Submission for OMB Review; 30-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH), 4934-4935 [2015-01685]

Download as PDF 4934 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices assessment of histological and serological endpoints. I. Participation in the Public Workshop National Institutes of Health There is no fee to attend the public workshop, but attendees must register in advance. Space is limited and registration will be on a first-come, firstserved basis. Persons interested in attending this workshop must register online at https://www.great3.org before March 1, 2015. For those without Internet access, please contact Kelly Richards (see FOR FURTHER INFORMATION CONTACT) to register. Onsite registration will not be available. If you need special accommodations due to a disability, please contact Kelly Richards (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. comments in writing, or request more information on the proposed project, contact: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301–435–0941 or Email your request, including your address to curriem@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH), 0925–0648, Expiration Date 1/31/2015, EXTENSION, National Institutes of Health (NIH), Office of the Director (OD). Need and Use of Information Collection: There are no changes being requested for this submission. The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. This generic will provide information about the NIH Institutes and Centers customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information but it will not yield data that can be generalized to the overall population. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated burden hours are 49,358. DEPARTMENT OF HEALTH AND HUMAN SERVICES Submission for OMB Review; 30-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH) II. Transcripts Transcripts of the workshop will be available for review at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the Internet at https:// www.regulations.gov approximately 30 days after the workshop. A transcript will also be available in either hard copy or on CD–ROM after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Fax requests to 301–827– 9267. Dated: January 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–01625 Filed 1–28–15; 8:45 am] BILLING CODE 4164–01–P Under the provisions of Section 3507(a)(1)(D) of 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. This proposed information collection was previously published in the Federal Register on November 21, 2014, volume #79, page 69500 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH 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. 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, submit SUMMARY: Estimated Annualized Burden Hours ESTIMATED ANNUAL REPORTING BURDEN Number of espondents mstockstill on DSK4VPTVN1PROD with NOTICES Type of collection Customer Satisfaction Surveys ....................................................................... In-Depth Interviews (IDIs) or Small Discussion Groups .................................. Focus Groups .................................................................................................. Usability and Pilot Testing ............................................................................... Conference/Training—Pre and Post Surveys ................................................. VerDate Sep<11>2014 18:16 Jan 28, 2015 Jkt 235001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Annual frequency per esponse 1,000 1,000 1,000 150,000 100,000 E:\FR\FM\29JAN1.SGM 1 1 1 1 2 29JAN1 Hours per response 30/60 90/60 90/60 5/60 10/60 Total annual burden hours 500 1,500 1,500 12,525 33,333 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices Dated: January 22, 2015. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2015–01685 Filed 1–28–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: Potential Commercial Applications • Drug Development • Toxicity Studies • Drug Design 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 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. SUPPLEMENTARY INFORMATION: Technology descriptions follow. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Miniature System for Manipulating Small Animals in High-Throughput Screening Small Molecules Description of Technology: The invention pertains to a miniaturized plating and feeding system based on a 96-well microplate base and is intended to reduce manipulation of organisms as well as amounts of test drug/anesthetic, thereby mitigating waste. The kit comprises a feeder plate, transfer adaptor and receiver plate. The feeder plate is defined by, for example, a plastic 96-well plate with rounded wells. The rounded bottoms can dispense to or permit access to the test organism of liquid food or drug through about 7 holes of approximately 350 microns in diameter. A top portion of the well provides test organisms (e.g., drosophila, daphnia) with sufficient VerDate Sep<11>2014 18:16 Jan 28, 2015 Jkt 235001 space to enjoy normal life-cycles without confinement stress. The feeder plate includes means for interfacing with complementary components of the transfer and receiver plates through receiving holes and complementary dowels or pins. A transfer adapter allows the interconnection of the feeder plate to the receiver plate. The transfer plate can be configured to be square or rounded for the transfer of organisms from the feeder plate to the receiver plate. • A LRRK2 inhibitor would be a unique form of anti-inflammatory therapy that will complement or compete with an array of cytokines in primary treatment for lBD. • A LRRK2 inhibitor would provide a much needed alternate mode of therapy. Small animals High Throughput Space efficiency Resource economy Development Stage • Early stage • Prototype Inventors: Maria De Los Angeles Jaime and Brian Oliver (NIDDK). Intellectual Property: HHS Reference No. E–034–2015/0—US Provisional Application No. 62/080,181 filed November 14, 2015. Licensing Contact: Michael Shmilovich, Esq.; 301–435–5019; shmilovm@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Diabetes and Digestive and Kidney Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize High-Throughput Small Animal Manipulation for Drug Design. For collaboration opportunities, please contact Marguerite J. Miller at millermarg@niddk.nih.gov. LRKK2 Inhibitors: Novel Treatment for Intestinal Bowel Disorders Description of Technology: Use of Leucine Rich Repeat Kinase 2 (LRRK2) inhibitors for the treatment of Intestinal Bowel Disorders (IBD) is disclosed. IBD is a broad term that describes conditions with chronic or recurring immune response and inflammation of the gastrointestinal tract. Crohn’s disease and ulcerative colitis, two common forms of idiopathic IBD, are chronic, relapsing inflammatory disorders of the gastrointestinal tract. LRRK2 is a kinase encoded by a gene that contains a non-coding polymorphism (SNP). LRRK2 has been associated with and is a risk factor for inflammatory bowel disease. NIH PO 00000 Frm 00083 Fmt 4703 inventors have shown that human cells expressing this SNP have increased levels of LRRK2 and, correspondingly, mice with increased levels of LRRK2 exhibit more severe Dextran Sulfate colitis. In various studies of the role of LRRK2 in cell signaling, NIH inventors have shown that increased levels of LRRK2 lead to increased proinflammatory cytokine secretion. Also, an inhibitor of LRRK2 is shown to abrogate the pro-inflammatory activity of LRRK2 both in vitro and in vivo. Potential Commercial Applications: Treatment for or prevention of Intestinal Bowel Disorders. Competitive Advantages Competitive Advantages • • • • 4935 Sfmt 4703 Development Stage • Early-stage • In vitro data available • In vivo data available (animal) Inventors: Warren Strober, Ivan J. Fuss, Tetsuya Takagawa, Atsushi Kitani (all of NIAID). Intellectual Property: HHS Reference No. E–070–2014/0—US Provisional Application No. 61/993,637 filed May 15, 2014. Licensing Contact: Suryanarayana Vepa, Ph.D., J.D.; 301–435–5020; vepas@mail.nih.gov. Dated: January 22, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–01610 Filed 1–28–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning E:\FR\FM\29JAN1.SGM 29JAN1

