63124 Federal Register / Vol. 88, No. 177 / Thursday, September 14, 2023 / Notices 

1A record of the Commissioners’ votes, the 

Commission’s statement on adequacy, and any 

individual Commissioner’s statements will be 

available from the Office of the Secretary and at the 

Commission’s website. 

2The Commission has found the responses 

submitted on behalf of Ameriforge, Core Pipe 

Products, Inc., and Kerkau Manufacturing to be 

individually adequate. Comments from other 

interested parties will not be accepted (see 19 CFR 

207.62(d)(2)). 

1Prior Agency decisions have addressed whether 

it is appropriate to consider a provision of 21 U.S.C. 

824(a) when determining whether to grant a 

practitioner registration application. For over fortyfive years, Agency decisions have concluded that it 

is. Robert Wayne Locklear, M.D., 86 FR 33738, 

33744–45 (2021) (collecting cases); see also Dinorah 

Drug Store, Inc., 61 FR 15972, 15973–74 (1996). 2Effective December 2, 2022, the Medical 

Marijuana and Cannabidiol Research Expansion 

Act, Public Law 117–215, 136 Stat. 2257 (2022) 

(Marijuana Research Amendments or MRA), 

amended the Controlled Substances Act (CSA) and 

other statutes. Relevant to this matter, the MRA 

redesignated 21 U.S.C. 823(f), cited in the OSC, as 

21 U.S.C. 823(g)(1). Accordingly, this Decision cites 

to the current designation, 21 U.S.C. 823(g)(1), and 

to the MRA-amended CSA throughout. 

3Based on the Declaration from a DEA Diversion 

Investigator, the Agency finds that the 

Nicholas A. Shufro, 

Deputy Assistant Administrator for Risk 

Management, Federal Emergency 

Management Agency, Department of 

Homeland Security. 

[FR Doc. 2023–19891 Filed 9–13–23; 8:45 am] 

BILLING CODE 9110–12–P 

INTERNATIONAL TRADE 

COMMISSION 

[Investigation Nos. 701–TA–585–586 and 

731–TA–1383–1384 (Review)] 

Stainless Steel Flanges From China 

and India; Scheduling of Expedited 

Five-Year Reviews 

AGENCY: United States International 

Trade Commission. 

ACTION: Notice. 

SUMMARY: The Commission hereby gives 

notice of the scheduling of expedited 

reviews pursuant to the Tariff Act of 

1930 (‘‘the Act’’) to determine whether 

revocation of the antidumping and 

countervailing duty orders on stainless 

steel flanges from China and India 

would be likely to lead to continuation 

or recurrence of material injury within 

a reasonably foreseeable time. 

DATES: August 4, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Nitin Joshi (202) 708–1669, Office of 

Investigations, U.S. International Trade 

Commission, 500 E Street SW, 

Washington, DC 20436. Hearingimpaired persons can obtain 

information on this matter by contacting 

the Commission’s TDD terminal on 

(202) 205–1810. Persons with mobility 

impairments who will need special 

assistance in gaining access to the 

Commission should contact the Office 

of the Secretary at (202) 205–2000. 

General information concerning the 

Commission may also be obtained by 

accessing its internet server (https://

www.usitc.gov). The public record for 

this proceeding may be viewed on the 

Commission’s electronic docket (EDIS) 

at https://edis.usitc.gov. 

SUPPLEMENTARY INFORMATION: 

Background.—On August 4, 2023, the 

Commission determined that the 

domestic interested party group 

response to its notice of institution (88 

FR 26592, May 1, 2023) of the subject 

five-year reviews was adequate and that 

the respondent interested party group 

response was inadequate. The 

Commission did not find any other 

circumstances that would warrant 

conducting full reviews.1 Accordingly, 

the Commission determined that it 

would conduct expedited reviews 

pursuant to section 751(c)(3) of the Act 

(19 U.S.C. 1675(c)(3)). 

For further information concerning 

the conduct of these reviews and rules 

of general application, consult the 

Commission’s Rules of Practice and 

Procedure, part 201, subparts A and B 

(19 CFR part 201), and part 207, 

subparts A, D, E, and F (19 CFR part 

207). 

Staff report.—A staff report 

containing information concerning the 

subject matter of the reviews has been 

placed in the nonpublic record, and will 

be made available to persons on the 

Administrative Protective Order service 

list for these reviews on September 19, 

2023. A public version will be issued 

thereafter, pursuant to § 207.62(d)(4) of 

the Commission’s rules. 

