Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10103 

behaviors, tachycardia, and 

hypertension. There are no commercial 

or approved medical uses for MDMB4en-PINACA and it is not a controlled 

substance under the CSA. As such, 

additional permanent controls will be 

necessary to fulfill U.S. obligations if 

MDMB-4en-PINACA is controlled under 

Schedule II of the 1971 Convention. 

3-Methoxyphencyclidine; chemical 

name: 1-(1-(3-methoxyphenyl)

cyclohexyl)piperidine) is a novel Nmethyl-D-aspartate (NMDA) receptor 

antagonist with structural and 

biochemical similarities to 

phencyclcycidine (PCP) and other 

arylcyclohexylamines. 3- 

Methoxyphencyclidine is classified as 

an arylcyclohexylamine and produces 

dissociative anesthetic and 

hallucinogenic effects. Use of this 

substance is associated with 

intoxication and published case reports 

of both fatal and non-fatal overdose. 3- 

Methoxyphencyclidine is encountered 

by law enforcement in drug seizure 

reports. 3-Methoxyphencyclidine is an 

analogue of the Schedule II 

hallucinogen PCP. There is no approved 

medical use for 3- 

Methoxyphencyclidine in the United 

States and is not a controlled substance 

under the CSA. If intended for human 

consumption, 3-Methoxyphencyclidine 

may be treated as a ‘‘controlled 

substance analogue’’ under the CSA 

pursuant to 21 U.S.C. 802(32)(A) and 

813. As such, additional permanent 

controls will be necessary to fulfill U.S. 

obligations if 3-Methoxyphencyclidine 

is controlled under Schedule II of the 

1971 Convention. 

Diphenidine (chemical name: 1-(1,2- 

diphenylethyl) piperidine) is a noncompetitive NMDA receptor antagonist 

classified as a diarylethylamine and 

produces dissociative anesthetic and 

hallucinogenic effects. It was originally 

synthesized in the 1920s but reports of 

abuse started in the last decade. Use of 

this substance is associated with 

intoxication and published case reports 

of both fatal and non-fatal overdose 

outside of the United States. 

Diphenidine is encountered by law 

enforcement in drug seizure reports. 

Diphenidine is not approved for 

medical use in the United States and is 

not a controlled substance under the 

CSA. As such, additional permanent 

controls will be necessary to fulfill U.S. 

obligations if diphenidine is controlled 

under Schedule II of the 1971 

Convention. 

Flubromazolam, clonazolam, and 

diclazepam belong to a class of 

substances known as benzodiazepines. 

Benzodiazepines produce central 

nervous system depression and are 

commonly used to treat insomnia, 

anxiety, and seizure disorders. 

Flubromazolam is a triazole analogue of 

the designer benzodiazepine, 

flubromazepam. Flubromazolam can be 

purchased on the internet and is used as 

a recreational substance in the United 

States. Flubromazolam has been 

identified in an increasing number of 

law enforcement seizures and has been 

associated with an increasing number of 

drug overdose deaths. According to the 

NFLIS database, in 2020 there were 

1,446 clonazolam encounters (as of 

December 2020). It is abused by a broad 

range of groups including youths, young 

adults, and older adults. Clonazolam 

has been involved in an increasing 

number of drug seizure events as well 

as drug overdose deaths, alone and in 

combination with alcohol. As such, the 

NFLIS database reported 249 encounters 

in 2020 (as of December 2020). 

Diclazepam is a designer 

benzodiazepine sold on the internet and 

most often found as a liquid solution, 

but it may be sold as a powder, tablet, 

blotter paper, or pellet. In 2020, the 

NFLIS database reported 113 encounters 

of diclazepam (as of December 2020). In 

2018, flubromazolam, clonazolam, and 

dicalazepam were all identified by law 

enforcement in driving under the 

influence of drugs cases in the United 

States. Flubromazolam, clonazolam, and 

diclazepam are not approved for 

medical use in the United States and are 

not controlled substances under the 

CSA. As such, additional permanent 

controls will be necessary to fulfill U.S. 

obligations if flubromazolam, 

clonazolam, and dicalazepam are 

controlled under Schedule IV of the 

1971 Convention. 

FDA, on behalf of the Secretary of 

HHS, invites interested persons to 

submit comments on the notifications 

from the United Nations concerning 

these drug substances. FDA, in 

cooperation with the National Institute 

on Drug Abuse, will consider the 

comments on behalf of HHS in 

evaluating the WHO scheduling 

recommendations. Then, under section 

201(d)(2)(B) of the CSA, HHS will 

recommend to the Secretary of State 

what position the United States should 

take when voting on the 

recommendations for control of 

substances under the 1971 Convention 

at the CND meeting in April 2021. 

Comments regarding the WHO 

recommendations for control of 

isotonitazene under the 1961 Single 

Convention will also be forwarded to 

the relevant Agencies for consideration 

in developing the U.S. position 

regarding narcotic substances at the 

CND meeting. 

Dated: February 12, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03268 Filed 2–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

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

as amended, and the Determination of 

the Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, CDC, pursuant to 

Public Law 92–463. The grant 

applications and the discussions could 

disclose confidential trade secrets or 

commercial property such as patentable 

material, and personal information 

concerning individuals associated with 

the grant applications, the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

SIP21–008, Examining Approaches to 

Improve Care and Management of 

People with Lupus. 

