Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: HRSA Ryan White HIV/AIDS Program AIDS Education and Training Centers Evaluation Activities, OMB No. 0915-0281-Revision, 21790-21791 [2019-09976]
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21790
Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices
ingredients under section 904(a)(1) as
most of these submissions are expected
to be for products subject to the
deeming compliance period.
Based on FDA’s experience and the
actual number of product ingredient
listings submitted over the past 3 years,
FDA estimates that 35 establishments
will each submit 2 reports (1 every 6
months). FDA also estimates that the
confirmation or updating of product
(ingredient) listing information required
by section 904(c) of the FD&C Act is
expected to take 0.40 hour (24 minutes)
and will take 48 minutes annually for
two confirmations or updates per
establishment, for a total 28 burden
hours. FDA estimates that obtaining a
DUNS (data universal numbering
system) number will take 30 minutes.
FDA assumes that all new establishment
facilities that will be required to
initially register under section 905 of
the FD&C Act would obtain a DUNS
number. FDA estimates that up to 100
establishments would need to obtain
this number each year. The total
industry burden to obtain a DUNS
number is 50 hours.
FDA estimates the total burden for
this collection to be 830 hours. We have
adjusted our burden estimate, which has
resulted in a decrease of 93,086 hours to
the currently approved burden. Based
on data we reviewed from the past 3
years and projecting the number of
remaining establishments that have not
registered and submitted product
ingredient listings, we revised the
number of respondents and burden
hours in this information collection.
Dated: May 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09997 Filed 5–14–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSK3GLQ082PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: HRSA Ryan White HIV/
AIDS Program AIDS Education and
Training Centers Evaluation Activities,
OMB No. 0915–0281—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
VerDate Sep<11>2014
22:43 May 14, 2019
Jkt 247001
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than June 14, 2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
HRSA Ryan White HIV/AIDS Program
AIDS Education and Training Centers
Evaluation Activities: (OMB No. 0915–
0281) Revision.
Abstract: The RWHAP AETC
program, authorized by Title XXVI of
the Public Health Service Act, supports
a network of regional and national
centers that conduct targeted,
multidisciplinary education and
training programs for health care
providers serving people living with
HIV (PLWH). The purpose of the
RWHAP AETC program is to increase
the size and strengthen the skills of the
current and novice HIV clinical
workforce in the United States and to
develop and disseminate information on
treatment and prevention of HIV to atrisk populations. Through the provision
of specialized professional education
and training, the RWHAP Regional
AETCs aim to improve outcomes along
the HIV care continuum including
diagnosis, linkage, retention, and viral
suppression and to reduce HIV
incidence by improving the
achievement and maintenance of viral
load suppression of PLWH. In addition,
the RWHAP AETC program includes the
National Coordinating Resource Center
(NCRC), which offers a virtual library of
online training resources for adaptation
by HIV care providers and other
healthcare professionals to meet local
training needs. The RWHAP AETC
NCRC works closely with the HRSA
HIV/AIDS Bureau (HAB) to coordinate
cross-regional collaborative efforts,
manage the NCRC website, plan and
execute the national RWHAP Clinical
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Conference, and develop an online
curriculum for clinical learners.
The RWHAP AETC proposes several
revisions to the Event Records (ER) and
the Participant Information Form (PIF).
The ER will have 11 new data elements;
however, only 7 data elements will
require responses from all respondents.
The option to respond to the other four
data elements will depend on how
participants respond to previous
questions. There are four data element
deletions to the ER.
The PIF will have one new data
element that asks whether respondents
prescribe antiretroviral therapy to their
patients. Two data elements were
deleted. These revisions reflect changes
in the National AETC program guidance
on reporting sources of funding and
multi-session events.
Despite a net increase of eight data
elements across both the ER and PIF
instruments, pilot respondents reported
a decrease in burden. HRSA HAB
modified the data instruments to help
inform the evaluation of AETC
outcomes, improve the logical flow of
questions within each instrument and to
improve the overall clarity of each of the
questions being asked.
A 60-day Federal Register Notice was
published in the Federal Register on
December 18, 2018, vol. 83, No. 242; pp.
64845–47. There were no public
comments.
