22202 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner will select the nonvoting 

member to represent industry interests. 

III. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Contact 

information, current curriculum vitae, 

and the name of the committee of 

interest should be sent to the FDA 

Advisory Committee Membership 

Nomination Portal (see ADDRESSES) 

within 30 days of publication of this 

document (see DATES). FDA will forward 

all nominations to the organizations 

expressing interest in participating in 

the selection process for the committee. 

(Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process). 

FDA seeks to include the views of 

women, and men, members of all racial 

and ethnic groups and individuals with 

and without disabilities on its advisory 

committees and, therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: April 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09082 Filed 4–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0386] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco 

Product Establishments and Listing of 

Ingredients in Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed extension of an existing 

collection of information pertaining to 

registration and product listing for 

owners and operators of domestic 

tobacco product establishments and 

listing of ingredients in tobacco 

products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 22, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments and 

Listing of Ingredients in Tobacco 

Products (OMB Control Number 0910– 

0650)—Extension) 

On June 22, 2009, the President 

signed the Tobacco Control Act (Pub. L. 

111–31) into law. The Tobacco Control 

Act amended the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 301) by, among other things, 

adding a chapter granting FDA 

important authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Section 905(b) of the FD&C Act (21 

U.S.C. 387e(b)), as amended by the 

Tobacco Control Act, requires that every 

person who owns or operates any 

establishment in any State engaged in 

the manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products 

register with FDA the name, places of 

business, and all establishments owned 

or operated by that person. Every person 

must register by December 31 of each 

year. Section 905(c) of the FD&C Act 

requires that first-time persons engaging 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22203 

in the manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products 

shall register with the Secretary the 

name, places of business, and all such 

establishments of that person. Section 

905(d) states that persons required to 

register under section 905(b) or 905(c) of 

the FD&C Act shall register any 

additional establishment that they own 

or operate in any state which begins the 

manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products. 

Section 905(h) of the FD&C Act 

addresses foreign establishment 

registration requirements, which will go 

into effect when regulations are 

promulgated by the Secretary. Section 

905(i)(1) of the FD&C Act, as amended 

by the Tobacco Control Act, requires 

that all registrants shall, at the time of 

registration under any such subsection, 

file with FDA a list of all tobacco 

products which are being manufactured, 

prepared, compounded, or processed by 

that person for commercial distribution, 

along with certain accompanying 

consumer information, such as all 

labeling and a representative sampling 

of advertisements. Section 904(a)(1) of 

the FD&C Act (21 U.S.C. 387d(a)(1)), as 

amended by the Tobacco Control Act, 

requires each tobacco product 

manufacturer or importer, or agent 

thereof, to submit a listing of all 

ingredients, including tobacco, 

substances, compounds, and additives 

that are added by the manufacturer to 

the tobacco, paper, filter, or other part 

of each tobacco product by brand or by 

quantity in each brand and sub-brand. 

Since the Tobacco Control Act was 

enacted on June 22, 2009, the 

information required under section 

904(a)(1) of the FD&C Act must be 

submitted to FDA by December 22, 

2009, and include the ingredients added 

as of the date of submission. Section 

904(c) of the FD&C Act also requires 

submission of information whenever 

additives, or the quantities of additives, 

are changed. 

FDA issued guidance documents on 

both: (1) ‘‘Registration and Product 

Listing for Owners and Operators of 

Domestic Tobacco Product 

Establishments’’ and (2) ‘‘Listing of 

Ingredients in Tobacco Products’’ to 

assist persons making such submissions 

to FDA under the Tobacco Control Act. 

While electronic submission of 

registration and product listing 

information and ingredient listing 

information are not required, FDA is 

strongly encouraging electronic 

submission to facilitate efficiency and 

timeliness of data management and 

collection. To that end, FDA designed 

electronic submission applications to 

streamline the data entry process for 

registration and product listing and for 

ingredient listing. These tools allow for 

importation of large quantities of 

structured data, attachment of files (e.g., 

in PDFs and certain media files), and 

automatic acknowledgement of FDA’s 

receipt of submissions. 

