[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)]
[Notices]
[Pages 80073-80074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1311]


Paul S. Singh: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) permanently debarring Paul S. Singh 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. Singh 
was convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. Dr. Singh was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Singh failed to request a hearing. Dr. Singh's failure to request a 
hearing constitutes a waiver of his right to a hearing concerning this 
action.

[[Page 80074]]


DATES: This order is effective November 15, 2016.

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, Division of Enforcement, 
Office of Enforcement and Import Operations, Office of Regulatory 
Affairs (ELEM-4144), Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the regulation of any drug product under the FD&C Act. On July 31, 
2015, the U.S. District Court for the Eastern District of California 
entered judgment against Dr. Singh for one count of mail fraud, in 
violation of 18 U.S.C. 1341.
    FDA's finding that the debarment is appropriate is based on the 
felony conviction referenced herein. The factual basis for this 
conviction is as follows: Dr. Singh was the President and Secretary of 
Paul S. Singh, DO, Inc., and provided obstetric and gynecological 
services to women. Beginning on or about May 2008, and continuing to at 
least on or about June 2012, within the Eastern District of California 
and elsewhere, Dr. Singh devised a scheme and artifice to defraud 
health care benefit programs, patients, and others of money and 
property by means of materially false and fraudulent pretenses, 
representations, and promises.
    During the time period described, Dr. Singh provided his patients 
forms of birth control, including the insertion of an intrauterine 
device (``IUD''). IUDs are regulated by FDA. At the relevant time, FDA 
had only approved one IUD, which used copper as its active ingredient, 
the ParaGard T-380A IUD. ParaGard T-380A was sold only by its 
manufacturer and was not available on third-party Web sites.
    The insertion of a non-FDA approved copper IUD risks a patient's 
health and safety. Dr. Singh knew of this risk and knew that inserting 
a non-FDA approved copper IUD was prohibited by FDA. Despite this, Dr. 
Singh obtained non-FDA approved copper IUDs by purchasing them on the 
Internet and inserted them in his patients. Dr. Singh failed to inform 
his patients that he had inserted a non-FDA approved copper IUD, and 
none of his patients consented to the insertion of one. On or about 
August 17, 2010, FDA agents met with Dr. Singh and warned him that he 
could not insert non-FDA approved copper IUDs, and he agreed that he 
would stop doing so. Notwithstanding this warning, Dr. Singh continued 
to insert non-FDA approved copper IUDs in his patients and falsely 
claimed to his patients that he was inserting FDA-approved copper IUDs.
    Dr. Singh billed at least 10 different health care benefit programs 
for payment for the insertion of non-FDA approved copper IUDs in his 
patients. In submitting these claims, Dr. Singh knowingly 
misrepresented the type of IUD he had inserted. Dr. Singh caused the 
U.S. mails to be used to carry out an essential part of his scheme. At 
all relevant times, Dr. Singh acted with the intent to defraud. As a 
result of Dr. Singh's conduct, he made false claims of over $83,000 to 
health care benefit programs, his patients, and others.
    As a result of this conviction, FDA sent Dr. Singh by certified 
mail on August 17, 2016, a notice 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)(B) of the FD&C Act, that Dr. Singh 
was convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. FDA determined that 
Dr. Singh's felony conviction was related to the regulation of drug 
products because the conduct underlying his conviction undermined FDA's 
regulatory oversight over drug products marketed in the United States--
it involved using and misrepresenting as approved unapproved IUDs that 
presented health risks to patients. The proposal also offered Dr. Singh 
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 August 23, 2016. Dr. Singh did not 
request a hearing and has, therefore, waived his opportunity for a 
hearing and any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under sections 306(a)(2)(B) 
of the FD&C Act, under authority delegated to him (Staff Manual Guide 
1410.35), finds that Paul S. Singh has been convicted of a felony under 
Federal law for conduct relating to the regulation of a drug product 
under the FD&C Act. Section 306(c)(2)(A)(ii) of the FD&C Act requires 
that Dr. Singh's debarment be permanent.
    As a result of the foregoing finding, Paul S. Singh 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 201(dd) (21 U.S.C. 321(dd)), 306(c)(1)(B), and 
306(c)(2)(A)(ii) 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 Paul S. 
Singh, in any capacity during his 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. Singh 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 from Paul S. Singh 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Singh for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2016-N-1311 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.
    Publicly available submissions will be placed in the docket, and 
will be viewable at http://www.regulations.gov or at the Division of 
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: November 9, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs.
[FR Doc. 2016-27418 Filed 11-14-16; 8:45 am]
 BILLING CODE 4164-01-P