81 FR 64180 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 181 (September 19, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 181 (September 19, 2016)
| Page Range | 64180-64181 | |
| FR Document | 2016-22391 |
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)] [Notices] [Pages 64180-64181] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22391] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious 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 Allergy and Infectious Diseases Special Emphasis Panel; International Center of Excellence for Malaria Research. Date: October 13-14, 2016. Time: 8:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Yong Gao, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room #3G13B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Rockville, MD 20892-7616, (240) 669-5048, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) [[Page 64181]] Dated: September 13, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016-22391 Filed 9-16-16; 8:45 am] BILLING CODE 4140-01-P
![64180 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
guidance was a significant advance in DEPARTMENT OF HEALTH AND complaint received under section
promoting anticancer drug HUMAN SERVICES 351(l)(6)(C) of the PHS Act in the
development. Since the S9 guidance Federal Register.
was issued, some parties have Food and Drug Administration FDA has received notice of the
experienced challenges implementing [Docket No. FDA–2015–N–2489] following complaint under section
the nonclinical recommendations for 351(l)(6)(C) of the PHS Act: Amgen v.
developing anticancer pharmaceuticals Receipt of Notice That a Patent Sandoz, 3:16–cv–02581 (N.D. Cal., filed
outlined in that guidance. In June 2016, Infringement Complaint Was Filed May 12, 2015).
the ICH Assembly endorsed the current Against a Biosimilar Applicant FDA has only a ministerial role in
draft Q&As guidance entitled ‘‘S9 publishing notice of a complaint
AGENCY: Food and Drug Administration,
Nonclinical Evaluation for Anticancer received under section 351(l)(6)(C) of
HHS.
Pharmaceuticals—Questions and the PHS Act, and does not perform a
Answers’’ and agreed that the draft ACTION: Notice.
substantive review of the complaint.
Q&As guidance should be made SUMMARY: The Food and Drug Dated: September 12, 2016.
available for public comment. The draft Administration (FDA) is publishing Leslie Kux,
Q&As guidance is the product of the notice that an applicant for a proposed Associate Commissioner for Policy.
Safety Implementation Working Group biosimilar product notified FDA that a [FR Doc. 2016–22376 Filed 9–16–16; 8:45 am]
(IWG) of the ICH. Comments about this patent infringement action was filed in
BILLING CODE 4164–01–P
draft will be considered by FDA and the connection with the applicant’s
Safety IWG. biologics license application (BLA).
The draft Q&As guidance provides Under the Public Health Service Act DEPARTMENT OF HEALTH AND
guidance on implementing the S9 (PHS Act), an applicant for a proposed HUMAN SERVICES
guidance. The Q&As were developed by biosimilar product or interchangeable
the IWG to provide additional clarity for product must notify FDA within 30 days National Institutes of Health
after the applicant was served with a
the nonclinical development of
complaint in a patent infringement National Institute of Allergy and
anticancer pharmaceuticals. Topics Infectious Diseases; Notice of Closed
action described under the PHS Act.
addressed in the draft Q&As guidance Meeting
FDA is required to publish notice of the
include the patient population covered complaint in the Federal Register.
by the S9 guidance, recovery groups in Pursuant to section 10(d) of the
FOR FURTHER INFORMATION CONTACT:
nonclinical studies, development of Federal Advisory Committee Act, as
Daniel Orr, Center for Drug Evaluation
antibody-drug conjugates, juvenile amended (5 U.S.C. App.), notice is
and Research, Food and Drug
animal studies, and the need for long- hereby given of the following meeting.
Administration, 10903 New Hampshire
term toxicity studies when Ave., Bldg. 51, Rm. 6208, Silver Spring, The meeting will be closed to the
pharmaceutical development moves to MD 20993–0002, 240–402–0979, public in accordance with the
patients with earlier stage diseases. daniel.orr@fda.hhs.gov. provisions set forth in sections
This draft guidance is being issued SUPPLEMENTARY INFORMATION: The 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
consistent with FDA’s good guidance Biologics Price Competition and as amended. The grant applications and
practices regulation (21 CFR 10.115). Innovation Act of 2009 (BPCI Act) was the discussions could disclose
The draft guidance, when finalized, will enacted as part of the Patient Protection confidential trade secrets or commercial
represent the current thinking of FDA and Affordable Care Act (Pub. L. 111– property such as patentable material,
on ‘‘S9 Nonclinical Evaluation for 148) on March 23, 2010. The BPCI Act and personal information concerning
Anticancer Pharmaceuticals—Questions amended the PHS Act and created an individuals associated with the grant
and Answers.’’ It does not establish any abbreviated licensure pathway for applications, the disclosure of which
rights for any person and is not binding biological products shown to be would constitute a clearly unwarranted
on FDA or the public. You can use an biosimilar to, or interchangeable with, invasion of personal privacy.
alternative approach if it satisfies the an FDA-licensed biological reference Name of Committee: National Institute of
requirements of the applicable statutes product. Section 351(k) of the PHS Act Allergy and Infectious Diseases Special
(42 U.S.C. 262(k)), added by the BPCI Emphasis Panel; International Center of
and regulations. Excellence for Malaria Research.
