Center for Scientific Review; Notice of Closed Meetings, 29570-29571 [2017-13571]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES 29570 Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices Instructions: All submissions received must include the Docket No. FDA– 2017–N–3199 for ‘‘Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in BsUFA II.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Azada Hafiz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, VerDate Sep<11>2014 18:29 Jun 28, 2017 Jkt 241001 MD 20993, 240–402–6073, Fax: 301– 847–8443, Azada.Hafiz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The timely review of 351(k) applications is central to FDA’s mission to protect and promote the public health. The BsUFA was first enacted by Congress in 2012 and authorizes FDA to collect user fees for 351(k) applications. FDA dedicates BsUFA user fees to the efficient review of 351(k) applications and to facilitate the development of safe and effective biosimilar biological products for the American public. FDA dedicates the additional fee resources to hire reviewers and support staff and upgrade its information technology systems. With the availability of these additional fee resources, FDA was able to agree to certain review performance goals, including a complete review of 351(k) applications and taking regulatory action within specified timeframes. The current authorization of the program (BsUFA I) expires in September 2017. As directed by statute, FDA prepared recommendations for the reauthorization of BsUFA for a new 5year period by conducting negotiations with the regulated industry and holding regular consultations with public stakeholders including patient advocates, consumer advocates, and healthcare professionals. Following these discussions, related public meetings, and Agency requests for public comment, FDA transmitted proposed recommendations for BsUFA II for fiscal years 2018–2022. FDA’s BsUFA II recommendations include an FDA commitment to implement a new review program for 351(k) applications to promote the efficiency and effectiveness of the first-cycle review process and minimize the number of review cycles necessary for approval of these complex applications. The Program is described in detail in section I.B of the document entitled ‘‘Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022’’ available at https://www.fda.gov/ downloads/forindustry/userfees/ biosimilaruserfeeactbsufa/ ucm521121.pdf. II. BsUFA II Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs FDA recognizes that increasing communication between the Agency and applicants during FDA’s review has the potential to increase efficiency in the review process. To enhance review PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 transparency and improve communication between the FDA review team and the applicant, FDA has proposed for BsUFA II a new review model (the Program), for the review of all 351(k) applications. The Program will allow for additional communication between FDA review teams and the applicants of biosimilar biological products in the form of a Biological Product Development Type 4 (pre-351(k) BLA) meetings, mid-cycle communications, and late-cycle meetings. To accommodate this increased interaction during regulatory review and to address the need for additional time to review these complex applications, FDA’s review clock will begin after the 60-day administrative filing review period for applications reviewed under the Program. The goal of the Program is to improve the efficiency and effectiveness of the first-cycle review process by increasing communications during application review. This will provide sponsors with the opportunity to clarify previous submissions and provide additional data and analyses that are readily available, potentially avoiding the need for an additional review cycle when concerns can be promptly resolved without compromising FDA’s standards for approval. Dated: June 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–13609 Filed 6–28–17; 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 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 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR16–274: E:\FR\FM\29JNN1.SGM 29JNN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices Adverse Drug Reaction Scientific Review Panel. Date: July 26, 2017. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Alexander D Politis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 20892, (301) 435– 1150, politisa@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Mechanisms of Bacterial Virulence and Pathogenesis. Date: July 27–28, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301–435– 1146, jig@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Synthetic and Biological Chemistry. Date: July 27, 2017. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Mike Radtke, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301–435– 1728, radtkem@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Nutrient and Lipid Regulation. Date: July 27, 2017. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Gary Hunnicutt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, ≤6701 Rockledge Drive, Room 6164, MSC 7892, Bethesda, MD 20892, 301–435– 0229, gary.hunnicutt@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neurodegeneration: Mechanisms and Pathways. Date: July 27, 2017. Time: 12:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). VerDate Sep<11>2014 18:29 Jun 28, 2017 Jkt 241001 Contact Person: Laurent Taupenot, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4188, MSC 7850, Bethesda, MD 20892, 301–435– 1203, laurent.taupenot@nih.gov. Name of Committee: Biology of Development and Aging Integrated Review Group; International and Cooperative Projects—1 Study Section. Date: July 28, 2017. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892, (301) 237– 9838, bhagavas@csr.nih.gov. (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: June 23, 2017. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2017–13571 Filed 6–28–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting 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 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 Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Time-Sensitive Obesity Review. Date: July 21, 2017. Time: 1:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 29571 Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898, barnardm@extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: June 23, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–13572 Filed 6–28–17; 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 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Vascular and Hematology. Date: July 24–25, 2017. Time: 10:30 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Anshumali Chaudhari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4124, MSC 7802, Bethesda, MD 20892, (301) 435– 1210, chaudhaa@csr.nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group; NeuroAIDS and other End-Organ Diseases Study Section. Date: July 25–26, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\29JNN1.SGM 29JNN1

Agencies

[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29570-29571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13571]


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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 (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 individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR16-274:

[[Page 29571]]

Adverse Drug Reaction Scientific Review Panel.
    Date: July 26, 2017.
    Time: 11:00 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Alexander D Politis, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 
20892, (301) 435-1150, politisa@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Topics in Mechanisms of Bacterial Virulence 
and Pathogenesis.
    Date: July 27-28, 2017.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-
1146, jig@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Fellowships: Synthetic and Biological Chemistry.
    Date: July 27, 2017.
    Time: 8:30 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 
Wisconsin Avenue, Bethesda, MD 20814.
    Contact Person: Mike Radtke, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301-435-
1728, radtkem@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Nutrient and Lipid Regulation.
    Date: July 27, 2017.
    Time: 1:00 p.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Gary Hunnicutt, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, >6701 Rockledge Drive, Room 6164, MSC 7892, Bethesda, MD 
20892, 301-435-0229, gary.hunnicutt@nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Neurodegeneration: Mechanisms and Pathways.
    Date: July 27, 2017.
    Time: 12:30 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).
    Contact Person: Laurent Taupenot, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4188, MSC 7850, Bethesda, MD 
20892, 301-435-1203, laurent.taupenot@nih.gov.

    Name of Committee: Biology of Development and Aging Integrated 
Review Group; International and Cooperative Projects--1 Study 
Section.
    Date: July 28, 2017.
    Time: 12:00 p.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892.
    Contact Person: Seetha Bhagavan, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 
20892, (301) 237-9838, bhagavas@csr.nih.gov.

(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: June 23, 2017.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-13571 Filed 6-28-17; 8:45 am]
 BILLING CODE 4140-01-P
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