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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12014 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is denying a 

request for a hearing submitted by Dr. 

Steven M. Lynch, and is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring Dr. 

Lynch for 2 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 Dr. Lynch 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. Lynch’s debarment, FDA 

has considered the relevant factors 

listed in the FD&C Act. Dr. Lynch 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. Lynch, 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. Lynch’s colleague in 

the same medical practice, The Plastic 

Surgery Group (TPSG), 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. Lynch 

then proceeded to inject approximately 

18 patients, who believed they were 

being injected with BOTOX, with TRItoxin as a substitute. 

Dr. Lynch is subject to debarment 

based on a finding, under section 

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

U.S.C. 335a(b)(2)(B)(i)(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 notice to 

Dr. Lynch dated November 30, 2010, 

FDA’s Office of Regulatory Affairs 

(ORA) proposed to debar him for 4 years 

from providing services in any capacity 

to a person having an approved or 

pending drug product application. 

In a letter dated December 30, 2010, 

through counsel, Dr. Lynch requested a 

hearing on the proposal. In his request 

for a hearing, Dr. Lynch acknowledges 

his conviction under Federal law, as 

alleged by FDA. By letter dated 

February 4, 2011, Dr. Lynch submitted 

materials and arguments in support of 

his request. Dr. Lynch acknowledges 

that he was convicted of a Federal 

misdemeanor, as found in the proposal 

to debar, but argues that he should not 

be debarred for reasons related to the 

factual basis set forth in the proposal to 

debar. In particular, with respect to the 

considerations for determining the 

appropriateness and period of 

debarment under section 306(c)(3) of the 

FD&C Act, he argues that there are 

genuine and substantial issues of fact for 

resolution at a hearing, namely factual 

issues bearing on whether he 

participated in or even knew of certain 

conduct that resulted in his violation of 

the FD&C Act. 

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 or the 

action requested (see 21 CFR 12.24(b)). 

The Chief Scientist has considered Dr. 

Lynch’s arguments, as well as the 

proposal to debar itself, and concludes 

that, although Dr. Lynch has failed to 

raise a genuine and substantial issue of 

fact requiring a hearing, the appropriate 

period of debarment is 2 years. 

II. Arguments 

In support of his hearing request, Dr. 

Lynch first asserts that he is not subject 

to debarment under section 

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

contends that he pled guilty to a 

misdemeanor violation of the FD&C Act 

(see section 303(a)(1)), which is a strict 

liability offense, and that thus there was 

no demonstration or admission of 

criminal intent or knowledge 

underlying the conviction. Dr. Lynch 

concludes, therefore, that the conduct 

underlying his conviction did not 

undermine the process for the 

regulation of drugs. 

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

Act specifically provides for the 

debarment of individuals convicted of 

Federal misdemeanors related to the 

regulation of drug products under the 

FD&C Act. Given that misdemeanor 

violations of the FD&C Act themselves 

are strict liability offenses, it stands to 

reason that criminal intent is not a 

critical component to debar an 

individual under section 

306(b)(2)(B)(i)(I). During his criminal 

proceedings, Dr. Lynch 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 an 

unapproved drug, TRI-toxin, for sale as 

an approved drug product, BOTOX. Dr. 

Lynch’s conduct 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. Lynch is, in fact, subject 

to debarment under section 

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

Dr. Lynch next challenges the manner 

in which ORA applied the 

considerations under section 306(c)(3) 

of the FD&C Act in determining the 

appropriateness and period of his 

debarment. In the proposal to debar Dr. 

Lynch, ORA stated that there are four 

applicable considerations under section 

306(c)(3) of the FD&C Act: (1) The 

nature and seriousness of his offense 

under section 306(c)(3)(A); (2) the 

nature and extent of management 

participation in the offense under 

section 306(c)(3)(B); (3) the nature and 

extent of voluntary steps taken to 

mitigate the impact on the public under 

section 306(c)(3)(C); and (4) prior 

convictions involving matters within 

the jurisdiction of FDA under section 

306(c)(3)(F). ORA found with respect to 

Dr. Lynch that the first two 

considerations weigh in favor of 

debarment and noted that the third and 

fourth considerations would be treated 

as favorable factors for him. In making 

all of its findings under section 306(c)(3) 

of the FD&C Act, ORA characterized Dr. 

Lynch’s conduct based on records from 

his criminal proceedings. 

Under section 306(c)(3)(A) of the 

FD&C Act, in determining the 

appropriateness and period of 

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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12015 

debarment, FDA considers ‘‘the nature 

and seriousness of the offense 

involved.’’ In the proposal to debar, 

ORA relied on the criminal information 

to which Dr. Lynch pled guilty to find 

that the conduct underlying his 

convictions: 

created a risk of injury to consumers due to 

the use of an unapproved drug, undermined 

[FDA’s] oversight of an approved drug 

product by representing that [he] used the 

approved drug while actually substituting an 

unapproved drug in its place, and seriously 

undermined the integrity of [FDA’s] 

regulation of drug products. 

