81 FR 80073 - Paul S. Singh: Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 220 (November 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 220 (November 15, 2016)
| Page Range | 80073-80074 | |
| FR Document | 2016-27418 |
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)] [Notices] [Pages 80073-80074] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27418] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices 80073
We are not using notice and comment effects, distributive impacts, and requires that agencies assess anticipated
rulemaking in this notification of equity). A regulatory impact analysis costs and benefits before issuing any
Medicare Part A premiums for CY 2017 (RIA) must be prepared for major rule whose mandates require spending
as that procedure is unnecessary notices with economically significant in any 1 year of $100 million in 1995
because of the lack of discretion in the effects ($100 million or more in any 1 dollars, updated annually for inflation.
statutory formula that is used to year). As stated in section IV of this In 2016, that threshold is approximately
calculate the premium and the solely notice, we estimate that the overall $146 million. This notice does not
ministerial function that this notice effect of the changes in the Part A impose mandates that will have a
serves. The APA permits agencies to premium will be a cost to voluntary consequential effect of $146 million or
waive notice and comment rulemaking enrollees (section 1818 and section more on state, local, or tribal
when notice and public comment 1818A of the Act) of about $17 million. governments or on the private sector.
thereon are unnecessary. On this basis, As a result, this notice is non- Executive Order 13132 establishes
we waive publication of a proposed economically significant under section certain requirements that an agency
notice and a solicitation of public 3(f)(1) of Executive Order 12866 and is must meet when it promulgates a
comments. not a major action under the proposed rule (and subsequent final
Congressional Review Act. In rule) that imposes substantial direct
VI. Collection of Information accordance with the provisions of requirement costs on state and local
Requirements Executive Order 12866, this notice was governments, preempts state law, or
This document does not impose reviewed by the Office of Management otherwise has Federalism implications.
information collection requirements, and Budget. Since this notice does not impose any
that is, reporting, recordkeeping or The RFA requires agencies to analyze costs on state or local governments, the
third-party disclosure requirements. options for regulatory relief of small requirements of Executive Order 13132
Consequently, there is no need for entities, if a rule has a significant impact are not applicable.
review by the Office of Management and on a substantial number of small
entities. For purposes of the RFA, small Dated: September 23, 2016.
Budget under the authority of the
entities include small businesses, Andrew M. Slavitt,
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.). nonprofit organizations, and small Acting Administrator, Centers for Medicare
governmental jurisdictions. Most & Medicaid Services.
VII. Regulatory Impact Analysis hospitals and most other providers and Dated: November 8, 2016.
A. Statement of Need suppliers are small entities, either by Sylvia M. Burwell,
nonprofit status or by having revenues Secretary, Department of Health and Human
Section 1818(d) of the Act requires of less than $7.5 million to $38.5 Services.
the Secretary of the Department of million in any 1 year (for details, see the [FR Doc. 2016–27388 Filed 11–10–16; 4:15 pm]
Health and Human Services (the Small Business Administration’s Web BILLING CODE 4120–01–P
Secretary) during September of each site at http://www.sba.gov/sites/default/
year to determine and publish the files/files/Size_Standards_Table.pdf).
amount to be paid, on an average per Individuals and states are not DEPARTMENT OF HEALTH AND
capita basis, from the Federal Hospital included in the definition of a small HUMAN SERVICES
Insurance Trust Fund for services entity. As discussed above, this annual
incurred in the impending CY notice announces Medicare’s Hospital Food and Drug Administration
(including the associated administrative Insurance (Part A) premium for [Docket No. FDA–2016–N–1311]
costs) on behalf of individuals aged 65 uninsured enrollees in CY 2017. As a
and over who will be entitled to benefits result, we are not preparing an analysis Paul S. Singh: Debarment Order
under Medicare Part A. for the RFA because the Secretary has
determined that this notice will not AGENCY: Food and Drug Administration,
B. Overall Impact
have a significant economic impact on HHS.