Act, describes the requirements for a
II. Electronic Access BLA for a proposed biosimilar product Date: October 13–14, 2016.
Time: 8:00 a.m. to 5:30 p.m.
or a proposed interchangeable product Agenda: To review and evaluate grant
Persons with access to the Internet (351(k) BLA). Section 351(l) of the PHS
may obtain the document at http:// applications.
Act, also added by the BPCI Act, Place: Bethesda North Marriott Hotel &
www.regulations.gov, http:// describes certain procedures for Conference Center, 5701 Marinelli Road,
www.fda.gov/Drugs/Guidance exchanging patent information and Bethesda, MD 20852.
ComplianceRegulatoryInformation/ resolving patent disputes between a Contact Person: Yong Gao, Ph.D., Scientific
Guidances/default.htm, or http:// 351(k) BLA applicant and the holder of Review Officer, Scientific Review Program,
www.fda.gov/BiologicsBloodVaccines/ the BLA reference product. If a 351(k) Division of Extramural Activities, Room
GuidanceComplianceRegulatory applicant is served with a complaint for #3G13B, National Institutes of Health/NIAID,
mstockstill on DSK3G9T082PROD with NOTICES
Information/Guidances/default.htm. 5601 Fishers Lane, MSC 9823, Rockville, MD
a patent infringement described in 20892–7616, (240) 669–5048, yong.gao@
Dated: September 12, 2016. section 351(l)(6) of the PHS Act, the nih.gov.
Leslie Kux,
applicant is required, under section (Catalogue of Federal Domestic Assistance
351(l)(6)(C) of the PHS Act, to provide Program Nos. 93.855, Allergy, Immunology,
Associate Commissioner for Policy. the FDA with notice and a copy of the and Transplantation Research; 93.856,
[FR Doc. 2016–22375 Filed 9–16–16; 8:45 am] complaint within 30 days of service. Microbiology and Infectious Diseases
BILLING CODE 4164–01–P FDA is required to publish notice of a Research, National Institutes of Health, HHS)
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![Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices 64181
Dated: September 13, 2016. Time: 8:00 a.m. to 5:00 p.m. (Catalogue of Federal Domestic Assistance
Natasha M. Copeland, Agenda: To review and evaluate grant Program Nos. 93.855, Allergy, Immunology,
applications. and Transplantation Research; 93.856,
Program Analyst, Office of Federal Advisory
Place: Residence Inn Bethesda, 7335 Microbiology and Infectious Diseases
Committee Policy.
Wisconsin Avenue, Bethesda, MD 20814. Research, National Institutes of Health, HHS)
[FR Doc. 2016–22391 Filed 9–16–16; 8:45 am] Contact Person: Carla T. Walls, Ph.D.,
BILLING CODE 4140–01–P Scientific Review Administrator, Scientific Dated: September 13, 2016.
Review Branch, National Institute of Child Natasha M. Copeland,
Health and Human Development, NIH, 6710 Program Analyst, Office of Federal Advisory
DEPARTMENT OF HEALTH AND B Rockledge Drive, Bethesda, MD 20892, Committee Policy.
HUMAN SERVICES (301) 435–6898, wallsc@mail.nih.gov.
[FR Doc. 2016–22389 Filed 9–16–16; 8:45 am]
(Catalogue of Federal Domestic Assistance
BILLING CODE 4140–01–P
National Institutes of Health Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
Eunice Kennedy Shriver National 93.929, Center for Medical Rehabilitation
Institute of Child Health & Human Research; 93.209, Contraception and DEPARTMENT OF HEALTH AND
Development; Notice of Closed Infertility Loan Repayment Program, National HUMAN SERVICES
Meetings Institutes of Health, HHS)
National Institutes of Health
Dated: September 13, 2016.
Pursuant to section 10(d) of the
Michelle Trout, National Institute of Allergy and
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory Infectious Diseases; Notice of Closed
Committee Policy. Meeting
hereby given of the following meetings.
