17048 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 

industry #226 entitled ‘‘Target Animal 

Safety Data Presentation and Statistical 

Analysis.’’ The purpose of this 

document is to provide 

recommendations to industry regarding 

the presentation and statistical analyses 

of target animal safety (TAS) data 

submitted to the Center for Veterinary 

Medicine (CVM) as part of a study 

report to support approval of a new 

animal drug. These recommendations 

apply to TAS data generated from both 

TAS and field effectiveness studies 

conducted in companion animals (e.g., 

dogs, cats, and horses) and food animals 

(e.g., swine, ruminants, fish, and 

poultry). 

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 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 1, 2015. 

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draft guidance to http://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: 

Virginia Recta, Center for Veterinary 

Medicine (HFV–164), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0840, 

virginia.recta@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #226 

entitled ‘‘Target Animal Safety Data 

Presentation and Statistical Analysis.’’ It 

is intended to provide recommendations 

to industry regarding the presentation 

and statistical analyses of TAS data 

submitted to CVM as part of a study 

report to support approval of a new 

animal drug. These recommendations 

apply to TAS data generated from both 

TAS and field effectiveness studies 

conducted in companion animals (e.g., 

dogs, cats, and horses) and food animals 

(e.g., swine, ruminants, fish, and 

poultry). 

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 current 

thinking of FDA on ‘‘Target Animal 

Safety Data Presentation and Statistical 

Analysis.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it 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 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. 

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: March 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07264 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Same-sex relationships: Updates 

to Healthy Marriage and Relationship 

Education. 

OMB No.: New Collection 

Description: The Administration for 

Children and Families (ACF) will 

examine how healthy marriage 

programs currently approach, and could 

approach, serving sexual minority 

populations, that is, lesbian, gay, and 

bisexual populations. ACF expects to 

collect and analyze data from a range of 

information collection efforts— 

including interviews with program 

administrators, program managers, 

healthy marriage and relationship 

programming experts, and focus groups 

with program applicants and program 

attendees—to propose methods and 

practices for serving such couples/

individuals/youth. 

Respondents: Current healthy 

marriage program applicants and 

participants, program managers and 

facilitators, and experts in the field. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total/annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Focus Group Guide for Program Applicants ................................................... 30 1 1.5 45 

Focus Group Guide for Program Attendees .................................................... 60 1 1.5 90 

Focus Group Guide for Program Attendees .................................................... 60 1 1.5 90 

Interview Guide for Program Managers .......................................................... 6 1 1 6 

Interview Guide for Program Facilitators ......................................................... 12 1 1 12 

Interview Guide for Program Experts .............................................................. 12 1 1 12 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES