Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 14271 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–05301 Filed 3–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–22–0765; Docket No. CDC–2022– 

0032] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing efforts to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other federal 

agencies to comment on proposed and/ 

or continuing information collections, 

as required by the Paperwork Reduction 

Act of 1995. This notice invites 

comments on an information collection 

titled, CDC’s Fellowship Management 

System (FMS). CDC uses the 

information collected to aid and 

enhance the selection of fellowship 

participants and host sites and to track 

participant information that helps 

strengthen the current, emerging, and 

ever-changing public health workforce. 

DATES: CDC must receive written 

comments on or before May 13, 2022. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2022– 

0032 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

regulations.gov. 

Please note: Submit all comments through 

the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS 

H21–8, Atlanta, Georgia 30329; phone: 

404–639–7570; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. 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; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. 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 submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

Data collection for fellowship 

programs using CDC’s Fellowship 

Management System (OMB Control No. 

0920–0765, Exp. 3/31/2023)— 

Revision—Center for Surveillance, 

Education, and Laboratory Services 

(CSELS), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Division of Scientific Education 

and Professional Development (DSEPD/ 

CSELS) requests a three-year revision to 

continue the use of the CDC Fellowship 

Management System (FMS) to collect 

data under the approved OMB Control 

Number (0920–0765). 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, 

and 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 likely 

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 


jspears on DSK121TN23PROD with NOTICES1
14272 Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 

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 

in to use FMS, expanding the benefits 

of the system to a broader set of CDC 

programs. Finally, the platform change 

should also enhance user experience. 

This Revision does not propose 

substantive changes to the nature or 

extent of information collected from 

respondents, and 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 burden table reflects OMBapproved changes since 2020 and 

anticipated growth in fellowships from 

2022 onward. CDC requests approval for 

an estimated total of 14,914 annual 

burden hours. There is no cost to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Fellowship applicants ........................ FMS Fellowship Application Information Collection Instrument.5146 1 87/60 7,462 

Reference Letter Writers ................... FMS Fellowship Application Information Collection Instrument.6842 1 15/60 1,711 

Public Health Agency or Organization Staff.FMS Host Site Information Collection Instrument.960 1 75/60 1,200 

Public Health Agency or Organization Staff.FMS Activity Tracking Information 

Collection Instrument.

555 2 30/60 555 

Fellowship Alumni ............................. FMS Alumni Tracking Information 

Collection Instrument.

6463 1 37/60 3,986 

Total ........................................... ........................................................... ........................ ........................ ........................ 14,914 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–05302 Filed 3–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0959] 

Determination That MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that MPI DMSA 

KIDNEY REAGENT (Technetium Tc99m Succimer Kit), Injectable, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for Technetium 

Tc-99m Succimer Kit, Injectable, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Weiner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6208, 

Silver Spring, MD 20993–0002, 240 

402–0374, Michelle.Weiner@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) Has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

MPI DMSA KIDNEY REAGENT 

(Technetium Tc-99m Succimer Kit), 

Injectable, is the subject of NDA 

N017944, held by GE Healthcare, and 

initially approved on May 18, 1982. MPI 

DMSA KIDNEY REAGENT is indicated 

to be used as an aid in the scintigraphic 

evaluation of renal parenchymal 

disorders. MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, is currently 

listed in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Hyman, Phelps, & McNamara, P.C. 

submitted a citizen petition dated 

August 27, 2021 (Docket No. FDA– 


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