Agency Forms Undergoing Paperwork Reduction Act Review, 21126-21128 [2013-08150]
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21126
Federal Register / Vol. 78, No. 68 / Tuesday, April 9, 2013 / Notices
with L92H, R191Q, and wtNE, when
they were cells transfected with I31T,
P110L, and G185R mutants; Figure 5B
as HL–60 cells transfected with wtNE,
mutNE, and EGFP, when they were cells
transfected with P110L, I31T, and INE;
Figure 6B as HL–60 cells transfected
with G185R, mock, D145–152, and
P110L NE mutants, when they were
cells transfected with I31T, P110L,
G185R, and 32. The false +-actin
Western blot in Figure 6B was also
included in HL73063–01, Figure 8
(where the I31Tlane was labeled
correctly), and HL79615–01, Figure 7.
4. Falsified the reported methodology
for flow cytometry experiments in
Figure 4A, NEM, Figures 1 and 2, and
Tables 2 and 3, CMA, and Figures 4, 5,
and 6, ISB, to validate the key
hypothesis showing accelerated
apoptosis in SCN and CN patients. The
methodology claimed that flow
cytometry experiments were gated for
GFP+ populations, or that cell purity
was greater than 96%, when based on
the available original records, the
experiments were not performed as
stated.
5. Falsified Figure 2, CMA, Figure 2,
HL73063–01, Figure 3, HL79615–01,
and Figure 5, CA89135–01A1,
demonstrating that the overnight
cultures of CD34+ and CD33+ bone
marrow cells from SCN/AML patients
showed normal cell survival, and only
the CD15+ overnight cultures showed
accelerated apoptosis, when the actual
record available contradicted this result.
Respondent used flow cytometry data
files to generate histograms with the
desired result to support the hypothesis
that the progression from SCN to
leukemia (AML) involves acquired G–
CSFR mutations that override the proapoptotic effect of the NE mutations in
primitive progenitor cells.
Dr. Aprikyan has entered into a
Settlement Agreement in which he
denied ORI’s findings of research
misconduct based on the UW Faculty
Adjudication Hearing Panel decision.
The settlement is not an admission of
liability on the part of the Respondent.
Respondent entered into the Agreement
solely because contesting the findings
would cause him undue financial
hardship and stress, lead to lengthy and
costly appellate proceedings, and he
wished to seek finality. Respondent
agreed not to appeal the ORI findings of
research misconduct set forth above. He
has agreed, beginning on March 12,
2013:
(1) If within two (2) years from the
effective date of the Agreement,
Respondent receives or applies for U.S.
Public Health Service (PHS) support,
Respondent agreed to have his research
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16:19 Apr 08, 2013
Jkt 229001
supervised for a period of two (2) years;
Respondent agreed that prior to the
submission of an application for PHS
support for a research project on which
his participation is proposed and prior
to his participation in any capacity on
PHS-supported research, Respondent
shall ensure that a plan for supervision
of his duties is submitted to ORI for
approval; the supervision plan must be
designed to ensure the scientific
integrity of his research contribution;
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) If within two (2) years from the
effective date of the Agreement,
Respondent receives PHS support,
Respondent agreed that for two (2)
years, any institution employing him
shall 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) Respondent agreed not to serve in
any advisory capacity to PHS including,
but not limited to, service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant for
a period of two (2) years beginning with
the effective date of the Agreement.
FOR FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013–08207 Filed 4–8–13; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–12MX]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Research to Inform the Prevention of
Asthma in Healthcare—New—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Healthcare is the largest industry in
the United States and performs a vital
function in society. Evidence from both
surveillance and epidemiologic research
indicates that healthcare workers have
an elevated risk for work-related asthma
(WRA) associated with exposure to
groups of agents such as cleaning
products, latex, indoor air pollution,
volatile organic compounds (VOCs) and
bioaerosols. Recent epidemiologic
studies of WRA among healthcare
workers have utilized job exposure
matrices (JEMs) based on probability of
exposure, however, specific exposures/
etiologic agents are not well
characterized and quantitative exposure
measurements are lacking. In this
project, NIOSH will augment the
existing JEM with quantitative exposure
data, which will significantly enhance
the existing JEMs and develop a survey
questionnaire for asthma in healthcare.
