80 FR 35654 - Health Resources and Services Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 119 (June 22, 2015)

Page Range		35654-35655
FR Document		2015-15288

Federal Register, Volume 80 Issue 119 (Monday, June 22, 2015)

[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35654-35655]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Health Resources and Services Administration

Delegation of Authority

    Notice is hereby given that I have delegated to the Administrator 
of the Health Resources and Services Administration, or his or her 
successor,

[[Page 35655]]

the following authorities vested in the Secretary:
     The authorities vested under Section 343 of the Illegal 
Immigration Reform and Immigrant Responsibility Act (IIRIRA) of 1996, 
[8 U.S.C. 1182(a)(5)], as amended, titled ``Certification Requirements 
for Foreign Healthcare Workers.''
    These authorities may be redelegated. Exercise of these authorities 
is concurrent and does not supplant existing delegations of authority 
from the Secretary. Exercise of these authorities shall be in 
accordance with established policies, procedures, guidelines, and 
regulations as prescribed by the Secretary.
    This delegation is effective immediately upon date of signature.

    Dated: June 16, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015-15288 Filed 6-19-15; 8:45 am]
BILLING CODE 4165-15-P

35654 Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices

SUPPLEMENTARY INFORMATION: allowed those drugs to be shipped into debarred from providing services in any
the United States to Aphrodite. When capacity to a person with an approved
I. Background
the drugs arrived, he would alert or pending drug product application
Section 306(a)(2)(B) of the FD&C Act individuals at Gallant Pharma to under sections 505, 512, or 802 of the
(21 U.S.C. 335a(a)(2)(B)) requires retrieve the illegal drugs. He FD&C Act (21 U.S.C. 355, 360b, or 382),
debarment of an individual if FDA finds additionally would take some of the or under section 351 of the Public
that the individual has been convicted misbranded and non-FDA-approved Health Service Act (42 U.S.C. 262),
of a felony under Federal law for drugs from the packages intended for effective (see DATES) (see section
conduct relating to the regulation of any Gallant Pharma for use on his patients 201(dd), 306(c)(1)(B), and
drug product under the FD&C Act. at Aphrodite. 306(c)(2)(A)(ii) of the FD&C Act, (21
On July 23, 2014, the U.S. District Between August 2009 and August U.S.C. 321(dd), 335a(c)(1)(B), and
Court for the Eastern District of Virginia 2012, Dr. Sarraf received and handed off 335a(c)(2)(A)(ii)). Any person with an
entered judgment against Dr. Sarraf after at least 40 shipments containing approved or pending drug product
a jury found him guilty of one count of illegally imported drugs and devices. application who knowingly employs or
conspiracy, in violation of 18 U.S.C. Between August 2009 and August 2012, retains as a consultant or contractor, or
371, three counts of importation Dr. Sarraf purchased approximately otherwise uses the services of
contrary to law, in violation of 18 U.S.C. $250,000 in misbranded and non-FDA- Anoushirvan Sarraf, in any capacity
545 and 18 U.S.C. 2, two counts of approved drugs and devices from during his debarment, will be subject to
receipt and delivery of misbranded Gallant Pharma. civil money penalties (section 307(a)(6)
drugs, in violation of 21 U.S.C. 331(c), As a result of his convictions, on of the FD&C Act (21 U.S.C. 335b(a)(6))).
333(a)(2), and 18 U.S.C. 2, and one March 9, 2015, FDA sent Dr. Sarraf a If Dr. Sarraf provides services in any
count of unlicensed wholesale notice by certified mail proposing to capacity to a person with an approved
distribution of prescription drugs, in permanently debar him from providing or pending drug product application
violation of 21 U.S.C. 331(t), services in any capacity to a person that during his period of debarment he will
333(b)(1)(D), 353(e)(2)(A), 353(e)(3)(B), has an approved or pending drug be subject to civil money penalties
and 18 U.S.C. 2. product application. The proposal was (section 307(a)(7) of the Act (21 U.S.C.
FDA’s finding that debarment is based on the finding, under section 335b(a)(7))). In addition, FDA will not
