226 Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices 

false and misleading labeling and 

generally misrepresented the nature of 

the products sold on his website. Mr. 

Kulakevich reshipped the misbranded 

etizolam to customers located in the 

United States. 

As a result of this conviction, FDA 

sent Mr. Kulakevich, by certified mail, 

on August 3, 2021, 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. Kulakevich’s felony conviction 

under Federal law for conspiracy to 

commit offenses against the United 

States, in violation of 18 U.S.C. 2 and 

371, was for conduct relating to the 

importation into the United States of 

any drug or controlled substance 

because he illegally imported, relabeled, 

and then introduced unapproved 

etizolam 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. Kulakevich’s offense and 

concluded that the offense warranted 

the imposition of a 5-year period of 

debarment. 

The proposal informed Mr. 

Kulakevich 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. Mr. Kulakevich 

received the proposal and notice of 

opportunity for a hearing on August 17, 

2021. Mr. Kulakevich 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. William 

Kulakevich 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. Kulakevich is debarred for a period 

of 5 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. Kulakevich is a prohibited act. 

Any application by Mr. Kulakevich 

for termination of debarment under 

section 306(d)(1) of the FD&C Act 

should be identified with Docket No. 

FDA–2021–N–0506 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 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: December 28, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–28479 Filed 1–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1353] 

Joint Meeting of the Anesthetic and 

Analgesic Drug Products Advisory 

Committee and the Drug Safety and 

Risk Management Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Anesthetic and Analgesic 

Drug Products Advisory Committee and 

the Drug Safety and Risk Management 

Advisory Committee. The general 

function of the committees is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

February 15, 2022, from 9:30 a.m. to 5 

p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–1353. 

The docket will close on February 14, 

2022. Submit either electronic or 

written comments on this public 

meeting by February 14, 2022. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before February 14, 2022. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 14, 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. 

Comments received on or before 

February 1, 2022, will be provided to 

the committees. Comments received 

after that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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 


tkelley on DSK125TN23PROD with NOTICE 
Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices 227 

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–1353 for ‘‘Joint Meeting of the 

Anesthetic and Analgesic Drug Products 

Advisory Committee and the Drug 

Safety and Risk Management Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

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.’’ FDA 

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 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 the 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: 

Moon Hee V. Choi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–2894, Fax: 301–847–8533, email: 

AADPAC@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committees will be asked to discuss new 

drug application (NDA) 213231, for 

tramadol hydrochloride injection, 

submitted by Avenue Therapeutics, Inc., 

for the management of moderate to 

moderately severe pain in adults in a 

medically supervised healthcare setting. 

The issues for the committees to discuss 

include the clinical relevance of 

tramadol hydrochloride injection, an 

opioid intended for management of 

acute pain in a medically supervised 

healthcare setting, when its onset of 

action is delayed, and its proposed 

dosing is a fixed-dosing regimen. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. All electronic 

and written submissions submitted to 

the Docket (see ADDRESSES) on or before 

February 1, 2022, will be provided to 

the committees. Oral presentations from 

the public will be scheduled between 

approximately 2 p.m. and 3 p.m. Eastern 

Time. Those individuals interested in 

making formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 24, 2022. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

January 25, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Moon Hee V. 

Choi (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 


tkelley on DSK125TN23PROD with NOTICE 
228 Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices 

Dated: December 28, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–28474 Filed 1–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–3077] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Obtaining 

Information To Understand Challenges 

and Opportunities Encountered by 

Compounding Outsourcing Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 3, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0883. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Obtaining Information To Understand 

Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities 

OMB Control Number 0910–0883— 

Extension 

This information collection supports 

FDA research in obtaining a range of 

information pertaining to human 

prescription drug compounding by 

outsourcing facilities. Generally, drug 

compounding is the practice of 

combining, mixing, or altering 

ingredients of a drug to create a 

medication tailored to an individual 

patient’s needs. Although compounded 

drugs can serve an important medical 

need for certain patients when an 

approved drug is not medically 

appropriate, compounded drugs also 

present a risk to patients. Compounded 

drugs are not FDA-approved; therefore, 

they do not undergo FDA premarket 

review for safety, effectiveness, and 

quality. 

