12950 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Erin 

Stone, M.A., Division of Healthcare 

Quality Promotion, National Center for 

Emerging and Zoonotic Infectious 

Diseases, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

Mailstop H16–2, Atlanta, Georgia, 

30329; Email: IPCGuidelines@cdc.gov; 

Telephone: (404) 639–4000. 

SUPPLEMENTARY INFORMATION: 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data related to the Draft Guideline. 

Please note that comments received, 

including attachments and other 

supporting materials, are part of the 

public record and are subject to public 

disclosure. Comments will be posted on 

https://www.regulations.gov. Therefore, 

do not include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. If 

you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be on 

public display. CDC will review all 

submissions and may choose to redact, 

or withhold, submissions containing 

private or proprietary information such 

as Social Security numbers, medical 

information, inappropriate language, or 

duplicate/near duplicate examples of a 

mass-mail campaign. CDC will carefully 

consider all comments submitted in 

preparation of the final Infection Control 

in Healthcare Personnel: Epidemiology 

and Control of Selected Infections 

Transmitted Among Healthcare 

Personnel and Patients and may revise 

the Draft Guideline as appropriate. 

Background 

On February 26, 2020, CDC published 

a notice in the Federal Register 

requesting public comment on the ‘Draft 

Infection Control in Healthcare 

Personnel: Epidemiology and Control of 

Selected Infections Transmitted Among 

Healthcare Personnel and Patients: 

Diphtheria, Group A Streptococcus, 

Meningococcal Disease, and Pertussis 

Sections’ (85 FR 11084). Because the 

original notice was published in the 

early days of the COVID–19 pandemic, 

interested persons may not have had the 

opportunity to provide comment. For 

this reason, CDC has decided to re-open 

the comment period to provide the 

public with additional time to review 

the draft document and provide 

comment. 

The Draft Guideline updates four 

sections of the Guideline for Infection 

Control in Health Care Personnel, 1998 

(‘‘1998 Guideline’’), Part E: 

Epidemiology and Control of Selected 

Infections Transmitted Among Health 

Care Personnel and Patients, and their 

corresponding recommendations in Part 

II of the 1998 Guideline: ‘‘4. 

Diphtheria;’’ ‘‘9. Meningococcal 

Disease;’’ ‘‘12. Pertussis;’’ and ‘‘18. 

Streptococcus, group A infection.’’ The 

updated recommendations in the Draft 

Guideline are intended for use by the 

leaders and staff of Occupational Health 

Services (OHS) to facilitate providing 

occupational infection prevention and 

control (IPC) services to healthcare 

personnel (HCP) for the management of 

exposed or infected HCP who may be 

contagious to others in the workplace. 

Since 2015, the Healthcare Infection 

Control Practices Advisory Committee 

(HICPAC) has worked with national 

partners, academicians, public health 

professionals, healthcare providers, and 

other partners to develop this Draft 

Guideline as a recommendation for CDC 

to update sections of the 1998 

Guideline. HICPAC includes 

representatives from public health, 

infectious diseases, regulatory and other 

federal agencies, professional societies, 

and other stakeholders. 

The updated draft recommendations 

in this Draft Guideline are informed by 

reviews of the 1998 Guideline; current 

CDC resources, guidance, and 

guidelines; and new resources and 

evidence, when available. This Draft 

Guideline and the updated final 

Guideline will not be a federal rule or 

regulation. 

Dated: March 1, 2021. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2021–04515 Filed 3–4–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0033] 

Morton Grove Pharmaceuticals Inc. et 

al.; Withdrawal of Approval of Seven 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of seven 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

applicants notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

April 5, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 065428 ........ Cefprozil Tablets, 250 milligrams (mg) and 500 mg ............. Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC., 

6451 Main St., Morton Grove, IL 60053. 

ANDA 077699 ........ Mefloquine Hydrochloride (HCl) Tablets, 250 mg ................. Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228. 

ANDA 078383 ........ Pioglitazone HCl Tablets, Equivalent to (EQ) 15 mg base; 

EQ 30 mg base; EQ 45 mg base.

Neopharma Inc., 211 College Road East, Suite 101, Princeton, NJ 08540. 

ANDA 078953 ........ Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) 

and 100 mg/5 mL (20 mg/mL).

Do. 

ANDA 079049 ........ Alendronate Sodium Tablets, EQ 5 mg base; EQ 10 mg 

base; EQ 35 mg base; EQ 70 mg base.

Do. 


jbell on DSKJLSW7X2PROD with NOTICES
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 


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