43768 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–3615 for ‘‘Administering the 

Hatch-Waxman Amendments: Ensuring 

a Balance Between Innovation and 

Access; Public Meeting; Request for 

Comments.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Philip Bonforte, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1668, 

Silver Spring, MD 20993, 240–402– 

6980, email: GenericDrugPolicy@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 22, 2017, FDA 

published a notice of public meeting 

with a 60-day comment period to 

request comments on the appropriate 

balance between encouraging 

innovation in drug development and 

accelerating the availability to the 

public of lower cost alternatives to 

innovator drugs. Interested persons 

were originally given until September 

18, 2017, to comment. 

Following publication of the June 22, 

2017, notice of public meeting with 

request for comments, FDA received 

requests to allow interested persons 

additional time to comment. The 

requesters asserted that the time period 

of 60 days was insufficient to respond 

fully to FDA’s specific requests for 

comments and to allow potential 

respondents to thoroughly evaluate and 

address pertinent issues. 

FDA has considered the requests and 

is extending the comment period for the 

notice of public meeting until November 

17, 2017. 

Dated: September 14, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19904 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0508] 

Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised guidance for 

industry entitled ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments.’’ This guidance is 

intended to assist persons making 

tobacco product establishment 

registration and product listing 

submissions to FDA. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 19, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 

comments as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43769 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2009–D–0508 for ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

Submit written requests for single 

copies of this guidance to the Center for 

Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, 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. 

FOR FURTHER INFORMATION CONTACT: 

Matthew Brenner, Center for Tobacco 

Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002, email: CTPRegulations@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised guidance for industry entitled 

‘‘Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments.’’ This 

guidance is intended to assist persons 

making tobacco product establishment 

registration and product listing 

submissions to FDA. We are issuing this 

guidance consistent with our good 

guidance practices regulation (§ 10.115 

(21 CFR 10.115)). We are implementing 

this guidance without prior public 

comment because we have determined 

that prior public participation is not 

feasible or appropriate given the 

upcoming compliance deadline for 

registration and listing for certain 

owners and operators of tobacco 

product manufacturing establishments. 

In addition, the compliance policy for 

certain product listing labeling 

submissions set forth in this revised 

guidance presents a less burdensome 

policy consistent with the public health 

(§ 10.115(g)(2)). Although this guidance 

document is immediately in effect, it 

remains subject to comment in 

accordance with FDA’s GGP regulation. 

This revised guidance communicates 

a compliance policy for certain product 

listing labeling submissions. 

Specifically, FDA does not, at this time, 

intend to enforce the requirement that 

owners and operators of tobacco 

product establishments submit the 

labeling for each individually listed 

tobacco product if the registrant submits 

information that represents the labeling 

for a selected line of products. In 

deciding whether a registrant’s 

submitted information falls within this 

compliance policy, FDA may consider 

whether the tobacco products’ labeling 

is essentially identical (e.g., the same 

formatting, fonts, colors, background 

text, and images) and whether the 

variations are limited to package size, 

nicotine strength, propylene glycol/ 

vegetable glycerin ratio, and flavor. 

Under this compliance policy, a 

registrant could submit information that 

represents the labeling for a selected 

line of products, and FDA would not 

intend to enforce the requirements in 

subsections 905(i)(1)(A) and (B) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 387e(1)(A) 

and (B)) with regard to labeling 

submissions. 

This revised guidance also updates 

the compliance date for registration and 

listing for persons who owned or 

operated domestic manufacturing 

establishments engaged in the 

manufacture of newly deemed products 

prior to August 8, 2016, and continued 

to own or operate such establishment(s) 

on or after August 8, 2016. Such persons 

are required to register and submit 

product listing information under 

section 905 of the FD&C Act by 

December 31, 2016. However, in a 

guidance issued in May 2017, FDA 

announced that it does not intend to 

enforce these requirements with respect 

to newly deemed products provided the 

registration and product listing 

submissions are received by FDA on or 

before September 30, 2017. 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

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 

section 905 of the FD&C Act have been 

approved under OMB control number 

0910–0650. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

guidance at either https://

www.regulations.gov or https://

www.fda.gov/TobaccoProducts/ 

Labeling/RulesRegulationsGuidance/ 

default.htm. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
43770 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 

Dated: September 14, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19928 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–3998] 

Flavor Developer and Manufacturer 

Site Tours Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Tobacco Products (CTP), is announcing 

an invitation for participation in its 

voluntary Flavor Developer and 

Manufacturer Site Tours Program. This 

program is intended to give CTP staff an 

opportunity to visit companies that 

develop and/or manufacture flavors 

(including flavor mixtures) that are sold 

to tobacco product manufacturers in 

order to gain a better understanding of 

the development, testing, and 

production of flavors and flavor 

mixtures used in the manufacturing of 

tobacco products. The site tours in this 

program are not intended as regulatory 

inspections. The purpose of this notice 

is to invite parties interested in 

participating in the Flavor Developer 

and Manufacturer Site Tours Program to 

submit requests to CTP. 

