80 FR 42826 - David J. Brancato: Grant of Special Termination; Final Order Terminating Debarment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 138 (July 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 138 (July 20, 2015)
| Page Range | 42826-42827 | |
| FR Document | 2015-17712 |
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)] [Notices] [Pages 42826-42827] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17712] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![42826 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices
present their views on the DEPARTMENT OF HEALTH AND Under section 306(d)(4)(C) and
reauthorization. The FD&C Act further HUMAN SERVICES (d)(4)(D) of the FD&C Act, FDA may
requires that FDA continue meeting limit the period of debarment of a
with these stakeholders at least once Food and Drug Administration permanently debarred individual if the
every month during negotiations with Agency finds that: (1) The debarred
the regulated industry to continue [Docket No. FDA–1992–N–0199] individual has provided substantial
discussions of stakeholder views on the assistance in the investigation or
reauthorization. It is anticipated that David J. Brancato: Grant of Special prosecution of offenses described in
these monthly stakeholder consultation Termination; Final Order Terminating section 306(a) or (b) of the FD&C Act or
meetings will commence in September Debarment relating to a matter under FDA’s
or October 2015. AGENCY: Food and Drug Administration, jurisdiction; (2) termination of the
FDA is issuing this Federal Register debarment serves the interest of justice;
HHS.
notice to request that stakeholder and (3) termination of the debarment
representatives from patient and ACTION: Notice. does not threaten the integrity of the
consumer groups, health care SUMMARY: The Food and Drug drug approval process.
professional associations, as well as Administration (FDA) is issuing an Special termination of debarment is
scientific and academic experts, notify order under the Federal Food, Drug, and discretionary with FDA. FDA generally
FDA of their intent to participate in the Cosmetic Act (the FD&C Act) granting considers a determination by the
periodic stakeholder consultation Department of Justice concerning the
special termination of the debarment of
meetings on PDUFA reauthorization. substantial assistance of a debarred
David J. Brancato. FDA bases this order
FDA believes that consistent individual conclusive in most cases. Dr.
on a finding that Dr. Brancato provided
stakeholder representation at these Brancato cooperated with the United
substantial assistance in the
meetings will be important to ensure States Attorney’s Office in the
investigations or prosecutions of
progress in these discussions. If you investigation of several individuals, as
offenses relating to a matter under
wish to participate in the stakeholder substantiated by letters submitted to the
FDA’s jurisdiction, and that special
consultation meetings, please designate Agency by Thomas Holland, a Special
termination of Dr. Brancato’s debarment
one or more representatives from your Agent in the Office of the Inspector
serves the interest of justice and does
organization who will commit to General, U.S. Department of Health and
not threaten the integrity of the drug Human Services, and the U.S.
attending these meetings and preparing approval process.
for the discussions. Stakeholders who Attorney’s Office for the District of
DATES: This order is effective July 20, Columbia. His cooperation contributed
identify themselves through this notice
will be included in all stakeholder 2015. to the successful prosecution of these
consultation discussions while FDA ADDRESSES: Comments should reference individuals, and in one instance
negotiates with the regulated industry. If Docket No. FDA–1992–N–0199 and be continued over a period of 7 years.
a stakeholder decides to participate in sent to the Division of Dockets Accordingly, FDA finds that Dr.
these monthly meetings at a later time, Management (HFA–305), Food and Drug Brancato provided substantial assistance
that stakeholder may join the remaining Administration, 5630 Fishers Lane, Rm. as required by section 306(d)(4)(C) of
monthly stakeholder consultation 1061, Rockville, MD 20852. the FD&C Act.