appropriate is based on the felony 306(a)(2)(B) of the FD&C Act, that Dr. accept or review any abbreviated new
convictions referenced herein. The Sarraf was convicted of felonies under drug applications submitted by or with
factual basis for these convictions is as Federal law for conduct related to the the assistance of Anoushirvan Sarraf
follows: Dr. Sarraf was a physician and regulation of a drug product. FDA during his period of debarment (section
owner of Aphrodite in McLean, determined that Dr. Sarraf’s felony 306(c)(1)(A) of the FD&C Act (21 U.S.C.
Virginia, in the Eastern District of convictions were related to the 335a(c)(1)(A))).
Virginia. Dr. Sarraf provided his regulation of drug products because the Any application by Dr. Sarraf for
medical license to Gallant Pharma conduct underlying his convictions special termination of debarment under
International Inc. (Gallant Pharma), for undermined FDA’s regulatory oversight section 306(d)(4) of the FD&C Act (21
use by international co-conspirators, over drug products marketed in the U.S.C. 335a(d)(4)) should be identified
received importations in his and United States, by intentionally with Docket No. FDA–2014–N–2101
Aphrodite’s name on behalf of Gallant introducing into interstate commerce and sent to the Division of Dockets
Pharma, and purchased misbranded and drug misbranded products. The Management (see ADDRESSES). All such
non-FDA approved drugs and devices proposal also offered Dr. Sarraf an submissions are to be filed in four
from Gallant Pharma. In exchange for opportunity to request a hearing, copies. The public availability of
use of his medical license, mailing provided him 30 days from the date of information in these submissions is
name, and address, Dr. Sarraf received receipt of the letter in which to file the governed by 21 CFR 10.20.
discounted pricing from Gallant request, and advised him that failure to Publicly available submissions may
Pharma. request a hearing constituted a waiver of be seen in the Division of Dockets
Beginning in or around June 2009, the opportunity for a hearing and of any Management between 9 a.m. and 4 p.m.,
and continuing until at least August contentions concerning this action. The Monday through Friday.
2013, in the Eastern District of Virginia proposal was received on March 12,
and elsewhere, Dr. Sarraf knowingly Dated: June 16, 2015.
2015. Dr. Sarraf failed to respond within
and intentionally conspired and agreed Douglass Stearn,
the timeframe prescribed by regulation
to commit offenses against the United and has, therefore, waived his Director, Division of Compliance Policy,
States by: Fraudulently and knowingly Office of Enforcement, Office of Regulatory
opportunity for a hearing and has
importing misbranded drugs; knowingly Affairs.
waived any contentions concerning his
engaging in the wholesale distribution [FR Doc. 2015–15163 Filed 6–19–15; 8:45 am]
debarment (21 CFR part 12).
of prescription drugs in Virginia BILLING CODE 4164–01–P
without being licensed to do so; II. Findings and Order
receiving in interstate commerce, Therefore, the Director, Office of
delivering and proffering delivery for Enforcement and Import Operations, DEPARTMENT OF HEALTH AND
pay, misbranded drugs; defrauding the Office of Regulatory Affairs, under HUMAN SERVICES
United States and its Agencies by section 306(a)(2)(B) of the FD&C Act, Health Resources and Services
impeding, impairing, and defeating the under authority delegated to the Administration
tkelley on DSK3SPTVN1PROD with NOTICES

lawful functions of FDA to protect the Director (Staff Manual Guide 1410.35),
health and safety of the public. finds that Anoushirvan Sarraf has been Delegation of Authority
Dr. Sarraf provided Gallant Pharma convicted of seven felonies under
with his medical license to enable Federal law for conduct relating to the Notice is hereby given that I have
Gallant Pharma to order non-FDA- regulation of a drug product. delegated to the Administrator of the
approved chemotherapy and cosmetic As a result of the foregoing findings, Health Resources and Services
drugs from around the world, and Anoushirvan Sarraf is permanently Administration, or his or her successor,

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Document Created: 2018-02-22 11:13:54
Document Modified: 2018-02-22 11:13:54

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
FR Citation		80 FR 35654