66724 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 

medicine, public health, biological and 

physical sciences, epidemiology and 

biostatistics, clinical trial design, health 

care data management and analysis, 

patient advocacy, health care 

economics, medical ethics or other 

relevant professions. 

The MEDCAC works from an agenda 

provided by the Designated Federal 

Official. The MEDCAC reviews and 

evaluates medical literature and 

technology assessments, and hears 

public testimony on the evidence 

available to address the impact of 

medical items and services on health 

outcomes of Medicare beneficiaries. The 

MEDCAC may also advise the Centers 

for Medicare & Medicaid Services (CMS) 

as part of Medicare’s ‘‘coverage with 

evidence development’’ initiative. 

II. Provisions of the Notice 

As of June 2015, there will be 16 

membership terms expiring. Of the 16 

memberships expiring, 2 are industry 

representatives, 1 is a patient advocate, 

and the remaining 13 membership 

openings are for the at-large standing 

MEDCAC membership. 

We wish to ensure adequate 

representation of the interests of both 

women and men, members of all ethnic 

groups and physically challenged 

individuals. Therefore, we encourage 

nominations of qualified candidates 

from these groups. 

All nominations must be 

accompanied by curricula vitae. 

Nomination packages should be sent to 

Maria Ellis at the address listed in the 

ADDRESSES section of this notice. 

Nominees are selected based upon their 

individual qualifications. Nominees for 

membership must have expertise and 

experience in one or more of the 

following fields: 

• Clinical medicine including 

subspecialties 

• Administrative medicine 

• Public health 

• Biological and physical sciences 

• Epidemiology and biostatistics 

• Clinical trial design 

• Health care data management and 

analysis 

• Patient advocacy 

• Health care economics 

• Medical ethics 

• Other relevant professions 

We are looking particularly for 

experts in a number of fields. These 

include cancer screening, genetic 

testing, clinical epidemiology, 

psychopharmacology, screening and 

diagnostic testing analysis, and vascular 

surgery. We also need experts in 

biostatistics in clinical settings, 

dementia treatment, minority health, 

observational research design, stroke 

epidemiology, and women’s health. 

The nomination letter must include a 

statement that the nominee is willing to 

serve as a member of the MEDCAC and 

appears to have no conflict of interest 

that would preclude membership. We 

are requesting that all curricula vitae 

include the following: 

• Date of birth 

• Place of birth 

• Social security number 

• Title and current position 

• Professional affiliation 

• Home and business address 

• Telephone and fax numbers 

• Email address 

• List of areas of expertise 

In the nomination letter, we are 

requesting that nominees specify 

whether they are applying for a patient 

advocate position, for an at-large 

standing position, or as an industry 

representative. Potential candidates will 

be asked to provide detailed information 

concerning such matters as financial 

holdings, consultancies, and research 

grants or contracts in order to permit 

evaluation of possible sources of 

financial conflict of interest. Department 

policy prohibits multiple committee 

memberships. A federal advisory 

committee member may not serve on 

more than one committee within an 

agency at the same time. 

Members are invited to serve for 

overlapping 2-year terms. A member 

may continue to serve after the 

expiration of the member’s term until a 

successor is named. Any interested 

person may nominate one or more 

qualified persons. Self-nominations are 

also accepted. Individuals interested in 

the representative positions must 

include a letter of support from the 

organization or interest group they 

would represent. The current 

Secretary’s Charter for the MEDCAC is 

available on the CMS Web site at: 

http://www.cms.hhs.gov/FACA/

Downloads/medcaccharter.pdf, or you 

may obtain a copy of the charter by 

submitting a request to the contact listed 

in the FOR FURTHER INFORMATION

CONTACT section of this notice. 

Authority: 5 U.S.C. App. 2, section 10(a)(1) 

and (a)(2). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program.) 

Dated: November 4, 2014. 

Patrick Conway, 

Deputy Administrator for Innovation and 

Quality and CMS Chief Medical Officer, 

Centers for Medicare & Medicaid Services. 

