82 FR 49211 - Trand Doan Nguyen; Denial of Hearing; Final Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 204 (October 24, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 204 (October 24, 2017)
| Page Range | 49211-49214 | |
| FR Document | 2017-23019 |
[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)] [Notices] [Pages 49211-49214] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23019] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0278] Trand Doan Nguyen; Denial of Hearing; Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is denying Trang Doan Nguyen's (Nguyen's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Nguyen for 5 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 Nguyen was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Nguyen's debarment, FDA has considered the relevant factors listed in the FD&C Act. Nguyen has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action. DATES: The order is effective October 24, 2017. ADDRESSES: Any application by Nguyen for special termination of debarment under section 306(d) of the FD&C Act (application) may be submitted as follows: Electronic SubmissionsFederal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your application will be made public, you are solely responsible for ensuring that your application does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your application, that information will be posted on https://www.regulations.gov. If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: Your application must include the Docket No. FDA- 2011-N-0278. An application will be placed in the docket and, unless submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit an application with confidential information that you do not wish to be made publicly available, submit your application only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of your application. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this [[Page 49212]] information on the cover sheet and not in the body of your application and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Nathan R. Sabel, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, MD 20993, 301-796-8588. SUPPLEMENTARY INFORMATION: I. Background On December 12, 2008, in the U.S. District Court for the District of Missouri, Nguyen pled guilty to a misdemeanor for introducing a misbranded drug into interstate commerce in violation of sections 301(a) and 303(a)(1) of the FD&C Act (21 U.S.C. 331(a) and 333(a)(1)). The basis for Nguyen's guilty plea was her admission that she repackaged unapproved versions of the drugs LIPITOR and CELEBREX, some of which were counterfeit, and relabeled them in a manner that did not disclose that they were unapproved or that they were counterfeit and then shipped them to other States. The drugs were misbranded under section 502(a) of the FD&C Act (21 U.S.C. 352(a)) in that their labeling was false and misleading. Nguyen is subject to debarment based on a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)): (1) That she was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and (2) that the type of conduct underlying the conviction undermines the process for the regulation of drugs. By letter dated July 6, 2011, FDA served Nguyen a notice proposing to debar her for 5 years from providing services in any capacity to a person having an approved or pending drug product application and providing an opportunity for Nguyen to request a hearing. In a letter dated July 29, 2011, Nguyen requested a hearing on the proposal. In her request for a hearing, Nguyen acknowledges her conviction under Federal law, as stated by FDA in the proposal to debar. However, she argues that the proposal to debar her contains material inaccuracies with respect to certain facts related to her misdemeanor conviction. The Directors of the Office of Scientific Integrity (OSI) reviewed Nguyen's request for a hearing, as well as the materials offered in support, and find that Nguyen has not created a basis for a hearing because hearings will be granted only if there is a genuine and substantial issue of fact for resolution at a hearing. Hearings will not be granted on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged (see 21 CFR 12.24(b)). The Director of OSI has considered Nguyen's arguments and concludes that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing. II. Arguments Nguyen raises a number of arguments in support of her hearing request. She does not appear, however, to dispute that she is subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. As noted above, to debar Nguyen under section 306(b)(2)(B)(i)(I), FDA must find both: (1) That Nguyen was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating the regulation of a drug product under the FD&C Act and (2) that the type of conduct underlying the conviction undermines the process for the regulation of drugs. As set forth in the proposal to debar Nguyen, her Federal misdemeanor conviction involved a violation of the FD&C Act's requirements for drugs. As a result, the conduct underlying her conviction both related to the regulation of drug products under the FD&C Act and undermined the process for the regulation of drugs. Nguyen does not contradict the findings to that effect in the proposal to debar and has thus failed to create a material factual dispute with respect to whether