Since asthma continues to be a
problem among healthcare workers, the
overall goal of this project is to prevent
work-related asthma among healthcare
workers. The primary objective is to
identify modifiable occupational risk
factors for asthma in healthcare that will
inform strategies for prevention.
Specific Aims that support the Primary
Objective are:
Aim 1. Measure frequency of asthma
onset, related symptoms, and
exacerbation of asthma in selected
healthcare occupations
Aim 2. Assess associations between
asthma outcomes and exposures to
identify modifiable risk factors
In order to accomplish the goal and
aims of this project NIOSH has
developed a survey designed to collect
information about work history,
workplace exposures and asthma health
from workers in the healthcare industry.
Aim 1 of this project will be completed
using data exclusively from this survey.
While aim 2 will be completed using
asthma outcome data from the survey
and exposure data from the JEM
E:\FR\FM\09APN1.SGM
09APN1
21127
Federal Register / Vol. 78, No. 68 / Tuesday, April 9, 2013 / Notices
developed from survey data and
exposure data from previously
environmental sampling at healthcare
facilities.
Approximately 15,000 health care
workers in the New York City area will
be recruited for this study. The goal is
to conduct a cross-sectional
epidemiologic survey of approximately
5,000 healthcare workers who are
members of Service Employees
International Union (SEIU) Local 1199.
Only health care workers whose job
titles are in one of nine job titles will be
recruited. These nine job titles include:
certified nursing assistants (CNAs),
central supply, environmental services,
licensed practical nurses (LPNs), lab
techs, operating room (OR) techs,
registered nurses (RNs), respiratory
therapists, and dental assistants.
Furthermore, recruitment of health care
workers will only be from hospitals and
nursing homes.
Completion of the survey by
SEIU1199 members will be done either
online or over the telephone. After the
initial recruitment period, SEIU1199
members will have approximately two
weeks to complete the online survey.
After this two week period, the
SEIU1199 Communication Center will
begin calling members who have not
completed the online survey and
attempt to complete the survey with
them by telephone interview. NIOSH
anticipates 20% of the responses to be
made using the online survey and the
remaining 80% to be by telephone
interview.
There are no costs to respondents for
this study. Summary results of this
study will be made available to
SEIU1199 members who completed the
survey through a letter mailed to their
homes. Summary results will also be
published in the SEIU1199 newsletter
for the remaining members. Results of
this this study will also be disseminated
to other industry stakeholders besides
SEIU1199. These stakeholders and the
desired consequences of the
dissemination are:
1. Healthcare workers will learn about
hazards in their work environment and
become better prepared to participate in
the development of strategies to
minimize risk.
2. Health and safety staff at the
facilities where participants are
employed, who can potentially use the
information for prevention.
3. Researchers can build on the
findings to conduct additional research
that will advance our understanding of
asthma in healthcare and how to
prevent it.
4. Clinicians will learn how
occupational exposures can impact the
respiratory health of their patients who
work in healthcare, which should
improve the care they provide.
5. Professional societies and
government agencies will use findings
from this and other studies to develop
recommendations for preventing asthma
and related symptoms in healthcare
workers.
Finally, manuscripts of results and
conclusions will be drafted and
published in peer reviewed journals.
The target sample size for this study
is 5,000. Based on the SEIU1199
membership data, the percentage of
eligible union members that fall into the
targeted nine job categories is known.
Therefore, a participant job-category
distribution estimate can be made.
Completion of either the online or
telephone survey will take
approximately 30 minutes. There is no
cost to respondents other than their
time. The total estimated annual burden
hours are 1,255.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Form name
Certified Nursing Assistants ....................................................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Online .....................................
Telephone ..............................
Central Supply Workers ..........................................................
Dental Assistants .....................................................................
Environmental Service Workers ..............................................
Licensed Practical Nurses .......................................................
Lab Technicians ......................................................................
Operating Room Technicians ..................................................
Registered Nurses ...................................................................
Respiratory Therapists ............................................................
sroberts on DSK5SPTVN1PROD with NOTICES
Number of
respondents
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149
594
4
17
9
36
114
457
70
280
39
155
14
55
84
336
18
72
09APN1
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Avg. burden
per response
(in hrs)
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
30/60
21128
Federal Register / Vol. 78, No. 68 / Tuesday, April 9, 2013 / Notices
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–08150 Filed 4–8–13; 8:45 am]
BILLING CODE 4163–18–P
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0258]
Molecular Diagnostic Instruments With
Combined Functions; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSK5SPTVN1PROD with NOTICES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Molecular Diagnostic
Instruments with Combined Functions.’’
