7838 Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 

award up to $50 million in additional 

universal service funding to Tribal 

Areas, including Alaska, to accelerate 

mobile broadband availability in these 

remote and underserved areas. In its 

May 2012 Third Order on 

Reconsideration (FCC 12–52), the 

Commission revised certain rules 

adopted in the USF/ICC Transformation 

Order, including the deadline by which 

MF–I and TMF–I support recipients 

must file their annual reports pursuant 

to 47 CFR 54.1009(a). The information 

being collected under this information 

collection will be used by the 

Commission to ensure that MF–I and 

TMF–I support recipients are meeting 

the public interest obligations 

associated with receiving such support. 

Federal Communications Commission. 

Katura Jackson, 

Federal Register Liaison Officer. 

[FR Doc. 2022–02896 Filed 2–9–22; 8:45 am] 

BILLING CODE 6712–01–P 

OFFICE OF GOVERNMENT ETHICS 

Agency Information Collection 

Activities; Information Collection 

Renewal; Comment Request for OGE 

Form 319 Request for a Medical 

Exception to the Covid–19 Vaccination 

Requirement 

AGENCY: Office of Government Ethics 

(OGE). 

ACTION: Notice and request for 

comments. 

SUMMARY: After this first round notice 

and public comment period, the Office 

of Government Ethics (OGE) plans to 

request that the Office of Management 

and Budget (OMB) renew its approval 

under the Paperwork Reduction Act for 

an existing information collection, 

entitled the OGE Form 319 Request for 

a Medical Exception to the Covid–19 

Vaccination Requirement. The form was 

originally granted emergency clearance 

on November 19, 2021. 

DATES: Written comments by the public 

and agencies on this proposed extension 

are invited and must be received by 

April 11, 2022. 

ADDRESSES: Comments may be 

submitted to OGE by any of the 

following methods: 

Email: usoge@oge.gov (Include 

reference to ‘‘OGE Form 319 Request for 

a Medical Exception to the Covid–19 

Vaccination Requirement comment’’ in 

the subject line of the message.) 

Mail, Hand Delivery/Courier: Office of 

Government Ethics, 1201 New York 

Avenue NW, Suite 500, Attention: 

Jennifer Matis, Associate Counsel, 

Washington, DC 20005–3917. 

Instructions: Comments may be 

posted on OGE’s website, www.oge.gov. 

Sensitive personal information, such as 

account numbers or Social Security 

numbers, should not be included. 

Comments generally will not be edited 

to remove any identifying or contact 

information. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Matis at the U.S. Office of 

Government Ethics; telephone: 202– 

482–9216; TTY: 800–877–8339; Email: 

jmatis@oge.gov. A copy of the form may 

be obtained, without charge, by 

contacting Jennifer Matis. 

SUPPLEMENTARY INFORMATION: 

Title: Request for a Medical Exception 

to the Covid–19 Vaccination 

Requirement. 

Agency Form Number: OGE Form 

319. 

Abstract: The OGE Form 319 collects 

information necessary to document the 

consideration, decision, and 

implementation of OGE employee 

requests for reasonable accommodation 

from the COVID vaccination 

requirement set forth in Executive Order 

14043, Requiring Coronavirus Disease 

2019 Vaccination for Federal Employees 

(Sept. 9, 2021). 

OMB Control Number: 3209–0011. 

Type of Information Collection: 

Extension of a currently approved 

collection. 

Type of Review Request: Regular. 

Affected public: Medical providers 

who are asked to provide 

documentation in support of an 

employee’s request for a medical 

exception to the requirement for 

COVID–19 vaccination. 

Estimated Annual Number of 

Respondents: 1 (based on an estimate of 

five respondents over a ten year period, 

rounded up). 

Estimated Time per Response: 10 

minutes. 

Estimated Total Annual Cost Burden 

(in dollars): 17. 

Request for Comments: OGE is 

publishing this first round notice of its 

intent to request paperwork clearance 

renewal for the OGE Form 319. Public 

comment is invited specifically on the 

need for and practical utility of this 

information collection, the accuracy of 

OGE’s burden estimate, the 

enhancement of quality, utility and 

clarity of the information collected, and 

the minimization of burden (including 

the use of information technology). 

