Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Traumatic Brain Injury (TBI) State Partnership Program, OMB approval number 0985-NEW, 6198-6201 [2020-02091]
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing
OPREinfocollection@acf.hhs.gov.
Alternatively, copies can also be
obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: NSCAW is the only
source of nationally representative,
longitudinal, firsthand information
about the functioning and well-being,
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; National Survey of Child and
Adolescent Well-Being-Third Cohort
(NSCAW III) (OMB #0970–0202)
Office of Planning, Research,
and Evaluation; Administration for
Children and Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), within the
U.S. Department of Health and Human
Services (HHS), is proposing to collect
data on the child welfare workforce as
part of the third cohort of children and
families for the National Survey of Child
and Adolescent Well-Being (NSCAW
III). Previous and current data
collections for NSCAW have been
approved by OMB under OMB #0970–
0202. This request is for additional data
collection.
SUMMARY:
service needs, and service utilization of
children and families who come to the
attention of the child welfare system.
OMB previously approved data
collection under OMB Control Number
0970–0202 for NSCAW. The Phase I
submission, approved November 2016,
included recruitment and sampling
process data collection activities. The
Phase II submission, approved July
2017, included baseline and 18-month
follow-up data collection activities.
The proposed new data collection
activities will provide national
representative data on the
characteristics and activities of the
workforce in child welfare agencies
participating in NSCAW III. Surveys
will collect information on workforce
characteristics and competencies,
training and professional development
opportunities, and organizational and
agency factors.
Respondents: The respondents are
agency directors, supervisors, and
caseworkers. All surveys will be
conducted in-person.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
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Agency Director Survey .......................................................
Supervisor Survey ................................................................
Caseworker Survey ..............................................................
Estimated Total Annual Burden
Hours: 129.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 628b; Continuing
Appropriations Act of 2020.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–02075 Filed 2–3–20; 8:45 am]
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Annual
number of
respondents
65
130
390
22
43
130
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Submission for OMB
Review; Public Comment Request;
Traumatic Brain Injury (TBI) State
Partnership Program, OMB approval
number 0985–NEW
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) 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 the
Paperwork Reduction Act of 1995. This
30-Day notice collects comments on the
information collection requirements
related to Proposed New information
collection requirements related to the
Traumatic Brain Injury (TBI) State
Partnership Program.
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
Average
burden hours
per response
Annual
burden hours
.42
.50
.75
9
22
98
Submit written comments on the
collection of information by March 5,
2020.
DATES:
Submit electronic
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:
Dana Fink, Administration for
Community Living, Washington, DC
20201, (202) 795–7604, or dana.fink@
acl.hhs.gov.
ADDRESSES:
In
compliance with the Paperwork
Reduction Act, ACL has submitted the
following proposed new information
collection to OMB for review and
clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
The purpose of the federal Traumatic
Brain Injury (TBI) State Partnership
Program is to create and strengthen a
system of services and supports that
maximizes the independence, wellbeing, and health of people with TBIs
across the lifespan and all other
demographics, their family members,
and support networks. The TBI State
Partnership Program funds the
development and implementation of
statewide systems that ensure access to
TBI related services, including
transitional services, rehabilitation,
education and employment, and longterm community support. To best
monitor, guide, and support TBI State
Partnership Program grantees, ACL
needs regular information about the
grantees’ activities and outcomes. The
simplest, least burdensome and most
useful way to accomplish this goal is to
require grantees to submit information
as part of their required semiannual
reports via the proposed electronic data
submission instrument.
In 1996, the Public Health Service Act
was amended ‘‘to provide for the
conduct of expanded studies and the
establishment of innovative programs
with respect to traumatic brain injury,
and for other purposes’’ (Pub. L. 104–
166). This legislation allowed for the
implementation of ‘‘grants to States for
the purpose of carrying out
demonstration projects to improve
access to health and other services
regarding traumatic brain injury.’’ The
TBI Reauthorization Act of 2014 (Pub. L.
