Center for Scientific Review; Notice of Closed Meetings, 51169-51170 [2019-20965]

Download as PDF Federal Register / Vol. 84, No. 188 / Friday, September 27, 2019 / Notices Section 3060 of the 21st Century Cures Act’’ to provide clarification of its interpretation of section 520(o)(1)(A)– (D) of the FD&C Act (21 U.S.C. 360j(o)(1)(A)–(D)), as added by the Cures Act, for certain medical software functions that are not medical devices, including software functions that are intended: (1) For administrative support of a health care facility, (2) for maintaining or encouraging a healthy lifestyle, (3) to serve as electronic patient records, or (4) for transferring, storing, converting formats, or displaying data. Section 520(o)(2) of the FD&C Act describes the regulation of a product with multiple functions, including at least one device function and at least one software function that is not a device. FDA intends to provide recommendations on the regulation of such products with multifunctionality in a separate guidance document. On December 8, 2017, FDA announced in the Federal Register a draft guidance entitled ‘‘Clinical and Patient Decision Support Software’’ (82 FR 57987). FDA is issuing a revised draft guidance, now entitled ‘‘Clinical Decision Support Software,’’ after considering comments received on the draft guidance that issued December 8, II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Clinical Decision Support Software.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://www.fda.gov/ drugs/guidance-compliance-regulatoryinformation/guidances-drugs. Persons unable to download an electronic copy of ‘‘Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400062 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the following FDA regulations, guidance, and form have been approved by OMB as listed in the following table: 21 CFR part; guidance; or FDA form Topic 807, subpart E ............................................................ 814, subparts A through E ......................................... 814, subpart H ........................................................... 812 ............................................................................. ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. 800, 801, and 809 ...................................................... 314 ............................................................................. 601; Form FDA 356h ................................................. Premarket Notification .......................................................................... Premarket Approval .............................................................................. Humanitarian Device Exemption .......................................................... Investigational Device Exemption ......................................................... De Novo Classification Process ........................................................... 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 Medical Device Labeling Regulations .................................................. Applications for FDA Approval to Market a New Drug ........................ Biologics License; Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use—Form FDA 356h. 0910–0485 0910–0001 0910–0338 Dated: September 23, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–21000 Filed 9–26–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings jbell on DSK3GLQ082PROD with NOTICES 2017. This draft guidance provides FDA’s risk-based policy for Device CDS software functions in response to comments received. 51169 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 VerDate Sep<11>2014 18:29 Sep 26, 2019 Jkt 247001 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: Genes, Genomes, and Genetics Integrated Review Group; Therapeutic Approaches to Genetic Diseases Study Section. Date: October 24, 2019. Time: 8:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San Diego, CA 92109. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 OMB Control No. Contact Person: Methode Bacanamwo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2200, Bethesda, MD 20892, 301–827–7088, methode.bacanamwo@nih.gov. Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Xenobiotic and Nutrient Disposition and Action Study Section. Date: October 24–25, 2019. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Mayflower Park Hotel, 405 Olive Way, Seattle, WA 98101. Contact Person: Jonathan K. Ivins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2190, MSC, 7850 Bethesda, MD 20892, (301) 594– 1245, ivinsj@csr.nih.gov. E:\FR\FM\27SEN1.SGM 27SEN1 51170 Federal Register / Vol. 84, No. 188 / Friday, September 27, 2019 / Notices (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: September 23, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–20965 Filed 9–26–19; 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: National Institutes of Health, HHS. ACTION: 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: Chris Kornak at 240–627–3705 or Chris.Kornak@nih.gov. Licensing information may be obtained by communicating with 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 