[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42826-42827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1992-N-0199]


David J. Brancato: Grant of Special Termination; Final Order 
Terminating Debarment

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) granting 
special termination of the debarment of David J. Brancato. FDA bases 
this order on a finding that Dr. Brancato provided substantial 
assistance in the investigations or prosecutions of offenses relating 
to a matter under FDA's jurisdiction, and that special termination of 
Dr. Brancato's debarment serves the interest of justice and does not 
threaten the integrity of the drug approval process.

DATES: This order is effective July 20, 2015.

ADDRESSES: Comments should reference Docket No. FDA-1992-N-0199 and be 
sent 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, 12420 Parklawn Dr. (ELEM-4144), 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: In a Federal Register notice dated January 
6, 1994 (59 FR 00751), David J. Brancato, a former review chemist with 
FDA's Division of Generic Drugs was permanently debarred from providing 
services in any capacity to a person with an approved or pending drug 
product application under section 306(a) of the FD&C Act (21 U.S.C. 
335a(a)). The debarment was based on FDA's finding that Dr. Brancato 
was convicted of a felony under Federal law for conduct relating to the 
development, or approval of any drug product, or otherwise relating to 
the regulation of a drug product. On May 26, 1998, Dr. Brancato applied 
for special termination of debarment, under section 306(d)(4) of the 
FD&C Act, as amended by the Generic Drug Enforcement Act. On April 15, 
2015, the Agency requested additional information. On April 20, 2015, 
Dr. Brancato provided the requested information.
    Under section 306(d)(4)(C) and (d)(4)(D) of the FD&C Act, FDA may 
limit the period of debarment of a permanently debarred individual if 
the Agency finds that: (1) The debarred individual has provided 
substantial assistance in the investigation or prosecution of offenses 
described in section 306(a) or (b) of the FD&C Act or relating to a 
matter under FDA's jurisdiction; (2) termination of the debarment 
serves the interest of justice; and (3) termination of the debarment 
does not threaten the integrity of the drug approval process.
    Special termination of debarment is discretionary with FDA. FDA 
generally considers a determination by the Department of Justice 
concerning the substantial assistance of a debarred individual 
conclusive in most cases. Dr. Brancato cooperated with the United 
States Attorney's Office in the investigation of several individuals, 
as substantiated by letters submitted to the Agency by Thomas Holland, 
a Special Agent in the Office of the Inspector General, U.S. Department 
of Health and Human Services, and the U.S. Attorney's Office for the 
District of Columbia. His cooperation contributed to the successful 
prosecution of these individuals, and in one instance continued over a 
period of 7 years. Accordingly, FDA finds that Dr. Brancato provided 
substantial assistance as required by section 306(d)(4)(C) of the FD&C 
Act.
    The additional requisite showings, i.e., that termination of 
debarment serves the interest of justice and poses no threat to the 
integrity of the drug approval process, are difficult standards to 
satisfy. In determining whether these have been met, the Agency weighs 
the significance of all favorable and unfavorable factors in light of 
the remedial, public health-related purposes underlying debarment. 
Termination of debarment will not be granted unless, weighing all 
favorable and unfavorable information, there is a high level of 
assurance that the conduct that formed the basis for debarment has not 
recurred and will not recur, and that the individual will not otherwise 
pose a threat to the integrity of the drug approval process.
    The evidence presented to FDA in support of termination shows that 
Dr. Brancato was convicted for a first offense; that he has no prior or 
subsequent convictions for conduct described under the FD&C Act and has 
committed no other wrongful acts affecting the drug approval process; 
and that his character and scientific accomplishments are highly 
regarded by his professional peers. The evidence

[[Page 42827]]

presented supports the conclusion that the conduct upon which Dr. 
Brancato's debarment was based is unlikely to recur. For these reasons, 
the Agency finds that termination of Dr. Brancato's debarment serves 
the interest of justice and will not pose a threat to the integrity of 
the drug approval process.
    Under section 306(d)(4)(D) of the FD&C Act, the period of debarment 
of an individual who qualifies for special termination may be limited 
to less than permanent but to no less than 1 year. Dr. Brancato's 
period of debarment, which commenced on January 6, 1994, has lasted 
more than 1 year. Accordingly, the Director of the Office of 
Enforcement and Import Operations, under section 306(d)(4) of the FD&C 
Act and under authority delegated to the Director (Staff Manual Guide 
1410.35), finds that David J. Brancato's application for special 
termination of debarment should be granted, and that the period of 
debarment should terminate immediately, thereby allowing him to provide 
services in any capacity to a person with an approved or pending drug 
product application. The Director of Enforcement and Import Operations 
further finds that because the Agency is granting Dr. Brancato's 
application, an informal hearing under section 306(d)(4)(C) of the FD&C 
Act is unnecessary.
    As a result of the foregoing findings, Dr. David J. Brancato's 
debarment is terminated effective (see DATES) (21 U.S.C. 335a(d)(4)(C) 
and (d)(4)(D)).

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17712 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P