Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12007 

(1) Family Violence Prevention and 

Services Act (FVPSA) grant funds will be 

used to provide shelter, supportive services, 

or prevention services to adult and youth 

victims of family violence, domestic 

violence, or dating violence, and their 

dependents (§ 10408(b)(1)). 

(2) Not less than 70 percent of the funds 

distributed shall be for the primary purpose 

of providing immediate shelter and 

supportive services as defined in § 10402(9) 

and (12) to adult and youth victims of family 

violence, domestic violence, or dating 

violence as defined in §§ 10402(2), (3), and 

(4), and their dependents (§ 10408(b)(2)). 

(3) Not less than 25 percent of the funds 

distributed shall be for the purpose of 

providing supportive services and prevention 

services as described in § 10408(b)(1)(B) 

through (H), to victims of family violence, 

domestic violence, or dating violence, and 

their dependents (§ 10408(b)(2)). 

(4) Grant funds will not be used as direct 

payment to any victim of family violence, 

domestic violence, or dating violence, or to 

any dependent of such victim (§ 10408(d)(1)). 

(5) No income eligibility standard will be 

imposed on individuals with respect to 

eligibility for assistance or services supported 

with funds appropriated to carry out the 

FVPSA (§ 10406(c)(3)). 

(6) No fees will be levied for assistance or 

services provided with funds appropriated to 

carry out the FVPSA (§ 10406(c)(3)). 

(7) The address or location of any shelter 

or facility assisted under the FVPSA that 

otherwise maintains a confidential location 

will, except with written authorization of the 

person or persons responsible for the 

operation of such shelter, not be made public 

(§ 10406(c)(5)(H)). 

(8) Procedures are established to ensure 

compliance with the provisions of 

§ 10406(c)(5) regarding non-disclosure of 

confidential of private information 

(§ 10407(a)(2)(A)). 

(9) The applicant or grantee will comply 

with the conditions set forth in the FVPSA 

at § 10406(c)(5) and all other FVPSA 

obligations regarding non-disclosure of 

confidential or private information. These 

include, but are not limited to, the following 

requirements: (A) Grantees shall not disclose 

any personally identifying information 

collected in connection with services 

requested (including services utilized or 

denied), through grantee’s funded activities 

or reveal personally identifying information 

without informed, written, reasonably timelimited consent by the person about whom 

information is sought, whether for the 

FVPSA-funded activities or any other federal 

or state program (additional consent 

requirements have been omitted but see 

§ 10406(c)(5)(B)(ii)(I) for further 

requirements); (B) grantees may not release 

information compelled by statutory or court 

order unless adhering to the requirements of 

§ 10406(c)(5)(C); (C) grantees may share nonpersonally identifying information in the 

aggregate for the purposes enunciated in 

§ 10406(c)(5)(D)(i) as well as for other 

purposes found in § 10406(c)(5)(D)(ii) and 

(iii). 

(10) As prescribed by § 10406(c)(2) of the 

FVPSA, the Tribe will use grant funds in a 

manner that avoids prohibited discrimination 

on the basis of age, disability, sex, race, color, 

national origin, or, as appropriate, religion. 

(11) Funds made available under the 

FVPSA will be used to supplement and not 

supplant other federal, state, Tribal and local 

public funds expended to provide services 

and activities that promote the objectives of 

the FVPSA (§ 10406(c)(6)). 

(12) Receipt of supportive services under 

the FVPSA will be voluntary. No condition 

will be applied for the receipt of emergency 

shelter (§ 10408(d)(2)). 

(13) The Tribe has a law or procedure to 

bar an abuser from a shared household or a 

household of the abused person, which may 

include eviction laws or procedures, where 

appropriate (§ 10407(a)(2)(H)). 

lllllllllllllllllllll

Tribally Designated Official 

lllllllllllllllllllll

Tribe or Tribal Organization 

Appendix B 

LGBTQ (also known as ‘‘Two-Spirited’’) 

Accessibility Policy 

As the Authorized Organizational 

Representative (AOR) signing this 

application on behalf of [Insert full, formal 

name of applicant organization] 

I hereby attest and certify that: 

