41320 Federal Register / Vol. 87, No. 132 / Tuesday, July 12, 2022 / Notices 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Aggregate Reports for Tuberculosis 

Program Evaluation (OMB Control No. 

0920–0457, Exp. 12/31/2022)— 

Extension—National Center for HIV, 

Viral Hepatitis, STD, and TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Centers for Disease Control and 

Prevention, National Center for HIV, 

Viral Hepatitis, STD, and TB 

Prevention, Division of Tuberculosis 

Elimination (CDC/NCHHSTP/DTBE) 

requests an Extension of the Aggregate 

Reports for Tuberculosis Program 

Evaluation information collection, 

previously approved under OMB 

Control No. 0920–0457. This request is 

for a three-year period. 

The requested Extension allows 

awardees to address the change in the 

national strategies for TB control and 

prevention emphasizing treatment of 

individuals with latent TB infection 

(LTBI) and at high risks of progression 

to TB disease. This data collection will 

help programs to assess high-risk 

populations served and to evaluate the 

adaptation and effectiveness of new 

diagnostic tests and drug regimens in 

treating LTBI. 

DTBE is the lead agency for 

tuberculosis elimination in the United 

States. To ensure the elimination of 

tuberculosis in the United States, CDC 

monitors indicators for key program 

activities, such as finding tuberculosis 

infections in recent contacts of cases, 

and in other persons likely to be 

infected, and providing therapy for 

latent tuberculosis infection. In 2000, 

CDC implemented two program 

evaluation reports for annual 

submission: (1) Aggregate report of 

follow-up and treatment for contacts to 

tuberculosis cases, and (2) Aggregate 

report of targeted testing and treatment 

for latent tuberculosis infection. The 

respondents for these reports are the 67 

state and local tuberculosis control 

programs receiving federal cooperative 

agreement funding through DTBE. 

These reports emphasize treatment 

outcomes, high-priority target 

populations vulnerable to tuberculosis, 

and electronic report entry and 

submission to CDC through the National 

Tuberculosis Indicators Project (NTIP), a 

secure web-based system for program 

evaluation data. No other federal agency 

collects this type of national 

tuberculosis data. The Aggregate report 

of follow-up for contacts of tuberculosis 

and Aggregate report of targeted testing 

and treatment for latent tuberculosis 

infection are the only data source about 

latent tuberculosis infection for 

monitoring national progress toward 

tuberculosis elimination with these 

activities. CDC provides ongoing 

assistance in the preparation and 

utilization of these reports at the local 

and state levels of public health 

jurisdiction. CDC also provides 

respondents with technical support for 

NTIP access. 

CDC requests OMB approval for an 

estimated 268 annual burden hours. 

Participation by respondents is 

voluntary, and there is no cost to 

participants other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Health Department Awardee (State, Local, 

City, or other jurisdiction).

Follow-up and Treatment of Contacts to Tuberculosis Cases Form (3a).67 1 2 

Targeted Testing and Treatment for Latent 

Tuberculosis Infection (3b).

67 1 2 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–14757 Filed 7–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–22–0765] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request ’’Fellowship 

Management System (FMS)’’ to the 

Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on March 14, 2022 to obtain 

comments from the public and affected 

agencies. CDC did not receive comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 132 / Tuesday, July 12, 2022 / Notices 41321 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Fellowship Management System 

(FMS) (OMB Control No. 0920–0765, 

Exp. 3/31/2023)—Revision—Center for 

Surveillance, Epidemiology, and 

Laboratory Services (CSELS), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

CDC’s Division of Scientific 

Education and Professional 

Development (DSEPD), in the Center for 

Surveillance, Epidemiology, and 

Laboratory Services (CSELS), requests 

OMB approval to continue use of the 

CDC Fellowship Management System 

(FMS) (OMB Control No. 0920–0765), 

with changes. The mission of DSEPD is 

to improve health outcomes through a 

competent, sustainable, and empowered 

public health workforce. Professionals 

in public health, epidemiology, 

medicine, economics, information 

science, veterinary medicine, nursing, 

public policy, and other related 

professionals seek opportunities, 

through CDC fellowships, to broaden 

their knowledge, and skills to improve 

the science and practice of public 

health. CDC fellows are assigned to 

state, tribal, local, and territorial public 

health agencies; federal government 

agencies, including CDC and 

Department of Health and Human 

Services’ (HHS) operational divisions, 

such as Centers for Medicare & 

Medicaid Services; and to 

nongovernmental organizations, 

including academic institutions, tribal 

organizations, and private public health 

organizations. 

