Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices 12951 

Application No. Drug Applicant 

ANDA 090732 ........ Anastrozole Tablets, 1 mg ..................................................... Do. 

ANDA 203161 ........ Irbesartan Tablets, 75 mg, 150 mg, and 300 mg .................. Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of April 5, 2021. 

Approval of each entire application is 

withdrawn, including any strengths and 

dosage forms inadvertently missing 

from the table. Introduction or delivery 

for introduction into interstate 

commerce of products without 

approved new drug applications 

violates section 301(a) and (d) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 331(a) and (d)). Drug 

products that are listed in the table that 

are in inventory on April 5, 2021 may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04520 Filed 3–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2354] 

Data Standards; Requirement Begins 

for the Clinical Data Interchange 

Standards Consortium Version 1.1 of 

the Standard for Exchange of 

Nonclinical Data Developmental and 

Reproductive Toxicology 

Implementation Guide and Version 1.6 

of the Study Data Tabulation Model; 

Clarification to Food and Drug 

Administration Data Standards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is announcing the date that 

support will begin for version 1.1 of the 

Clinical Data Interchange Standards 

Consortium (CDISC) Standard for 

Exchange of Nonclinical Data 

Developmental and Reproductive 

Toxicology Implementation Guide 

(SENDIG–DART) and version 1.6 of the 

Clinical Data Interchange Standards 

Consortium (CDISC) Study Data 

Tabulation Model (SDTM) and the dates 

when such new standard and version 

update will be required in certain 

submissions. The Agency will update 

the FDA Data Standards Catalog 

(Catalog) to reflect these changes. An 

additional note is added to the Catalog 

clarifying the requirements for the 

submission of a simplified trial 

summary dataset to determine a study 

start date at the point of submission at 

the electronic gateway. 

DATES: Support for version 1.1 of the 

CDISC SENDIG–DART and version 1.6 

of the CDISC SDTM will begin on March 

15, 2021. The requirement for electronic 

submissions to be submitted using 

version 1.1 of the CDISC SENDIG–DART 

will begin March 15, 2023, for new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and certain 

biologics license applications (BLAs), 

and March 15, 2024, for certain 

investigational new drug applications 

(INDs). The requirement for electronic 

submissions to be submitted using 

version 1.6 of the CDISC SDTM will 

begin on March 15, 2022. 

ADDRESSES: You may submit comments 

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– 

2020–N–235 for ‘‘Data Standards; 

Requirements Begin for the Clinical 

Data Interchange Standards Consortium 

Version 1.1 of the Standard for 

Exchange of Nonclinical Data 

Developmental and Reproductive 

Toxicology Implementation Guide and 

Version 1.6 of the Study Data 

Tabulation Model. Clarification to the 

FDA Data Standards Catalog.’’ 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 


jbell on DSKJLSW7X2PROD with NOTICES
12952 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

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: 

Bryan Spells, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1117, Silver Spring, 

MD 20993–0002, 240–402–6511, email: 

cderdatastandards@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA’s 

CDER is issuing this Federal Register 

notice to announce the date that support 

will begin for version 1.1 of the CDISC 

SENDIG–DART and version 1.6 of the 

CDISC SDTM and the dates when such 

new standard and version update will 

be required in certain submissions. The 

FDA guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Standardized Study Data’’ 

(October 2020) (eStudy Data guidance), 

posted on FDA’s Study Data Standards 

Resources web page at https://

www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

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 the Center for 

Biologics Evaluation and Research 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 1.1 of the CDISC 

SENDIG–DART and version 1.6 of the 

CDISC SDTM will begin on March 15, 

2021, the transition date. The 

requirement for electronic submissions 

to be submitted using version 1.1 of the 

CDISC SENDIG–DART will begin March 

15, 2023, for NDAs, ANDAs and certain 

BLAs, and March 15, 2024, for certain 

INDs. The requirement for electronic 

submissions to be submitted using 

version 1.6 of the CDISC SDTM will 

begin on March 15, 2022. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04609 Filed 3–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0180] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Clearance 

for the Collection of Quantitative Data 

on Tobacco Products and 

Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the generic 

clearance for the collection of 

quantitative data on tobacco products 

and communications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 4, 2021. 

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 May 4, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 4, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is 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– 

2018–N–0180 for ‘‘Generic Clearance for 

the Collection of Quantitative Data on 

Tobacco Products and 

Communications.’’ 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 


jbell on DSKJLSW7X2PROD with NOTICES