Need and Proposed Use of the
Information: As part of an ongoing effort
to evaluate RWHAP AETC activities,
information is needed on AETC training
sessions, clinical consultations, and
technical assistance activities. Each
regional center collects information on
RWHAP AETC training events and is
required to report aggregate data on
their activities to HRSA’s HAB. The goal
of national data collection efforts is to
create a uniform set of data elements
that will produce an accurate summary
of the national scope of RWHAP AETC
professional training, consultation, and
events. The elements included in the
national database have been selected for
their relevance in demonstrating the
RWHAP AETCs’ efforts in achieving the
program’s stated goals: To improve care
for PLWH by providing education,
training, and clinical consultation; and
to provide support to clinicians and
other providers. HRSA HAB uses the
data collected when conducting
programmatic assessments and to
determine future program needs. The
national data elements are intended to
be a meaningful core set of elements
that individual RWHAP AETCs can use
in programmatic and strategic planning.
HRSA HAB also uses this information to
E:\FR\FM\15MYN1.SGM
15MYN1
21791
Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices
respond to requests from HHS,
Congress, and others.
Likely Respondents: RWHAP AETC
trainees are asked to complete the PIF
either at the start or at conclusion of an
event. Trainers are asked to complete an
ER for each training event they conduct
during the year. In addition, each
regional RWHAP AETC (eight total) and
the RWHAP AETC National
Coordinating Resource Center will
compile these data into a data set and
submit to HRSA HAB once a year.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
Number of
respondents
Form name
Number of
responses
per
respondent
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
The estimated annual response
burden to trainers, as well as trainees of
training programs is follows:
Average
burden per
response
(in hours)
Total
responses
Total
burden hours
Participant Information Form (PIF) ......................................
Event Record (ER) ...............................................................
61,288
10,522
1
1
61,288
10,522
0.05
0.13
3,064
1,368
Total ..............................................................................
71,810
........................
71,810
........................
4,432
The estimated annual burden to
RWHAP AETCs is as follows:
Number of
respondents
Responses
per
respondent
Total
responses
Hours
per response
Total burden
hours
9
1
9
10
90
Aggregate Data Set .............................................................
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–09976 Filed 5–14–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(Advisory Council). The meeting will be
open to the public; a public comment
session will be held during the meeting.
Pre-registration is required for members
of the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
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VerDate Sep<11>2014
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Jkt 247001
FOR FURTHER INFORMATION CONTACT:
The meeting is scheduled to be
held on July 10, 2019, from 9:00 a.m. to
5:00 p.m. and July 11, 2019, from 9:00
a.m. to 5:00 p.m. ET (times are tentative
and subject to change). The confirmed
times and agenda items for the meeting
will be posted on the website for the
Advisory Council at https://
www.hhs.gov/ash/carb/ when this
information becomes available. Preregistration for attending the meeting in
person is required to be completed no
later than July 2, 2019; public
attendance at the meeting is limited to
the available space.
SUPPLEMENTARY INFORMATION:
DATES:
AGENCY:
SUMMARY:
should send an email to CARB@hhs.gov.
Registration information is available on
the website https://www.hhs.gov/ash/
carb/ and must be completed by July 2,
2019; all in-person attendees must preregister by this date. Additional
information about registering for the
meeting and providing public comment
can be obtained at https://www.hhs.gov/
ash/carb/ on the Meetings page.
Hilton McLean Tysons
Corner, International Ballroom C, 7920
Jones Branch Dr., McLean, VA 22102.
The meeting can also be accessed
through a live webcast and via
teleconference on the day of the
meeting. For more information, visit
https://www.hhs.gov/ash/carb/.
ADDRESSES:
PO 00000
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Jomana Musmar, Designated Federal
Officer, Presidential Advisory Council
on Combating Antibiotic-Resistant
Bacteria, Office of the Assistant
Secretary for Health, U.S. Department of
Health and Human Services, Room
L133, Switzer Building, 330 C St. SW,
Washington, DC 20201. Phone Number:
(202) 795–7678. Email: CARB@hhs.gov.
Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. Activities of the Advisory
Council are governed by the provisions
of Public Law 92–463, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall
function solely for advisory purposes.
E:\FR\FM\15MYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Pages 21790-21791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09976]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request Title: HRSA Ryan White HIV/AIDS Program AIDS Education and
Training Centers Evaluation Activities, OMB No. 0915-0281--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than June 14,
2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer, at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: HRSA Ryan White HIV/AIDS
Program AIDS Education and Training Centers Evaluation Activities: (OMB
No. 0915-0281) Revision.