Agencies

[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4934-4935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01685]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Generic 
Clearance for the Collection of Qualitative Feedback on Agency Service 
Delivery (NIH)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of 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. This 
proposed information collection was previously published in the Federal 
Register on November 21, 2014, volume #79, page 69500 and allowed 60 
days for public comment. No public comments were received. The purpose 
of this notice is to allow an additional 30 days for public comment. 
The NIH 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.
    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, submit comments in writing, or 
request more information on the proposed project, contact: Ms. Mikia P. 
Currie, Program Analyst, Office of Policy for Extramural Research 
Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 
20892, or call a non-toll-free number 301-435-0941 or Email your 
request, including your address to curriem@mail.nih.gov. Formal 
requests for additional plans and instruments must be requested in 
writing.
    Proposed Collection: Generic Clearance for the Collection of 
Qualitative Feedback on Agency Service Delivery (NIH), 0925-0648, 
Expiration Date 1/31/2015, EXTENSION, National Institutes of Health 
(NIH), Office of the Director (OD).
    Need and Use of Information Collection: There are no changes being 
requested for this submission. The information collection activity will 
garner qualitative customer and stakeholder feedback in an efficient, 
timely manner, in accordance with the Administration's commitment to 
improving service delivery. This generic will provide information about 
the NIH Institutes and Centers customer or stakeholder perceptions, 
experiences and expectations, provide an early warning of issues with 
service, or focus attention on areas where communication, training, or 
changes in operations might improve delivery of products or services. 
It will also allow feedback to contribute directly to the improvement 
of program management. Feedback collected under this generic clearance 
will provide useful information but it will not yield data that can be 
generalized to the overall population.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated burden hours are 
49,358.

Estimated Annualized Burden Hours

                                        Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                      Annual
               Type of collection                    Number of     frequency per     Hours per     Total annual
                                                    respondents      response        response      burden hours
----------------------------------------------------------------------------------------------------------------
Customer Satisfaction Surveys...................           1,000               1           30/60             500
In-Depth Interviews (IDIs) or Small Discussion             1,000               1           90/60           1,500
 Groups.........................................
Focus Groups....................................           1,000               1           90/60           1,500
Usability and Pilot Testing.....................         150,000               1            5/60          12,525
Conference/Training--Pre and Post Surveys.......         100,000               2           10/60          33,333
----------------------------------------------------------------------------------------------------------------



[[Page 4935]]

    Dated: January 22, 2015.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2015-01685 Filed 1-28-15; 8:45 am]
BILLING CODE 4140-01-P
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