Proposed Information Collection Activity; Comment Request, 8324-8325 [2015-03144]
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Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices
OCM will also provide an opportunity
for participating practices to receive
retrospective episode-based
performance payments. After
calculating the benchmark for each
OCM participant, CMS will set a target
price for chemotherapy episodes, which
includes a discount. Participants whose
Medicare expenditures are below the
target price may receive semi-annual
lump-sum performance-based
payments, subject to the achievement of
quality measures. In addition to the
performance-based payments,
participants will receive a PerBeneficiary-Per-Month payment (PBPM)
for Medicare beneficiaries with nearly
all cancer types for each of the 6 months
of the episode. The monthly PBPM
payment is intended to pay for the
enhanced services driven by the
practice requirements, aimed at
transforming practices towards
comprehensive, person-centered, and
coordinated care. The OCM PBPM is
$160 per OCM beneficiary per month for
the duration of each 6-month episode,
and will remain constant for the 5-year
model.
OCM also aims to incorporate other
payers in addition to Medicare, such as
commercial insurers and state Medicaid
agencies. Payers must also be able to
meet the following requirements for
participation in the model:
1. Commit to participation in OCM for
its 5-year duration, and start
performance period no later than 90
days after OCM–FFS’ performance
period.
2. Sign a Memorandum of
Understanding with the Innovation
Center.
3. Enter into agreements with
physician practices participating in
OCM that include requirements to
provide high quality care.
4. Share model methodologies with
the Innovation Center.
5. Provide payments to practices for
enhanced services and performance as
required in the RFA.
6. Align practice quality and
performance measures with OCM, when
possible.
7. Provide participating practices with
aggregate and patient-level data about
payment and utilization for their
patients receiving care in OCM, at
regular intervals.
The OCM start date is expected to be
in spring 2016.
For more specific details regarding
OCM (including the RFA), we refer
applicants to the informational
materials on the Innovation Center Web
site at: https://innovation.cms.gov/
initiatives/Oncology-Care/. Applicants
are responsible for monitoring the Web
site to obtain the most current
information available.
III. Collection of Information
Requirements
Section 1115A(d)(3) of the Act, as
added by section 3021 of the Affordable
Care Act (Pub. L. 111–148), states that
chapter 35 of title 44, United States
Code (the Paperwork Reduction Act of
1995), shall not apply to the testing and
evaluation of models or expansion of
such models under this section.
Consequently, this document need not
be reviewed by the Office of
Management and Budget under the
authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 35).
Dated: December 22, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2015–03060 Filed 2–12–15; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Uniform Project Description
(UPD) Program Narrative Format for
Discretionary Grant Application Forms.
OMB No.: 0970–0139.
Description: The proposed
information collection would renew the
Administration for Children and
Families (ACF) Uniform Project
Description (UPD). The UPD provides a
uniform grant application format for
applicants to submit project information
in response to ACF discretionary
funding opportunity announcements.
ACF uses this information, along with
other OMB-approved information
collections (Standard Forms), to
evaluate and rank applications. Use of
the UPD helps to protect the integrity of
ACF’s award selection process. All ACF
discretionary grant programs are
required to use this application format.
An ACF application consists of general
information and instructions; the
Standard Form 424 series, which
requests basic information, budget
information, and assurances; the Project
Description that requests the applicant
to describe how program objectives will
be achieved; a rationale for the project’s
budgeted costs; and other assurances
and certifications. Guidance for the
content of information requested in the
Project Description is based in OMB
Circular 45 CFR 75.203.
