Proposed Collection; 60-Day Comment Request Surveys To Support an Evaluation of the National Human Genome Research Institute (NHGRI) Summer Workshop in Genomics (Short Course), 13865-13866 [2015-06086]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
Medical Devices for Reprocessing in
Health Care Facilities: FDA Reviewer
Guidance’’ dated April 1996.
This final guidance contains the
addition of ‘‘Appendix E: Devices for
which a 510(k) Should Contain Data to
Validate Reprocessing Instructions,’’
which includes a subset of medical
devices that FDA has identified that
pose a greater likelihood of microbial
transmission and represent a high risk
of infection if they are not adequately
reprocessed. Because of this greater
public health risk, 510(k) submissions
for these devices should include
protocols and complete test reports of
the validation of the reprocessing
instructions so that FDA has the
information it needs to evaluate
substantial equivalence.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on reprocessing
validation methods and labeling for
medical devices. 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of
‘‘Reprocessing Medical Devices in
Health Care Settings: Validation
Methods and Labeling’’ may send an
email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1748 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. 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–
VerDate Sep<11>2014
18:09 Mar 16, 2015
Jkt 235001
3520). The collections of information in
21 CFR parts 801 and 809 have been
approved under OMB control number
0910–0485 (medical device labeling);
the collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120
(premarket notification); the collections
of information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078 (investigational
device exemption); the collections of
information in 21 CFR part 814,
subparts A through E have been
approved under OMB control number
0910–0231 (premarket approval); the
collections of information in 21 CFR
part 814, subpart H have been approved
under OMB control number 0910–0332
(humanitarian use devices); and the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073
(quality system regulation).
V. 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.
Dated: March 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06029 Filed 3–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request Surveys To Support an
Evaluation of the National Human
Genome Research Institute (NHGRI)
Summer Workshop in Genomics (Short
Course)
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
National Human Genome Research
Institute (NHGRI), National Institutes of
Health (NIH), will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
13865
and Budget (OMB) for review and
approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments And For
Further Information: To obtain a copy of
the data collection plans and
instruments, submit comments in
writing, or request more information on
the proposed project, contact: Carla L.
Easter, Ph.D., Chief, Education and
Community Involvement Branch,
NHGRI, Building 31, Room B1B55, 31
Center Drive, MSC 2070, Bethesda, MD
20892 or call non-toll-free number (301)
594–1364 or Email your request,
including your address to: easterc@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Surveys to
Support an Evaluation of the NHGRI
Summer Workshop in Genomics (Short
Course), 0925–NEW, National Human
Genome Research Institute (NHGRI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The purpose of the proposed
data collection activity is to complete a
full-scale outcome evaluation of
NHGRI’s Summer Workshop in
Genomics (a.k.a., the ‘‘Short Course’’)
focusing on program participants
between 2004 and 2012. This training
program is an intensive multi-day
course that updates instructors and
researchers of biology and nursing (and
other related disciplines) on the latest
research trends and topics in genomic
science. The course focuses on the
continuing effort to find the genetic
basis of various diseases and disorders,
and current topics on the ethical, legal
and social implications of genomics.
E:\FR\FM\17MRN1.SGM
17MRN1
13866
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
The Education and Community
Involvement Branch (ECIB) designed the
program to accomplish the following
goals, which align with elements of both
the NIH and NHGRI missions:
• Expand NIH and NHGRI’s
professional network to reach out to
diverse communities, and to create new
partnership opportunities.
• Prepare the next generation of
genomics professionals for an era of
genomic medicine.
• Train and diversify the pipeline of
genome professionals in alignment with
the NIH and US Department of Health
and Human Services diversity efforts.
The ECIB has systematically collected
feedback annually after the program
from participants since inception of the
Short Course in 2003, and then used the
data to tweak the program, but it has not
conducted a long-term, cumulative and
substantive outcome evaluation. NHGRI
and the ECIB propose to conduct such
an outcome evaluation, focusing on
three main objectives:
(1) To understand the degree of
genetic and genomic curriculum
integration by faculty participants;
(2) To explore the barriers and
supports faculty experience and changes
when integrating curriculum; and
(3) To investigate the influence of the
program on the participants’ career
path.
Survey findings will provide valuable
information about the various methods
and pathways instructors use to
disseminate new knowledge (and the
associated timelines), the barriers and
supports experienced by faculty as they
integrate new knowledge into their
teaching, and insights about additional
avenues of support that NHGRI could
provide teaching faculty from the types
of institutions identified. Key indicators
will also provide evidence about the
degree to which the Short Course is
meeting its goals. Collectively, the
outcome evaluation will inform future
program design and budget allocations.