113–196) allowed the Department of
Health and Human Services Secretary to
review oversight of the federal TBI
programs (TBI State Partnership Grant
program and the TBI Protection and
Advocacy program) and reconsider
which operating division should lead
them. With avid support from TBI
stakeholders, the Secretary found that
the goals of the federal TBI programs
closely align with ACL’s mission to
advance policy and implement
programs that support the rights of older
Americans and people with disabilities
to live in their communities. As a result,
on Oct. 1, 2015, the federal TBI
programs moved from the Health
Resources and Services Administration
to ACL. These programs were
reauthorized again by the Traumatic
Brain Injury Reauthorization Act of
2018 (Pub. L. 115–377).
The proposed performance measures
assess progress toward surmounting the
four commonly recognized barriers to
accessing care for people with TBI:
(1) A lack of information about
available services and supports with
little or no assistance in accessing them
(information and referral services);
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(2) A shortage of health professionals
who may encounter individuals with
TBI but lack relevant training to identify
or treat the resulting symptoms
(professional training);
(3) The absence of a TBI diagnosis or
the assignment of an incorrect diagnosis
(screening); and (4) Critical TBI services
are spread across numerous agencies
resulting in services being difficult for
individuals and families to identify and
navigate (resource facilitation).
The proposed performance measures
are designed to account for the varied
approaches used across state grantees
and are consistent with the TBI State
Partnership Program’s purpose and
ACL’s mission.
Comments in Response to the 60–Day
Federal Register Notice
ACL published a 60-day Federal
Register Notice from 11/13/2017–01/12/
2018 (Vol. 82, No. 217 pp. 52305–
52306). ACL received a large volume of
substantive stakeholder comments,
causing revisions to the IC based on
those public comments. The period in
publication between the 60-day FRN
and 30-day FRN, allowed ACL to
thoughtfully review and apply the
significant number of substantive public
comments to the proposed new TBI IC.
In response to the original Federal
Register notice in 2018, twenty-three
(23) individuals provided written
comments in response to the Federal
Register notice containing the original
proposed TBI Performance Measures,
presented in the form of a reporting
instrument for future TBI grantees.
Commenters provided feedback on
specific reporting instrument questions
as well as general suggestions and
recommendations for ACL about what
grantees should report.
• 268 separate comments were made
about one or more specific survey
questions.
• 102 separate comments asked for a
definition, further guidance, or
clarification with regard to terminology
used.
• 81 comments made a general
recommendation, not specific to a
particular question.
ACL also received feedback in 2018
through multiple face-to-face
interactions with a majority of the
current TBI grantees regarding the
proposed measures.
ACL revised the instrument in 2019,
in order to remain compliant with PRA
5 CFR 1320.8(d), ACL published an
abbreviated public comment period
prior to publishing the 30-day FRN and
submitting to OMB. ACL solicited
comments during the abbreviated public
comment period regarding: (1) The
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accuracy of ACL’s revised estimate of
the burden for the proposed collection
of information performance reporting
data elements and (2) whether the
proposed revisions to the collection of
information enhance the quality, utility,
and clarity of the information to be
collected.
During the abbreviated public
comment period published in the 83 FR
53738 received 14 additional comments.
These comments have been addressed
largely through the addition of
definitions and guidance. The tool has
been simplified, some questions have
been eliminated or simplified because of
concern about the burden, and three
open-ended narrative questions added.
The most prevalent comments and
themes emerging from the public
comments are summarized below:
Intended scope of the questions: The
suggestion that occurred most across all
commenters was for ACL to better
define the scope of the questions. Many
commenters asked whether ACL
expected grantees to limit their
reporting to their own grant activities,
the staff they train with the grant funds,
and the people with TBI they interact
with using grant funds or if they would
be expected to report about activities
going on in the state beyond their grant
activities. Commenters raised the issue
of intended scope in general and
specifically about almost all the
questions in the instrument. Several
commenters noted that the grants were
awarded to different types of state
agencies in different states and the
reporting instrument did not make clear
what ACL meant by the term ‘‘TBI
System,’’ which could be interpreted to
mean different things such as: The
Medicaid system, the criminal justice
system, the educational system, the
vocational rehabilitation system, the
broader medical system, or all of these
together. Many indicated that grantees
would have limited or no access to data
about activities or people supported
outside the grant activities being
conducted by their own partnering
organizations.