Written submissions.—As provided in 

§ 207.62(d) of the Commission’s rules, 

interested parties that are parties to the 

reviews and that have provided 

individually adequate responses to the 

notice of institution,2 and any party 

other than an interested party to the 

reviews may file written comments with 

the Secretary on what determination the 

Commission should reach in the 

reviews. Comments are due on or before 

September 27, 2023, and may not 

contain new factual information. Any 

person that is neither a party to the fiveyear reviews nor an interested party 

may submit a brief written statement 

(which shall not contain any new 

factual information) pertinent to the 

reviews by September 27, 2023. If 

comments contain business proprietary 

information (BPI), they must conform 

with the requirements of §§ 201.6, 

207.3, and 207.7 of the Commission’s 

rules. The Commission’s Handbook on 

Filing Procedures, available on the 

Commission’s website at https://

www.usitc.gov/documents/handbook_

on_filing_procedures.pdf, elaborates 

upon the Commission’s procedures with 

respect to filings. 

In accordance with §§ 201.16(c) and 

207.3 of the rules, each document filed 

by a party to the reviews must be served 

on all other parties to the reviews (as 

identified by either the public or BPI 

service list), and a certificate of service 

must be timely filed. The Secretary will 

not accept a document for filing without 

a certificate of service. 

Determination.—The Commission has 

determined these reviews are 

extraordinarily complicated and 

therefore has determined to exercise its 

authority to extend the review period by 

up to 90 days pursuant to 19 U.S.C. 

1675(c)(5)(B). 

Authority: These reviews are being 

conducted under authority of title VII of 

the Act; this notice is published 

pursuant to § 207.62 of the 

Commission’s rules. 

By order of the Commission. 

Issued: September 11, 2023. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2023–19873 Filed 9–13–23; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Green Wave Analytical Decision and 

Order 

On August 10, 2022, the Drug 

Enforcement Administration 

(hereinafter, DEA or Government) 

issued an Order to Show Cause 

(hereinafter, OSC) to Green Wave 

Analytical (hereinafter, Applicant) of 

San Diego, California. Request for Final 

Agency Action (hereinafter, RFAA), 

Exhibit (hereinafter, RFAAX) 10, at 1, 6. 

The OSC proposed the denial of 

Applicant’s application for a DEA 

Certificate of Registration (hereinafter, 

registration), Control No. W21055614H, 

alleging that Applicant has ‘‘committed 

such acts as would render [its] 

registration inconsistent with the public 

interest.’’ Id. at 1, 2 (citing 21 U.S.C. 

824(a)(4),1 823(g)(1) 2). 

The Agency makes the following 

findings of fact based on the 

uncontroverted evidence submitted by 

the Government in its RFAA dated 

March 3, 2023.3


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Federal Register / Vol. 88, No. 177 / Thursday, September 14, 2023 / Notices 63125 

Government’s service of the OSC on Applicant was 

adequate. RFAAX 1, at 7. Further, based on the 

Government’s assertions in its RFAA, the Agency 

finds that more than thirty days have passed since 

Applicant was served with the OSC and Applicant 

has neither requested a hearing nor submitted a 

corrective action plan, and therefore, has waived 

any such rights. RFAA, at 6; see also 21 CFR 

1301.43 and 21 U.S.C. 824(c)(2). 

4Regarding the quantities of controlled 

substances possessed by Applicant, J.P. stated ‘‘I 

guess there are about 250 to 400 × 2 mL small vials 

with septum caps. Most are variable amounts left 

as they were analyzed in most cases. I guess that 

is about 400 to 500 total mLs of Phenobarbital 

Sodium Injection Solution.’’ RFAAX 1, at 3–4; 

RFAAX 5, at 1. 

5The DI noted that ‘‘in addition to quantities of 

phenobarbital injections and opium suppositories, 

[Applicant] also had quantities of morphine sulfate 

and tetrahydrocannabinol (THC) residue.’’ Id. 

6As listed by the DI, ‘‘the controlled substances 

(as identified by label) that [Applicant] unlawfully 

possessed included suppositories of opium . . . 

approximately 500 milligrams (mg) of morphine 

sulfate . . . 200 mg of phenobarbital . . . 1,714 

vials of phenobarbital of various concentrations; 

and one vial containing THC residue.’’ RFAAX 1, 

at 5; see also RFAAX 6. 

7The record purported to show that on March 3, 

2020, Applicant ‘‘ordered two packages of 180 mg 

powdered opium from VEV, and the supplier 

portions and [Applicant’s] portions after delivery 

were not completed.’’ RFAAX 1, at 5; RFAAX 7. 

