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
62636 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by December 19, 

2014. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Heather Longstaff, Center for Veterinary 

Medicine (HFV–145), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0651, 

email: heather.longstaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (GFI #227) 

entitled ‘‘Two-Phased Chemistry, 

Manufacturing, and Controls (CMC) 

Technical Sections.’’ It is intended to 

provide recommendations to industry 

regarding CMC data submitted to CVM 

to support approval of a new animal 

drug or abbreviated new animal drug. 

As specified in the Animal Drug User 

Fee Amendments of 2013 (ADUFA III) 

and Animal Generic Drug User Fee 

Amendments of 2013 (AGDUFA II) 

respective goals letters, the Agency 

agreed to develop guidance for a twophased CMC technical section 

submission and review process by the 

end of fiscal year 2014. 

The two-phased process allows for 

two separate CMC submissions, each 

with its own review clock, and each 

including complete appropriate CMC 

information that is available for review 

at the time of submission. The draft 

guidance specifies the technical details 

of how the process works, the review 

clocks, the information that is 

appropriate for each technical section 

submission, and the possible review 

outcomes. The guidance also includes 

CVM’s recommendations for meetings 

between the Division of Manufacturing 

Technologies and the sponsor during 

this process to ensure concurrence with 

the approach used for the CMC 

technical section. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in this guidance have 

been approved under 0910–0032 and 

0910–0669. 

IV. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: October 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24796 Filed 10–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects (Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995), the 

Health Resources and Services 

Administration (HRSA) announces 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). Prior to submitting the 

ICR to OMB, HRSA seeks comments 

from the public regarding the burden 

estimate, below, or any other aspect of 

the ICR. 

DATES: Comments on this Information 

Collection Request must be received no 

later than December 19, 2014. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 10–29, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call the HRSA Information Collection 

Clearance Officer at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

The Secretary’s Discretionary Advisory 

Committee on Heritable Disorders in 

Newborns and Children’s Public Health 

System Assessment Surveys OMB No. 

0915-xxxx–New 

Abstract: The purpose of the public 

health system assessment surveys is to 

inform the Secretary’s Discretionary 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(Committee) on the ability to add 

newborn screening for particular 

conditions within a state, including the 

feasibility, readiness, and overall 

capacity to screen for a new condition. 

The Committee was established under 

the Public Health Service Act, 42 U.S.C. 

217a: Advisory Councils or Committees. 

This Committee fulfills the functions 

previously undertaken by the former 

Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children, established under Section 

1111 of the Public Health Service Act 

(PHS), 42 U.S.C. 300b–10, as amended 

in the Newborn Screening Saves Lives 

Act of 2008. The Committee is governed 

by the provisions of the Federal 

Advisory Committee Act (FACA), as 


tkelley on DSK3SPTVN1PROD with NOTICES