meetings after notifying FDA of this The additional requisite showings,
FOR FURTHER INFORMATION CONTACT:
intention (see ADDRESSES). These i.e., that termination of debarment
Kenny Shade, Office of Regulatory
stakeholder discussions will satisfy the serves the interest of justice and poses
Affairs, Food and Drug Administration, no threat to the integrity of the drug
consultation requirement in section 12420 Parklawn Dr. (ELEM–4144),
736B(d)(3) of the FD&C Act. approval process, are difficult standards
Rockville, MD 20857, 301–796–4640. to satisfy. In determining whether these
II. Notification of Intent To Participate SUPPLEMENTARY INFORMATION: In a have been met, the Agency weighs the
in Periodic Stakeholder Consultation Federal Register notice dated January 6, significance of all favorable and
Meetings 1994 (59 FR 00751), David J. Brancato, unfavorable factors in light of the
If you intend to participate in a former review chemist with FDA’s remedial, public health-related purposes
continued periodic stakeholder Division of Generic Drugs was underlying debarment. Termination of
consultation meetings regarding PDUFA permanently debarred from providing debarment will not be granted unless,
reauthorization, please provide services in any capacity to a person with weighing all favorable and unfavorable
notification by email to an approved or pending drug product information, there is a high level of
PDUFAReauthorization@fda.hhs.gov by application under section 306(a) of the assurance that the conduct that formed
August 28, 2015. Your email should FD&C Act (21 U.S.C. 335a(a)). The the basis for debarment has not recurred
contain complete contact information, debarment was based on FDA’s finding and will not recur, and that the
including name, title, affiliation, that Dr. Brancato was convicted of a individual will not otherwise pose a
address, email address, phone number, felony under Federal law for conduct threat to the integrity of the drug
and notice of any special relating to the development, or approval approval process.
accommodations required because of of any drug product, or otherwise The evidence presented to FDA in
disability. Stakeholders will receive relating to the regulation of a drug support of termination shows that Dr.
confirmation and additional information product. On May 26, 1998, Dr. Brancato Brancato was convicted for a first
mstockstill on DSK4VPTVN1PROD with NOTICES
about the first meeting after FDA applied for special termination of offense; that he has no prior or
receives this notification. debarment, under section 306(d)(4) of subsequent convictions for conduct
the FD&C Act, as amended by the described under the FD&C Act and has
Dated: July 14, 2015. Generic Drug Enforcement Act. On committed no other wrongful acts
Leslie Kux, April 15, 2015, the Agency requested affecting the drug approval process; and
Associate Commissioner for Policy. additional information. On April 20, that his character and scientific
[FR Doc. 2015–17684 Filed 7–17–15; 8:45 am] 2015, Dr. Brancato provided the accomplishments are highly regarded by
BILLING CODE 4164–01–P requested information. his professional peers. The evidence
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![Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42827
presented supports the conclusion that substances that may be used by facilities may be used by a facility registered as
the conduct upon which Dr. Brancato’s registered as outsourcing facilities under an outsourcing facility under section
debarment was based is unlikely to the Federal Food, Drug, and Cosmetic 503B of the FD&C Act (21 U.S.C. 353B)
recur. For these reasons, the Agency Act (the FD&C Act) to compound animal to compound drugs for use in animals
finds that termination of Dr. Brancato’s drugs from bulk substances, in in accordance with FDA’s draft GFI
debarment serves the interest of justice accordance with FDA’s draft guidance #230, ‘‘Compounding Animal Drugs
and will not pose a threat to the for industry (GIF) #230, ‘‘Compounding from Bulk Drug Substances.’’ That
integrity of the drug approval process. Animal Drugs from Bulk Drug notice describes the information that
Under section 306(d)(4)(D) of the Substances.’’ The FDA is taking this should be provided to the FDA in
FD&C Act, the period of debarment of action in response to a request for an support of each nomination.
an individual who qualifies for special extension to allow interested persons
termination may be limited to less than additional time to submit nominations. FDA has received a request for a 90-
permanent but to no less than 1 year. Dr. DATES: Submit either electronic or
day extension of the nomination period
Brancato’s period of debarment, which written nominations for the bulk drug as the requestor wanted more time to
commenced on January 6, 1994, has substances list by November 16, 2015. nominate drugs to the list and to
lasted more than 1 year. Accordingly, provide supporting data. FDA has
ADDRESSES: You may submit
the Director of the Office of Enforcement nominations by any of the following considered the request and is extending
and Import Operations, under section methods: the nomination period for 90 days, until
306(d)(4) of the FD&C Act and under November 16, 2015. The FDA believes
authority delegated to the Director (Staff Electronic Submissions that a 90-day extension allows adequate
Manual Guide 1410.35), finds that Submit electronic nominations in the time for interested persons to submit
David J. Brancato’s application for following way: nominations without significantly
special termination of debarment should • Federal eRulemaking Portal: http:// delaying consideration of these
be granted, and that the period of www.regulations.gov. Follow the nominations.