Under section 306(c)(3)(B), ORA also 

considered the ‘‘nature and extent of 

[Dr. Lynch’s] management participation 

in the offense’’ and specifically found 

that he was a corporate principal who 

‘‘pleaded guilty to misbranding TRItoxin’’ and ‘‘participated in the [TPSG’s] 

unlawful conduct of administering [an] 

unapproved drug on multiple occasions 

to patients.’’ ORA concluded, therefore, 

that the nature and seriousness of 

Lynch’s offenses and the nature and 

extent of management participation 

were unfavorable factors with respect to 

him. 

Dr. Lynch counters ORA’s findings 

with respect to those two considerations 

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

with the following arguments: (1) That 

he did not admit any criminal intent or 

intentional wrongdoing when he pled 

guilty to a misdemeanor offense under 

the FD&C Act; (2) that, in fact, another 

physician at TPSG took unilateral action 

in ordering the TRI-toxin and directing 

a nurse to substitute it for BOTOX; (3) 

that the TRI-toxin vials that they used 

for injecting patients with TRI-toxin 

were identical to the vials he used for 

BOTOX before the substitution; and (4) 

that since the conviction for the 

underlying misdemeanor was of an 

individual, that there was no 

management participation and that, 

thus, the nature and extent of 

management participation is 

inapplicable as a factor in determining 

appropriateness and period of 

debarment. Dr. Lynch concedes that he 

pled guilty to the misdemeanor offense 

because he was, in fact, guilty of 

offering TRI-toxin for sale to their 

patients as BOTOX. He argues, however, 

that the criminal records do not 

establish any intent or knowledge on his 

part and that thus the conduct 

underlying his conviction does not 

warrant debarment in light of the 

considerations in section 306(c)(3) of 

the FD&C Act. 

As noted previously, ORA relied on 

the records of Dr. Lynch’s criminal 

proceedings for its findings in the 

proposal to debar. There is nothing 

definitive in the criminal records before 

FDA to contradict Dr. Lynch’s assertions 

with respect to the nature of his 

involvement in the misdemeanor 

offense to which he pled guilty. The 

criminal information to which Dr. 

Lynch pled guilty alleges that TPSG, as 

opposed to Dr. Lynch, began ordering 

TRI-toxin for use in the medical 

practice, and there are no allegations 

that Dr. Lynch took part in the ordering 

process. Indeed, the proposal to debar 

states that, as claimed by Dr. Lynch, 

another physician in the practice, 

William F. DeLuca, Jr., was responsible 

for authorizing a nurse to substitute TRItoxin for BOTOX, not Dr. Lynch. At Dr. 

Lynch’s sentencing hearing, at which 

six other codefendants, including 

DeLuca, were also sentenced, the 

presiding judge also made clear that he 

believed DeLuca was the physician 

responsible for making the ‘‘mistake’’ 

that led to the other physician’s 

offenses. In addressing DeLuca, the 

court 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. 

In addressing one of the other three 

physicians who pled guilty under 

circumstances similar to Dr. Lynch’s, 

the court further stated: ‘‘There have 

been disputes on how in the past over 

who knew what and at what point in 

time. It is clear from the facts in this 

case that you had no knowledge that the 

substance was anything other than 

[BOTOX] until your discovery of it in 

November of 2004.’’ 

In short, consistent with the proposal 

to debar Dr. Lynch for 4 years, the 

records of his criminal proceedings 

establish that the misdemeanor 

convictions for the physicians in TPSG 

other than DeLuca were not based on 

any affirmative involvement in ordering 

the TRI-toxin or substituting the TRItoxin for BOTOX. Furthermore, in 

proposing to debar Dr. Lynch for 4 

years, ORA did not rely on any findings 

with respect to Dr. Lynch’s intent or 

knowledge. Rather, citing the records of 

Dr. Lynch’s criminal proceedings, the 

proposal to debar simply rests on Dr. 

Lynch’s position of authority within 

TPSG and his conduct in misbranding 

TRI-toxin by administering it to patients 

who believed they were receiving 

BOTOX. As a result, under § 12.24(b), 

there is no genuine and substantial issue 

of fact raised by Dr. Lynch’s arguments 

for resolution at a hearing. 

As set forth in the proposal to debar 

and summarized above, Dr. Lynch 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) 

of the FD&C Act with respect to the 

nature and seriousness of the offense 

involved is a favorable factor. As 

reflected in the records of the criminal 

proceedings, Dr. Lynch’s offense did not 

rest on any intent or knowledge of 

wrongdoing on his part, nor may such 

intent or knowledge be inferred from the 

circumstances of his offense or the 

findings in the proposal to debar. 

Although, as a practicing physician, Dr. 

