[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63401-63402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.fda.gov/media/152270/download. The decision is also available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-debarment-list-drug-product-applications/fda-expired-debarment-list-drug-product-applications.

    Dated: November 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24973 Filed 11-15-21; 8:45 am]
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