Response and Changes to Instrument:
ACL intends for TBI grantees to report
only about their own grant activities, the
staff they train using grant funds, the
partners they work with, and the people
affected by TBI they interact with using
grant funds. Additional guidance and
definitions will be added to the online
version of the instrument to clarify this
intent and provide more guidance for
grantees operating in different systems.
For example:
(1) If a grantee is using grant funds to
serve people with TBI within the
criminal justice system statewide, the
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scope of their reporting will be limited
to the statewide criminal justice system.
(2) If a grantee is using their grant
funds to assist people interacting with
the vocational rehabilitation system in
one region of the state, the scope of their
reporting will be limited to that region’s
vocational rehabilitation system.
(3) If grant funds are going to several
partnering organizations to work with
people with TBI, the scope of that
grantee’s reporting will include the
grant-funded activities of all of those
partnering organizations (to the extent
possible).
In addition, ACL added some new
structured and open-ended questions to
the instrument to allow grantees to
identify their main areas of focus and
describe report full or partial data from
across their partners depending on what
they can access.
Purpose of performance measures and
accounting for state and grantee
differences: Several commenters
indicated they thought the instrument
did not adequately account for the
differences in how state systems are
structured and the different focus areas
of different grantees. Several
commenters expressed concern that
individual grantees would be negatively
evaluated. Specific questions were
edited to allow for grantees that are not
able to provide data about activities and
people outside of the scope of their
grants or are otherwise not able to
respond to every question.
Response and Changes to Instrument:
ACL does not intend to use this
reporting instrument to score grantees’
individual performance or to compare
grantees’ performance with one another.
ACL’s intent is to gather a standard set
of information from all grantee states, so
that it can be aggregated to provide a
better picture of the national impact of
the grant program. However, ACL
understands that states are working
within different systems and focusing
on different activities and that states’
current capacity to collect and report
data varies. ACL anticipates that some
grantees will not be able to respond to
every question on the instrument and
this will not negatively affect those
grantees. ACL hopes that every question
will be applicable and feasible to
answer for at least a subset of grantees,
therefore providing a more complete
(although not perfect) picture of grant
activities than is currently available.
ACL revised the instrument questions
to account more for state and grantee
differences. For example, new
structured and open-ended questions
have been added at the beginning of the
instrument to allow grantees to identify
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their main areas of focus and describe
where the data they report are coming
from so that ACL can interpret it
appropriately. Using skip patterns
programmed into the online tool,
additional questions related to these
areas of focus will only appear to
grantees who indicate they are working
in those areas. ACL will program the
instrument into the online system so
that some grantees may be directed to
answer or not to answer some questions
depending on how they answer initial
questions about their grant activities
and scope. Finally, an additional field
has been added to most questions to
allow grantees who do not respond or
who can only respond partially to
provide some descriptive notes about
the data they submit.
Estimating prevalence and unmet
need: Several commenters noted that
reporting the prevalence of TBI and
estimating the needs of people living
with a TBI and their families would be
very challenging for many grantees.
Some noted that many states do not
have registries or good/recent
epidemiology data. Others indicated
grantees would have no way of
estimating the number of people who
might need supports but are not
accessing them. Several suggested that
grantees might be able to respond to
these questions if additional funding
and/or technical assistance to carry out
further study are provided.
Response and Changes to Instrument:
These questions have been eliminated
from the proposed instrument.
Defining services and supports:
Several commenters expressed concern
that the instrument asked questions
about ‘‘services and supports’’ and
wondered what ACL means by that
term. Noting that grantees are currently
focusing on system change work and are
not allowed to use grant funds to
provide direct in-home hands-on
services and supports, some asked
whether the funding announcement for
new grants will include a different set
of objectives and scope than they have
in the past. Finally, several commenters
interpreted the term to mean Medicaid
home and community-based services
and noted that not all states have a TBI
Medicaid waiver. Those that do not are
not likely to be able to access
information about participants in other
Medicaid waivers who are living with a
TBI, so they would not be able to report
about people with TBI receiving
Medicaid services and supports.
