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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

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 

mstockstill on DSK4VPTVN1PROD with NOTICES