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
Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 7841 

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 

300 tablets of azithromycin IP and was 

a misbranded drug because the article 

was determined to be a prescription 

drug but did not include the symbol ‘‘Rx 

only’’ on its label. FDA also determined 

that one of the products contained in 

this parcel was 600 tablets of 

azithromycin IP and was a misbranded 

drug because the article was determined 

to be a prescription drug but did not 

include the symbol ‘‘Rx only’’ on its 

label. Both products were refused entry 

on March 25, 2020. 

On or about July 8, 2020, Ms. Marmas 

offered for import a parcel intercepted 

and processed by FDA at SFO MF that 

was addressed to her. FDA determined 

that the product contained in this parcel 

was 2,304 capsules of azithromycin 250 

milligrams (mg) and was a misbranded 

drug because the article was determined 

to be a prescription drug but did not 

include the symbol ‘‘Rx only’’ on its 

label and the drug was not included in 

a list required by section 510(j) of the 

FD&C Act. The product was refused 

entry on August 5, 2020. 

On or about July 17, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

SFO MF that was addressed to her. This 

parcel contained multiple products. 

FDA determined that one of the 

products contained in this parcel was 

300 tablets of amoxicillin 875 mg and 

was a misbranded drug for multiple 

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; and (3) the drug was not 

included in a list required by section 

510(j) of the FD&C Act. FDA also 

determined that one of the products 

contained in this parcel was 1,400 

capsules of clindamycin 300 mg and 

was a misbranded drug because the 

article had been determined to lack 

adequate directions for use and the drug 

was not included in a list required by 

section 510(j) of the FD&C Act. Both 

products were refused entry on 

September 23, 2020. 

On or about July 17, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

SFO MF that was addressed to her. This 

parcel contained multiple products. 

FDA determined that one of the 

products contained in this parcel was 84 

tablets of azithromycin 250 mg and was 

a misbranded drug for multiple 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; and (3) the 

drug was not included in a list required 

by section 510(j) of the FD&C Act. FDA 

also determined that one of the products 

contained in this parcel was 1,800 

capsules of clindamycin 150 mg and 

was a misbranded drug because the 

article had been determined to lack 

adequate directions for use and because 

the drug was not included in a list 

required by section 510(j) of the FD&C 

Act. FDA also determined that one of 

the products contained in this parcel 

was 500 tablets of roxithromycin 150 mg 

and was a misbranded drug because the 

article had been determined to lack 

adequate directions for use and because 

the drug was not included in a list 

required by section 510(j) of the FD&C 

Act. All three products were refused 

entry on September 23, 2020. 

On or about July 21, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

SFO MF that was addressed to her. FDA 

determined that the product contained 

in this parcel was 2,520 capsules of 

fluconazole 200 mg and was a 

misbranded drug because the drug was 

manufactured, prepared, propagated, 

compounded, or processed in an 

establishment not duly registered under 

section 510 of the FD&C Act and 

because the drug was not included in a 

list required by section 510(j) of the 

FD&C Act. The product was refused 

entry on August 17, 2020. 

On or about July 30, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

SFO MF that was addressed to her. FDA 

determined that the product contained 

in this parcel was 2,000 capsules of 

doxycycline hyclate 100 mg and was a 

misbranded drug because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only.’’ 

The product was refused entry on 

October 5, 2020. 

On or about July 30, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

SFO MF that was addressed to her. This 

parcel contained multiple products. 

FDA determined that one of the 

products contained in this parcel was 

500 capsules of amoxicillin trihydrate 

500 mg and was a misbranded drug for 

multiple 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; and (3) the drug was not 

included in a list required by section 

510(j) of the FD&C Act. FDA determined 

that one of the other products contained 

in this parcel was 2,000 capsules of 

clindamycin 300 mg and was a 

misbranded drug because the article had 

been determined to lack adequate 

directions for use and because the drug 

was not included in a list required by 

section 510(j) of the FD&C Act. FDA 

determined that one of the other 

products contained in this parcel was 

300 tablets of amoxicillin/clavulanic 

acid 875 mg/125 mg and was a 

misbranded drug for multiple 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; and (3) the 

drug was not included in a list required 

by section 510(j) of the FD&C Act. All 

three products were refused entry on 

October 9, 2020. 

On or about July 31, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

SFO MF that was addressed to her. This 

parcel contained multiple products. 

FDA determined that one of the 

products contained in this parcel was 

576 capsules of azithromycin 250 mg 

and was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label and 

the article had been determined to lack 

adequate directions for use. FDA 

determined that the other product 

contained in this parcel was 1,600 

tablets of clarithromycin 500 mg and 

was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. Both 

products were refused entry on 

September 4, 2020. 

On or about August 13, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

SFO MF that was addressed to her. FDA 

determined that the product contained 

in this parcel was 2,860 capsules of 

doxycycline hyclate 100 mg and was a 

misbranded drug because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only.’’ 

The product was refused entry on 

October 6, 2020. 

On or about September 30, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

Chicago International Airport MF that 

was addressed to her. FDA determined 

that the product contained in this parcel 

was 1,000 tablets of amoxycillin and 

potassium clavulanate IP and was a 

misbranded drug because the drug was 

manufactured, prepared, propagated, 


jspears on DSK121TN23PROD with NOTICES1
7842 Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 

compounded, or processed in an 

establishment not duly registered under 

section 510 of the FD&C Act and 

because the drug was not included in a 

list required by section 510(j) of the 

FD&C Act. The product was refused 

entry on October 26, 2020. 