Response and Changes to Instrument:
ACL does not intend for grantees to use
grant funds to provide direct in-home
hands-on services and supports, such as
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those provided through Medicaid HCBS
programs. The instrument’s questions
were revised to ask more clearly about
the specific types of ways grantees may
be assisting or supporting people with
TBI and their families, such as with
information and referral, screening,
resource facilitation, service
coordination/case management,
outreach and education, building
stronger partnerships, and other systems
change work.
The remaining questions about
utilization of home and communitybased services and supports are
intended to capture information about
the extent to which people with TBI
who are eligible for these types of
services are accessing them, which may
be an indicator of long-term systems
change that grantees are working
towards. These questions will only be
applicable to grantees specifically
working to increase access to and
utilization of home and communitybased services in their states.
Medically oriented questions: Several
commenters expressed confusion about
the instrument including questions they
interpreted to be medically oriented,
such as questions about technological
tools, diagnosis, and treatment. They
noted that grant activities might include
screening people to identify a history of
TBI and/or to better support people with
TBI to live more fully in the
community—but not diagnosis or
medical treatment. They noted these
questions would not be applicable to
many grantees nor would grantees have
access to data about diagnoses and
treatment.
Response and Changes to Instrument:
The instrument questions have been
revised to ask more clearly about the
specific ways grantees may be assisting
people with TBI and their families, such
as by screening for a lifetime history of
TBI and facilitating access to
community-based services. Questions
about diagnosis and treatment have
been removed.
Estimated Program Burden: These
revisions based on public comments
caused a change in the annual reporting
burden estimates; there is a program
change decrease of ¥1,008 annual
burden hours from the 60-day FRN. In
addition, the 60-day FRN respondent
estimate was based on the highest
number of possible awards anticipated;
there is an adjustment decrease of ¥18
respondents.
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Adjusted number of respondents
Number of
responses
(per
respondent)
Average
burden hours
(per response)
Total burden
hours
27 .................................................................................................................................................
2
8
432
60-day FRN number of respondents
Number of
responses
(per
respondent)
Average
burden hours
(per response)
Total burden
hours
45 .................................................................................................................................................
2
16
1,440
Dated: January 22, 2020.
Mary Lazare,
Principal Deputy Administrator.
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
[FR Doc. 2020–02091 Filed 2–3–20; 8:45 am]
BILLING CODE 4154–01–P
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5473]
Promotional Labeling and Advertising
Considerations for Prescription
Biological Reference and Biosimilar
Products—Questions and Answers;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Promotional Labeling and Advertising
Considerations for Prescription
Biological Reference and Biosimilar
Products—Questions and Answers.’’
FDA is issuing this guidance to provide
manufacturers, packers, distributors,
and their representatives (firms) with
information to consider when
developing FDA-regulated promotional
labeling and advertisements
(promotional materials) for prescription
reference and biosimilar products
licensed under the Public Health
Service Act (PHS Act). Although the
guidance covers promotional issues
involving both reference and biosimilar
products, some questions and answers
are focused on only biosimilar product
promotional materials. The guidance
does not discuss considerations unique
to promotional materials for
interchangeable biosimilars.
DATES: Submit either electronic or
written comments on the draft guidance
by April 6, 2020 to ensure that the
Agency considers your comment on this
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SUMMARY:
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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
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–
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2019–D–5473 for ‘‘Promotional Labeling
and Advertising Considerations for
Prescription Biological Reference and
Biosimilar Products—Questions and
Answers.’’ Received comments 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
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 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
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]]>Agencies
[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Notices]
[Pages 6198-6201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02091]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Submission for OMB
Review; Public Comment Request; Traumatic Brain Injury (TBI) State
Partnership Program, OMB approval number 0985-NEW
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) 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 the Paperwork Reduction Act of 1995. This
30-Day notice collects comments on the information collection
requirements related to Proposed New information collection
requirements related to the Traumatic Brain Injury (TBI) State
Partnership Program.
