Notice of Board Meeting, 8585 [2022-03230]
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Federal Register / Vol. 87, No. 31 / Tuesday, February 15, 2022 / Notices
Audit
conducted pursuant to 52 U.S.C.
30111(b).
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
CONTACT PERSON FOR MORE INFORMATION:
[Docket No. FDA–2022–N–0072]
MATTERS TO BE CONSIDERED:
Food and Drug Administration
Judith Ingram, Press Officer. Telephone:
(202) 694–1220.
Authority: Government in the
Sunshine Act, 5 U.S.C. 552b.
Laura E. Sinram,
Acting Secretary and Clerk of the
Commission.
Data Standards; Requirement Begins
for Version 3.1.1 of the Clinical Data
Interchange Standards Consortium
Standard for Exchange of Nonclinical
Data Implementation Guide
AGENCY:
Food and Drug Administration,
HHS.
[FR Doc. 2022–03291 Filed 2–11–22; 11:15 am]
ACTION:
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Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Biologics Evaluation and
Research and (CBER) and Center for
Drug Evaluation and Research (CDER)
are announcing the date that support
begins for version 3.1.1 of the Clinical
Data Interchange Standards Consortium
(CDISC) Standard for Exchange of
Nonclinical Data Implementation Guide
(SENDIG), and the date that this version
update is required in certain
submissions. The Agency will update
the FDA Data Standards Catalog
(Catalog) to reflect these changes.
DATES: Support for version 3.1.1 of the
CDISC SENDIG begins February 15,
2022. The requirement for electronic
submissions to be submitted using
version 3.1.1 of the CDISC SENDIG
begins March 15, 2023, for new drug
applications (NDAs), abbreviated new
drug applications (ANDAs), certain
biologics license applications (BLAs),
and certain investigational new drug
applications (INDs).
ADDRESSES: You may submit either
electronic or written comments at any
time as follows.
SUMMARY:
FEDERAL RETIREMENT THRIFT
INVESTMENT BOARD
Notice of Board Meeting
DATES:
February 23, 2022 at 10:00 a.m.
Telephonic. Dial-in (listen
only) information: Number: 1–415–527–
5035, Code: 2763 825 4435; or via web:
https://tspmeet.webex.com/tspmeet/
onstage/g.php?MTID=e668eeb9f8e4ab
246455527de529d7a2b.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Weaver, Director, Office of
External Affairs, (202) 942–1640.
SUPPLEMENTARY INFORMATION:
Board Meeting Agenda
Open Session
1. Approval of the January 24, 2022
Board Meeting Minutes
2. Investment Manager Annual Service
Review
3. Monthly Reports
(a) Participant Activity Report
(b) Investment Performance
(c) Legislative Report
4. Investment Policy Review Frequency
5. Quarterly Report
(d) Metrics
6. Converge Update
7. Agency Recognition
Closed Session
lotter on DSK11XQN23PROD with NOTICES1
8. Information Covered Under 5 U.S.C.
552b(c)(10)
Authority: 5 U.S.C. 552b (e)(1).
Dated: February 10, 2022.
Dharmesh Vashee,
General Counsel, Federal Retirement Thrift
Investment Board.
[FR Doc. 2022–03230 Filed 2–14–22; 8:45 am]
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
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8585
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–0072 for ‘‘Data Standards;
Requirement Begins for Version 3.1.1 of
the Clinical Data Interchange Standards
Consortium Standard for Exchange of
Nonclinical Data Implementation
Guide.’’ Received comments 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, 240–402–7500.
• 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
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15FEN1
Agencies
[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Notices]
[Page 8585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03230]
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FEDERAL RETIREMENT THRIFT INVESTMENT BOARD
Notice of Board Meeting
DATES: February 23, 2022 at 10:00 a.m.
ADDRESSES: Telephonic. Dial-in (listen only) information: Number: 1-
415-527-5035, Code: 2763 825 4435; or via web: https://tspmeet.webex.com/tspmeet/onstage/g.php?MTID=e668eeb9f8e4ab246455527de529d7a2b.
FOR FURTHER INFORMATION CONTACT: Kimberly Weaver, Director, Office of
External Affairs, (202) 942-1640.
SUPPLEMENTARY INFORMATION:
Board Meeting Agenda
Open Session
1. Approval of the January 24, 2022 Board Meeting Minutes
2. Investment Manager Annual Service Review
3. Monthly Reports
(a) Participant Activity Report
(b) Investment Performance
(c) Legislative Report
4. Investment Policy Review Frequency
5. Quarterly Report
(d) Metrics
6. Converge Update
7. Agency Recognition
Closed Session
8. Information Covered Under 5 U.S.C. 552b(c)(10)
Authority: 5 U.S.C. 552b (e)(1).
Dated: February 10, 2022.
Dharmesh Vashee,
General Counsel, Federal Retirement Thrift Investment Board.
[FR Doc. 2022-03230 Filed 2-14-22; 8:45 am]
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