Keith J. Pierce: Debarment Order, 60611-60612 [2017-27485]

Download as PDF Federal Register / Vol. 82, No. 244 / Thursday, December 21, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–1277] Keith J. Pierce: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Keith J. Pierce for a period of 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Pierce was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the FD&C Act. Dr. Pierce was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Pierce failed to request a hearing. Dr. Pierce’s failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is applicable December 21, 2017. ADDRESSES: Submit applications for special termination of debarment to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs (ELEM 4144), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301–796–4640. SUPPLEMENTARY INFORMATION: SUMMARY: daltland on DSKBBV9HB2PROD with NOTICES I. Background Section 306(b)(2)(B) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)) permits debarment of an individual if FDA finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. On March 3, 2016, the U.S. District Court for the Eastern District of Michigan entered judgment against Dr. Pierce for one count of failure to maintain records required under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) and FDA’s VerDate Sep<11>2014 20:57 Dec 20, 2017 Jkt 244001 regulations at § 312.62(b) (21 CFR 312.62(b)), a Federal misdemeanor offense under the FD&C Act sections 301(e) and 303(a) (21 U.S.C. 331(e) and 333(a)(1)). FDA’s finding that the debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for this conviction was as follows: At the time the conduct underlying the conviction occurred, Dr. Pierce was licensed to practice medicine under the laws of Michigan. In 2003, Aventis Pharmaceuticals operated a clinical trial for KETEK (telithromycin), investigating its use as a drug to treat acute maxillary sinusitis (AMS). This clinical trial was conducted pursuant to an investigational new drug application (IND) held by Aventis Pharmaceuticals, and was therefore subject to FDA’s oversight and jurisdiction. (see section 505(i) of the FD&C Act and part 312 (21 CFR part 312)). Between approximately April and July 2003, Dr. Pierce served as an investigator under the IND by conducting clinical testing of KETEK on patients in his medical practice. FDA’s regulations at part 312 require, among other things, that clinical investigators prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. The failure to establish or maintain any record required under section 505(i) of the FD&C Act is a prohibited act under sections 301(e) and 303(a) of the FD&C Act. Records required under section 505(i) of the FD&C Act include records required to be kept under FDA’s regulations at § 312.62. Between approximately April and July 2003, Dr. Pierce failed to maintain adequate and accurate case histories on each individual administered the investigational drug or employed as a control in the investigation, as required by § 312.62. In particular, Dr. Pierce failed to adequately and accurately document information about trial participants’ previous research participation and relevant medical histories. As a result of his conviction, on July 17, 2017, FDA sent Dr. Pierce a notice by certified mail proposing to debar him for a period of 5 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(b)(2)(B) of the FD&C Act, that Dr. Pierce was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 60611 including the process for development or approval, of any drug product under the FD&C Act. FDA determined that Dr. Pierce’s misdemeanor conviction was for illegal conduct relating to the development or approval of KETEK (telithromycin) for the treatment of AMS in that he failed to maintain adequate and accurate case histories for individuals in his clinical investigations. FDA finds that Dr. Pierce’s conduct undermined the Agency’s ability to rely on clinical data obtained in the process of developing new drugs for approval and therefore related to the development or approval of a drug product under the FD&C Act. The proposal also offered Dr. Pierce an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. The proposal was received on July 24, 2017. Dr. Pierce failed to respond within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(b)(2)(B) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Dr. Keith J. Pierce has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the FD&C Act. As a result of the foregoing finding, Dr. Keith J. Pierce is debarred for 5 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see sections 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(iii) of the FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(iii)). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Pierce, in any capacity during his debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Pierce provides services in any capacity to a person with E:\FR\FM\21DEN1.SGM 21DEN1 60612 Federal Register / Vol. 82, No. 244 / Thursday, December 21, 2017 / Notices change to this notice. The matching program will be conducted for an initial term of 18 months (approximately January 13, 2018 through July 13, 2019) and within 3 months of expiration may be renewed for up to 12 additional months if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement. ADDRESSES: Interested parties may submit written comments on this notice, by mail or email, to Linda Boyer, Director, Division of Federal Systems, Office of Child Support Enforcement, Administration for Children and Families, by email at linda.boyer@ acf.hhs.gov, or