8The DI also noted that some of the ‘‘Order 

Information/Chain of Custody’’ forms stated the 

name ‘‘Expert Chemical Analysis, Inc.’’ as the 

purchaser. Id. Based on a review of DEA registration 

records and business entity records available online 

through the California Secretary of State, the DI 

found that ‘‘Expert Chemical Analysis, Inc.’’ was a 

non-registrant company controlled by J.P. at the 

same address as Applicant. RFAAX 1, at 6. 

9As to Factor A, the record contains no evidence 

of a recommendation from any state licensing board 

or professional disciplinary authority. 21 U.S.C. 

Continued 

I. Findings of Fact 

According to the DEA Diversion 

Investigator assigned to investigate 

Applicant (hereinafter, the DI), on May 

18, 2021, Applicant applied, through its 

owner (hereinafter, J.P.), for a DEA 

registration as an analytical lab. RFAAX 

1, at 2; see also RFAAX 3. Applicant’s 

previous DEA registration, Control No. 

RG0546359, expired on September 30, 

2020, and since then, Applicant has not 

held an active DEA registration. RFAAX 

1, at 3; see also RFAAX 4. As part of her 

investigation of the application, the DI 

exchanged emails with J.P. regarding 

Applicant’s possession of controlled 

substances. RFAAX 1, at 3; see also 

RFAAX 5. The DI asked J.P. if Applicant 

continued to possess controlled 

substances at its facility, and J.P. stated 

that Applicant had old samples of 

phenobarbital injection (Schedule IV) 

and ‘‘a very small amount’’ of opium 

suppositories (Schedule II) stored. 

RFAAX 1, at 3; RFAAX 5, at 4–5. 

Further, J.P. added that Applicant was 

uncertain of the proper disposal 

procedure for such substances. RFAAX 

1, at 3; RFAAX 5, at 4. 

The DI attempted to schedule with 

J.P. an onsite preregistration inspection 

of Applicant and time to assist J.P. with 

disposal of the controlled substances 

that Applicant continued to unlawfully 

possess.4 RFAAX 1, at 3; RFAAX 5, at 

1–3. On August 3, 2021, the DI, along 

with another Diversion Investigator, 

traveled to Applicant’s registered 

address ‘‘for the purpose of [Applicant] 

voluntarily surrendering its controlled 

substances and with the understanding 

that the preregistration inspection 

would occur at a later date.’’ RFAAX 1, 

at 4. According to the DI, J.P. showed 

her the area of the facility where 

controlled substances were kept locked 

in a cabinet, and the DI found that 

Applicant possessed greater quantities 

and more types of controlled substances 

than J.P. had previously claimed. Id. 

Further, only some portions of the 

substances possessed by Applicant were 

labeled as controlled substances, with 

other portions unlabeled and 

unidentified.5 Id. Applicant surrendered 

all of the substances, which the DI took 

possession of, inventoried, and 

delivered to the DEA Southwest 

Laboratory. Id.; see also RFAAX 6.6

While still at Applicant’s location, the 

DI also asked J.P. for the accompanying 

receiving records, logs, and/or inventory 

documentation, to which J.P. indicated 

that ‘‘he did not have any such records, 

except for a partially completed DEA 

Form 222 in which [Applicant] acquired 

powdered opium suppositories from 

Vitae Enim Vitae Scientific, Inc. (VEV).’’ 

RFAAX 5, at 1; see also RFAAX 7.7

Thereafter, the DI requested 

administrative subpoenas for VEV’s 

records ‘‘[t]o determine whether 

[Applicant] received any controlled 

substance[s] as a DEA registrant, for 

which it lacked records of receipt, and 

whether [Applicant] received any 

controlled substances after its DEA 

registration expired, for which it lacked 

legal authorization.’’ RFAAX 1, at 5–6. 

On August 9, 2021, DEA issued an 

administrative subpoena to VEV, 

pursuant to which VEV produced 

records of controlled substance 

distributions to Applicant and ‘‘Order 

Information/Chain of Custody’’ forms. 

