Agency Information Collection Activities: Proposed Collection: Public Comment Request, 31051-31052 [2015-13088]
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Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
principles in the International
Conference on Harmonisation (ICH) Q9,
and knowledge management as defined
in ICH Q10) by the regulated industry.
This will also provide the FDA
pathways to better regulate postapproval
changes by utilizing more flexibility and
risk-based principles, as envisioned by
the pharmaceutical product quality
initiatives laid out in FDA’s
‘‘Pharmaceutical Current Good
Manufacturing Practices (cGMPs) for the
21st Century—A Risk Based Approach’’
(see https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
Manufacturing/QuestionsandAnswerson
CurrentGoodManufacturingPracticesc
GMPforDrugs/UCM071836).
This draft guidance is being issued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The draft guidance, when finalized, will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 current thinking of FDA
on ‘‘Established Conditions: Reportable
CMC Changes for Approved Drug and
Biologic Products.’’ 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.
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III. Paperwork Reduction Act
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 211, 314,
and 601 have been approved under
OMB control numbers 0910–0139,
0910–0001, and 0910–0338,
respectively.
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, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
VerDate Sep<11>2014
14:50 May 29, 2015
Jkt 235001
Information/default.htm, or https://
www.regulations.gov.
Dated: May 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–13104 Filed 5–29–15; 8:45 am]
BILLING CODE 4164–01–P
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 31, 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
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 594–4306.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Outreach Benefits Counseling
Program Measures OMB No. 0915–
XXXX—New.
Abstract: The Rural Outreach Benefits
Counseling Program (Benefits
Counseling Program) is authorized by
section 330A(e) of the Public Health
Service (PHS) Act (42 U.S.C. 254c(e)), as
SUMMARY:
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31051
amended, to ‘‘promote rural health care
services outreach by expanding the
delivery of health care services to
include new and enhanced services in
rural areas.’’ The purpose of the 3-year
Benefits Counseling Program is to
expand outreach, education, and
enrollment efforts to eligible uninsured
and newly insured individuals and
families in rural communities.
The overarching goals of this grant
funding are to coordinate and conduct
innovative outreach activities through a
strong consortium in order to: (1)
Identify and enroll uninsured
individuals and families who are
eligible for public health insurance,
such as Medicare, Medicaid, and the
Children’s Health Insurance Program,
and qualified health plans offered
through Health Insurance Marketplaces
and/or private health insurance plans in
rural communities and (2) educate the
newly insured individuals and families
in rural communities about their health
insurance benefits, help connect them to
primary care and preventive services to
which they now have access, and help
them retain their health insurance
coverage.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act (GPRA) of 1993. These
measures cover the principal topic areas
of interest to the Federal Office of Rural
Health Policy (FORHP), including: (a)
Access to care; (b) population
demographics; (c) staffing; (d)
consortium/network; (e) sustainability;
and (f) benefits counseling process and
outcomes. Several measures will be
used for the Benefits Counseling
Program. All measures will speak to
FORHP’s progress toward meeting the
goals set.
Likely Respondents: The respondents
will be recipients of the Rural Outreach
Benefits Counseling Program grant
funding.
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
E:\FR\FM\01JNN1.SGM
01JNN1
31052
Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
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.
Number of
respondents
Form name
Number of
responses per
respondent
Total Estimated Annualized burden
hours:
Total
responses
Average
urden per
response
in hours)
Total burden
hours
Rural Outreach Benefits Counseling Grant Program Measures ...................................................................................
10
1
10
1.5
15
Total ..............................................................................
10
1
10
1.5
15
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. 2015–13088 Filed 5–29–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Ryan Asherin, Oregon Health
Authority: Based on the report of an
investigation conducted by the Oregon
Health Authority (OHA) and analysis
conducted by ORI in its oversight
review, ORI found that Ryan Asherin,
former Surveillance Officer and
Principal Investigator, OHA, Public
Health Division engaged in research
misconduct in research supported by
the Centers for Disease Control and
Prevention (CDC) Emerging Infections
Program Grant 5U01CI00306–05.
ORI found that the Respondent
engaged in research misconduct by
falsifying and/or fabricating data that
were included in the CDC research
record, a manuscript submitted to JAMA
Intern Med in January 2013, a published
CDC report (CDC Morbidity and
Mortality Weekly Report 61(09):157–
162, March 2012), and presentations in
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SUMMARY:
VerDate Sep<11>2014
14:50 May 29, 2015
Jkt 235001
2012 to CDC and at the 11th Biennial
Congress of the Anaerobe Society.
ORI found that the Respondent
falsified and/or fabricated fifty-six (56)
case report forms (CRFs) while
acquiring data on the incidence of
Clostridium difficile infections in
Klamath County, Oregon. Specifically,
the Respondent (1) fabricated responses
to multiple questions on the CRFs for
patient demographic data, patient health
information, and Clostridium difficile
infection data, including the diagnoses
of toxic megacolon and ileus and the
performance of a colectomy, with no
evidence in patient medical records to
support the responses; and (2) falsified
the CRFs by omitting data on the CRFs
that clearly were included in patient
medical records.