by mail at Mary E. Switzer Building, 330 C Street SW, 5th Floor, Washington, DC 20201. Comments received will be available for public inspection at this address from 9:00 a.m. to 5:00 p.m. ET, Monday Dated: December 14, 2017. through Friday. Leslie Kux, FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. General questions about the matching [FR Doc. 2017–27485 Filed 12–20–17; 8:45 am] program may be submitted to Linda BILLING CODE 4164–01–P Boyer, Director, Division of Federal Systems, Office of Child Support Enforcement, Administration for DEPARTMENT OF HEALTH AND Children and Families, by email at HUMAN SERVICES linda.boyer@acf.hhs.gov, by mail at Privacy Act of 1974; Matching Program Mary E. Switzer Building, 330 C Street SW, 5th Floor, Washington, DC 20201, AGENCY: Administration for Children or by telephone at 202–401–5410. and Families, Department of Health and SUPPLEMENTARY INFORMATION: The Human Services. Privacy Act of 1974, as amended (5 ACTION: Notice of a new matching U.S.C. 552a), provides for certain program. protections for individuals applying for SUMMARY: In accordance with subsection and receiving federal benefits. The law governs the use of computer matching (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and by federal agencies when records in a system of records (meaning, records Human Services, Administration for about individual retrieved by personal Children and Families, Office of Child identifier) are matched with other Support Enforcement (HHS/ACF/ federal or state agency records. The OCSE), is providing notice of a rePrivacy Act requires agencies involved established matching program between in a matching program to: OCSE and state workforce agencies 1. Enter into a written agreement, (SWAs) administering the which must be prepared in accordance Unemployment Compensation (UC) with the Privacy Act, approved by the Program. The matching program will Data Integrity Board of each provide SWAs with new hire (i.e., participating federal agency, provided to employment status) and quarterly wage Congress and the Office of Management information from OCSE’s National and Budget (OMB), and made available Directory of New Hires (NDNH) system to the public, as required by 5 U.S.C. of records, for the purpose of assisting 552a(o), (u)(3)(A), and (u)(4). SWAs in preventing, detecting, and 2. Notify the individuals whose addressing program violations and information will be used in the errors, and for related secondary matching program that the information purposes. they provide is subject to verification DATES: The deadline for comments on through matching, as required by 5 this notice is January 22, 2018. The reU.S.C. 552a(o)(1)(D). 3. Verify match findings before established matching program will commence not sooner than 30 days after suspending, terminating, reducing, or making a final denial of an individual’s publication of this notice, provided no benefits or payments or taking other comments are received that warrant a daltland on DSKBBV9HB2PROD with NOTICES an approved or pending drug product application during his period of debarment he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications from Dr. Pierce during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Any application by Dr. Pierce for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2017– N–1277 and sent to the Dockets Management Staff (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by § 10.20. Publicly available submissions may be seen in the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. VerDate Sep<11>2014 20:57 Dec 20, 2017 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 adverse action against the individual, as required by 5 U.S.C. 552a(p). 4. Report the matching program to Congress and the OMB, in advance and annually, as required by 5 U.S.C. 552a(o) (2)(A)(i), (r), and (u)(3)(D). 5. Publish advance notice of the matching program in the Federal Register as required by 5 U.S.C. 552a(e)(12). This matching program meets these requirements. Participating Agencies Office of Child Support Enforcement (OCSE) is the source agency, and state workforce agencies (SWAs) administering the Unemployment Compensation (UC) Program are the recipient agencies. Authority for Conducting the Matching Program 42 U.S.C. 653(j)(8). Purpose(s) The matching program provides each SWA with new hire and quarterly wage information from OCSE’s National Directory of New Hires (NDNH) system of records, pertaining to adult UC applicants and recipients, resulting from comparing client name and Social Security number combinations in the SWA’s files to data in NDNH. The match results assist the SWAs in establishing or verifying eligibility for assistance, reducing payment errors, and maintaining program integrity, including determining whether duplicate participation exists or if the client resides in another state. The SWAs may also use the NDNH information for secondary purposes, such as updating UC recipients’ reported participation in work activities, updating recipients’ and their employers’ contact information, and administering the SWAs’ tax compliance function. Categories of Individuals The categories of individuals whose information is involved in the matching program are adult members of households who receive or have applied for UC benefits. Categories of Records The categories of records involved in the matching program are new hire and quarterly wage information. The specific data elements that will be provided to OCSE in a SWA input file are: • Submitting state code (2-digit FIPS code) • Date stamp (input file transmission date) E:\FR\FM\21DEN1.SGM 21DEN1

