20638 Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 

general, and in relation to their cost, 

their impact on related programs, their 

effectiveness in targeting for services 

under this Act unserved older 

individuals with greatest economic need 

(including low-income minority 

individuals and older individuals 

residing in rural areas) and unserved 

older individuals with greatest social 

need (including low-income minority 

individuals and older individuals 

residing in rural areas), and their 

structure and mechanisms for delivery 

of services, including, where 

appropriate, comparisons with 

appropriate control groups composed of 

persons who have not participated in 

such programs. Evaluations shall be 

conducted by persons not immediately 

involved in the administration of the 

program or project evaluated’’. 

The purpose of this data collection is 

to fulfill this requirement and 

understand how well this program is 

meeting its goals and mission through 

the conduct of a process and outcome 

evaluation that is a rigorous and 

independent assessment of the 

Program’s progress, efficiency and 

effectiveness. This information 

collection will enable AoA to effectively 

report its results to the President, to 

Congress, to the Department of Health 

and Human Services and to the public. 

The information will also aid in 

program refinement and continuous 

improvement. 

The evaluation design is comprised of 

three primary components: 

1. A process study, which examines 

the strategies, activities, and resources 

of the program at each level of the Aging 

Network—State Unit on Aging (SUA), 

Area Agency on Aging (AAA), and Local 

Service Provider (LSP); 

2. A cost study, which determines the 

cost per meal by cost category and 

program type at the local service 

provider level; and 

3. A client outcome study, which 

examines the health and social effects of 

the program on participants compared 

to non-participants. Included is an 

analysis of the nutrient quality of the 

meals provided. 

The process study will include all 56 

SUAs, a sample of AAAs (N=300), a 

sample of local service providers 

(N=200), and a sample of program 

participants and non-participants 

(N=2400). The SUA process component 

includes a short faxable data verification 

survey which asks the SUA to verify 

basic information on topics such as 

organization structure, staff and 

volunteers and population served and a 

survey that covers a variety of topics. 

The AAA process component includes a 

short faxable survey that focuses on 

program funding, staffing, and client 

characteristics and a web-based survey 

that covers a range of topics. The local 

service provider process component 

includes a short faxable survey that is 

comparable to the AAA faxable survey 

and a web-based survey that covers a 

range of topics. The cost study will be 

conducted with a sample of local 

service providers (including AAAs that 

provide direct nutrition services) and 

includes a data collection tool that asks 

about the component costs associated 

with meal production and delivery. 

The client outcome study includes 

subcomponents: (1) A survey of a 

matched sample of program participants 

and non-participants and consists of an 

assessment of health and well-being 

outcomes, individual level 

characteristics, and program service use 

and quality assessments; (2) an 

assessment of diet quality using a 24– 

Hour Recall of nutrient intake; (3) a 

study of healthcare utilization using 

linked Medicare files with client data 

collected via the initial survey described 

above and brief, follow-up interviews to 

measure service use over the year 

following the initial survey; and (4) an 

analysis of the nutrient quality of the 

meals provided to program participants 

collected from the local service 

providers. Data will be collected via 

face-to-face interviews with the aid of 

Computer Assisted Personal Interview 

(CAPI) software. Respondents’ diet 

quality and the nutrient content of the 

meals provided through the program 

will be measured using the USDA’s 

Automated Multiple Pass Method 

(AMPM) software. Respondents will be 

re-contacted at 6 and 12 months via 

telephone with a brief survey to 

measure frequency of participation in 

the Program since the previous 

interview. 

This information will be used by AoA 

to measure how well and under what 

circumstances does the OAA Title III–C 

Elderly Nutrition Services Program meet 

its legislative intent and goals. The 

proposed data collection tools may be 

found on the AoA Web site at 

http://www.aoa.gov/AoARoot/ 

Program_Results/ 

Program_Evaluation.aspx. 

AoA estimates the burden of this 

collection of information as follows: 

1,432.08 hours for organizations and 

3,336.00 hours for individuals for a total 

of 4,768.08 hours. 

Dated: April 2, 2012. 

Kathy Greenlee, 

Assistant Secretary for Aging. 

[FR Doc. 2012–8241 Filed 4–4–12; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0330] 

Ashish Macwan: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Ashish Macwan for 5 years from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on a finding that Mr. Macwan 

was convicted of one count of 

conspiracy to commit an offense against 

the United States for conduct relating to 

the development and approval, 

including the process for development 

and approval, of a drug product and to 

the regulation of drug products under 

the FD&C Act. In addition, the type of 

conduct underlying the conviction 

undermined the process for the 

regulation of drugs. Mr. Macwan was 

given notice of the proposed debarment 

and an opportunity to request a hearing 

within the time frame prescribed by 

regulation. Mr. Macwan failed to request 

a hearing, which constitutes a waiver of 

his right to a hearing concerning this 

action. 

