Federal Register / Vol. 87, No. 31 / Tuesday, February 15, 2022 / Notices 8585 

MATTERS TO BE CONSIDERED: Audit 

conducted pursuant to 52 U.S.C. 

30111(b). 

* * * * * 

CONTACT PERSON FOR MORE INFORMATION: 

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. 

[FR Doc. 2022–03291 Filed 2–11–22; 11:15 am] 

BILLING CODE 6715–01–P 

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=e668eeb9f8e4ab

246455527de529d7a2b. 

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] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0072] 

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. 

ACTION: Notice. 

SUMMARY: 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. 

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 

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 


lotter on DSK11XQN23PROD with NOTICES1
8586 Federal Register / Vol. 87, No. 31 / Tuesday, February 15, 2022 / Notices 

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.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Helena Sviglin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1197, 

Silver Spring, MD 20993–0002, 301– 

796–5331, cderdatastandards@

fda.hhs.gov, or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, Bldg. 

71, Rm. 7301, Silver Spring, MD 20993– 

0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: FDA’s 

CBER and CDER are issuing this Federal 

Register notice to announce the date 

that support begins for version 3.1.1 of 

the CDISC SENDIG and the date that 

this version update is required in 

certain submissions. The FDA guidance 

for industry ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data’’ (June 2021) 

(eStudy Data guidance), posted on 

FDA’s Study Data Standards Resources 

web page at https://www.fda.gov/ 

forindustry/datastandards/studydata

standards/default.htm, implements the 

electronic submission requirements of 

section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

379k–1(a)) for study data contained in 

NDAs, ANDAs, certain BLAs, and 

certain INDs submitted to CDER or 

CBER by specifying the format for 

electronic submissions. The eStudy Data 

guidance states that a Federal Register 

notice will specify any new standards 

and version updates to FDA-supported 

study data standards that will be added 

to the Catalog, when the support for 

such standards and version updates 

begins or ends, and when the 

requirement to use such standards and 

version updates in submissions begins 

or ends. 

Support for version 3.1.1 of the CDISC 

SENDIG begins February 15, 2022. The 

transition date for this version update is 

March 15, 2022. The requirement for 

electronic submissions to be submitted 

using version 3.1.1 of the CDISC 

SENDIG is March 15, 2023, for NDAs, 

ANDAs, certain BLAs, and certain INDs. 

Dated: February 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03225 Filed 2–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0105] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; World Health 

Organization; Scheduling 

Recommendations; Brorphine; 

Metonitazene; Eutylone; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

interested persons with the opportunity 

to submit written comments concerning 

recommendations by the World Health 

Organization (WHO) to impose 

international manufacturing and 

distributing restrictions, under 

international treaties, on certain drug 

substances. The comments received in 

response to this notice will be 

considered in preparing the United 

States’ position on these proposals for a 

meeting of the United Nations 

Commission on Narcotic Drugs (CND) in 

Vienna, Austria, in March 2022. This 

notice is issued under the Controlled 

Substances Act (CSA). 

DATES: Submit either electronic or 

written comments by February 28, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 28, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 28, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

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 

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–0105 for ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; World 

Health Organization; Scheduling 

Recommendations; Brorphine; 

Metonitazene; Eutylone; Request for 

Comments.’’ 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, 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 


lotter on DSK11XQN23PROD with NOTICES1