31902 Federal Register / Vol. 87, No. 101 / Wednesday, May 25, 2022 / Notices 

clinical trial purposes. No other activity 

for these drug codes is authorized for 

this registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Kristi N. O’Malley, 

Assistant Administrator. 

[FR Doc. 2022–11265 Filed 5–24–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1014] 

Importer of Controlled Substances 

Application: Almac Clinical Services 

Inc. (ACSI) 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Almac Clinical Services Inc. 

(ACSI) has applied to be registered as an 

importer of basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before June 24, 2022. Such 

persons may also file a written request 

for a hearing on the application on or 

before June 24, 2022. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. All 

requests for a hearing must be sent to: 

(1) Drug Enforcement Administration, 

Attn: Hearing Clerk/OALJ, 8701 

Morrissette Drive, Springfield, Virginia 

22152; and (2) Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing should 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on April 14, 2022, Almac 

Clinical Services Inc. (ACSI), 25 Fretz 

Road, Souderton, Pennsylvania 18964, 

applied to be registered as an importer 

of the following basic class(es) of 

controlled substance(s): 

Controlled 

substance 

Drug 

code Schedule 

Psilocybin ........................ 7437 I 

Oxycodone ...................... 9143 II 

Hydromorphone ............... 9150 II 

Morphine .......................... 9300 II 

Tapentadol ...................... 9780 II 

Fentanyl ........................... 9801 II 

The company plans to import the 

listed controlled substances as finished 

dosage form units for clinical trials 

purposes only. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Kristi N. O’Malley, 

Assistant Administrator. 

[FR Doc. 2022–11261 Filed 5–24–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1010] 

Bulk Manufacturer of Controlled 

Substances Application: PCI Synthesis 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: PCI Synthesis, has applied to 

be registered as a bulk manufacturer of 

basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before July 25, 2022. Such persons 

may also file a written request for a 

hearing on the application on or before 

July 25, 2022. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on April 1, 2022, PCI 

Synthesis, 9 Opportunity Way, 

Newburyport, Massachusetts 01952– 

0195, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Amphetamine .................. 1100 II 

Methamphetamine ........... 1105 II 

The company plans to develop 

manufacturing processes, conduct 

analytical method validation and 

conduct bulk product stability studies. 

No other activities for these drug codes 

are authorized for this registration. 

Kristi N. O’Malley, 

Assistant Administrator. 

[FR Doc. 2022–11256 Filed 5–24–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1012] 

Importer of Controlled Substances 

Application: Research Triangle 

Institute 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Research Triangle Institute 

has applied to be registered as an 


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