[FR Doc. 2014–26699 Filed 11–7–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0362] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practice Regulations for 

Finished Pharmaceuticals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the current good manufacturing practice 

(CGMP) regulations for finished 

pharmaceuticals. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 9, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 


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information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Current Good Manufacturing Practice 

Regulations for Finished 

Pharmaceuticals—21 CFR Parts 210 

and 211 (OMB Control Number 0910– 

0139)—Extension 

Under section 501(a)(2)(B) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 351(a)(2)(B)), 

a drug is adulterated if the methods 

used in, or the facilities or controls used 

for, its manufacture, processing, 

packing, or holding do not conform to 

or are not operated or administered in 

conformity with CGMPs to ensure that 

such drug meets the requirements of the 

FD&C Act as to safety, and has the 

identity and strength, and meets the 

quality and purity characteristics, which 

it purports or is represented to possess. 

The FDA has the authority under 

section 701(a) of the FD&C Act (21 

U.S.C. 371(a)) to issue regulations for 

the efficient enforcement of the FD&C 

Act regarding CGMP procedures for 

manufacturing, processing, and holding 

drugs and drug products. The CGMP 

regulations help ensure that drug 

products meet the statutory 

requirements for safety and have their 

purported or represented identity, 

strength, quality, and purity 

characteristics. The information 

collection requirements in the CGMP 

regulations provide FDA with the 

necessary information to perform its 

duty to protect public health and safety. 

CGMP requirements establish 

accountability in the manufacturing and 

processing of drug products, provide for 

meaningful FDA inspections, and 

enable manufacturers to improve the 

quality of drug products over time. The 

CGMP recordkeeping requirements also 

serve preventive and remedial purposes 

and provide crucial information if it is 

necessary to recall a drug product. 

The general requirements for 

recordkeeping under part 211 (21 CFR 

part 211) are set forth in § 211.180. Any 

production, control, or distribution 

record associated with a batch and 

required to be maintained in 

compliance with part 211 must be 

retained for at least 1 year after the 

expiration date of the batch and, for 

certain over-the-counter (OTC) drugs, 3 

years after distribution of the batch 

(§ 211.180(a)). Records for all 

components, drug product containers, 

closures, and labeling are required to be 

maintained for at least 1 year after the 

expiration date and 3 years for certain 

OTC products (§ 211.180(b)). 

All part 211 records must be readily 

available for authorized inspections 

during the retention period 

(§ 211.180(c)), and such records may be 

retained either as original records or as 

true copies (§ 211.180(d)). In addition, 

21 CFR 11.2(a) provides that ‘‘for 

records required to be maintained but 

not submitted to the Agency, persons 

may use electronic records in lieu of 

paper records or electronic signatures in 

lieu of traditional signatures, in whole 

or in part, provided that the 

requirements of this part are met.’’ To 

the extent this electronic option is used, 

the burden of maintaining paper records 

should be substantially reduced, as 

should any review of such records. 

In order to facilitate improvements 

and corrective actions, records must be 

maintained so that data can be used for 

evaluating, at least annually, the quality 

standards of each drug product to 

determine the need for changes in drug 

product specifications or manufacturing 

or control procedures (§ 211.180(e)). 

Written procedures for these evaluations 

are to be established and include 

provisions for a review of a 

representative number of batches and, 

where applicable, records associated 

with the batch; provisions for a review 

of complaints, recalls, returned, or 

salvaged drug products; and 

investigations conducted under 

§ 211.192 for each drug product. 

The specific recordkeeping 

requirements provided in table 1 are as 

follows: 

Section 211.34—Consultants advising 

on the manufacture, processing, 

packing, or holding of drug products 

must have sufficient education, training, 

and experience to advise on the subject 

for which they are retained. Records 

must be maintained stating the name, 

address, and qualifications of any 

consultants and the type of service they 

provide. 

Section 211.67(c)—Records must be 

kept of maintenance, cleaning, 

sanitizing, and inspection as specified 

in §§ 211.180 and 211.182. 

Section 211.68—Appropriate controls 

must be exercised over computer or 

related systems to assure that changes in 

master production and control records 

or other records are instituted only by 

authorized personnel. 

Section 211.68(a)—Records must be 

maintained of calibration checks, 

inspections, and computer or related 

system programs for automatic, 

mechanical, and electronic equipment. 

Section 211.68(b)—All appropriate 

controls must be exercised over all 

computers or related systems and 

control data systems to assure that 

changes in master production and 

control records or other records are 

instituted only by authorized persons. 

Section 211.72—Filters for liquid 

filtration used in the manufacture, 

processing, or packing of injectable drug 

products intended for human use must 

not release fibers into such products. 

