Submission for OMB Review; Comment Request: National Institutes of Health Information Collection Forms To Support Genomic Data Sharing for Research Purposes, 6119-6120 [2013-01851]

Download as PDF 6119 Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103–227, the ProChildren Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the HHS mission to protect and advance the physical and mental health of the American people. Dated: January 18, 2013. Yvette Roubideaux, Director, Indian Health Service. [FR Doc. 2013–01876 Filed 1–28–13; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request: National Institutes of Health Information Collection Forms To Support Genomic Data Sharing for Research Purposes PHS, DHHS, National Institutes of Health (NIH). ACTION: Request for comments AGENCY: 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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 5, 2012 (77 FR 61008), 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. 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 SUMMARY: October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: National Institutes of Health Information Collection Forms to Support Genomic Data Sharing for Research Purposes; Type of Information Collection Request: New; Need and Use of Information Collection: The NIH mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The sharing of research data supports this mission and is essential to facilitate the translation of research results into knowledge, products, practices, and procedures that improve human health. By enabling secondary research questions to be addressed, data sharing maximizes the public benefit achieved through research investments. NIH’s Policy for Sharing of Data Obtained in NIH Supported or Conducted GenomeWide Association Studies (GWAS) was established to enable the full value of GWAS data to be realized. GWAS data are maintained in a central data repository, the database of Genotypes and Phenotypes (dbGaP), which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH. As stipulated in the NIH GWAS Policy, all principal investigators (PIs) who receive NIH funding to conduct genomic research are expected to register studies with genomic data in dbGaP. The nature of the genomic, phenotypic, and other associated data generated through large-scale human genomic studies requires responsible stewardship throughout research and data sharing activities. Since the data being collected and shared are from human research participants, the protection of participant interests is paramount. PIs submitting data to dbGaP must describe any limitations on sharing the data, as defined in the Study Registration and Data Submission: PI .............................................................................................. Senior Official .................................................................................. srobinson on DSK4SPTVN1PROD with Estimated number of responses per respondent Estimated number of respondents Type of respondent informed consent provided by the participants from whom the data were originally collected. PIs must also provide basic study information such as the type of data that will be submitted to dbGaP and a description of the study. Researchers interested in using dbGaP data for secondary research must submit a request through dbGaP and be granted permission from the relevant NIH Data Access Committees to access the data. As part of the request process, researchers must provide information such as a description of the proposed research use of the dbGaP datasets, a data security plan, and a Data Use Certification, in which the researcher agrees to the terms and conditions for use of the data. NIH has developed online forms, which will be available through dbGaP, in an effort to reduce the burden for researchers to complete the study registration, data submission, and data access processes. Frequency of Response: As necessary. Description of Respondents: PIs and senior officials from their institutions. Estimate of Burden: The burden associated with this information collection is calculated in two parts: (1) the burden associated with registering genomic studies and submitting data to dbGaP and (2) the burden associated with applying for genomic data in dbGaP. The annual reporting burden for study registration and data submission is as follows: Estimated Number of Respondents: 100; Estimated Number of Responses per Respondent: 1; and Estimated Total Annual Burden Hours Requested: 63. The annual cost to respondents is estimated at $2,506. The annual reporting burden for applying for genomic data in dbGaP is as follows: Estimated Number of Respondents: 1, 266; Estimated Number of Responses per Respondent: 2; and Estimated Total Annual Burden Hours Requested: 1,583. The annual cost to respondents is estimated at $63,452. There are no capital, operating, or maintenance costs to the respondents. Average burden per response (in hours) Estimated total annual burden hours 50 50 1 1 45/60 30/60 38 25 Total ................................................................................... Data Access Request: PI .............................................................................................. Senior Official .................................................................................. 100 ............................ ............................ 63 633 633 2 2 45/60 30/60 950 633 Total ................................................................................... 1,266 ............................ ............................ 1,583 VerDate Mar<15>2010 17:39 Jan 28, 2013 Jkt 229001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\29JAN1.SGM 29JAN1 6120 Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices Request For Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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. 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: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instrument, contact: Sarah Carr, Acting Director, Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; telephone 301–496–9838; fax 301–496– 9839; or email GWAS@od.nih.gov, Attention: Ms. Carr. 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. Dated: January 18, 2013. Sarah Carr, Acting Director, Office of Clinical Research and Bioethics Policy, Office of Science Policy, National Institutes of Health. [FR Doc. 2013–01851 Filed 1–28–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES srobinson on DSK4SPTVN1PROD with National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. AGENCY: VerDate Mar<15>2010 16:47 Jan 28, 2013 Jkt 229001 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. 207 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. SUMMARY: Novel Derivatives of Docosahexaenoylethanolamide as Therapeutics for Neuronal Disorders Description of Technology: This technology provides derivatives of Docosahexaenoylethanolamide (synaptamide or DEA) which have increased potency and hydrolysis resistance as compared to DEA (structures of these derivatives are available upon request), as well as methods of using these derivatives to promote neurogenesis, neurite growth, and/or synaptogenesis. Docosahexaenoic acid (DHA), an n-3 polyunsaturated fatty acid that accumulates in the brain during development, has been shown to play a key role in learning and memory development. Studies have also shown that DEA, a metabolite derived from DHA is very potent in accelerating neuronal growth and development. The inventors have discovered that the novel DEA derivatives they have designed are even more potent than DEA or DHA in accelerating neuronal growth, synaptogenesis and development. The inventors have shown that treatment of progenitor neural cells with some of these novel DEA derivatives leads to an increase in the amount of somatic neurons produced after differentiation. These novel compounds can be developed as therapeutics for conditions such as trauma, stroke, multiple sclerosis, Alzheimer’s disease, brain and spinal cord injuries, and peripheral nerve injuries for rehabilitation. Potential Commercial Applications: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 • Agents to promote neurogenesis, neurite growth, and synaptogenesis. • Therapeutics for neurological conditions, such as traumatic brain injury, spinal cord injury, peripheral nerve injury, stroke, multiple sclerosis, autism, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis. Competitive Advantages: These derivatives of DEA provide increased potency and hydrolysis resistance compared to DEA. Development Stage: • Prototype. • Early-stage. • Pre-clinical. • In vitro data available. Inventors: Erika Englund (NCATS), Juan Marugan (NCATS), Samarjit Patnaik (NCATS), Hee-Yong Kim (NIAAA) Publications: 1. Kim HY, et al. NDocosahexaenoylethanolamide promotes development of hippocampal neurons. Biochem J. 2011 Apr 15;435(2):327–36. [PMID 21281269]. 2. Kim HY, et al. A synaptogenic amide N-docosahexaenoylethanolamide promotes hippocampal development. Prostaglandins Other Lipid Mediat. 2011 Nov;96(1–4):114–20. [PMID 21810478]. 3. Cao D, et al. Docosahexaenoic acid promotes hippocampal neuronal development and synaptic function. J Neurochem. 2009 Oct;111(2):510–21. [PMID 19682204]. Intellectual Property: HHS Reference No. E–070–2012/0 — U.S. Provisional Application No. 61/624,741 filed 16 Apr 2012. Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301–435–5020; vepas@mail.nih.gov. Collaborative Research Opportunity: The National Center for Advancing Translational Sciences is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Dr. Juan Marugan at maruganj@mail.nih.gov or Dr. Krishna Balakrishnan at balakrik@mail.nih.gov. High-Affinity Rabbit Monoclonal Antibodies to Mesothelin for Treatment of Cancer Description of Technology: Mesothelin is a cell surface protein that is highly expressed in aggressive cancers, such as malignant mesothelioma, ovarian cancer and pancreatic cancer. Because of this selective expression, mesothelin is an E:\FR\FM\29JAN1.SGM 29JAN1

