60-day FRN

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: http://
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: http://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

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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:

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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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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

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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
respondents

Form name

Number of responses
per respondent

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
Type of respondent

Civil Rights Complaint Form .............

Individuals or households, Not-forprofit institutions.
Individuals or households, Not-forprofit institutions.

Health Information
plaint Form.
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Number of
respondents

Forms

Privacy

Com-

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

...........................................................

Number of
responses per
respondent
1

45/60

2620

10,286

1

45/60

7715

........................

........................

........................

10,335

[FR Doc. 2015–32551 Filed 12–24–15; 8:45 am]
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Total burden
hours

3493

Terry S. Clark,
Asst Information Collection Clearance
Officer.

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Average
burden hours
per response

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