Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12011 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20857. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., Rockville, 

MD 20857. Transcripts will also be 

available on the Internet at http://

www.fda.gov/Drugs/NewsEvents/

ucm431040.htm approximately 45 days 

after the workshop. 

Dated: February 27, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05017 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0147] 

Demonstrating the Substantial 

Equivalence of a New Tobacco 

Product: Responses to Frequently 

Asked Questions; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance for industry 

entitled ‘‘Demonstrating the Substantial 

Equivalence of a New Tobacco Product: 

Responses to Frequently Asked 

Questions.’’ This guidance provides 

information in response to questions 

that FDA has received from 

manufacturers on demonstrating the 

substantial equivalence of a new 

tobacco product, including questions on 

when a modification to the label 

requires a premarket submission and 

review by FDA. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Demonstrating the Substantial 

Equivalence of a New Tobacco Product: 

Responses to Frequently Asked 

Questions’’ to the Center for Tobacco 

Products, Food and Drug 

Administration, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your request or include a fax 

number to which the guidance 

document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance document. 

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: 

Annette Marthaler, Center for Tobacco 

Products, Food and Drug 

Administration, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002; 1–877–287–1373, 

CTPRegulations@fda.hhs.gov, email: 

annette.marthaler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Demonstrating the Substantial 

Equivalence of a New Tobacco Product: 

Responses to Frequently Asked 

Questions.’’ In this guidance, FDA 

addresses questions from manufacturers 

on demonstrating the substantial 

equivalence of a new tobacco product. 

In the Federal Register of September 9, 

2011 (76 FR 55927), FDA announced the 

availability of the draft guidance of the 

same title. After carefully reviewing and 

considering comments and information 

submitted in response to the draft 

guidance, which covered a range of 

topics on demonstrating the substantial 

equivalence of a new tobacco product, 

FDA is finalizing this guidance on many 

of the topics, including modifications to 

labels and changes to product quantity 

and intends to address the other topics 

in future regulatory documents. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved information collections found 

in FDA regulations. 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 sections 

905(j) and 910 of the FD&C Act (21 

U.S.C. 387e(j) and 387j), as amended by 

the Tobacco Control Act, have been 

approved under OMB control number 

0910–0673; the collections of 

information in 21 CFR part 25 have been 

approved under OMB control number 

0910–0322. 

IV. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

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, and 

will be posted to the docket at http:// 

www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.regulations.gov or 

http://www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatory

Information/default.htm. 

Dated: February 27, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05023 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0303] 

William F. DeLuca, Jr.; Denial of 

Hearing; Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying a 

request for a hearing submitted by Dr. 

William F. DeLuca, Jr. and is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Dr. DeLuca for 5 years from providing 

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12012 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

services in any capacity to a person that 

has an approved or pending drug 

product application. FDA bases this 

order on a finding that Dr. DeLuca was 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

In determining the appropriateness and 

period of Dr. DeLuca’s debarment, FDA 

has considered the relevant factors 

listed in the FD&C Act. Dr. DeLuca has 

failed to file with the Agency 

information and analyses sufficient to 

create a basis for a hearing concerning 

this action. 

DATES: The order is effective March 5, 

2015. 

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: 

Nathan Doty, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–8556. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 11, 2009, in the U.S. 

District Court for the Northern District 

of New York, Dr. DeLuca, a physician, 

pled guilty to a misdemeanor under the 

FD&C Act, namely misbranding a drug 

in violation of sections 301(k), 502(i)(3), 

and 303(a)(1) of the FD&C Act (21 U.S.C. 

331(k), 352(i)(3), 333(a)(1)) and 18 

U.S.C. 2. The basis for this conviction 

was conduct surrounding his injection 

of patients seeking treatment with 

BOTOX/BOTOX Cosmetic (BOTOX) 

with a product, TRI-toxin, distributed 

by Toxin Research International, Inc. 

