Agency Information Collection Activities: Proposed Collection: Public Comment Request, 80777-80778 [2015-32549]
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Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices
open to participating in a well-designed
and well-conducted meeting on a caseby-case basis. Given the expanse of
diseases affecting the U.S. patient
population and the effort required to
conduct a successful PFDD meeting,
externally-led PFDD meetings should
target disease areas where there is an
identified need for patient input on
topics related to drug development.
FDA will determine its level of
participation in these meetings on an
individual basis, taking into account a
number of factors, including any
identified need for a better
understanding of patient perspective,
recent interactions with patient
stakeholders, proposed meeting details,
and FDA staff capacity. More
information regarding considerations to
take into account when deciding to plan
an externally-led PFDD meeting can be
found on this Web site: https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm453856.htm.
FDA recommends that patient
organizations who are interested in
conducting an externally-led PFDD
meeting submit an LOI that
communicates (1) the value of the
proposed meeting in the context of drug
development for a particular disease
area, and (2) important details regarding
the meeting plan. Guidelines for
developing a letter of intent are
provided here: https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM453857.pdf. Please submit the
letter of intent to patientfocused@
fda.hhs.gov. FDA’s CDER Office of
Strategic Programs will receive and
review the letter.
Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32476 Filed 12–24–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
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
SUMMARY:
VerDate Sep<11>2014
13:31 Dec 24, 2015
Jkt 238001
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 February 26, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–24, 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 paperwork@hrsa.gov
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:
Sickle Cell Disease Treatment
Demonstration Program—Quality
Improvement Data Collection.
OMB No. 0915–xxxx–New
Abstract: In response to the growing
need for resources devoted to sickle cell
disease and other hemoglobinopathies,
the United States Congress, under
Section 712 of the American Jobs
Creation Act of 2004 (Pub. L. 108–357)
(42 U.S.C. 300b–1 note), authorized a
demonstration program for the
prevention and treatment of sickle cell
disease (SCD) to be administered by the
Maternal and Child Health Bureau
(MCHB) of the Health Resources and
Services Administration (HRSA) in the
U.S. Department of Health and Human
Services. The program is known as the
Sickle Cell Disease Treatment
Demonstration Program (SCDTDP). The
SCDTDP is designed to improve access
to services for individuals with sickle
cell disease, improve and expand
patient and provider education, and
improve and expand the continuity and
coordination of service delivery for
individuals with sickle cell disease and
sickle cell trait. The specific aims for the
program are threefold: (1) Increase the
number of providers treating persons
with sickle cell disease, (2) increase the
number of providers prescribing
hydroxyurea, and (3) increase the
number of providers knowledgeable
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80777
about treating sickle cell disease as well
as increase the number of sickle cell
patients that are seen by providers
knowledgeable about sickle cell disease.
To achieve the goals and objectives of
the program, the SCDTDP uses quality
improvement (QI) methods in a
collective impact model which supports
cross-sector collaboration for achieving
measurable effects on major social
issues. The collective impact model
requires shared measurement which
facilitates tracking progress in a
standardized method in order to
promote learning and enhance
continuous improvement.
Need and Proposed Use of the
Information: The purpose of the
proposed data collection strategy is to
implement a system to monitor the
progress of MCHB-funded activities in
improving care and health outcomes for
individuals living with sickle cell
disease/trait and meeting the goals of
the SCDTDP. Each regional grantee site
will be asked to report on a core set of
evidence-based measures related to
healthcare utilization among
individuals with sickle cell disease and
the quality of care of the SCD
population.
The data collected for the Sickle Cell
Disease Treatment Demonstration
Program will consist of administrative
medical claims data collected from State
Medicaid Programs and Medicaid
Managed Care Organizations that
administer Medicaid on behalf of states.
The data is collected either for or by
State Medicaid offices for delivery of
services subject to Medicaid
reimbursement.
The data collection strategy will
provide an effective and efficient
mechanism to do the following: (1)
Assess the improvements in access to
care for sickle cell patients provided by
activities in the SCDTDP; (2) collect,
coordinate, and distribute data, best
practices, and findings from regional
grantee sites to drive improvement on
quality measures; (3) refine a common
model protocol regarding the prevention
and treatment of sickle cell disease; (4)
examine/address barriers that
individuals and families living with
sickle cell disease face when accessing
quality health care and health
education; (5) evaluate the grantees’
performance in meeting the objectives of
the SCDTDP; and (6) provide HRSA and
Congress with information on the
overall progress of the program.
Likely Respondents: Four regional
grantee sites funded by HRSA under the
SCDTDP will be the respondents for this
data collection activity and submit
responses gathered from State Medicaid
E:\FR\FM\28DEN1.SGM
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80778
Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices
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
Offices and State Medicaid Managed
Care Organizations (MCOs).
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
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
Number of responses
per respondent
Number of
respondents
Form name
Total responses
Average burden per
response
(in hours)
Total burden hours
SCDTDP Data form ......
4
Range:16–80 ...............
Range:64–320 .............
Range:4–6 ...................
Range:256–1920
Total .......................
4
Range:16–80 ...............
Range:64–320 .............
