82 FR 29570 - Center for Scientific Review; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 124 (June 29, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 124 (June 29, 2017)
| Page Range | 29570-29571 | |
| FR Document | 2017-13571 |
[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)] [Notices] [Pages 29570-29571] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13571] ----------------------------------------------------------------------- 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, [email protected]. 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, [email protected]. 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, [email protected]. 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, [email protected]. 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, [email protected]. 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, [email protected]. (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
![29570 Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices
Instructions: All submissions received MD 20993, 240–402–6073, Fax: 301– transparency and improve
must include the Docket No. FDA– 847–8443, Azada.Hafiz@fda.hhs.gov. communication between the FDA
2017–N–3199 for ‘‘Program for SUPPLEMENTARY INFORMATION: review team and the applicant, FDA has
Enhanced Review Transparency and proposed for BsUFA II a new review
Communication for Original 351(k) I. Background model (the Program), for the review of
Biologics License Applications in The timely review of 351(k) all 351(k) applications. The Program
BsUFA II.’’ Received comments, those applications is central to FDA’s mission will allow for additional
filed in a timely manner (see to protect and promote the public communication between FDA review
ADDRESSES), will be placed in the docket health. The BsUFA was first enacted by teams and the applicants of biosimilar
and, except for those submitted as Congress in 2012 and authorizes FDA to biological products in the form of a
‘‘Confidential Submissions,’’ publicly collect user fees for 351(k) applications. Biological Product Development Type 4
viewable at https://www.regulations.gov FDA dedicates BsUFA user fees to the (pre-351(k) BLA) meetings, mid-cycle
or at the Dockets Management Staff efficient review of 351(k) applications communications, and late-cycle
between 9 a.m. and 4 p.m., Monday and to facilitate the development of safe meetings. To accommodate this
through Friday. and effective biosimilar biological increased interaction during regulatory
products for the American public. FDA review and to address the need for
• Confidential Submissions—To dedicates the additional fee resources to additional time to review these complex
submit a comment with confidential hire reviewers and support staff and applications, FDA’s review clock will
information that you do not wish to be upgrade its information technology begin after the 60-day administrative
made publicly available, submit your systems. With the availability of these filing review period for applications
comments only as a written/paper additional fee resources, FDA was able reviewed under the Program.
submission. You should submit two to agree to certain review performance The goal of the Program is to improve
copies total. One copy will include the goals, including a complete review of the efficiency and effectiveness of the
information you claim to be confidential 351(k) applications and taking first-cycle review process by increasing
with a heading or cover note that states regulatory action within specified communications during application
‘‘THIS DOCUMENT CONTAINS timeframes. The current authorization of review. This will provide sponsors with
CONFIDENTIAL INFORMATION.’’ The the program (BsUFA I) expires in the opportunity to clarify previous
Agency will review this copy, including September 2017. submissions and provide additional
the claimed confidential information, in As directed by statute, FDA prepared data and analyses that are readily
its consideration of comments. The recommendations for the available, potentially avoiding the need
second copy, which will have the reauthorization of BsUFA for a new 5- for an additional review cycle when
claimed confidential information year period by conducting negotiations concerns can be promptly resolved
redacted/blacked out, will be available with the regulated industry and holding without compromising FDA’s standards
for public viewing and posted on regular consultations with public for approval.
https://www.regulations.gov. Submit stakeholders including patient
both copies to the Dockets Management Dated: June 23, 2017.
advocates, consumer advocates, and
Staff. If you do not wish your name and Anna K. Abram,
healthcare professionals. Following
contact information to be made publicly these discussions, related public Deputy Commissioner for Policy, Planning,
available, you can provide this Legislation, and Analysis.
meetings, and Agency requests for
information on the cover sheet and not public comment, FDA transmitted [FR Doc. 2017–13609 Filed 6–28–17; 8:45 am]
in the body of your comments and you proposed recommendations for BsUFA BILLING CODE 4164–01–P
must identify this information as II for fiscal years 2018–2022. FDA’s
‘‘confidential.’’ Any information marked BsUFA II recommendations include an
as ‘‘confidential’’ will not be disclosed FDA commitment to implement a new DEPARTMENT OF HEALTH AND
except in accordance with 21 CFR 10.20 review program for 351(k) applications HUMAN SERVICES
and other applicable disclosure law. For to promote the efficiency and National Institutes of Health
more information about FDA’s posting effectiveness of the first-cycle review
of comments to public dockets, see 80 process and minimize the number of Center for Scientific Review; Notice of
FR 56469, September 18, 2015, or access review cycles necessary for approval of Closed Meetings
the information at: https://www.gpo.gov/ these complex applications. The
fdsys/pkg/FR-2015-09-18/pdf/2015- Program is described in detail in section Pursuant to section 10(d) of the
23389.pdf. I.B of the document entitled ‘‘Biosimilar Federal Advisory Committee Act, as
Biological Product Reauthorization amended (5 U.S.C. App.), notice is
Docket: For access to the docket to hereby given of the following meetings.