DATES: This order is effective April 5, 

2012. 

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, Office of Regulatory 

Affairs (HFC–230), Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg, Rm. 4144, Rockville, MD 

20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(II) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(II)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a conspiracy to commit a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product or 

relating to the regulation of any drug 

product under the FD&C Act and if FDA 

finds that the type of conduct that 


Tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 20639 

served as the basis for the conviction 

undermines the process for the 

regulation of drugs. 

On November 30, 2010, judgment was 

entered against Mr. Macwan in the 

United District Court for the District of 

New Jersey based upon a plea of guilty 

to one count of conspiracy to commit an 

offense against the United States, in 

violation of 18 U.S.C. 371. 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for the conviction is as 

follows: Mr. Macwan was employed at 

Able Laboratories, Inc. (Able) as a 

chemist in Able’s Quality Control 

Department from in or around mid-1999 

through May 2003. In or around January 

2005, Mr. Macwan was promoted to 

Assistant Manager in the Quality 

Control Department and was 

responsible for supervising numerous 

chemists, monitoring the chemists’ 

compliance with current Good 

Manufacturing Practices, as required by 

the FD&C Act and FDA regulations. 

Able developed, manufactured, and sold 

several generic drug products, including 

products for cardiac and psychiatric 

conditions and prescription pain 

relievers. 

From in or around 1999 through on or 

about May 19, 2005, Mr. Macwan 

conspired to cause the introduction and 

delivery for introduction into interstate 

commerce of a drug that was adulterated 

and misbranded, with an intent to 

defraud and mislead, contrary to 18 

U.S.C. 371, 21 U.S.C. 331(a), and 

333(a)(2). 

Mr. Macwan and his coconspirators 

impaired, impeded, defeated, and 

obstructed FDA’s lawful government 

function to approve the manufacture 

and distribution of generic drug 

products by violating Good 

Manufacturing Practices; violating 

Standards of Procedure by failing to 

properly investigate, log, and archive 

questionable, aberrant, and 

unacceptable laboratory results so that 

Able could conceal improprieties and 

continue to distribute and sell its drug 

products; manipulating and falsifying 

testing data and information to conceal 

from FDA failing laboratory results 

relating to Able’s generic drug products; 

creating and maintaining false, 

fraudulent, and inaccurate test results to 

make it appear that drug products had 

the requisite identity, strength, quality, 

and purity characteristics so the drug 

products could be distributed and sold 

to increase Able’s sales and profit; and 

creating and maintaining false, 

fraudulent, and inaccurate data and 

records to obtain FDA approval to 

market new product lines. 

In furtherance of the conspiracy, in or 

around September 2003, Mr. Macwan 

falsified and manipulated testing data 

relating to the finished product testing 

for acetaminophen with codeine 

phosphate, a prescription pain relieving 

drug product. In addition, in or around 

September 2003, Mr. Macwan and his 

coconspirators falsified and 

manipulated testing data relating to the 

finished product testing for 

phentermine hydrochloride, a 

prescription drug developed to treat 

obesity. 

As a result of his conviction, on 

December 20, 2011, FDA sent Mr. 

Macwan a notice by certified mail 

proposing to debar him for 5 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)(i)(II) of the FD&C Act, that 

Mr. Macwan was convicted of a 

conspiracy under Federal law for 

conduct relating to the development and 

approval, including the process for 

development and approval of a drug 

product, and to the regulation of drug 

products under the FD&C Act, and the 

conduct that served as a basis for the 

conviction undermined the process for 

the regulation of drugs. The proposal 

also offered Mr. Macwan 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. Mr. Macwan 

failed to request a hearing within the 

timeframe prescribed by regulation and, 

therefore, has waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment 

(21 CFR Part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under section 306(b)(2)(B)(i)(II) 

of the FD&C Act, under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Ashish Macwan has 

been convicted of a conspiracy under 

Federal law for conduct relating to the 

development and approval, including 

the process for development and 

approval of a drug product, and to the 

regulation of drug products under the 

FD&C Act, and that the type of conduct 

that served as a basis for the conviction 

undermined the process for the 

regulation of drugs. 

As a result of the foregoing finding, 

Mr. Macwan is debarred for 5 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), 

(c)(2)(A)(iii), and 201(dd) of the FD&C 

Act (21 U.S.C. 335a(c)(1)(B), 

(c)(2)(A)(iii), and 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. Macwan, in any capacity 

during Mr. Macwan’s 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. Macwan 

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 

submitted by or with the assistance of 

Mr. Macwan during his period of 

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

FD&C Act). 

Any application by Mr. Macwan for 

termination of debarment under section 

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

identified with Docket No. FDA–2009– 

N–0330 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: March 27, 2012. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2012–8233 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0659] 

Shashikant Shah: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Shashikant Shah for 5 years from 


Tkelley on DSK3SPTVN1PROD with NOTICES