Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Chart Abstraction of Ryan White HIV/AIDS Program Recipient Data, OMB No. 0906-xxxx-New, 20638-20639 [2019-09666]
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Federal Register / Vol. 84, No. 91 / Friday, May 10, 2019 / Notices
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
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received, go to https://
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docket number, found in brackets in the
heading of this document, into the
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You may submit comments on any
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Submit written requests for single
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INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
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for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Rm. 1670, Silver
Spring, MD 20993, 240–402–7930,
elizabeth.giaquinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a final guidance entitled ’’Determining
Whether to Submit an ANDA or a
505(b)(2) Application.’’ This guidance is
intended to serve as a foundational
guidance to assist applicants in
determining which one of the
abbreviated approval pathways under
the FD&C Act is appropriate for the
submission of a marketing application
to FDA. This guidance highlights
criteria for submitting applications
under the abbreviated approval
pathways described in section 505(j)
and 505(b)(2) of the FD&C Act (21
U.S.C. 355(j) and 21 U.S.C. 355(b)(2),
respectively), identifies considerations
to help potential applicants determine
whether an application would be more
appropriately submitted under section
505(j) or pursuant to section 505(b)(2) of
the FD&C Act, and provides direction to
potential applicants on requesting
assistance from FDA in making this
determination.
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) (the Hatch-Waxman
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Amendments) added section 505(b)(2)
and 505(j) of the FD&C Act, which
describe abbreviated approval pathways
for drug products regulated by the
Agency under the FD&C Act. The HatchWaxman Amendments reflect
Congress’s efforts to balance the need to
‘‘make available more low cost generic
drugs by establishing a generic drug
approval procedure’’ with new
incentives for drug development in the
form of exclusivities and patent term
extensions. With the passage of the
Hatch-Waxman Amendments, the FD&C
Act describes different routes for
obtaining approval of two broad
categories of drug applications: New
drug applications (NDAs) and
abbreviated new drug applications
(ANDAs).
This guidance focuses on those
applications that can be submitted as
ANDAs under section 505(j) of the
FD&C Act, petitioned ANDAs under
section 505(j)(2)(C) of the FD&C Act, or
NDAs pursuant to section 505(b)(2) of
the FD&C Act. This guidance does not
discuss stand-alone NDAs.
In the Federal Register of October 13,
2017 (82 FR 47749), FDA announced the
availability of the draft guidance of the
same title dated October 2017. FDA
received four comments on the draft
guidance and those comments were
considered as the guidance was
finalized. We note that we received
comments requesting clarification on
the process for obtaining therapeutic
equivalence evaluations. We will
address therapeutic equivalence in a
forthcoming guidance document (see
‘‘Guidance Agenda: New and Draft
Guidances CDER Plans to Publish
During Calendar Year 2019’’). The final
guidance contains minor clarifications
to the draft guidance. The guidance
announced in this notice finalizes the
draft guidance dated October 2017.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Determining
Whether to Submit an ANDA or a
505(b)(2) Application.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
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Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 314.94 have
been approved under OMB control
number 0910–0001. The collection of
information for controlled
correspondence and pre-ANDA meeting
requests has been approved under OMB
control number 0910–0797.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: May 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09662 Filed 5–9–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Chart
Abstraction of Ryan White HIV/AIDS
Program Recipient Data, OMB No.
0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than July 9, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
SUMMARY:
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Federal Register / Vol. 84, No. 91 / Friday, May 10, 2019 / Notices
Information Collection Clearance
Officer, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Chart Abstraction of Ryan White HIV/
AIDS Program Data, OMB No. 0906–
xxxx–New.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states, and local
clinics/community-based organizations
to deliver efficient and effective HIV
care, treatment, and support to lowincome people with HIV. Nearly twothirds of clients (patients) live at or
below 100 percent of the Federal
poverty level and approximately threequarters of RWHAP clients are racial
and ethnic minorities. Since 1990, the
RWHAP has developed a
comprehensive system of HIV service
providers who deliver high quality
direct health care and support services
to over half a million people with HIV—
more than 50 percent of all people with
diagnosed HIV in the United States.
HRSA is required to assess the quality
of care provided by RWHAP grant
recipients. HHS guidelines (e.g.,
Guidelines for the Use of Antiretroviral
Agents in Adults and Adolescents
Living with HIV; Guidelines for the
Prevention and Treatment of
Opportunistic Infections in HIVInfected Adults and Adolescents; and
Sexually Transmitted Diseases
Treatment Guidelines, 2015) and U.S.
Preventative Services Task Force
(USPSTF) guidelines serve as the basis
for assessing the quality of care within
the RWHAP. The purpose of the Chart
Abstraction of RWHAP Data study is to
assess the extent to which the care
provided with funding from the
RWHAP is meeting the HHS and
USPSTF guidelines. The study will
collect data from RWHAP service
providers via a provider screening
phone interview, a provider pre-site
visit interview, and medical records
data abstraction. The data will reflect
the full range of HIV outpatient
ambulatory health services, primary
care, and screening and treatment for
hepatitis, sexually transmitted
infections (STIs), and opioid use
disorder provided through the RWHAP
and allow HRSA to assess the extent to
which care provided with funding
through the RWHAP meets the HHS and
USPSTF guidelines.