Section 211.80(d)—Each container or 

grouping of containers for components 

or drug product containers or closures 

must be identified with a distinctive 

code for each lot in each shipment 

received. This code must be used in 

recording the disposition of each lot. 

Each lot must be appropriately 

identified as to its status. 

Section 211.100(b)—Written 

production and process control 

procedures must be followed in the 

execution of the various production and 

process control functions and must be 

documented at the time of performance. 

Any deviation from the written 

procedures must be recorded and 

justified. 

Section 211.105(b)—Major equipment 

must be identified by a distinctive 

identification number or code that must 

be recorded in the batch production 

record to show the specific equipment 

used in the manufacture of each batch 

of a drug product. In cases where only 

one of a particular type of equipment 

exists in a manufacturing facility, the 


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66726 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 

name of the equipment may be used in 

lieu of a distinctive identification 

number or code. 

Section 211.122(c)—Records must be 

maintained for each shipment received 

of each different labeling and packaging 

material indicating receipt, 

examination, or testing. 

Section 211.130(e)—Inspection of 

packaging and labeling facilities must be 

made immediately before use to assure 

that all drug products have been 

removed from previous operations. 

Inspection must also be made to assure 

that packaging and labeling materials 

not suitable for subsequent operations 

have been removed. Results of 

inspection must be documented in the 

batch production records. 

Section 211.132(c)—Certain retail 

packages of OTC drug products must 

bear a statement that is prominently 

placed so consumers are alerted to the 

specific tamper-evident feature of the 

package. The labeling statement is 

required to be so placed that it will be 

unaffected if the tamper-resistant feature 

of the package is breached or missing. 

If the tamper-evident feature chosen is 

one that uses an identifying 

characteristic, that characteristic is 

required to be referred to in the labeling 

statement. 

Section 211.132(d)—A request for an 

exemption from packaging and labeling 

requirements by a manufacturer or 

packer is required to be submitted in the 

form of a citizen petition under 21 CFR 

10.30. 

Section 211.137—Requirements 

regarding product expiration dating and 

compliance with 21 CFR 201.17. 

Section 211.160(a)—The 

establishment of any specifications, 

standards, sampling plans, test 

procedures, or other laboratory control 

mechanisms, including any change in 

such specifications, standards, sampling 

plans, test procedures, or other 

laboratory control mechanisms, must be 

drafted by the appropriate 

organizational unit and reviewed and 

approved by the quality control unit. 

These requirements must be followed 

and documented at the time of 

performance. Any deviation from the 

written specifications, standards, 

sampling plans, test procedures, or 

other laboratory control mechanisms 

must be recorded and justified. 

Section 211.165(e)—The accuracy, 

sensitivity, specificity, and 

reproducibility of test methods 

employed by a firm must be established 

and documented. Such validation and 

documentation may be accomplished in 

accordance with § 211.194(a)(2). 

Section 211.166—Stability testing 

program for drug products. 

Section 211.173—Animals used in 

testing components, in-process 

materials, or drug products for 

compliance with established 

specifications must be maintained and 

controlled in a manner that assures their 

suitability for their intended use. They 

must be identified, and adequate 

records must be maintained showing the 

history of their use. 

Section 211.180(e)—Written records 

required by part 211 must be 

maintained so that data can be used for 

evaluating, at least annually, the quality 

standards of each drug product to 

determine the need for changes in drug 

product specifications or manufacturing 

or control procedures. Written 

procedures must be established and 

followed for such evaluations and must 

include provisions for a representative 

number of batches, whether approved or 

unapproved or rejected, and a review of 

complaints, recalls, returned, or 

salvaged drug products, and 

investigations conducted under 

§ 211.192 for each drug product. 

Section 211.180(f)—Procedures must 

be established to assure that the 

responsible officials of the firm, if they 

are not personally involved in or 

immediately aware of such actions, are 

notified in writing of any investigations, 

conducted under § 211.198, 211.204, or 

211.208, any recalls, reports of 

inspectional observations issued, or any 

regulatory actions relating to good 

manufacturing practices brought by 

FDA. 

Section 211.182—Specifies 

requirements for equipment cleaning 

records and the use log. 

Section 211.184—Specifies 

requirements for component, drug 

product container, closure, and labeling 

records. 

