Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 48869 

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section No. of recordkeepers 

No. of records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours 

TOTAL .......................................................................... ........................ ........................ ........................ ........................ 422,207 

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

The medical device labeling 

regulations also refer to currently 

approved collections of information 

found in FDA regulations. The 

collections of information under 

§ 800.12(d) and 801.437(i) have been 

approved under OMB control number 

0910–0183; the collections of 

information under § 800.12(e) have been 

approved under OMB control number 

0910–0231; and the collections of 

information under § 801.435(g) have 

been approved under OMB control 

number 0910–0073. 

Further, FDA concludes that labeling 

statements under §§ 801.63, 

801.405(b)(2) and (b)(3), 801.420(c)(2) 

and (c)(3), 801.430(c) and (e)(1), 

801.433, 801.437(d) through (g), and 

809.30(d)(2), (d)(3), and (e) do not 

constitute a ‘‘collection of information’’ 

under the PRA. Rather, these labeling 

statements are ‘‘public disclosure’’ of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of ‘‘disclosure to the 

public’’ (5 CFR 1320.3(c)(2)). 

Reporting 

These estimates are based on FDA’s 

registration and listing database for 

medical device establishments and 

FDA’s knowledge of and experience 

with device labeling. 

Recordkeeping 

These estimates are based on FDA’s 

registration and listing database for 

medical device establishments, Agency 

communications with industry, and 

FDA’s knowledge of and experience 

with device labeling. 

The medical device labeling 

regulations also refer to previously 

approved collections of information. 

The collections of information under 

§ 800.12(d) and 801.437(i) have been 

approved under OMB control number 

0910–0183; and the collections of 

information under § 800.12(e) have been 

approved under OMB control number 

0910–0231. 

The information collection 

requirements under § 801.63, 

801.405(b)(2) and (b)(3), 801.420(c)(2) 

and (c)(3), 801.430(c) and (e)(1), 

801.433, 801.437(d) through (g), and 

809.30(d)(2), (d)(3), and (e) are not 

considered information collection 

because the public information is 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public (5 

CFR 1320.3(c)(2)). 

Dated: August 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20098 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0064] 

Ray Nathan; Denial of Hearing; Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying Ray 

Nathan’s request for a hearing and is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) permanently debarring 

Nathan 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 Nathan was convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. 

Nathan has failed to file with the 

Agency information and analysis 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: This order is effective August 9, 

2011. 

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: G. 

Matthew Warren, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4210, Silver Spring, 

MD 20993, 301–796–4613. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On May 3, 2007, the U.S. District 

Court for the District of Massachusetts 

entered a criminal judgment against 

Nathan pursuant to his guilty plea for 

wire fraud under 18 U.S.C. 1343 and 

1342. The basis for this conviction was 

Nathan’s scheme to obtain from Lyne 

Laboratories (Lyne) a copy of a 

certificate of analysis for the drug 

PhosLo to determine how to 

manufacture a generic version of the 

drug. Nathan, a founder of a startup 

drug company named Argus 

Therapeutics (Argus), admitted that he 

created a fake email account for a senior 

employee at Nabi Biopharmaceuticals 

(Nabi), a Florida company. In an effort 

to obtain the certificate of analysis, he 

then sent an email from that account to 

an employee at Lyne, which 

manufactured PhosLo as a subcontractor 

for Nabi. When the Lyne employee 

requested a physical address to which 

the certificate should be sent, Nathan 

provided the address of another 

principal at Argus via email. Nathan 

subsequently sent a third email from the 

fraudulent email account to inquire 

about the status of his request. 

Nathan is subject to debarment based 

on a finding, under section 306(a)(2)(A) 

of the FD&C Act (21 U.S.C. 

335a(a)(2)(A)), that he was convicted of 

a felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. By a 

letter dated March 2, 2010, FDA served 

Nathan a notice proposing to 

permanently debar him from providing 

services in any capacity to a person 

having an approved or pending drug 

product application. In a letter dated 

April 6, 2010, Nathan requested a 

hearing on the proposal, and he 

submitted materials in support of that 

request on May 10, 2010. In his request 

for a hearing, Nathan acknowledges his 

conviction for wire fraud under Federal 

law, as alleged by FDA. However, he 

argues that the conduct underlying the 

conviction does not relate to the 

development or approval, including the 


sroberts on DSK5SPTVN1PROD with NOTICES
48870 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 

process for development or approval, of 

any drug product or otherwise relate to 

the regulation of drugs under the FD&C 

Act. 

We reviewed Nathan’s request for a 

hearing, as well as the materials 

submitted in support of that request, 

and find that Nathan has not created a 

basis for a hearing because hearings will 

be granted only if there is a genuine and 

substantial issue of fact. Hearings will 

not be granted on issues of policy or 

law, on mere allegations, denials, or 

general descriptions of positions and 

contentions, or on data and information 

insufficient to justify the factual 

determination urged (see 21 CFR 

12.24(b)). 

