17050 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 

registered nurse in the home health 

field, it was Ms. Fernandez’s duty to 

provide skilled nursing services to 

patients and maintain proper 

documentation of all treatments 

provided to patients. 

From on or about August 17, 2007, 

through on or about March 19, 2009, 

Ms. Fernandez conspired with others to 

defraud Medicare. 

Ms. Fernandez and her coconspirators 

submitted, and caused the submission 

of, false and fraudulent claims to 

Medicare, and concealed the submission 

of these false and fraudulent claims. 

Ms. Fernandez and her coconspirators 

falsified and caused Medicare 

beneficiaries to falsify weekly visit/time 

record sheets, and falsified skilled 

nursing progress notes representing that 

she had administered insulin injections 

and provided other medical services to 

Medicare beneficiaries. She caused Ideal 

to submit false and fraudulent claims to 

Medicare for home health benefits by 

falsely representing that she had 

provided these health services. As a 

result of these fraudulent claims, she 

caused Medicare to make payments to 

Ideal of approximately $82,040. Ms. 

Fernandez engaged in this criminal 

conduct repeatedly over a period of 

approximately 19 months. 

As a result of her convictions, on 

September 8, 2014, FDA sent Ms. 

Fernandez a notice by certified mail 

proposing to debar her 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 the finding, under section 

306(b)(2)(B)(ii)(I) of the FD&C Act, that 

Ms. Fernandez was convicted of felonies 

under Federal law for conduct involving 

health care fraud and conspiracy to 

commit health care fraud, and the 

Agency found, on the basis of the 

conviction and other information, that 

Ms. Fernandez had demonstrated a 

pattern of conduct sufficient to find that 

there is reason to believe she may 

violate requirements under the FD&C 

Act relating to drug products. This 

conclusion was based on the fact that 

Ms. Fernandez had legal and 

professional obligations to ensure that 

she submitted accurate medical claims 

for services she provided. Instead, Ms. 

Fernandez submitted, and caused the 

submission of, false weekly visit/time 

records and false daily blood sugar/

insulin log sheets. She engaged in this 

conduct repeatedly over a period of 

almost 2 years. Her convictions indicate 

that she knowingly and willfully 

disregarded her legal and professional 

obligations to keep accurate medical 

records and to submit accurate claims 

for the services she provided. Having 

considered the conduct that forms the 

basis of her conviction and the fact that 

this conduct occurred in the course of 

her profession and showed a disregard 

for the obligations of her profession and 

the law, FDA found that Ms. Fernandez 

has demonstrated a pattern of conduct 

sufficient to find that there is reason to 

believe that, if she were to provide 

services to a person that has an 

approved or pending drug application, 

she may violate requirements under the 

FD&C Act relating to drug products. The 

proposal offered Ms. Fernandez an 

opportunity to request a hearing, 

providing her with 30 days from the 

date of receipt of the letter in which to 

file the request, and advised her 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 

September 12, 2014. Ms. Fernandez 

failed to respond within the timeframe 

prescribed by regulation and has, 

therefore, waived her opportunity for a 

hearing and has waived any contentions 

concerning her 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 Odalys Fernandez has been 

convicted of five 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 Ms. Fernandez 

has demonstrated a pattern of conduct 

sufficient to find that there is reason to 

believe she 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, 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 (section 

306(c)(2)(A)). FDA has concluded that 

the 3-year periods of debarment for the 

five 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 health care fraud 

convictions, resulting in a total 

debarment period of 6 years. 

As a result of the foregoing findings, 

Odalys Fernandez is debarred for 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 as a consultant or contractor, or 

otherwise uses the services of Ms. 

Fernandez in any capacity during her 

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 Ms. 

Fernandez provides services in any 

capacity to a person with an approved 

or pending drug product application 

during her period of debarment she 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 

submitted by or with the assistance of 

Odalys Fernandez during her period of 

debarment (section 306(c)(1)(A) of the 

FD&C Act). 

Any application by Ms. Fernandez for 

termination of debarment under section 

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

identified with Docket No. FDA–2014– 

N–0563 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. 