she is subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. In her request for a hearing, Nguyen argues nonetheless that she is entitled to a hearing because, in the proposal to debar, FDA relied on findings that are not supported by the record in determining the appropriateness and period of debarment under section 306(c)(3) of the FD&C Act. Under section 306(i) of the FD&C Act, FDA may not take any action under sections 306(b) or section 306(c) with respect to any person ``unless [FDA] has issued an order for such action made on the record after opportunity for agency hearing on disputed issues of material fact.'' Section 306(c)(3) explicitly requires FDA to consider, ``where applicable,'' certain factors ``[i]n determining the appropriateness and the period of debarment'' for any permissive debarment. The proposal to debar Nguyen set forth four applicable considerations under section 306(c)(3): (1) The nature and seriousness of her offense under section 306(c)(3)(A); (2) the nature and extent of management participation in the offense under section 306(c)(3)(B); (3) the nature and extent of voluntary steps taken to mitigate the impact on the public under section 306(c)(3)(C); and (4) prior convictions involving matters within the jurisdiction of FDA under section 306(c)(3)(F) of the FD&C Act. In the proposal, FDA found that the first three considerations weigh in favor of debarring Nguyen and noted that the fourth consideration would be treated as a favorable factor for her because the Agency was unaware of any prior convictions involving matters within the jurisdiction of FDA. Nguyen's challenge to specific findings in the proposal to debar fails to create a genuine and substantial dispute of fact for resolution at a hearing with respect to any of the applicable considerations under section 306(c)(3) of the FD&C Act. In her request for a hearing, Nguyen argues that the records of her criminal proceedings do not support certain findings in the proposal to debar. Specifically, she contends that neither the plea agreement nor the criminal information to which she pled guilty support the following findings: (1) That she was ``aware that the drugs [in question] needed to be relabeled for sale in the United States,'' (2) that some of the drugs bore labeling in Portuguese before they were relabeled, or (3) that the conduct underlying her conviction continued for 13 months. Even after disregarding the findings in the proposal to debar to which Nguyen objects, we find that she should be debarred for the maximum period of 5 years. Nguyen's factual objections relate primarily to the consideration of the nature and seriousness of her offense under section 306(c)(3)(A) of the FD&C [[Page 49213]] Act. As noted previously, Nguyen pled guilty to a misdemeanor under the FD&C Act by admitting that she acquired, repackaged, relabeled, and distributed unapproved prescription drugs in interstate commerce. In her criminal proceedings, Nguyen also admitted that some of these unapproved prescription drugs were counterfeit drugs. By definition, a counterfeit drug is a drug whose container or labeling falsely describes the manufacturer, processer, packer, or distributer of that drug (see 21 U.S.C. 331(g)(2)) and thereby can effectively conceal the actual manufacturer, processer, packer, or distributer from consumers and government regulators. An unapproved drug in this context is a drug requiring but lacking FDA approval that is not generally recognized as safe and effective for its intended use (see 21 U.S.C. 331(g)(1)). As such, the products that Nguyen admitted to acquiring, repackaging, relabeling, and further distributing were not simply misbranded in some technical sense. With respect to Nguyen's assertion that her offense was committed without knowledge, section 306(b)(2)(B)(i) of the FD&C Act specifically provides for the debarment of individuals convicted of Federal misdemeanors related to the regulation of drug products under the FD&C Act. Given that a misdemeanor violation of the FD&C Act itself is a strict liability offense, meaning an offense that does not require proof of knowledge as an element of the crime, it stands to reason that criminal intent is not required to subject an individual to debarment under section 306(b)(2)(B)(i). As recognized by the U.S. Supreme Court, an individual who is responsible for the operation of an FDA-regulated business is also responsible for any violations of the FD&C Act that arise out of the conduct of the business, whether or not he or she intends to commit the violations or even knows that the violations have been committed. (United States v. Park, 421 U.S. 658 (1975); United States v. Dotterweich, 320 U.S. 277 (1943)). In keeping with the FD&C Act's purpose of protecting the public from adulterated and misbranded products, Congress chose to place the burden of protecting the public on those who manufacture and distribute those products rather than on consumers, who cannot protect themselves. (Dotterweich, 320 U.S. at 280-81.) Nguyen herself chose to run a business that acquired, repackaged, relabeled, and further distributed prescription drugs to consumers who were unable to protect themselves from the unapproved and counterfeit products that Nguyen admitted to providing them. Even though the law subjects Nguyen to permissive debarment as a responsible