FDA also developed paper forms 

(Form FDA 3741—Registration and 

Listing for Owners and Operators of 

Domestic Tobacco Product 

Establishments, and Form FDA 3742— 

Listing of Ingredients in Tobacco 

Products) as an alternative submission 

tool. Both the electronic submission 

application and the paper forms can be 

accessed at http://www.fda.gov/tobacco. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total operating 

and maintenance costs 

Form FDA 3741: Registration and Product Listing for Owners and Operators 

of Domestic Establishments (Electronic and Paper Submission)/Section 

905(b), 905(c), 905(d) 905(h), or 

905(i) of the FD&C Act ....................... 125 1 .6 200 3.75 750 $0.98 

Form FDA 3742: Listing of Ingredients 

(Electronic and Paper Submissions)/

Section 904(a)(1) or 904(c) of the 

FD&C Act ........................................... 125 1 .6 200 3 600 0.98 

Obtaining a DUNS Number (10% of 

Total Respondents) ............................ 8 1 8 .5 (30 

minutes) 

4 ........................

Total ................................................ ........................ .......................... ........................ ........................ 1,354 1.96 

Since this collection of information 

was last approved by OMB on October 

15, 2012, its burden has remained the 

same at 1,354 reporting hours. This 

burden estimate was determined as a 

result of FDA experience over the past 

3 years in the regulation of tobacco 

products and is based on the actual 

number of establishment registration 

and product listings and product 

ingredient submissions received during 

this time period. FDA estimates that the 

submission of registration information 

as required by section 905 of the FD&C 

Act will remain at 3.75 hours per 

establishment and, based on the actual 

number of registration information 

submitted in the past 3 years and its 

experience, the Agency estimates that 

approximately 200 registrations will be 

submitted from 125 tobacco product 

establishments annually, for a total of 

750 reporting burden hours. FDA 

estimates that the submission of 

ingredient listing information as 

required by section 904 of the FD&C Act 

will remain at 3 hours per tobacco 

product and, based on the actual 

number of product ingredient listings 

submitted over the past 3 years and its 

experience, the Agency estimates that 

approximately 200 ingredient listings 

will be submitted from 125 tobacco 

establishments, for a total of 600 

reporting burden hours. 

FDA also estimates that obtaining a 

Dun and Bradstreet (DUNS) number will 

take 0.5 hours, and that 8 respondents 

(1 percent (1.25) of establishments 

required to register under section 905 

and 5 percent (6.25) of submitters 

required to list ingredients under 

section 904) will not already have a 

DUNS number. The total burden is 

estimated to be 4 hours. Total burden 

hours for this collection, therefore is 

1,354 hours. 


tkelley on DSK3SPTVN1PROD with NOTICES
22204 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 

Dated: April 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09092 Filed 4–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0882] 

Generic Drug User Fees; Public 

Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting on the Generic Drug 

User Fee Amendments of 2012 

(GDUFA). The legislative authority for 

GDUFA expires at the end of September 

2017. At that time, new legislation will 

be required for FDA to continue to 

collect generic drug user fees for future 

fiscal years. The Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) 

requires that before FDA begins 

negotiations with the regulated industry 

on GDUFA reauthorization; we publish 

a notice in the Federal Register 

requesting public input on the 

reauthorization, hold a public meeting 

at which the public may present its 

views on the reauthorization, including 

specific suggestions for changes to the 

goals referred to in the Generic Drug 

User Fee Act Program Performance 

Goals and Procedures (i.e., the 

Commitment Letter), provide a period of 

30 days after the public meeting to 

obtain written comments from the 

public, and publish the comments on 

FDA’s Web site. FDA invites public 

comment on the GDUFA program and 

suggestions regarding the features FDA 

should propose for the next GDUFA 

program. 

DATES: The public meeting will be held 

on June 15, 2015, from 9 a.m. to 5 p.m. 