Id. at 6; see also RFAAX 8. As noted by 

the DI, the records show that ‘‘between 

on or about October 21, 2020, and July 

15, 2021, on approximately 14 

occasions—while [Applicant] was not 

registered—[Applicant] received 

approximately 7.958 [g] of powder 

phenobarbital sodium, and at least 21 

[ml] of phenobarbital sodium at a 

concentration of 130 [mg/ml].’’ Id.8

On July 6, 2022, DEA issued another 

administrative subpoena to VEV, 

pursuant to which VEV produced 

records of controlled substance 

distributions from VEV to Applicant 

between December 3, 2018, and 

September 30, 2020, ‘‘Order 

Information/Chain of Custody’’ forms, 

and DEA Forms 222. Id.; see also 

RFAAX 9. As noted by the DI, the 

records show that ‘‘between on or about 

May 7, 2019, and September 29, 2020, 

on approximately 31 occasions—while 

[Applicant] was registered—[Applicant] 

received approximately 645 vials of 65 

mg/ml phenobarbital sodium, 775 vials 

of 130 mg/ml phenobarbital sodium, 

30.7 g of powder phenobarbital sodium, 

3.9 g of powder opium, and 0.5 g of 

powder morphine sulfate, yet 

[Applicant] did not maintain any 

records of receipt.’’ Id. 

II. Discussion 

Pursuant to Section 303(g)(1) of the 

CSA ‘‘[t]he Attorney General shall 

register practitioners . . . to dispense 

. . . controlled substances . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which he practices.’’ 21 

U.S.C. 823(g)(1). Section 303(g)(1) 

further provides that an application for 

a practitioner’s registration may be 

denied upon a determination that ‘‘the 

issuance of such registration . . . would 

be inconsistent with the public 

interest.’’ Id. In making the public 

interest determination, the CSA requires 

consideration of the following factors: 

(A) The recommendation of the 

appropriate State licensing board or 

professional disciplinary authority. 

(B) The applicant’s experience in 

dispensing, or conducting research with 

respect to controlled substances. 

(C) The applicant’s conviction record 

under Federal or State laws relating to 

the manufacture, distribution, or 

dispensing of controlled substances. 

(D) Compliance with applicable State, 

Federal, or local laws relating to 

controlled substances. 

(E) Such other conduct which may 

threaten the public health and safety. 

21 U.S.C. 823(g)(1). 

The DEA considers these public 

interest factors in the disjunctive. Robert 

A. Leslie, M.D., 68 FR 15227, 15230 

(2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t 

Admin., 412 F.3d 165, 173–74 (D.C. Cir. 

2005). Any one factor, or combination of 

factors, may be decisive. David H. Gillis, 

M.D., 58 FR 37507, 37508 (1993). While 

the Agency has considered all of the 

public interest factors in 21 U.S.C. 

823(g)(1),9 the Government’s evidence 


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63126 Federal Register / Vol. 88, No. 177 / Thursday, September 14, 2023 / Notices 

823(g)(1)(A). Nonetheless, an absence of such 

evidence ‘‘does not weigh for or against a 

determination as to whether continuation of [or 

granting of a] DEA certification is consistent with 

the public interest.’’ Roni Dreszer, M.D., 76 FR 

19434, 19444 (2011). As to Factor C, there is no 

evidence in the record that Applicant has been 

convicted of an offense under either federal or state 

law ‘‘relating to the manufacture, distribution, or 

dispensing of controlled substances.’’ 21 U.S.C. 

823(g)(1)(C). Likewise to Factor A, Agency cases 

have found that ‘‘the absence of such a conviction 

is of considerably less consequence in the public 

interest inquiry’’ and is therefore not dispositive. 

Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010). 

Finally, as to Factor E, the Government’s evidence 

fits squarely within the parameters of Factors B and 

D and does not raise ‘‘other conduct which may 

threaten the public health and safety.’’ 21 U.S.C. 

823(g)(1)(E). Accordingly, Factor E does not weigh 

for or against Applicant. 

10The Agency need not adjudicate the criminal 

violations alleged in the instant Order to Show 

Cause. Ruan v. United States, 142 S. Ct. 2370 (2022) 

(decided in the context of criminal proceedings). 

in support of its prima facie case for 

denial of Applicant’s application is 

confined to Factors B and D. See RFAA, 

at 6–9. Moreover, the Government has 

the burden of proof in this proceeding. 

21 CFR 1301.44. 

Here, the Agency finds that the 

Government’s evidence satisfies its 

prima facie burden of showing that 

Applicant’s registration would be 

‘‘inconsistent with the public interest.’’ 

21 U.S.C. 824(a)(4). 

1. Factors B and D 

Evidence is considered under Public 

Interest Factors B and D when it reflects 

compliance (or non-compliance) with 

laws related to controlled substances 

and experience dispensing controlled 

substances. See Kareem Hubbard, M.D., 

87 FR 21156, 21162 (2022). In the 

current matter, the Government has 

alleged that Applicant has violated both 

federal and California state law 

regulating controlled substances. 

