some Brazilian states where Zika
virus transmission has occurred, there
has been an increase in cases of infants
born with microcephaly. Zika virus
infections have been confirmed in
several infants with microcephaly and
in fetal losses in women infected during
pregnancy. In addition to microcephaly,
a range of other problems have been
detected among fetuses and infants
infected with Zika virus before birth,
such as absent or poorly developed
brain structures, defects of the eye,
hearing deficits, and impaired growth.
The Ministry of Health in Brazil, with
support from the Pan American Health
Organization (PAHO), the U.S. Centers
for Disease Control and Prevention
(CDC), and other partners, is
investigating the association between
Zika virus infection and microcephaly,
as well as other adverse pregnancy and
infant outcomes.
Pregnancy Registry. It is anticipated that
the Registry will provide critical
information to direct CDC clinical
recommendations and public health
guidance and messages.
The data to be collected for the
Registry includes information about
Zika infection-related tests and
procedures conducted as part of the
mother’s and child’s routine clinical
care, and in line with existing CDC,
American College of Obstetricians and
Gynecologists and Society of Maternal
Fetal Medicine, and American Academy
of Pediatrics recommendations for
evaluation, diagnosis, and follow-up of
women infected with Zika virus during
pregnancy and their children. No
additional tests or procedures will be
performed specifically for Registry
purposes.
This request is submitted to extend
the collection period of collection OMB
number 0920–1143 for an additional
three years. The total estimated annual
burden hours are 23,833. There are no
costs to the respondents other than their
time.
ESTIMATES OF ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Form
name
State, Territorial and Local Health
Departments.
Maternal Health History Form ..........
1,100
10
30/60
5,500
Supplemental Imaging Form ............
Laboratory Results Form .................
Assessment at Delivery Form ..........
Infant Health Follow-Up Form ..........
1,100
1,100
1,100
1,100
10
10
10
30
10/60
15/60
30/60
15/60
1,833
2,750
5,500
8,250
...........................................................
........................
........................
........................
23,833
Clinicians and Other Providers .........
Total ...............................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–03775 Filed 3–1–19; 8:45 am]
BILLING CODE 4163–18–P
Number of
respondents
Number of
responses per
respondent
Type of respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
[OMB #0985–0059]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data Collection
Materials for the Annual Performance
Reporting of the Administration for
Community Living’s American Indian,
Alaskan Natives and Native Hawaiian
Programs
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
SUMMARY:
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Total
burden hours
Office of Management and Budget
(OMB) for review and clearance as
required under Paperwork Reduction
Act of 1995. This 30-Day notice collects
comments on the information collection
requirements related to the Revision of
a Currently Approved Collection (ICR
Rev) and solicits comments on the
information collection requirements
related to the annual Program
Performance Report (PPR) for the
American Indian, Alaskan Natives and
Native Hawaiian Programs under Title
VI of the Older Americans Act.
DATES: Submit written comments on the
collection of information by April 3,
2019.
Submit written comments
on the collection of information by:
(a) Email to: OIRA_submission@
omb.eop.gov, Attn: OMB Desk Officer
for ACL;
ADDRESSES:
E:\FR\FM\04MRN1.SGM
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Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
(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:
Kristen Hudgins, Social Science
Analyst, Administration for Community
Living, Washington, DC 20201, 202–
795–7732 or kristen.hudgins@
acl.hhs.gov.
In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. The data
collection materials for the annual
performance data for the Administration
for Community Living’s American
Indian, Alaskan Natives and Native
Hawaiian Programs (OAA Title VI) is a
revision of a currently approved annual
program performance data collection
SUPPLEMENTARY INFORMATION:
(OMB# 0985–0059). These data
collection materials have been updated
to better align with comparable data
collected for ACL’s other nutritional,
supportive, and caregiving grants.
Proposed changes include adding data
components and updating others for
more accurate reporting of persons
served and activities provided through
the Title VI-funded programs. The
revised data collection will provide data
necessary to determine the effectiveness
of the program. Some examples of these
changes are updating definitions in Title
VI to be more in line with Title III,
asking for unduplicated numbers of
people served for different services and
the number of hours spent providing
said services. Additionally, the
caregiver portion of the PPR has been
updated to collect more information
around types of caregivers served and
unduplicated numbers of caregivers.
Another element added has to do with
information on expenditures. This data
collection will also support ACL in
tracking performance outcomes and
Topic/issue
efficiency measures with respect to the
annual and long-term performance
targets established in compliance with
the Government Performance Results
Modernization Act (GPRAMA).