Section 211.186—Specifies master 

production and control records 

requirements. 

Section 211.188—Specifies batch 

production and control records 

requirement. 

Section 211.192—Specifies the 

information that must be maintained on 

the investigation of discrepancies found 

in the review of all drug product 

production and control records by the 

quality control staff. 

Section 211.194—Explains and 

describes laboratory records that must 

be retained. 

Section 211.196—Specifies the 

information that must be included in 

records on the distribution of the drug. 

Section 211.198—Specifies and 

describes the handling of all complaint 

files received by the applicant. 

Section 211.204—Specifies that 

records be maintained of returned and 

salvaged drug products and describes 

the procedures involved. 

Written procedures, referred to here 

as standard operating procedures 

(SOPs), are required for many part 211 

records. The current SOP requirements 

were initially provided in a final rule 

published in the Federal Register of 

September 29, 1978 (43 FR 45014), and 

are now an integral and familiar part of 

the drug manufacturing process. The 

major information collection impact of 

SOPs results from their creation. 

Thereafter, SOPs need to be periodically 

updated. A combined estimate for 

routine maintenance of SOPs is 

provided in table 1. The 25 SOP 

provisions under part 211 in the 

combined maintenance estimate 

include: 

Section 211.22(d)—Responsibilities 

and procedures of the quality control 

unit; 

Section 211.56(b)—Sanitation 

procedures; 

Section 211.56(c)—Use of suitable 

rodenticides, insecticides, fungicides, 

fumigating agents, and cleaning and 

sanitizing agents; 

Section 211.67(b)—Cleaning and 

maintenance of equipment; 

Section 211.68(a)—Proper 

performance of automatic, mechanical, 

and electronic equipment; 

Section 211.80(a)—Receipt, 

identification, storage, handling, 

sampling, testing, and approval or 

rejection of components and drug 

product containers or closures; 

Section 211.94(d)—Standards or 

specifications, methods of testing, and 

methods of cleaning, sterilizing, and 

processing to remove pyrogenic 

properties for drug product containers 

and closures; 

Section 211.100(a)—Production and 

process control; 

Section 211.110(a)—Sampling and 

testing of in-process materials and drug 

products; 

Section 211.113(a)—Prevention of 

objectionable microorganisms in drug 

products not required to be sterile; 

Section 211.113(b)—Prevention of 

microbiological contamination of drug 

products purporting to be sterile, 

including validation of any sterilization 

process; 

Section 211.115(a)—System for 

reprocessing batches that do not 

conform to standards or specifications, 

to insure that reprocessed batches 

conform with all established standards, 

specifications, and characteristics; 

Section 211.122(a)—Receipt, 

identification, storage, handling, 

sampling, examination and/or testing of 

labeling and packaging materials; 


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Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 66727 

Section 211.125(f)—Control 

procedures for the issuance of labeling; 

Section 211.130—Packaging and label 

operations, prevention of mixup and 

cross contamination, identification and 

handling of filed drug product 

containers that are set aside and held in 

unlabeled condition, and identification 

of the drug product with a lot or control 

number that permits determination of 

the history of the manufacture and 

control of the batch; 

Section 211.142—Warehousing; 

Section 211.150—Distribution of drug 

products; 

Section 211.160—Laboratory controls; 

Section 211.165(c)—Testing and 

release for distribution; 

Section 211.166(a)—Stability testing; 

Section 211.167—Special testing 

requirements; 

Section 211.180(f)—Notification of 

responsible officials of investigations, 

recalls, reports of inspectional 

observations, and any regulatory actions 

relating to good manufacturing practice; 

Section 211.198(a)—Written and oral 

complaint procedures, including quality 

control unit review of any complaint 

involving specifications failures, and 

serious and unexpected adverse drug 

experiences; 

Section 211.204—Holding, testing, 

and reprocessing of returned drug 

products; and 

Section 211.208—Drug product 

salvaging. 

In addition, the following regulations 

in parts 610 and 680 (21 CFR parts 610 

and 680) reference certain CGMP 

regulations in part 211: §§ 610.12(g), 

610.13(a)(2), 610.18(d), 680.2(f), and 

680.3(f). In table 1, the burden 

associated with the information 

collection requirements in these 

regulations is included in the burden 

estimates under §§ 211.165, 211.167, 

211.188, and 211.194, as appropriate. 

