80 FR 55632 - Syed Huda: Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 179 (September 16, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 179 (September 16, 2015)
| Page Range | 55632-55634 | |
| FR Document | 2015-23204 |
[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)] [Notices] [Pages 55632-55634] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23204] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-2102] Syed Huda: 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 Syed Huda 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 Mr. Huda was convicted of two felonies under Federal law for conduct relating to the regulation of a drug product. Mr. Huda was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Huda failed to respond. Mr. Huda's failure to respond constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective September 16, 2015. ADDRESSES: Submit applications for special termination of debarment to the Division of Dockets Management (HFA- [[Page 55633]] 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kenny Shade (ELEM-4144) Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs, 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 May 16, 2014, the U.S. District Court for the Eastern District of Virginia entered judgment against Mr. Huda for one count of importation contrary to law, in violation of 18 U.S.C. 545 and 2, one count of introducing misbranded drugs into interstate commerce, in violation of 21 U.S.C. 331(a), 333(a)(2), and 18 U.S.C. 2, one count of unlicensed wholesale distribution of prescription drugs, in violation of 21 U.S.C. 331(t), 333(b)(1)(D), 353(e)(2)(A), and 18 U.S.C. 2, and one count of wire fraud, in violation of 18 U.S.C. 1343. FDA's finding that debarment is appropriate is based on the felony convictions referenced herein. The factual basis for this conviction is as follows: Mr. Huda was a cofounder and co-owner of Gallant Pharma International Inc. (Gallant Pharma), between August 2009 and August 2013. Gallant was a company dedicated to the illegal importation and sale of misbranded and non-FDA approved chemotherapy drugs and injectable cosmetic drugs and devices in the United States. As cofounder and co-owner of Gallant Pharma, Mr. Huda was primarily responsible for the United States based portion of the conspiracy, including: (1) Identifying a drop shipper willing to accept illegal importations of behalf of Gallant Pharma, (2) locating space for Gallant Pharma to store misbranded and non-FDA approved drugs and devices, (3) establishing relationships with customers in the Washington, DC metropolitan area, (4) interviewing and hiring sales representatives in other parts of the United States, and (5) establishing merchant accounts with credit card processors, for receipt of illegal proceeds via wire transfer into Canadian bank accounts. Gallant Pharma was not licensed as a prescription drug wholesaler by the Commonwealth of Virginia. Some of the drugs and devices that Mr. Huda acquired were not approved by the FDA for use on patients in the United States. Mr. Huda admitted that the drugs sold by Gallant Pharma were prescription only; and were misbranded in that, among other things, they did not bear adequate directions for use and were not subject to an exemption from that requirement; and they were accompanied by non-FDA approved packaging and inserts. The drugs Gallant Pharma sold also lacked the FDA-required pedigree, which protects patient health by tracking each sale, purchase, or trade of a drug from the time of manufacturing to delivery to the patient. Immediately after establishing Gallant Pharma's presence in the Eastern District of Virginia, on or about September 25, 2009, Mr. Huda received a cease and desist letter from a law firm on behalf of Medicis, the exclusive authorized marketer of RESTYLANE and PERLANE in the United States and Canada. The letter informed Gallant Pharma that its marketing of these drugs violated the FD&C Act and could subject Gallant Pharma to substantial criminal and civil penalties. The letter included Gallant Pharma's marketing materials, which falsely claimed that Gallant Pharma had been ``strictly working with the current FDA rules and regulations for almost 10 years.'' Mr. Huda personally solicited orders on behalf of Gallant Pharma, and on or about October 19, 2010, he sold 10 vials of misbranded TAXOTERE to a physician in Oceanside, CA, in exchange for $2450, thereby causing misbranded drugs to travel in interstate commerce from the Eastern District of Virginia. Mr. Huda was aware of several occasions in which physicians complained after receiving drugs with packaging and inserts written in language other than English, and he authorized a price reduction upon receiving such complaints. Between August 2009 and August 2013, Gallant Pharma received illegal proceeds of at least $12,400,000 from the sale of misbranded and non-FDA approved drugs and devices in the United States. Mr. Huda admitted that he was an organizer or leader of this criminal activity and that his actions were in all respects knowing, voluntary, and intentional, and did not occur by accident, mistake, or for another innocent reason. As a result of his conviction, on May 20, 2015, FDA sent Mr. Huda 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 the finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Huda was convicted of felonies under Federal law for conduct related to the regulation of a drug product. The proposal also offered Mr. Huda 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 May 26, 2015. Mr. Huda 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, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Syed Huda has been convicted of felonies under Federal law for conduct relating to the regulation of a drug product. As a result of the foregoing finding, Syed Huda 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 section 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(ii)). 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 Syed Huda, 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 Mr. Huda 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 Syed Huda during his period of debarment (section 306(c)(1)(B) of the FD&C Act. Any application by Mr. Huda for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. [[Page 55634]] FDA-2014-N-2102 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 may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-23204 Filed 9-15-15; 8:45 am] BILLING CODE 4164-01-P
![55632 Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
Other laboratories ........................................... Burden of Canine Brucellosis Information 10 1 1
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Leroy A. Richardson, Corrective Action Documentation are subject to a penalty are allowed to
Chief, Information Collection Review Office, Process. provide reasonable cause justifications
Office of Scientific Integrity, Office of the as to why a penalty should not be
Associate Director for Science, Office of the
OMB No.: 0970–0215.
imposed or may develop and implement
Director, Centers for Disease Control and Description: 42 U.S.C. 612 (Section
corrective compliance procedures to
Prevention. 412 of the Social Security Act as
[FR Doc. 2015–23226 Filed 9–15–15; 8:45 am] amended by Public Law 104–193, the eliminate the source of the penalty.