This draft guidance document provides
industry and Agency staff with FDA’s
current thinking on regulation of
molecular diagnostic instruments that
have both device functions and nondevice functions, and on the type of
information that FDA recommends that
applicants include in a submission for
a molecular diagnostic instrument that
measures or characterizes nucleic acid
analytes and has combined functions.
This draft guidance is not final nor is it
in effect at this time.
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 comment of 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 8, 2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Molecular
Diagnostic Instruments with Combined
Functions’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
17:57 Apr 08, 2013
Andrew Grove, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5515, Silver Spring,
MD 20993–0002, 301–796–6198; or
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, RKWL Bldg.,
suite 601, 11400 Rockville Pike,
Rockville, MD 20852, 1–800–835–4709.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
VerDate Mar<15>2010
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. Identify
comments with the docket number
found in brackets in the heading of this
document.
Jkt 229001
Molecular diagnostic instruments, for
example, real-time thermocyclers, are
critical components of certain in vitro
diagnostic devices. They are often used
to perform multiple unrelated assays,
such as those that detect methicillinresistant Staphylococcus aureus,
Hepatitis C virus, and genetic markers of
cystic fibrosis. These types of
instruments cannot generally be
approved alone, i.e., without an
accompanying assay, because their
safety and effectiveness cannot be
evaluated without reference to the
assays that they run and their defined
performance parameters. However, the
same instruments may also be used for
additional purposes that do not require
FDA approval or clearance, such as for
basic scientific research. In the past,
FDA has provided informal advice in
response to individual inquiries
regarding the permissibility of having
such non-device functions on an
instrument intended to be used with
approved in vitro diagnostic assays.
This draft guidance is meant to
communicate FDA’s policy regarding
molecular diagnostic instruments with
combined functions.
This draft guidance applies to
molecular diagnostic instruments that
are medical devices used with assays
that measure or characterize nucleic
acid analytes, human or microbial, and
that combine both approved and nonapproved functions in a single
instrument. This draft guidance applies
to the instrument itself (hardware) as
well as to any firmware or software
intended to operate on or to control the
instrument. This draft guidance also
addresses software that is distributed as
a stand alone device for use with an
approved molecular diagnostic assay.
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The draft guidance does not apply to
instruments approved for use with
assays that are intended to screen
donors of blood and blood components,
human cells, tissues, and cellular and
tissue-based products for communicable
diseases.
The recommendations in this draft
guidance are not intended to imply that
assays/reagents that have not received
FDA marketing authorization may be
marketed by an instrument
manufacturer for clinical use on a
molecular diagnostic instrument with
combined approved and non-approved
functions. They are also not intended to
change FDA’s position regarding the
marketing of Research Use Only and
Investigational Use Only assays for
clinical use.
II. Significance of Guidance
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 molecular diagnostic instruments
with combined functions. 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 statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Molecular Diagnostic
Instruments with Combined Functions,’’
you may either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1763 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance documents. These
collections of information 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 part 807, subpart E, have been
approved under OMB control number
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21126-21128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08150]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-12MX]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
Research to Inform the Prevention of Asthma in Healthcare--New--
National Institute for Occupational Safety and Health (NIOSH), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
Healthcare is the largest industry in the United States and
performs a vital function in society. Evidence from both surveillance
and epidemiologic research indicates that healthcare workers have an
elevated risk for work-related asthma (WRA) associated with exposure to
groups of agents such as cleaning products, latex, indoor air
pollution, volatile organic compounds (VOCs) and bioaerosols. Recent
epidemiologic studies of WRA among healthcare workers have utilized job
exposure matrices (JEMs) based on probability of exposure, however,
specific exposures/etiologic agents are not well characterized and
quantitative exposure measurements are lacking. In this project, NIOSH
will augment the existing JEM with quantitative exposure data, which
will significantly enhance the existing JEMs and develop a survey
questionnaire for asthma in healthcare.