corporate officer regardless of her knowledge or intent to commit the violation, Nguyen has admitted that she personally engaged in the conduct underlying the violation as a hands-on participant. Nguyen admitted in her plea that she repackaged the drugs and affixed labeling to these prescription drugs that did not disclose that the drugs were counterfeit and not approved by FDA. Nguyen admitted that she repackaged and affixed this false and misleading labeling to these prescription drugs and then shipped these drugs in interstate commerce for eventual use by the unknowing public. In light of these undisputed and admitted facts, even crediting Nguyen's objections related to her level of knowledge, the precise language of the product labeling on some of the drugs she received, and the precise length of time she committed this offense, these objections do not minimize the nature and seriousness the conduct Nguyen both committed and admitted. The proposal to debar alleges that Nguyen's conduct ``created a significant risk of injury to consumers who were exposed to misbranded drugs and seriously undermined the integrity of the Agency's regulation of drug products.'' Because of the uncontested and admitted facts already discussed, Nguyen's objections, even if taken as true, would not undermine this conclusion. Therefore, we conclude that the nature and seriousness of her conduct weighs in favor of debarring Nguyen. Having found that the consideration in section 306(c)(3)(A) of the FD&C Act weighs in favor of debarring Nguyen, we turn to the remaining three applicable considerations. Nguyen does not dispute the unfavorable facts in the FDA proposal to debar that relate to the considerations in sections 306(c)(3)(B) and (C) of the FD&C Act. Specifically, Nguyen does not dispute the findings in the proposal that she used a company of which she was the owner and operator, AQ Pharmaceuticals, Inc., to distribute the unapproved and counterfeit drugs and that she served in a managerial role in this offense. Nor does Nguyen contradict the findings in the proposal to debar that she and her company did not discontinue their illegal conduct until it was discovered by authorities. In her hearing request, Nguyen does not point to any voluntary steps taken to mitigate the effect of her offenses on the public. Thus, the considerations in sections 306(c)(3)(B) and (C) of the FD&C Act regarding Nguyen's management role and the voluntary steps taken by Nguyen to mitigate the impact of her offense on the public both weigh in favor of her debarment. Although Nguyen appears to have no previous criminal convictions related to matters within the jurisdiction of FDA (see section 306(c)(3)(F) of the FD&C Act), this consideration alone does not counter to a sufficient degree the nature and seriousness of the conduct underlying her misdemeanor conviction, her managerial role in the offense, and the lack of any voluntary steps taken to mitigate the impact of that offense of the public, to warrant decreasing the period of debarment from 5 years. III. Findings and Order Therefore, the Director of OSI, under section 306(b)(1)(B)(i)(I) of the FD&C Act and under authority delegated to him by the Commissioner of Food and Drugs, finds that Nguyen has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating the regulation of a drug product under the FD&C Act and that the conduct underlying the conviction undermines the regulation of drugs. FDA has considered the relevant factors listed in section 306(c)(3) of the FD&C Act and determined that a debarment of 5 years is appropriate. As a result of the foregoing findings, Nguyen is debarred for 5 years from providing services in any capacity to a person with an approved or pending drug product application under section 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) (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)). Any person with an approved or pending drug product application, who knowingly uses the services of Nguyen, in any capacity during her period of debarment, will be subject to civil money penalties. If Nguyen, during her period of debarment, provides services in any capacity to a person with an approved or pending drug product application, she will be subject to civil money penalties. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Nguyen during her period of debarment. [[Page 49214]] Dated: October 19, 2017. G. Matthew Warren, Director, Office of Scientific Integrity. [FR Doc. 2017-23019 Filed 10-23-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 49211
I. Background be updated to list March 15, 2019, as the solely responsible for ensuring that your
On December 17, 2014, FDA ‘‘date support ends.’’ Studies that start application does not include any
published a final guidance for industry after March 15, 2019, will be required to confidential information that you or a
entitled ‘‘Providing Regulatory use the most current B3-format annual third party may not wish to be posted,
Submissions in Electronic Format— version of WHODG. such as medical information, your or
Standardized Study Data’’ (eStudy Data Dated: October 18, 2017. anyone else’s Social Security number, or
Guidance), posted on FDA’s Study Data confidential business information, such
Leslie Kux,
Standards Resources Web page at as a manufacturing process. Please note
Associate Commissioner for Policy.