information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: SUMMARY: jbell on DSK3GLQ082PROD with NOTICES Improvement of Broadly HIVNeutralizing Antibodies; Anti-HIV–1 Antibody VRC01.23 for Prevention or Treatment of HIV Infection Description of Technology: Scientists at NIAID have developed broadly neutralizing antibodies (bNAbs) with enhanced neutralizing activity against HIV–1. Specifically, previously unknown gp120 interactions with a newly elucidated quaternary receptor (CD4)-binding site in the HIV–1 envelope have been discovered by engrafting the extended heavy-chain framework region 3 (FR3) loop of VRC03 onto several potent bNAbs (including VerDate Sep<11>2014 18:29 Sep 26, 2019 Jkt 247001 VRC01, VRC07 and N6). The new antibodies show improved binding with CD4 by interacting with both binding sites and as a result show improved neutralization of various HIV–1 strains. Furthermore, they show reduced autoreactivity and, as a result, have prolonged in vivo half-life. One of several antibodies that were developed using this technology is VRC01.23. It combines the VRC03 framework 3 alteration, with a G54W mutation in the heavy chain, and a 3 amino acid deletion in the light chain. The modifications improved the potency while reducing the autoreactivity. In particular, VRC01.23 is capable of neutralizing 96% of HIV– 1 viruses tested at geometric mean IC50 =0.042 ug/ml, which is ∼10-fold more potent than VRC01. 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: • Improving human monoclonal antibodies for HIV treatment or prevention • New candidates for use as a therapeutic or as a prophylactic Competitive Advantages: • Interaction with multiple HIV binding sites • Reduced autoreactivity when using the VRC03 framework 3 region mutation • Improved neutralization breadth and potency over existing antibodies • Extended in vivo half-life Development Stage: • Pre-clinical Inventors: Paolo Lusso, Qingbo Liu, Peter Kwong, Young Do Kwon, and John Mascola, all of NIAID. Publications: Liu, Qingbo, et al. ‘‘Improvement of antibody functionality by structure-guided paratope engraftment.’’ Nature communications 10.1 (2019): 721. Intellectual Property: HHS Reference No. E–034–2018–0–PCT–01—PCT Application No. PCT/US2019/019021 filed on 21 February 2019. Licensing Contact: To license this technology, please contact Chris Kornak at 240–627–3705 or Chris.Kornak@ nih.gov, and reference E–034–2018. 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 this technology. For PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 collaboration opportunities, please contact Chris Kornak at 240–627–3705 or Chris.Kornak@nih.gov. Dated: September 18, 2019. Wade W. Green, Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2019–20994 Filed 9–26–19; 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: 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. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. Antagonists of Hyaluronan Signaling for Treatment of Airway Diseases, such as Asthma and Chronic Obstructive Pulmonary Disease (COPD), constitute a major health burden in the development word. It is estimated that nearly15.0% of the adult population in the US are affected with such diseases, and the economic cost burden is over $23 billion annually. Unfortunately, the current options for treatment of such diseases are quite limited, consisting only of bronchodilators and inhaled steroids. The need for a novel and more effective class of therapeutics agents is imperative. The subject invention provides for a potentially more specific and effective treatment of airway diseases as compared with existing treatments. It is based on the inhibition of Hyaluronan (HA), a structural polysaccharide that plays a role in the signaling pathway that leads to the SUMMARY: E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Notices]
[Pages 51169-51170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20965]


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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, 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.

    Name of Committee: Genes, Genomes, and Genetics Integrated 
Review Group; Therapeutic Approaches to Genetic Diseases Study 
Section.
    Date: October 24, 2019.
    Time: 8:00 a.m. to 7:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San 
Diego, CA 92109.
    Contact Person: Methode Bacanamwo, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 2200, Bethesda, MD 20892, 301-
827-7088, [email protected].

    Name of Committee: Digestive, Kidney and Urological Systems 
Integrated Review Group; Xenobiotic and Nutrient Disposition and 
Action Study Section.
    Date: October 24-25, 2019.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Mayflower Park Hotel, 405 Olive Way, Seattle, WA 98101.
    Contact Person: Jonathan K. Ivins, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 2190, MSC, 7850 Bethesda, MD 
20892, (301) 594-1245, [email protected].


[[Page 51170]]


(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: September 23, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-20965 Filed 9-26-19; 8:45 am]
BILLING CODE 4140-01-P
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