Although most of the CGMP 

provisions covered in this document 

were created many years ago, there will 

be some existing firms expanding into 

new manufacturing areas and startup 

firms that will need to create SOPs. As 

provided in table 1, FDA is assuming 

that approximately 100 firms will have 

to create up to 25 SOPs for a total of 

2,500 records, and the Agency estimates 

that it will take 20 hours per 

recordkeeper to create 25 new SOPs for 

a total of 50,000 hours. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

SOP Maintenance ..................................................... 4,360 1 4,360 25 ........................... 109,000 

New startup SOPs ..................................................... 100 25 2500 20 ........................... 50,000 

211.34—Consultants ................................................. 4,360 .25 1,090 0.50 (30 minutes) .. 545 

211.67(c)—Equipment cleaning and maintenance ... 4,360 50 218,000 .25 (15 minutes) ..... 54,500 

211.68—Changes in master production and control 

records or other records.

4,360 2 8,720 1 ............................. 8,720 

211.68(a)—Automatic, mechanical, and electronic 

equipment.

4,360 10 43,600 .50 (30 minutes) ..... 21,800 

211.68(b)—Computer or related systems ................. 4,360 5 21,800 .25 (15 minutes) ..... 5,450 

211.72—Filters .......................................................... 4,360 .25 1,090 1 ............................. 1,090 

211.80(d)—Components and drug product containers or closures.4,360 .25 1,090 .10 (6 minutes) ...... 109 

211.100(b)—Production and process controls .......... 4,360 3 13,080 2 ............................. 26,160 

211.105(b)—Equipment identification ....................... 4,360 .25 1,090 .25 (15 minutes) ..... 273 

211.122(c)—Labeling and packaging material .......... 4,360 50 218,000 .25 (15 minutes) ..... 54,500 

211.130(e)—Labeling and packaging facilities ......... 4,360 50 218,000 .25 (15 minutes) ..... 54,500 

211.132(c)—Tamper-evident packaging ................... 1,769 20 35,380 .50 (30 minutes) ..... 17,690 

211.132(d)—Tamper-evident packaging ................... 1,769 .2 354 .50 (30 minutes) ..... 177 

211.137—Expiration dating ....................................... 4,360 5 21,800 .50 (30 minutes) ..... 10,900 

211.160(a)—Laboratory controls ............................... 4,360 2 8,720 1 ............................. 8,720 

211.165(e)—Test methodology ................................. 4,360 1 4,360 1 ............................. 4,360 

211.166—Stability testing .......................................... 4,360 2 8,720 .50 (30 minutes) ..... 4,360 

211.173—Laboratory animals ................................... 1,077 1 1,077 .25 (15 minutes) ..... 269 

211.180(e)—Production, control, and distribution 

records.

4,360 .2 872 .25 (15 minutes) ..... 218 

211.180(f)—Procedures for notification of regulatory 

actions.

4,360 .2 872 1 ............................. 872 

211.182—Equipment cleaning and use log .............. 4,360 2 8,720 .25 (15 minutes) ..... 2,180 

211.184—Component, drug product container, closure, and labeling records.4,360 3 13,080 .50 (30 minutes) ..... 6,540 

211.186—Master production and control records ..... 4,360 10 43,600 2 ............................. 87,200 

211.188—Batch production and control records ....... 4,360 25 109,000 2 ............................. 218,000 

211.192—Discrepancies in drug product production 

and control records.

4,360 2 8,720 1 ............................. 8,720 

211.194—Laboratory records .................................... 4,360 25 109,000 .50 (30 minutes) ..... 54,500 

211.196—Distribution records ................................... 4,360 25 109,000 .25 (15 minutes) ..... 27,250 

211.198—Compliant files .......................................... 4,360 5 21,800 1 ............................. 21,800 

211.204—Returned drug products ............................ 4,360 10 43,600 .50 (30 minutes) ..... 21,800 

Total .................................................................... ........................ .......................... ........................ ................................ 882,203 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
66728 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 

Dated: November 4, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26596 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–2013–N–1106] 

Armando Santos: 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 

Armando Santos from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application for a period of 12 

years. FDA bases this order on a finding 

that Mr. Santos was convicted of seven 

felony counts under Federal law for 

conduct involving health care fraud, 

conspiracy to commit health care fraud, 

and false statements related to health 

care matters and that this pattern of 

conduct is sufficient to find that there 

is reason to believe he may violate 

requirements under the FD&C Act 

relating to drug products. Mr. Santos 

was given notice of the proposed 

debarment and an opportunity to 

request a hearing within the timeframe 

prescribed by regulation. Mr. Santos 

failed to respond. Mr. Santos’s failure to 

respond constitutes a waiver of his right 

to a hearing concerning this action. 

DATES: This order is effective November 

10, 2014. 

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., Element Bldg., Rm. 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 that 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 it 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 August 15, 2011, the U.S. District 

Court for the Southern District of 

Florida entered judgment against Mr. 

Santos after a jury found him guilty of 

four counts of health care fraud in 

violation of 18 U.S.C. 1347, one count 

of conspiracy to commit health care 

fraud in violation of 18 U.S.C. 1349, and 

two counts of false statements related to 

health care matters in violation of 18 

U.S.C. 1035(a)(2). 

The FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein. The 

factual basis for these convictions is as 

follows: Mr. Santos was a registered 

nurse working for a home health agency 

located in the Southern District of 

Florida. As a registered nurse in the 

home health field, it was Mr. Santos’s 

duty to provide skilled nursing services 

to patients and maintain proper 

documentation of all treatments 

provided to patients. 

From on or about June 29, 2007, 

through on or about March 13, 2009, Mr. 

Santos conspired with others to defraud 

Medicare. Mr. Santos and his 

coconspirators, among other things, 

submitted and caused the submission of 

false and fraudulent claims to Medicare, 

and paid kickbacks and bribes to 

Medicare beneficiaries in exchange for 

the use of their Medicare beneficiary 

numbers as the bases of claims filed for 

home health care. Mr. Santos and his 

co-conspirators signed patient 

assessment forms falsely certifying that 

Medicare beneficiaries were in need of 

home health services that were 

medically unnecessary. 

Mr. Santos created false weekly visit/ 

time records in which he claimed to be 

providing skilled nursing services to 

two separate Medicare beneficiaries at 

the same time. On four separate 

occasions, Mr. Santos submitted and 

caused the submission of false and 

fraudulent claims to Medicare, 

representing that he had provided 

various home health services to 

beneficiaries pursuant to physicians’ 

plans of care. He caused a home health 

agency to submit approximately 

$230,315 in false and fraudulent claims 

to Medicare for home health services 

allegedly rendered to Medicare 

beneficiaries, when such home health 

services were not medically necessary 

and had not been provided. As a result 

of these fraudulent claims, Mr. Santos 

caused Medicare to make payments of 

approximately $152,664 to a MiamiDade County home health agency. 

In addition, Mr. Santos knowingly 

and willfully made materially false 

statements and representations, in 

connection with the delivery of and 

payment for health care benefits, items, 

and services. Specifically, Mr. Santos 

prepared documents entitled ‘‘Skilled 

Nursing Progress Note[s]’’ which falsely 

stated that he had injected Medicare 

beneficiaries with insulin on two 

occasions, when he knew he had not 

performed these services. 

As a result of his convictions, on 

April 9, 2014, FDA sent Mr. Santos a 

notice by certified mail proposing to 

debar him for 12 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 

Mr. Santos was convicted of seven 

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 that the Agency found, on 

the basis of these convictions and other 

information, that Mr. Santos had 

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. This conclusion was based on 

the fact that Mr. Santos had legal and 

professional obligations to ensure that 

he kept accurate medical records for 

each patient and that he submitted 

accurate medical claims for services he 

provided. Instead, Mr. Santos signed 

patient assessment forms falsely 

certifying that Medicare beneficiaries 

were in need of home health services 

that were medically unnecessary, and 

he submitted false weekly visit/time 

records. Mr. Santos additionally 

prepared false ‘‘Skilled Nursing Progress 

Note[s]’’ stating that he had injected two 

Medicare beneficiaries with insulin 

when he had not done so. He submitted 

and caused the submission of false and 

fraudulent claims to Medicare. He 

engaged in this conduct repeatedly over 

a period of almost 2 years. His 

convictions indicate that he knowingly 

and willfully disregarded his legal and 

professional obligations to keep accurate 

medical records and to submit accurate 

claims for the services he provided. 


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