83 FR 63656 - Su-Chiao Kuo: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 237 (December 11, 2018)

Page Range		63656-63657
FR Document		2018-26778

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Su-Chiao Kuo for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Kuo was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Kuo was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Kuo failed to request a hearing. Dr. Kuo's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

Federal Register, Volume 83 Issue 237 (Tuesday, December 11, 2018)

[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63656-63657]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1990]


Su-Chiao Kuo: 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 Dr. 
Su-Chiao Kuo for a period of 3 years from providing services in any 
capacity to a person that has an approved or pending drug product 
application. FDA bases this order on a finding that Dr. Kuo was 
convicted of a misdemeanor under the FD&C Act for causing the 
introduction or delivery for introduction into interstate commerce of 
prescription drugs that were misbranded. In addition, FDA has 
determined that the type of conduct that served as the basis for the 
conviction undermines the process for the regulation of drugs. Dr. Kuo 
was given notice of the proposed

[[Page 63657]]

debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. Dr. Kuo failed to request a hearing. Dr. 
Kuo's failure to request a hearing constitutes a waiver of her right to 
a hearing concerning this action.

DATES: This order is applicable December 11, 2018.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement, 
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 
301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds 
that the individual has been convicted of a misdemeanor under Federal 
law for conduct relating to the regulation of drug products under the 
FD&C Act, and if FDA finds that the type of conduct that served as the 
basis for the conviction undermines the process for the regulation of 
drugs.
    On January 14, 2014, in the United States District Court for the 
Northern District of Ohio, judgment was entered against Dr. Kuo after 
she entered a plea of guilty to one count of misbranding, in violation 
of section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which is a 
misdemeanor offense under section 303(a)(1) of the FD&C Act (21 U.S.C. 
333(a)(1)).
    FDA's finding that debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for this 
conviction is as follows: Between June 22, 2005, and November 18, 2008, 
Dr. Kuo was a physician (oncologist) in Ohio. During this time, Dr. Kuo 
purchased and received oncology drugs, including TAXOTERE (docetaxel) 
and ZOMETA (zoledronic acid), from a drug distributor located in 
Canada. These new drugs originated outside the United States and were 
not approved by FDA for introduction or delivery for introduction into 
interstate commerce in the United States. Thus, Dr. Kuo caused the 
introduction or delivery for introduction into interstate commerce of 
prescription drugs that were misbranded for lacking adequate directions 
for use in their labeling.
    As a result of this conviction, on July 13, 2018, FDA sent Dr. Kuo 
a notice by certified mail proposing to debar her for 3 years from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding 
under section 306(b)(2)(B)(i)(I) of the FD&C Act that Dr. Kuo was 
convicted of a misdemeanor under Federal law for conduct relating to 
the regulation of drug products under the FD&C Act, and that the type 
of conduct that served as the basis for the conviction undermines the 
process for the regulation of drugs.
    The proposal offered Dr. Kuo an opportunity to request a hearing, 
provided her 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. Dr. Kuo received the proposal on 
July 23, 2018. Dr. Kuo did not request a hearing within the timeframe 
prescribed by regulation and has, therefore, waived her opportunity for 
a hearing and has waived any contentions concerning her debarment (21 
CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 
306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the 
Director (Staff Manual Guide 1410.35), finds that Dr. Su-Chiao Kuo has 
been convicted of a misdemeanor under Federal law for conduct relating 
to the regulation of drug products under the FD&C Act and that the type 
of conduct that served as the basis for the conviction undermines the 
process for the regulation of drugs.
    As a result of the foregoing findings and in consideration of the 
factors described in section 306(c)(3) of the FD&C Act, Dr. Su-Chiao 
Kuo is debarred for 3 years from providing services in any capacity to 
a person with an approved or pending drug product application under 
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 
382), or under section 351 of the Public Health Service Act (42 U.S.C. 
262), effective (see DATES) (see sections 306(c)(1)(B), (c)(3), and 
201(dd) (21 U.S.C. 321(dd)) of the FD&C Act). Any person with an 
approved or pending drug product application who knowingly employs or 
retains as a consultant or contractor, or otherwise uses the services 
of Dr. Kuo in any capacity during her debarment, will be subject to 
civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 
335b(a)(6)). If Dr. Kuo provides services in any capacity to a person 
with an approved or pending drug product application during her period 
of debarment, she will be subject to civil money penalties (section 
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review 
any abbreviated new drug applications submitted by or with the 
assistance of Dr. Kuo during her period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Kuo for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2018-N-1990 and sent to the Dockets Management Staff (see 
ADDRESSES). All such submissions are to be filed in four copies. 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.

