Submission for OMB Review; 30-Day Comment Request; Data Collection To Understand How NIH Programs Apply Methodologies To Improve Their Research Programs (MIRP), 71624-71625 [2013-28636]

Download as PDF 71624 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents 21 CFR Section Number of responses per respondent Average burden per response Total annual responses Total hours 516.29; Termination of MUMS designation ......................... 516.30; Requirements for annual reports ............................ 516.36; Insufficient quantities .............................................. 2 15 1 1 5 1 2 75 1 1 2 3 2 150 3 Total .............................................................................. ........................ ........................ ........................ ........................ 1,362 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimate for this reporting requirement was derived in our Office of Minor Use and Minor Species Animal Drug Development by extrapolating the current investigational new animal drug/new animal drug application reporting requirements for similar actions by this same segment of the regulated industry and from previous interactions with the minor use/minor species community. Dated: November 22, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–28598 Filed 11–27–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Data Collection To Understand How NIH Programs Apply Methodologies To Improve Their Research Programs (MIRP) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on September 9, 2013, page 55084 and allowed 60-days for public comment. One comment was received. However, the issues addressed in the comment were not related to the information collection proposed, and will not be considered in the finalization process. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), 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, sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:56 Nov 27, 2013 Jkt 232001 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: 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, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. DATES: Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Ms. Dione Washington, Strategic Planning and Evaluation Branch, OSPIDA, NIAID, NIH, 6610 Rockledge Dr., Rm 2501, Bethesda, MD 20892–6620, or Email your request, including your address to washingtondi@niaid.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Data collection to understand how NIH programs apply methodologies to improve their research programs (MIRP), 0925–NEW, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Need and Use of Information Collection: In this submission, NIAID is requesting an OMB generic clearance for formative research activities relating to the collection of data to assist the Institute in understanding the usefulness of a range of methodologies that are employed to increase organizational effectiveness. The Office of Management and Budget (OMB) and Office of Science and Technology Policy (OSTP) have instructed agencies to apply rigorous strategy management principles to ensure resources are directed at high-priority programs and avoid duplication of effort. A key aspect to ensuring resources dedicated to these PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 programs are applied efficiently and effectively is to understand how NIH research programs apply methodologies to improve their organizational effectiveness. The degree of an organization’s effectiveness is commonly recognized to be influenced by many factors. These can include the clarity of its purpose and strategy, how it allocates and structures its work, the processes used to carry out operations, the way technologies are used to support work, the people involved and their skills and abilities, the way relationships are managed with partners and stakeholders, and how leadership functions, particularly in terms of its ability to ensure that all the other components are aligned in supporting work towards the mission. Many methodologies are commonly employed in all sectors, including government, with the goal of increasing organizational effectiveness. Some examples of those used widely are strategic planning and strategy management, total quality management, change management, organizational assessment and intervention, organizational design, process improvement, leadership development, performance management, and workforce training and professional development, among others. There are many models and approaches to each of these methodologies. Each one can be implemented in a wide range of ways. Reflection on and learning from methodologies that have been used and the ways in which they have been employed is critical to continually ensuring that government functions effectively. The primary use for information gathered through voluntary survey pilot testing, surveys, focus groups, interviews, and collaborative data interpretation meetings to understand the use of strategy management in research programs supported by the NIH. The information will improve approaches to implementing strategic management, which will lead to more efficient use of resources. Results gathered in these data will be used to E:\FR\FM\29NON1.SGM 29NON1 71625 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices enhance implementation of methodologies to improve organizational effectiveness. The main goal of this information is to improve program outcomes and increase the efficiency of resource utilization. The knowledge gained from these collections will be used to strengthen the planning, implementation, and monitoring of NIH research programs, as well as to strengthen strategy management in NIH research programs. The questions asked, and the data to be collected