Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices 12949 

Specific questions of interest to the 

AHRQ include, but are not limited to, 

the following: 

1. What clinical algorithms are used 

in clinical practice, hospitals, health 

systems, payment systems, or other 

instances? What is the estimated impact 

of these algorithms in size and 

characteristics of population affected, 

quality of care, clinical outcomes, 

quality of life and health disparities? 

2. Do the algorithms in question 1 

include race/ethnicity as a variable and, 

if so, how was race and ethnicity 

defined (including from whose 

perspective and whether there is a 

designation for mixed race or 

multiracial individuals)? 

3. Do the algorithms in question 1 

include measures of social determinants 

of health (SDOH) and, if so, how were 

these defined? Are these independently 

or collectively examined for their 

potential contribution to healthcare 

disparities and biases in care? 

4. For the algorithms in question 1, 

what evidence, data quality and types 

(such as claims/utilization data, clinical 

data, social determinants of health), and 

data sources were used in their 

development and validation? What is 

the sample size of the datasets used for 

development and validation? What is 

the representation of Black, Indigenous, 

and People of Color (BIPOC) and what 

is the power to detect between-group 

differences? What methods were used to 

validate the algorithms and measure 

health outcomes associated with the use 

of the algorithms? 

5. For the algorithms in question 1, 

what approaches are used in updating 

these algorithms? 

6. Which clinical algorithms have 

evidence that they contribute to 

healthcare disparities, including 

decreasing access to care, quality of care 

or worsening health outcomes for 

BIPOC? What are the priority 

populations or conditions for assessing 

whether algorithms increase racial/ 

ethnic disparities? What are the 

mechanisms by which use of algorithms 

contribute to poor care for BIPOC? 

7. To what extent are users of 

algorithms including clinicians, health 

systems, and health plans aware of the 

inclusion of race/ethnicity or other 

variables that could introduce bias in 

these algorithms and the implications 

for clinical decision making? What 

evidence is available about the degree to 

which the use of clinical algorithms 

contributes to bias in care delivery and 

resulting disparities in health outcomes? 

To what extent are patients aware of the 

inclusion of race/ethnicity or other 

variables that can result in bias in 

algorithms that influence their care? Do 

providers or health systems 

communicate this information with 

patients in ways that can be 

understood? 

8. What are approaches to identifying 

sources of bias and/or correcting or 

developing new algorithms that may be 

free of bias? What evidence, data quality 

and types (such as claims/utilization 

data, clinical data, information on social 

determinants of health), and data 

sources and sample size are used in 

their development and validation? What 

is the impact of these new approaches 

and algorithms on outcomes? 

9. What challenges have arisen or can 

arise by designing algorithms developed 

using traditional biomedical or 

physiologic factors (such as blood 

glucose) yet include race/ethnicity as a 

proxy for other factors such as specific 

biomarkers, genetic information, etc.? 

What strategies can be used to address 

these challenges? 

10. What are existing and developing 

standards (national and international) 

about how clinical algorithms should be 

developed, validated, and updated in a 

way to avoid bias? Are you aware of 

guidance on the inclusion or race/ 

ethnicity, related variables such as 

SDOH, prior utilization, or other 

variables to minimize the risk of bias? 

11. To what extent are users of 

clinical algorithms educated about how 

algorithms are developed or may 

influence their decision-making? What 

educational curricula and training is 

available for clinicians that addresses 

bias in clinical algorithms? 

AHRQ is interested in all of the 

questions listed above, but respondents 

are welcome to address as many or as 

few as they choose and to address 

additional areas of interest not listed. 

This RFI is for planning purposes 

only and should not be construed as a 

policy, solicitation for applications, or 

as an obligation on the part of the 

Government to provide support for any 

ideas identified in response to it. AHRQ 

will use the information submitted in 

response to this RFI at its discretion and 

will not provide comments to any 

responder’s submission. However, 

responses to the RFI may be reflected in 

future solicitation(s) or policies. The 

information provided will be analyzed 

and may appear in reports. Respondents 

will not be identified in any published 

reports. Respondents are advised that 

the Government is under no obligation 

to acknowledge receipt of the 

information received or provide 

feedback to respondents with respect to 

any information submitted. No 

proprietary, classified, confidential, or 

sensitive information should be 

included in your response. The contents 

of all submissions will be made 

available to the public upon request. 

Materials submitted must be publicly 

available or can be made public. 

Dated: March 1, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–04509 Filed 3–4–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2020–0011] 

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; ReOpening of Comment Period 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (DHHS). 

ACTION: Notice with comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), in the 

Department of Health and Human 

Services (DHHS), announces the reopening of a docket to obtain a 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 (‘‘Draft Guideline’’). 

DATES: Written comments must be 

received on or before May 4, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2020– 

0011, by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Healthcare Quality 

Promotion, National Center for 

Emerging and Zoonotic Infectious 

Diseases, Centers for Disease Control 

and Prevention, Attn: Docket No. CDC– 

2020–0011, Infection Prevention and 

Control Guidelines, 1600 Clifton Rd. 

NE, Mailstop H16–2, Atlanta, Georgia, 

30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 


jbell on DSKJLSW7X2PROD with NOTICES
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. 


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