debarment should terminate instructions for submitting comments.
immediately, thereby allowing him to II. Nomination Process
provide services in any capacity to a Written Submissions
The process for nominations for bulk
person with an approved or pending Submit written nominations in the
following ways: drug substances that may be used by
drug product application. The Director
of Enforcement and Import Operations • Mail/Hand delivery/Courier (for facilities registered as outsourcing
further finds that because the Agency is paper submissions): Division of Dockets facilities under section 503B of the
granting Dr. Brancato’s application, an Management (HFA–305), Food and Drug FD&C Act to compound animal drugs
informal hearing under section Administration, 5630 Fishers Lane, Rm. from bulk drug substances is described
306(d)(4)(C) of the FD&C Act is 1061, Rockville, MD 20852. in the previous notice published May
unnecessary. Instructions: All submissions received 19, 2015. FDA cannot guarantee that all
As a result of the foregoing findings, must include the Docket No. FDA– drugs nominated during the nomination
Dr. David J. Brancato’s debarment is 2015–N–1196. All nominations received period will be considered for initial
terminated effective (see DATES) (21 may be posted without change to inclusion in Appendix A at the time of
U.S.C. 335a(d)(4)(C) and (d)(4)(D)). http://www.regulations.gov, including its initial publication. Nominations
Dated: July 15, 2015.
any personal information provided. For submitted during the nomination period
additional information on submitting (ending on November 16, 2015) that are
Leslie Kux,
nominations, see the ‘‘Request for not evaluated and included in
Associate Commissioner for Policy. Nominations’’ heading of the Appendix A at the time of its initial
[FR Doc. 2015–17712 Filed 7–17–15; 8:45 am] SUPPLEMENTARY INFORMATION section of publication will receive consideration
BILLING CODE 4164–01–P this document. for later addition to Appendix A. In
Docket: For access to the docket to addition, individuals and organizations
read background documents or may petition FDA, in accordance with
DEPARTMENT OF HEALTH AND nominations received, go to http://
HUMAN SERVICES 21 CFR 10.30, to make additional
www.regulations.gov and insert the
amendments to Appendix A after the
docket number, found in brackets in the
Food and Drug Administration nomination period.
heading of this document, into the
[Docket No. FDA–2015–N–1196] ‘‘Search’’ box and follow the prompts III. Request for Nominations
and/or go to the Division of Dockets
List of Bulk Drug Substances That May Management, 5630 Fishers Lane, Rm. Interested persons may submit either
Be Used by an Outsourcing Facility To 1061, Rockville, MD 20852. electronic nominations to http://
Compound Drugs for Use in Animals; FOR FURTHER INFORMATION CONTACT: Neal www.regulations.gov or written
Extension of Nomination Period Bataller, Center for Veterinary Medicine, nominations to the Division of Dockets
Food and Drug Administration (HFV– Management (see ADDRESSES). It is only
AGENCY: Food and Drug Administration,
HHS. 210), 7519 Standish Pl., Rockville, MD necessary to send one set of
20855, 240–402–5745, neal.bataller@ nominations. Identify nominations with
ACTION: Notice; extension of nomination
fda.hhs.gov. the docket number found in brackets in
mstockstill on DSK4VPTVN1PROD with NOTICES
period.
SUPPLEMENTARY INFORMATION:
the heading of this document. Received
SUMMARY: The Food and Drug nominations may be seen in the
Administration (FDA) is extending the I. Background Division of Dockets Management
nomination period for the notice that In the Federal Register of May 19, between 9 a.m. and 4 p.m., Monday
appeared in the Federal Register of May 2015 (80 FR 28622), FDA published a through Friday, and will be posted to
19, 2015. In the notice, FDA requested notice with a 90-day nomination period the docket at http://
nominations for a list of bulk drug for the list of bulk drug substances that www.regulations.gov.
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Document Created: 2015-12-15 12:58:03
Document Modified: 2015-12-15 12:58:03
| 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 July 20, 2015. | |
| Contact | Kenny Shade, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144), Rockville, MD 20857, 301-796-4640. | |
| FR Citation | 80 FR 42826 |
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