60-day FRN

73776

Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices

and vitamin D analogs, systemic drugs,
biologic products, and phototherapy.
FDA is interested in the perspectives of
patients with psoriasis on (1) the impact
of their skin disease, including the
extent and location (e.g., nail, palm,
scalp, genital) of involvement, (2)
treatment approaches, and (3) decision
factors taken into account when
selecting a treatment.
The questions that will be asked of
patients and patient stakeholders at the
meeting are listed in this section,
organized by topic. For each topic, a
brief initial patient panel discussion
will begin the dialogue. This will be
followed by a facilitated discussion
inviting comments from other patient
and patient stakeholder participants. In
addition to input generated through this
public meeting, FDA is interested in
receiving patient input addressing these
questions through written comments,
which can be submitted to the public
docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
(1) Of all the symptoms that you
experience because of your condition,
which one to three symptoms have the
most significant impact on your life?
(Examples may include red, thickened,
scaling skin, itching, burning, or
soreness, etc.)
(2) Are there specific activities that
are important to you but that you cannot
do at all or as fully as you would like
because of your condition? (Examples of
activities may include sleeping through
the night, daily hygiene, participation in
sports or social activities, intimacy with
a spouse or partner, etc.)
(3) How do your symptoms and their
negative impacts affect your daily life
on the best days? On the worst days?
(4) How have your condition and its
symptoms changed over time?
(a) Would you define your condition
today as being well managed?
(5) What worries you most about your
condition?

tkelley on DSK3SPTVN1PROD with NOTICES

Topic 2: Patients’ Perspectives on
Current Approaches to Treatment
(1) What are you currently doing to
help treat your condition or its
symptoms? (Examples may include
prescription medicines, over-thecounter products, phototherapy, and
other therapies including non-drug
therapies such as diet modification.)
(a) How has your treatment regimen
changed over time, and why?
(2) How well does your current
treatment regimen control your
condition?

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(a) How well do your treatments
address specific skin symptoms? Which
symptoms are not addressed as well?
(b) How well have these treatments
worked for you as your condition has
changed over time?
(3) What are the most significant
downsides to your current treatments,
and how do they affect your daily life?
(Examples of downsides may include
going to the hospital or clinic for
treatment, time devoted to treatment,
etc.)
(4) Assuming there is no complete
cure for your condition, what specific
things would you look for in an ideal
treatment for your condition?
(a) What would you consider to be a
meaningful improvement (for example
symptom improvements or functional
improvements) in your condition that a
treatment could provide?
(5) What factors do you take into
account when making decisions about
selecting a course of treatment?
(a) What information on the potential
benefits of these treatments factors most
into your decision?
(b) How do you weigh the potential
benefits of these treatments versus the
common side effects of the treatments?
(Common side effects could include
headache, nausea, injection site
reactions.)
(c) How do you weigh potential
benefits of these treatments versus the
less common but serious risks
associated with the treatments?
(Examples of less common but serious
risks are infections, cancer, liver
damage, kidney damage, birth defects,
blood disorders, etc.)

Patients who are interested in
presenting comments as part of the
initial panel discussions will be asked
to indicate in their registration which
topic(s) they wish to address. These
patients also must send to
[email protected] a brief
summary of responses to the topic
questions by February 29, 2016.
Panelists will be notified of their
selection approximately 7 days before
the public meeting. We will try to
accommodate all patients and patient
stakeholders who wish to speak, either
through the panel discussion or
audience participation; however, the
duration of comments may be limited by
time constraints.
Docket Comments: Regardless of
whether you attend the public meeting,
you can submit electronic or written
responses to the questions pertaining to
Topics 1 and 2 to the public docket (see
ADDRESSES) by May 17, 2016.
Transcripts: As soon as a transcript is
available, FDA will post it at http://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm470608.htm.

B. Meeting Attendance and
Participation
If you wish to attend this meeting,
visit https://
psoriasispfdd.eventbrite.com. Please
register by March 10, 2016. If you are
unable to attend the meeting in person,
you can register to view a live Webcast
of the meeting. You will be asked to
indicate in your registration if you plan
to attend in person or via the Webcast.
Seating will be limited, so early
registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
may limit the number of participants
from each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meeting will be based on space
availability. If you need special
accommodations because of a disability,
please contact Meghana Chalasani (see
FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting.

Agency Information Collection
Activities: Proposed Collection: Public
Comment Request

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Dated: November 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29992 Filed 11–24–15; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration

Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (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 Information
Collection Request must be received no
later than January 25, 2016.
SUMMARY:

