Proposed Data Collections Submitted for Public Comment and Recommendations, 15127-15129 [2014-05880]
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Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Parag Patel, D.O., Advocate Health
Care Network d/b/a Advocate Health
Care: Based on an investigation
conducted by Advocate Health Care
Network d/b/a Advocate Health Care
(Advocate Health Care) and additional
analysis conducted by ORI in its
oversight review, ORI and Advocate
Health Care found that Dr. Parag Patel,
Cardiologist, Department of Medicine,
Advocate Health and Hospitals
Corporation d/b/a Advocate Lutheran
General Hospital, Park Ridge, Illinois,
engaged in research misconduct in
research supported by National Heart,
Lung, and Blood Institute (NHLBI),
National Institutes of Health (NIH),
grant U01 HL089458.
ORI and Advocate Health Care found
that the Respondent engaged in research
misconduct by directing or intimidating
fellows and others to influence left
ventricular ejection fraction (LVEF)
scores of ≤ 35% and requesting
attending physicians to reassess scores
of LVEF to be reported as ≤ 35% for
research subjects after being diagnosed
with acute myocardial infarction,
thereby causing and being responsible
for falsification of research records.
These falsifications made subjects
eligible for enrollment into the ‘‘Vest
Prevention of Early Sudden Death Trial’’
(VEST) when they otherwise may not
have been eligible.
The Respondent, Advocate Health
Care, and the U.S. Department of Health
and Human Services (HHS) want to
conclude this matter without further
expenditure of time or other resources
and have entered into a Voluntary
Settlement Agreement (Agreement) to
resolve this matter. Respondent neither
admits nor denies ORI’s and Advocate
Health Care’s findings of research
misconduct. This settlement does not
constitute an admission of liability on
the part of the Respondent.
Dr. Patel has voluntarily agreed for a
period of two (2) years, beginning on
February 21, 2014:
(1) To have any U.S. Public Health
Service (PHS)-supported research in
which he is involved be supervised;
Respondent agreed that prior to the
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SUMMARY:
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submission of an application for PHS
support for a research project on which
the Respondent’s participation is
proposed and prior to Respondent’s
participation in any capacity on PHSsupported 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 as outlined below;
Respondent agreed that he shall not
participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI;
Respondent agreed to maintain
responsibility for compliance with the
agreed-upon supervision plan;
(2) That the requirements for
Respondent’s supervision plan are as
follows:
• A committee of two to three
qualified physicians at the institution’s
discretion, who are familiar with
Respondent’s field of research, but not
including Respondent’s supervisor or
collaborators, will provide oversight and
guidance; the committee will review
primary data from Respondent’s
participation in PHS-supported research
on a quarterly basis and submit a report
to ORI at six (6) month intervals setting
forth the committee’s meeting dates,
Respondent’s compliance with
appropriate research standards, and
confirming the integrity of Respondent’s
research contribution; and
• The committee will conduct an
advance review of any PHS grant
applications (including supplements,
resubmissions, etc.), manuscripts
reporting PHS-funded research
submitted for publication, and abstracts;
the review will include a discussion
with Respondent of the primary data
represented in those documents and
will include a certification to ORI that
the data presented in the proposed
application/publication are supported
by the research record;
(3) That any institution employing
him shall submit, in conjunction with
each application for PHS funds, or
report, manuscript, or abstract involving
PHS-supported 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
(4) To exclude himself voluntarily
from serving in any advisory capacity to
PHS including, but not limited to,
service on any PHS advisory committee,
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15127
board, and/or peer review committee, or
as a consultant.
FOR FURTHER INFORMATION CONTACT:
Acting Director, Office of Research
Integrity, 1101 Wootton Parkway,
Suite 750, Rockville, MD 20852, (240)
453–8800.
Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2014–05921 Filed 3–17–14; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–0263]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Leroy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited 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)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Requirements for the Importation of
Nonhuman Primates into the United
States—Revision—(OMB No. 0920–
0263, expiration date: 4/30/2016)—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Division of Global Migration and
Quarantine (DGMQ), Centers for Disease
Control and Prevention (CDC).