Lynch should be expected to take the 

appropriate steps to avoid administering 

an unapproved new drug to patients or 

misrepresenting the drug being 

administered, his failure to do so over 

a 10-month period does not warrant 

considering the nature and seriousness 

of his offense as an unfavorable factor, 

relative to the range of conduct that 

might underlie a Federal misdemeanor 

conviction. 

On the other hand, because of Dr. 

Lynch’s position of authority within 

TPSG and, thus, presumed ability to 

prevent the series of events that resulted 

in the offense underlying his 

misdemeanor conviction, the nature and 

extent of management participation in 

the offense is an unfavorable factor, for 

the purposes of the consideration under 

306(c)(3)(B) of the FD&C Act. Dr. Lynch 

asserts that there was no management 

participation, and that, thus, this factor 

is inapplicable because the underlying 

conviction was of an individual. 

However, the criminal information to 

which Dr. Lynch pled guilty alleges that 

TPSG began ordering TRI-toxin for use 

in the medical practice. It is undisputed 

that Dr. Lynch is a principal in TPSG, 

and this is the basis for considering the 

nature and extent of management 

participation as a factor in determining 

the appropriateness and period of 

debarment. FDA has relied on this factor 

in other debarment cases where the 

underlying conviction was of an 

individual (see 78 FR 68455 (November 

14, 2013); 77 FR 27236 (May 9, 2012)). 

The limited scope of his direct actions 

in committing the underlying 

misdemeanor offense does not mitigate 

the extent of his management 

participation, as established during his 

criminal proceedings and as set out in 

the proposal to debar. It is true that 

nothing in the criminal proceedings or 

the proposal to debar reflects any 

involvement by him in the decision to 

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12016 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

1See United States v. Park, 421 U.S. 658, 673– 

74 (1975) (holding that a high-level manager within 

a business entity bears a responsibility to prevent 

and correct violations of the FD&C Act). 

order the TRI-toxin and substitute it for 

BOTOX, and the proposal to debar 

specifically finds that another physician 

authorized a nurse to place that order. 

However, Dr. Lynch, as a principal of 

TPSG, was responsible for failing to 

ensure that there were controls and 

procedures in place to prevent other 

physicians or a nurse from ordering 

unapproved drugs for administration to 

patients. His own admitted inaction on 

that front warrants treating his 

management participation as an 

unfavorable factor.1

Consistent with the proposal to debar, 

the record establishes that the medical 

practice of which Dr. Lynch was a part 

ultimately took voluntary steps to 

mitigate the effect on the public health 

from its unlawful conduct (see section 

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

Furthermore, it is undisputed that Dr. 

Lynch had no previous criminal 

convictions related to matters within the 

jurisdiction of FDA (see section 

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

these will be treated as favorable factors. 

In light of the foregoing four 

considerations, one of which weighs 

against Dr. Lynch, debarment for 2 years 

is appropriate. 

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, finds that Dr. Lynch 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 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 2 years 

is appropriate. 

As a result of the foregoing findings, 

Dr. Lynch is debarred for 2 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. 

Lynch, in any capacity during his 

period of debarment, will be subject to 

civil money penalties. If Dr. Lynch, 

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. Lynch during his period of 

debarment. 

Any application by Dr. Lynch for 

termination of debarment under section 

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

identified with Docket No. FDA–2010– 

N–0301 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. 2015–05044 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

publishing this notice of petitions 

received under the National Vaccine 

Injury Compensation Program (the 

Program), as required by Section 

2112(b)(2) of the Public Health Service 

(PHS) Act, as amended. While the 

Secretary of Health and Human Services 

is named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact the Clerk, United States 

Court of Federal Claims, 717 Madison 

Place NW., Washington, DC 20005, 

(202) 357–6400. For information on 

HRSA’s role in the Program, contact the 

Director, National Vaccine Injury 

Compensation Program, 5600 Fishers 

Lane, Room 11C–26, Rockville, MD 

20857; (301) 443–6593. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the U.S. Court of Federal Claims and to 

serve a copy of the petition on the 

Secretary of Health and Human 

Services, who is named as the 

respondent in each proceeding. The 

Secretary has delegated this 

responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at Section 

2114 of the PHS Act or as set forth at 

42 CFR 100.3, as applicable. This Table 

lists for each covered childhood vaccine 

the conditions which may lead to 

compensation and, for each condition, 

the time period for occurrence of the 

first symptom or manifestation of onset 

or of significant aggravation after 

vaccine administration. Compensation 

may also be awarded for conditions not 

listed in the Table and for conditions 

that are manifested outside the time 

periods specified in the Table, but only 

if the petitioner shows that the 

condition was caused by one of the 

listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

January 1, 2015, through January 31, 

2015. This list provides the name of 

petitioner, city and state of vaccination 

(if unknown then city and state of 

person or attorney filing claim), and 

case number. In cases where the Court 

has redacted the name of a petitioner 

and/or the case number, the list reflects 

such redaction. 

mstockstill on DSK4VPTVN1PROD with NOTICES