8262 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices 

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 

Performance Progress and Monitoring 

Report (PPMR) (OMB Control No. 0920– 

1132, Exp. 10/31/2022)—Extension— 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Each year, approximately 80% of the 

CDC’s budget is distributed via 

contracts, grants and cooperative 

agreements, from the Office of Financial 

Resources (OFR) to partners (Awardees) 

throughout the world in an effort to 

promote health, prevent disease, injury 

and disability and prepare for new 

health threats. OFR is responsible for 

the stewardship of these funds while 

providing excellent, professional 

services to our partners and 

stakeholders. 

Currently, CDC uses the Performance 

Progress and Monitoring Report (PPMR, 

OMB Control No. 0920–1132, 

Expiration: 10/31/2022), a set of 

progress reporting forms for NonResearch awards to collect information 

semi-annually from Awardees regarding 

the progress made over specified time 

periods on CDC funded projects. The 

PPMR was originally modified from SF– 

PPR (OMB Control No. 0970–0406, 

Expiration: 10/31/2015), a similar 

progress report that was owned by the 

Administration for Children and 

Families (ACF) within the Department 

of Health and Human Services (HHS). 

The PPMR was created by CDC to 

provide an agency-wide collection tool 

that would be able to obtain data on the 

progress of CDC Awardees for the 

purposes of evaluation, and to bring the 

Awardee reporting procedure into 

compliance with the Paperwork 

Reduction Act (PRA). 

The information collected enables the 

accurate, reliable, uniform, and timely 

submission to CDC of each Awardee’s 

work plans and progress reports, 

including strategies, activities and 

performance measures. The information 

collected by the PPMR is designed to 

align with, and support the goals 

outlined for each of the CDC Awardees. 

Collection and reporting of the 

information will occur in an efficient, 

standardized, and user-friendly manner 

that will generate a variety of routine 

and customizable reports. The PPMR 

will allow each Awardee to summarize 

activities and progress towards meeting 

performance measures and goals over a 

specified time period specific to each 

award. CDC will also have the capacity 

to generate reports that describe 

activities across multiple Awardees. In 

addition, CDC will use the information 

collection to respond to inquiries from 

HHS, Congress and other stakeholder 

inquiries about program activities and 

their impact. The current submission 

process allows Awardees to submit a 

completed PDF version of the PPMR by 

uploading it to www.grants.gov, or 

directly to the programs at CDC that will 

be performing the evaluation. 

This Extension request is being 

submitted to allow CDC to continue 

collection of this valuable information 

from Awardees for an additional three 

years. There are no anticipated changes 

to the information collection 

instruments or associated burden at this 

time. CDC requests OMB approval for an 

estimated 13,014 annual burden hours. 

There is no cost to respondents 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) 

Total burden 

(in hours) 

CDC Award Recipients ..................... Performance Progress and Monitoring Report (PPMR—Att. A–F).5,200 1 2 10,400 

CDC Award Recipients ..................... Performance Progress and Monitoring Report (PPMR—Att. G).1,632 1 5/60 136 

NHSS Award Recipients ................... Performance Progress and Monitoring Report (PPMR—Att. A–F).60 1 41 2,478 

Total ........................................... ........................................................... ........................ ........................ ........................ 13,014 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–03080 Filed 2–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0083] 

Food and Drug Administration Hiring 

and Retention Final Assessment; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is holding a virtual meeting entitled 

‘‘FDA Hiring and Retention Final 

Assessment’’ and an opportunity for 

public comment. The topic to be 

discussed is the FDA Hiring and 

Retention Final Assessment, which was 

an independent assessment performed 

by Booz Allen Hamilton, published on 

December 10, 2021. This public meeting 

will take place virtually due to 

extenuating circumstances and will be 

held by webcast only. 

DATES: The public meeting will be held 

on March 15, 2022, from 9 a.m. to 12 

noon Eastern Time. Submit either 

electronic or written comments on this 

public meeting by May 16, 2022. See the 


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Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices 8263 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

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 by May 16, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 16, 2022. 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– 

2022–N–0083 for ‘‘FDA Hiring and 

Retention Final Assessment; Public 

Meeting; Request for Comments.’’ 

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 

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 

‘‘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: 

Patricia Stewart, Office of Operations, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–4735, patricia.stewart@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is holding a public meeting to 

share high-level findings from a recently 

completed final assessment of FDA’s 

hiring and retention processes, 

conducted by a qualified, independent 

contractor with expertise in assessing 

transformation of Human Resource 

operations. We recognize that the 

critical work to protect public health is 

made possible in part by the Agency’s 

ability to attract and retain a talented, 

diverse, and dedicated workforce. As 

FDA continues to fulfill its strategic 

mission, it is imperative that we identify 

and leverage the talent, skills, and 

diversity within—and outside of—the 

Agency. 

These priorities are reflected in FDA’s 

plan to enhance its hiring and retention 

programs; recruit qualified candidates 

with diverse backgrounds, experiences, 

and talents; provide internal 

development opportunities; and further 

enhance the Agency’s ability to nurture 

a supportive and fair work environment. 

The public meeting will provide an 

update on FDA’s progress toward the 

Prescription Drug User Fee Act (PDUFA 

VI) and the Biosimilar User Fee 

Amendments Act of 2017 (BsUFA II) 

hiring and retention commitments and 

solicit input on actions regarding the 

hiring process. To view the evaluation 

assessment report, please visit https://

www.fda.gov/media/154873/download. 