Comments in Response to the 60-Day
Federal Register Notice
A notice was published in the Federal
Register on August 15, 2018, Vol. 83,
No. 158, pp. 40519–40520. ACL
received comments from ten (10)
organizations and two (2) individuals
about the Program Performance Report
(PPR) redesign. ACL reviewed all of the
comments. However, some of the
comments were deemed to not be
relevant because they were: (a) About
the data submission process itself; (b)
did not request a change; (c) only
related to format; or (d) indicated topics
for technical assistance and training for
the final data collection. For ease of
review, the remaining comments and
their responses have been grouped by
topic or issue. The ACL responses for
each topic/issue are detailed below:
Comment
ACL response
Additional comment boxes
for story telling.
One of the comments was to include a comment box to
the PPR to allow for programs to better share their
stories.
Additional data reporting ......
There were some concerns expressed around having
to keep track of and report additional data.
‘‘Tribal Organization’’ ...........
There was a suggestion posited by two organizations to
change the term ‘‘Tribal Organization’’ to something
more encompassing.
Staffing/Volunteers ...............
Five organizations commented that they found the
prospect of collecting data on volunteers and their
hours to be an unnecessary reporting burden.
There was one comment noting that there were too
many questions around nutrition education and counseling.
ACL has added a comment box at the end of the PPR
for program staff to share contextual information
about how their program is addressing the needs of
Elders in their community.
Although ACL understands that reporting can be a burdensome process, having better and richer data is a
priority for the Title VI program, particularly where it
allows us to align with the data collection for Title III.
ACL has decided to use the term ‘‘Grantee Name’’ to
be more inclusive of tribal consortia, Native Hawaiian
organizations, and other entities that did not feel covered under the previous term of ‘‘Tribal Organization’’.
Upon consideration of the issues brought up through
the FRN comments, ACL has decided to remove the
question on volunteers and volunteer hours.
ACL understands that reporting can be a burdensome
process and so have updated the questions under
‘‘Other Nutrition Services’’ to only ask one additional
question regarding number of persons receiving nutrition counseling. In keeping with Title III’s SPR we
have updated Nutrition Education hours to ‘‘sessions’’.
ACL has decided to remove this question from the PPR
and will consider posing it to grantees through a different data collection source at a later date.
ACL will not add an ombudsman question back into the
Title VI PPR as official ombudsman services should
be reported through the State Ombudsman and collected in the NORS tool. However, ACL has decided
to add in a question related to visiting nursing homes
and other assisted living facilities as we agree that
these activities are important to capture.
ACL has decided to add an optional text box for programs to share other supportive services they may
offer that are not currently listed.
ACL appreciates the suggestion to collect more data
but has decided in the interest of balancing data collection and burden to not make the distinction between the different ‘‘types’’ of transportation provided
by a program.
Nutrition Questions ..............
Meal Mileage ........................
Ombudsman .........................
There were many comments (both positive and asking
for clarification) related to a proposed question
around home-delivered meal mileage.
Removal of the ombudsman question ............................
Other Supportive Services ...
Suggestions to add space for grantees to report on the
types of supportive services they provide.
Transportation ......................
Suggestions to split transportation into assisted and unassisted as they are in Title III’s SPR.
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Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
Topic/issue
Comment
ACL response
Social Events .......................
Question about the purpose of ‘‘social events held’’ and
whether it would be better to change to ‘‘social/recreation events held’’ to allow cost sharing with Title III.
The comments on the newly added finance section for
Part A/B were varied and ran from asking that the
question be removed and others asking for more options to share data.
Title III does not ask for this information. A social event,
as it is being defined in Title VI, can be recorded as
‘‘Other’’ in SPR.
ACL is sensitive to the burden that may be caused by
asking for new kinds of information from our grantees, we find that requiring this information will allow
us to better advocate for our programs and their financial needs. Based on the comments ACL has
added an optional text box for grantees to explain
more about their financial situations, and has also
added additional options under the section asking for
types of funding used.
ACL has updated the language in this section to be
less wordy and using the term ‘‘caregiver’’ rather
than ‘‘persons’’ to make it clearer that the intended
recipients of services are caregivers and not those
they care for.
ACL has chosen to maintain consistency in this area
with Title III’s SPR and will ensure that training and
technical materials make it clear how we are defining
Information and Assistance and how to best collect it.
ACL is sensitive to the burden that may be caused by
asking for new kinds of information from our grantees, we find that requiring this information will allow
us to better advocate for our programs and their financial needs. ACL chose respite care from the five
required services based on the thinking that the cost
of this service would be easier to track.
Finance Section for Part A/B
Caregiver (language) ...........
Suggestions to change some of the language in the
caregiver section to make it clearer.
Caregiver (Information and
Assistance).
There were a couple of suggestions that Information
and Assistance should be separated from one another.
Finance Section for Part C ..
Suggestion to not add the finance section and asking
for the cost of respite care to be pulled out.
The proposed form(s) may be found
on the ACL website at https://
www.acl.gov/about-acl/public-input.