BOTOX is a biological product derived 

from Botulinum Toxin Type A that is 

manufactured by Allergan, Inc., and was 

approved by FDA for use on humans for 

the treatment of facial wrinkles in 1991. 

According to the records of the criminal 

proceedings, Dr. DeLuca directed a 

nurse to obtain 31 vials of TRI-toxin, an 

unapproved drug product, which was 

represented by its distributor as 

‘‘Botulinum Toxin Type A.’’ Dr. DeLuca 

then proceeded to inject approximately 

62 patients, who believed they were 

being injected with BOTOX, with TRItoxin as a substitute. 

Dr. DeLuca is subject to debarment 

based on a finding, under section 

306(b)(2)(B)(i) of the FD&C Act (21 

U.S.C. 335a(b)(2)(B)(i)): (1) That he was 

convicted of a misdemeanor under 

Federal law relating to the regulation of 

a drug product under the FD&C Act and 

(2) that the type of conduct underlying 

the conviction undermines the process 

for the regulation of drugs. By letter 

dated November 30, 2010, FDA notified 

Dr. DeLuca of its proposal to debar him 

for 5 years from providing services in 

any capacity to a person having an 

approved or pending drug product 

application. 

In a letter dated December 28, 2010, 

through counsel, Dr. DeLuca requested 

a hearing on the proposal. In his request 

for a hearing, Dr. DeLuca acknowledges 

his convictions under Federal law, as 

alleged by FDA. However, he argues that 

section 306(b)(2)(B)(i) of the FD&C Act, 

which was added by the Generic Drug 

Enforcement Act (GDEA), does not 

apply to him because he was never 

involved in the development, approval, 

or regulation of drug products, nor was 

the conduct underlying his conviction 

related to the development, approval, or 

regulation of drug products. 

We reviewed Dr. DeLuca’s request for 

a hearing and find that Dr. DeLuca has 

not created a sufficient basis for a 

hearing. Hearings are 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 has considered Dr. 

DeLuca’s arguments and concludes that 

they are unpersuasive and fail to raise 

a genuine and substantial issue of fact 

requiring a hearing. 

II. Arguments 

In support of his hearing request, Dr. 

DeLuca asserts that section 

306(b)(2)(B)(i)(I) of the FD&C Act does 

not apply to him because he was never 

involved in the development, approval, 

or regulation of drug products, nor was 

the underlying conduct of his 

conviction related to those activities. He 

argues that application of the permissive 

debarment provisions to him expands 

the intended scope of section 

306(b)(2)(b)(i)(I) of the FD&C Act 

beyond congressional intent. Dr. DeLuca 

further asserts that the statutory 

provision is limited to conduct that 

directly or indirectly affects FDA’s 

regulatory efforts associated with drug 

approval, that the intended targets of 

GDEA are those who manufacture and 

distribute drugs, and that the court’s 

decision in Bhutani v. U.S. Food and 

Drug Administration, 161 Fed. Appx. 

589, 591 (7th Cir. 2006) and FDA’s 

debarment order for Premchand 

Girdhari (65 FR 3454, January 21, 2000) 

also expressed this limitation. He asserts 

that, because his conduct did not fall 

within any such activities and he was 

not a company manufacturing or 

distributing drugs, but merely a 

physician using a drug, albeit an 

unapproved drug, section 

306(b)(2)(B)(i)(I) if the FD&C Act is 

inapplicable to him. 

During his criminal proceedings, Dr. 

DeLuca pled guilty to misbranding and 

causing the misbranding of a drug in 

violation of sections 301(k), 502(i)(3) 

and 303(a)(1) of the FD&C Act by 

offering TRI-toxin, a drug not approved 

for use, in place of an approved drug 

product, BOTOX. This conduct clearly 

relates to the regulation of drugs under 

the FD&C Act because it was in direct 

violation of the FD&C Act. The conduct 

also undermined the process for the 

regulation of drugs in that it permitted 

an unapproved drug to be substituted 

for an approved drug without the 

knowledge of the patient. As a result, 

Dr. DeLuca is subject to debarment 

under section 306(b)(2)(B)(i)(I) of the 

FD&C Act. 

