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
Federal Register / Vol. 83, No. 12 / Thursday, January 18, 2018 / Notices 2643 

ADDRESSES: Office of the Assistant 

Secretary for Planning and Evaluation, 

Room 404E, Humphrey Building, 

Department of Health and Human 

Services, Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: For 

information about how the guidelines 

are used or how income is defined in a 

particular program, contact the Federal, 

state, or local office that is responsible 

for that program. For information about 

poverty figures for immigration forms, 

the Hill-Burton Uncompensated 

Services Program, and the number of 

people in poverty, use the specific 

telephone numbers and addresses given 

below. 

For general questions about the 

poverty guidelines themselves, contact 

Kendall Swenson, Office of the 

Assistant Secretary for Planning and 

Evaluation, Room 422F.5, Humphrey 

Building, Department of Health and 

Human Services, Washington, DC 

20201—telephone: (202) 690–7409—or 

visit http://aspe.hhs.gov/poverty/. 

For information about the percentage 

multiple of the poverty guidelines to be 

used on immigration forms such as 

USCIS Form I–864, Affidavit of Support, 

contact U.S. Citizenship and 

Immigration Services at 1–800–375– 

5283. 

For information about the Hill-Burton 

Uncompensated Services Program (free 

or reduced-fee health care services at 

certain hospitals and other facilities for 

persons meeting eligibility criteria 

involving the poverty guidelines), 

contact the Health Resources and 

Services Administration Information 

Center at 1–800–275–4772. You also 

may visit https://www.hrsa.gov/gethealth-care/affordable/hill-burton/ 

index.html. 

For information about the number of 

people in poverty, visit the Poverty 

section of the Census Bureau’s website 

at https://www.census.gov/topics/ 

income-poverty/poverty.html or contact 

the Census Bureau’s Customer Service 

Center at 1–800–923–8282 (toll-free) or 

visit https://ask.census.gov for further 

information. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 673(2) of the Omnibus Budget 

Reconciliation Act (OBRA) of 1981 (42 

U.S.C. 9902(2)) requires the Secretary of 

the Department of Health and Human 

Services to update the poverty 

guidelines at least annually, adjusting 

them on the basis of the Consumer Price 

Index for All Urban Consumers (CPI–U). 

The poverty guidelines are used as an 

eligibility criterion by Medicaid and a 

number of other Federal programs. The 

poverty guidelines issued here are a 

simplified version of the poverty 

thresholds that the Census Bureau uses 

to prepare its estimates of the number of 

individuals and families in poverty. 

As required by law, this update is 

accomplished by increasing the latest 

published Census Bureau poverty 

thresholds by the relevant percentage 

change in the Consumer Price Index for 

All Urban Consumers (CPI–U). The 

guidelines in this 2018 notice reflect the 

2.1 percent price increase between 

calendar years 2016 and 2017. After this 

inflation adjustment, the guidelines are 

rounded and adjusted to standardize the 

differences between family sizes. In rare 

circumstances, the rounding and 

standardizing adjustments in the 

formula result in small decreases in the 

poverty guidelines for some household 

sizes even when the inflation factor is 

not negative. In cases where the year-toyear change in inflation is not negative 

and the rounding and standardizing 

adjustments in the formula result in 

reductions to the guidelines from the 

previous year for some household sizes, 

the guidelines for the affected 

household sizes are fixed at the prior 

year’s guidelines. As in prior years, 

these 2018 guidelines are roughly equal 

to the poverty thresholds for calendar 

year 2017 which the Census Bureau 

expects to publish in final form in 

September 2018. 

The poverty guidelines continue to be 

derived from the Census Bureau’s 

current official poverty thresholds; they 

are not derived from the Census 

Bureau’s Supplemental Poverty Measure 

(SPM). 

The following guideline figures 

represent annual income. 

2018 POVERTY GUIDELINES FOR THE

48 CONTIGUOUS STATES AND THE

DISTRICT OF COLUMBIA

Persons in family/household Poverty 

guideline 

1 ............................................ $12,140 

2 ............................................ 16,460 

3 ............................................ 20,780 

4 ............................................ 25,100 

5 ............................................ 29,420 

6 ............................................ 33,740 

7 ............................................ 38,060 

8 ............................................ 42,380 

For families/households with more 

than 8 persons, add $4,320 for each 

additional person. 