DATES: Submit written comments on the collection of information by
March 5, 2020.
ADDRESSES: Submit electronic 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: Dana Fink, Administration for
Community Living, Washington, DC 20201, (202) 795-7604, or
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with the Paperwork Reduction
Act, ACL has submitted the following proposed new information
collection to OMB for review and clearance.
[[Page 6199]]
The purpose of the federal Traumatic Brain Injury (TBI) State
Partnership Program is to create and strengthen a system of services
and supports that maximizes the independence, well-being, and health of
people with TBIs across the lifespan and all other demographics, their
family members, and support networks. The TBI State Partnership Program
funds the development and implementation of statewide systems that
ensure access to TBI related services, including transitional services,
rehabilitation, education and employment, and long-term community
support. To best monitor, guide, and support TBI State Partnership
Program grantees, ACL needs regular information about the grantees'
activities and outcomes. The simplest, least burdensome and most useful
way to accomplish this goal is to require grantees to submit
information as part of their required semiannual reports via the
proposed electronic data submission instrument.
In 1996, the Public Health Service Act was amended ``to provide for
the conduct of expanded studies and the establishment of innovative
programs with respect to traumatic brain injury, and for other
purposes'' (Pub. L. 104-166). This legislation allowed for the
implementation of ``grants to States for the purpose of carrying out
demonstration projects to improve access to health and other services
regarding traumatic brain injury.'' The TBI Reauthorization Act of 2014
(Pub. L. 113-196) allowed the Department of Health and Human Services
Secretary to review oversight of the federal TBI programs (TBI State
Partnership Grant program and the TBI Protection and Advocacy program)
and reconsider which operating division should lead them. With avid
support from TBI stakeholders, the Secretary found that the goals of
the federal TBI programs closely align with ACL's mission to advance
policy and implement programs that support the rights of older
Americans and people with disabilities to live in their communities. As
a result, on Oct. 1, 2015, the federal TBI programs moved from the
Health Resources and Services Administration to ACL. These programs
were reauthorized again by the Traumatic Brain Injury Reauthorization
Act of 2018 (Pub. L. 115-377).
The proposed performance measures assess progress toward
surmounting the four commonly recognized barriers to accessing care for
people with TBI:
(1) A lack of information about available services and supports
with little or no assistance in accessing them (information and
referral services);
(2) A shortage of health professionals who may encounter
individuals with TBI but lack relevant training to identify or treat
the resulting symptoms (professional training);
(3) The absence of a TBI diagnosis or the assignment of an
incorrect diagnosis (screening); and (4) Critical TBI services are
spread across numerous agencies resulting in services being difficult
for individuals and families to identify and navigate (resource
facilitation).
The proposed performance measures are designed to account for the
varied approaches used across state grantees and are consistent with
the TBI State Partnership Program's purpose and ACL's mission.
Comments in Response to the 60-Day Federal Register Notice
ACL published a 60-day Federal Register Notice from 11/13/2017-01/
12/2018 (Vol. 82, No. 217 pp. 52305-52306). ACL received a large volume
of substantive stakeholder comments, causing revisions to the IC based
on those public comments. The period in publication between the 60-day
FRN and 30-day FRN, allowed ACL to thoughtfully review and apply the
significant number of substantive public comments to the proposed new
TBI IC.
In response to the original Federal Register notice in 2018,
twenty-three (23) individuals provided written comments in response to
the Federal Register notice containing the original proposed TBI
Performance Measures, presented in the form of a reporting instrument
for future TBI grantees. Commenters provided feedback on specific
reporting instrument questions as well as general suggestions and
recommendations for ACL about what grantees should report.
268 separate comments were made about one or more specific
survey questions.
102 separate comments asked for a definition, further
guidance, or clarification with regard to terminology used.