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73777

Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices
Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 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 the HRSA 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:
HIV Quality Measures (HIVQM) Module
OMB No. 0915–xxxx–New.
Abstract: The Ryan White HIV/AIDS
Program (RWHAP) provides entities
funded by the program with flexibility
to respond effectively to the changing
HIV epidemic, with an emphasis on
providing life-saving and life-extending
services for people living with HIV.
Under the Ryan White HIV/AIDS
Treatment Extension Act of 2009,
RWHAP Parts A–D recipients are
required to establish clinical quality
management programs in order to assess
their HIV services according to the most
recent Department of Health and Human
Services guidelines and to develop
strategies to improve access to quality
HIV services. The HIV Quality Measures
(HIVQM) module will be the HIV/AIDS
Bureau’s (HAB) voluntary online
reporting tool created to help facilitate
recipients in meeting these
requirements. Recipients and their
providers will enter aggregate data in
the HIVQM module on HAB
performance measures and then will be
able to generate reports to assess their
performance and compare their results
ADDRESSES:

to results at the state, regional, and
national levels. The HAB performance
measures include the following priority
performance measure categories: (1)
Core (those measures that emphasize
essential aspects of care and treatment,
align with the milestones along the HIV
care continuum, and are most feasible
for data collection); (2) all ages; (3)
adolescent/adult; (4) HIV-positive
children; (5) HIV-exposed children; (6)
medical case management; (7) oral
health; (8) AIDS Drug Assistance
Program (ADAP); and (9) system level
measures. The use of the HIVQM
module will be voluntary for RWHAP
recipients and services providers.
Need and Proposed Use of the
Information: The HIVQM Module will
be a voluntary online reporting tool that
supports recipients in monitoring their
performance in serving patients
particularly in access to care and the
provision of quality HIV services, and to
reduce HIV-related morbidity and
mortality among people living with
HIV/AIDS. These data will help
RWHAP recipients document their
strengths, identify gaps in performance
and areas for improvement, and plan
how to enhance future delivery of
quality care to their patients.
The HIVQM module will also assist
RWHAP recipients in meeting the
requirement to construct quality
assurance structures in their provision
of HIV care services. In addition, for
recipients and service providers
participating in the Centers for Medicare
and Medicaid Incentive Programs, such
as the Medicare and Medicaid
Electronic Health Records Incentive
Program and the Physician Quality
Reporting System, the module will be
consistent to qualify and comply with
the requirements to receive incentives
from these programs. Finally, the
module will assist HAB in identifying
recipients and service providers that are

Average burden per response
(in hours)

Number of respondents

Number of responses per
respondent

HIVQM module ....................................................................

1,100

3

3,300

4

13,200

Total ..............................................................................

1,100

3

3,300

4

13,200

Form name

tkelley on DSK3SPTVN1PROD with NOTICES

supporting the aims of the National
HIV/AIDS Strategy in establishing a
system that links HIV positive
individuals to continuous and
coordinated quality care.
The module will be available for data
entry 3 times a year. The module will
be accessible via the HRSA Electronic
Handbook (EHB) Ryan White Services
Report (RSR) portal, an existing online
tool that RWHAP recipients already use
for required data collection on their
services. Recipients will choose which
performance measures they want to
monitor and enter data accordingly.
Reports of performance measures can be
generated and reviewed by the
recipients or their service providers and
can be compared to results at the state,
regional, and national levels.
Likely Respondents: Ryan White HIV/
AIDS Program Part A, Part B, Part C, and
Part D recipients and their service
providers and the AIDS Drug Assistance
Program recipients.
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:

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

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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

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Total responses

Total burden
hours

technology to minimize the information
collection burden.

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73778

Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–29948 Filed 11–24–15; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (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 January 25, 2016.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 10C–24, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
SUMMARY:

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 the HRSA 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:
Rural Health Care Coordination
Network Partnership Program
Performance Improvement
Measurement System.
OMB No. 0915–xxxx—New.
Abstract: The Rural Health Care
Coordination Network Partnership (Care
Coordination) Program is authorized
under Section 330A(f) of the Public
Health Service (PHS) Act (42 U.S.C.
254(c)(f)), as amended, to support the
development of formal, mature rural
health networks that focus on care
coordination activities for the following
chronic conditions: Diabetes, congestive
heart failure (CHF), and chronic
obstructive pulmonary disease (COPD).
This authority permits the Federal
Office of Rural Health Policy (FORHP)
to support grants for eligible entities to
promote, through planning and
implementation, the development of
integrated health care networks that
have combined the functions of the
entities participating in the networks in
order to: (i) Achieve efficiencies; (ii)
expand access to, coordinate, and
improve the quality of essential health
care services; and (iii) strengthen the
rural health care system as a whole.
FOR FURTHER INFORMATION CONTACT:

Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act (GPRA) of 1993. These
measures cover the principal topic areas
of interest to the Federal Office of Rural
Health Policy including: (a) Access to
care; (b) population demographics; (c)
staffing; (d) consortium/network; (e)
sustainability; and (f) project specific
domains. Several measures will be used
for this program. All measures will
speak to FORHP’s progress toward
meeting the goals set.
Likely Respondents: The respondents
would be recipients of the Rural Health
Care Coordination Network Partnership
grant program funding.
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 Information
Collection Request are summarized in
the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

tkelley on DSK3SPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Form name

Average
burden per
response
(in hours)

Total
responses

Total burden
hours

Rural Health Care Coordination Network Partnership
Grant Program Measures .................................................

8

1

8

3.5

28

Total ..............................................................................

8

1

8

3.5

28

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

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technology to minimize the information
collection burden.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Jackie Painter,
Director, Division of the Executive Secretariat.

Health Resources and Services
Administration

[FR Doc. 2015–29968 Filed 11–24–15; 8:45 am]

Agency Information Collection
Activities: Proposed Collection: Public
Comment Request

BILLING CODE 4165–15–P

PO 00000

Health Resources and Services
Administration, HHS.

AGENCY:

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