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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 between 9 a.m.
and 4 p.m., Monday through Friday, 2404027500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 2404025931.
SUPPLEMENTARY INFORMATION:

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I. Background Section 306b2BiII of the FD&C
Act 21 U.S.C. 335ab2BiII
permits FDA to debar an individual if it finds: 1 That the individual has been convicted of a conspiracy to commit a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act and 2
that the type of conduct serving as the basis of the conviction undermines the process for the regulation of drugs.
On August 7, 2007, Mr. Patel pled guilty to a felony count of conspiracy to distribute misbranded and adulterated drugs in violation of 18 U.S.C. 371. On December 16, 2010, the U.S. District Court for the District of New Jersey entered the conviction, sentenced Mr.
Patel to 2 years of probation, and imposed a $3,000 fine. Mr. Patels conviction stemmed from his employment at Able Laboratories, Inc.
Able, where he was a Research and Development Manager and later the Associate Director for Technical Service. Mr. Patel and others conspired to cause the introduction of misbranded and adulterated drugs into interstate commerce with the intent to defraud and mislead the United States, in violation of sections 301a and 303a2 of the FD&C Act 21 U.S.C.
331a and 333a2. According to the criminal information to which he pled guilty under a plea agreement, Mr. Patel and his coconspirators agreed to violate FDAs regulations regarding good manufacturing practice for drugs by, among other things, manipulating and falsifying testing data and information.

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Mr. Patel specifically admitted to an overt act in furtherance of the conspiracy, namely supervising the manipulation of the process for manufacturing promethazine, a prescription antihistamine medication.
By letter dated January 6, 2012, FDAs Office of Regulatory Affairs ORA
notified Mr. Patel of an opportunity for a hearing on a proposal to debar him for 5 years from providing services in any capacity to a person having an approved or pending drug product application. In its proposal, ORA concluded that Mr.
Patel should be debarred for 5 years based on four applicable considerations in section 306c3 of the FD&C Act: 1
The nature and seriousness of his offense, 2 the nature and extent of management participation in the offense, 3 the nature and extent of voluntary steps taken to mitigate the impact on the public, and 4 prior convictions involving matters within FDAs jurisdiction. ORA found that the first three of those considerations weigh in favor of debarment and noted, as to the fourth consideration, that FDA is unaware of any prior convictions.
In a letter dated March 8, 2012, Mr.
Patel requested a hearing on the proposal and submitted materials and arguments in support of his request. In his submission, Mr. Patel acknowledges his conviction of a conspiracy to commit a felony under Federal law and does not dispute that the conduct underlying that conviction related to the regulation of a drug product or that conduct of that type undermines the process for the regulation of drugs. He argues, however, that with respect to the considerations for determining the appropriateness and period of debarment under section 306c3 of the FD&C Act, there are genuine and substantial issues of fact for resolution at a hearing.
II. Statutory and Regulatory Framework Regarding Part 12 Hearings Under the authority delegated by the Commissioner of Food and Drugs, the Chief Scientist has considered Mr.
Patels submission. Under 12.24a2
21 CFR 12.24a2, the Agency reviews a hearing request to determine whether a hearing is justified. FDA has the authority to deny a hearing when it appears from the hearing request that there are no material disputes of fact.
See Costle v. Pacific Legal Found., 445
U.S. 198, 214 1980 a party seeking a hearing is required to meet a threshold burden of tendering evidence suggesting the need for a hearing, rehg denied, 446 U.S. 947 1980, citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 62021 1973; Pineapple
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Growers Assn v. FDA, 673 F.2d 1083, 108586 9th Cir. 1982 holding that no hearing is necessary unless material issues of fact have been raised.
In determining whether there are material issues of fact suitable for a hearing, FDA considers the specific criteria set out in 12.24b and grants a hearing only if the material submitted in support of the request shows the following: 1 There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law; 2 the factual issue can be resolved by available and specifically identified reliable evidence;
a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions; 3 the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requestor; a hearing will be denied if the Agency concludes that the data and information submitted are insufficient to justify the factual determination urged, even if accurate;
4 resolution of the factual issue in the way sought by the person is adequate to justify the action requested; a hearing will not be granted on factual issues that are not determinative with respect to the action requested e.g., if the Agency concludes that the action would be the same even if the factual issue were resolved in the way sought; 5 the action requested is not inconsistent with any provision in the FD&C Act or any FDA regulation; and 6 the requirements in other applicable regulations, e.g., 21 CFR 10.20, 12.21, and 12.22, and in the notice of an opportunity for hearing are met.
III. Arguments In his request for a hearing, Mr. Patel challenges ORAs findings with respect to the three considerations that it concluded weighed in favor of his debarment. Mr. Patel also contends that there are two additional considerations under section 306c3 of the FD&C Act that were not considered by ORA and should weigh in his favor against debarment. Section 306c3 of the FD&C Act explicitly requires that FDA
consider, where applicable, certain factors in determining the appropriateness and the period of debarment for any permissive debarment.
A. Nature and Seriousness of the Offense Regarding the nature and seriousness of his offense, Mr. Patel contends that, in reaching its conclusion regarding the nature and seriousness of his felony
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