Proposed Collection; 60-Day Comment Request; National Children's Study (NCS) Vanguard Data and Sample Archive and Access System (Eunice Kennedy Shriver National Institute of Child Health and Human Development), 55905-55906 [2018-24465]

Download as PDF 55905 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices seeking statements of capability or interest from parties interested in collaborative research, such as from bioanalytic research groups to develop rapid influenza monitoring, diagnostic, and surveillance devices and biotechnology companies to formulate and test influenza next generation sequencing kits for challenging influenza infected samples, for example zoonotic infections of influenza A virus subtypes differing from currently circulating human influenza viruses or in mixed infections. NIAID will consider executing a Confidentiality Agreement with a prospective collaborator to facilitate receipt of a Capability Statement if requested. For collaboration opportunities, please contact Jenish Patel, Ph.D., 240–669– 2894; jenish.patel@nih.gov. Dated: October 19, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018–24468 Filed 11–7–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; National Children’s Study (NCS) Vanguard Data and Sample Archive and Access System (Eunice Kennedy Shriver National Institute of Child Health and Human Development) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on SUMMARY: electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: National Children’s Study (NCS) Vanguard Data and Sample Archive and Access System, 0925–0730 exp., date 2/28/ 2019—EXTENSION Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: NICHD requires institutional and investigator contact information from users of the NCS Data and Sample Archive and Access System (NCS Archive). This information collected from potential data users is necessary to fulfill the requirements of their proposed research projects, ensure compliance with Department of Health and Human Services regulations for the protection of human subjects in research (45 CFR 46) and the Common Rule (45 CFR 46 Subpart A), and to document, track, and monitor the use of the NCS Archive, which provides opportunities for qualified researchers to use data and samples collected by the NCS Vanguard phase, for approved research projects. The information in addition will help NIH better understand the use of archived data and samples by the research community. There is no plan to publish the data collected under this request other than to post on the NCS Archive website the titles of approved research projects together with project investigators’ institutional affiliations. The data otherwise are for internal monitoring purposes only, to assess the archive resource requirements and for quality improvement. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 109. proposed data collection projects, the National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. 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. 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: Jack Moye, Jr., MD, Bldg. 6710B Rm. 2130 MSC 7002, 9000 Rockville Pike, Bethesda, MD, 20892–7002, or call non-toll-free number (301) 594–8624 or Email your request, including your address to: NCSArchive@s-3.net. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address 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, ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent daltland on DSKBBV9HB2PROD with NOTICES Research Research Research Research scientists scientists scientists scientists Number of respondents Form Average time per response (hours) Frequency of response Total annual burden hours ....... ....... ....... ....... NCS Vanguard Data User Agreement ................ NCS Vanguard Data Request Form ................... NCS Vanguard Data and Sample Request Form Research Materials Distribution Agreement ........ 300 50 50 100 1 1 1 1 10/60 20/60 30/60 10/60 50 17 25 17 Total ........................ .............................................................................. 500 500 ........................ 109 VerDate Sep<11>2014 16:51 Nov 07, 2018 Jkt 247001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1 55906 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices Dated: November 1, 2018. Jennifer M. Guimond, Project Clearance Liaison, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. [FR Doc. 2018–24465 Filed 11–7–18; 8:45 am] BILLING CODE 4140–01–P (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 5, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health [FR Doc. 2018–24471 Filed 11–7–18; 8:45 am] BILLING CODE 4140–01–P daltland on DSKBBV9HB2PROD with NOTICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Mental Health; Notice of Closed Meetings National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. National Eye Institute; Notice of Closed Meeting VerDate Sep<11>2014 16:51 Nov 07, 2018 Jkt 247001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Institutional Training Grant Applications (T32 and T35). Date: November 27–28, 2018. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Ste. 3400, Bethesda, MD 20817 (Virtual Meeting). Contact Person: Anne E. Schaffner, Ph.D., Chief, Scientific Review Branch, Division of Extramural Research, National Eye Institute, 5635 Fishers Lane, Suite 1300, Msc 9300, Bethesda, MD 20892–9300, (301) 451–2020, aes@nei.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: November 2, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–24467 Filed 11–7–18; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00056 Fmt 4703 AGENCY: Sfmt 4703 National Institutes of Health, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: National Institute of Mental Health Special Emphasis Panel Member Conflicts: Mental Health Services Research. Date: November 26, 2018. Time: 4:00 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301–451–2356, gavinevanskm@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Rare Genetic Disorders as a Window into the Genetic Architecture of Mental Disorders. Date: November 27, 2018. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Vinod Charles, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 6151, MSC 9606, Bethesda, MD 20892–9606, 301–443–1606, charlesvi@mail.nih.gov. Government-Owned Inventions; Availability for Licensing Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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: James M. Robinson, 301–761–7542; James.Robinson4@nih.gov. Licensing information and copies of the patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Methods for diagnosing and treating Mycobacterium tuberculosis (Mtb) infection through detection of CD153 expression level. Description of Technology: Mycobacterium tuberculosis (Mtb) infection continues to be the leading cause of death due to a single infectious agent and poses significant global health challenges. Past research has shown that CD4 T cells are essential for resistance to Mtb infection, and for decades it has been thought that IFN(g) production is the primary mechanism of CD4 T cellmediated protection. NIAID researchers have discovered that the expression of TNF superfamily molecule CD153 (TNSF8) is required for control of the pulmonary Mtb infection by CD4 T cells. The results have shown that, in Mtb infected mice, CD153 expression is highest on Ag-specific Th1 cells in the lung tissue parenchyma. On the contrary, CD153 deficient mice have developed high pulmonary bacterial loads and succumb early to Mtb infection. In Mtb infected non-human primates, CD153 expression is much higher on Ag-specific CD4 T cells in the SUMMARY: E:\FR\FM\08NON1.SGM 08NON1

