Advisory Council for the Elimination of Tuberculosis: Notice of Charter Renewal, 17764-17765 [2015-07541]
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Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Generic
Clearance for Questionnaire Testing and
Methodological Research for the
Medicare Current Beneficiary Survey
(MCBS); Use: The purpose of this OMB
clearance package is to clear a Generic
Clearance to support an effort to
evaluate the operations and content of
the Medicare Current Beneficiary
Survey (MCBS). The MCBS is a
continuous, multipurpose survey of a
nationally representative sample of
aged, disabled, and institutionalized
Medicare beneficiaries. The MCBS,
which is sponsored by the Centers for
Medicare & Medicaid Services (CMS), is
the only comprehensive source of
information on the health status, health
care use and expenditures, health
insurance coverage, and socioeconomic
and demographic characteristics of the
entire spectrum of Medicare
beneficiaries.
The core of the MCBS is a series of
interviews with a stratified random
sample of the Medicare population,
including aged and disabled enrollees,
residing in the community or in
institutions. Questions are asked about
enrollees’ patterns of health care use,
charges, insurance coverage, and
payments over time. Respondents are
asked about their sources of health care
coverage and payment, their
demographic characteristics, their
health and work history, and their
family living circumstances. In addition
to collecting information through the
core questionnaire, the MCBS collects
information on special topics through
supplements. For example, questions
are asked about enrollees’ income and
assets, access to health care, health and
functional status and satisfaction with
care. Special supplements also focus on
emerging trends in health care. Form
Number: CMS–10549 (OMB control
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number 0938–New); Frequency:
Occasionally; Affected Public:
Individuals or Households; Number of
Respondents: 1,500; Total Annual
Responses: 1,500; Total Annual Hours:
1,117. (For policy questions regarding
this collection contact William Long at
410–786–7927.)
Dated: March 26, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–07322 Filed 4–1–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Availability: Test Tools and
Test Procedures Approved by the
National Coordinator for the ONC HIT
Certification Program
Office of the National
Coordinator for Health Information
Technology (ONC), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
This notice announces the
availability of test tools and test
procedures approved by the National
Coordinator for Health Information
Technology (the National Coordinator)
for the testing of EHR technology to two
2014 Edition Release 2 EHR certification
criteria under the ONC HIT Certification
Program. The approved test tools and
test procedures for the ‘‘optional—
transitions of care’’ certification
criterion (§ 170.314(b)(8)) and the
revised ‘‘view, download, and transmit
to 3rd party’’ certification criterion
(§ 170.314(e)(1)) are identified on the
ONC Web site at: https://healthit.gov/
policy-researchers-implementers/
testing-and-test-methods. The test tools
and test procedures for all the other
2014 Edition Release 2 EHR certification
criteria were previously approved by the
National Coordinator.
FOR FURTHER INFORMATION CONTACT:
Alicia Morton, Director, Office of
Certification, Office of the National
Coordinator for Health Information
Technology, 202–549–7851.
SUPPLEMENTARY INFORMATION: On
January 7, 2011, the Department of
Health and Human Services issued a
final rule establishing a permanent
certification program for the purposes of
testing and certifying health information
technology (‘‘Establishment of the
Permanent Certification Program for
Health Information Technology,’’ 76 FR
1262) (Permanent Certification Program
final rule). The permanent certification
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program was renamed the ‘‘ONC HIT
Certification Program’’ in a final rule
published on September 4, 2012 (77 FR
54163) (‘‘2014 Edition EHR Certification
Criteria final rule’’). In the preamble of
the Permanent Certification Program
final rule, we stated that when the
National Coordinator had approved test
tools and test procedures for
certification criteria adopted by the
Secretary ONC would publish a notice
of availability in the Federal Register
and identify the approved test tools and
test procedures on the ONC Web site.
In the 2014 Edition Release 2 EHR
Certification Criteria final rule the
Secretary adopted additional and
revised certification criteria as part of
the 2014 Edition EHR certification
criteria (79 FR 54430). The National
Coordinator has approved test tools and
test procedures for testing EHR
technology for two 2014 Edition Release
2 EHR certification criteria under the
ONC HIT Certification Program. These
approved test tools and test procedures
for the ‘‘optional—transitions of care’’
certification criterion (§ 170.314(b)(8))
and the revised ‘‘view, download, and
transmit to 3rd party’’ certification
criterion (§ 170.314(e)(1)) are identified
on the ONC Web site at: https://
healthit.gov/policy-researchersimplementers/testing-and-test-methods.