read background documents or the Performance Goals and Procedures
Fiscal Years 2018 Through 2022’’ The meetings will be closed to the
electronic and written/paper comments public in accordance with the
received, go to https:// available at https://www.fda.gov/
downloads/forindustry/userfees/ provisions set forth in sections
www.regulations.gov and insert the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
docket number, found in brackets in the biosimilaruserfeeactbsufa/
ucm521121.pdf. as amended. The grant applications and
heading of this document, into the the discussions could disclose
‘‘Search’’ box and follow the prompts II. BsUFA II Program for Enhanced confidential trade secrets or commercial
and/or go to the Dockets Management Review Transparency and property such as patentable material,
sradovich on DSK3GMQ082PROD with NOTICES
Staff, 5630 Fishers Lane, Rm. 1061, Communication for Original 351(k) and personal information concerning
Rockville, MD 20852. BLAs individuals associated with the grant
FOR FURTHER INFORMATION CONTACT: FDA recognizes that increasing applications, the disclosure of which
Azada Hafiz, Center for Drug Evaluation communication between the Agency would constitute a clearly unwarranted
and Research, Food and Drug and applicants during FDA’s review has invasion of personal privacy.
Administration, 10903 New Hampshire the potential to increase efficiency in Name of Committee: Center for Scientific
Ave., Bldg. 51, Rm. 1148, Silver Spring, the review process. To enhance review Review Special Emphasis Panel; PAR16–274:
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![Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices 29571
Adverse Drug Reaction Scientific Review Contact Person: Laurent Taupenot, Ph.D., Boulevard, Bethesda, MD 20892 (Telephone
Panel. Scientific Review Officer, Center for Conference Call).
Date: July 26, 2017. Scientific Review, National Institutes of Contact Person: Michele L. Barnard, Ph.D.,
Time: 11:00 a.m. to 4:00 p.m. Health, 6701 Rockledge Drive, Room 4188, Scientific Review Officer, Review Branch,
Agenda: To review and evaluate grant MSC 7850, Bethesda, MD 20892, 301–435– DEA, NIDDK, National Institutes of Health,
applications. 1203, laurent.taupenot@nih.gov. Room 7353, 6707 Democracy Boulevard,
Place: National Institutes of Health, 6701 Name of Committee: Biology of Bethesda, MD 20892–2542, (301) 594–8898,
Rockledge Drive, Bethesda, MD 20892 Development and Aging Integrated Review barnardm@extra.niddk.nih.gov.
(Virtual Meeting). Group; International and Cooperative (Catalogue of Federal Domestic Assistance
Contact Person: Alexander D Politis, Ph.D., Projects—1 Study Section. Program Nos. 93.847, Diabetes,
Scientific Review Officer, Center for Date: July 28, 2017. Endocrinology and Metabolic Research;
Scientific Review, National Institutes of Time: 12:00 p.m. to 6:00 p.m. 93.848, Digestive Diseases and Nutrition
Health, 6701 Rockledge Drive, Room 3210, Agenda: To review and evaluate grant Research; 93.849, Kidney Diseases, Urology
MSC 7808, Bethesda, MD 20892, (301) 435– applications. and Hematology Research, National Institutes
1150, politisa@csr.nih.gov. Place: National Institutes of Health, 6701 of Health, HHS)
Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892.
Review Special Emphasis Panel; Member Dated: June 23, 2017.
Contact Person: Seetha Bhagavan, Ph.D.,
Conflict: Topics in Mechanisms of Bacterial Scientific Review Officer, Center for David Clary,
Virulence and Pathogenesis. Scientific Review, National Institutes of Program Analyst, Office of Federal Advisory
Date: July 27–28, 2017. Health, 6701 Rockledge Drive, Room 5194, Committee Policy.
Time: 8:00 a.m. to 5:00 p.m. MSC 7846, Bethesda, MD 20892, (301) 237– [FR Doc. 2017–13572 Filed 6–28–17; 8:45 am]
Agenda: To review and evaluate grant 9838, bhagavas@csr.nih.gov. BILLING CODE 4140–01–P
applications. (Catalogue of Federal Domestic Assistance
Place: National Institutes of Health, 6701
Program Nos. 93.306, Comparative Medicine;
Rockledge Drive, Bethesda, MD 20892
93.333, Clinical Research, 93.306, 93.333, DEPARTMENT OF HEALTH AND
(Virtual Meeting).
93.337, 93.393–93.396, 93.837–93.844,
Contact Person: Guangyong Ji, Ph.D.,
93.846–93.878, 93.892, 93.893, National
HUMAN SERVICES
Scientific Review Officer, Center for
Institutes of Health, HHS)
Scientific Review, National Institutes of National Institutes of Health
Health, 6701 Rockledge Drive, Room 3211, Dated: June 23, 2017.