CDC uses FMS to collect, process, and 

manage data from nonfederal applicants 

seeking training or public health 

support services through CDC 

fellowships. FMS is used to 

electronically submit fellowship 

applications, submit fellowship host site 

proposals, track completion of 

fellowship activities, and maintain 

fellowship alumni directories online. 

FMS is a flexible and robust electronic 

information system standardized and 

tailored for each CDC fellowship, 

collecting only the minimum amount of 

information needed. The system is 

critical to streamlining data 

management for CDC and reducing 

burden for respondents. FMS is key to 

CDC’s ability to protect the public’s 

health by supporting training 

opportunities that strengthen the public 

health workforce. 

The proposed revision has two 

purposes: (1) increase the number of 

likely respondents, and (2) change the 

software platform on which FMS 

operates. The increase in the estimated 

number of respondents is a result of 

increased funding that will allow 

DSEPD to expand many of the 

fellowships managed through FMS. The 

change in software platform will 

provide CDC with an even more 

efficient, effective, and secure electronic 

mechanism for collecting, processing, 

and monitoring fellowship information. 

The proposed software platform is the 

Microsoft® Power Platform® (Microsoft 

Corporation, Cary, Washington). 

Integration of the suite of Microsoft 

tools for data management, analysis, and 

visualization will allow CDC to access 

fellowship data in real time; moreover, 

data cleaning and manipulation do not 

need to be done outside the system, 

which will increase the security of these 

data. These increased functionalities 

will facilitate the enhanced use of 

administrative data collections for 

program improvement and evidence 

building activities across CDC and other 

federal agencies. The update to the 

software platform will also make it 

easier for additional fellowships to opt 

to use FMS, expanding the benefits of 

the system to a broader set of CDC 

programs. Finally, the platform change 

also should enhance user experience. 

This revision does not propose 

substantive changes to the nature or 

extent of information collected from 

respondents. 

OMB approval is requested for three 

years. The revision will allow all 

respondents—fellowship applicants, 

public health agencies hosting 

fellowship participants, and fellowship 

alumni—the continued use of FMS for 

submission of electronic data with 

increased efficiency and reduced 

burdens. 

The annualized burden table reflects 

OMB-approved changes since 2020 and 

anticipated growth in fellowships from 

2022 onward. There is no cost to 

respondents other than their time. The 

total estimated annualized burden hours 

are 13,186. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Fellowship Applicants ..................................... FMS Application Module ................................ 5,146 1 87/60 

Reference Letter Writers ................................. FMS Application Module ................................ 6,842 1 15/60 

Subset of FMS Fellowship Applicants ............ FMS Application Module (13.6) ..................... 220 1 30/60 

Public Health Agency or Organization Staff ... FMS Host Site Module ................................... 960 1 75/60 

Public Health Agency or Organization Staff ... FMS Activity Tracking Module ....................... 555 2 30/60 

Fellowship alumni ........................................... FMS Alumni Directory .................................... 3,484 1 37/60 


jspears on DSK121TN23PROD with NOTICES1
41322 Federal Register / Vol. 87, No. 132 / Tuesday, July 12, 2022 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–14758 Filed 7–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–1349] 

Mikart, LLC, et al.; Withdrawal of 

Approval of 31 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 31 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 

August 11, 2022. 

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 040846 ............... Hydrocodone Bitartrate and Acetaminophen Tablets, 325 milligrams 

(mg); 2.5 mg.

Mikart, LLC, 1750 Chattahoochee Ave. NW, 

Atlanta, GA 30318. 

ANDA 040851 ............... Benzonatate Capsules, 100 mg, 150 mg, and 200 mg ........................ Do. 

ANDA 072903 ............... Ibuprofen Tablets, 200 mg .................................................................... ANI Pharmaceuticals, Inc., 210 Main St. 

