82 FR 58006 - Submission for OMB Review; 30-Day Comment Request; A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI (National Cancer Institute)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 235 (December 8, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 58006-58007 | |
| FR Document | 2017-26495 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 58006-58007] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26495] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI (National Cancer Institute) AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Amy Williams, Director of the Office of Advocacy Relations (OAR), NCI, NIH, 31 Center Drive, Bldg. 31, Room 10A28, MSC 2580, Bethesda, MD 20892, call non-toll-free number 240-781-3406, or email your request, including your address, to [email protected]. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on October 2, 2017, page 45870 (82 FR 45870) and allowed 60 days for public comment. No public comments were received. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National [[Page 58007]] Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection Title: A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI, 0925- 0641. Extension. National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for OMB to approve the extension of the generic collection titled, ``A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI'' for an additional three years of data collection. The Office of Advocacy Relations (OAR) disseminates cancer- related information to a variety of stakeholders, seeks input and feedback, and facilitates collaboration to advance NCI's authorized programs. It is beneficial for NCI, through the OAR, to pretest strategies, concepts, activities and materials while they are under development. Additionally, administrative forms are a necessary part of collecting demographic information and areas of interest for advocates. Since OAR is responsible for matching advocates to NCI programs and initiatives across the cancer continuum, it is necessary to measure the satisfaction of both internal and external stakeholders with this collaboration. This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the many initiatives and products that OAR and NCI produce. The OAR will use a variety of qualitative (interviews) methodology to conduct this research, allowing NCI to: (1) Understand characteristics (attitudes, beliefs, and behaviors) of the intended target audience and use this information in the development of effective strategies, concepts, activities; (2) use a feedback loop to help refine, revise, and enhance OAR's efforts-- ensuring that they have the greatest relevance, utility, appropriateness, and impact for/to target audiences; and (3) expend limited program resource dollars wisely and effectively. The anticipated respondents will consist of: Adult cancer research advocates; members of the public; health care professionals; and organizational representatives. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 45. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average time Type of respondent Number of responses per per response Total annual respondents respondent (in hours) burden hour ---------------------------------------------------------------------------------------------------------------- Individual In-Depth Interviews.................. 40 1 30/60 20 Profile Completion.............................. 50 1 30/60 25 --------------------------------------------------------------- Total....................................... 90 90 .............. 45 ---------------------------------------------------------------------------------------------------------------- Dated: December 2, 2017. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2017-26495 Filed 12-7-17; 8:45 am] BILLING CODE 4140-01-P
![58006 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
NIH. The ODP fulfills this mission by preventing or ameliorating high-risk DEPARTMENT OF HEALTH AND
providing leadership for the behaviors and exposures, the occurrence HUMAN SERVICES
development, coordination, and of a disease, disorder, or injury, or the
implementation of prevention research progression of detectable but National Institutes of Health
in collaboration with NIH Institutes, asymptomatic disease. Prevention
Centers, and Offices and other partners. research also includes research studies Submission for OMB Review; 30-Day
The first ODP strategic plan was to develop and evaluate disease Comment Request; A Generic
released in February 2014 and charted prevention, health promotion Submission for Formative Research,
new directions and, at the same time, recommendations, and public health Pre-testing, Stakeholder Measures and
built upon and expanded existing programs. The ODP definition of Advocate Forms at NCI (National
programs. The Office has made prevention includes the following Cancer Institute)
considerable progress on the priorities categories of research: AGENCY: National Institutes of Health,
identified in the initial plan, and the • Identification of modifiable risk and HHS.
ODP remains committed to playing an protective factors for diseases/disorders/ ACTION: Notice.
integral role in advancing trans-NIH injuries
prevention-related activities. Input • Studies on assessment of risk, SUMMARY: In compliance with the
received from this Request for including genetic susceptibility Paperwork Reduction Act of 1995, the
Information will inform the • Development of methods for National Institutes of Health (NIH) has
development of the final FY 2019–2023 screening and identification of markers submitted to the Office of Management
Strategic Plan, which will outline for those at risk for onset or progression and Budget (OMB) a request for review
activities coordinated by the ODP to of asymptomatic diseases/disorders, or and approval of the information
assess, facilitate, and stimulate research those at risk for adverse, high-risk collection listed below.
in disease prevention, and disseminate behaviors/injuries DATES: Comments regarding this
the results of this research to improve • Development and evaluation of information collection are best assured
public health. interventions to promote health for of having their full effect if received
The ODP is seeking input on the groups of individuals without within 30-days of the date of this
following strategic priorities: recognized signs or symptoms of the publication.