81 comments made a general recommendation, not specific to
a particular question.
ACL also received feedback in 2018 through multiple face-to-face
interactions with a majority of the current TBI grantees regarding the
proposed measures.
ACL revised the instrument in 2019, in order to remain compliant
with PRA 5 CFR 1320.8(d), ACL published an abbreviated public comment
period prior to publishing the 30-day FRN and submitting to OMB. ACL
solicited comments during the abbreviated public comment period
regarding: (1) The accuracy of ACL's revised estimate of the burden for
the proposed collection of information performance reporting data
elements and (2) whether the proposed revisions to the collection of
information enhance the quality, utility, and clarity of the
information to be collected.
During the abbreviated public comment period published in the 83 FR
53738 received 14 additional comments. These comments have been
addressed largely through the addition of definitions and guidance. The
tool has been simplified, some questions have been eliminated or
simplified because of concern about the burden, and three open-ended
narrative questions added. The most prevalent comments and themes
emerging from the public comments are summarized below:
Intended scope of the questions: The suggestion that occurred most
across all commenters was for ACL to better define the scope of the
questions. Many commenters asked whether ACL expected grantees to limit
their reporting to their own grant activities, the staff they train
with the grant funds, and the people with TBI they interact with using
grant funds or if they would be expected to report about activities
going on in the state beyond their grant activities. Commenters raised
the issue of intended scope in general and specifically about almost
all the questions in the instrument. Several commenters noted that the
grants were awarded to different types of state agencies in different
states and the reporting instrument did not make clear what ACL meant
by the term ``TBI System,'' which could be interpreted to mean
different things such as: The Medicaid system, the criminal justice
system, the educational system, the vocational rehabilitation system,
the broader medical system, or all of these together. Many indicated
that grantees would have limited or no access to data about activities
or people supported outside the grant activities being conducted by
their own partnering organizations.
Response and Changes to Instrument: ACL intends for TBI grantees to
report only about their own grant activities, the staff they train
using grant funds, the partners they work with, and the people affected
by TBI they interact with using grant funds. Additional guidance and
definitions will be added to the online version of the instrument to
clarify this intent and provide more guidance for grantees operating in
different systems. For example:
(1) If a grantee is using grant funds to serve people with TBI
within the criminal justice system statewide, the
[[Page 6200]]
scope of their reporting will be limited to the statewide criminal
justice system.
(2) If a grantee is using their grant funds to assist people
interacting with the vocational rehabilitation system in one region of
the state, the scope of their reporting will be limited to that
region's vocational rehabilitation system.
(3) If grant funds are going to several partnering organizations to
work with people with TBI, the scope of that grantee's reporting will
include the grant-funded activities of all of those partnering
organizations (to the extent possible).
In addition, ACL added some new structured and open-ended questions
to the instrument to allow grantees to identify their main areas of
focus and describe report full or partial data from across their
partners depending on what they can access.
Purpose of performance measures and accounting for state and
grantee differences: Several commenters indicated they thought the
instrument did not adequately account for the differences in how state
systems are structured and the different focus areas of different
grantees. Several commenters expressed concern that individual grantees
would be negatively evaluated. Specific questions were edited to allow
for grantees that are not able to provide data about activities and
people outside of the scope of their grants or are otherwise not able
to respond to every question.
Response and Changes to Instrument: ACL does not intend to use this
reporting instrument to score grantees' individual performance or to
compare grantees' performance with one another. ACL's intent is to
gather a standard set of information from all grantee states, so that
it can be aggregated to provide a better picture of the national impact
of the grant program. However, ACL understands that states are working
within different systems and focusing on different activities and that
states' current capacity to collect and report data varies. ACL
anticipates that some grantees will not be able to respond to every
question on the instrument and this will not negatively affect those
grantees. ACL hopes that every question will be applicable and feasible
to answer for at least a subset of grantees, therefore providing a more
complete (although not perfect) picture of grant activities than is
currently available.