OMB approval is requested for 2
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
155.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Students .............................
Faculty ...............................
110
200
1
1
30/60
30/60
55
100
............................................
310
....................
....................
155
Form name
Type of
respondents
Short Course Survey—Students .....................................
Short Course Survey—Faculty ........................................
Totals ........................................................................
Dated: March 11, 2015.
Gloria Butler,
NHGRI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2015–06086 Filed 3–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 12, 2015, from 8:30 a.m. to
5 p.m.
VerDate Sep<11>2014
18:09 Mar 16, 2015
Jkt 235001
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm. For those
unable to attend in person, the meeting
will also be Web cast and will be
available at the following link: https://
collaboration.fda.gov/vrbpac0515/.
Contact Person: Sujata Vijh, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6128, Silver Spring, MD 209930–0002,
240–402–7107; or Denise Royster,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6134, Silver Spring,
MD 209930–0002, 240–402–8158; or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Total
annual
burden
hours
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On May 12, 2015, from 8:30
a.m. to 5 p.m., the committee will meet
in open session to discuss the
development and licensure of Ebola
vaccines.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before May 5, 2015. Oral
presentations from the public will be
scheduled between 1:15 p.m. and 2:15
p.m. Those individuals interested in
making formal oral presentations should
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13865-13866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request Surveys To Support an
Evaluation of the National Human Genome Research Institute (NHGRI)
Summer Workshop in Genomics (Short Course)
SUMMARY: 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 National Human Genome
Research Institute (NHGRI), National Institutes of Health (NIH), will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
To Submit Comments And For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Carla L.
Easter, Ph.D., Chief, Education and Community Involvement Branch,
NHGRI, Building 31, Room B1B55, 31 Center Drive, MSC 2070, Bethesda, MD
20892 or call non-toll-free number (301) 594-1364 or Email your
request, including your address to: easterc@mail.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Surveys to Support an Evaluation of the NHGRI
Summer Workshop in Genomics (Short Course), 0925-NEW, National Human
Genome Research Institute (NHGRI), National Institutes of Health (NIH).
Need and Use of Information Collection: The purpose of the proposed
data collection activity is to complete a full-scale outcome evaluation
of NHGRI's Summer Workshop in Genomics (a.k.a., the ``Short Course'')
focusing on program participants between 2004 and 2012. This training
program is an intensive multi-day course that updates instructors and
researchers of biology and nursing (and other related disciplines) on
the latest research trends and topics in genomic science. The course
focuses on the continuing effort to find the genetic basis of various
diseases and disorders, and current topics on the ethical, legal and
social implications of genomics.
[[Page 13866]]
The Education and Community Involvement Branch (ECIB) designed the
program to accomplish the following goals, which align with elements of
both the NIH and NHGRI missions:
Expand NIH and NHGRI's professional network to reach out
to diverse communities, and to create new partnership opportunities.
Prepare the next generation of genomics professionals for
an era of genomic medicine.
Train and diversify the pipeline of genome professionals
in alignment with the NIH and US Department of Health and Human
Services diversity efforts.
The ECIB has systematically collected feedback annually after the
program from participants since inception of the Short Course in 2003,
and then used the data to tweak the program, but it has not conducted a
long-term, cumulative and substantive outcome evaluation. NHGRI and the
ECIB propose to conduct such an outcome evaluation, focusing on three
main objectives:
(1) To understand the degree of genetic and genomic curriculum
integration by faculty participants;
(2) To explore the barriers and supports faculty experience and
changes when integrating curriculum; and
(3) To investigate the influence of the program on the
participants' career path.
Survey findings will provide valuable information about the various
methods and pathways instructors use to disseminate new knowledge (and
the associated timelines), the barriers and supports experienced by
faculty as they integrate new knowledge into their teaching, and
insights about additional avenues of support that NHGRI could provide
teaching faculty from the types of institutions identified. Key
indicators will also provide evidence about the degree to which the
Short Course is meeting its goals. Collectively, the outcome evaluation
will inform future program design and budget allocations.
OMB approval is requested for 2 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 155.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average Total
Number of responses burden per annual
Form name Type of respondents respondents per response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Short Course Survey--Students....... Students.............. 110 1 30/60 55
Short Course Survey--Faculty........ Faculty............... 200 1 30/60 100
---------------------------------------------------
Totals.......................... ...................... 310 ........... ........... 155
----------------------------------------------------------------------------------------------------------------
Dated: March 11, 2015.
Gloria Butler,
NHGRI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-06086 Filed 3-16-15; 8:45 am]
BILLING CODE 4140-01-P
