Notice2021-24973
Sanyasi Raju Kalidindi; Grant of Special Termination
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 16, 2021
Effective
September 15, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) has issued an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting special termination of the debarment of Sanyasi Raju Kalidindi. FDA based the order on a finding that Dr. Kalidindi provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction and that terminating Dr. Kalidindi's debarment served the interest of justice and protected the integrity of the drug approval process.
Full Text
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<title>Federal Register, Volume 86 Issue 218 (Tuesday, November 16, 2021)</title>
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[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63401-63402]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-24973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1992-N-0011]
Sanyasi Raju Kalidindi; Grant of Special Termination
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has issued an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting
special termination of the debarment of Sanyasi Raju Kalidindi. FDA
based the order on a finding that Dr. Kalidindi provided substantial
assistance in the investigations or prosecutions of offenses relating
to a matter under FDA's jurisdiction and that terminating Dr.
Kalidindi's debarment served the interest of justice and protected the
integrity of the drug approval process.
DATES: The order became effective September 15, 2021.
ADDRESSES: Comments should reference Docket No. FDA-1992-N-0011 and be
sent to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Karena Cooper, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4218, Silver Spring, MD 20993, 301 796-1612.
SUPPLEMENTARY INFORMATION: In a Federal Register notice dated April 21,
1993 (58 FR 21470), FDA debarred Dr. Kalidindi from providing services
in any capacity to a person with an approved or pending drug product
[[Page 63402]]
application under section 306(a) of the FD&C Act (21 U.S.C. 335a(a)).
FDA based the debarment on a finding under section 306(a)(2) of the
FD&C Act that Dr. Kalidindi had been 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.
Section 306(d)(4) of the FD&C Act provides that any individual
debarred under section 306(a)(2) may apply to FDA for special
termination of debarment. Pursuant to section 306(d)(4)(C)-(D), FDA may
grant a request for special termination and limit the period of
debarment to less than permanent but no less than 1 year if the Agency
finds: (1) That the individual has provided substantial assistance in
the investigations or prosecutions of offenses described in section
306(a) or (b) of the FD&C Act, or relating to any matter under the
jurisdiction of FDA and (2) that doing so best serves the interest of
justice and protects the integrity of the drug approval process.
On May 27, 1998, FDA denied a previous petition for special
termination of debarment submitted by Dr. Kalidindi. On January 13,
2020, Dr. Kalidindi again petitioned for special termination of
debarment under section 306(d)(4) of the FD&C Act. On April 10, 2020,
FDA's Office of Regulatory Affairs proposed denying that petition and
offered Dr. Kalidindi an opportunity to request a hearing on the
proposal to deny the petition. On May 9, 2020, Dr. Kalidindi requested
a hearing and, on June 8, 2020, submitted materials in support of his
hearing request.
By a decision dated September 15, 2021, FDA's Chief Scientist
granted Dr. Kalidindi's petition for special termination based on her
conclusion that doing so best served the interest of justice and
protected the integrity of the drug approval process. In so concluding,
she found that there were no genuine and substantial issues of fact
with respect to the level and scope of substantial assistance provided
by Dr. Kalidindi in the investigation and prosecution of others for
offenses described in section 306(a) or (b) of the FD&C Act, or
otherwise relating to FDA's jurisdiction, and that the level and scope
of such substantial assistance, among other considerations, justified
special termination of his debarment after 28 years. The Chief
Scientist's decision is available at <a href="https://www.fda.gov/media/152270/download">https://www.fda.gov/media/152270/download</a>. The decision is also available at <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-debarment-list-drug-product-applications/fda-expired-debarment-list-drug-product-applications">https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-debarment-list-drug-product-applications/fda-expired-debarment-list-drug-product-applications</a>.
Dated: November 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24973 Filed 11-15-21; 8:45 am]
BILLING CODE 4164-01-P
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