We have examined the impact of this a substantial number of small entities. ACTION: Notice.
notice as required by Executive Order In addition, section 1102(b) of the
12866 on Regulatory Planning and Social Security Act requires us to SUMMARY: The U.S. Food and Drug
Review (September 30, 1993), Executive prepare a regulatory impact analysis if Administration (FDA or Agency) is
Order 13563 on Improving Regulation a rule may have a significant impact on issuing an order under the Federal
and Regulatory Review (January 18, the operations of a substantial number Food, Drug, and Cosmetic Act (the
2011), the Regulatory Flexibility Act of small rural hospitals. This analysis FD&C Act) permanently debarring Paul
(RFA) (September 19, 1980, Pub. L. 96– must conform to the provisions of S. Singh from providing services in any
354), section 1102(b) of the Social section 604 of the RFA. For purposes of capacity to a person that has an
Security Act, section 202 of the section 1102(b) of the Act, we define a approved or pending drug product
Unfunded Mandates Reform Act of 1995 small rural hospital as a hospital that is application. FDA bases this order on a
(March 22, 1995; Pub. L. 104–4), located outside of a Metropolitan finding that Dr. Singh was convicted of
Executive Order 13132 on Federalism Statistical Area for Medicare payment a felony under Federal law for conduct
(August 4, 1999) and the Congressional regulations and has fewer than 100 relating to the regulation of a drug
Review Act (5 U.S.C. Part I, Ch. 8). beds. As discussed above, we are not product under the FD&C Act. Dr. Singh
Executive Orders 12866 and 13563 preparing an analysis for section 1102(b) was given notice of the proposed
mstockstill on DSK3G9T082PROD with NOTICES
direct agencies to assess all costs and of the Act, because the Secretary has permanent debarment and an
benefits of available regulatory determined that this notice will not opportunity to request a hearing within
alternatives and, if regulation is have a significant impact on the the timeframe prescribed by regulation.
necessary, to select regulatory operations of a substantial number of Dr. Singh failed to request a hearing. Dr.
approaches that maximize net benefits small rural hospitals. Singh’s failure to request a hearing
(including potential economic, Section 202 of the Unfunded constitutes a waiver of his right to a
environmental, public health and safety Mandates Reform Act of 1995 also hearing concerning this action.
VerDate Sep<11>2014 22:00 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\15NON1.SGM 15NON1](https://thefederalregister.org/doc/81_FR_80293/page/1.svg)
![80074 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
DATES: This order is effective November failed to inform his patients that he had under authority delegated to him (Staff
15, 2016. inserted a non-FDA approved copper Manual Guide 1410.35), finds that Paul
ADDRESSES: Submit applications for IUD, and none of his patients consented S. Singh has been convicted of a felony
special termination of debarment to the to the insertion of one. On or about under Federal law for conduct relating
Division of Dockets Management (HFA– August 17, 2010, FDA agents met with to the regulation of a drug product
305), Food and Drug Administration, Dr. Singh and warned him that he could under the FD&C Act. Section
5630 Fishers Lane, Rm. 1061, Rockville, not insert non-FDA approved copper 306(c)(2)(A)(ii) of the FD&C Act requires
MD 20852. IUDs, and he agreed that he would stop that Dr. Singh’s debarment be
FOR FURTHER INFORMATION CONTACT:
doing so. Notwithstanding this warning, permanent.
Kenny Shade, Division of Enforcement, Dr. Singh continued to insert non-FDA
approved copper IUDs in his patients As a result of the foregoing finding,
Office of Enforcement and Import Paul S. Singh is permanently debarred
Operations, Office of Regulatory Affairs and falsely claimed to his patients that
he was inserting FDA-approved copper from providing services in any capacity
(ELEM–4144), Food and Drug to a person with an approved or
Administration, 12420 Parklawn Dr., IUDs.
Dr. Singh billed at least 10 different pending drug product application under
Rockville, MD 20857, 301–796–4640. sections 505, 512, or 802 of the FD&C
health care benefit programs for
SUPPLEMENTARY INFORMATION: payment for the insertion of non-FDA Act (21 U.S.C. 355, 360b, or 382), or
I. Background approved copper IUDs in his patients. In under section 351 of the Public Health
submitting these claims, Dr. Singh Service Act (42 U.S.C. 262), effective
Section 306(a)(2)(B) of the FD&C Act knowingly misrepresented the type of (see DATES) (see sections 201(dd) (21
(21 U.S.C. 335a(a)(2)(B)) requires IUD he had inserted. Dr. Singh caused U.S.C. 321(dd)), 306(c)(1)(B), and
debarment of an individual if FDA finds the U.S. mails to be used to carry out an
that the individual has been convicted 306(c)(2)(A)(ii) of the FD&C Act). Any
essential part of his scheme. At all person with an approved or pending
of a felony under Federal law for relevant times, Dr. Singh acted with the
conduct relating to the regulation of any drug product application who
intent to defraud. As a result of Dr. knowingly employs or retains as a
drug product under the FD&C Act. On Singh’s conduct, he made false claims of
July 31, 2015, the U.S. District Court for consultant or contractor, or otherwise
over $83,000 to health care benefit uses the services of Paul S. Singh, in
the Eastern District of California entered programs, his patients, and others.
