[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14556-14557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0783]


Cheng Yi Liang: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
permanently debarring Cheng Yi Liang, from providing services in any 
capacity to a person that has an approved or pending drug product 
application. We base this order on a finding that Mr. Liang was 
convicted of a felony under Federal law for conduct relating to the 
development or approval, including the process for the development or 
approval, of a drug product. Mr. Liang was given notice of the proposed 
permanent debarment and an opportunity to request a hearing within the 
timeframe prescribed by regulation. Mr. Liang failed to respond. Mr. 
Liang's failure to respond constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is effective March 6, 2013.

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

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory 
Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for

[[Page 14557]]

conduct relating to the development or approval, including the process 
for development or approval, of any drug product.
    On March 5, 2012, the U.S. District Court for the District of 
Maryland accepted Mr. Liang's plea of guilty and adjudged him guilty of 
one count of making a false statement to a Federal Agency, a Federal 
felony offense under 18 U.S.C. 1001 and securities fraud, a Federal 
felony offense under 15 U.S.C. 78j(b) and 78ff.
    FDA's finding that debarment is appropriate is based on the felony 
conviction for securities fraud referenced herein for conduct relating 
to the development or approval, including the process for development 
or approval, of any drug product. The factual basis for this conviction 
is as follows: Mr. Liang was a chemist for FDA, working in the Center 
for Drug Evaluation and Research (CDER) at the Office of New Drug 
Quality Assessment. As a part of his duties with FDA, Mr. Liang had 
access to the FDA's Document Archiving, Reporting and Regulatory 
Tracking Systems (DAARTS), which CDER used internally to manage, track, 
receive and report on new drug applications as well as emerging 
significant drug safety issues.
    Between in or about July 2006 and in or about March 2011, Mr. Liang 
reviewed the DAARTS system to learn non-public information regarding 
when an FDA announcement regarding an experimental drug was imminent 
and to learn the substance of the announcement. Mr. Liang used this 
non-public information relating to drug approvals to cause the 
execution of trades on national securities exchanges, resulting in 
total profits and losses avoided of $3,776,152 during that period of 
time.
    As a result of his conviction, on November 6, 2012, FDA sent Mr. 
Liang a notice by certified mail proposing to permanently debar him 
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(a)(2)(A) of the FD&C Act, that Mr. Liang 
was convicted of a felony under Federal law for conduct relating to the 
development or approval, including the process for development or 
approval, of any drug product. The proposal also offered Mr. Liang an 
opportunity to request a hearing, providing him 30 days from the date 
of receipt of the letter in which to file the request, and advised him 
that failure to request a hearing constituted a waiver of the 
opportunity for a hearing and of any contentions concerning this 
action. The proposal was received on November 9, 2012. Mr. Liang failed 
to respond within the timeframe prescribed by regulation and has, 
therefore, waived his opportunity for a hearing and has waived any 
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, Associate Commissioner for Regulatory Affairs, Office of 
Regulatory Affairs, under section 306(a)(2)(A) of the FD&C Act, under 
authority delegated to the Director (Staff Manual Guide 1410.21), finds 
that Cheng Yi Liang has been convicted of a felony under Federal law 
for conduct relating to the development or approval, including the 
process for development or approval, of a drug product.
    As a result of the foregoing finding, Mr. Liang is permanently 
debarred 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)(2)(A)(ii), and 201(dd) of the 
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). 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 Mr. Liang in any capacity during Mr. 
Liang's 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 Mr. Liang 
provides services in any capacity to a person with an approved or 
pending drug product application during his period of debarment, he 
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 Mr. Liang 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Liang for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2012-N-0783 and sent to the Division of Dockets 
Management (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 may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 8, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of 
Regulatory Affairs.
[FR Doc. 2013-05160 Filed 3-5-13; 8:45 am]
BILLING CODE 4160-01-P