The test tools and test procedures for all
the other 2014 Edition Release 2 EHR
certification criteria were previously
approved by the National Coordinator
(80 FR 4577) and are available for
review at the Web site listed above.
Authority: 42 U.S.C. 300jj–11.
Dated: March 20, 2015.
Lisa Lewis,
Acting National Coordinator for Health
Information Technology
[FR Doc. 2015–07572 Filed 4–1–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Council for the Elimination of
Tuberculosis: Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Advisory Council for the Elimination of
Tuberculosis, Department of Health and
Human Services, has been renewed for
a 2-year period through March 15, 2017.
For information, contact Hazel Dean,
Sc.D., M.P.H., Designated Federal
Officer, Advisory Council for the
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Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
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 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:
Brutrinia D. Cain, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–4633, Brutrinia.Cain@
fda.hhs.gov.
[FR Doc. 2015–07541 Filed 4–1–15; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE CODE 4163–18–P
I. Background
Elimination of Tuberculosis,
Department of Health and Human
Services, 1600 Clifton Road NE.,
Mailstop E–10, Atlanta, Georgia 30333,
telephone 404/639–8000 or fax 404/
639–8600.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0045]
Abuse-Deterrent Opioids—Evaluation
and Labeling; 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 ‘‘Abuse-Deterrent Opioids—
Evaluation and Labeling’’. This
guidance explains FDA’s current
thinking about the studies that should
be conducted to demonstrate that a
given formulation has abuse-deterrent
properties. This guidance also makes
recommendations about how those
studies should be performed and
evaluated, and discusses how to
describe those studies and their
implications in product labeling. It is
intended to assist sponsors who wish to
develop opioid drug products with
potentially abuse-deterrent properties
and is not intended to apply to products
that are not opioids or opioid products
that do not have the potential for abuse.
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 Building,
4th Floor, Silver Spring, MD 20993–
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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FDA is announcing the availability of
a guidance for industry entitled ‘‘AbuseDeterrent Opioids—Evaluation and
Labeling.’’ Prescription opioid products
are an important component of modern
pain management. However, abuse and
misuse of these products have created a
serious and growing public health
problem. One potentially important step
towards the goal of creating safer opioid
analgesics has been the development of
opioids that are formulated with some
properties intended to deter abuse. FDA
considers development of these
products a high public health priority.
The guidance is intended to provide
industry with a framework for
evaluating and labeling abuse-deterrent
opioid products. The guidance
discusses how the potentially abusedeterrent properties of an opioid
analgesic formulated to deter abuse
should be studied, specifically
addressing in vitro studies,
pharmacokinetic studies, clinical abuse
potential studies, and postmarket
studies. The guidance also describes the
types of information that may be
suitable for inclusion in labeling.
Providing a clear framework for the
evaluation and labeling of the abusedeterrent properties of opioid analgesics
intended to deter abuse should help to
incentivize the development of safer,
less abusable opioid analgesics, and
should also facilitate the dissemination
of fair and accurate information
regarding such products.
In the Federal Register of January 14,
2013 (78 FR 2676), FDA announced the
availability of a draft version of this
guidance and provided interested
parties an opportunity to submit
comments. The Agency has carefully
reviewed and considered the comments
it received in developing this final
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17765
version of the guidance. The Agency has
made revisions to the guidance as it
deemed appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the evaluation and
labeling of abuse-deterrent opioids. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Comments
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.
III. 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: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07562 Filed 4–1–15; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0005]
Agency Information Collection
Activities: Application for Family Unity
Benefits, Form I–817; Revision of a
Currently Approved Collection
U.S. Citizenship and
Immigration Services (USCIS),
Department of Homeland Security
(DHS).
ACTION: 60-Day notice.
AGENCY:
DHS, USCIS invites the
general public and other Federal
agencies to comment upon this
proposed revision of a currently
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17764-17765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07541]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Council for the Elimination of Tuberculosis: Notice of
Charter Renewal
This gives notice under the Federal Advisory Committee Act (Pub. L.
92-463) of October 6, 1972, that the Advisory Council for the
Elimination of Tuberculosis, Department of Health and Human Services,
has been renewed for a 2-year period through March 15, 2017.
For information, contact Hazel Dean, Sc.D., M.P.H., Designated
Federal Officer, Advisory Council for the
[[Page 17765]]
Elimination of Tuberculosis, Department of Health and Human Services,
1600 Clifton Road NE., Mailstop E-10, Atlanta, Georgia 30333, telephone
404/639-8000 or fax 404/639-8600.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2015-07541 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4163-18-P