Agencies

[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Pages 6119-6120]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01851]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request: National Institutes 
of Health Information Collection Forms To Support Genomic Data Sharing 
for Research Purposes

AGENCY: PHS, DHHS, National Institutes of Health (NIH).

ACTION: Request for comments

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

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 to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on October 5, 2012 (77 FR 61008), 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. 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.
    Proposed Collection: Title: National Institutes of Health 
Information Collection Forms to Support Genomic Data Sharing for 
Research Purposes; Type of Information Collection Request: New; Need 
and Use of Information Collection: The NIH mission is to seek 
fundamental knowledge about the nature and behavior of living systems 
and the application of that knowledge to enhance health, lengthen life, 
and reduce the burdens of illness and disability. The sharing of 
research data supports this mission and is essential to facilitate the 
translation of research results into knowledge, products, practices, 
and procedures that improve human health.
    By enabling secondary research questions to be addressed, data 
sharing maximizes the public benefit achieved through research 
investments. NIH's Policy for Sharing of Data Obtained in NIH Supported 
or Conducted Genome-Wide Association Studies (GWAS) was established to 
enable the full value of GWAS data to be realized. GWAS data are 
maintained in a central data repository, the database of Genotypes and 
Phenotypes (dbGaP), which is administered by the National Center for 
Biotechnology Information (NCBI), part of the National Library of 
Medicine at NIH.
    As stipulated in the NIH GWAS Policy, all principal investigators 
(PIs) who receive NIH funding to conduct genomic research are expected 
to register studies with genomic data in dbGaP. The nature of the 
genomic, phenotypic, and other associated data generated through large-
scale human genomic studies requires responsible stewardship throughout 
research and data sharing activities. Since the data being collected 
and shared are from human research participants, the protection of 
participant interests is paramount. PIs submitting data to dbGaP must 
describe any limitations on sharing the data, as defined in the 
informed consent provided by the participants from whom the data were 
originally collected. PIs must also provide basic study information 
such as the type of data that will be submitted to dbGaP and a 
description of the study.
    Researchers interested in using dbGaP data for secondary research 
must submit a request through dbGaP and be granted permission from the 
relevant NIH Data Access Committees to access the data. As part of the 
request process, researchers must provide information such as a 
description of the proposed research use of the dbGaP datasets, a data 
security plan, and a Data Use Certification, in which the researcher 
agrees to the terms and conditions for use of the data. NIH has 
developed online forms, which will be available through dbGaP, in an 
effort to reduce the burden for researchers to complete the study 
registration, data submission, and data access processes.
    Frequency of Response: As necessary.
    Description of Respondents: PIs and senior officials from their 
institutions.
    Estimate of Burden: The burden associated with this information 
collection is calculated in two parts: (1) the burden associated with 
registering genomic studies and submitting data to dbGaP and (2) the 
burden associated with applying for genomic data in dbGaP. The annual 
reporting burden for study registration and data submission is as 
follows: Estimated Number of Respondents: 100; Estimated Number of 
Responses per Respondent: 1; and Estimated Total Annual Burden Hours 
Requested: 63. The annual cost to respondents is estimated at $2,506. 
The annual reporting burden for applying for genomic data in dbGaP is 
as follows: Estimated Number of Respondents: 1, 266; Estimated Number 
of Responses per Respondent: 2; and Estimated Total Annual Burden Hours 
Requested: 1,583. The annual cost to respondents is estimated at 
$63,452. There are no capital, operating, or maintenance costs to the 
respondents.

----------------------------------------------------------------------------------------------------------------
                                                                Estimated
                                              Estimated         number of      Average burden    Estimated total
           Type of respondent                 number of       responses per   per response (in    annual burden
                                             respondents       respondent          hours)             hours
----------------------------------------------------------------------------------------------------------------
Study Registration and Data Submission:
    PI..................................                50                 1             45/60                38
Senior Official.........................                50                 1             30/60                25
                                         -----------------------------------------------------------------------
        Total...........................               100  ................  ................                63
Data Access Request:
    PI..................................               633                 2             45/60               950
Senior Official.........................               633                 2             30/60               633
                                         -----------------------------------------------------------------------
        Total...........................             1,266  ................  ................             1,583
----------------------------------------------------------------------------------------------------------------


[[Page 6120]]

    Request For Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate 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) Evaluate 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) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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.
    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: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instrument, contact: Sarah Carr, Acting Director, Office of Clinical 
Research and Bioethics Policy, Office of Science Policy, NIH, 6705 
Rockledge Drive, Suite 750, Bethesda, MD 20892; telephone 301-496-9838; 
fax 301-496-9839; or email GWAS@od.nih.gov, Attention: Ms. Carr.
    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.

    Dated: January 18, 2013.
Sarah Carr,
Acting Director, Office of Clinical Research and Bioethics Policy, 
Office of Science Policy, National Institutes of Health.
[FR Doc. 2013-01851 Filed 1-28-13; 8:45 am]
BILLING CODE 4140-01-P