Federal Register / Vol. 83, No. 12 / Thursday, January 18, 2018 / Notices 2641 

circular. If an alternative standard is 

proposed, the offeror must furnish data 

and/or information regarding the 

alternative in sufficient detail for the 

Government to determine if it meets the 

Government’s requirements. 

We believe the burden for FAR 

52.211–7 to be negative, as it is purely 

a permissive means for offerors to 

propose reducing regulatory burden on 

a given solicitation. There are other 

places A–119 has an effect, though we 

believe these to be positive. One is by 

enabling the single process initiative. 

Another is the general replacement of 

Mil standards with commercial 

standards, e.g., ISO 9000. Also, A–119 is 

the basis for the language in FAR 

53.105, which reduces the chaos in data 

standards development. The whole 

purpose of A–119 was to reduce 

regulatory burden by promoting the use 

of industry standards in lieu of federal 

ones. 

To the extent that the data on the 

annual frequency of the use of voluntary 

consensus standards under FAR 52.211– 

7 is not available, we believe 100 is 

reasonable. As an aside, FAR part 45 

recognizes the use of voluntary 

consensus standards in the management 

of Government property. However, in 

these cases, there is no Government 

standard per se, with the voluntary 

consensus standard serving as the 

Government standard. Consequently, 

when under part 45 voluntary 

consensus standards are used, they are 

not an alternative to a Government 

standard under FAR 52.211–7. 

This collection implements OMB 

Circular A–119, Federal Participation in 

the Development and Use of Voluntary 

Consensus Standards. FAR solicitation 

provision 52.211–7, Alternatives to 

Government-Unique Standards, is the 

collection instrument. We have 

previously indicated that ‘‘to the extent 

that the data on the annual frequency of 

the use of voluntary consensus 

standards under FAR 52.211–7 is not 

available, we believe that 100 is 

reasonable.’’ This is the number that has 

been reported since the inception of this 

PRA collection, which indicates that 

revised data has been consistently 

unavailable since responses are 

provided to contracting personnel at the 

local level in response to a local 

solicitation. We checked the FPDS data 

dictionary and there are no codes to flag 

data fields or provide a count of when 

Mil standards are used in solicitations/ 

contracts. Considering the lack of FPDS 

or other data, we recommend 

continuing the PRA coverage at the 

current level. 

B. Public Comment 

A 60 day notice was published in the 

Federal Register at 82 FR 51256, on 

November 3, 2017. One comment was 

received; however, it was not 

substantive, and did not change the 

estimate of the burden. 

C. Annual Reporting Burden 

Respondents: 100. 

Responses per Respondent: 1. 

Total Responses: 100. 

Hours per Response: 1. 

Total Burden Hours: 100. 

Affected Public: Businesses or other 

for-profit and not-for-profit. 

Respondent’s Obligation: Required to 

obtain or retain benefits. 

Reporting Frequency: On occasion. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat Division (MVCB), 

1800 F Street NW, Washington, DC 

20405, telephone 202–501–4755. Please 

cite OMB Control No. 9000–0153, OMB 

Circular A–119, in all correspondence. 

Dated: January 12, 2018. 

Lorin S. Curit, 

Director, Federal Acquisition Policy Division, 

Office of Government-wide Acquisition 

Policy, Office of Acquisition Policy, Office 

of Government-wide Policy. 

[FR Doc. 2018–00779 Filed 1–17–18; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0890] 

William Ralph Kincaid; Denial of 

Hearing; Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

denying William Ralph Kincaid’s 

(Kincaid’s) request for a hearing and is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Kincaid 

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 

Kincaid was convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. Kincaid was given notice of 

the proposed debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

Kincaid submitted a request for hearing 

but failed to file with the Agency 

information and analysis sufficient to 

create a basis for a hearing. 

DATES: This order is applicable January 

18, 2018. 

ADDRESSES: Any application by Kincaid 

for special termination of debarment 

under section 306(d) of the FD&C Act 

(application) may be submitted as 

follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application as a written/paper 

submission and in the manner detailed 

(see ‘‘Written/Paper Submissions’’ and 

‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: Your application must 

include the Docket No. FDA–2015–N– 

0890. An application will be placed in 

the docket and, unless submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 


sradovich on DSK3GMQ082PROD with NOTICES
2642 Federal Register / Vol. 83, No. 12 / Thursday, January 18, 2018 / Notices 

• Confidential Submissions—To 

submit an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of your application. 

The second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your application and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/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. 

Publicly available submissions may be 

seen in the docket. 