Range:4–6 ...................
Range:256–1920.
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.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–32549 Filed 12–24–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier HHS–OS–0945–0002–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
ACTION:
information, please include the OMB
control number 0945–0002 for
reference.
Proposed Project: Complaint Forms
for Discrimination; Health Information
Privacy Complaints OMB No. 0945–
0002—Extension—Office of Civil Rights
Abstract: The Office for Civil Rights is
seeking an extension on an approval for
a 3-year clearance on a previous
collection. Individuals may file written
complaints with the Office for Civil
Rights when they believe they have
been discriminated against by programs
or entities that receive Federal financial
assistance from the Health and Human
Service or if they believe that their right
to the privacy of protected health
information has been violated. Annual
Number of Respondents frequency of
submission is record keeping and
reporting on occasion.
Notice.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
number 0945–0002, scheduled to expire
on December 31, 2015. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before January 27, 2016.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
SUMMARY:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Forms
Type of respondent
Civil Rights Complaint Form .............
3493
1
45/60
2620
Com-
Individuals or households, Not-forprofit institutions.
Individuals or households, Not-forprofit institutions.
10,286
1
45/60
7715
Total ...........................................
...........................................................
........................
........................
........................
10,335
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Health Information
plaint Form.
Privacy
Terry S. Clark,
Asst Information Collection Clearance
Officer.
[FR Doc. 2015–32551 Filed 12–24–15; 8:45 am]
BILLING CODE 4153–01–P
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]]>Agencies
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80777-80778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32549]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 February 26, 2016.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10C-24, 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 paperwork@hrsa.gov 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: Sickle Cell Disease Treatment
Demonstration Program--Quality Improvement Data Collection.
OMB No. 0915-xxxx-New
Abstract: In response to the growing need for resources devoted to
sickle cell disease and other hemoglobinopathies, the United States
Congress, under Section 712 of the American Jobs Creation Act of 2004
(Pub. L. 108-357) (42 U.S.C. 300b-1 note), authorized a demonstration
program for the prevention and treatment of sickle cell disease (SCD)
to be administered by the Maternal and Child Health Bureau (MCHB) of
the Health Resources and Services Administration (HRSA) in the U.S.
Department of Health and Human Services. The program is known as the
Sickle Cell Disease Treatment Demonstration Program (SCDTDP). The
SCDTDP is designed to improve access to services for individuals with
sickle cell disease, improve and expand patient and provider education,
and improve and expand the continuity and coordination of service
delivery for individuals with sickle cell disease and sickle cell
trait. The specific aims for the program are threefold: (1) Increase
the number of providers treating persons with sickle cell disease, (2)
increase the number of providers prescribing hydroxyurea, and (3)
increase the number of providers knowledgeable about treating sickle
cell disease as well as increase the number of sickle cell patients
that are seen by providers knowledgeable about sickle cell disease.
To achieve the goals and objectives of the program, the SCDTDP uses
quality improvement (QI) methods in a collective impact model which
supports cross-sector collaboration for achieving measurable effects on
major social issues. The collective impact model requires shared
measurement which facilitates tracking progress in a standardized
method in order to promote learning and enhance continuous improvement.
Need and Proposed Use of the Information: The purpose of the
proposed data collection strategy is to implement a system to monitor
the progress of MCHB-funded activities in improving care and health
outcomes for individuals living with sickle cell disease/trait and
meeting the goals of the SCDTDP. Each regional grantee site will be
asked to report on a core set of evidence-based measures related to
healthcare utilization among individuals with sickle cell disease and
the quality of care of the SCD population.
The data collected for the Sickle Cell Disease Treatment
Demonstration Program will consist of administrative medical claims
data collected from State Medicaid Programs and Medicaid Managed Care
Organizations that administer Medicaid on behalf of states. The data is
collected either for or by State Medicaid offices for delivery of
services subject to Medicaid reimbursement.
The data collection strategy will provide an effective and
efficient mechanism to do the following: (1) Assess the improvements in
access to care for sickle cell patients provided by activities in the
SCDTDP; (2) collect, coordinate, and distribute data, best practices,
and findings from regional grantee sites to drive improvement on
quality measures; (3) refine a common model protocol regarding the
prevention and treatment of sickle cell disease; (4) examine/address
barriers that individuals and families living with sickle cell disease
face when accessing quality health care and health education; (5)
evaluate the grantees' performance in meeting the objectives of the
SCDTDP; and (6) provide HRSA and Congress with information on the
overall progress of the program.
Likely Respondents: Four regional grantee sites funded by HRSA
under the SCDTDP will be the respondents for this data collection
activity and submit responses gathered from State Medicaid
[[Page 80778]]
Offices and State Medicaid Managed Care Organizations (MCOs).
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total responses per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
SCDTDP Data form............ 4 Range:16-80.... Range:64-320... Range:4-6...... Range:256-1920
-----------------------------------------------------------------------------------
Total................... 4 Range:16-80.... Range:64-320... Range:4-6...... Range:256-1920.
----------------------------------------------------------------------------------------------------------------
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.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-32549 Filed 12-24-15; 8:45 am]
BILLING CODE 4165-15-P