The public meeting may be extended or 

may end early depending on the level of 

public participation. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1, where routine 

security check procedures will be 

performed. For parking and security 

information, refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Connie Wisner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1718, 

Silver Spring, MD 20993, 240–402– 

7946, Connie.Wisner@fda.hhs.gov; or 

Kimberly Giordano, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1611, 

Silver Spring, MD 20993, 301–796– 

1071, Kimberly.Giordano@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, the Food and Drug 

Administration Safety and Innovation 

Act, which included GDUFA (Pub. L. 

112–144, title III), was signed into law 

by the President. GDUFA authorizes 

FDA to collect fees from drug 

companies that submit marketing 

applications for certain generic human 

drug applications, certain drug master 

files, and certain facilities. Designed to 

speed access to safe and effective 

generic drugs to the public, GDUFA 

requires that generic drug manufacturers 

pay user fees to finance critical and 

measurable generic drug program 

enhancements. GDUFA also requires 

that generic drug facilities around the 

world provide identification 

information annually to FDA. 

Additional information concerning 

GDUFA, including the text of the law, 

the Commitment Letter, key Federal 

Register documents, GDUFA-related 

guidances, performance reports, and 

financial reports may be found on the 

FDA Web site at http://www.fda.gov/

gdufa. 

II. Purpose of Public Meeting 

FDA is announcing a public meeting 

on GDUFA. The authority for GDUFA 

expires at the end of September 2017. 

Without new legislation, FDA will no 

longer be able to collect user fees to 

fund the human generic drug review 

process. Section 744(C)(d)(2) (21 U.S.C. 

379j–43(d)(2)) of the FD&C Act requires 

that before FDA begins negotiations 

with the regulated industry on GDUFA 

reauthorization, we do the following: (1) 

Publish a notice in the Federal Register 

requesting public input on the 

reauthorization, (2) hold a public 

meeting at which the public may 

present its views on the reauthorization, 

including specific suggestions for 

changes to the goals referred to in the 

Commitment Letter, (3) provide a period 

of 30 days after the public meeting to 

obtain written comments from the 

public, and (4) publish the comments on 

the FDA Web site. This notice, the 

public meeting, the 30-day comment 

period after the meeting, and the posting 

of the comments on the FDA Web site 

will satisfy these requirements. The 

purpose of the public meeting is to 

receive public input on the 

reauthorization of GDUFA, including 

specific suggestions for changes to the 

goals referred to in the Commitment 

Letter. FDA is interested in responses to 

the following two general questions and 

welcomes any other relevant 

information the public would like to 

share: 

• What is your assessment of the 

overall performance of the GDUFA 

program to date? 

• What aspects of GDUFA should be 

retained, changed, or discontinued to 

further strengthen and improve the 

program? 

In general, the meeting format will 

include presentations by FDA, scientific 

and academic experts, health care 

professionals, representatives of patient 

and consumer advocacy groups, the 

generic drug industry, and the general 

public. The amount of time available for 

public testimony will be determined by 

the number of persons who register to 

present at the meeting. A draft agenda 

and other background information for 

the public meeting will be posted at 

http://www.fda.gov/gdufa by June 8, 

2015. 

III. Meeting Attendance and 

Participation 

FDA is seeking participation (i.e., 

attendance and oral presentations) at the 

public meeting by all interested parties, 

including but not limited to scientific 

and academic experts, health care 

professionals, representatives of patient 

and consumer advocacy groups, the 

generic drug industry, and the general 

public. If you wish to attend the 

meeting, please email your registration 

information to GenericDrugPolicy@

fda.hhs.gov by June 1, 2015. Your email 

should contain complete contact 

information for each attendee, including 

name, title, affiliation, address, email 

address, and telephone number. 

Registration is free and is on a firstcome, first-served basis. Early 

registration is recommended because 

seating is limited. Registrants will 

receive confirmation once they have 

been accepted. If registration becomes 

full prior to the meeting, FDA will place 

a notice on http://www.fda.gov/gdufa. 

Onsite registration on the day of the 


tkelley on DSK3SPTVN1PROD with NOTICES