Date: May 13, 2021. 

Time: 11:00 a.m.–6:00 p.m., EDT. 

Place: Teleconference. 

Agenda: To review and evaluate grant 

applications. 

FOR FURTHER INFORMATION CONTACT: Jaya 

Raman, Ph.D., Scientific Review Officer, 

National Center for Chronic Disease 

Prevention and Health Promotion, CDC, 

4770 Buford Highway, Mailstop S107–8, 

Atlanta, Georgia 30341, Telephone (770) 

488–6511, JRaman@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 


jbell on DSKJLSW7X2PROD with NOTICES
10104 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–03234 Filed 2–17–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0275] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Certification To 

Accompany Drug, Biological Product, 

and Device Applications or 

Submissions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 March 22, 

2021. 

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 0910–0616. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Certification To Accompany Drug, 

Biological Product, and Device 

Applications or Submissions (Form 

FDA 3674) 

OMB Control Number 0910–0616— 

Extension 

The information required under 

section 402(j)(5)(B) of the Public Health 

Service Act (PHS Act) (42 U.S.C. 

282(j)(5)(B)) is submitted in the form of 

a certification, Form FDA 3674, which 

accompanies applications and 

submissions currently submitted to FDA 

and already approved by OMB. The 

OMB control numbers and expiration 

dates for those applications and 

submissions are: 21 CFR parts 312 and 

314 (human drugs), OMB control 

number 0910–0014, expiring March 31, 

2022, and OMB control number 0910– 

0001, expiring March 31, 2021; 21 CFR 

parts 312 and 601 (biological products), 

OMB control number 0910–0014, 

expiring March 31, 2022, and OMB 

control number 0910–0338, expiring 

February 28, 2023; 21 CFR parts 807 and 

814 (devices), OMB control number 

0910–0120, expiring June 30, 2020, and 

OMB control number 0910–0231, 

expiring March 31, 2023. 

Title VIII of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Pub. L. 110–85) 

amended the PHS Act by adding section 

402(j). The provisions broadened the 

scope of clinical trials subject to 

submitting information and required 

additional information to be submitted 

to the clinical trials databank (https://

clinicaltrials.gov/) (FDA has verified the 

website address, but FDA is not 

responsible for any subsequent changes 

to the website after this document 

publishes in the Federal Register) 

previously established by the National 

Institutes of Health (NIH)/National 

Library of Medicine. This includes 

expanded information on applicable 

clinical trials and summary information 

on the results of certain clinical trials. 

The provisions include responsibilities 

for FDA as well as several amendments 

to the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

One provision, section 402(j)(5)(B) of 

the PHS Act, requires that a certification 

accompany human drug, biological, and 

device product submissions made to 

FDA. Specifically, at the time of 

submission of an application under 

sections 505, 515, or 520(m) of the 

FD&C Act (21 U.S.C. 355, 360e, or 

360j(m)), or under section 351 of the 

PHS Act (42 U.S.C. 262), or submission 

of a report under section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)), such 

application or submission must be 

accompanied by a certification, Form 

FDA 3674, that all applicable 

requirements of section 402(j) of the 

PHS Act have been met. Where 

available, such certification must 

include the appropriate National 

Clinical Trial (NCT) numbers that are 

assigned upon submission of required 

information to the NIH databank at 

https://clinicaltrials.gov/. 

The proposed extension of the 

collection of information is necessary to 

satisfy the previously mentioned 

statutory requirement. The importance 

of obtaining these data relates to 

adherence to the legal requirements for 

submissions to the clinical trials registry 

and results data bank and ensuring that 

individuals and organizations 

submitting applications or reports to 

FDA under the listed provisions of the 

FD&C Act or the PHS Act adhere to the 

appropriate legal and regulatory 

requirements for certifying to having 

complied with those requirements. The 

failure to submit the certification 

required by section 402(j)(5)(B) of the 

PHS Act, and the knowing submission 

of a false certification, are both 

prohibited acts under section 301 of the 

FD&C Act (21 U.S.C. 331). Violations are 

subject to civil money penalties. Form 

FDA 3674 provides a convenient 

mechanism for sponsors/applicants/ 

submitters to satisfy the certification 

requirements of the statutory provision. 

To assist sponsors/applicants/ 

submitters in understanding the 

statutory requirements associated with 

Form FDA 3674, we have provided a 

guidance available at: https://

www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125335.htm. This 

guidance recommends the applications 

and submissions FDA considers should 

be accompanied by the certification 

form, Form FDA 3674. The applications 

and submissions identified in the 

guidance are reflected in the burden 

analysis. FDA last updated this 

guidance in 2017. 

Investigational New Drug 

Applications. FDA’s Center for Drug 

Evaluation and Research (CDER) 

received 1,661 investigational new drug 

applications (INDs) and 11,328 clinical 

protocol IND amendments in calendar 

year (CY) 2019. CDER anticipates that 

IND and clinical protocol amendment 

submission rates will remain at or near 

this level in the near future. 

FDA’s Center for Biologics Evaluation 

and Research (CBER) received 639 new 

INDs and 581 clinical protocol IND 

amendments in CY 2019. CBER 

anticipates that IND and clinical 

protocol amendment submission rates 

will remain at or near this level in the 

near future. The estimated total number 

of submissions (new INDs and new 


jbell on DSKJLSW7X2PROD with NOTICES