Section 503A of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 353a) describes the conditions 

that must be satisfied for compounded 

human prescription drug products to be 

exempt from certain sections of the 

FD&C Act: (1) Section 501(a)(2)(B) (21 

U.S.C. 351(a)(2)(B)) (current good 

manufacturing practice (CGMP) 

requirements), (2) section 502(f)(1) (21 

U.S.C. 352(f)(1)) (labeling of drugs with 

adequate directions for use), and (3) 

section 505 (21 U.S.C. 355) (approval of 

drugs under new drug applications or 

abbreviated new drug applications). 

The Drug Quality and Security Act of 

2013 (Pub. L. 113–54) created 

‘‘outsourcing facilities’’—a new industry 

sector of drug compounders held to 

higher quality standards to protect 

patient health. Section 503B of the 

FD&C Act (21 U.S.C. 353b) describes the 

conditions that outsourcing facilities 

must satisfy for drug products 

compounded in an outsourcing facility 

by or under the direct supervision of a 

licensed pharmacist to be exempt from 

certain sections of the FD&C Act. 

Outsourcing facilities are intended to 

offer a more reliable supply of 

compounded drugs that hospitals, 

clinics, and other providers need. 

FDA continues to find concerning 

quality and safety problems during 

inspections of outsourcing facilities. 

FDA has implemented and will 

continue to implement programs to 

support compounding quality and 

compliance. One initiative is FDA’s 

Compounding Quality Center of 

Excellence (Center of Excellence), 

https://www.fda.gov/drugs/humandrug-compounding/compoundingquality-center-excellence, which was 

developed to focus on improving the 

quality of compounded human 

prescription drugs to promote patient 

safety. One of our top priorities is to 

help ensure that compounded drugs are 

safe by focusing on quality. FDA, State 

regulators, pharmacy associations, and 

compounders, including outsourcing 

facilities, share the responsibility for 

patient safety. 

The Center of Excellence engages and 

collaborates with compounders, 

including outsourcing facilities, and 

other stakeholders to improve the 

overall quality of compounded drugs. 

Furthermore, the Center of Excellence 

promotes collaboration to help 

compounders implement robust quality 

management systems that are better for 

business and the safety of patients. 

To help strengthen the outsourcing 

facility industry’s ability to provide 

quality compounded drugs to patients 

who need them, the Center of 

Excellence offers training sessions and 

opportunities to develop manufacturing 

quality and other policies for 

outsourcing facilities, including CGMPs. 

The Center of Excellence offers 

several training sessions (available at 

https://www.fda.gov/drugs/humandrug-compounding/compoundingquality-center-excellence-trainingprograms). Self-guided training sessions 

teach the following topics: (1) 

Environmental monitoring, (2) sterile 

drug compounding, (3) cleanroom 

performance tests, and (4) conducting 

investigations and formulating 

corrective and preventive actions. 

Instructor-led sessions teach the 

regulatory framework for these topics: 

(1) Human drug compounding, (2) 

airflow practices, (3) insanitary 

conditions and sterility, (4) stability and 

beyond use dates, (5) requirements for 

outsourcing facility guides, and (6) 

conducting investigations and 

formulating corrective and preventive 

actions. Management and staff from 

outsourcing facilities have attended the 

training sessions. Feedback on the 

training sessions has been positive, and 

interest in the sessions continues to 

grow. 

In addition, the Center of Excellence 

is conducting in-depth research to better 

understand outsourcing facilities’ 

challenges and opportunities in 

different areas to help guide decisions 

regarding future training and other 

engagement. Outsourcing facilities 

encounter the following challenges and 

opportunities: (1) Operational barriers 

and opportunities related to the 

outsourcing facility market and business 

viability, (2) knowledge and operational 

barriers and opportunities related to 


tkelley on DSK125TN23PROD with NOTICE