The needs of lesbian, gay, bisexual, 

transgender, and questioning (also known as 

‘‘Two-Spirited’’) program participants are 

taken into consideration in applicant’s 

program design. Applicant considered how 

its program will be inclusive of and nonstigmatizing toward such participants. If not 

already in place, awardee and, if applicable, 

subawardees must establish and publicize 

policies prohibiting harassment based on 

race, sexual orientation, gender, gender 

identity (or expression), religion, and 

national origin. The submission of an 

application for this funding opportunity 

constitutes an assurance that applicants have 

or will put such policies in place within 12 

months of the award. Awardees should 

ensure that all staff members are trained to 

prevent and respond to harassment or 

bullying in all forms during the award 

period. Programs should be prepared to 

monitor claims, address them seriously, and 

document their corrective action(s) so all 

participants are assured that programs are 

safe, inclusive, and non-stigmatizing by 

design and in operation. In addition, any 

subawardees or subcontractors: 

• Have in place or will put into place 

within 12 months of the award policies 

prohibiting harassment based on race, sexual 

orientation, gender, gender identity (or 

expression), religion, and national origin; 

• Will enforce these policies; 

• Will ensure that all staff will be trained 

during the award period on how to prevent 

and respond to harassment or bullying in all 

forms, and; 

• Have or will have within 12 months of 

the award, a plan to monitor claims, address 

them seriously, and document their 

corrective action(s). 

Insert Date of Signature: 

Print Name and Title of the AOR: 

Signature of AOR: 

[End of full FOA] 

Authority: The statutory authority for this 

program is 42 U.S.C. 10401–10414. 

Mary M. Wayland, 

Senior Grants Policy Specialist, Division of 

Grants Policy, Office of Administration. 

[FR Doc. 2015–05010 Filed 3–4–15; 8:45 am] 

BILLING CODE 4184–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0300] 

John D. Noonan; 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. 

John D. Noonan (Dr. Noonan), and is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) debarring Dr. Noonan 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. Noonan 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. 

Noonan’s debarment, FDA has 

considered the relevant factors listed in 

the FD&C Act. Dr. Noonan 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

12008 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

of New York, Dr. Noonan, 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. Noonan’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. Noonan 

then proceeded to inject approximately 

10 patients, who believed they were 

being injected with BOTOX, with TRItoxin as a substitute. 

Dr. Noonan 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. Noonan 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. Noonan requested 

a hearing on the proposal. In his request 

for a hearing, Dr. Noonan acknowledges 

his conviction under Federal law, as 

alleged by FDA. By letter dated January 

28, 2011, Dr. Noonan submitted 

materials and arguments in support of 

his request. Dr. Noonan 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. 

Noonan’s arguments, as well as the 

proposal to debar itself, and concludes 

that, although Dr. Noonan 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. 

Noonan 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. Noonan 

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. Noonan 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. 

Noonan’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. Noonan is, in fact, 

subject to debarment under section 

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

Dr. Noonan 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. 

Noonan, 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. Noonan 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. 

Noonan’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 

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. Noonan 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) of the FD&C 

Act, ORA also considered the ‘‘nature 

and extent of [Dr. Noonan’s] 

management participation in the 

offense’’ and specifically found that he 

was a corporate principal who ‘‘pleaded 

guilty to misbranding TRI-toxin’’ 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 

Noonan’s offenses and the nature and 

extent of management participation 

were unfavorable factors with respect to 

him. 

Dr. Noonan 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12009 

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). 

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. Noonan 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. Noonan’s criminal 

proceedings for its findings in the 

proposal to debar. There is nothing 

definitive in the criminal records before 

FDA to contradict Dr. Noonan’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. 

Noonan pled guilty alleges that TPSG, 

as opposed to Dr. Noonan, began 

ordering TRI-toxin for use in the 

medical practice, and there are no 

allegations that Dr. Noonan took part in 

the ordering process. Indeed, the 

proposal to debar states that, as claimed 

by Dr. Noonan, another physician in the 

practice, William F. DeLuca, Jr., was 

responsible for authorizing a nurse to 

substitute TRI-toxin for BOTOX, not Dr. 

Noonan. At Dr. Noonan’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 Dr. Noonan, 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. Noonan 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. Noonan for 4 

years, ORA did not rely on any findings 

with respect to Dr. Noonan’s intent or 

knowledge. Rather, citing the records of 

Dr. Noonan’s criminal proceedings, the 

proposal to debar simply rests on Dr. 

Noonan’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. Noonan’s arguments 

for resolution at a hearing. 