Publicly available submissions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: March 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07267 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0500] 

Early Clinical Trials With Live 

Biotherapeutic Products: Chemistry, 

Manufacturing, and Control 

Information; Guidance for Industry; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; requests for comments. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17051 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

request for additional comments on the 

chemistry, manufacturing, and control 

(CMC) information that a sponsor of an 

investigational new drug application 

(IND) should provide in its IND in order 

to meet regulatory requirements when 

commercially available foods or dietary 

supplements containing live 

biotherapeutic products (LBPs) are used 

as investigational new drugs in early 

phase clinical trials. The request for 

additional comments on the CMC 

information is related to the guidance 

entitled, ‘‘Early Clinical Trials with Live 

Biotherapeutic Products: Chemistry, 

Manufacturing, and Control 

Information; Guidance for Industry,’’ 

dated February 2012 (February 2012 

guidance). 

DATES: Submit either electronic or 

written comments on the requested 

CMC information by May 29, 2015. 

ADDRESSES: Submit written requests for 

single copies of the February 2012 

guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

requested CMC information 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: 

Jessica T. Walker, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a request for 

additional comments on the CMC 

information that a sponsor of an IND 

should provide in its IND in order to 

meet the requirements under § 312.23 

(21 CFR 312.23), when commercially 

available foods or dietary supplements 

containing LBPs are subject to study as 

investigational new drugs in early phase 

clinical trials. 

In the Federal Register of February 

21, 2012 (77 FR 9947), FDA announced 

the publication of a final guidance 

entitled ‘‘Early Clinical Trials with Live 

Biotherapeutic Products: Chemistry, 

Manufacturing, and Control 

Information; Guidance for Industry,’’ 

dated February 2012. The guidance 

provides IND sponsors with 

recommendations regarding CMC 

information that should be included in 

IND submissions for early clinical trials 

with LBPs, including LBPs lawfully 

marketed as foods or dietary 

supplements in the United States and 

proposed for clinical uses regulated 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262). The 

guidance also outlines the Drug 

Substance and Drug Product 

information that should be provided in 

the CMC section of an IND to meet the 

requirements under § 312.23 and to 

support proceeding to clinical 

evaluation of an LBP in human subjects. 

II. CMC Information 

FDA is considering modifying the 

February 2012 guidance to address the 

CMC information that should be 

provided in an IND, under certain 

conditions. Specifically, FDA is 

considering whether to revise the 

guidance to address when the label on 

the commercially available product(s) 

would be considered adequate to satisfy 

the requirement for CMC information 

under § 312.23. For example, we are 

considering whether the label would be 

adequate to satisfy the CMC information 

when the following conditions are met: 

(1) The LBP product that is proposed for 

investigational use is a commercially 

available food or dietary supplement; (2) 

the investigation does not involve a 

route of administration, dose, patient 

population, or other factor that 

significantly increases the risk (or 

decreases the acceptability of risk) 

associated with the use of the food or 

dietary supplement; (3) the investigation 

is not intended to support a marketing 

application for a drug claim for the food 

or dietary supplement; and (4) the 

investigation is conducted in 

compliance with the requirements for 

INDs (part 312), the requirements for 

review by an institutional review board 

(21 CFR part 56), and with the 

requirements for informed consent (21 

CFR part 50). FDA is seeking public 

comment on this issue. 

III. Comments 

Interested persons may submit either 

electronic comments regarding the 

requested CMC information 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the February 2012 guidance 

at either http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://www.regulations.

gov. 

Dated: March 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07273 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1439] 

Critical Path Innovation Meetings; 

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 guidance for industry 

entitled ‘‘Critical Path Innovation 

Meetings.’’ This guidance describes a 

Critical Path Innovation Meeting 

(CPIM), a means by which FDA’s Center 

for Drug Evaluation and Research 

(CDER) and investigators from industry, 

academia, government, and patient 

advocacy groups can communicate to 

improve efficiency and success in drug 

development. The goals of the CPIM are 

to discuss a methodology or technology 

proposed by the meeting requester and 

for CDER to provide general advice on 

how this methodology or technology 

might enhance drug development. The 

discussions and background 

information submitted through the 

CPIM are nonbinding on both FDA and 

CPIM requesters. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 


asabaliauskas on DSK5VPTVN1PROD with NOTICES