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– 


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Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 48871 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Haja 

Sittana El Mubarak, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5519, Silver Spring, 

MD 20993–0002, 301–796–6193. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance document provides 

recommendations on the types of 

information and data that FDA believes 

needs to be included in a 510(k) for 

herpes simplex virus (HSV) types 1 and 

2 serological assays. HSV serological 

assays are devices that consist of 

antigens and antisera used in various 

serological tests to identify antibodies to 

HSV in serum. Additionally, some of 

the assays consist of HSV antisera 

conjugated with a fluorescent dye 

(immunofluorescent assays) used to 

identify HSV directly from clinical 

specimens or tissue culture isolates 

derived from clinical specimens. The 

identification aids in the diagnosis of 

diseases caused by HSVs and provides 

epidemiological information on these 

diseases. Herpes simplex viral 

infections range from common and mild 

lesions of the skin and mucous 

membranes to a severe form of 

encephalitis (inflammation of the brain). 

Neonatal herpes virus infections range 

from a mild infection to a severe 

generalized disease with a fatal 

outcome. We revised the existing 

guidance by rewriting the method 

comparison section and the sample 

selection inclusion and exclusion 

criteria section. The revisions define 

and differentiate the required studies 

and the study populations for the 

assessment of the safety and 

effectiveness of the different types of 

HSV types 1 and 2 serological assays. 

Additionally, the revisions include 

several corrections and clarifications 

throughout the document to ensure 

accuracy, consistency, and ease of 

reading. The draft of this guidance 

issued on September 28, 2010 (75 FR 

59726) and the comment period closed 

on December 27, 2010. We received no 

comments on the draft guidance. 

Elsewhere in this issue of the Federal 

Register, FDA is finalizing the 

amendment of the special controls 

guidance document and designating this 

guidance as the class II special control 

for HSV types 1 and 2 serological 

assays. Following the effective date in 

the final rule finalizing the amendment 

of the special controls guidance 

document, this revised guidance 

document will serve as the special 

control for this device and supersedes 

the guidance with the same name that 

issued on April 3, 2007 (72 FR 15888). 

II. Significance of Special Controls 

Guidance Document 

FDA believes that adherence to the 

recommendations described in this 

guidance document, in addition to the 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of the HSV types 1 and 2 

serological assays classified under 21 

CFR 866.3305. In order to be classified 

as a class II device, HSV types 1 and 2 

serological assays must comply with the 

requirements of special controls; 

manufacturers must address the issues 

requiring special controls as identified 

in the guidance document, either by 

following the recommendations in the 

guidance document or by some other 

means that provides equivalent 

assurances of safety and effectiveness. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological 

Assays,’’ you may either send an e-mail 

request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1713 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act 

This guidance refers to previously 

approved collections of information 

found in FDA regulations and guidance 

documents. 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 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; and 

the collections of information in 21 CFR 

part 801 and 21 CFR 809.10 have been 

approved under OMB control number 

0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

Dated: August 3, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20117 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–2011–N–0002] 

Immunology Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Immunology Devices 

Panel of the Medical Devices Advisory 

Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

Agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on October 14, 2011, from 8 a.m. to 6 p.m. 

Location: Hilton Washington DC North/ 

Gaithersburg, salons A, B, and C, 620 Perry 

Pkwy., Gaithersburg, MD. 

Contact Person: Shanika Craig, Center for 

Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 301– 

796–6639, or FDA Advisory Committee 

Information Line, 1–800–741–8138 (301– 

443–0572 in the Washington, DC area), and 


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