As set forth in the proposal to debar 

and summarized previously, Dr. Noonan 

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. Noonan’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. 

Noonan 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. 

Noonan’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. 

Noonan 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. Noonan pled 

guilty alleges that TPSG began ordering 

TRI-toxin for use in the medical 

practice. It is undisputed that Dr. 

Noonan 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 

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. Noonan, 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. Noonan 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. 

Noonan 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. Noonan, 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. Noonan has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval of a drug 

mstockstill on DSK4VPTVN1PROD with NOTICES

12010 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

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. Noonan 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. 

Noonan, in any capacity during his 

period of debarment, will be subject to 

civil money penalties. If Dr. Noonan, 

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. Noonan during his period of 

debarment. 

Any application by Dr. Noonan for 

termination of debarment under section 

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

identified with Docket No. FDA–2010– 

N–0300 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. 2015–05042 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–2015–N–0001] 

Clinical Outcomes Assessment 

Development and Implementation: 

Opportunities and Challenges; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Clinical Outcomes Assessment 

Development and Implementation: 

Opportunities and Challenges.’’ The 

purpose of the public workshop is to 

provide updates on accomplishments, 

challenges, and ongoing efforts in the 

use of clinical outcome assessments 

(COAs), and plan for the future of COA 

development and utilization in drug 

development programs, including how 

to incorporate the patient voice in drug 

development using well-defined and 

reliable patient-centered outcome 

measures. The public workshop will 

also discuss standards for COA use and 

collaborative processes for COA 

development and dissemination. 

Date and Time: The public workshop 

will be held on April 1, 2015, from 8:30 

a.m. to 5 p.m. Participants are 

encouraged to arrive early to ensure 

time for parking and routine security 

checks before the workshop. 

Location: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, The Great Room 

(Rm. 1503), Silver Spring, MD 20993– 

0002. Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. Attendees are 

responsible for their own 

accommodations. 

The public workshop will also be 

available to be viewed online via 

Webcast at https://

collaboration.fda.gov/

COApublicworkshop2015. Persons 

interested in participating by Webcast 

must register online by March 27, 2015. 

Contact Person: Michelle Campbell, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6471, Silver Spring, 

MD 20993–0002, 240–402–6019, email: 

COApublicworkshop@fda.hhs.gov. 

Registration: Registration is free for 

the public workshop. Interested parties 

are encouraged to register early because 

space is limited to 150 attendees. 

Workshop space will be filled in order 

of receipt of registration. Those accepted 

in to the workshop will receive 

confirmation. Registration will close 

after the workshop is filled. Registration 

at the site is not guaranteed but may be 

possible on a space available basis on 

the day of the public workshop 

beginning at 7:30 a.m. If registration is 

filled, attendance to the workshop will 

be available only through the Webcast. 

To register, visit http://www.fda.gov/

Drugs/NewsEvents/ucm431040.htm. For 

those without Internet access, please 

call Michelle Campbell (See Contact 

Person) to register. 

If you need special accommodations 

due to a disability, please contact 

Michelle Campbell (See Contact Person) 

at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: The 

Center for Drug Evaluation and Research 

(CDER) reviews COAs, including 

patient-reported outcome measures, 

clinician-reported outcome measures, 

and observer-reported outcome 

measures, when submitted with an 

investigational new drug application, a 

new drug application, or a biologics 

licensing application. CDER also 

reviews a COA when submitted for 

qualification as a drug development 

tool. Qualification of a COA is a 

regulatory determination that the COA 

is well-suited for a specific context of 

use in drug development. Following a 

public announcement of the 

qualification decision by FDA, the COA 

will be publicly available for use in any 

appropriate drug development program. 

This workshop will focus on current 

challenges and opportunities in COA 

development and use, including 

establishing appropriate standards for 

use; current efforts to encourage 

inclusion of well-defined and reliable 

patient-centered outcome measures in 

drug development; use of collaborative 

efforts in developing and utilizing COAs 

through various partnerships; and future 

efforts to address challenges and gaps of 

COA development and use for patientcentered drug development and medical 

product labeling. 

For more information on this public 

workshop, visit http://www.fda.gov/

Drugs/NewsEvents/ucm431040.htm. 

The Agency encourages patient 

advocates, health care providers, 

researchers, regulators, individuals from 

academia, industry, and other interested 

persons to attend this public workshop. 

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