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[Federal Register Volume 82, Number 244 (Thursday, December 21, 2017)]
[Notices]
[Pages 60611-60612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27485]



[[Page 60611]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1277]


Keith J. Pierce: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) debarring Dr. Keith J. Pierce for a period of 5 years from 
providing services in any capacity to a person that has an approved or 
pending drug product application. FDA bases this order on a finding 
that Dr. Pierce was convicted of a misdemeanor under Federal law for 
conduct relating to the development or approval, including the process 
for development or approval, of a drug product under the FD&C Act. Dr. 
Pierce was given notice of the proposed debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Pierce failed to request a hearing. Dr. Pierce's failure to request a 
hearing constitutes a waiver of his right to a hearing concerning this 
action.

DATES: This order is applicable December 21, 2017.

ADDRESSES: Submit applications for special termination of debarment to 
the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement, 
Office of Enforcement and Import Operations, Office of Regulatory 
Affairs (ELEM 4144), Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(2)(B) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)) 
permits debarment of an individual if FDA finds that the individual has 
been convicted of a misdemeanor under Federal law for conduct relating 
to the development or approval, including the process for development 
or approval, of any drug product under the FD&C Act. On March 3, 2016, 
the U.S. District Court for the Eastern District of Michigan entered 
judgment against Dr. Pierce for one count of failure to maintain 
records required under section 505(i) of the FD&C Act (21 U.S.C. 
355(i)) and FDA's regulations at Sec.  312.62(b) (21 CFR 312.62(b)), a 
Federal misdemeanor offense under the FD&C Act sections 301(e) and 
303(a) (21 U.S.C. 331(e) and 333(a)(1)).
    FDA's finding that the debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for this 
conviction was as follows: At the time the conduct underlying the 
conviction occurred, Dr. Pierce was licensed to practice medicine under 
the laws of Michigan. In 2003, Aventis Pharmaceuticals operated a 
clinical trial for KETEK (telithromycin), investigating its use as a 
drug to treat acute maxillary sinusitis (AMS). This clinical trial was 
conducted pursuant to an investigational new drug application (IND) 
held by Aventis Pharmaceuticals, and was therefore subject to FDA's 
oversight and jurisdiction. (see section 505(i) of the FD&C Act and 
part 312 (21 CFR part 312)). Between approximately April and July 2003, 
Dr. Pierce served as an investigator under the IND by conducting 
clinical testing of KETEK on patients in his medical practice. FDA's 
regulations at part 312 require, among other things, that clinical 
investigators prepare and maintain adequate and accurate case histories 
that record all observations and other data pertinent to the 
investigation on each individual administered the investigational drug 
or employed as a control in the investigation. The failure to establish 
or maintain any record required under section 505(i) of the FD&C Act is 
a prohibited act under sections 301(e) and 303(a) of the FD&C Act. 
Records required under section 505(i) of the FD&C Act include records 
required to be kept under FDA's regulations at Sec.  312.62. Between 
approximately April and July 2003, Dr. Pierce failed to maintain 
adequate and accurate case histories on each individual administered 
the investigational drug or employed as a control in the investigation, 
as required by Sec.  312.62. In particular, Dr. Pierce failed to 
adequately and accurately document information about trial 
participants' previous research participation and relevant medical 
histories.
    As a result of his conviction, on July 17, 2017, FDA sent Dr. 
Pierce a notice by certified mail proposing to debar him for a period 
of 5 years from providing services in any capacity to a person that has 
an approved or pending drug product application. The proposal was based 
on a finding, under section 306(b)(2)(B) of the FD&C Act, that Dr. 
Pierce was convicted of a misdemeanor under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of any drug product under the FD&C Act. FDA 
determined that Dr. Pierce's misdemeanor conviction was for illegal 
conduct relating to the development or approval of KETEK 
(telithromycin) for the treatment of AMS in that he failed to maintain 
adequate and accurate case histories for individuals in his clinical 
investigations. FDA finds that Dr. Pierce's conduct undermined the 
Agency's ability to rely on clinical data obtained in the process of 
developing new drugs for approval and therefore related to the 
development or approval of a drug product under the FD&C Act. The 
proposal also offered Dr. Pierce an opportunity to request a hearing, 
providing him 30 days from the date of receipt of the letter in which 
to file the request, and advised him that failure to request a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. The proposal was received on July 
24, 2017. Dr. Pierce failed to respond within the timeframe prescribed 
by regulation and has, therefore, waived his opportunity for a hearing 
and any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 306(b)(2)(B) of 
the FD&C Act, under authority delegated to him (Staff Manual Guide 
1410.35), finds that Dr. Keith J. Pierce has been convicted of a 
misdemeanor under Federal law for conduct relating to the development 
or approval, including the process for development or approval, of a 
drug product under the FD&C Act.
    As a result of the foregoing finding, Dr. Keith J. Pierce is 
debarred for 5 years from providing services in any capacity to a 
person with an approved or pending drug product application under 
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 
382), or under section 351 of the Public Health Service Act (42 U.S.C. 
262), effective (see DATES) (see sections 201(dd), 306(c)(1)(B), and 
306(c)(2)(A)(iii) of the FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), 
and 335a(c)(2)(A)(iii)). Any person with an approved or pending drug 
product application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Dr. Pierce, in any 
capacity during his debarment, will be subject to civil money penalties 
(section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. 
Pierce provides services in any capacity to a person with

[[Page 60612]]

an approved or pending drug product application during his period of 
debarment he will be subject to civil money penalties (section 
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review 
any abbreviated new drug applications from Dr. Pierce during his period 
of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Pierce for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2017-N-1277 and sent to the Dockets Management Staff (see 
ADDRESSES). All such submissions are to be filed in four copies. The 
public availability of information in these submissions is governed by 
Sec.  10.20.
    Publicly available submissions may be seen in the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27485 Filed 12-20-17; 8:45 am]
BILLING CODE 4164-01-P