FOR FURTHER INFORMATION CONTACT: Julie 

Finegan, Office of Scientific Integrity, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4218, Silver Spring, MD 20993, 301– 

796–8618. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 24, 2013, the U. S. District 

Court for the Eastern District of 

Tennessee entered a criminal judgment 

against William Ralph Kincaid pursuant 

to his guilty plea. Kincaid pled guilty to 

a felony under the FD&C Act, namely 

receiving in interstate commerce a 

misbranded drug with intent to defraud 

or mislead, in violation of sections 

301(c) and 303(a)(2) of the FD&C Act (21 

U.S.C. 331(c) and 333(a)(2)) and 18 

U.S.C. 2. The basis for this conviction 

was Kincaid’s admission that he 

obtained drugs from Quality Specialty 

Products (QSP), a foreign company, for 

use at East Tennessee HematologyOncology Associates, P.C. (McLeod 

Cancer). These drugs were not FDA 

approved and were misbranded in that 

they lacked adequate directions for use 

and were manufactured in an 

establishment that was not registered 

with FDA and that did not list with FDA 

the drug products it manufactured. 

From approximately September 2007 to 

early 2008 and from August 2009 to 

February 2012, McLeod Cancer 

purchased more than $2 million in 

misbranded unapproved drugs for use at 

McLeod Cancer. Additionally, Kincaid 

and McLeod Cancer billed Medicare, 

TennCare, and other government health 

benefit programs approximately $2.5 

million for these unapproved drugs. 

Kincaid is subject to debarment based 

on a finding, under section 306(a)(2) of 

the FD&C Act (21 U.S.C. 335a(a)(2)), that 

he was convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. By the letter dated May 20, 

2015, FDA notified Kincaid of a 

proposal to permanently debar him from 

providing services in any capacity to a 

person having an approved or pending 

drug product application. The proposal 

also offered Kincaid 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 60 days 

from the date of receipt of the letter to 

support that request with information 

sufficient to justify a hearing. In a letter 

dated June 17, 2015, Kincaid requested 

a hearing and indicated that the 

information justifying the hearing 

would be forthcoming. More than 60 

days have passed from the date Kincaid 

received FDA’s letter, and Kincaid has 

not filed any additional information to 

support his request. 

Under the authority delegated to him 

by the Commissioner of Food and 

Drugs, the Director of the Office of 

Scientific Integrity (OSI) has considered 

Kincaid’s request for a hearing. Hearings 

will not be granted on issues of policy 

or law, on mere allegations, denials, or 

general descriptions of positions and 

contentions, or on data and information 

insufficient to justify the factual 

determination urged (see 21 CFR 

21.24(b)). 

Because Kincaid has not presented 

any information to support his hearing 

request, OSI concludes that Kincaid 

failed to raise a genuine and substantial 

issue of fact requiring a hearing. 

Therefore, OSI denies Kincaid’s request 

for a hearing. 

II. Findings and Order 

Therefore, OSI, under section 

306(a)(2) of the FD&C Act and under the 

authority delegated, finds that William 

Ralph Kincaid has been convicted of a 

felony under Federal law for conduct 

relating to the regulation of a drug 

product under the FD&C Act. 

As a result of the foregoing findings, 

William Ralph Kincaid is permanently 

debarred from providing services in any 

capacity to a person with an approved 

or pending drug product application 

under section 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) (21 U.S.C. 

335a(c)(1)(B) and (c)(2)(A)(ii) and 21 

U.S.C. 321(dd)). Any person with an 

approved or pending drug product 

application who knowingly uses the 

services of Kincaid, in any capacity 

during his period of debarment, will be 

subject to civil money penalties. See 

section 307(a)(6) of the FD&C Act (21 

U.S.C. 335b(a)(6)). If Kincaid, during his 

period of debarment, provides services 

in any capacity to a person with an 

approved or pending drug product 

application, he will be subject to civil 

money penalties. See section 307(a)(7) 

of the FD&C Act (21 U.S.C. 335b(a)(7)). 

In addition, FDA will not accept or 

review any abbreviated new drug 

applications submitted by or with the 

assistance of Kincaid during his period 

of debarment. 

Dated: January 10, 2018. 

G. Matthew Warren, 

Director, Office of Scientific Integrity. 

[FR Doc. 2018–00719 Filed 1–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Annual Update of the HHS Poverty 

Guidelines 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: This notice provides an 

update of the Department of Health and 

Human Services (HHS) poverty 

guidelines to account for last calendar 

year’s increase in prices as measured by 

the Consumer Price Index. 

DATES: Applicable beginning January 13, 

2018, unless an office administering a 

program using the guidelines specifies a 

different applicability date for that 

particular program. 


sradovich on DSK3GMQ082PROD with NOTICES