Comments received in response to this 

notice will be summarized for and 

included with the OGE request for 

extension of OMB paperwork approval. 

The comments will also become a 

matter of public record. 

A Notice Regarding Injunctions: The 

vaccination requirement issued 

pursuant to E.O. 14043 is currently the 

subject of a nationwide injunction. 

While that injunction remains in place, 

OGE will not process requests for a 

medical exception from the COVID–19 

vaccination requirement pursuant to 

E.O. 14043. OGE will also not request 

the submission of any medical 

information related to a request for an 

exception from the vaccination 

requirement pursuant to E.O. 14043 

while the injunction remains in place. 

But OGE may nevertheless receive 

information regarding a medical 

exception. That is because, if OGE were 

to receive a request for an exception 

from the COVID–19 vaccination 

requirement pursuant to E.O. 14043 

during the pendency of the injunction, 

OGE will accept the request, hold it in 

abeyance, and notify the employee who 

submitted the request that 

implementation and enforcement of the 

COVID–19 vaccination requirement 

pursuant to E.O. 14043 is currently 

enjoined and that an exception therefore 

is not necessary so long as the 

injunction is in place. In other words, 

during the pendency of the injunction, 

any information collection related to 

requests for medical exception from the 

COVID–19 vaccination requirement 

pursuant to E.O. 14043 is not 

undertaken to implement or enforce the 

COVID–19 vaccination requirement. 

Approved: February 7, 2022. 

Emory Rounds, 

Director, U.S. Office of Government Ethics. 

[FR Doc. 2022–02826 Filed 2–9–22; 8:45 am] 

BILLING CODE 6345–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2022–0024] 

Proposed 2022 CDC Clinical Practice 

Guideline for Prescribing Opioids 

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) within 

the Department of Health and Human 

Services (HHS), announces the opening 

of a docket to obtain comment on the 

proposed clinical practice guideline, 

CDC Clinical Practice Guideline for 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 7839 

Prescribing Opioids—United States, 

2022 (the clinical practice guideline). 

The clinical practice guideline updates 

and expands the CDC Guideline for 

Prescribing Opioids for Chronic Pain— 

United States, 2016, and provides 

evidence-based recommendations for 

clinicians who provide pain care, 

including those prescribing opioids, for 

outpatients age 18 years and older with 

acute pain (duration less than 1 month), 

subacute pain (duration of 1–3 months), 

or chronic pain (duration of 3 months or 

more), not including sickle cell diseaserelated pain management, cancer pain 

treatment, palliative care, and end-oflife care. The clinical practice guideline 

includes recommendations for primary 

care clinicians (including physicians, 

nurse practitioners, and physician 

assistants) as well as for outpatient 

clinicians in other specialties (including 

those managing dental and postsurgical 

pain in outpatient settings and 

emergency clinicians providing pain 

management for patients being 

discharged from emergency 

departments). This voluntary clinical 

practice guideline provides 

recommendations and does not require 

mandatory compliance; and the clinical 

practice guideline is intended to be 

flexible so as to support, not supplant, 

clinical judgment and individualized, 

patient-centered decision-making. 

DATES: Written comments must be 

received on or before April 11, 2022. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2022– 

0024, by either of the following 

methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: National Center for Injury 

Prevention and Control, Centers for 

Disease Control and Prevention, 4770 

Buford Highway NE, Mailstop S106–9, 

Atlanta, GA 30341, Attn: Docket No. 

CDC–2022–0024. 

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. Do not 

submit comments by email. CDC does 

not accept comments by email. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Arlene I. Greenspan, National Center for 

Injury Prevention and Control, Centers 

for Disease Control and Prevention, 

4770 Buford Highway NE, MS S106–9, 

Atlanta, GA 30341; Telephone: 770– 

488–4696. Email: opioids@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. 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. 

Do not submit comments by email. CDC 

does not accept comments by email. 

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. 