• Strategic Priority I: Systematically target condition
monitor NIH investments in prevention ADDRESSES: Written comments and/or
• Translation of proven effective
research and the progress and results of suggestions regarding the item(s)
prevention interventions into practice
that research. contained in this notice, especially
• Strategic Priority II: Identify • Effectiveness studies that examine
regarding the estimated public burden
prevention research areas for investment factors related to the organization,
and associated response time, should be
or expanded effort by the NIH. management, financing, and adoption of
directed to the: Office of Management
• Strategic Priority III: Promote the prevention services and practices
and Budget, Office of Regulatory Affairs,
use of the best available methods in • Methodological and statistical OIRA_submission@omb.eop.gov or by
prevention research and support the procedures for assessing risk and fax to 202–395–6974, Attention: Desk
development of better methods. measuring the effects of preventive Officer for NIH.
• Strategic Priority IV: Promote interventions.
FOR FURTHER INFORMATION CONTACT: To
collaborative prevention research Responses to this RFI are voluntary
and may be submitted anonymously. request more information on the
projects and facilitate coordination of proposed project or to obtain a copy of
such projects across the NIH and with Please do not include any personally
identifiable or other information that the data collection plans and
other public and private entities. instruments, contact: Amy Williams,
• Strategic Priority V: Advance the you do not wish to make public.
Director of the Office of Advocacy
understanding of prevention research, Proprietary, classified, confidential, or
sensitive information should not be Relations (OAR), NCI, NIH, 31 Center
increase the availability of prevention Drive, Bldg. 31, Room 10A28, MSC
research resources and programs, and included in responses. Comments
submitted will be compiled for 2580, Bethesda, MD 20892, call non-
enhance ODP’s stakeholder engagement. toll-free number 240–781–3406, or
The ODP is also seeking input on the discussion and incorporated into the
strategic plan as appropriate. Any email your request, including your
following questions:
• What new strategic priorities personal identifiers (personal names, address, to amy.williams@nih.gov.
should the ODP consider adding to its email addresses, etc.) will be removed SUPPLEMENTARY INFORMATION: This
plan? when responses are compiled. proposed information collection was
• What opportunities or challenges in This RFI is for informational and previously published in the Federal
disease prevention research and planning purposes only and is not a Register on October 2, 2017, page 45870
methods could the ODP help to address? solicitation for applications or an (82 FR 45870) and allowed 60 days for
• Who should the ODP partner with obligation on the part of the United public comment. No public comments
to address pressing needs in disease States (U.S.) Government to provide were received. The National Cancer
prevention research and methods? support for any ideas identified in Institute (NCI), National Institutes of
• What areas transcend disease response to it. Please note that the U.S. Health, may not conduct or sponsor,
prevention research that the ODP Government will not pay for the and the respondent is not required to
respond to, an information collection
sradovich on DSK3GMQ082PROD with NOTICES
should consider as it develops its new preparation of any information
plan? submitted or for use of that information. that has been extended, revised, or
The definition of prevention research implemented on or after October 1,
used by the ODP to guide its work and Dated: December 1, 2017. 1995, unless it displays a currently valid
decision-making encompasses research Lawrence A. Tabak, OMB control number.
designed to yield results directly Deputy Director, National Institutes of Health. In compliance with Section
applicable to identifying and assessing [FR Doc. 2017–26453 Filed 12–7–17; 8:45 am] 3507(a)(1)(D) of the Paperwork
risk, developing interventions for BILLING CODE 4140–01–P Reduction Act of 1995, the National
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![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 58007
Institutes of Health (NIH) has submitted feedback, and facilitates collaboration to allowing NCI to: (1) Understand
to the Office of Management and Budget advance NCI’s authorized programs. It is characteristics (attitudes, beliefs, and
(OMB) a request for review and beneficial for NCI, through the OAR, to behaviors) of the intended target
approval of the information collection pretest strategies, concepts, activities audience and use this information in the
listed below. and materials while they are under development of effective strategies,
Proposed Collection Title: A Generic development. Additionally, concepts, activities; (2) use a feedback
Submission for Formative Research, Pre- administrative forms are a necessary loop to help refine, revise, and enhance
testing, Stakeholder Measures and part of collecting demographic OAR’s efforts—ensuring that they have
Advocate Forms at NCI, 0925- 0641. the greatest relevance, utility,
information and areas of interest for
Extension. National Cancer Institute appropriateness, and impact for/to
advocates. Since OAR is responsible for
(NCI), National Institutes of Health target audiences; and (3) expend limited
(NIH). matching advocates to NCI programs
and initiatives across the cancer program resource dollars wisely and
Need and Use of Information
continuum, it is necessary to measure effectively. The anticipated respondents
Collection: This is a request for OMB to
the satisfaction of both internal and will consist of: Adult cancer research
approve the extension of the generic
collection titled, ‘‘A Generic Submission external stakeholders with this advocates; members of the public;
for Formative Research, Pre-testing, collaboration. This customer satisfaction health care professionals; and
Stakeholder Measures and Advocate research helps ensure the relevance, organizational representatives.