Since asthma continues to be a problem among healthcare workers,
the overall goal of this project is to prevent work-related asthma
among healthcare workers. The primary objective is to identify
modifiable occupational risk factors for asthma in healthcare that will
inform strategies for prevention. Specific Aims that support the
Primary Objective are:
Aim 1. Measure frequency of asthma onset, related symptoms, and
exacerbation of asthma in selected healthcare occupations
Aim 2. Assess associations between asthma outcomes and exposures to
identify modifiable risk factors
In order to accomplish the goal and aims of this project NIOSH has
developed a survey designed to collect information about work history,
workplace exposures and asthma health from workers in the healthcare
industry. Aim 1 of this project will be completed using data
exclusively from this survey. While aim 2 will be completed using
asthma outcome data from the survey and exposure data from the JEM
[[Page 21127]]
developed from survey data and exposure data from previously
environmental sampling at healthcare facilities.
Approximately 15,000 health care workers in the New York City area
will be recruited for this study. The goal is to conduct a cross-
sectional epidemiologic survey of approximately 5,000 healthcare
workers who are members of Service Employees International Union (SEIU)
Local 1199. Only health care workers whose job titles are in one of
nine job titles will be recruited. These nine job titles include:
certified nursing assistants (CNAs), central supply, environmental
services, licensed practical nurses (LPNs), lab techs, operating room
(OR) techs, registered nurses (RNs), respiratory therapists, and dental
assistants. Furthermore, recruitment of health care workers will only
be from hospitals and nursing homes.
Completion of the survey by SEIU1199 members will be done either
online or over the telephone. After the initial recruitment period,
SEIU1199 members will have approximately two weeks to complete the
online survey. After this two week period, the SEIU1199 Communication
Center will begin calling members who have not completed the online
survey and attempt to complete the survey with them by telephone
interview. NIOSH anticipates 20% of the responses to be made using the
online survey and the remaining 80% to be by telephone interview.
There are no costs to respondents for this study. Summary results
of this study will be made available to SEIU1199 members who completed
the survey through a letter mailed to their homes. Summary results will
also be published in the SEIU1199 newsletter for the remaining members.
Results of this this study will also be disseminated to other industry
stakeholders besides SEIU1199. These stakeholders and the desired
consequences of the dissemination are:
1. Healthcare workers will learn about hazards in their work
environment and become better prepared to participate in the
development of strategies to minimize risk.
2. Health and safety staff at the facilities where participants are
employed, who can potentially use the information for prevention.
3. Researchers can build on the findings to conduct additional
research that will advance our understanding of asthma in healthcare
and how to prevent it.
4. Clinicians will learn how occupational exposures can impact the
respiratory health of their patients who work in healthcare, which
should improve the care they provide.
5. Professional societies and government agencies will use findings
from this and other studies to develop recommendations for preventing
asthma and related symptoms in healthcare workers.
Finally, manuscripts of results and conclusions will be drafted and
published in peer reviewed journals.
The target sample size for this study is 5,000. Based on the
SEIU1199 membership data, the percentage of eligible union members that
fall into the targeted nine job categories is known. Therefore, a
participant job-category distribution estimate can be made.
Completion of either the online or telephone survey will take
approximately 30 minutes. There is no cost to respondents other than
their time. The total estimated annual burden hours are 1,255.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs)
----------------------------------------------------------------------------------------------------------------
Certified Nursing Assistants.......... Online.................. 149 1 30/60
Telephone............... 594 1 30/60
Central Supply Workers................ Online.................. 4 1 30/60
Telephone............... 17 1 30/60
Dental Assistants..................... Online.................. 9 1 30/60
Telephone............... 36 1 30/60
Environmental Service Workers......... Online.................. 114 1 30/60
Telephone............... 457 1 30/60
Licensed Practical Nurses............. Online.................. 70 1 30/60
Telephone............... 280 1 30/60
Lab Technicians....................... Online.................. 39 1 30/60
Telephone............... 155 1 30/60
Operating Room Technicians............ Online.................. 14 1 30/60
Telephone............... 55 1 30/60
Registered Nurses..................... Online.................. 84 1 30/60
Telephone............... 336 1 30/60
Respiratory Therapists................ Online.................. 18 1 30/60
Telephone............... 72 1 30/60
----------------------------------------------------------------------------------------------------------------
[[Page 21128]]
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-08150 Filed 4-8-13; 8:45 am]
BILLING CODE 4163-18-P
