29868 Federal Register / Vol. 87, No. 95 / Tuesday, May 17, 2022 / Notices 

On November 2, 2021, Mr. Head was 

convicted, as defined in section 

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

District Court for the Eastern District of 

Kentucky-Central Division of Frankfort, 

when the court entered judgment 

against him for the offense of conspiracy 

to import misbranded prescription 

drugs, in violation of 18 U.S.C. 371. 

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 indictment, filed 

on November 5, 2020, and in the plea 

agreement in Mr. Head’s case, filed June 

10, 2021, in or about June 2015 and 

continuing through October 2019, Mr. 

Head conducted a business under the 

name ‘‘Dr. Head’s Meds.’’ In conducting 

this business, on multiple occasions Mr. 

Head purchased thousands of generic 

medication tablets for erectile 

dysfunction from overseas suppliers 

located in countries such as India and 

Singapore. At his request, these 

suppliers sent packages containing 

generic versions of VIAGRA and CIALIS 

to Mr. Head’s residence and other 

locations via the U.S. Postal Service. 

The labeling accompanying these 

packages described their contents in an 

inaccurate or misleading manner, such 

as ‘‘Supplement.’’ After receiving the 

bulk shipments of generic erectile 

dysfunction tablets, Mr. Head sold them 

in smaller quantities to customers in the 

United States. 

As a result of this conviction, FDA 

sent Mr. Head, by certified mail, on 

January 21, 2022, a notice proposing to 

debar him for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

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

that Mr. Head’s felony conviction under 

Federal law for conspiracy to import 

misbranded prescription drugs, in 

violation of 18 U.S.C. 371, was for 

conduct relating to the importation into 

the United States of any drug or 

controlled substance because he 

illegally imported and introduced 

misbranded prescription drug products 

into interstate commerce. In proposing a 

debarment period, FDA weighed the 

considerations set forth in section 

306(c)(3) of the FD&C Act that it 

considered applicable to Mr. Head’s 

offense and concluded that the offense 

warranted the imposition of a 5-year 

period of debarment. 

The proposal informed Mr. Head of 

the proposed debarment and offered 

him an opportunity to request a hearing, 

providing him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. U.S. 

Postal Service records indicate that after 

a delivery attempt to Mr. Head’s 

residence was made and a notice left, 

the proposal and notice of opportunity 

for a hearing letter was picked up at his 

local post office on February 22, 2022. 

Mr. Head failed to request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

his opportunity for a hearing and 

waived any contentions concerning his 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

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

authority delegated to the Assistant 

Commissioner, finds that Mr. Howard 

Stanley Head, Jr. has been convicted of 

a felony under Federal law for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance. FDA finds that the offense 

should be accorded a debarment period 

of 5 years as provided by section 

306(c)(2)(A)(iii) of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Head is debarred for a period of five 

years from importing or offering for 

import any drug into the United States, 

effective (see DATES). Pursuant to section 

301(cc) of the FD&C Act (21 U.S.C. 

331(cc)), the importing or offering for 

import into the United States of any 

drug or controlled substance by, with 

the assistance of, or at the direction of 

Mr. Head is a prohibited act. 

Any application by Mr. Head for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2021– 

N–1226 and sent to the Dockets 

Management Staff (see ADDRESSSES). 

The public availability of information in 

these submissions is governed by 21 

CFR 10.20(j). 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: May 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10505 Filed 5–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information (RFI): 2022 

HHS Environmental Justice Strategy 

and Implementation Plan Draft Outline; 

Comment Period Extended 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services (HHS). 

ACTION: Notice of request for 

information; comment period extended. 

SUMMARY: On April 8, 2022, the 

Department of Health and Human 

Services (HHS) published into the 

Federal Register a Request for 

Information (RFI) which is located at 87 

FR 20876 to receive input from the 

public on HHS’s draft outline to further 

the development of the 2022 

Environmental Justice Strategy and 

Implementation Plan. Consistent with 

the policy of this administration 

directing HHS to make achieving 

environmental justice part of its 

mission, HHS would like to identify 

priority actions and strategies to best 

address environmental injustices and 

health inequities for people of color, 

disadvantaged, vulnerable, low-income, 

marginalized, and indigenous 

populations. With the engagement of 

and input from the public, the 2022 

Environmental Justice Strategy and 

Implementation Plan will serve as a 

guide to confront environmental and 

health disparities and implement a 

multifaceted approach that will serve 

vulnerable populations and 

communities disproportionately 

impacted by environmental burdens. 