judgment against Dr. Singh for one any capacity during his debarment, will
As a result of this conviction, FDA
count of mail fraud, in violation of 18 be subject to civil money penalties
sent Dr. Singh by certified mail on
U.S.C. 1341. August 17, 2016, a notice proposing to (section 307(a)(6) of the FD&C Act (21
FDA’s finding that the debarment is permanently debar him from providing U.S.C. 335b(a)(6))). If Dr. Singh provides
appropriate is based on the felony services in any capacity to a person that services in any capacity to a person with
conviction referenced herein. The has an approved or pending drug an approved or pending drug product
factual basis for this conviction is as product application. The proposal was application during his period of
follows: Dr. Singh was the President and based on a finding, under section debarment he will be subject to civil
Secretary of Paul S. Singh, DO, Inc., and 306(a)(2)(B) of the FD&C Act, that Dr. money penalties (section 307(a)(7) of the
provided obstetric and gynecological Singh was convicted of a felony under FD&C Act). In addition, FDA will not
services to women. Beginning on or Federal law for conduct relating to the accept or review any abbreviated new
about May 2008, and continuing to at regulation of a drug product under the drug applications from Paul S. Singh
least on or about June 2012, within the FD&C Act. FDA determined that Dr. during his period of debarment (section
Eastern District of California and Singh’s felony conviction was related to 306(c)(1)(B) of the FD&C Act).
elsewhere, Dr. Singh devised a scheme the regulation of drug products because Any application by Dr. Singh for
and artifice to defraud health care the conduct underlying his conviction special termination of debarment under
benefit programs, patients, and others of undermined FDA’s regulatory oversight section 306(d)(4) of the FD&C Act
money and property by means of over drug products marketed in the should be identified with Docket No.
materially false and fraudulent United States—it involved using and FDA–2016–N–1311 and sent to the
pretenses, representations, and misrepresenting as approved Division of Dockets Management (see
promises. unapproved IUDs that presented health ADDRESSES). All such submissions are to
During the time period described, Dr. risks to patients. The proposal also
Singh provided his patients forms of be filed in four copies. The public
offered Dr. Singh an opportunity to
birth control, including the insertion of availability of information in these
request a hearing, providing him 30
an intrauterine device (‘‘IUD’’). IUDs are submissions is governed by 21 CFR
days from the date of receipt of the letter
regulated by FDA. At the relevant time, 10.20.
in which to file the request, and advised
FDA had only approved one IUD, which him that failure to request a hearing Publicly available submissions will be
used copper as its active ingredient, the constituted a waiver of the opportunity placed in the docket, and will be
ParaGard T–380A IUD. ParaGard T– for a hearing and of any contentions viewable at http://www.regulations.gov
380A was sold only by its manufacturer concerning this action. The proposal or at the Division of Dockets
and was not available on third-party was received on August 23, 2016. Dr. Management (see ADDRESSES) between 9
Web sites. Singh did not request a hearing and has, a.m. and 4 p.m., Monday through
The insertion of a non-FDA approved therefore, waived his opportunity for a Friday.
copper IUD risks a patient’s health and
mstockstill on DSK3G9T082PROD with NOTICES
hearing and any contentions concerning Dated: November 9, 2016.
safety. Dr. Singh knew of this risk and his debarment (21 CFR part 12).
knew that inserting a non-FDA Armando Zamora,
approved copper IUD was prohibited by II. Findings and Order Deputy Director, Office of Enforcement and
FDA. Despite this, Dr. Singh obtained Therefore, the Director, Office of Import Operations, Office of Regulatory
non-FDA approved copper IUDs by Enforcement and Import Operations, Affairs.
purchasing them on the Internet and Office of Regulatory Affairs, under [FR Doc. 2016–27418 Filed 11–14–16; 8:45 am]
inserted them in his patients. Dr. Singh sections 306(a)(2)(B) of the FD&C Act, BILLING CODE 4164–01–P
VerDate Sep<11>2014 22:00 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 E:\FR\FM\15NON1.SGM 15NON1](https://thefederalregister.org/doc/81_FR_80293/page/2.svg)
Document Created: 2016-11-15 00:48:09
Document Modified: 2016-11-15 00:48:09
| 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 effective November 15, 2016. | |
| 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. | |
| FR Citation | 81 FR 80073 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR