82 FR 55105 - Sunshine Act; Notice of Board Member Meeting

FEDERAL RETIREMENT THRIFT INVESTMENT BOARD

Federal Register Volume 82, Issue 222 (November 20, 2017)

Page Range		55105-55105
FR Document		2017-25184

Federal Register, Volume 82 Issue 222 (Monday, November 20, 2017)

[Federal Register Volume 82, Number 222 (Monday, November 20, 2017)]
[Notices]
[Page 55105]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25184]


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FEDERAL RETIREMENT THRIFT INVESTMENT BOARD


Sunshine Act; Notice of Board Member Meeting

Agenda

    November 28, 2017, 8:30 a.m. (In-Person).

Open Session

1. Approval of the minutes for the October 23, 2017 Board Member 
Meeting
2. Monthly Reports
    (a) Participant Activity
    (b) Investment Performance
    (c) Legislative Report
3. Quarterly Reports
    (d) Metrics
    (e) Project Activity
4. Capital Market and L Fund Annual Asset Allocation Review
5. TSP Investment Option Benchmark Study
6. 2018 Proposed Internal Audit Schedule
7. Enterprise Risk Framework and Dashboard
8. Blended Retirement Update
9. IT Update

Closed Session

    Information covered under 5 U.S.C. 552b (c)(6) and (c)(9)(B).
    Adjourn.

CONTACT PERSON FOR MORE INFORMATION: Kimberly Weaver, Director, Office 
of External Affairs, (202) 942-1640.

    Dated: November 16, 2017.
Megan Grumbine,
General Counsel,
Federal Retirement Thrift Investment Board.