Abstract: The RWHAP AETC program, authorized by Title XXVI of the
Public Health Service Act, supports a network of regional and national
centers that conduct targeted, multidisciplinary education and training
programs for health care providers serving people living with HIV
(PLWH). The purpose of the RWHAP AETC program is to increase the size
and strengthen the skills of the current and novice HIV clinical
workforce in the United States and to develop and disseminate
information on treatment and prevention of HIV to at-risk populations.
Through the provision of specialized professional education and
training, the RWHAP Regional AETCs aim to improve outcomes along the
HIV care continuum including diagnosis, linkage, retention, and viral
suppression and to reduce HIV incidence by improving the achievement
and maintenance of viral load suppression of PLWH. In addition, the
RWHAP AETC program includes the National Coordinating Resource Center
(NCRC), which offers a virtual library of online training resources for
adaptation by HIV care providers and other healthcare professionals to
meet local training needs. The RWHAP AETC NCRC works closely with the
HRSA HIV/AIDS Bureau (HAB) to coordinate cross-regional collaborative
efforts, manage the NCRC website, plan and execute the national RWHAP
Clinical Conference, and develop an online curriculum for clinical
learners.
The RWHAP AETC proposes several revisions to the Event Records (ER)
and the Participant Information Form (PIF). The ER will have 11 new
data elements; however, only 7 data elements will require responses
from all respondents. The option to respond to the other four data
elements will depend on how participants respond to previous questions.
There are four data element deletions to the ER.
The PIF will have one new data element that asks whether
respondents prescribe antiretroviral therapy to their patients. Two
data elements were deleted. These revisions reflect changes in the
National AETC program guidance on reporting sources of funding and
multi-session events.
Despite a net increase of eight data elements across both the ER
and PIF instruments, pilot respondents reported a decrease in burden.
HRSA HAB modified the data instruments to help inform the evaluation of
AETC outcomes, improve the logical flow of questions within each
instrument and to improve the overall clarity of each of the questions
being asked.
A 60-day Federal Register Notice was published in the Federal
Register on December 18, 2018, vol. 83, No. 242; pp. 64845-47. There
were no public comments.
Need and Proposed Use of the Information: As part of an ongoing
effort to evaluate RWHAP AETC activities, information is needed on AETC
training sessions, clinical consultations, and technical assistance
activities. Each regional center collects information on RWHAP AETC
training events and is required to report aggregate data on their
activities to HRSA's HAB. The goal of national data collection efforts
is to create a uniform set of data elements that will produce an
accurate summary of the national scope of RWHAP AETC professional
training, consultation, and events. The elements included in the
national database have been selected for their relevance in
demonstrating the RWHAP AETCs' efforts in achieving the program's
stated goals: To improve care for PLWH by providing education,
training, and clinical consultation; and to provide support to
clinicians and other providers. HRSA HAB uses the data collected when
conducting programmatic assessments and to determine future program
needs. The national data elements are intended to be a meaningful core
set of elements that individual RWHAP AETCs can use in programmatic and
strategic planning. HRSA HAB also uses this information to
[[Page 21791]]
respond to requests from HHS, Congress, and others.
Likely Respondents: RWHAP AETC trainees are asked to complete the
PIF either at the start or at conclusion of an event. Trainers are
asked to complete an ER for each training event they conduct during the
year. In addition, each regional RWHAP AETC (eight total) and the RWHAP
AETC National Coordinating Resource Center will compile these data into
a data set and submit to HRSA HAB once a year.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
The estimated annual response burden to trainers, as well as
trainees of training programs is follows:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Participant Information Form 61,288 1 61,288 0.05 3,064
(PIF)..........................
Event Record (ER)............... 10,522 1 10,522 0.13 1,368
-------------------------------------------------------------------------------
Total....................... 71,810 .............. 71,810 .............. 4,432
----------------------------------------------------------------------------------------------------------------
The estimated annual burden to RWHAP AETCs is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
respondents respondent Total responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate Data Set................................................. 9 1 9 10 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-09976 Filed 5-14-19; 8:45 am]
BILLING CODE 4165-15-P