Dr. DeLuca’s narrow interpretation of 

section 306(b)(2)(B)(i) of the FD&C Act, 

as well as the other provisions added to 

the statute by GDEA, is unpersuasive. 

Under well-recognized rules of statutory 

construction, the starting point in 

interpreting a statute is the text of the 

statute itself. (BedRoc Limited LLC. v. 

United States, 541 U.S. 176, 183 (2004), 

on remand, 368 F.3 1149 (9th Cir. 

2004)). It is clear from section 

306(b)(2)(B)(i) of the FD&C Act that the 

‘‘regulation of drugs’’ is not limited to 

activities related to the approval of 

drugs. If that were the case, there would 

be no need for the language ‘‘or 

otherwise relating to the regulation of 

drug products’’ as the provision already 

clearly covers approval activities with 

the language ‘‘relating to the 

development, or approval, including the 

process for development or approval.’’ 

Under rules of statutory construction, 

all the words in a statute are to be given 

meaning and no words or provisions are 

to be rendered superfluous. (Montclair 

v. Ramsdell, 107 U.S. 147, 152 (1883), 

Astoria Federal Savings and Loan Ass’n 

v. Solimino, 501 U.S. 104, 112 (1991).) 

Dr. DeLuca’s arguments regarding the 

legislative history and intent of GDEA 

also are unpersuasive. Dr. DeLuca cites 

to the House Report for the bill passed 

by the House. However, that bill did not 

ultimately become section 

306(b)(2)(B)(i) of the FD&C Act. If the 

language of the statute is clear, there is 

no need to look outside the statute to its 

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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12013 

legislative history in order to ascertain 

the statute’s meaning. (Chamber of 

Commerce of United States v. Whiting, 

131 S. Ct. 1968 (2011).) Dr. DeLuca’s 

conduct in misbranding Tri-toxin by 

holding it for sale and administering it 

to patients as the approved drug BOTOX 

clearly relates to FDA’s regulation of 

approved drugs. Likewise, his argument 

that section 306(b)(2)(B)(i) of the FD&C 

Act could not have been intended to 

cover him because he did not work for 

a person with a pending or approved 

drug product application when he was 

convicted or that section 306(b)(2)(B)(i) 

applies to only individuals who 

manufacture and distribute drugs 

ignores both the plain language of the 

statute and the remedial purpose of the 

Agency’s debarment authority. 

Furthermore, Dr. DeLuca’s argument 

that Bhutani v. U.S. Food and Drug 

Administration, 161 Fed. Appx. 589, 

591 (7th Cir. 2006), and FDA’s 

debarment order for Premchand 

Girdhari (65 FR 3454) evidence the 

court’s and FDA’s view that the statute 

is to be interpreted to exclude him is 

without merit. Both the court decision 

and FDA’s debarment order address the 

specific fact situations at issue. Both 

situations involved persons who 

manufactured and distributed drugs. 

The decision and order did not purport 

to define the full scope of section 

306(b)(2)(B)(i) of the FD&C Act or hold 

that conduct such as Dr. DeLuca’s was 

not within the scope of the statutory 

provision. 

Finally, Dr. DeLuca argues that FDA 

does not typically debar physicians for 

criminal violations of the FD&C Act. 

FDA has, however, debarred several 

other physicians under section 

306(b)(2)(B)(i)(I) of the FD&C Act for 

convictions under the FD&C Act on the 

basis of similar conduct. (See, e.g., 77 

FR 27235, May 9, 2012; 76 FR 69272, 

November 8, 2011; 76 FR 30947, May 

27, 2011; 76 FR 21910, April 19, 2011; 

76 FR 13192, March 10, 2011; 76 FR 

11789, March 3, 2011 (debarring 

physicians for felony violations of the 

FD&C Act for substituting TRI-toxin for 

BOTOX); 77 FR 27236, May 9, 2012; 76 

FR 66072, October 25, 2011; 76 FR 

48168, August 8, 2011; 76 FR 37126, 

June 24, 2011; 76 FR 30946, May 27, 

2011; 76 FR 18556, April 4, 2011; 76 FR 

18557, April 4, 2011; 76 FR 12971, 

March 9, 2011 (debarring physicians for 

a misdemeanor violations of the FD&C 

Act for substituting TRI-toxin for 

BOTOX). 

Dr. DeLuca’s arguments do not raise 

any genuine and substantial issue of fact 

for a hearing. Furthermore, Dr. DeLuca’s 

legal arguments do not create a basis for 

a hearing and, in any event, are 

unpersuasive. Accordingly, the Chief 

Scientist denies Dr. DeLuca’s request for 

a hearing. 

As set forth in the proposal to debar 

and summarized in this document, Dr. 

DeLuca pled guilty to a misdemeanor 

under the FD&C Act for his role in 

offering a drug under the name of 

another. Based on the undisputed 

record before the Agency, the 

consideration in section 306(c)(3)(A) 

and (B) of the FD&C Act with respect to 

the nature and seriousness of the offense 

and extent in management participation 

involved are unfavorable in light of Dr. 

DeLuca’s conduct in bringing the 

unapproved drug into the medical 

practice and his management position 

in The Plastic Surgery Group. At Dr. 

DeLuca’s sentencing hearing, at which 

six other codefendants were also 

sentenced, the presiding judge in 

addressing Dr. DeLuca stated: 

And we’re here because of your actions and 

inactions. As I said, your mistakes were 

different in kind and degree from those of 

your colleagues. It was you who brought this 

drug into the practice, and it was your 

conduct and your failure to check out either 

the company or the drug that you were 

ordering, as you should have done, your 

negligence in doing that that has brought us 

here today in the end. 

Consistent with the proposal to debar, 

the record established that the medical 

practice of which Dr. DeLuca was a part 

ultimately took voluntary steps to 

mitigate the effect on the public health 

from its unlawful conduct and that Dr. 

DeLuca had no previous criminal 

convictions related to matters within 

FDA’s jurisdictions. As such, the 

considerations in sections 306(c)(3)(C) 

and (F) of the FD&C Act will be treated 

as favorable factors. 

In light of the totality of the 

circumstances underlying the foregoing 

four considerations, the seriousness of 

the offense and Dr. DeLuca’s 

management participation make 

debarment for 5 years, consistent with 

the proposal to debar, appropriate in 

spite of the favorable factors under 

306(c)(3)(C) and (F) of the FD&C Act. 

III. Findings and Order 

Therefore, the Chief Scientist, under 

section 306(b)(2)(B)(i)(I) of the FD&C 

Act and under authority delegated to 

him by the Commissioner of Food and 

Drugs, finds: (1) That Dr. DeLuca has 

been convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval of a drug 

product or otherwise relating to the 

regulation of a drug product under the 

FD&C Act and (2) that the conduct 

underlying the conviction undermines 

the regulation of drugs. FDA has 

considered the relevant factors listed in 

section 306(c)(3) of the FD&C Act and 

determined that a debarment of 5 years 

is appropriate. 

As a result of the foregoing findings, 

Dr. DeLuca is debarred for 5 years 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 (see 

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

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

Any person with an approved or 

pending drug product application who 

knowingly uses the services of Dr. 

DeLuca, in any capacity during his 

period of debarment, will be subject to 

civil money penalties. If Dr. DeLuca, 

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 

Dr. DeLuca during his period of 

debarment. 

Any application by Dr. DeLuca for 

termination of debarment under section 

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

identified with Docket No. FDA–2010– 

N–0303 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. Persons with 

access to the Internet may obtain 

documents in the Docket at http://

www.regulations.gov/. 

Dated: February 24, 2015. 

Stephen Ostroff, 

Director, Office of the Chief Scientist. 

[FR Doc. 2015–05043 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0301] 

Steven M. Lynch; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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