80 FR 13865 - 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)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 51 (March 17, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 51 (March 17, 2015)
| Page Range | 13865-13866 | |
| FR Document | 2015-06086 |
[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)] [Notices] [Pages 13865-13866] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 13865
Medical Devices for Reprocessing in 3520). The collections of information in and Budget (OMB) for review and
Health Care Facilities: FDA Reviewer 21 CFR parts 801 and 809 have been approval.
Guidance’’ dated April 1996. approved under OMB control number Written comments and/or suggestions
This final guidance contains the 0910–0485 (medical device labeling); from the public and affected agencies
addition of ‘‘Appendix E: Devices for the collections of information in 21 CFR are invited on one or more of the
which a 510(k) Should Contain Data to part 807, subpart E have been approved following points: (1) Whether the
Validate Reprocessing Instructions,’’ under OMB control number 0910–0120 proposed collection of information is
which includes a subset of medical (premarket notification); the collections necessary for the proper performance of
devices that FDA has identified that of information in 21 CFR part 812 have the function of the agency, including
pose a greater likelihood of microbial been approved under OMB control whether the information will have
transmission and represent a high risk number 0910–0078 (investigational practical utility; (2) The accuracy of the
of infection if they are not adequately device exemption); the collections of agency’s estimate of the burden of the
reprocessed. Because of this greater information in 21 CFR part 814, proposed collection of information,
public health risk, 510(k) submissions subparts A through E have been including the validity of the
for these devices should include approved under OMB control number methodology and assumptions used; (3)
protocols and complete test reports of 0910–0231 (premarket approval); the Ways to enhance the quality, utility, and
the validation of the reprocessing collections of information in 21 CFR clarity of the information to be
instructions so that FDA has the part 814, subpart H have been approved collected; and (4) Ways to minimize the
information it needs to evaluate under OMB control number 0910–0332 burden of the collection of information
substantial equivalence. (humanitarian use devices); and the on those who are to respond, including
collections of information in 21 CFR the use of appropriate automated,
II. Significance of Guidance electronic, mechanical, or other
part 820 have been approved under
This guidance is being issued OMB control number 0910–0073 technological collection techniques or
consistent with FDA’s good guidance (quality system regulation). other forms of information technology.
practices regulation (21 CFR 10.115). To Submit Comments And For
The guidance represents the Agency’s V. Comments Further Information: To obtain a copy of
current thinking on reprocessing Interested persons may submit either the data collection plans and
validation methods and labeling for electronic comments regarding this instruments, submit comments in
medical devices. It does not create or document to http://www.regulations.gov writing, or request more information on
confer any rights for or on any person or written comments to the Division of the proposed project, contact: Carla L.
and does not operate to bind FDA or the Dockets Management (see ADDRESSES). It Easter, Ph.D., Chief, Education and
public. An alternative approach may be is only necessary to send one set of Community Involvement Branch,
used if such approach satisfies the comments. Identify comments with the NHGRI, Building 31, Room B1B55, 31
requirements of the applicable statute docket number found in brackets in the Center Drive, MSC 2070, Bethesda, MD
and regulations. heading of this document. Received 20892 or call non-toll-free number (301)
comments may be seen in the Division 594–1364 or Email your request,
III. Electronic Access including your address to: easterc@
of Dockets Management between 9 a.m.
Persons interested in obtaining a copy and 4 p.m., Monday through Friday, and mail.nih.gov. Formal requests for
of the guidance may do so by using the will be posted to the docket at http:// additional plans and instruments must
Internet. A search capability for all www.regulations.gov. be requested in writing.
CDRH guidance documents is available Comment Due Date: Comments
Dated: March 11, 2015.
at http://www.fda.gov/MedicalDevices/ regarding this information collection are
DeviceRegulationandGuidance/ Leslie Kux, best assured of having their full effect if
GuidanceDocuments/default.htm. Associate Commissioner for Policy. received within 60 days of the date of
Guidance documents are also available [FR Doc. 2015–06029 Filed 3–16–15; 8:45 am] this publication.
at http://www.fda.gov/BiologicsBlood BILLING CODE 4164–01–P Proposed Collection: Surveys to
Vaccines/GuidanceCompliance Support an Evaluation of the NHGRI
RegulatoryInformation/Guidances/ Summer Workshop in Genomics (Short
default.htm or http:// DEPARTMENT OF HEALTH AND Course), 0925–NEW, National Human
www.regulations.gov. Persons unable to HUMAN SERVICES Genome Research Institute (NHGRI),
download an electronic copy of National Institutes of Health (NIH).
National Institutes of Health Need and Use of Information
‘‘Reprocessing Medical Devices in
Health Care Settings: Validation Collection: The purpose of the proposed
Proposed Collection; 60-Day Comment
Methods and Labeling’’ may send an data collection activity is to complete a
Request Surveys To Support an
email request to CDRH- full-scale outcome evaluation of
Evaluation of the National Human
Guidance@fda.hhs.gov to receive an NHGRI’s Summer Workshop in
Genome Research Institute (NHGRI)
electronic copy of the document. Please Genomics (a.k.a., the ‘‘Short Course’’)
Summer Workshop in Genomics (Short
use the document number 1748 to focusing on program participants
Course)
identify the guidance you are between 2004 and 2012. This training
requesting. SUMMARY: In compliance with the program is an intensive multi-day
requirement of Section 3506(c)(2)(A) of course that updates instructors and
IV. Paperwork Reduction Act of 1995
mstockstill on DSK4VPTVN1PROD with NOTICES
the Paperwork Reduction Act of 1995, researchers of biology and nursing (and
This guidance refers to previously for opportunity for public comment on other related disciplines) on the latest
approved collections of information proposed data collection projects, the research trends and topics in genomic
found in FDA regulations. These National Human Genome Research science. The course focuses on the
collections of information are subject to Institute (NHGRI), National Institutes of continuing effort to find the genetic
review by the Office of Management and Health (NIH), will publish periodic basis of various diseases and disorders,
Budget (OMB) under the Paperwork summaries of proposed projects to be and current topics on the ethical, legal
Reduction Act of 1995 (44 U.S.C. 3501– submitted to the Office of Management and social implications of genomics.