Forms at NCI’’ for an additional three utility, and appropriateness of the many OMB approval is requested for 3
years of data collection. The Office of initiatives and products that OAR and years. There are no costs to respondents
Advocacy Relations (OAR) disseminates NCI produce. The OAR will use a other than their time. The total
cancer-related information to a variety variety of qualitative (interviews) estimated annualized burden hours are
of stakeholders, seeks input and methodology to conduct this research, 45.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time
Number of Total annual
Type of respondent responses per per response
respondents burden hour
respondent (in hours)
Individual In-Depth Interviews ......................................................................... 40 1 30/60 20
Profile Completion ........................................................................................... 50 1 30/60 25
Total .......................................................................................................... 90 90 ........................ 45
Dated: December 2, 2017. DATES: Only written comments and/or 2007/0–EP–04], Filed: September 14,
Karla Bailey, applications for a license which are 2009; IL Patent Application No.:
Project Clearance Liaison, National Cancer received by the National Human 200872, [HHS Ref. No.: E–217–2007/0–
Institute, National Institutes of Health. Genome Research Institute’s Technology IL–05], Filed: May 30, 2008; JP Patent
[FR Doc. 2017–26495 Filed 12–7–17; 8:45 am] Transfer Office on or before December Application No.: 2010–510363, [HHS
BILLING CODE 4140–01–P
26, 2017 will be considered. Ref. No.: E–217–2007/0–JP–06, Filed:
ADDRESSES: Requests for copies of the May 30, 2008; U.S. Patent Application
patent application, inquiries, comments, No.: 12/530,433, [HHS Ref. No.: E–217–
DEPARTMENT OF HEALTH AND and other materials relating to the 2007/0–US–07], Filed: Sept 8, 2009;
HUMAN SERVICES contemplated exclusive license should U.S. Patent Application No.: 13/
be directed to: Eggerton Campbell, 791,576, [HHS Ref. No.: E–217–2007/0–
National Institutes of Health Ph.D., Senior Licensing and Patenting US–08], Filed: March 8, 2013; JP Patent
Manager, Technology Transfer Office Application No.: 2014–208695, [HHS
Prospective Grant of Exclusive Patent (TTO), National Human Genome Ref. No.: E–217–2007/0–JP–09], Filed:
License: N-Acetyl Mannosamine as a Research Institute (NHGRI), National
Therapeutic Agent May 30, 2008; U.S. Patent Application
Institutes of Health (NIH), 5635 Fishers No.: 14/754,304, [HHS Ref. No.: E–217–
Lane, Suite 3058, MSC 9307, Bethesda, 2007/0–US–10], Filed: June 29, 2015;
AGENCY: National Institutes of Health, MD 20892–9307. Telephone: 301–402–
HHS. CA Patent Application No.: 2903133,
1648. Fax: 301–402–9722. email: [HHS Ref. No.: E–217–2007/0–CA–11],
ACTION: Notice. eggerton.campbell@nih.gov.
Filed: May 30, 2008; IL Patent
SUPPLEMENTARY INFORMATION: Application No.: 245026, [HHS Ref. No.:
SUMMARY: The National Human Genome E–217–2007/0–IL–12], Filed: March 8,
Intellectual Property
Research Institute, an institute of the 2013; JP Patent Application No.: 2016–
National Institutes of Health, U.S. Provisional Patent Application 159061, [HHS Ref. No.: E–217–2007/0–
Department of Health and Human No.: 60/932,451, [HHS Ref. No.: E–217– JP–13], Filed: August 15, 2016; EP
Services, is contemplating the grant of 2007/0–US–01], Filed May 31, 2007;
sradovich on DSK3GMQ082PROD with NOTICES
Patent Application No.: 16196935.7,
an exclusive patent license to practice PCT Patent Application No.: PCT/
[HHS Ref. No.: E–217–2007/0–EP–14],
the inventions embodied in the Patents US2008/006895, [HHS Ref. No.: E–217–
Filed: March 8, 2013; U.S. Patent
and Patent Applications listed in the 2007/0–PCT–02], Filed: May 30, 2008;
SUPPLEMENTARY INFORMATION section of CA Patent Application 2680842, [HHS Application No.: 15/702,529, [HHS Ref.
this notice to Leadiant Biosciences, Inc, Ref. No.: E–217–2007/0–CA–03], Filed: No.: E–217–2007/0–US–08], Filed:
located in Gaithersburg, Maryland, May 30, 2008; EP Patent Application September 12, 2017; and all continuing
USA. No.: 08767999.9, [HHS Ref. No.: E–217– applications and foreign counterparts.
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Document Created: 2017-12-08 01:43:15
Document Modified: 2017-12-08 01:43:15
| 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 | |
| Action | Notice. | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Amy Williams, Director of the Office of Advocacy Relations (OAR), NCI, NIH, 31 Center Drive, Bldg. 31, Room 10A28, MSC 2580, Bethesda, MD 20892, call non-toll-free number 240-781-3406, or | |
| FR Citation | 82 FR 58006 |
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