Personal Responsibility and Work Finally, there is an annual report, which
BILLING CODE 4163–18–P
Opportunity Reconciliation Act of 1996 requires the Tribes to describe program
(PRWORA)), mandates that federally characteristics. All of the above
DEPARTMENT OF HEALTH AND recognized Indian Tribes with an requirements are currently approved by
HUMAN SERVICES approved Tribal TANF program collect OMB and the Administration for
and submit to the Secretary of the Children and Families is simply
Administration for Children and Department of Health and Human proposing to extend them without any
Families Services data on the recipients served changes.
by the Tribes’ programs. This Respondents: Indian Tribes.
Submission for OMB Review;
information includes both aggregated
Comment Request
and disaggregated data on case
Title: Tribal TANF Data Report, TANF characteristics and individual
Annual Report, and Reasonable Cause/ characteristics. In addition, Tribes that
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Final Tribal TANF Data Report ........................................................................ 70 4 451 126,280
Tribal TANF Annual Report ............................................................................. 70 1 40 2,800
Tribal TANF Reasonable Cause/Corrective .................................................... 70 1 60 4,200
Estimated Total Annual Burden Office of Management and Budget, SUMMARY: The U.S. Food and Drug
Hours: 133,280. Paperwork Reduction Project, Fax: 202– Administration (FDA or Agency) is
Additional Information: Copies of the 395–7285, Email: OIRA_SUBMISSION@ issuing an order under the Federal
proposed collection may be obtained by OMB.EOP.GOV, Attn: Desk Officer for Food, Drug, and Cosmetic Act (the
writing to the Administration for the Administration for Children and FD&C Act) permanently debarring Syed
Families. Huda from providing services in any
Children and Families, Office of
capacity to a person that has an
Planning, Research and Evaluation, 370 Robert Sargis,
approved or pending drug product
L’Enfant Promenade, SW., Washington, Reports Clearance Officer. application. FDA bases this order on a
DC 20447, Attn: ACF Reports Clearance [FR Doc. 2015–23179 Filed 9–15–15; 8:45 am] finding that Mr. Huda was convicted of
Officer. All requests should be BILLING CODE 4184–01–P two felonies under Federal law for
identified by the title of the information conduct relating to the regulation of a
collection. Email address: drug product. Mr. Huda was given
infocollection@acf.hhs.gov. DEPARTMENT OF HEALTH AND notice of the proposed permanent
HUMAN SERVICES debarment and an opportunity to
OMB Comment: OMB is required to
make a decision concerning the Food and Drug Administration request a hearing within the timeframe
collection of information between 30 prescribed by regulation. Mr. Huda
asabaliauskas on DSK7TPTVN1PROD with NOTICES
and 60 days after publication of this failed to respond. Mr. Huda’s failure to
[Docket No. FDA–2014–N–2102] respond constitutes a waiver of his right
document in the Federal Register.
Therefore, a comment is best assured of to a hearing concerning this action.
Syed Huda: Debarment Order
having its full effect if OMB receives it DATES: This order is effective September
within 30 days of publication. Written AGENCY: Food and Drug Administration, 16, 2015.
comments and recommendations for the HHS. ADDRESSES: Submit applications for
proposed information collection should special termination of debarment to the
ACTION: Notice.
be sent directly to the following: Division of Dockets Management (HFA–
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![55634 Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices
FDA–2014–N–2102 and sent to the DEPARTMENT OF HEALTH AND of Environmental Health Sciences
Division of Dockets Management (see HUMAN SERVICES (NIEHS), National Institutes of Health
ADDRESSES). All such submissions are to (NIH).
be filed in four copies. The public National Institutes of Health SUPPLEMENTARY INFORMATION: This
availability of information in these request for OMB review and approval of
submissions is governed by 21 CFR Proposed Collection; 60-Day Comment
Request; Hazardous Waste Worker the information collection is required by
10.20. regulation 42 CFR part 65(a)(6). The
Publicly available submissions may Training
National Institute of Environmental
be seen in the Division of Dockets AGENCY: National Institutes of Health, Health Sciences (NIEHS) was given
Management between 9 a.m. and 4 p.m., HHS. major responsibility for initiating a
Monday through Friday. ACTION: Notice. worker safety and health training
Dated: September 10, 2015. program under Section 126 of the
Leslie Kux, SUMMARY: In compliance with the Superfund Amendments and
requirement of Section 3506(c)(2)(A) of Reauthorization Act of 1986 (SARA) for
Associate Commissioner for Policy.