Background 

In the CDC Guideline for Prescribing 

Opioids for Chronic Pain—United 

States, 2016, CDC communicated the 

intent to evaluate and reassess evidence 

and recommendations as new evidence 

became available and to determine 

when new evidence would prompt an 

update. To achieve these aims, CDC 

funded the Evidence-based Practice 

Centers at the Agency for Healthcare 

Research and Quality (AHRQ) to 

conduct systematic reviews of the 

scientific evidence in the following five 

areas: (1) Noninvasive 

nonpharmacological treatments for 

chronic pain; (2) nonopioid 

pharmacologic treatments for chronic 

pain; (3) opioid treatments for chronic 

pain; (4) treatments for acute pain; and 

(5) acute treatments for episodic 

migraine. Based upon the new evidence 

described in these reviews, an update to 

the CDC Guideline for Prescribing 

Opioids for Chronic Pain—United 

States, 2016 was warranted. 

CDC developed the clinical practice 

guideline using the Grading of 

Recommendations, Assessment, 

Development, and Evaluation (GRADE) 

framework, which specifies the 

systematic review of scientific evidence 

and offers a transparent approach to 

grading quality of evidence and strength 

of recommendations. Recommendations 

were made based on systematic reviews 

of the available scientific evidence 

while considering benefits and harms; 

patients’, caregivers’, and clinicians’ 

values and preferences for pain 

treatment; and resource allocation (e.g., 

costs to patients or health systems, 

including clinician time). CDC drafted 

recommendation statements in the 

clinical practice guideline focused on 

assisting clinicians in determining 

whether to initiate opioids for pain; 

opioid selection and dosage; opioid 

duration and follow-up; and assessing 

risk and addressing potential harms of 

opioid use. 

This clinical practice guideline is 

voluntary; it provides recommendations 

and does not require mandatory 

compliance. It is intended to be flexible 

to support, not supplant, clinical 

judgment and individualized, patientcentered decision-making. This clinical 

practice guideline is not intended to be 

applied as inflexible standards of care 

across patient populations by healthcare 

professionals, health systems, thirdparty payers, organizations, or 

governmental jurisdictions. The clinical 

practice guideline is intended to achieve 

the following: Improved communication 

between clinicians and patients about 

the risks and benefits of pain treatment, 

including opioid therapy for pain; 

improved safety and effectiveness for 

pain treatment, resulting in improved 

function and quality of life for patients 

experiencing pain; and a reduction in 

the risks associated with long-term 

opioid therapy, including opioid use 

disorder, overdose, and death. 

To help assure the clinical practice 

guideline’s integrity, credibility, and 

consideration of patients’, caregivers’, 

and providers’ values and preferences, 

CDC obtained input from patients, 

caregivers, experts, clinicians, the 

public, and a federally chartered 

advisory committee, the Board of 

Scientific Counselors of the National 

Center for Injury Prevention and Control 

(BSC/NCIPC). CDC is also currently 

obtaining feedback from a panel of 

external peer reviewers who are experts 

in topic areas related to opioid 

prescribing. The panel of external peer 

reviewers’ feedback will be addressed 

and incorporated into the final clinical 

practice guideline at the same time that 

public comments received in response 

to this Notice are considered. 

For more information about the 

clinical practice guideline or the process 

of updating it, please visit https://

www.cdc.gov/opioids/guideline-update/ 

index.html. 

Supporting and Related Material in the 

Docket 

The docket contains the following 

supporting and related materials to help 


jspears on DSK121TN23PROD with NOTICES1
7840 Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 