https://www.fda.gov/forindustry/ that if you include your name, contact
[FR Doc. 2017–23029 Filed 10–23–17; 8:45 am] information, or other information that
datastandards/studydatastandards/
default.htm. The eStudy Data Guidance
BILLING CODE 4164–01–P identifies you in the body of your
implements the electronic submission application, that information will be
posted on https://www.regulations.gov.
requirements of section 745A(a) of the DEPARTMENT OF HEALTH AND • If you want to submit an
Federal Food, Drug, and Cosmetic Act HUMAN SERVICES application with confidential
for study data contained in NDAs, information that you do not wish to be
ANDAs, BLAs, and certain INDs to Food and Drug Administration made available to the public, submit the
CBER or CDER by specifying the format [Docket No. FDA–2011–N–0278] application as a written/paper
for electronic submissions. The initial submission and in the manner detailed
timetable for the implementation of Trand Doan Nguyen; Denial of Hearing; (see ‘‘Written/Paper Submissions’’ and
electronic submission requirements for Final Debarment Order ‘‘Instructions’’).
study data was December 17, 2016 (24
months after issuance of final guidance AGENCY: Food and Drug Administration, Written/Paper Submissions
for NDAs, BLAs, ANDAs, and 36 HHS. Submit written/paper submissions as
months for INDs). The eStudy Data ACTION: Notice. follows:
guidance states that a Federal Register • Mail/Hand delivery/Courier (for
notice will specify the transition date SUMMARY: The Food and Drug written/paper submissions): Dockets
for all version updates (with the month Administration (FDA) is denying Trang Management Staff (HFA–305), Food and
and day for the transition date Doan Nguyen’s (Nguyen’s) request for a Drug Administration, 5630 Fishers
corresponding to March 15). hearing and is issuing an order under Lane, Rm. 1061, Rockville, MD 20852.
FDA currently supports the use of the Federal Food, Drug, and Cosmetic • For a written/paper application
WHODG for the coding of concomitant Act (the FD&C Act) debarring Nguyen submitted to the Dockets Management
medications in studies submitted to for 5 years from providing services in Staff, FDA will post your application, as
CBER or CDER in NDAs, ANDAs, BLAs, any capacity to a person that has an well as any attachments, except for
and certain INDs in the electronic approved or pending drug product information submitted, marked and
common technical document format. application. FDA bases this order on a identified, as confidential, if submitted
Generally, the studies included in a finding that Nguyen was convicted of a as detailed in ‘‘Instructions.’’
submission are conducted over many misdemeanor under Federal law for Instructions: Your application must
years and may have used different conduct relating to the development or include the Docket No. FDA–2011–N–
WHODG versions to code concomitant approval of a drug product or otherwise 0278. An application will be placed in
medications. The expectation is that relating the regulation of a drug product the docket and, unless submitted as
sponsors and applicants will use the under the FD&C Act and that the type ‘‘Confidential Submissions,’’ publicly
most current B3-format annual version of conduct underlying the conviction viewable at https://www.regulations.gov
of WHODG at the time of study start. undermines the process for the or at the Dockets Management Staff
However, there is no requirement to regulation of drugs. In determining the between 9 a.m. and 4 p.m., Monday
recode earlier studies. The transition appropriateness and period of Nguyen’s through Friday.