2018 POVERTY GUIDELINES FOR

ALASKA

Persons in family/household Poverty 

guideline 

1 ............................................ $15,180 

2 ............................................ 20,580 

3 ............................................ 25,980 

4 ............................................ 31,380 

5 ............................................ 36,780 

6 ............................................ 42,180 

7 ............................................ 47,580 

8 ............................................ 52,980 

For families/households with more 

than 8 persons, add $5,400 for each 

additional person. 

2018 POVERTY GUIDELINES FOR

HAWAII

Persons in family/household Poverty 

guideline 

1 ............................................ $13,960 

2 ............................................ 18,930 

3 ............................................ 23,900 

4 ............................................ 28,870 

5 ............................................ 33,840 

6 ............................................ 38,810 

7 ............................................ 43,780 

8 ............................................ 48,750 

For families/households with more 

than 8 persons, add $4,970 for each 

additional person. 

Separate poverty guideline figures for 

Alaska and Hawaii reflect Office of 

Economic Opportunity administrative 

practice beginning in the 1966–1970 

period. (Note that the Census Bureau 

poverty thresholds—the version of the 

poverty measure used for statistical 

purposes—have never had separate 

figures for Alaska and Hawaii.) The 

poverty guidelines are not defined for 

Puerto Rico or other outlying 

jurisdictions. In cases in which a 

Federal program using the poverty 

guidelines serves any of those 

jurisdictions, the Federal office that 

administers the program is generally 

responsible for deciding whether to use 

the contiguous-states-and-DC guidelines 

for those jurisdictions or to follow some 

other procedure. 

Due to confusing legislative language 

dating back to 1972, the poverty 

guidelines sometimes have been 

mistakenly referred to as the ‘‘OMB’’ 

(Office of Management and Budget) 

poverty guidelines or poverty line. In 

fact, OMB has never issued the 

guidelines; the guidelines are issued 

each year by the Department of Health 

and Human Services. The poverty 

guidelines may be formally referenced 

as ‘‘the poverty guidelines updated 

periodically in the Federal Register by 


sradovich on DSK3GMQ082PROD with NOTICES
2644 Federal Register / Vol. 83, No. 12 / Thursday, January 18, 2018 / Notices 

the U.S. Department of Health and 

Human Services under the authority of 

42 U.S.C. 9902(2).’’ 

Some federal programs use a 

percentage multiple of the guidelines 

(for example, 125 percent or 185 percent 

of the guidelines), as noted in relevant 

authorizing legislation or program 

regulations. Non-Federal organizations 

that use the poverty guidelines under 

their own authority in non-Federallyfunded activities also may choose to use 

a percentage multiple of the guidelines. 

The poverty guidelines do not make a 

distinction between farm and non-farm 

families, or between aged and non-aged 

units. (Only the Census Bureau poverty 

thresholds have separate figures for aged 

and non-aged one-person and twoperson units.) 

Note that this notice does not provide 

definitions of such terms as ‘‘income’’ or 

‘‘family,’’ because there is considerable 

variation in defining these terms among 

the different programs that use the 

guidelines. These variations are 

traceable to the different laws and 

regulations that govern the various 

programs. This means that questions 

such as ‘‘Is income counted before or 

after taxes?’’, ‘‘Should a particular type 

of income be counted?’’, and ‘‘Should a 

particular person be counted as a 

member of the family/household?’’ are 

actually questions about how a specific 

program applies the poverty guidelines. 

All such questions about how a specific 

program applies the guidelines should 

be directed to the entity that administers 

or funds the program, since that entity 

has the responsibility for defining such 

terms as ‘‘income’’ or ‘‘family,’’ to the 

extent that these terms are not already 

defined for the program in legislation or 

regulations. 

Dated: January 12, 2018. 

Eric D. Hargan, 

Acting Secretary of Health and Human 

Services. 

[FR Doc. 2018–00814 Filed 1–12–18; 4:15 pm] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Automated Commercial Environment 

(ACE) Becoming the Sole CBPAuthorized Electronic Data 

Interchange (EDI) System for 

Processing Electronic Drawback 

Filings 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: General notice. 