DATES: To be assured consideration, 

comments must be received at the email 

address provided below, no later than 

midnight Eastern Time (ET) on June 18, 

2022. HHS will not reply individually to 

responders but will consider all 

comments submitted by the deadline. 

Do not provide confidential information 

as comments may be published or 

otherwise used for agency purposes. 

ADDRESSES: Please submit all responses 

via email to OASHcomments@hhs.gov 

as a Word document or in the body of 

an email. 

FOR FURTHER INFORMATION CONTACT: Dr. 

LaToria Whitehead, Senior Public 

Health Analyst, email: ceq6@cdc.gov, 

phone: (770) 488–3633. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 95 / Tuesday, May 17, 2022 / Notices 29869 

Dated: May 11, 2022. 

Arsenio Mataka, 

Senior Advisor, Office of the Assistant 

Secretary for Health, Department of Health 

and Human Services. 

[FR Doc. 2022–10540 Filed 5–16–22; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0407–60D] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the information 

collection request (ICR) must be 

received on or before July 18, 2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier OS–0990–0407– 

60D and project title for reference. 

Submit requests to Sherrette A. Funn, 

the Reports Clearance Officer, at 

Sherrette.Funn@hhs.gov or call (202) 

795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Think Cultural 

Health (TCH) website Quality 

Improvement Effort. 

Type of Collection: Reinstatement 

with Change. 

OMB No. 0990–0407. 

Abstract: The Office of Minority 

Health (OMH), Office of the Secretary 

(OS), Department of Health and Human 

Services (HHS) is requesting approval 

by OMB on a reinstatement with change 

to a previously approved data 

collection. The Think Cultural Health 

(TCH) website is an initiative of the 

HHS OMH’s Center for Linguistic and 

Cultural Competence in Health Care 

(CLCCHC) and is a repository of 

resources and tools to promote cultural 

and linguistic competency in health and 

health care. The TCH website offers a 

suite of e-learning programs that afford 

health and health care professionals the 

ability to earn continuing education 

credits through training in cultural and 

linguistic competency. The revision to 

this information collection request 

includes revisions to the online website 

registration form to streamline and 

change response options for some 

elements. 

Need and Proposed Use of the 

Information: The data will be used to 

ensure that the offerings on the TCH 

website are relevant, useful, and 

appropriate to their target audiences. 

The findings from the data collection 

will be of interest to HHS OMH in 

supporting maintenance and revisions 

of the offerings on the TCH website. 

Likely Respondents: Likely 

respondents are users of the TCH elearning program(s) and/or eresource(s). There are no requirements 

for annual, quarterly or monthly 

responses. A single respondent 

completes the registration process to 

access an e-learning program or eresource on the website only one time 

and completes a course-specific 

evaluation form for each e-learning 

program course/unit or e-resource per 

completion. A respondent may be 

invited to participate in the follow-up 

survey, a focus group, or a key 

informant interview and will not be 

asked to participate in more than one 

follow-up activity (i.e., survey, focus 

group, or key informant interview). 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Forms Respondents Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Registration Form ............................. Health and Health Care Professionals.9,460 1 3/60 473 

Course/unit Evaluation Form ............ Health and Health Care Professionals.9,460 1 5/60 788 

Follow-Up Survey .............................. Health and Health Care Professionals.4,208 1 10/60 701 

Focus Groups ................................... Health and Health Care Professionals.15 1 120/60 30 

Key Informant Interviews .................. Health and Health Care Professionals.13 1 60/60 13 

Total ........................................... ........................................................... 23,156 ........................ ........................ 2,005 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–10521 Filed 5–16–22; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors of the NIH Clinical Center. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended for the review, discussion, 

and evaluation of individual grant 

applications conducted by the 


khammond on DSKJM1Z7X2PROD with NOTICES