    Dated: December 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26778 Filed 12-10-18; 8:45 am]
BILLING CODE 4164-01-P

63656 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices

consistent with product labeling (21 maintain approximately 12 procedures records as described in the guidance
CFR 211.170). and records for reserve samples will take approximately 0.5 hours for
FDA estimates that annually (‘‘Records per Recordkeeper’’ in table 1, each record (‘‘Average Burden per
approximately 74 outsourcing facilities row 13) for drug products. FDA also Recordkeeping’’ in table 1, row 13).
(‘‘No. of Recordkeepers’’ in table 1, row estimates that preparing and FDA estimates the burden of this
13) will individually establish and maintaining these procedures and collection of information as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

Quality assurance activities ..................................... 74 13 962 3 ................................ 2,886
Facility design .......................................................... 74 20 1,480 1.5 ............................. 2,220
Control systems and procedures for maintaining 74 6 444 5 ................................ 2,220
suitable facilities.
Environmental and personnel monitoring ................ 74 1,200 88,800 0.25 (15 minutes) ...... 22,200
Containers and closures .......................................... 74 300 22,200 0.25 (15 minutes) ...... 5,550
Equipment ................................................................ 74 150 11,100 0.25 (15 minutes) ...... 2,775
Components ............................................................. 74 150 11,100 4 ................................ 44,400
Production and process controls ............................. 74 1,325 98,050 0.25 (15 minutes) ...... 24,513
Release testing ........................................................ 74 1,725 127,650 1.5 ............................. 191,475
Laboratory controls .................................................. 74 200 14,800 0.5 (30 minutes) ........ 7,400
Stability/Expiration dating ......................................... 74 75 5,550 5 ................................ 27,750
Packaging and labels ............................................... 74 20 1,480 5.5 ............................. 8,140
Reserve samples ..................................................... 74 12 888 0.5 (30 minutes) ........ 444

Total .................................................................. ........................ ........................ ........................ .................................... 341,973
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
Type of disclosure disclosures per burden per Total hours
respondents disclosures
respondent disclosure

Notification that a drug product fails to meet a ste- 10 1 10 5 ................................ 50
rility criterion.
An expiration date is added to the drug product’s 74 540 39,960 0.25 (15 minutes) ...... 9,990
label.

Total .................................................................. ........................ ........................ ........................ .................................... 10,040
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Type of reporting Number of responses per Total annual burden per Total hours
respondents responses
respondent response

Notification to FDA that a drug product fails to meet a ste-
rility criterion ..................................................................... 10 1 10 5 50
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access DEPARTMENT OF HEALTH AND Su-Chiao Kuo for a period of 3 years
HUMAN SERVICES from providing services in any capacity
Persons with access to the internet to a person that has an approved or
may obtain the draft guidance at either Food and Drug Administration pending drug product application. FDA
https://www.fda.gov/Drugs/Guidance bases this order on a finding that Dr.
[Docket No. FDA–2018–N–1990]
ComplianceRegulatoryInformation/ Kuo was convicted of a misdemeanor
Guidances/default.htm or https:// Su-Chiao Kuo: Debarment Order under the FD&C Act for causing the
www.regulations.gov. introduction or delivery for introduction
AGENCY: Food and Drug Administration,
amozie on DSK3GDR082PROD with NOTICES1