E:\FR\FM\18MRN1.SGM
18MRN1
15128
Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / Notices
Background and Brief Description
CDC is submitting this revision to
obtain authority to collect electronic
information from importers/filers on
nonhuman primate and nonhuman
primate products over which CDC has
authority, notably those found in 42
CFR part 71. This request is consistent
with requirements of the Security and
Accountability for Every (SAFE) Port
Act that states that all agencies that
require documentation for clearing or
licensing the importation and
exportation of cargo participate in the
International Trade Data System (ITDS),
and is also consistent with CDC
authorities under Section 361 of the
Public Health Service Act (PHSA) (42
U.S.C. 264).
This electronic data is specified by
CDC using Partner Government Agency
(PGA) Message Sets and is collected by
Customs and Border Protection (CBP)
from importers/filers when they submit
the information needed through
International Trade Data System ITDS
and the Automated Commercial
Environment (ITDS/ACE) to clear an
import. CDC has developed a PGA
message set for each regulated import
specified in 42 CFR part 71, and each
the amount of 798 hours. Of these
additional hours, 608 hours pertain to
requests for CDC Message Set data via
ITDS/ACE, and 190 hours pertain to
required statements/documentation of
products being rendered non-infectious.
CDC is maintaining its authority to
collect hard copies of required
documentation, as currently authorized
by the Office of Management and
Budget (OMB), because the use of ITDS/
ACE will not be required for imports
entering the United States until a later
date. CDC will accept both hard copy
and electronic filing of import-related
documentation until the use of ACE is
required for cargo entering the United
States.
Respondents to this data collection
have not changed and remain new and
registered importers of live nonhuman
primates and importers of nonhuman
primate products. The number of
additional hours requested for this
information collection total 798 hours.
The total burden for this information
collection request is 943 hours. There
are no costs to respondents except for
their time to complete the forms, and
complete and submit data and
documentation.
PGA Message Set includes only those
data requirements necessary in order to
determine whether or not a CDCregulated import poses a risk to public
health and that the importer has met
CDC’s regulatory requirements for entry.
CDC included the PGA Message Sets for
review because there is no set form or
format for the electronic submission of
import related data to CBP and CDC.
CDC is permitted access to the
Automated Commercial Environment
(ACE) data pursuant to 6 CFR 29.8(b)
and 49 CFR 1520.11(b), which permit
federal employees with a need to know
to have access to this data.
CDC is maintaining its authority to
collect hard copies of required
documentation, as currently authorized
by the Office of Management and
Budget, because the use of ITDS/ACE
will not be required for imports entering
the United States until a later date. CDC
will accept both hard copy and
electronic filing of import-related
documentation until the use of ACE is
required for cargo entering the United
States.
Through this revision, CDC is
requesting a net increase in the
estimated number of burden hours in
ESTIMATED ANNUALIZED BURDEN HOURS
Form name/CFR reference
Nonhuman Primate Importer .............
CDC 75.10A Application for Registration as an Importer of
Nonhuman Primates (New Importer).
CDC 75.10A Application for Registration as an Importer of
Nonhuman Primates (Re-Registration).
71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (New Importer).
71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (Registered Importer).
Recordkeeping and reporting requirements for importing NHPs:
Notification of shipment arrival
71.53(n) (no form).
Quarantine release 71.53(l) (No
form).
71.53 (v) Form: Filovirus Diagnostic
Specimen Submission Form for
Non-human Primate Materials.
CDC Partner Government Agency
Message Set for Importing Live
Nonhuman Primates.
CDC Partner Government Agency
Message Set for Importing
Nonhuman Primate Products.
Documentation of Non-infectiousness 71.53(t).
..........................................................
Nonhuman Primate Importer .............
Nonhuman Primate Importer .............
Nonhuman Primate Importer .............
Nonhuman Primate Importer .............