On or about October 2, 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 

230 tablets of LQUIN levofloxacin and 

was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label and 

the article had been determined to lack 

adequate directions for use. FDA 

determined that the other product 

contained in this parcel was 129 tablets 

of AZICIP azithromycin and was a 

misbranded drug because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label and the article had been 

determined to lack adequate directions 

for use. Both products were refused 

entry on October 28, 2020. 

On or about October 16, 2020, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

Chicago International Airport MF that 

was addressed to her. This parcel 

contained multiple products. FDA 

determined that one of the products 

contained in this parcel was 1,500 

capsules of amoxicillin and was a 

misbranded drug for multiple reasons: 

(1) The required label or labeling was 

determined to not be in English in 

violation of § 201.15(c)(1) (21 CFR 

201.15(c)(1)); (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; (4) the drug was 

manufactured, prepared, propagated, 

compounded, or processed in an 

establishment not duly registered under 

section 510 of the FD&C Act; and (5) the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. FDA 

determined that the other product 

contained in this parcel was 1,600 

tablets of FLOXCIPRO 250 ciprofloxacin 

and was a misbranded drug for multiple 

reasons: (1) The required label or 

labeling was determined to not be in 

English in violation of § 201.15(c)(1); (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; (4) the 

drug was manufactured, prepared, 

propagated, compounded, or processed 

in an establishment not duly registered 

under section 510 of the FD&C Act; and 

(5) the article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. Both 

products were refused entry on 

December 3, 2020. 

On or about November 16, 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 

300 tablets of AZICIP azithromycin and 

was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. FDA 

determined that the other product 

contained in this parcel was 1,000 

tablets of CIPRODAC ciprofloxacin and 

was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. Both 

products were refused entry on 

December 10, 2020. 

On or about December 15, 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 capsules of cephalexin IP 500 mg 

(CEPHADEX 500) and was a misbranded 

drug as the article was determined to be 

a prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. FDA 

determined that one of the products 

contained in this parcel was 30 capsules 

of vancomycin hydrochloride IP 250 mg 

(VANLID 250) and was a misbranded 

drug as the article was determined to be 

a prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. FDA 

determined that one of the other 

products contained in this parcel was 

250 tablets of trimethoprim and 

sulphamethoxazole IP (BACTRIM DS) 

and was a misbranded drug as the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. All 

three products were refused entry on 

January 19, 2021. 

On or about April 23, 2021, 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 capsules of RESTECLIN 500 

(tetracycline) and was a misbranded 

drug as the article was determined to be 

a prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. FDA 

determined that one of the products 

contained in this parcel was 400 tablets 

of RIFAGUR 400 (rifaximin) and was a 

misbranded drug as the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label. Both products were refused 

entry on May 18, 2021. 

On or about May 26, 2021, 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 

500 tablets of amoxycillin and 

potassium clavulanate IP and was a 

misbranded drug because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label. The product was refused 

entry on June 25, 2021. FDA determined 

that the other product contained in this 

parcel was 300 tablets of azithromycin 

IP 500 mg and was a misbranded drug 

because the article was determined to be 

a prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. This 

product was refused entry on June 24, 

2021. 

On or about July 15, 2021, Ms. 

Marmas offered for import a parcel 

intercepted and processed by FDA at 

Chicago International Airport MF that 

was addressed to her. FDA determined 

that the product contained in this parcel 

was 500 tablets of amoxycillin and 

potassium clavulanate IP; CIPMOX CV– 

625 and was a misbranded drug because 

the article had been determined to lack 

adequate directions for use and because 

the drug was not included in a list 

required by section 510(j) of the FD&C 

Act. The product was refused entry on 

August 13, 2021. 

As a result of this 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, in accordance with 

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

FDA sent Ms. Marmas, by certified mail 

on November 3, 2021, a notice 

proposing to debar her for a 5-year 

period from importing or offering for 

import any drug into the United States. 

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 Ms. 

Marmas’ pattern of conduct and 

concluded that her conduct warranted 

the imposition of a 5-year period of 

debarment. 

The proposal informed Ms. Marmas of 

the proposed debarment and offered her 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 / Notices 7843 

an opportunity to request a hearing, 

providing 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Ms. 

Marmas received the proposal and 

notice of opportunity for a hearing on 

November 12, 2021. Ms. Marmas failed 

to request a hearing within the 

timeframe prescribed by regulation and 

has, therefore, waived her opportunity 

for a hearing and waived any 

contentions concerning her 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)(D) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. Brenda K. 

Marmas 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 her personal or household use) that 

are not designated in an authorized 

electronic data interchange system as 

products regulated by FDA. FDA finds 

that this pattern of conduct 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, 

Ms. Marmas is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

applicable (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 Ms. Marmas is a 

prohibited act. 

Any application by Ms. Marmas for 

termination of debarment under section 

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

identified with Docket No. FDA–2021– 

N–1030 and sent to the Dockets 

Management Staff (see ADDRESSES). 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 http://www.regulations.gov 

or at the Dockets Management Staff (see 

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

Monday through Friday. 

Dated: February 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02801 Filed 2–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0556] 

Development of Non-Opioid 

Analgesics for Acute Pain; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Development of Non-Opioid 

Analgesics for Acute Pain.’’ In 

connection with the SUPPORT for 

Patients and Communities Act 

(SUPPORT Act), the purpose of this 

guidance is to spur the development of 

alternatives to opioids for the 

management of acute pain by providing 

information about product 

development-related issues, ‘‘opioidsparing’’ claims, and expedited 

programs as they pertain to this 

purpose. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 11, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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– 

2021–N–0556 for ‘‘Development of NonOpioid Analgesics for Acute Pain.’’ 

Received comments 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 


jspears on DSK121TN23PROD with NOTICES1