RFAAX 10, at 1–5.10

Under federal law, those engaged in 

chemical analysis are required to be 

registered with the DEA. 21 CFR 

1301.13(e)(1)(x). Regarding 

recordkeeping, the CSA requires that 

DEA registrants maintain complete and 

accurate records of the manufacture, 

receipt, sale, delivery, or disposal of 

controlled substances. 21 U.S.C. 

827(a)(3). Additional relevant 

recordkeeping requirements can be 

found at 21 CFR 1304.03(a) (all 

registrants shall maintain required 

records), 1304.04(a) (records must be 

retained and available for DEA 

inspection for at least two years), 

1304.21(a) (records must be complete 

and accurate), 1304.23(a) (registrants 

registered for chemical analysis with 

controlled substances must maintain 

records for each controlled substance). 

Here, the record demonstrates that 

prior to the expiration of its previous 

registration on September 30, 2020, 

Applicant failed to maintain necessary 

records as required by the CSA despite 

receiving and possessing controlled 

substances. Further, the record 

demonstrates that following the 

expiration of its previous registration on 

September 30, 2020, Applicant 

unlawfully continued to receive and 

possess large quantities of controlled 

substances without maintaining 

necessary records for two years as 

required by the CSA. As Applicant’s 

conduct displays clear violations of 

federal law relating to controlled 

substances, the Agency hereby finds 

that Applicant violated 21 U.S.C. 

827(a)(3) and 21 CFR 1301.13(e)(1)(x), 

1304.03(a), 1304.04(a), 1304.21(a), 

1304.23(a). 

Accordingly, the Agency finds that 

Factors B and D weigh in favor of denial 

of Applicant’s application and thus 

finds Applicant’s registration to be 

inconsistent with the public interest in 

balancing the factors of 21 U.S.C. 

823(g)(1). The Agency further finds that 

Applicant failed to provide sufficient 

evidence to rebut the Government’s 

prima facie case. 

III. Sanction 

Where, as here, the Government has 

established grounds to deny Applicant’s 

application, the burden shifts to the 

registrant to show why it can be 

entrusted with the responsibility carried 

by a registration. Garret Howard Smith, 

M.D., 83 FR 18882, 18910 (2018). When 

a registrant has committed acts 

inconsistent with the public interest, it 

must both accept responsibility and 

demonstrate that it has undertaken 

corrective measures. Holiday CVS, 

L.L.C., dba CVS Pharmacy Nos 219 and 

5195, 77 FR 62316, 62339 (2012) 

(internal quotations omitted). Trust is 

necessarily a fact-dependent 

determination based on individual 

circumstances; therefore, the Agency 

looks at factors such as the acceptance 

of responsibility, the credibility of that 

acceptance as it relates to the 

probability of repeat violations or 

behavior, the nature of the misconduct 

that forms the basis for sanction, and the 

Agency’s interest in deterring similar 

acts. See, e.g., Robert Wayne Locklear, 

M.D., 86 FR 33746. 

Here, Applicant did not request a 

hearing, submit a corrective action plan, 

respond to the OSC, or otherwise avail 

itself of the opportunity to refute the 

Government’s case. As such, Applicant 

has made no representations as to its 

future compliance with the CSA nor 

demonstrated that it can be entrusted 

with registration. Moreover, the 

evidence presented by the Government 

clearly shows that Applicant violated 

the CSA and the Agency has found that 

Applicant is ineligible for DEA 

registration. See supra at II.1. 

Accordingly, the Agency will order the 

denial of Applicant’s application. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

823(g)(1) and 21 U.S.C. 824(a), I hereby 

deny the pending application for a 

Certificate of Registration, Control No. 

W21055614H, submitted by Green Wave 

Analytical, as well as any other pending 

application of Green Wave Analytical 

for additional registration in California. 

This Order is effective October 16, 2023. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on September 5, 2023, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2023–19820 Filed 9–13–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 23–7] 

Rachel Pittala, APRN; Decision and 

Order 

On October 18, 2022, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Rachel Pittala, 

APRN (Respondent) of Orlando, Florida. 

OSC/ISO, at 1. The OSC/ISO informed 

Respondent of the immediate 

suspension of her DEA Certificate of 

Registration, Control No. MP4600791, 

pursuant to 21 U.S.C. 824(d), alleging 

that Respondent’s continued registration 

constitutes ‘‘‘an imminent danger to the 

public health or safety.’ ’’ OSC/ISO, at 1 

(quoting 21 U.S.C. 824(d)). The OSC/ 


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