60-day FRN

Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices
the Administration for Children and
Families.

4730, Silver Spring, MD 20993–0002,
301–796–5850.

Robert Sargis,
Reports Clearance Officer.

I. Background

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]

Bioequivalence Recommendations for
Risperidone; Draft Guidance for
Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry on risperidone injection
entitled ‘‘Draft Guidance on
Risperidone.’’ The recommendations
provide specific guidance on the design
of studies to support abbreviated new
drug applications (ANDAs) for
risperidone injection. This draft
guidance is the second revision of a
previously issued draft guidance on the
same subject.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 27, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to http://
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:
Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm.

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SUMMARY:

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In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry,
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
site at http://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm. As
described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific bioequivalence (BE)
recommendations and provide a
meaningful opportunity for the public to
consider and comment on those
recommendations. This notice
announces the availability of a second
revision of draft BE recommendations
for risperidone injection.
FDA initially approved new drug
application 021346 for Risperdal Consta
Long-Acting Injection in October 2003.
There are no approved ANDAs for this
product. In February 2010, FDA issued
a draft guidance for industry on BE
recommendations for generic
risperidone injection. In August 2013,
we issued a revised draft guidance on
the same subject. We are now issuing a
second revision of the draft guidance for
industry on BE recommendations for
generic risperidone injection (Draft
Guidance on Risperidone).
In February 2011, Johnson & Johnson
Pharmaceutical Research and
Development, LLC, manufacturer of
Risperdal Consta, the reference listed
drug, submitted a citizen petition
requesting that FDA require that any
ANDA referencing Risperdal Consta
meet certain requirements, including
requirements related to demonstrating
BE (Docket No. FDA–2011–P–0086).
FDA is reviewing the issues raised in
the petition. FDA will consider any
comments on the revised draft BE
recommendations in responding to the
petition.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for risperidone injection. 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.

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II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or http://
www.regulations.gov.
Dated: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
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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 Information
Collection Request must be received no
later than July 27, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov 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
SUMMARY:

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Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices

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:
Medicare Rural Hospital Flexibility
Grant Program Performance OMB No.
0915–0363–Rev.
Abstract: The Medicare Rural
Hospital Flexibility Program (Flex) is
authorized by Section 1820 of the Social
Security Act (42 U.S.C. 1395i–4), as
amended. The purpose of Flex is
engaging state designated entities in
activities relating to planning and
implementing rural health care plans
and networks; designating facilities as
Critical Access Hospitals (CAHs);
providing support for CAHs for quality
improvement, quality reporting,
performance improvements, and
benchmarking; and integrating rural
emergency medical services (EMS).
Specifically, the Flex program
provides funding for states to support
technical assistance activities in
hospitals to improve the quality of
health care provided by CAHs; improve
the financial and operational outcomes
of CAHs; improve the Community
Health and Emergency Medical Service
(EMS) Needs of CAHs; enhance the
health of rural communities through

community/population health
improvement; improve identification
and management of Time Critical
Diagnoses (TCD) and engage EMS
capacity and performance in Rural
Communities; assist in the conversion of
qualified small rural hospitals to CAH
status; and support the financial and
operational transition to value based
models and health care transformation
models in the health care system. State
designated Flex Programs will act as a
resource and focal point for these
activities, ensuring residents in rural
communities have access to high quality
health care services. Measures and goals
identified in the Flex program take into
consideration existing measures and
priorities HHS has set for hospitals, to
avoid both conflict and duplication of
efforts.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the Flex program
and to enable HRSA to provide
aggregate program data required by
Congress under the Government
Performance and Results Act (GPRA) of
2010. These measures cover principal
topic areas of interest to the Federal
Office of Rural Health Policy (FORHP),
including: (a) Quality reporting; (b)
quality improvement interventions; (c)
financial and operational improvement
initiatives; (d) population health
management; and (e) innovative care
models. Several measures will be used
Number of
respondents

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Form name

Number of
responses per
respondent

for this program and will inform
FORHP’s progress toward meeting the
goals set in GPRA. Furthermore,
obtaining this information is important
for identifying and understanding
programmatic improvement across
program areas, as well as guiding future
iterations of the Flex Program and
prioritizing areas of need and support.
Likely Respondents: Respondents will
be the Flex Program coordinator for
each state participating in the Flex
Program. There are currently 45 states
participating in the Flex Program.
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:
Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Medicare Rural Hospital Flexibility Grant Program .............

45

1

45

216

9,720

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

45

1

45

216

9,720

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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Advisory Committee on
Interdisciplinary, Community-Based
Linkages; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on
Interdisciplinary, Community-Based
Linkages (ACICBL).
Dates and Times: June 17, 2015 (9:30 a.m.–
4:30 p.m.).
Place: Webinar/Conference Call Format.

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Status: The meeting will be open to the
public.
Purpose: The ACICBL provides advice and
recommendations to the Secretary of the
Department of Health and Human Services
(Secretary) concerning policy, program
development, and other matters of
significance related to interdisciplinary,
community-based training grant programs
authorized under sections 750–759, title VII,
part D of the Public Health Service Act, as
amended by the Affordable Care Act. The
following sections are included under this
part: 751—Area Health Education Centers;
752—Continuing Education Support for
Health Professionals Serving in Underserved
Communities; 753—Geriatrics Workforce
Enhancement; 754—Quentin N. Burdick
Program for Rural Interdisciplinary Training;
755—Allied Health and Other Disciplines;
756—Mental and Behavioral Health
Education and Training, and 759—Program
for Education and Training in Pain Care.

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