Respondents: Applicants to ACF
Discretionary Funding Opportunity
Announcements.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF Uniform Project Description .....................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Instrument
4,850
1
60
291,000
Estimated Total Annual Burden
Hours: 291,000.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
VerDate Sep<11>2014
16:51 Feb 13, 2015
Jkt 235001
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
ACF specifically requests comments
on: (a) Whether the proposed collection
of information is necessary for the
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proper performance of the functions of
the agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden information to be collected; and
(d) ways to minimize the burden of the
collection of information on
respondents, including through the use
E:\FR\FM\17FEN1.SGM
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Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–03144 Filed 2–13–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0148]
Complicated Urinary Tract Infections:
Developing Drugs for Treatment;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Complicated Urinary Tract
Infections: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of complicated urinary tract
infections (cUTIs). This guidance
finalizes the revised draft guidance of
the same name issued on February 24,
2012.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:51 Feb 13, 2015
Jkt 235001
8325
I. Background
III. Comments
FDA is announcing the availability of
a guidance for industry entitled
‘‘Complicated Urinary Tract Infections:
Developing Drugs for Treatment.’’ The
purpose of this guidance is to assist
sponsors in the development of drugs
for the treatment of cUTIs.
This guidance includes
recommendations for an efficacy
endpoint and noninferiority trial design.
The efficacy endpoint, based on
resolution of clinical symptoms and
eradication of bacteria from the urinary
tract, was derived from previously
conducted clinical trials for the
treatment of cUTI. The guidance
provides a scientific justification for a
noninferiority margin based on
historical observational data compared
to the results of previously conducted
clinical trials. After careful
consideration of comments received in
response to the revised draft guidance
issued on February 24, 2012, important
clarifications about trial populations
and endpoints for cUTI were included
in this guidance. In addition, this
guidance reflects recent developments
in scientific information that pertain to
drugs being developed for the treatment
of cUTI.
Issuance of this guidance fulfills a
portion of the requirements of title VIII,
section 804, of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144), which requires
FDA to review and, as appropriate,
revise not fewer than three guidance
documents per year for the conduct of
clinical trials with respect to
antibacterial and antifungal drugs.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
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IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03100 Filed 2–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Society of Clinical Research
Associates—Food and Drug
Administration; ‘‘Food and Drug
Administration Clinical Trial
Requirements, Regulations,
Compliance and Good Clinical
Practice’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of Public Workshop.
The Food and Drug
Administration (FDA) is announcing the
following conference: Educational
Conference co-sponsored with the
Society of Clinical Research Associates
(SOCRA). The public workshop FDA’s
clinical trial requirements is designed to
aid the Clinical Research Professional’s
understanding of the mission,
responsibilities and authority of the
FDA and to facilitate interaction with
FDA representatives. The program will
focus on the relationships among the
FDA and clinical trial staff, investigators
and institutional review boards (IRB).
Individual FDA representatives will
discuss the informed consent process
and informed consent documents;
regulations relating to drugs, devices
and biologics, as well as inspections of
SUMMARY:
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8324-8325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03144]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Uniform Project Description (UPD) Program Narrative Format
for Discretionary Grant Application Forms.
OMB No.: 0970-0139.
Description: The proposed information collection would renew the
Administration for Children and Families (ACF) Uniform Project
Description (UPD). The UPD provides a uniform grant application format
for applicants to submit project information in response to ACF
discretionary funding opportunity announcements. ACF uses this
information, along with other OMB-approved information collections
(Standard Forms), to evaluate and rank applications. Use of the UPD
helps to protect the integrity of ACF's award selection process. All
ACF discretionary grant programs are required to use this application
format. An ACF application consists of general information and
instructions; the Standard Form 424 series, which requests basic
information, budget information, and assurances; the Project
Description that requests the applicant to describe how program
objectives will be achieved; a rationale for the project's budgeted
costs; and other assurances and certifications. Guidance for the
content of information requested in the Project Description is based in
OMB Circular 45 CFR 75.203.
Respondents: Applicants to ACF Discretionary Funding Opportunity
Announcements.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF Uniform Project Description............. 4,850 1 60 291,000
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 291,000.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
ACF specifically requests comments on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use
[[Page 8325]]
of automated collection techniques or other forms of information
technology. Consideration will be given to comments and suggestions
submitted within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-03144 Filed 2-13-15; 8:45 am]
BILLING CODE 4184-01-P
