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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