Mr. Asherin has entered into a
Voluntary Settlement Agreement
(Agreement) and has voluntarily agreed
for a period of two (2) years, beginning
on May 12, 2015:
including, but not limited to, service on any
PHS advisory committee, board, and/or peer
review committee, or as a consultant.
(1) To have his research supervised;
Respondent agrees that prior to submission of
an application for U.S. Public Health Service
(PHS) support for a research project on which
the Respondent’s participation is proposed
and prior to Respondent’s participation in
any capacity on PHS-supported research,
Respondent shall ensure that a plan for
supervision of Respondent’s duties is
submitted to ORI for approval; the
supervision plan must be designed to ensure
the scientific integrity of Respondent’s
research contribution; Respondent agrees that
he will not participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI;
Respondent agrees to maintain responsibility
for compliance with the agreed upon
supervision plan;
(2) that any institution employing him
must submit, in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported research in which Respondent is
involved, a certification to ORI that the data
provided by Respondent are based on actual
experiments or are otherwise legitimately
derived and that the data, procedures, and
methodology are accurately reported in the
application, report, manuscript, or abstract;
and
(3) to exclude himself voluntarily from
serving in any advisory capacity to PHS
SUMMARY:
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Fmt 4703
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FOR FURTHER INFORMATION CONTACT:
Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453–
8200.
Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015–13054 Filed 5–29–15; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the 2015 Hurricane Sandy
Conference: Translating Research Into
Practice
Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) Office of the
Assistant Secretary for Preparedness
and Response (ASPR) is hereby giving
notice that ASPR will convene a
Hurricane Sandy Conference:
Translating Research into Practice
public meeting on August 10–11, 2015.
The purpose of the meeting is to broadly
share, with interested stakeholders,
outcomes of Hurricane Sandy recovery
science research and training projects
awarded under ASPR FOAs EP–HIT–
13–001 and EP–HIT–14–001, Centers for
Disease Control and Prevention (CDC)
FOAs TP13–001 and OH13–002, and
National Institute of Environmental
Health Sciences (NIEHS) FOAs RFA–
ES–13–008 and NOT–ES–13–003.
Meeting participants will discuss
opportunities to build a community of
practice around Hurricane Sandy
recovery research and the path forward
for translating Hurricane Sandy
recovery science research results into
practice; highlight Hurricane Sandy
recovery science grants as a model for
disaster research science preparedness;
and demonstrate the benefit of
E:\FR\FM\01JNN1.SGM
01JNN1
]]>Agencies
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31051-31052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13088]
-----------------------------------------------------------------------
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 July 31, 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 the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 594-4306.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Rural Outreach Benefits
Counseling Program Measures OMB No. 0915-XXXX--New.
Abstract: The Rural Outreach Benefits Counseling Program (Benefits
Counseling Program) is authorized by section 330A(e) of the Public
Health Service (PHS) Act (42 U.S.C. 254c(e)), as amended, to ``promote
rural health care services outreach by expanding the delivery of health
care services to include new and enhanced services in rural areas.''
The purpose of the 3-year Benefits Counseling Program is to expand
outreach, education, and enrollment efforts to eligible uninsured and
newly insured individuals and families in rural communities.
The overarching goals of this grant funding are to coordinate and
conduct innovative outreach activities through a strong consortium in
order to: (1) Identify and enroll uninsured individuals and families
who are eligible for public health insurance, such as Medicare,
Medicaid, and the Children's Health Insurance Program, and qualified
health plans offered through Health Insurance Marketplaces and/or
private health insurance plans in rural communities and (2) educate the
newly insured individuals and families in rural communities about their
health insurance benefits, help connect them to primary care and
preventive services to which they now have access, and help them retain
their health insurance coverage.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data to the program and to
enable HRSA to provide aggregate program data required by Congress
under the Government Performance and Results Act (GPRA) of 1993. These
measures cover the principal topic areas of interest to the Federal
Office of Rural Health Policy (FORHP), including: (a) Access to care;
(b) population demographics; (c) staffing; (d) consortium/network; (e)
sustainability; and (f) benefits counseling process and outcomes.
Several measures will be used for the Benefits Counseling Program. All
measures will speak to FORHP's progress toward meeting the goals set.
Likely Respondents: The respondents will be recipients of the Rural
Outreach Benefits Counseling Program grant funding.
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
[[Page 31052]]
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:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Rural Outreach Benefits 10 1 10 1.5 15
Counseling Grant Program
Measures.......................
-------------------------------------------------------------------------------
Total....................... 10 1 10 1.5 15
----------------------------------------------------------------------------------------------------------------
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. 2015-13088 Filed 5-29-15; 8:45 am]
BILLING CODE 4165-15-P