West, Baudette, MN 56623. 

ANDA 073519 ............... Tolmetin Sodium Capsules, Equivalent to (EQ) 400 mg base ............. Do. 

ANDA 074267 ............... Guanabenz Acetate Tablets, EQ 4 mg base and EQ 8 mg base ........ Do. 

ANDA 074498 ............... Indapamide Tablets, 1.25 mg and 2.5 mg ............................................ Do. 

ANDA 074840 ............... Etodolac Capsules, 200 mg and 300 mg ............................................. Do. 

ANDA 074844 ............... Etodolac Capsules, 200 mg and 300 mg ............................................. Do. 

ANDA 075212 ............... Ranitidine Hydrochloride (HCl) Tablets, EQ 75 mg base ..................... Do. 

ANDA 076030 ............... Flecainide Acetate Tablets, 50 mg, 100 mg, and 150 mg ................... Do. 

ANDA 076086 ............... Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg ............... Do. 

ANDA 077426 ............... Ranitidine HCl Tablets, EQ 150 mg base and EQ 300 mg base ......... Do. 

ANDA 077641 ............... Zonisamide Capsules, 25 mg, 50 mg, and 100 mg ............................. Do. 

ANDA 077979 ............... Alprazolam Extended Release Tablets, 0.5 mg, 1 mg, 2 mg, and 3 

mg.

Do. 

ANDA 085269 ............... Meclizine HCl Tablets, 12.5 mg ............................................................ Do. 

ANDA 085740 ............... Meclizine HCI Tablets, 25 mg ............................................................... Do. 

ANDA 087296 ............... Chlorthalidone Tablets, 25 mg .............................................................. Do. 

ANDA 088164 ............... Chlorthalidone Tablets, 25 mg .............................................................. Do. 

ANDA 088641 ............... Glucamide Tablets, 250 mg .................................................................. Do. 

ANDA 088732 ............... Meclizine HCl Tablets, 12.5 mg ............................................................ Do. 

ANDA 088768 ............... Chlorpropamide Tablets, 100 mg ......................................................... Do. 

ANDA 088826 ............... Chlorpropamide Tablets, 250 mg ......................................................... Do. 

ANDA 090572 ............... Cetirizine HCl, Syrup 5 mg/5 milliliters (mL) ......................................... Tris Pharma, Inc., 2031 U.S. Hwy. 130, Suite 

D, Monmouth Junction, NJ 08852. 

ANDA 090906 ............... Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1 gram (gm) .. Alvogen PB Research and Development, U.S. 

Agency for Lotus Pharmaceutical Co., Ltd., 

Nantou Plant, 44 Whippany Rd., Suite 300, 

Morristown, NJ 07960. 

ANDA 201944 ............... Potassium Chloride Extended Release Capsules, 8 milliequivalent 

(mEq) and 10 mEq.

Tris Pharma, Inc. 

ANDA 202095 ............... Levetiracetam Extended Release Tablets, 500 mg and 750 mg ......... Alvogen PB Research and Development, U.S. 

Agency for Lotus Pharmaceutical Co., Ltd. 

ANDA 202246 ............... Levonorgestrel Tablets, 1.5 mg ............................................................ Alvogen, Inc., 44 Whippany Rd., Suite 300, 

Morristown, NJ 07960. 

ANDA 203298 ............... Calcium Acetate Capsules, 667 mg ...................................................... Alvogen PB Research and Development, U.S. 

Agency for Lotus Pharmaceutical Co., Ltd. 

ANDA 204180 ............... Amiloride HCl Tablets, 5 mg ................................................................. USpharma Windlas, LLC, 115 Blue Jay Dr., 

Suite 101, Liberty, MO 64068. 

ANDA 205442 ............... Linezolid Injection, 600 mg/300 mL (2 mg/mL) .................................... Hospira, Inc., 275 North Field Dr., Bldg. H1, 

Lake Forest, IL 60045. 

ANDA 205790 ............... Prasugrel Tablets, EQ 5 mg base and EQ 10 mg base ...................... USpharma Windlas, LLC. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of August 11, 

2022. 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 


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