the Paperwork Reduction Act of 1995, hazardous waste workers and
[FR Doc. 2015–23204 Filed 9–15–15; 8:45 am]
for opportunity for public comment on emergency responders. A network of
BILLING CODE 4164–01–P
proposed data collection projects, the non-profit organizations that are
(NIEHS), the National Institutes of committed to protecting workers and
Health (NIH) will publish periodic their communities by delivering high-
DEPARTMENT OF HEALTH AND
summaries of proposed projects to be quality, peer-reviewed safety and health
HUMAN SERVICES
submitted to the Office of Management curricula to target populations of
National Institutes of Health and Budget (OMB) for review and hazardous waste workers and
approval. emergency responders has been
National Institute on Aging; Notice of Written comments and/or suggestions developed. In twenty-eight years (FY
Closed Meeting from the public and affected agencies 1987–2015), the NIEHS Worker Training
are invited to address one or more of the program has successfully supported 20
Pursuant to section 10(d) of the following points: (1) Whether the
Federal Advisory Committee Act, as primary grantees that have trained more
proposed collection of information is than 3.3 million workers across the
amended (5 U.S.C. App.), notice is necessary for the proper performance of
hereby given of the following meeting. country and presented over 194,000
the function of the agency, including classroom and hands-on training
The meeting will be closed to the whether the information will have
public in accordance with the courses,which have accounted for
practical utility; (2) The accuracy of the nearly 39 million contact hours of actual
provisions set forth in sections agency’s estimate of the burden of the
552b(c)(4) and 552b(c)(6), title 5 U.S.C., training. Generally, the grant will
proposed collection of information, initially be for one year, and subsequent
as amended. The grant applications and including the validity of the
the discussions could disclose continuation awards are also for one
methodology and assumptions used; (3) year at a time. Grantees must submit a
confidential trade secrets or commercial The quality, utility, and clarity of the
property such as patentable material, separate application to have the support
information to be collected; and continued for each subsequent year.
and personal information concerning (4) Minimize the burden of the
individuals associated with the grant Grantees are to provide information in
collection of information on those who accordance with S65.4 (a), (b), (c) and
applications, the disclosure of which are to respond, including the use of
would constitute a clearly unwarranted 65.6(a) on the nature, duration, and
appropriate automated, electronic, purpose of the training, selection
invasion of personal privacy. mechanical, or other technological criteria for trainees’ qualifications and
Name of Committee: National Institute on collection techniques or other forms of competency of the project director and
Aging Special Emphasis Panel; Synaptic information technology.
Plasticity in Alzheimer’s Disease. staff, cooperative agreements in the case
DATES: Comments regarding this of joint applications, the adequacy of
Date: November 6, 2015.
Time: 12:00 p.m. to 5:00 p.m.
information collection are best assured training plans and resources, including
Agenda: To review and evaluate grant of having their full effect if received budget and curriculum, and response to
applications. within 60 days of the date of this meeting training criteria in OSHA’s
Place: National Institute on Aging, publication. Hazardous Waste Operations and
Gateway Building, 2C212, 7201 Wisconsin ADDRESSES: To obtain a copy of the data Emergency Response Regulations (29
Avenue, Bethesda, MD 20892, (Telephone CFR 1910.120). As a cooperative
collection plans and instruments,
Conference Call).
Contact Person: Maurizio Grimaldi, MD, submit comments in writing, or request agreement, there are additional
Ph.D., Scientific Review Officer, National more information on the proposed requirements for the progress report
Institute On Aging, National Institutes Of project, contact: Joseph T. Hughes, Jr., section of the application. Grantees are
Health, 7201 Wisconsin Avenue, Room Director, Worker Training Program, to provide their information in hard
2c218, Bethesda, MD 20892, 301–496–9374, Division of Extramural Research and copy as well as enter information into
grimaldim2@mail.nih.gov. Training, NIEHS, P.O. Box 12233, the WTP Grantee Data Management
(Catalogue of Federal Domestic Assistance Research Triangle Park, NC 27709 or System. The information collected is
call non-toll-free number (919) 541– used by the Director through officers,
asabaliauskas on DSK7TPTVN1PROD with NOTICES
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS) 0217 or Email your request, including employees, experts, and consultants to
your address to: hughes3@niehs.nih.gov. evaluate applications based on technical
Dated: September 10, 2015. Formal requests for additional plans and merit to determine whether to make
Melanie J. Gray, instruments must be requested in awards. Frequency of Response:
Program Analyst, Office of Federal Advisory writing. Proposed Collection: Hazardous Biannual. Affected Public: Non-profit
Committee Policy. Waste Worker Training—42 CFR part organizations. Type of Respondents:
[FR Doc. 2015–23229 Filed 9–15–15; 8:45 am] 65, 0925–0348, Expiration Date 12/31/ Grantees. The annual reporting burden
BILLING CODE 4140–01–P 2015 –EXTENSION, National Institute is as follows: Estimated Number of
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Document Created: 2018-02-26 10:16:53
Document Modified: 2018-02-26 10:16:53
| 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 September 16, 2015. | |
| Contact | Kenny Shade (ELEM-4144) Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640. | |
| FR Citation | 80 FR 55632 |
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