are rooted in established business-based paradigms but administered in a manner that minimizes public information collection burden. These include, but are not limited to, surveys, focus groups, and/ or cognitive interviews. Separate and distinct generic clearances are requested to facilitate the efficiency of submission and review of these projects as required by the OMB Office of Information and Regulatory Affairs OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4775. specifically adapted for use (and relevance) in a biomedical research environment, in order to discern: 1) Factors that enhance (or inhibit) organizational effectiveness in research programs; 2) utility and acceptance of these kinds of efforts among biomedical researchers and research stakeholders. The results from this formative research project will inform quality improvement activities in several areas, including goal setting, capability and resource evaluation, operational efficiency, and performance monitoring. Utilized data collection methodologies will be ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Pilot Test ....................... Dated: November 21, 2013. Brandie Taylor, Project Clearance Liaison, Chief, Evaluation Section, OPSIDA, NIAID, NIH. [FR Doc. 2013–28636 Filed 11–27–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 900 1 45/60 675 2500 1000 375 150 1 1 1 1 30/60 90/60 2/60 4/60 1250 1500 750 600 Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office SUMMARY: VerDate Mar<15>2010 17:56 Nov 27, 2013 Jkt 232001 of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Device for Vascular Dilation National Institutes of Health sroberts on DSK5SPTVN1PROD with NOTICES Number of responses per respondent Science professional, researchers, institutional officials, network leadership, program administrators, and research site staff.. ............................................................................... ............................................................................... ............................................................................... ............................................................................... Survey ........................... Interview ........................ Focus group .................. Data interpretation meeting with stakeholders. Description of Technology: The invention is an enhanced vascular dilator that eliminates the vascular injury caused by the size mismatch between vascular introducer sheaths and vascular dilators, as the two are advanced into a blood vessel. The invention provides a ‘‘shoulder’’ to match the diameter of the introducer sheath so that there is a smooth transition, without size mismatch, between the dilator and the introducer sheath. The invention allows the dilator to be withdrawn in segments from the introducer sheath. This is especially valuable to reduce vascular injury when using large-bore introducer sheaths for interventional procedures including transcatheter valves and endografts. Potential Commercial Applications: • Caval access. • Vascular access. Competitive Advantages: Nonperforating. Development Stage: Prototype. PO 00000 Frm 00065 Average burden per response (in hours) Number of respondents Form name Fmt 4703 Sfmt 4703 Total annual burden hour Inventors: Robert Lederman (NHLBI), Ozgur Kocaturk (NHLBI), Adam Greenbaum (Henry Ford Hospital). Intellectual Property: HHS Reference No. E–759–2013/0—US Provisional Patent Application 61/890,961 filed 15 October 2013. Licensing Contact: Michael Shmilovich; 301–435–5019; shmilovm@mail.nih.gov. Collaborative Research Opportunity: The National Heart, Lung, and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize interventional catheterbased procedures to reduce vascular injury. For collaboration opportunities, please contact Peg Koelble at koelblep@nhlbi.nih.gov. Her2 Monoclonal Antibodies, Antibody Drug Conjugates, and Site Specific Antibody Conjugate Methods Description of Technology: Antibody drug conjugates (ADC) can demonstrate high efficacy as cancer therapeutics, however, much more can be done to improve their efficacy and safety profile. Site-specific antibody drug conjugation is a promising way to do this. The scientists at the NIH have identified a fully human monoclonal antibody, m860, that binds to cell surface-associated Her2 with affinity E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71624-71625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28636]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Data 
Collection To Understand How NIH Programs Apply Methodologies To 
Improve Their Research Programs (MIRP)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health, has submitted 
to the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below. This proposed 
information collection was previously published in the Federal Register 
on September 9, 2013, page 55084 and allowed 60-days for public 
comment. One comment was received. However, the issues addressed in the 
comment were not related to the information collection proposed, and 
will not be considered in the finalization process. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Institute of Allergy and Infectious Diseases (NIAID), 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.
    Direct Comments to OMB: 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: NIH Desk Officer.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, or request more information on the 
proposed project, contact: Ms. Dione Washington, Strategic Planning and 
Evaluation Branch, OSPIDA, NIAID, NIH, 6610 Rockledge Dr., Rm 2501, 
Bethesda, MD 20892-6620, or Email your request, including your address 
to washingtondi@niaid.nih.gov. Formal requests for additional plans and 
instruments must be requested in writing.
    Proposed Collection: Data collection to understand how NIH programs 
apply methodologies to improve their research programs (MIRP), 0925-
NEW, National Institute of Allergy and Infectious Diseases (NIAID), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: In this submission, NIAID 
is requesting an OMB generic clearance for formative research 
activities relating to the collection of data to assist the Institute 
in understanding the usefulness of a range of methodologies that are 
employed to increase organizational effectiveness. The Office of 
Management and Budget (OMB) and Office of Science and Technology Policy 
(OSTP) have instructed agencies to apply rigorous strategy management 
principles to ensure resources are directed at high-priority programs 
and avoid duplication of effort. A key aspect to ensuring resources 
dedicated to these programs are applied efficiently and effectively is 
to understand how NIH research programs apply methodologies to improve 
their organizational effectiveness. The degree of an organization's 
effectiveness is commonly recognized to be influenced by many factors. 
These can include the clarity of its purpose and strategy, how it 
allocates and structures its work, the processes used to carry out 
operations, the way technologies are used to support work, the people 
involved and their skills and abilities, the way relationships are 
managed with partners and stakeholders, and how leadership functions, 
particularly in terms of its ability to ensure that all the other 
components are aligned in supporting work towards the mission. Many 
methodologies are commonly employed in all sectors, including 
government, with the goal of increasing organizational effectiveness. 
Some examples of those used widely are strategic planning and strategy 
management, total quality management, change management, organizational 
assessment and intervention, organizational design, process 
improvement, leadership development, performance management, and 
workforce training and professional development, among others. There 
are many models and approaches to each of these methodologies. Each one 
can be implemented in a wide range of ways. Reflection on and learning 
from methodologies that have been used and the ways in which they have 
been employed is critical to continually ensuring that government 
functions effectively.
    The primary use for information gathered through voluntary survey 
pilot testing, surveys, focus groups, interviews, and collaborative 
data interpretation meetings to understand the use of strategy 
management in research programs supported by the NIH. The information 
will improve approaches to implementing strategic management, which 
will lead to more efficient use of resources. Results gathered in these 
data will be used to

[[Page 71625]]

enhance implementation of methodologies to improve organizational 
effectiveness. The main goal of this information is to improve program 
outcomes and increase the efficiency of resource utilization. The 
knowledge gained from these collections will be used to strengthen the 
planning, implementation, and monitoring of NIH research programs, as 
well as to strengthen strategy management in NIH research programs.
    The questions asked, and the data to be collected are rooted in 
established business-based paradigms but specifically adapted for use 
(and relevance) in a biomedical research environment, in order to 
discern: 1) Factors that enhance (or inhibit) organizational 
effectiveness in research programs; 2) utility and acceptance of these 
kinds of efforts among biomedical researchers and research 
stakeholders. The results from this formative research project will 
inform quality improvement activities in several areas, including goal 
setting, capability and resource evaluation, operational efficiency, 
and performance monitoring. Utilized data collection methodologies will 
be administered in a manner that minimizes public information 
collection burden. These include, but are not limited to, surveys, 
focus groups, and/or cognitive interviews. Separate and distinct 
generic clearances are requested to facilitate the efficiency of 
submission and review of these projects as required by the OMB Office 
of Information and Regulatory Affairs
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 4775.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
                   Form name                                Type of respondent               Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)      burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot Test.....................................  Science professional, researchers,                  900               1           45/60             675
                                                  institutional officials, network
                                                  leadership, program administrators,
                                                  and research site staff..
Survey.........................................  .......................................            2500               1           30/60            1250
Interview......................................  .......................................            1000               1           90/60            1500
Focus group....................................  .......................................             375               1            2/60             750
Data interpretation meeting with stakeholders..  .......................................             150               1            4/60             600
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: November 21, 2013.
Brandie Taylor,
Project Clearance Liaison, Chief, Evaluation Section, OPSIDA, NIAID, 
NIH.
[FR Doc. 2013-28636 Filed 11-27-13; 8:45 am]
BILLING CODE 4140-01-P