Dated: December 4, 2018.
HHS. into interstate commerce of prescription
Leslie Kux, drugs that were misbranded. In
ACTION: Notice. addition, FDA has determined that the
Associate Commissioner for Policy.
[FR Doc. 2018–26724 Filed 12–10–18; 8:45 am] SUMMARY: The Food and Drug type of conduct that served as the basis
Administration (FDA) is issuing an for the conviction undermines the
BILLING CODE 4164–01–P
order under the Federal Food, Drug, and process for the regulation of drugs. Dr.
Cosmetic Act (FD&C Act) debarring Dr. Kuo was given notice of the proposed

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Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices 63657

debarment and an opportunity to 3 years from providing services in any application during her period of
request a hearing within the timeframe capacity to a person that has an debarment, she will be subject to civil
prescribed by regulation. Dr. Kuo failed approved or pending drug product money penalties (section 307(a)(7) of the
to request a hearing. Dr. Kuo’s failure to application. The proposal was based on FD&C Act). In addition, FDA will not
request a hearing constitutes a waiver of a finding under section 306(b)(2)(B)(i)(I) accept or review any abbreviated new
her right to a hearing concerning this of the FD&C Act that Dr. Kuo was drug applications submitted by or with
action. convicted of a misdemeanor under the assistance of Dr. Kuo during her
DATES: This order is applicable Federal law for conduct relating to the period of debarment (section
December 11, 2018. regulation of drug products under the 306(c)(1)(B) of the FD&C Act).
FD&C Act, and that the type of conduct Any application by Dr. Kuo for
ADDRESSES: Submit applications for
that served as the basis for the termination of debarment under section
termination of debarment to the Dockets
conviction undermines the process for 306(d)(1) of the FD&C Act should be
Management Staff (HFA–305), Food and
the regulation of drugs. identified with Docket No. FDA–2018–
Drug Administration, 5630 Fishers The proposal offered Dr. Kuo an
Lane, Rm. 1061, Rockville, MD 20852. N–1990 and sent to the Dockets
opportunity to request a hearing, Management Staff (see ADDRESSES). All
FOR FURTHER INFORMATION CONTACT: provided her 30 days from the date of such submissions are to be filed in four
Kenny Shade, Division of Enforcement, receipt of the letter in which to file the copies. The public availability of
Food and Drug Administration, 12420 request, and advised her that failure to information in these submissions is
Parklawn Dr., Rockville, MD 20857, request a hearing constituted a waiver of governed by 21 CFR 10.20(j).
301–796–4640. the opportunity for a hearing and of any Publicly available submissions will be
SUPPLEMENTARY INFORMATION: contentions concerning this action. Dr. placed in the docket and will be
I. Background Kuo received the proposal on July 23, viewable at https://www.regulations.gov
2018. Dr. Kuo did not request a hearing or at the Dockets Management Staff (see
Section 306(b)(2)(B)(i)(I) of the FD&C within the timeframe prescribed by ADDRESSES) between 9 a.m. and 4 p.m.,
Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) regulation and has, therefore, waived
permits debarment of an individual if Monday through Friday.
her opportunity for a hearing and has
FDA finds that the individual has been waived any contentions concerning her Dated: December 4, 2018.
convicted of a misdemeanor under debarment (21 CFR part 12). Leslie Kux,
Federal law for conduct relating to the Associate Commissioner for Policy.
regulation of drug products under the II. Findings and Order
[FR Doc. 2018–26778 Filed 12–10–18; 8:45 am]
FD&C Act, and if FDA finds that the Therefore, the Director, Office of BILLING CODE 4164–01–P
type of conduct that served as the basis Enforcement and Import Operations,
for the conviction undermines the Office of Regulatory Affairs, under
process for the regulation of drugs. section 306(b)(2)(B)(i)(I) of the FD&C DEPARTMENT OF HEALTH AND
On January 14, 2014, in the United Act, under authority delegated to the HUMAN SERVICES