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![13866 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
The Education and Community Short Course in 2003, and then used the disseminate new knowledge (and the
Involvement Branch (ECIB) designed the data to tweak the program, but it has not associated timelines), the barriers and
program to accomplish the following conducted a long-term, cumulative and supports experienced by faculty as they
goals, which align with elements of both substantive outcome evaluation. NHGRI integrate new knowledge into their
the NIH and NHGRI missions: and the ECIB propose to conduct such teaching, and insights about additional
• Expand NIH and NHGRI’s an outcome evaluation, focusing on avenues of support that NHGRI could
professional network to reach out to three main objectives: provide teaching faculty from the types
diverse communities, and to create new (1) To understand the degree of of institutions identified. Key indicators
partnership opportunities. genetic and genomic curriculum will also provide evidence about the
• Prepare the next generation of integration by faculty participants; degree to which the Short Course is
genomics professionals for an era of (2) To explore the barriers and meeting its goals. Collectively, the
genomic medicine. supports faculty experience and changes outcome evaluation will inform future
• Train and diversify the pipeline of when integrating curriculum; and
program design and budget allocations.
genome professionals in alignment with (3) To investigate the influence of the
the NIH and US Department of Health program on the participants’ career OMB approval is requested for 2
and Human Services diversity efforts. path. years. There are no costs to respondents
The ECIB has systematically collected Survey findings will provide valuable other than their time. The total
feedback annually after the program information about the various methods estimated annualized burden hours are
from participants since inception of the and pathways instructors use to 155.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average Total
Type of Number of responses burden per annual
Form name 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. Location: FDA White Oak Campus, default.htm and scroll down to the
Gloria Butler, 10903 New Hampshire Ave., Building appropriate advisory committee meeting
NHGRI Project Clearance Liaison, National 31 Conference Center, the Great Room link, or call the advisory committee
Institutes of Health. (Rm. 1503), Silver Spring, MD 20993. information line to learn about possible
[FR Doc. 2015–06086 Filed 3–16–15; 8:45 am] Answers to commonly asked questions modifications before coming to the
BILLING CODE 4140–01–P including information regarding special meeting.
accommodations due to a disability, Agenda: On May 12, 2015, from 8:30
visitor parking, and transportation may a.m. to 5 p.m., the committee will meet
DEPARTMENT OF HEALTH AND be accessed at: http://www.fda.gov/ in open session to discuss the
HUMAN SERVICES AdvisoryCommittees/AboutAdvisory development and licensure of Ebola
Committees/ucm408555.htm. For those vaccines.
Food and Drug Administration unable to attend in person, the meeting FDA intends to make background
will also be Web cast and will be material available to the public no later
[Docket No. FDA–2015–N–0001]
available at the following link: https:// than 2 business days before the meeting.
Vaccines and Related Biological collaboration.fda.gov/vrbpac0515/. If FDA is unable to post the background
Products Advisory Committee; Notice Contact Person: Sujata Vijh, Center for material on its Web site prior to the
of Meeting Biologics Evaluation and Research, meeting, the background material will
Food and Drug Administration, 10903 be made publicly available at the
AGENCY: Food and Drug Administration, New Hampshire Ave., Bldg. 71, Rm. location of the advisory committee
HHS. 6128, Silver Spring, MD 209930–0002, meeting, and the background material
ACTION: Notice. 240–402–7107; or Denise Royster, will be posted on FDA’s Web site after
Center for Biologics Evaluation and the meeting. Background material is
This notice announces a forthcoming Research, Food and Drug available at http://www.fda.gov/
meeting of a public advisory committee Administration, 10903 New Hampshire AdvisoryCommittees/Calendar/
of the Food and Drug Administration Ave., Bldg. 71, Rm. 6134, Silver Spring, default.htm. Scroll down to the
(FDA). The meeting will be open to the MD 209930–0002, 240–402–8158; or appropriate advisory committee meeting
public. FDA Advisory Committee Information link.
Name of Committee: Vaccines and Line, 1–800–741–8138 (301–443–0572 Procedure: Interested persons may
Related Biological Products Advisory in the Washington, DC area). A notice in present data, information, or views,
mstockstill on DSK4VPTVN1PROD with NOTICES
Committee. the Federal Register about last minute orally or in writing, on issues pending
General Function of the Committee: modifications that impact a previously before the committee. Written
To provide advice and announced advisory committee meeting submissions may be made to the contact
recommendations to the Agency on cannot always be published quickly person on or before May 5, 2015. Oral
FDA’s regulatory issues. enough to provide timely notice. presentations from the public will be
Date and Time: The meeting will be Therefore, you should always check the scheduled between 1:15 p.m. and 2:15
held on May 12, 2015, from 8:30 a.m. to Agency’s Web site at http:// p.m. Those individuals interested in
5 p.m. www.fda.gov/AdvisoryCommittees/ making formal oral presentations should
VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1](https://thefederalregister.org/doc/80_FR_13916/page/2.svg)
Document Created: 2015-12-18 12:00:59
Document Modified: 2015-12-18 12:00:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| FR Citation | 80 FR 13865 |
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