Federal Register - February 25, 2021
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Fuente: Federal Register
Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices This live-attenuated RSV vaccine is designed to be administered intranasally by drops or spray to infants and young children. Based on experience with other live-attenuated RSV vaccine candidates, the present candidates are anticipated to be well tolerated in humans and are available for clinical evaluation. The National Institute of Allergy and Infectious Diseases has extensive experience and capability in evaluating live-attenuated RSV vaccine candidates in pediatric clinical studies, and opportunity for collaboration exists.
This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further development and evaluation under a research collaboration.
Potential Commercial Applications:
Viral diagnostics Vaccine research Competitive Advantages:
Ease of manufacture B cell and T cell activation Low-cost vaccines Intranasal administration/needle-free delivery Development Stage:
In vivo data assessment animal Inventors: Cyril Le Nouen NIAID, Ursula Buchholz NIAID, Peter Collins NIAID.
Intellectual Property: HHS Reference No. E10420200U.S. Provisional Application No. 63/023,949, filed May 13, 2020.
Licensing Contact: Peter Soukas, J.D., 3015948730; peter.soukas@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 3015948730;
peter.soukas@nih.gov.
Dated: February 18, 2021.
Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
SUMMARY:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/
PRAMain. Find this particular information collection by selecting Currently under 30-day ReviewOpen for Public Comments or by using the search function.
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: Lorena Kaplan, M.P.H., CHES, Office of Communications, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A32, Bethesda, Maryland 20892, or call non-toll free number 301
4966670 or Email your request, including your address to lorena.kaplan@nih.gov.
SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on December 11, 2020, page 8012380124 85 FR 8012380124 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 Eunice Kennedy Shriver National Institute for Child Health and Human Development, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection ADDRESSES:
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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 3507a1D 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.
Proposed Collection: Generic Clearance to Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development NICHD, 09250701, exp., date 02/28/
2021, REVISION, Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD, National Institutes of Health NIH.
Need and Use of Information Collection: This is a request for a revision to a generic clearance used for submissions specific to the Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD Safe to Sleep STS public education campaign. Submissions for the STS campaign will be used to assess the understanding and reach of STS
campaign materials and messages, and to monitor and improve campaign activities such as training workshops and overall implementation. The purpose of this information collection is to monitor and modify campaign activities, to plan future campaign activities, to develop messages and materials, and to develop distribution and outreach strategies that are effective at communicating their message to bring about the intended response, awareness, and/or behavioral change for the target audiences. This generic clearance will enable the NICHD to: 1 More efficiently assess the implementation of campaign activities; 2 better understand the target audiences knowledge, attitudes, and beliefs toward STS messages and materials; 3 better understand how the campaign activities have influenced the target audiences behaviors and practices; and 4 monitor and improve activities such as trainings, materials, and messages. Having a way to gather feedback on the STS campaign activities is critical to assessing the reach and effect of campaign efforts.
Data collected for the campaign can inform where future STS campaign resources can produce the most meaningful results. Data collected for the STS campaign generic clearance will be used by a number of audiences, including STS campaign staff, NICHD
leadership, STS campaign collaborators,
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