Nonhuman Primate Importer .............
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Nonhuman Primate Importer .............
Importer/Filer .....................................
Importer/Filer .....................................
Importer/Filer .....................................
Total ...........................................
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Fmt 4703
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Type of respondent
Total burden
hours
1
1
10/60
1
12
1
10/60
2
1
1
10
10
12
1
30/60
6
25
6
15/60
38
25
6
15/60
38
10
15
20/60
50
150
1
15/60
38
2,280
1
15/60
570
2,280
1
5/60
190
........................
........................
........................
943
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18MRN1
15129
Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / Notices
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–05880 Filed 3–17–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Federal Strategic Action Plan on
Services for Victims of Human
Trafficking: Enhancing the Health Care
System’s Response to Human
Trafficking
OMB No.: New Collection
Description:
In 2013, the U.S. Department of
Health and Human Services co-chaired
an inter-agency process with the
Departments of Justice and Homeland
Security to create the first Federal
Strategic Action Plan on Services for
Victims of Human Trafficking in the
United States. The Plan addresses the
needs for the implementation of
coordinated, effective, culturally
appropriate and trauma informed care
for victims of human trafficking. The
purpose of this initiative is to develop
a pilot training project that will
strengthen the health systems’ response
to human trafficking in four key ways
1. Increase knowledge about human
trafficking among health care providers;
2. Build the capacity of health care
providers to deliver culturally
appropriate and trauma-informed care
to victims of human trafficking;
3. Increase the identification of
victims of human trafficking; and
4. Increase services to survivors of
human trafficking.
The evaluation will measure
immediate outcomes, e.g., from preintervention to post-intervention, as
well as intermediate outcomes at a 3
month post intervention.
Respondents:
The target audience for training and
evaluation will be 200 health care
providers from hospitals, clinics, and
private health practices. The health care
providers will be from federal, state/
territorial, and local health departments,
the Veterans’ Administration,
professional associations, and tribal
institutions.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Estimated Total Annual Burden
Hours: 256
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.
The Department 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)
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18:34 Mar 17, 2014
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200
200
200
40
1
1
1
1
0.40
0.40
0.40
0.40
80.00
80.00
80.00
16.00
........................
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Pre-training survey ...........................................................................................
Post-training survey .........................................................................................
Email Follow-up ...............................................................................................
Telephone Follow-up .......................................................................................
Number of
responses per
respondent
........................
........................
256.00
ways to minimize the burden of the
collection of information on
respondents, including through the use
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. 2014–05824 Filed 3–17–14; 8:45 am]
BILLING CODE 4184–01–P
Food and Drug Administration
[Docket No. FDA–2013–N–0878]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Premarket Notification for a New
Dietary Ingredient
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On
November 25, 2013, the Agency
submitted a proposed collection of
information entitled ‘‘Premarket
Notification for a New Dietary
Ingredient’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0330. The
approval expires on February 28, 2015.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
that a collection of information entitled
‘‘Premarket Notification for a New
Dietary Ingredient’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
Sfmt 4703
E:\FR\FM\18MRN1.SGM
18MRN1
]]>Agencies
[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15127-15129]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-14-0263]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta,
GA 30333 or send an email to omb@cdc.gov.
Comments are invited 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) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Requirements for the Importation of Nonhuman Primates into the
United States--Revision--(OMB No. 0920-0263, expiration date: 4/30/
2016)--National Center for Emerging and Zoonotic Infectious Diseases
(NCEZID), Division of Global Migration and Quarantine (DGMQ), Centers
for Disease Control and Prevention (CDC).
[[Page 15128]]
Background and Brief Description
CDC is submitting this revision to obtain authority to collect
electronic information from importers/filers on nonhuman primate and
nonhuman primate products over which CDC has authority, notably those
found in 42 CFR part 71. This request is consistent with requirements
of the Security and Accountability for Every (SAFE) Port Act that
states that all agencies that require documentation for clearing or
licensing the importation and exportation of cargo participate in the
International Trade Data System (ITDS), and is also consistent with CDC
authorities under Section 361 of the Public Health Service Act (PHSA)
(42 U.S.C. 264).