Estimated Program Burden
Title VI funding is broken into three
categories. Parts A and B are for
nutritional and supportive
programming, and ask for the same
information. Part A is for American
Indian and Alaska Native grantees, and
Part B is for Native Hawaiian grantees.
Part C is for caregiver programming. All
Part C grantees must have Part A/B
funding; but not all Part A/B grantees
will have Part C programs. Therefore,
Number of
respondents
Respondent/data collection activity
there are 270 unique respondents, but
only 237 will have to complete all
portions of the PPR. ACL believes that
the increase in burden hours is justified
by the improved quality of the data and
will ultimately improve the services
provided to Native Elders.
Responses
per
respondent
Hours per
response
Annual burden
hours
PPR Part A/B ...................................................................................................
PPR Part C ......................................................................................................
270
237
1
1
1.83
1.66
494.1
393.4
Total ..........................................................................................................
........................
........................
........................
887.5
Dated: February 22, 2019.
Mary Lazare,
Principal Deputy Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–03847 Filed 3–1–19; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2018–N–3490]
BILLING CODE 4154–01–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exempt Infant
Formula Production: Current Good
Manufacturing Practices, Quality
Control Procedures, Conduct of
Audits, and Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
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that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by April 3,
2019.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0811. Also
include the FDA docket number found
ADDRESSES:
E:\FR\FM\04MRN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7379-7381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
[OMB #0985-0059]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Data Collection Materials for the Annual Performance
Reporting of the Administration for Community Living's American Indian,
Alaskan Natives and Native Hawaiian Programs
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 Paperwork Reduction Act of 1995. This 30-Day notice
collects comments on the information collection requirements related to
the Revision of a Currently Approved Collection (ICR Rev) and solicits
comments on the information collection requirements related to the
annual Program Performance Report (PPR) for the American Indian,
Alaskan Natives and Native Hawaiian Programs under Title VI of the
Older Americans Act.
DATES: Submit written comments on the collection of information by
April 3, 2019.
ADDRESSES: Submit written comments on the collection of information by:
(a) Email to: OIRA_submission@omb.eop.gov, Attn: OMB Desk Officer for
ACL;
[[Page 7380]]
(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: Kristen Hudgins, Social Science
Analyst, Administration for Community Living, Washington, DC 20201,
202-795-7732 or kristen.hudgins@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has
submitted the following proposed collection of information to OMB for
review and clearance. The data collection materials for the annual
performance data for the Administration for Community Living's American
Indian, Alaskan Natives and Native Hawaiian Programs (OAA Title VI) is
a revision of a currently approved annual program performance data
collection (OMB# 0985-0059). These data collection materials have been
updated to better align with comparable data collected for ACL's other
nutritional, supportive, and caregiving grants. Proposed changes
include adding data components and updating others for more accurate
reporting of persons served and activities provided through the Title
VI-funded programs. The revised data collection will provide data
necessary to determine the effectiveness of the program. Some examples
of these changes are updating definitions in Title VI to be more in
line with Title III, asking for unduplicated numbers of people served
for different services and the number of hours spent providing said
services. Additionally, the caregiver portion of the PPR has been
updated to collect more information around types of caregivers served
and unduplicated numbers of caregivers. Another element added has to do
with information on expenditures. This data collection will also
support ACL in tracking performance outcomes and efficiency measures
with respect to the annual and long-term performance targets
established in compliance with the Government Performance Results
Modernization Act (GPRAMA).
Comments in Response to the 60-Day Federal Register Notice
A notice was published in the Federal Register on August 15, 2018,
Vol. 83, No. 158, pp. 40519-40520. ACL received comments from ten (10)
organizations and two (2) individuals about the Program Performance
Report (PPR) redesign. ACL reviewed all of the comments. However, some
of the comments were deemed to not be relevant because they were: (a)
About the data submission process itself; (b) did not request a change;
(c) only related to format; or (d) indicated topics for technical
assistance and training for the final data collection. For ease of
review, the remaining comments and their responses have been grouped by
topic or issue. The ACL responses for each topic/issue are detailed
below:
------------------------------------------------------------------------
Topic/issue Comment ACL response
------------------------------------------------------------------------
Additional comment boxes for One of the comments ACL has added a
story telling. was to include a comment box at the
comment box to the end of the PPR for
PPR to allow for program staff to
programs to better share contextual
share their stories. information about
how their program
is addressing the
needs of Elders in
their community.
Additional data reporting... There were some Although ACL
concerns expressed understands that
around having to reporting can be a
keep track of and burdensome process,
report additional having better and
data. richer data is a
priority for the
Title VI program,
particularly where
it allows us to
align with the data
collection for
Title III.