MSC 7808, Bethesda, MD 20892, 301–435– Anna Snouffer, Center For Scientific Review; Notice of
1146, jig@csr.nih.gov. Deputy Director, Office of Federal Advisory Closed Meetings
Name of Committee: Center for Scientific Committee Policy.
Review Special Emphasis Panel; Pursuant to section 10(d) of the
[FR Doc. 2017–13571 Filed 6–28–17; 8:45 am] Federal Advisory Committee Act, as
Fellowships: Synthetic and Biological
Chemistry. BILLING CODE 4140–01–P amended (5 U.S.C. App.), notice is
Date: July 27, 2017. hereby given of the following meetings.
Time: 8:30 a.m. to 6:00 p.m. The meetings will be closed to the
Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND public in accordance with the
applications. HUMAN SERVICES provisions set forth in sections
Place: Hyatt Regency Bethesda, One 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Bethesda Metro Center, 7400 Wisconsin National Institutes of Health as amended. The grant applications and
Avenue, Bethesda, MD 20814.
Contact Person: Mike Radtke, Ph.D., National Institute of Diabetes and the discussions could disclose
Scientific Review Officer, Center for Digestive and Kidney Diseases; Notice confidential trade secrets or commercial
Scientific Review, National Institutes of of Closed Meeting property such as patentable material,
Health, 6701 Rockledge Drive, Room 4176, and personal information concerning
MSC 7806, Bethesda, MD 20892, 301–435– Pursuant to section 10(d) of the individuals associated with the grant
1728, radtkem@csr.nih.gov. Federal Advisory Committee Act, as applications, the disclosure of which
Name of Committee: Center for Scientific amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted
Review Special Emphasis Panel; Member hereby given of the following meeting. invasion of personal privacy.
Conflict: Nutrient and Lipid Regulation. The meeting will be closed to the
Date: July 27, 2017. Name of Committee: Center for Scientific
public in accordance with the Review Special Emphasis Panel, Member
Time: 1:00 p.m. to 3:00 p.m. provisions set forth in sections
Agenda: To review and evaluate grant Conflict: Vascular and Hematology.
applications. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: July 24–25, 2017.
Place: National Institutes of Health, 6701 as amended. The grant applications and Time: 10:30 a.m. to 7:00 p.m.
Rockledge Drive, Bethesda, MD 20892 the discussions could disclose Agenda: To review and evaluate grant
(Telephone Conference Call). confidential trade secrets or commercial applications.
Contact Person: Gary Hunnicutt, Ph.D., property such as patentable material, Place: National Institutes of Health, 6701
Scientific Review Officer, Center for and personal information concerning Rockledge Drive, Bethesda, MD 20892
Scientific Review, National Institutes of individuals associated with the grant (Virtual Meeting).
Health, ≤6701 Rockledge Drive, Room 6164, applications, the disclosure of which
Contact Person: Anshumali Chaudhari,
MSC 7892, Bethesda, MD 20892, 301–435– Ph.D., Scientific Review Officer, Center for
0229, gary.hunnicutt@nih.gov. would constitute a clearly unwarranted Scientific Review, National Institutes of
invasion of personal privacy. Health, 6701 Rockledge Drive, Room 4124,
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member Name of Committee: National Institute of MSC 7802, Bethesda, MD 20892, (301) 435–
Conflict: Neurodegeneration: Mechanisms Diabetes and Digestive and Kidney Diseases 1210, chaudhaa@csr.nih.gov.
sradovich on DSK3GMQ082PROD with NOTICES
and Pathways. Special Emphasis Panel, Time-Sensitive Name of Committee: AIDS and Related
Date: July 27, 2017. Obesity Review. Research Integrated Review Group;
Time: 12:30 p.m. to 5:00 p.m. Date: July 21, 2017. NeuroAIDS and other End-Organ Diseases
Agenda: To review and evaluate grant Time: 1:30 p.m. to 3:30 p.m. Study Section.
applications. Agenda: To review and evaluate grant Date: July 25–26, 2017.
Place: National Institutes of Health, 6701 applications. Time: 8:00 a.m. to 5:00 p.m.
Rockledge Drive, Bethesda, MD 20892, Place: National Institutes of Health, Two Agenda: To review and evaluate grant
(Virtual Meeting). Democracy Plaza, 6707 Democracy applications.
VerDate Sep<11>2014 18:29 Jun 28, 2017 Jkt 241001 PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1](https://thefederalregister.org/doc/82_FR_29694/page/2.svg)
Document Created: 2018-11-14 10:17:47
Document Modified: 2018-11-14 10:17:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | July 26, 2017. | |
| FR Citation | 82 FR 29570 |
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