This electronic data is specified by CDC using Partner Government
Agency (PGA) Message Sets and is collected by Customs and Border
Protection (CBP) from importers/filers when they submit the information
needed through International Trade Data System ITDS and the Automated
Commercial Environment (ITDS/ACE) to clear an import. CDC has developed
a PGA message set for each regulated import specified in 42 CFR part
71, and each PGA Message Set includes only those data requirements
necessary in order to determine whether or not a CDC-regulated import
poses a risk to public health and that the importer has met CDC's
regulatory requirements for entry. CDC included the PGA Message Sets
for review because there is no set form or format for the electronic
submission of import related data to CBP and CDC. CDC is permitted
access to the Automated Commercial Environment (ACE) data pursuant to 6
CFR 29.8(b) and 49 CFR 1520.11(b), which permit federal employees with
a need to know to have access to this data.
CDC is maintaining its authority to collect hard copies of required
documentation, as currently authorized by the Office of Management and
Budget, because the use of ITDS/ACE will not be required for imports
entering the United States until a later date. CDC will accept both
hard copy and electronic filing of import-related documentation until
the use of ACE is required for cargo entering the United States.
Through this revision, CDC is requesting a net increase in the
estimated number of burden hours in the amount of 798 hours. Of these
additional hours, 608 hours pertain to requests for CDC Message Set
data via ITDS/ACE, and 190 hours pertain to required statements/
documentation of products being rendered non-infectious.
CDC is maintaining its authority to collect hard copies of required
documentation, as currently authorized by the Office of Management and
Budget (OMB), because the use of ITDS/ACE will not be required for
imports entering the United States until a later date. CDC will accept
both hard copy and electronic filing of import-related documentation
until the use of ACE is required for cargo entering the United States.
Respondents to this data collection have not changed and remain new
and registered importers of live nonhuman primates and importers of
nonhuman primate products. The number of additional hours requested for
this information collection total 798 hours. The total burden for this
information collection request is 943 hours. There are no costs to
respondents except for their time to complete the forms, and complete
and submit data and documentation.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name/CFR reference respondents responses per response (in hours
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonhuman Primate Importer...................... CDC 75.10A Application for Registration 1 1 10/60 1
as an Importer of Nonhuman Primates
(New Importer).
Nonhuman Primate Importer...................... CDC 75.10A Application for Registration 12 1 10/60 2
as an Importer of Nonhuman Primates
(Re-Registration).
Nonhuman Primate Importer...................... 71.53(g)(1)(iii) and (h) Documentation 1 1 10 10
and Standard Operating Procedures (no
form) (New Importer).
Nonhuman Primate Importer...................... 71.53(g)(1)(iii) and (h) Documentation 12 1 30/60 6
and Standard Operating Procedures (no
form) (Registered Importer).
Nonhuman Primate Importer...................... Recordkeeping and reporting 25 6 15/60 38
requirements for importing NHPs:
Notification of shipment arrival
71.53(n) (no form).
Nonhuman Primate Importer...................... Quarantine release 71.53(l) (No form).. 25 6 15/60 38
Nonhuman Primate Importer...................... 71.53 (v) Form: Filovirus Diagnostic 10 15 20/60 50
Specimen Submission Form for Non-human
Primate Materials.
Importer/Filer................................. CDC Partner Government Agency Message 150 1 15/60 38
Set for Importing Live Nonhuman
Primates.
Importer/Filer................................. CDC Partner Government Agency Message 2,280 1 15/60 570
Set for Importing Nonhuman Primate
Products.
Importer/Filer................................. Documentation of Non-infectiousness 2,280 1 5/60 190
71.53(t).
Total...................................... ....................................... .............. .............. .............. 943
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 15129]]
Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-05880 Filed 3-17-14; 8:45 am]
BILLING CODE 4163-18-P