States District Court for the Northern Director (Staff Manual Guide 1410.35),
District of Ohio, judgment was entered finds that Dr. Su-Chiao Kuo has been Food and Drug Administration
against Dr. Kuo after she entered a plea convicted of a misdemeanor under
[Docket No. FDA–2018–N–1994]
of guilty to one count of misbranding, in Federal law for conduct relating to the
violation of section 301(a) of the FD&C regulation of drug products under the David J. Fishman: Debarment Order
Act (21 U.S.C. 331(a)), which is a FD&C Act and that the type of conduct
misdemeanor offense under section that served as the basis for the AGENCY: Food and Drug Administration,
303(a)(1) of the FD&C Act (21 U.S.C. conviction undermines the process for HHS.
333(a)(1)). the regulation of drugs. ACTION: Notice.
FDA’s finding that debarment is As a result of the foregoing findings
appropriate is based on the and in consideration of the factors SUMMARY: The Food and Drug
misdemeanor conviction referenced described in section 306(c)(3) of the Administration (FDA) is issuing an
herein. The factual basis for this FD&C Act, Dr. Su-Chiao Kuo is debarred order under the Federal Food, Drug, and
conviction is as follows: Between June for 3 years from providing services in Cosmetic Act (FD&C Act) debarring Dr.
22, 2005, and November 18, 2008, Dr. any capacity to a person with an David J. Fishman for a period of 3 years
Kuo was a physician (oncologist) in approved or pending drug product from providing services in any capacity
Ohio. During this time, Dr. Kuo application under sections 505, 512, or to a person that has an approved or
purchased and received oncology drugs, 802 of the FD&C Act (21 U.S.C. 355, pending drug product application. FDA
including TAXOTERE (docetaxel) and 360b, or 382), or under section 351 of bases this order on a finding that Dr.
ZOMETA (zoledronic acid), from a drug the Public Health Service Act (42 U.S.C. Fishman was convicted of a
distributor located in Canada. These 262), effective (see DATES) (see sections misdemeanor under the FD&C Act for
new drugs originated outside the United 306(c)(1)(B), (c)(3), and 201(dd) (21 causing the introduction or delivery for
States and were not approved by FDA U.S.C. 321(dd)) of the FD&C Act). Any introduction into interstate commerce of
for introduction or delivery for person with an approved or pending prescription drugs that were
introduction into interstate commerce in drug product application who misbranded. In addition, FDA has
the United States. Thus, Dr. Kuo caused knowingly employs or retains as a determined that the type of conduct that
the introduction or delivery for consultant or contractor, or otherwise served as the basis for the conviction
amozie on DSK3GDR082PROD with NOTICES1

introduction into interstate commerce of uses the services of Dr. Kuo in any undermines the process for the
prescription drugs that were capacity during her debarment, will be regulation of drugs. Dr. Fishman was
misbranded for lacking adequate subject to civil money penalties (section given notice of the proposed debarment
directions for use in their labeling. 307(a)(6) of the FD&C Act (21 U.S.C. and an opportunity to request a hearing
As a result of this conviction, on July 335b(a)(6)). If Dr. Kuo provides services within the timeframe prescribed by
13, 2018, FDA sent Dr. Kuo a notice by in any capacity to a person with an regulation. Dr. Fishman failed to request
certified mail proposing to debar her for approved or pending drug product a hearing. Dr. Fishman’s failure to

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Document Created: 2018-12-11 01:06:38
Document Modified: 2018-12-11 01:06:38

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is applicable December 11, 2018.
Contact		Kenny Shade, Division of Enforcement, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.
FR Citation		83 FR 63656

83 FR 63656 - Su-Chiao Kuo: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 237 (December 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration