62634 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

21 CFR section No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.40(c)(1)(ii) .......................................................... 2,361 1.52 3,600 0.08 (5 minutes) ........ 288 

610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) .......................... 40 12 480 0.20 (12 minutes) ...... 96 

610.40(h)(2)(vi) ........................................................ 2,361 7.62 18,000 0.08 (5 minutes) ........ 1,440 

610.42(a) .................................................................. 1 1 1 1 ................................ 1 

610.46(a)(1)(ii)(B) ..................................................... 1,945 5.40 10,500 0.17 (10 minutes) ...... 1,785 

610.46(a)(3) ............................................................. 1,945 5.40 10,500 0.17 (10 minutes) ...... 1,785 

610.46(b)(3) ............................................................. 4,961 0.35 1,755 1 ................................ 1,755 

610.47(a)(1)(ii)(B) ..................................................... 1,945 12.03 23,400 0.17 (10 minutes) ...... 3,978 

610.47(a)(3) ............................................................. 1,945 12.03 23,400 0.17 (10 minutes) ...... 3,978 

610.47(b)(3) ............................................................. 4,961 0.41 2,050 1 ................................ 2,050 

630.6(a) 3 .................................................................. 648 668.72 433,333 0.08 (5 minutes) ........ 34,667 

630.6(a) 4 .................................................................. 84 53.57 4,500 1.5 (90 minutes) ........ 6,750 

630.6(d)(1) ............................................................... 63 35.71 2,250 1 ................................ 2,250

Total .................................................................. ........................ ........................ ........................ .................................... 63,019 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 

4,961 + 2,361 = 366). 3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. 

4 Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents. 

Dated: October 14, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24797 Filed 10–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0960] 

Kelvin Soto: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Kelvin Soto from providing services in 

any capacity to a person that has an 

approved or pending drug product 

application for a period of 6 years. We 

base this order on a finding that Mr. 

Soto was convicted of four felony 

counts under Federal law for conduct 

involving health care fraud and 

conspiracy to commit health care fraud 

and that this pattern of conduct is 

sufficient to find that there is reason to 

believe he may violate requirements 

under the FD&C Act relating to drug 

products. Mr. Soto was given notice of 

the proposed debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

Mr. Soto failed to request a hearing. Mr. 

Soto’s failure to request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is effective October 

20, 2014. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs, Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., Rm. 

4144, Rockville, MD 20857, 301–796– 

4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(ii)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)) 

permits debarment of an individual if 

FDA finds that the individual has been 

convicted of a felony under Federal law 

for conduct that involves bribery; 

payment of illegal gratuities; fraud; 

perjury; false statement; racketeering; 

blackmail; extortion; falsification or 

destruction of records; interference 

with, obstruction of an investigation 

into, or prosecution of any criminal 

offense; and FDA finds, on the basis of 

the conviction and other information, 

that such individual has demonstrated a 

pattern of conduct sufficient to find that 

there is reason to believe the individual 

may violate requirements under the 

FD&C Act relating to drug products. 

On November 6, 2012, the U.S. 

District Court for the Southern District 

of Florida entered judgment against Mr. 

Soto after a jury found him guilty of four 

counts of health care fraud in violation 

of 18 U.S.C. 1347 and one count of 

conspiracy to commit health care fraud 

in violation of 18 U.S.C. 1349. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein. The 

factual basis for these convictions is as 

follows: Mr. Soto was a registered nurse 

working for Ideal Home Health Inc. 

(Ideal), which was a business in MiamiDade County, FL. Ideal purportedly 

provided skilled nursing services to 

Medicare beneficiaries who required 

home health services. As a registered 

nurse in the home health field, it was 

Mr. Soto’s duty to provide skilled 

nursing services to patients and 

maintain proper documentation of all 

treatments provided to patients. 

Mr. Soto conspired with others to 

defraud Medicare. Mr. Soto and his 

coconspirators, among other things, 

submitted and caused the submission of 

false and fraudulent claims to Medicare 

and concealed the submission of these 

false and fraudulent claims. 

Mr. Soto and his co-conspirators 

falsified and caused Medicare 

beneficiaries to falsify weekly visit/time 

record sheets, falsified skilled nursing 

progress notes representing that Mr. 

Soto had administered insulin 

injections and provided various other 

medical services to Medicare 

beneficiaries, and caused Ideal to 

submit false and fraudulent claims to 

Medicare for home health benefits by 

falsely representing that they had 

provided these home health services. As 

a result of these fraudulent claims, Mr. 

Soto caused Medicare to make payments 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 62635 

to Ideal, which amounted to 

approximately $58,400. 

As a result of his conviction on April 

9, 2014, FDA sent Mr. Soto a notice by 

certified mail proposing to debar him 

for 6 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)(ii)(I) of the FD&C Act that 

Mr. Soto was convicted of felonies 

under Federal law for conduct which 

involved health care fraud, and the 

Agency found, on the basis of the 

conviction and other information, that 

Mr. Soto had demonstrated a pattern of 

conduct sufficient to find that there is 

reason to believe he may violate 

requirements under the FD&C Act 

relating to drug products. This 

conclusion was based on the fact that 

Mr. Soto had legal and professional 

obligations to ensure that he submitted 

accurate medical claims for services he 

provided, as well as ensure that he 

provided the appropriate drug products 

to his patients. Instead, Mr. Soto 

submitted and caused the submission of 

false weekly visit/time record sheets 

and false daily blood sugar/insulin log 

sheets. He engaged in this conduct 

repeatedly over a period of more than 2 

years. His convictions indicate that he 

knowingly and willfully disregarded his 

legal and professional obligations to 

keep accurate medical records and to 

submit accurate claims for the services 

he provided. Having considered the 

conduct that forms the basis of his 

conviction and the fact that this conduct 

occurred in the course of his profession 

and showed a disregard for the 

obligations of his profession and the 

law, FDA found that Mr. Soto has 

demonstrated a pattern of conduct 

sufficient to find that there is reason to 

believe that, if he were to provide 

services to a person that has an 

approved or pending drug application, 

he may violate requirements under the 

FD&C Act relating to drug products. 

Therefore, FDA had reason to believe 

that, if Mr. Soto were to provide services 

to a person that has an approved or 

pending drug application, he may 

violate requirements under the FD&C 

Act relating to drug products. 

The proposal offered Mr. Soto an 

opportunity to request a hearing, 

providing him with 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 

April 14, 2014. Mr. Soto failed to 

respond within the timeframe 

prescribed by regulation and has, 

therefore, waived his opportunity for a 

hearing and has waived 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)(ii)(I) of the FD&C 

Act, under authority delegated to the 

Director (Staff Manual Guide 1410.35), 

finds that Kelvin Soto has been 

convicted of four counts of a felony and 

one count of conspiracy to commit a 

felony under Federal law for conduct 

involving health care fraud, and on the 

basis of the conviction and other 

information, finds that Mr. Soto has 

demonstrated a pattern of conduct 

sufficient to find that there is reason to 

believe he may violate requirements 

under the FD&C Act relating to drug 

products. 

Based on the factors under section 

306(c)(2)(A)(iii) of the FD&C Act (21 

U.S.C. 335a(c)(2)(A)(iii)), FDA finds that 

each offense be accorded a debarment 

period of 3 years. In the case of a person 

debarred for multiple offenses, FDA 

shall determine whether the periods of 

debarment shall run concurrently or 

consecutively (21 U.S.C. 335a(c)(2)(A)). 

FDA has concluded that the 3-year 

period of debarment for each of the five 

offenses of conviction need not be 

served consecutively. Rather, FDA has 

concluded that the 3-year periods of 

debarment for the four counts of health 

care fraud shall run concurrently. The 3- 

year period of debarment for the 

conspiracy conviction shall run 

consecutively to the periods of 

debarment for the health care fraud 

convictions, resulting in a total 

debarment period of 6 years. 

As a result of the foregoing finding, 

Kelvin Soto is debarred for a period of 

6 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)(ii) of the FD&C Act (21 

U.S.C. 321(dd), 335a(c)(1)(B), and 

335a(c)(2)(A)(ii)). Any person with an 

approved or pending drug product 

application who knowingly employs or 

retains Mr. Soto as a consultant or 

contractor, or otherwise uses the 

services of Kelvin Soto 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))). 

In addition, FDA will not accept or 

review any abbreviated new drug 

applications submitted by or with the 

assistance of Kelvin Soto during his 

period of debarment (section 

306(c)(l)(A) of the FD&C Act). 

Any application by Mr. Soto for 

termination of debarment under section 

306(d)(4) of the FD&C Act should be 

identified with Docket No. FDA–2013– 

N–0960 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: October 14, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24814 Filed 10–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1492] 

Two-Phased Chemistry, 

Manufacturing, and Controls Technical 

Sections; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry (GFI #227) entitled ‘‘TwoPhased Chemistry, Manufacturing, and 

Controls (CMC) Technical Sections.’’ 

The purpose of this document is to 

provide recommendations to sponsors 

submitting CMC data submissions. For 

review efficiency, the Center for 

Veterinary Medicine (CVM) prefers that 

CMC information be submitted in a 

single technical section. However, there 

may be instances when a two-phased 

technical submission process is more 

beneficial to improve the overall time to 

drug approval. Sponsors may submit the 

phased CMC technical section as a 

single technical section or a two-phased 

technical section. This guidance 

describes the use of the two-phased 

technical section submission process. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 


tkelley on DSK3SPTVN1PROD with NOTICES