ACL revised the instrument questions to account more for state and
grantee differences. For example, new structured and open-ended
questions have been added at the beginning of the instrument to allow
grantees to identify their main areas of focus and describe where the
data they report are coming from so that ACL can interpret it
appropriately. Using skip patterns programmed into the online tool,
additional questions related to these areas of focus will only appear
to grantees who indicate they are working in those areas. ACL will
program the instrument into the online system so that some grantees may
be directed to answer or not to answer some questions depending on how
they answer initial questions about their grant activities and scope.
Finally, an additional field has been added to most questions to allow
grantees who do not respond or who can only respond partially to
provide some descriptive notes about the data they submit.
Estimating prevalence and unmet need: Several commenters noted that
reporting the prevalence of TBI and estimating the needs of people
living with a TBI and their families would be very challenging for many
grantees. Some noted that many states do not have registries or good/
recent epidemiology data. Others indicated grantees would have no way
of estimating the number of people who might need supports but are not
accessing them. Several suggested that grantees might be able to
respond to these questions if additional funding and/or technical
assistance to carry out further study are provided.
Response and Changes to Instrument: These questions have been
eliminated from the proposed instrument.
Defining services and supports: Several commenters expressed
concern that the instrument asked questions about ``services and
supports'' and wondered what ACL means by that term. Noting that
grantees are currently focusing on system change work and are not
allowed to use grant funds to provide direct in-home hands-on services
and supports, some asked whether the funding announcement for new
grants will include a different set of objectives and scope than they
have in the past. Finally, several commenters interpreted the term to
mean Medicaid home and community-based services and noted that not all
states have a TBI Medicaid waiver. Those that do not are not likely to
be able to access information about participants in other Medicaid
waivers who are living with a TBI, so they would not be able to report
about people with TBI receiving Medicaid services and supports.
Response and Changes to Instrument: ACL does not intend for
grantees to use grant funds to provide direct in-home hands-on services
and supports, such as those provided through Medicaid HCBS programs.
The instrument's questions were revised to ask more clearly about the
specific types of ways grantees may be assisting or supporting people
with TBI and their families, such as with information and referral,
screening, resource facilitation, service coordination/case management,
outreach and education, building stronger partnerships, and other
systems change work.
The remaining questions about utilization of home and community-
based services and supports are intended to capture information about
the extent to which people with TBI who are eligible for these types of
services are accessing them, which may be an indicator of long-term
systems change that grantees are working towards. These questions will
only be applicable to grantees specifically working to increase access
to and utilization of home and community-based services in their
states.
Medically oriented questions: Several commenters expressed
confusion about the instrument including questions they interpreted to
be medically oriented, such as questions about technological tools,
diagnosis, and treatment. They noted that grant activities might
include screening people to identify a history of TBI and/or to better
support people with TBI to live more fully in the community--but not
diagnosis or medical treatment. They noted these questions would not be
applicable to many grantees nor would grantees have access to data
about diagnoses and treatment.
Response and Changes to Instrument: The instrument questions have
been revised to ask more clearly about the specific ways grantees may
be assisting people with TBI and their families, such as by screening
for a lifetime history of TBI and facilitating access to community-
based services. Questions about diagnosis and treatment have been
removed.
Estimated Program Burden: These revisions based on public comments
caused a change in the annual reporting burden estimates; there is a
program change decrease of -1,008 annual burden hours from the 60-day
FRN. In addition, the 60-day FRN respondent estimate was based on the
highest number of possible awards anticipated; there is an adjustment
decrease of -18 respondents.
[[Page 6201]]
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Number of Average burden
Adjusted number of respondents responses (per hours (per Total burden
respondent) response) hours
----------------------------------------------------------------------------------------------------------------
27........................................................... 2 8 432
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Number of Average burden
60-day FRN number of respondents responses (per hours (per Total burden
respondent) response) hours
----------------------------------------------------------------------------------------------------------------
45........................................................... 2 16 1,440
----------------------------------------------------------------------------------------------------------------
Dated: January 22, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020-02091 Filed 2-3-20; 8:45 am]
BILLING CODE 4154-01-P
