Su-Chiao Kuo: Debarment Order, 63656-63657 [2018-26778]

Download as PDF 63656 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices consistent with product labeling (21 CFR 211.170). FDA estimates that annually approximately 74 outsourcing facilities (‘‘No. of Recordkeepers’’ in table 1, row 13) will individually establish and records as described in the guidance will take approximately 0.5 hours for each record (‘‘Average Burden per Recordkeeping’’ in table 1, row 13). FDA estimates the burden of this collection of information as follows: maintain approximately 12 procedures and records for reserve samples (‘‘Records per Recordkeeper’’ in table 1, row 13) for drug products. FDA also estimates that preparing and maintaining these procedures and TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Quality assurance activities ..................................... Facility design .......................................................... Control systems and procedures for maintaining suitable facilities. Environmental and personnel monitoring ................ Containers and closures .......................................... Equipment ................................................................ Components ............................................................. Production and process controls ............................. Release testing ........................................................ Laboratory controls .................................................. Stability/Expiration dating ......................................... Packaging and labels ............................................... Reserve samples ..................................................... 74 74 74 13 20 6 962 1,480 444 3 ................................ 1.5 ............................. 5 ................................ 2,886 2,220 2,220 74 74 74 74 74 74 74 74 74 74 1,200 300 150 150 1,325 1,725 200 75 20 12 88,800 22,200 11,100 11,100 98,050 127,650 14,800 5,550 1,480 888 0.25 (15 minutes) ...... 0.25 (15 minutes) ...... 0.25 (15 minutes) ...... 4 ................................ 0.25 (15 minutes) ...... 1.5 ............................. 0.5 (30 minutes) ........ 5 ................................ 5.5 ............................. 0.5 (30 minutes) ........ 22,200 5,550 2,775 44,400 24,513 191,475 7,400 27,750 8,140 444 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 Notification that a drug product fails to meet a sterility criterion. An expiration date is added to the drug product’s label. Total .................................................................. 1 There Number of disclosures per respondent Number of respondents Type of disclosure Average burden per disclosure Total annual disclosures Total hours 10 1 10 5 ................................ 50 74 540 39,960 0.25 (15 minutes) ...... 9,990 ........................ ........................ ........................ .................................... 10,040 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1 Type of reporting Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Notification to FDA that a drug product fails to meet a sterility 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 amozie on DSK3GDR082PROD with NOTICES1 Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: December 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–26724 Filed 12–10–18; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:51 Dec 10, 2018 Jkt 247001 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. The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 E:\FR\FM\11DEN1.SGM 11DEN1 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 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 VerDate Sep<11>2014 17:51 Dec 10, 2018 Jkt 247001 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 63657 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–1994] David J. Fishman: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman 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. Fishman 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. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman’s failure to SUMMARY: E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63656-63657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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