date for support of the most current B3- debarment, FDA has considered the • Confidential Submissions—To
format annual version of WHODG is relevant factors listed in the FD&C Act. submit an application with confidential
March 15, 2018. Although the use of the Nguyen has failed to file with the information that you do not wish to be
current B3-format annual version of Agency information and analyses made publicly available, submit your
WHODG is supported as of this Federal sufficient to create a basis for a hearing application only as a written/paper
Register notice and sponsors or concerning this action. submission. You should submit two
applicants are encouraged to begin DATES: The order is effective October 24, copies total. One copy will include the
using it, the use of the most current B3- 2017. information you claim to be confidential
format annual version will only be ADDRESSES: Any application by Nguyen with a heading or cover note that states
required in submissions for studies that for special termination of debarment ‘‘THIS DOCUMENT CONTAINS
start after March 15, 2019. The Catalog under section 306(d) of the FD&C Act CONFIDENTIAL INFORMATION.’’ The
will list March 15, 2019, as the ‘‘date (application) may be submitted as Agency will review this copy, including
requirement begins.’’ The Study Data follows: the claimed confidential information, in
Technical Conformance Guide provides its consideration of your application.
Electronic Submissions
asabaliauskas on DSKBBXCHB2PROD with NOTICES
addition information and The second copy, which will have the
recommendations on the coding of • Federal eRulemaking Portal: claimed confidential information
concomitant medications (https:// https://www.regulations.gov. Follow the redacted/blacked out, will be available
www.fda.gov/downloads/forindustry/ instructions for submitting comments. for public viewing and posted on
datastandards/studydatastandards/ An application submitted electronically, https://www.regulations.gov. Submit
ucm384744.pdf). including attachments, to https:// both copies to the Dockets Management
FDA support for earlier versions of www.regulations.gov will be posted to Staff. If you do not wish your name and
WHODG will end for studies that start the docket unchanged. Because your contact information to be made publicly
after March 15, 2019. The Catalog will application will be made public, you are available, you can provide this
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information on the cover sheet and not an opportunity for Nguyen to request a debar, FDA relied on findings that are
in the body of your application and you hearing. In a letter dated July 29, 2011, not supported by the record in
must identify this information as Nguyen requested a hearing on the determining the appropriateness and
‘‘confidential.’’ Any information marked proposal. In her request for a hearing, period of debarment under section
as ‘‘confidential’’ will not be disclosed Nguyen acknowledges her conviction 306(c)(3) of the FD&C Act. Under
except in accordance with 21 CFR 10.20 under Federal law, as stated by FDA in section 306(i) of the FD&C Act, FDA
and other applicable disclosure law. For the proposal to debar. However, she may not take any action under sections
more information about FDA’s posting argues that the proposal to debar her 306(b) or section 306(c) with respect to
of comments to public dockets, see 80 contains material inaccuracies with any person ‘‘unless [FDA] has issued an
FR 56469, September 18, 2015, or access respect to certain facts related to her order for such action made on the
the information at: https://www.gpo.gov/ misdemeanor conviction. record after opportunity for agency
fdsys/pkg/FR-2015-09-18/pdf/2015- The Directors of the Office of hearing on disputed issues of material
23389.pdf. Scientific Integrity (OSI) reviewed fact.’’ Section 306(c)(3) explicitly
Docket: For access to the docket, go to Nguyen’s request for a hearing, as well requires FDA to consider, ‘‘where
https://www.regulations.gov and insert as the materials offered in support, and applicable,’’ certain factors ‘‘[i]n
the docket number, found in brackets in find that Nguyen has not created a basis determining the appropriateness and the
the heading of this document, into the for a hearing because hearings will be period of debarment’’ for any permissive
‘‘Search’’ box and follow the prompts granted only if there is a genuine and debarment. The proposal to debar
and/or go to the Dockets Management substantial issue of fact for resolution at Nguyen set forth four applicable
Staff, 5630 Fishers Lane, Rm. 1061, a hearing. Hearings will not be granted considerations under section 306(c)(3):
Rockville, MD 20852. on issues of policy or law, on mere (1) The nature and seriousness of her
FOR FURTHER INFORMATION CONTACT:
allegations, denials, or general offense under section 306(c)(3)(A); (2)
descriptions of positions and the nature and extent of management
Nathan R. Sabel, Office of Scientific
contentions, or on data and information participation in the offense under
Integrity, Food and Drug
insufficient to justify the factual section 306(c)(3)(B); (3) the nature and
Administration, 10903 New Hampshire
determination urged (see 21 CFR extent of voluntary steps taken to
Ave., Bldg. 1, Rm. 4218, Silver Spring,
12.24(b)). mitigate the impact on the public under
MD 20993, 301–796–8588. The Director of OSI has considered section 306(c)(3)(C); and (4) prior
SUPPLEMENTARY INFORMATION: Nguyen’s arguments and concludes that convictions involving matters within
I. Background they are unpersuasive and fail to raise the jurisdiction of FDA under section
a genuine and substantial issue of fact 306(c)(3)(F) of the FD&C Act. In the
On December 12, 2008, in the U.S. requiring a hearing. proposal, FDA found that the first three
District Court for the District of
II. Arguments considerations weigh in favor of
Missouri, Nguyen pled guilty to a debarring Nguyen and noted that the
misdemeanor for introducing a Nguyen raises a number of arguments fourth consideration would be treated as
misbranded drug into interstate in support of her hearing request. She a favorable factor for her because the
commerce in violation of sections 301(a) does not appear, however, to dispute Agency was unaware of any prior
and 303(a)(1) of the FD&C Act (21 U.S.C. that she is subject to debarment under convictions involving matters within
331(a) and 333(a)(1)). The basis for section 306(b)(2)(B)(i)(I) of the FD&C the jurisdiction of FDA.
Nguyen’s guilty plea was her admission Act. As noted above, to debar Nguyen Nguyen’s challenge to specific
that she repackaged unapproved under section 306(b)(2)(B)(i)(I), FDA findings in the proposal to debar fails to
versions of the drugs LIPITOR and must find both: (1) That Nguyen was create a genuine and substantial dispute
CELEBREX, some of which were convicted of a misdemeanor under of fact for resolution at a hearing with
counterfeit, and relabeled them in a Federal law for conduct relating to the respect to any of the applicable
manner that did not disclose that they development or approval of a drug considerations under section 306(c)(3)
were unapproved or that they were product or otherwise relating the of the FD&C Act. In her request for a
counterfeit and then shipped them to regulation of a drug product under the hearing, Nguyen argues that the records
other States. The drugs were FD&C Act and (2) that the type of of her criminal proceedings do not
misbranded under section 502(a) of the conduct underlying the conviction support certain findings in the proposal
FD&C Act (21 U.S.C. 352(a)) in that their undermines the process for the to debar. Specifically, she contends that
labeling was false and misleading. regulation of drugs. As set forth in the neither the plea agreement nor the
Nguyen is subject to debarment based proposal to debar Nguyen, her Federal criminal information to which she pled
on a finding, under section misdemeanor conviction involved a guilty support the following findings:
306(b)(2)(B)(i)(I) of the FD&C Act (21 violation of the FD&C Act’s (1) That she was ‘‘aware that the drugs
U.S.C. 335a(b)(2)(B)(i)(I)): (1) That she requirements for drugs. As a result, the [in question] needed to be relabeled for
was convicted of a misdemeanor under conduct underlying her conviction both sale in the United States,’’ (2) that some
Federal law for conduct relating to the related to the regulation of drug of the drugs bore labeling in Portuguese
development or approval of a drug products under the FD&C Act and before they were relabeled, or (3) that
product or otherwise relating to the undermined the process for the the conduct underlying her conviction
regulation of a drug product under the regulation of drugs. Nguyen does not continued for 13 months. Even after
asabaliauskas on DSKBBXCHB2PROD with NOTICES
FD&C Act and (2) that the type of contradict the findings to that effect in disregarding the findings in the
conduct underlying the conviction the proposal to debar and has thus proposal to debar to which Nguyen
undermines the process for the failed to create a material factual objects, we find that she should be
regulation of drugs. By letter dated July dispute with respect to whether she is debarred for the maximum period of 5
6, 2011, FDA served Nguyen a notice subject to debarment under section years.
proposing to debar her for 5 years from 306(b)(2)(B)(i)(I) of the FD&C Act. Nguyen’s factual objections relate
providing services in any capacity to a In her request for a hearing, Nguyen primarily to the consideration of the
person having an approved or pending argues nonetheless that she is entitled to nature and seriousness of her offense
drug product application and providing a hearing because, in the proposal to under section 306(c)(3)(A) of the FD&C
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![49214 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices
Dated: October 19, 2017. ACTION: Notice. SUPPLEMENTARY INFORMATION: The
G. Matthew Warren, holders of the applications listed in
Director, Office of Scientific Integrity. SUMMARY: The Food and Drug table 1 have informed FDA that these
[FR Doc. 2017–23019 Filed 10–23–17; 8:45 am] Administration (FDA) is withdrawing drug products are no longer marketed
BILLING CODE 4164–01–P
approval of 54 abbreviated new drug and have requested that FDA withdraw
applications (ANDAs) from two approval of the applications under the
applicants. The holders of the process in § 314.150(c) (21 CFR
DEPARTMENT OF HEALTH AND applications notified the Agency in
314.150(c)). The applicants have also,
HUMAN SERVICES writing that the drug products were no
by their requests, waived their
longer marketed and requested that the
opportunity for a hearing. Withdrawal
Food and Drug Administration approval of the applications be
withdrawn. of approval of an abbreviated
[Docket No. FDA–2017–N–5715] application under § 314.150(c) is
DATES: Approval is withdrawn as of without prejudice to refiling.
Watson Laboratories, Inc., and Barr November 24, 2017.
Laboratories, Inc., Subsidiaries of Teva
FOR FURTHER INFORMATION CONTACT:
Pharmaceuticals USA, Inc.; Withdrawal
Trang Tran, Center for Drug Evaluation
of Approval of 54 Abbreviated New
and Research, Food and Drug
Drug Applications
Administration, 10903 New Hampshire
AGENCY: Food and Drug Administration, Ave., Bldg. 75, Rm. 1671, Silver Spring,
HHS. MD 20993–0002, 240–402–7945.
TABLE 1
Application No. Drug Applicant
ANDA 061717 ........ Doxycycline Hyclate Capsules USP, Equivalent to (EQ) 50 milligrams Watson Laboratories, Inc., Subsidiary of Teva
(mg) base and EQ 100 mg base. Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 062087 ........ Erythromycin Estolate Capsules USP, EQ 250 mg base ......................... Do.
ANDA 062318 ........ Gentamicin Injection USP, EQ 10 mg base/milliliter (mL) and EQ 40 mg Do.
base/mL.
ANDA 062816 ........ Ampicillin for Injection USP, EQ 125 mg base/vial, EQ 250 mg base/ Do.
vial, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g
base/vial.
ANDA 062994 ........ Ampicillin for Injection USP, EQ 10 g base/vial ........................................ Do.
ANDA 062999 ........ Erythromycin Delayed-Release Tablets USP, 500 mg ............................. Barr Laboratories, Inc., Subsidiary of Teva
Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 064036 ........ Cefuroxime for Injection USP, EQ 7.5 g base/vial ................................... Watson Laboratories, Inc., Subsidiary of Teva
Pharmaceuticals USA, Inc.
ANDA 070296 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do.
ANDA 070412 ........ Furosemide Tablets USP, 20 mg .............................................................. Do.
ANDA 070435 ........ Ibuprofen Tablets USP, 200 mg ............................................................... Do.
ANDA 070436 ........ Ibuprofen Tablets USP, 400 mg ............................................................... Do.
ANDA 070437 ........ Ibuprofen Tablets USP, 600 mg ............................................................... Do.
ANDA 070449 ........ Furosemide Tablets USP, 20 mg .............................................................. Do.
ANDA 070450 ........ Furosemide Tablets USP, 40 mg .............................................................. Do.
ANDA 070515 ........ Tolazamide Tablets USP, 500 mg ............................................................ Do.
ANDA 070528 ........ Furosemide Tablets USP, 80 mg .............................................................. Do.
ANDA 071238 ........ Doxepin Hydrochloride (HCl) Capsules USP, EQ 50 mg base ................ Do.
ANDA 071547 ........ Ibuprofen Tablets USP, 800 mg ............................................................... Do.
ANDA 072397 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do.
ANDA 072407 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do.
ANDA 072602 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do.
ANDA 072630 ........ Albuterol Tablets USP, EQ 4 mg base ..................................................... Do.
ANDA 072825 ........ Baclofen Tablets USP, 20 mg ................................................................... Do.
ANDA 073013 ........ Metaproterenol Sulfate Tablets USP, 10 mg ............................................ Do.
ANDA 073445 ........ Meperidine HCl Injection USP, 100 mg/mL .............................................. Do.
ANDA 074025 ........ Guanabenz Acetate Tablets USP, EQ 4 mg base and EQ 8 mg base ... Do.
ANDA 074114 ........ Dobutamine Injection USP, EQ 12.5 mg base/mL ................................... Do.
ANDA 074163 ........ Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg ........................... Do.
ANDA 074287 ........ Piroxicam Capsules USP, 10 mg and 20 mg ........................................... Do.
ANDA 074303 ........ Pentamidine Isethionate for Injection, 300 mg/vial ................................... Do.
ANDA 074437 ........ Pindolol Tablets USP, 5 mg and 10 mg ................................................... Do.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ANDA 074456 ........ Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg ............................. Do.
ANDA 077643 ........ Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg .............. Do.
ANDA 080728 ........ Diphenhydramine HCl Capsules USP, 25 mg .......................................... Do.
ANDA 080968 ........ Dexamethasone Tablets USP, 0.75 mg ................................................... Do.
ANDA 081040 ........ Chlorzoxazone Tablets USP, 500 mg ....................................................... Do.
ANDA 081149 ........ Hydroxyzine HCl Tablets USP, 10 mg ...................................................... Do.
ANDA 081189 ........ Hydrochlorothiazide Tablets USP, 25 mg ................................................. Do.
ANDA 081216 ........ Estropipate Tablets USP, 6 mg ................................................................ Do.
ANDA 083232 ........ Hydrochlorothiazide Tablets USP, 50 mg ................................................. Do.
VerDate Sep<11>2014 17:47 Oct 23, 2017 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\24OCN1.SGM 24OCN1](https://thefederalregister.org/doc/82_FR_49415/page/4.svg)
Document Created: 2018-10-25 10:10:51
Document Modified: 2018-10-25 10:10:51
| 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 | The order is effective October 24, 2017. | |
| Contact | Nathan R. Sabel, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, MD 20993, 301-796-8588. | |
| FR Citation | 82 FR 49211 |
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