Agencies

[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55905-55906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24465]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; National Children's 
Study (NCS) Vanguard Data and Sample Archive and Access System (Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Institutes of Health Eunice Kennedy 
Shriver National Institute of Child Health and Human Development will 
publish periodic summaries of proposed projects to be submitted to the 
Office of Management and Budget (OMB) for review and approval.

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.

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: Jack Moye, 
Jr., MD, Bldg. 6710B Rm. 2130 MSC 7002, 9000 Rockville Pike, Bethesda, 
MD, 20892-7002, or call non-toll-free number (301) 594-8624 or Email 
your request, including your address to: 3.net">[email protected]3.net. Formal 
requests for additional plans and instruments must be requested in 
writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: Written comments and/or suggestions 
from the public and affected agencies are invited to address 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.
    Proposed Collection Title: National Children's Study (NCS) Vanguard 
Data and Sample Archive and Access System, 0925-0730 exp., date 2/28/
2019--EXTENSION Eunice Kennedy Shriver National Institute of Child 
Health and Human Development (NICHD), National Institutes of Health 
(NIH).
    Need and Use of Information Collection: NICHD requires 
institutional and investigator contact information from users of the 
NCS Data and Sample Archive and Access System (NCS Archive). This 
information collected from potential data users is necessary to fulfill 
the requirements of their proposed research projects, ensure compliance 
with Department of Health and Human Services regulations for the 
protection of human subjects in research (45 CFR 46) and the Common 
Rule (45 CFR 46 Subpart A), and to document, track, and monitor the use 
of the NCS Archive, which provides opportunities for qualified 
researchers to use data and samples collected by the NCS Vanguard 
phase, for approved research projects. The information in addition will 
help NIH better understand the use of archived data and samples by the 
research community. There is no plan to publish the data collected 
under this request other than to post on the NCS Archive website the 
titles of approved research projects together with project 
investigators' institutional affiliations. The data otherwise are for 
internal monitoring purposes only, to assess the archive resource 
requirements and for quality improvement.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 109.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Average time
               Type of respondent                                  Form                      Number of     Frequency of    per response    Total annual
                                                                                            respondents      response         (hours)      burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Research scientists............................  NCS Vanguard Data User Agreement.......             300               1           10/60              50
Research scientists............................  NCS Vanguard Data Request Form.........              50               1           20/60              17
Research scientists............................  NCS Vanguard Data and Sample Request                 50               1           30/60              25
                                                  Form.
Research scientists............................  Research Materials Distribution                     100               1           10/60              17
                                                  Agreement.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             500             500  ..............             109
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 55906]]

    Dated: November 1, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2018-24465 Filed 11-7-18; 8:45 am]
 BILLING CODE 4140-01-P