Need and Proposed Use of the
Information: National RWHAP clientlevel data is collected through the
RWHAP Client Level Data Reporting
System. The RWHAP Client Level Data
Reporting System dataset (OMB control
number 0915–0323) is HRSA’s primary
source of annual, client-level data
collected from its nearly 2,000 funded
grant recipients/service providers and
the data have been used to assess the
numbers and types of clients receiving
services and limited HIV outcomes.
However, the RWHAP Client Level Data
Reporting System dataset does not
include relevant data in order to fully
assess the extent to which the care
provided with funding from the
RWHAP is meeting the HHS and
USPSTF guidelines. This proposed new
ICR will provide the full range of HIV
outpatient ambulatory health services,
primary care, and screening and
treatment for hepatitis, STIs, and opioid
use disorder data and allow HRSA to
assess the extent to which care provided
with funding through the RWHAP meets
the HHS and USPSTF guidelines.
Likely Respondents: HRSA RWHAP
Part A, Part B, Part C, and Part D service
providers funded to deliver outpatient
ambulatory health services to eligible
clients.
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.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
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Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total
burden hours
Provider Site screening interview ........................................
Provider Pre-Site Visit Interview ..........................................
Medical Record Data Abstraction ........................................
100
50
50
1
1
1
100
50
50
.5
1
2
50
50
100
Total ..............................................................................
200
........................
200
........................
200
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
Health Information Technology
Advisory Committee 2019 Schedule
[FR Doc. 2019–09666 Filed 5–9–19; 8:45 am]
AGENCY:
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Office of the National
Coordinator for Health Information
Technology (ONC), HHS.
2019 public meeting dates of the
Health Information Technology
Advisory Committee.
ACTION:
The Health Information
Technology Advisory Committee
SUMMARY:
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[Federal Register Volume 84, Number 91 (Friday, May 10, 2019)]
[Notices]
[Pages 20638-20639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09666]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Chart
Abstraction of Ryan White HIV/AIDS Program Recipient Data, OMB No.
0906-xxxx-New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects, HRSA announces plans to
submit an Information Collection Request (ICR), described below, to the
Office of Management and Budget (OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be received no later than July 9,
2019.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA
[[Page 20639]]
Information Collection Clearance Officer, at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Chart Abstraction of Ryan
White HIV/AIDS Program Data, OMB No. 0906-xxxx-New.
Abstract: HRSA's Ryan White HIV/AIDS Program (RWHAP) funds and
coordinates with cities, states, and local clinics/community-based
organizations to deliver efficient and effective HIV care, treatment,
and support to low-income people with HIV. Nearly two-thirds of clients
(patients) live at or below 100 percent of the Federal poverty level
and approximately three-quarters of RWHAP clients are racial and ethnic
minorities. Since 1990, the RWHAP has developed a comprehensive system
of HIV service providers who deliver high quality direct health care
and support services to over half a million people with HIV--more than
50 percent of all people with diagnosed HIV in the United States.
HRSA is required to assess the quality of care provided by RWHAP
grant recipients. HHS guidelines (e.g., Guidelines for the Use of
Antiretroviral Agents in Adults and Adolescents Living with HIV;
Guidelines for the Prevention and Treatment of Opportunistic Infections
in HIV- Infected Adults and Adolescents; and Sexually Transmitted
Diseases Treatment Guidelines, 2015) and U.S. Preventative Services
Task Force (USPSTF) guidelines serve as the basis for assessing the
quality of care within the RWHAP. The purpose of the Chart Abstraction
of RWHAP Data study is to assess the extent to which the care provided
with funding from the RWHAP is meeting the HHS and USPSTF guidelines.
The study will collect data from RWHAP service providers via a provider
screening phone interview, a provider pre-site visit interview, and
medical records data abstraction. The data will reflect the full range
of HIV outpatient ambulatory health services, primary care, and
screening and treatment for hepatitis, sexually transmitted infections
(STIs), and opioid use disorder provided through the RWHAP and allow
HRSA to assess the extent to which care provided with funding through
the RWHAP meets the HHS and USPSTF guidelines.
Need and Proposed Use of the Information: National RWHAP client-
level data is collected through the RWHAP Client Level Data Reporting
System. The RWHAP Client Level Data Reporting System dataset (OMB
control number 0915-0323) is HRSA's primary source of annual, client-
level data collected from its nearly 2,000 funded grant recipients/
service providers and the data have been used to assess the numbers and
types of clients receiving services and limited HIV outcomes. However,
the RWHAP Client Level Data Reporting System dataset does not include
relevant data in order to fully assess the extent to which the care
provided with funding from the RWHAP is meeting the HHS and USPSTF
guidelines. This proposed new ICR will provide the full range of HIV
outpatient ambulatory health services, primary care, and screening and
treatment for hepatitis, STIs, and opioid use disorder data and allow
HRSA to assess the extent to which care provided with funding through
the RWHAP meets the HHS and USPSTF guidelines.
Likely Respondents: HRSA RWHAP Part A, Part B, Part C, and Part D
service providers funded to deliver outpatient ambulatory health
services to eligible clients.
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.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Provider Site screening 100 1 100 .5 50
interview......................
Provider Pre-Site Visit 50 1 50 1 50
Interview......................
Medical Record Data Abstraction. 50 1 50 2 100
-------------------------------------------------------------------------------
Total....................... 200 .............. 200 .............. 200
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-09666 Filed 5-9-19; 8:45 am]
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