DATES: Submit either an electronic or 

written request for participation in this 

program by November 20, 2017. See 

section IV of this document for 

information on requests for 

participation. 

ADDRESSES: If your company is 

interested in offering a site visit, please 

submit a request either electronically to 

https://www.regulations.gov or in 

writing to the Dockets Management Staff 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Karla Price, Office of Science, Center for 

Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002, 1–877–287–1373, email: 

AskCTP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) was enacted on June 22, 2009, 

amending the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by, among 

other things, adding a new chapter 

(chapter IX) granting FDA the authority 

to regulate tobacco product 

manufacturing, distribution, and 

marketing (Pub. L. 111–31). The 

Tobacco Control Act provides FDA 

authority to regulate cigarettes, cigarette 

tobacco, roll-your-own tobacco, 

smokeless tobacco, and any other 

tobacco products that the Agency by 

regulation deems to be subject to the 

law. On May 10, 2016, FDA published 

a final rule entitled ‘‘Deeming Tobacco 

Products to be Subject to the Federal 

Food, Drug, and Cosmetic Act, as 

Amended by the Family Smoking 

Prevention and Tobacco Control Act; 

Restrictions on the Sale and Distribution 

of Tobacco Products and Required 

Warning Statements for Tobacco 

Products’’ (81 FR 28974), which became 

effective on August 8, 2016. Under this 

rule, all products that meet the statutory 

definition of ‘‘tobacco product’’ set forth 

in section 201(rr) of the FD&C Act (21 

U.S.C. 321(rr)), including components 

and parts, but excluding accessories of 

newly deemed products, are now 

subject to chapter IX of the FD&C Act. 

CTP’s Office of Science is conducting 

the Flavor Developer and Manufacturer 

Site Tours Program to provide its staff 

an opportunity to visit companies that 

develop and/or manufacture flavors 

(including flavor mixtures) that are sold 

to tobacco product manufacturers. 

Flavor developers and manufacturers 

are regulated by FDA if they, among 

other things, manufacture products that 

meet the statutory definition of a 

‘‘tobacco product’’ set forth in section 

201(rr) of the FD&C Act. The site tours 

will aid the Agency in gaining a better 

understanding of the development, 

testing, and production of flavors and 

flavor mixtures used in the 

manufacturing of tobacco products. The 

goal for the Flavor Developer and 

Manufacturer Site Tours Program is for 

CTP staff to gain firsthand exposure to 

how flavors are developed, tested, and 

produced. 

II. Description of Flavor Developer and 

Manufacturer Site Tours Program 

In the Flavor Developer and 

Manufacturer Site Tours Program, small 

groups of CTP staff will observe the 

operations of flavor developers and 

manufacturers, including the 

development, testing, and production of 

flavors that can be used by tobacco 

product manufacturers. The site tours in 

this program are not intended as 

regulatory inspections; rather, the 

program is meant to educate CTP staff 

and improve their understanding of 

flavors used in the manufacturing of 

tobacco products. It is anticipated that 

the site tours will take place in 2018. 

III. Site Selection 

CTP hopes to be able to tour small, 

medium, and large flavor developers 

and manufacturers, as well as 

companies that develop and/or 

manufacture flavors that are used for 

different categories of tobacco products 

(e.g., cigarettes, cigars, smokeless 

tobacco, waterpipe tobacco, e-liquids). 

Final site selections will be based on the 

availability of funds and resources for 

the relevant fiscal year as well as the 

desire to visit a wide variety of flavor 

developers and manufacturers. All FDA 

travel expenses associated with the 

Flavor Developer and Manufacturer site 

tours will be the responsibility of FDA. 

IV. Requests for Participation 

To aid in site selection, your request 

for participation should include the 

following information: 

• A description of your company, 

including the size of the organization; 

• A list of the flavors your company 

develops and/or manufactures and the 

categories of tobacco product (e.g., 

cigarettes, cigars, smokeless tobacco, 

waterpipe tobacco, e-liquids) for which 

your flavors are typically used; 

• The physical address(es) of the 

site(s) for which you are submitting a 

request; and 

• A proposed 1-day tour agenda. 

Identify requests for participation 

with the docket number found in 

brackets in the heading of this 

document. Received requests are 

available for public examination in the 

Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: September 14, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19900 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


asabaliauskas on DSKBBXCHB2PROD with NOTICES