``Tribal Organization''..... There was a ACL has decided to
suggestion posited use the term
by two ``Grantee Name'' to
organizations to be more inclusive
change the term of tribal
``Tribal consortia, Native
Organization'' to Hawaiian
something more organizations, and
encompassing. other entities that
did not feel
covered under the
previous term of
``Tribal
Organization''.
Staffing/Volunteers......... Five organizations Upon consideration
commented that they of the issues
found the prospect brought up through
of collecting data the FRN comments,
on volunteers and ACL has decided to
their hours to be remove the question
an unnecessary on volunteers and
reporting burden. volunteer hours.
Nutrition Questions......... There was one ACL understands that
comment noting that reporting can be a
there were too many burdensome process
questions around and so have updated
nutrition education the questions under
and counseling. ``Other Nutrition
Services'' to only
ask one additional
question regarding
number of persons
receiving nutrition
counseling. In
keeping with Title
III's SPR we have
updated Nutrition
Education hours to
``sessions''.
Meal Mileage................ There were many ACL has decided to
comments (both remove this
positive and asking question from the
for clarification) PPR and will
related to a consider posing it
proposed question to grantees through
around home- a different data
delivered meal collection source
mileage. at a later date.
Ombudsman................... Removal of the ACL will not add an
ombudsman question. ombudsman question
back into the Title
VI PPR as official
ombudsman services
should be reported
through the State
Ombudsman and
collected in the
NORS tool. However,
ACL has decided to
add in a question
related to visiting
nursing homes and
other assisted
living facilities
as we agree that
these activities
are important to
capture.
Other Supportive Services... Suggestions to add ACL has decided to
space for grantees add an optional
to report on the text box for
types of supportive programs to share
services they other supportive
provide. services they may
offer that are not
currently listed.
Transportation.............. Suggestions to split ACL appreciates the
transportation into suggestion to
assisted and collect more data
unassisted as they but has decided in
are in Title III's the interest of
SPR. balancing data
collection and
burden to not make
the distinction
between the
different ``types''
of transportation
provided by a
program.
[[Page 7381]]
Social Events............... Question about the Title III does not
purpose of ``social ask for this
events held'' and information. A
whether it would be social event, as it
better to change to is being defined in
``social/recreation Title VI, can be
events held'' to recorded as
allow cost sharing ``Other'' in SPR.
with Title III.
Finance Section for Part A/B The comments on the ACL is sensitive to
newly added finance the burden that may
section for Part A/ be caused by asking
B were varied and for new kinds of
ran from asking information from
that the question our grantees, we
be removed and find that requiring
others asking for this information
more options to will allow us to
share data. better advocate for
our programs and
their financial
needs. Based on the
comments ACL has
added an optional
text box for
grantees to explain
more about their
financial
situations, and has
also added
additional options
under the section
asking for types of
funding used.
Caregiver (language)........ Suggestions to ACL has updated the
change some of the language in this
language in the section to be less
caregiver section wordy and using the
to make it clearer. term ``caregiver''
rather than
``persons'' to make
it clearer that the
intended recipients
of services are
caregivers and not
those they care
for.
Caregiver (Information and There were a couple ACL has chosen to
Assistance). of suggestions that maintain
Information and consistency in this
Assistance should area with Title
be separated from III's SPR and will
one another. ensure that
training and
technical materials
make it clear how
we are defining
Information and
Assistance and how
to best collect it.
Finance Section for Part C.. Suggestion to not ACL is sensitive to
add the finance the burden that may
section and asking be caused by asking
for the cost of for new kinds of
respite care to be information from
pulled out. our grantees, we
find that requiring
this information
will allow us to
better advocate for
our programs and
their financial
needs. ACL chose
respite care from
the five required
services based on
the thinking that
the cost of this
service would be
easier to track.
------------------------------------------------------------------------
The proposed form(s) may be found on the ACL website at https://www.acl.gov/about-acl/public-input.
Estimated Program Burden
Title VI funding is broken into three categories. Parts A and B are
for nutritional and supportive programming, and ask for the same
information. Part A is for American Indian and Alaska Native grantees,
and Part B is for Native Hawaiian grantees. Part C is for caregiver
programming. All Part C grantees must have Part A/B funding; but not
all Part A/B grantees will have Part C programs. Therefore, there are
270 unique respondents, but only 237 will have to complete all portions
of the PPR. ACL believes that the increase in burden hours is justified
by the improved quality of the data and will ultimately improve the
services provided to Native Elders.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
PPR Part A/B.................................... 270 1 1.83 494.1
PPR Part C...................................... 237 1 1.66 393.4
---------------------------------------------------------------
Total....................................... .............. .............. .............. 887.5
----------------------------------------------------------------------------------------------------------------
Dated: February 22, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019-03847 Filed 3-1-19; 8:45 am]
BILLING CODE 4154-01-P