This public meeting is intended to 

meet performance commitments 

included in PDUFA VI and BsUFA II. 

These user fee programs were 

reauthorized, for fiscal years 2018— 

2022, as part of the FDA 

Reauthorization Act of 2017 (Pub. L. 

115–52) signed by the President on 

August 18, 2017. The complete set of 

performance goals for each program is 

available at: 

• PDUFA VI program: https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf. 

• BsUFA II program: https://

www.fda.gov/downloads/forindustry/ 

userfees/biosimilaruserfeeactbsufa/ 

ucm521121.pdf. 

II. Topics for Discussion at the Public 

Meeting 

This public meeting will provide FDA 

the opportunity to update interested 

public stakeholders on topics related to 

the FDA hiring and retention programs. 

Booz Allen Hamilton will present their 

findings and recommendations that are 

outlined in the Hiring and Retention 

Final Assessment Report and we will 

provide an update on the Agency’s 

progress in addressing the findings from 

the independent third-party evaluation 

that was published December 10, 2021. 

To view the evaluation assessment 


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8264 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices 

report, please visit https://www.fda.gov/ 

media/154873/download. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website: https://pdufa-hrassessment.eventbrite.com. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by March 14, 2022, 11:59 p.m. 

Eastern Time. We will let registrants 

know if registration closes before the 

day of the public meeting. 

If you need special accommodations 

due to a disability, please contact 

Patricia Stewart (see FOR FURTHER

INFORMATION CONTACT) no later than 

March 8, 2022. 

Requests for Oral Presentations: 

During online registration, you may 

indicate if you wish to present during a 

public comment session, and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations and request time for a 

joint presentation. Following the close 

of registration, we will determine the 

amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

March 11, 2022. All requests to make 

oral presentations must be received by 

March 8, 2022, 11:59 p.m. Eastern Time. 

If selected for presentation, any 

presentation materials must be emailed 

to Patricia Stewart (see FOR FURTHER

INFORMATION CONTACT) no later than 

March 11, 2022. No commercial or 

promotional material will be permitted 

to be presented at the public meeting. 

Streaming Webcast of the public 

meeting: The webcast for this public 

meeting is accessible at https://pdufahr-assessment.eventbrite.com. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). 

Dated: February 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03097 Filed 2–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0304] 

Brian Michael Parks: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

Brian Michael Parks for a period of 5 

years from importing or offering for 

import any article of food (including 

dietary supplements) or drug into the 

United States. FDA bases this order on 

a finding that Mr. Parks was convicted 

of one felony count under Federal law 

for distribution of an unapproved new 

drug with the intent to defraud and 

mislead. The factual basis supporting 

Mr. Parks’ conviction, as described 

below, is conduct relating to the 

importation into the United States of 

any food and of any drug or controlled 

substance. Mr. Parks was given notice of 

the proposed debarment and was given 

an opportunity to request a hearing to 

show why he should not be debarred. 

As of November 17, 2021 (30 days after 

receipt of the notice), Mr. Parks had not 

responded. Mr. Parks’ failure to respond 

and request a hearing constitutes a 

waiver of his right to a hearing 

concerning this matter. 

DATES: This order is applicable February 

14, 2022. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Enforcement 

(ELEM–4029), Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(C)) permits FDA to 

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) of the FD&C Act, that the 

individual has been convicted of a 

felony for conduct relating to the 

importation into the United States of 

any food. Section 306(b)(1)(D) of the 

FD&C Act permits debarment of an 

individual from importing or offering 

for import any drug into the United 

States if the FDA finds, as required by 

section 306(b)(3)(C) of the FD&C Act 

that the individual has been convicted 

of a felony for conduct relating to the 

importation into the United States of 

any drug or controlled substance. 

On February 16, 2021, Mr. Parks was 

convicted, as defined in section 

306(l)(1) of the FD&C Act in the U.S. 

District Court for the Western District of 

Virginia, after his plea of guilty, when 

the court entered judgment against him 

for the offense of distribution of an 

unapproved new drug with the intent to 

defraud and mislead, in violation of 

sections 301(d) and 303(a)(2) of the 

FD&C Act 21 U.S.C. 331(d) and 

333(a)(2). The FDA’s finding that 

debarment is appropriate is based on the 

felony conviction referenced herein. 

The factual basis for this conviction is 

as follows: 

As contained in the information in 

Mr. Parks’ case, filed on November 23, 

2020, he was the owner and operator of 

MedFitRX Inc., later known as MedFit 

Sarmacuticals Inc. (collectively referred 

to as MedFitRX herein), a purported 

sport supplement company based in 

North Carolina. MedFitRX imported 

Selective Androgen Receptor 

Modulators (SARMs) in order to use 

them in MedFitRx products. SARMs are 

synthetic chemicals designed to mimic 

the effects of testosterone and other 

anabolic steroids. From approximately 

March 2016 to September 2019, Mr. 

Parks imported SARMs and other drug 

active ingredients from China on 

multiple occasions. The drug active 

ingredients he imported included MK– 

677, S–4, MK–2866, GW–501516, LGD– 

4033, and RAD140, among others. In 

addition, on or about May 17, 2018, Mr. 

Parks sold two MedFitRX products to 

undercover FDA Office of Criminal 

Investigation agents posing as 

consumers. The first product Mr. Parks 

sold to these undercover agents, Lucky 

SARMS Magical AF, contained the 

drugs S–23 and SR9009, which he had 

caused to be imported into the United 

States. The second product, Estrovert, 


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