Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17049 

Estimated Total Annual Burden 

Hours: 255. 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: OPRE Reports Clearance Officer. 

Email address: OPREinfocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on (a) whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Karl Koerper, 

Reports Clearance Officer. 

[FR Doc. 2015–07316 Filed 3–30–15; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; NIH Loan Repayment 

Program (Clinical and Pediatric Researchers). 

Date: April 24, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Environmental 

Health Sciences, Keystone Building, 530 

Davis Drive, Suite 3118, Research Triangle 

Park, NC 27709, (Virtual Meeting). 

Contact Person: RoseAnne M McGee, 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research and 

Training, Nat. Institute of Environmental 

Health Sciences, P.O. Box 12233, MD EC–30, 

Research Triangle Park, NC 27709 (919) 541– 

0752, mcgee1@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: March 25, 2015. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07249 Filed 3–30–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0563] 

Odalys Fernandez: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The U.S. Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) debarring Odalys Fernandez 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application for a 

period of 6 years. FDA bases this order 

on a finding that Ms. Fernandez was 

convicted of five felony counts under 

Federal law for conduct involving 

health care fraud, and one count of 

conspiracy to commit health care fraud, 

and that this pattern of conduct is 

sufficient to find that there is reason to 

believe she may violate requirements 

under the FD&C Act relating to drug 

products. Ms. Fernandez was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. Ms. Fernandez failed to 

request a hearing. Ms. Fernandez’s 

failure to request a hearing constitutes a 

waiver of her right to a hearing 

concerning this action. 

DATES: This order is effective March 31, 

2015. 

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, Division of Enforcement, 

Office of Enforcement and Import 

Operations, Office of Regulatory Affairs, 

Food and Drug Administration, 12420 

Parklawn Dr. (ELEM–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 which involves bribery, 

payment of illegal gratuities, fraud, 

perjury, false statement, racketeering, 

blackmail, extortion, falsification or 

destruction of records, or 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 9, 2012, the U.S. 

District Court for the Southern District 

of Florida entered judgment against Ms. 

Fernandez after a jury found her guilty 

of five 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: Ms. Fernandez was a registered 

nurse working for Ideal Home Health 

Inc. (Ideal), which was a business in 

Miami-Dade County, FL. Ideal 

purportedly provided skilled nursing 

services to Medicare beneficiaries who 

required home health services. As a 


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