The meetings will be closed to the [FR Doc. 2016–22394 Filed 9–16–16; 8:45 am]
public in accordance with the BILLING CODE 4140–01–P Pursuant to section 10(d) of the
provisions set forth in sections Federal Advisory Committee Act, as
552b(c)(4) and 552b(c)(6), title 5 U.S.C., amended (5 U.S.C. App.), notice is
as amended. The grant applications and DEPARTMENT OF HEALTH AND hereby given of the following meeting.
the discussions could disclose HUMAN SERVICES
The meeting will be closed to the
confidential trade secrets or commercial public in accordance with the
National Institutes of Health
property such as patentable material, provisions set forth in sections
and personal information concerning National Institute of Allergy and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
individuals associated with the grant Infectious Diseases; Notice of Closed as amended. The grant applications and
applications, the disclosure of which Meeting the discussions could disclose
would constitute a clearly unwarranted confidential trade secrets or commercial
invasion of personal privacy. Pursuant to section 10(d) of the property such as patentable material,
Federal Advisory Committee Act, as and personal information concerning
Name of Committee: National Institute of
Child Health and Human Development
amended (5 U.S.C. App.), notice is individuals associated with the grant
Special Emphasis Panel. hereby given of the following meeting. applications, the disclosure of which
Date: October 27, 2016. The meeting will be closed to the would constitute a clearly unwarranted
Time: 2:00 p.m. to 4:00 p.m. public in accordance with the invasion of personal privacy.
Agenda: To review and evaluate grant provisions set forth in sections
applications. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: National Institute of
Place: National Institutes of Health, 6710 B as amended. The grant applications and Allergy and Infectious Diseases Special
Rockledge Drive, Bethesda, MD 20892 the discussions could disclose Emphasis Panel; Rapid Assessment of Zika
(Telephone Conference Call). Virus (ZIKV) Complications (R21).
confidential trade secrets or commercial
Contact Person: Sathasiva B. Kandasamy, Date: October 13–14, 2016.
property such as patentable material,
Ph.D., Scientific Review Administrator, Time: 11:00 a.m. to 5:00 p.m.
Division of Scientific Review, National
and personal information concerning Agenda: To review and evaluate grant
Institute of Child Health and Human individuals associated with the grant applications.
Development, 6710 B Rockledge Drive, applications, the disclosure of which Place: National Institutes of Health, 5601
Bethesda, MD 20892, (301) 435–6680, would constitute a clearly unwarranted Fishers Lane, Rockville, MD 20892
skandasa@mail.nih.gov. invasion of personal privacy. (Telephone Conference Call).
Name of Committee: National Institute of Name of Committee: National Institute of Contact Person: Eleazar Cohen, Ph.D.,
Child Health and Human Development Initial Allergy and Infectious Diseases Special Scientific Review Officer, Scientific Review
Review Group Population Sciences Emphasis Panel; Global Infectious Disease Program, Division of Extramural Activities,
Subcommittee. Research Administration Development Room 3G62A, National Institute of Health,
Date: November 3, 2016. Award for Low-and Middle-Income Country NIAID, 5601 Fishers Lane, MSC 9823,
Time: 8:00 a.m. to 5:00 p.m. Institutions (G11). Bethesda, MD 20899823, (240) 669–5081,
Agenda: To review and evaluate grant Date: October 11, 2016. ecohen@niaid.nih.gov.
applications. Time: 1:00 p.m. to 5:00 p.m. (Catalogue of Federal Domestic Assistance
Place: Residence Inn Bethesda, 7335 Agenda: To review and evaluate grant
Wisconsin Avenue, Bethesda, MD 20814. Program Nos. 93.855, Allergy, Immunology,
applications. and Transplantation Research; 93.856,
Contact Person: Carla T. Walls, Ph.D., Place: National Institutes of Health, 5601
Scientific Review Administratior, Scientific Microbiology and Infectious Diseases
Fishers Lane, Rockville, MD 20892
mstockstill on DSK3G9T082PROD with NOTICES
Review Branch, National Institute of Child Research, National Institutes of Health, HHS)
(Telephone Conference Call).
Health and Human Development, NIH, 6710 Contact Person: B. Duane Price, Ph.D., Dated: September 13, 2016.
B Rockledge Drive, Bethesda, MD 20892, Scientific Review Officer, Scientific Review Natasha M. Copeland,
(301) 435–6898, wallsc@mail.nih.gov. Program, Division of Extramural Activities,
Program Analyst, Office of Federal Advisory
Name of Committee: National Institute of RM 3G50, National Institutes of Health,
Committee Policy.
Child Health and Human Development NIAID, 5601 Fishers Lane, MSC 9823,
Special Emphasis Panel. Bethesda, MD 20892–9823, 240–669–5074, [FR Doc. 2016–22392 Filed 9–16–16; 8:45 am]
Date: November 4, 2016. pricebd@niaid.nih.gov. BILLING CODE 4140–01–P
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Document Created: 2016-09-17 02:30:44
Document Modified: 2016-09-17 02:30:44
| 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 | October 13-14, 2016. | |
| FR Citation | 81 FR 64180 |
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