inform public comment: (1) The draft 

clinical practice guideline; (2) the 

GRADE tables; (3) the Opioid 

Workgroup (OWG) Report, prepared at 

the request of the BSC/NCIPC and 

which the BSC/NCIPC unanimously 

voted to have CDC adopt, and CDC’s 

response to observations outlined in the 

OWG Report; and (4) an Overview of 

Community Engagement and Public 

Comment Opportunities, which 

describes key themes that emerged 

about stakeholders’ values and 

preferences regarding pain management, 

as well as CDC’s response to input 

obtained from these efforts. The GRADE 

tables include clinical evidence review 

ratings of the evidence for the key 

clinical questions. The OWG Report 

describes the workgroup’s findings and 

observations about the initial draft 

clinical practice guideline as presented 

to the BSC/NCIPC at a public meeting 

on July 16, 2021. The OWG, comprising 

three BSC/NCIPC members in 

accordance with federal advisory 

committee policy, as well as patients 

with pain, caregivers, and family 

members of patients with pain, and 

clinicians and subject matter experts 

with a variety of relevant pain 

management expertise, was designed to 

provide independent, broad, external, 

transparent input to the BSC/NCIPC on 

the diverse and complex issues 

addressed in the clinical practice 

guideline. OWG meetings were 

coordinated by an NCIPC subject matter 

expert who served as the Designated 

Federal Official. CDC’s response to the 

OWG Report reflects and describes how 

CDC incorporated OWG observations 

and comments in the revised draft of the 

clinical practice guideline. The 

Overview of Community Engagement 

and Public Comment Opportunities 

document provides a summary of efforts 

implemented throughout the clinical 

practice guideline update process to 

better understand the lived experiences 

and perspectives of community 

members that we serve and to ensure 

additional input from patients, 

caregivers, clinicians, and the public. 

CDC’s response to the themes and 

findings that emerged throughout the 

community engagement and public 

comment opportunities describes how 

CDC carefully considered and 

incorporated diverse perspectives and 

input from multiple sources and 

stakeholders into the clinical practice 

guideline. 

Dated: February 7, 2022. 

Angela K. Oliver, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2022–02802 Filed 2–9–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1030] 

Brenda K. Marmas: 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 

Brenda K. Marmas for a period of 5 

years from importing or offering for 

import any drug into the United States. 

FDA bases this order on a finding that 

Ms. Marmas engaged in a pattern of 

importing or offering for import 

misbranded drugs (i.e., in an amount, 

frequency, or dosage that is inconsistent 

with her personal or household use) that 

are not designated in an authorized 

electronic data interchange system as 

products regulated by FDA. Ms. Marmas 

was given notice of the proposed 

debarment and was given an 

opportunity to request a hearing to show 

why she should not be debarred. As of 

December 12, 2021 (30 days after receipt 

of the notice), Ms. Marmas had not 

responded. Ms. Marmas’ failure to 

respond and request a hearing 

constitutes a waiver of her right to a 

hearing concerning this matter. 

DATES: This order is applicable February 

10, 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)(D) of the FD&C Act 

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

debarment of an individual from 

importing or offering for import any 

drug into the United States if FDA finds, 

as required by section 306(b)(3)(D) of 

the FD&C Act, that the individual has 

engaged in a pattern of importing or 

offering for import misbranded drugs 

(i.e., in an amount, frequency, or dosage 

that is inconsistent with personal or 

household use by the importer), and the 

shipments are not designated in an 

entry in an authorized electronic data 

exchange system as products regulated 

by FDA. 

After an investigation, FDA 

discovered that Ms. Marmas has 

engaged in numerous instances of 

importing or offering for import 

misbranded drugs; all the parcels 

containing the misbranded drugs 

serving as the basis for this action, 

described in further detail below, were 

intercepted by FDA at either the John F. 

Kennedy International Airport (JFK), 

San Francisco International Airport 

(SFO), or Chicago International Airport 

Mail Facilities (MF) and were addressed 

to Ms. Marmas at an address connected 

to her. 

On or about March 3, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

JFK MF that was addressed to her. This 

parcel contained multiple products. 

FDA determined that one of the 

products contained in this parcel was 

1,000 tablets of levofloxacin IP and was 

a misbranded drug for a number of 

reasons: (1) The article was determined 

to be a prescription drug but did not 

include the symbol ‘‘Rx only’’ on its 

label; (2) the article had been 

determined to lack adequate directions 

for use; (3) the drug was not included 

in a list required by section 510(j) of the 

FD&C Act (21 U.S.C. 360(j)); and (4) the 

drug was manufactured, prepared, 

propagated, compounded, or processed 

in an establishment not duly registered 

under section 510 of the FD&C Act. FDA 

also determined that another product 

contained in this parcel was 900 tablets 

of moxifloxacin hydrochloride and was 

a misbranded drug for a number of 

reasons: (1) The article was determined 

to be a prescription drug but did not 

include the symbol ‘‘Rx only’’ on its 

label; (2) the article had been 

determined to lack adequate directions 

for use; (3) the drug was not included 

in a list required by section 510(j) of the 

FD&C Act; and (4) the drug was 

manufactured, prepared, propagated, 

compounded, or processed in an 

establishment not duly registered under 

section 510 of the FD&C Act. Both 

products were refused entry on March 

26, 2020. 


jspears on DSK121TN23PROD with NOTICES1