Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 66729 

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, FDA finds that Mr. Santos 

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 has reason to believe 

that, if Mr. Santos 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. Santos an 

opportunity to request a hearing, 

providing him 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 16, 

2014. Mr. Santos failed to respond 

within the timeframe prescribed by 

regulation and has, therefore, waived 

his opportunity for a hearing and 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 him 

(Staff Manual Guide 1410.35), finds that 

Armando Santos has been convicted of 

seven counts of felonies under Federal 

law for conduct involving health care 

fraud, conspiracy to commit health care 

fraud, and false statements related to 

health care matters, and, on the basis of 

these convictions and other information, 

finds that Mr. Santos 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. 

As a result of the foregoing finding, 

Armando Santos is debarred for 12 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 306(c)(1)(B), 

306(c)(2)(A)(iii), and 201(dd) of the 

FD&C Act (21 U.S.C. 321(dd))). 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 Mr. Santos, 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))). If Mr. Santos provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment he 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 from Mr. Santos 

during his period of debarment (section 

306(c)(1)(B) of the FD&C Act). 

Any application by Mr. Santos for 

termination of debarment under section 

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

identified with Docket No. FDA–2013– 

N–1106 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. 

Any application by Mr. Santos for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2013– 

N–1106 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: November 4, 2014. 

Armando Zamora, 

Deputy Director, Office of Enforcement and 

Import Operations, Office of Regulatory 

Affairs. 

[FR Doc. 2014–26562 Filed 11–7–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Bone, Reproductive and Urologic 

Drugs Advisory Committee and the 

Drug Safety and Risk Management 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of an advisory committee of the 

Food and Drug Administration (FDA). 

At least one portion of the meeting will 

be closed to the public. 

Name of Committees: Bone, 

Reproductive and Urologic Drugs 

Advisory Committee and the Drug 

Safety and Risk Management Advisory 

Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on December 18, 2014, from 8:30 

a.m. to 5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Kalyani Bhatt, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

BRUDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The meeting will be closed to 

permit discussion of whether FDA 

should permit further clinical 

development of an existing 

investigational drug product, which will 

include the review of trade secret and/ 

or confidential information. 

Procedure: On December 18, 2014, 

from 8:30 a.m. to 9:45 a.m., the meeting 

is open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committees. Written 

submissions may be made to the contact 

person on or before December 4, 2014. 

Oral presentations from the public will 

be scheduled between approximately 

8:45 a.m. and 9:45 a.m. Those 

individuals interested in making formal 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
66730 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before November 24, 2014. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

November 25, 2014. 

Closed Committee Deliberations: On 

December 18, 2014, from 9:45 a.m. to 5 

p.m., the meeting will be closed to 

permit discussion and review of trade 

secret and/or confidential commercial 

information (5 U.S.C. 552b(c)(4)). 

During this session, the committees will 

review data from an investigational new 

drug (IND) application. Information 

regarding pending applications, 

including active INDs, is generally not 

publicly available under applicable laws 

and regulations, including 21 CFR 

312.120 and 314.430. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Kalyani 

Bhatt at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: November 4, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–26582 Filed 11–7–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

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 meetings. 

The meetings 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 grant applications and 

contact proposals and the discussions 

could disclose confidential trade secrets 

or commercial property such as 

patentable material, and personal 

information concerning individuals 

associated with the grant applications 

and contract proposals, the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

NHLBI T32 Institutional Training Grants. 

Date: December 2, 2014. 

Time: 3:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Room 7189, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Stephanie L Constant, 

Ph.D., Scientific Review Officer, Office of 

Scientific Review/DERA National Heart, 

Lung, and Blood Institute, 6701 Rockledge 

Drive, Room 7189, Bethesda, MD 20892, 301– 

443–8784, constantsl@nhlbi.nih.gov. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; Heart, Lung, and 

Blood Program Project Review Committee. 

Date: December 5, 2014. 

Time: 8:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Jeffrey H Hurst, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6701 Rockledge Drive, Room 7208, Bethesda, 

MD 20892, 301–435–0303, hurstj@

nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Multi-Ethnic Study of Atherosclerosis. 

Date: December 5, 2014. 

Time: 1:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Health, 6701 

Rockledge Drive, Room 7178, Rockville, MD 

20892 (Telephone Conference Call). 

Contact Person: William J Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7178, Bethesda, MD 20892–7924, 301–435– 

0725, johnsonwj@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: November 4, 2014. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–26606 Filed 11–7–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

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 meetings. 

The meetings 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID SEP for Career 

Development Grant Applications. 

Date: December 2, 2014. 

Time: 11:30 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 5601 

Fishers Lane, Rockville, MD 20892982 

(Telephone Conference Call). 

Contact Person: Zhuqing (Charlie) Li, 

Ph.D., Scientific Review Officer Scientific 

Review Program Division of Extramural 

Activities, National Institutes of Health/

NIAID 6700B Rockledge Drive, MSC 7616 

Bethesda, MD 20892–7616, 301–402–9523, 

zhuqing.li@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Peer Review Meeting. 

Date: December 3–4, 2014. 

Time: 8:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: 


asabaliauskas on DSK5VPTVN1PROD with NOTICES