The Chief Scientist and Deputy 

Commissioner for Science and Public 

Health has considered Nathan’s 

arguments and concludes that they are 

unpersuasive and fail to raise a genuine 

and substantial issue of fact requiring a 

hearing. 

II. Argument 

In support of his hearing request, 

Nathan argues that the conduct 

underlying his conviction for wire fraud 

does not relate to the development or 

approval of a drug product or otherwise 

relate to the regulation of drugs under 

the FD&C Act. We need not address 

whether the conduct relates to the 

regulation of drugs under the FD&C Act 

because it clearly relates to the 

development of a drug product. Nathan 

argues that the ‘‘development or 

approval’’ of a drug product subject to 

FDA’s premarket review begins with 

preclinical testing in animals and ends 

with postmarket studies. He contends 

that his actions in attempting to obtain 

a certificate of analysis for PhosLo do 

not relate to that process but instead 

relate to ‘‘pre-development’’ market 

research. Nathan maintains that he and 

Argus were attempting to evaluate 

production costs for a generic version of 

PhosLo and that Argus did not possess 

the funding necessary to pursue the 

steps that he asserts are associated with 

the actual development or approval of a 

drug product. 

Nathan’s narrow reading of section 

306(a)(2)(A) is not convincing. In 

analyzing the scope of a statute, the first 

step is to ‘‘determine whether the 

language at issue has a plain and 

unambiguous meaning.’’ (Robinson v. 

Shell Oil Co., 519 U.S. 337, 340 (1997)) 

Statutory interpretation turns on ‘‘the 

language itself, the specific context in 

which that language is used, and the 

broader context of the statute as a 

whole’’ (id. at 341). Here, as FDA has 

held in denying a hearing in a 

debarment proceeding in the past, ‘‘[t]he 

statutory language, ‘relating to the 

development or approval * * *,’ by 

definition encompasses all things that 

are logically connected to the 

development or approval of a drug 

product.’’ (59 FR 62399, December 5, 

1994) As defined by ‘‘MerriamWebster’s Collegiate Dictionary,’’ 

‘‘develop’’ means, inter alia, ‘‘to explore 

the possibilities of’’ and ‘‘to make 

suitable for commercial * * * 

purposes.’’ (see ‘‘Merriam-Webster’s 

Collegiate Dictionary,’’ 10th Edition 

(2002)). Although Nathan argues that 

researching manufacturing techniques 

and the commercial viability of those 

techniques is not part of the drug 

development process, it is clearly a 

necessary step in that process. At the 

very least, such research relates to that 

development process for a drug product. 

Indeed, the information that Nathan 

attempted to obtain through his illegal 

conduct would have enabled Argus to 

begin compiling the chemistry, 

manufacturing, and controls section for 

an abbreviated new drug application 

(see 21 CFR 314.94(a)(9), 314.50(d)(1)). 

Debarring individuals who have been 

convicted of a felony for attempting to 

obtain such key information through 

fraudulent means is consistent with the 

clear remedial goals of section 306 of 

the FD&C Act. 

III. Findings And Order 

Therefore, the Chief Scientist and 

Deputy Commissioner for Science and 

Public Health, under section 

306(a)(2)(A) of the FD&C Act and under 

authority delegated to him, finds that 

Nathan has been convicted a of a felony 

under Federal law for conduct relating 

to the development or approval, 

including the process for development 

or approval, of a drug product. 

As a result of the foregoing findings, 

Nathan is permanently debarred from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under section 

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 August 9, 

2011 (21 U.S.C. 335a(c)(1)(B) and 

(c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any 

person with an approved or pending 

drug product application who 

knowingly uses the services of Nathan, 

in any capacity during his period of 

debarment, will be subject to civil 

money penalties. If Nathan, during his 

period of debarment, provides services 

in any capacity to a person with an 

approved or pending drug product 

application, he will be subject to civil 

money penalties. In addition, FDA will 

not accept or review any abbreviated 

new drug applications submitted by or 

with the assistance of Nathan during his 

period of debarment. 

Any application by Nathan for 

termination of debarment under section 

306(d) of the FD&C Act (21 U.S.C. 

335a(d)) should be identified with 

Docket No. FDA–2010–N–0064 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: July 7, 2011. 

Jesse L. Goodman, 

Chief Scientist and Deputy Commissioner for 

Science and Public Health. 

[FR Doc. 2011–20181 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0428] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Herpes Simplex Virus Types 

1 and 2 Serological Assays.’’ This 

guidance document describes a means 

by which the herpes simplex virus types 

1 and 2 serological assay device type 

may comply with the requirement of 

special controls for class II devices. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological Assays’’ 

to the Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20993– 


sroberts on DSK5SPTVN1PROD with NOTICES