SUMMARY: This document announces 

that the Automated Commercial 

Environment (ACE) will be the sole 

electronic data interchange (EDI) system 

authorized by U.S. Customs and Border 

Protection (CBP) for processing 

electronic drawback filings under part 

181 (NAFTA drawback) and part 191 

(non-TFTEA drawback) of Title 19 of 

the Code of Federal Regulations. This 

document also announces that the 

Automated Commercial System (ACS) 

will no longer be a CBP-authorized EDI 

system for purposes of processing such 

filings. This notice further announces 

the deployment of a new ACE filing 

code for all electronic drawback filings, 

replacing the six distinct drawback 

codes previously filed in ACS. 

DATES: As of February 24, 2018, ACE 

will be the sole CBP-authorized EDI 

system for processing drawback filings 

under part 181 (NAFTA drawback) and 

part 191 (non-TFTEA drawback) of Title 

19 of the Code of Federal Regulations, 

and ACS will no longer be a CBPauthorized EDI system for such purpose. 

FOR FURTHER INFORMATION CONTACT: 

Randy Mitchell, Commercial Operations 

and Entry Division, Trade Policy and 

Programs, Office of Trade at (202) 863– 

6532 or RANDY.MITCHELL@

CBP.DHS.GOV. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 484 of the Tariff Act of 1930, 

as amended (19 U.S.C. 1484), 

establishes the requirement for 

importers of record to make entry for 

merchandise to be imported into the 

customs territory of the United States. 

Customs entry information is used by 

U.S. Customs and Border Protection 

(CBP) and Partner Government Agencies 

(PGAs) to determine whether 

merchandise may be released from CBP 

custody. Importers of record are also 

obligated to complete the entry by filing 

an entry summary declaring the value, 

classification, rate of duty applicable to 

the merchandise and such other 

information as is necessary for CBP to 

properly assess duties, collect accurate 

statistics and determine whether any 

other applicable requirement of law is 

met. 

The customs entry requirements were 

amended by Title VI of the North 

American Free Trade Agreement 

Implementation Act (Pub. L. 103–182, 

107 Stat. 2057, December 8, 1993), 

commonly known as the Customs 

Modernization Act, or Mod Act. In 

particular, section 637 of the Mod Act 

amended section 484(a)(1)(A) of the 

Tariff Act of 1930 (19 U.S.C. 

1484(a)(1)(A)) by revising the 

requirement to make and complete 

customs entry by submitting 

documentation to CBP to allow, in the 

alternative, the electronic transmission 

of such entry information pursuant to a 

CBP-authorized electronic data 

interchange (EDI) system. CBP created 

the Automated Commercial System 

(ACS) to track, control, and process all 

commercial goods imported into the 

United States. CBP established the 

specific requirements and procedures 

for the electronic filing of entry and 

entry summary data for imported 

merchandise through the Automated 

Broker Interface (ABI) to ACS. 

II. Transition Into the Automated 

Commercial Environment 

In an effort to modernize the business 

processes essential to securing U.S. 

borders, facilitating the flow of 

legitimate shipments, and targeting 

illicit goods pursuant to the Mod Act 

and the Security and Accountability for 

Every (SAFE) Port Act of 2006 (Pub. L. 

109–347, 120 Stat. 1884), CBP 

developed the Automated Commercial 

Environment (ACE) to eventually 

replace ACS as the CBP-authorized EDI 

system. Over the last several years, CBP 

has tested ACE and provided significant 

public outreach to ensure that the trade 

community is fully aware of the 

transition from ACS to ACE. 

On October 13, 2015, CBP published 

an Interim Final Rule in the Federal 

Register (80 FR 61278) that designated 

ACE as a CBP-authorized EDI system. 

The designation of ACE as a CBPauthorized EDI system was effective 

November 1, 2015. In the Interim Final 

Rule, CBP stated that ACS would be 

phased out and anticipated that ACS 

would no longer be supported for entry 

and entry summary filing. Filers were 

encouraged to adjust their business 

practices so that they would be prepared 

when ACS was decommissioned. 

CBP developed a staggered transition 

strategy for decommissioning ACS. The 

phases of the transition were announced 

in several Federal Register notices. See 

81 FR 10264 (February 29, 2016); 81 FR 

30320 (May 16, 2016); 81 FR 32339 

(May 23, 2016); 82 FR 38924 (August 16, 

2017); and 82 FR 51852 (November 8, 

2017). This notice announces another 

transition as the processing of electronic 

drawback filings under parts 181 and 

191 of title 19 of the Code of Federal 

Regulations (CFR) is transitioning into 

ACE. 


sradovich on DSK3GMQ082PROD with NOTICES