[FR Doc. 2017-25184 Filed 11-16-17; 4:15 pm]
 BILLING CODE 6760-01-P

Federal Register / Vol. 82, No. 222 / Monday, November 20, 2017 / Notices 55105

customs brokers, freight forwarders, Dated: November 16, 2017. applicant is served with a complaint for
logistics companies, trucking and Megan Grumbine, a patent infringement described in
drayage companies, VOCCs, port General Counsel, section 351(l)(6) of the PHS Act, the
authorities, and MTOs. Federal Retirement Thrift Investment Board. applicant is required to provide FDA
The many responses to the Petition [FR Doc. 2017–25184 Filed 11–16–17; 4:15 pm]
with notice and a copy of the complaint
illustrate the complexity of issues within 30 days of service. FDA is
BILLING CODE 6760–01–P
surrounding ocean container shipping required to publish notice of a
and marine terminal operations. complaint received under section
Given the importance of this issue, its 351(l)(6)(C) of the PHS Act in the
DEPARTMENT OF HEALTH AND Federal Register.
complexity, and the public interest
HUMAN SERVICES FDA received notice of the following
indicated by the number and quality of
comments submitted in response to the Food and Drug Administration complaint under section 351(l)(6)(C) of
Petition, the Commission will hold the PHS Act: Janssen Biotech, Inc. v.
public hearings to further explore the [Docket No. FDA–2017–N–4853] Celltrion Healthcare Co. Ltd., et al., 17–
issues raised by the Petition and address cv–11008 (D. Mass., filed May 31, 2017).
Receipt of Notice That a Patent FDA has only a ministerial role in
specific questions. Commentary and
Infringement Complaint Was Filed publishing notice of a complaint
answers to these questions will be
Against a Biosimilar Applicant received under section 351(l)(6)(C) of
helpful to the Commission as it
determines its next steps with regard to AGENCY: Food and Drug Administration, the PHS Act, and does not perform a
Petition P4–16. HHS. substantive review of the complaint.
By the Commission. ACTION: Notice. Dated: November 14, 2017.
Rachel E. Dickon, Leslie Kux,
SUMMARY: The Food and Drug
Assistant Secretary. Associate Commissioner for Policy.
Administration (FDA) is publishing
[FR Doc. 2017–25016 Filed 11–17–17; 8:45 am] [FR Doc. 2017–25070 Filed 11–17–17; 8:45 am]
notice that an applicant for a proposed
BILLING CODE 4164–01–P
BILLING CODE 6731–AA–P biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
DEPARTMENT OF HEALTH AND
biologics license application (BLA).
FEDERAL RETIREMENT THRIFT HUMAN SERVICES
Under the Public Health Service Act
INVESTMENT BOARD (PHS Act), an applicant for a proposed Food and Drug Administration
biosimilar product or interchangeable
Sunshine Act; Notice of Board Member [Docket No. FDA–2017–P–5124]
product must notify FDA within 30 days
Meeting
after the applicant was served with a
Medical Devices; Exemption From
Agenda complaint in a patent infringement
Premarket Notification: Over-the-
action described under the PHS Act.
November 28, 2017, 8:30 a.m. (In- Counter Denture Repair Kits
FDA is required to publish notice of the
Person). complaint in the Federal Register. AGENCY: Food and Drug Administration,
Open Session FOR FURTHER INFORMATION CONTACT: HHS.
1. Approval of the minutes for the Daniel Orr, Center for Drug Evaluation ACTION: Notice.
October 23, 2017 Board Member and Research, Food and Drug
Administration, 10903 New Hampshire SUMMARY: The Food and Drug
Meeting Administration (FDA or Agency) is
2. Monthly Reports Ave., Bldg. 51, Rm. 6246, Silver Spring,
MD 20993–0002, 240–402–0979, announcing that it has received a
(a) Participant Activity petition requesting exemption from the
daniel.orr@fda.hhs.gov.
(b) Investment Performance premarket notification requirements for
SUPPLEMENTARY INFORMATION: The
(c) Legislative Report over-the-counter (OTC) denture repair
Biologics Price Competition and
3. Quarterly Reports kits. These devices consist of material,
Innovation Act of 2009 (BPCI Act) was
(d) Metrics such as a resin monomer system of
enacted as part of the Patient Protection
(e) Project Activity powder and liquid glues, which is
and Affordable Care Act (Pub. L. 111–
4. Capital Market and L Fund Annual 148) on March 23, 2010. The BPCI Act intended to be applied permanently to
Asset Allocation Review amended the PHS Act and created an a denture to mend cracks or breaks. FDA
5. TSP Investment Option Benchmark abbreviated licensure pathway for is publishing this notice to obtain
Study biological products shown to be comments in accordance with
6. 2018 Proposed Internal Audit biosimilar to, or interchangeable with, procedures established by the Food and
Schedule an FDA-licensed biological reference Drug Administration Modernization Act
7. Enterprise Risk Framework and product. Section 351(k) of the PHS Act of 1997 (FDAMA).
Dashboard (42 U.S.C. 262(k)), added by the BPCI DATES: Submit either electronic or
8. Blended Retirement Update Act, describes the requirements for a written comments by January 19, 2018.
9. IT Update BLA for a proposed biosimilar product ADDRESSES: You may submit comments
or a proposed interchangeable product as follows. Please note that late,
nshattuck on DSK9F9SC42PROD with NOTICES

Closed Session
(351(k) BLA). Section 351(l) of the PHS untimely filed comments will not be
Information covered under 5 U.S.C. Act, also added by the BPCI Act, considered. Electronic comments must
552b (c)(6) and (c)(9)(B). describes certain procedures for be submitted on or before January 19,
Adjourn. exchanging patent information and 2018. The https://www.regulations.gov
CONTACT PERSON FOR MORE INFORMATION: resolving patent disputes between a electronic filing system will accept
Kimberly Weaver, Director, Office of 351(k) BLA applicant and the holder of comments until midnight Eastern Time
External Affairs, (202) 942–1640. the BLA reference product. If a 351(k) at the end of January 19, 2018.

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Document Created: 2018-10-25 10:41:14
Document Modified: 2018-10-25 10:41:14

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
FR Citation		82 FR 55105