Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43767 

(Response) As stated in the 

supporting statements included in the 

docket, FDA is working with a skilled 

and experienced research contractor to 

conduct the proposed study. In 

addition, FDA scientific experts possess 

skill and expertise in conducting such 

research. Survey and focus group best 

practices will be used, including 

avoiding bias in questions due to 

wording and question order and 

developing a statistical analysis plan. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Screening for pretest .............................................. 762 1 762 0.033 (2 minutes) ........ 25 

Pretest .................................................................... 100 1 100 0.25 (15 minutes) ........ 25 

Screening for main data collection ........................ 19,082 1 19,082 0.033 (2 minutes) ........ 630 

Main data collection ............................................... 2,500 1 2,500 0.25 (15 minutes) ........ 625 

Total ................................................................ ........................ ........................ ........................ ..................................... 1,305 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA’s burden estimate is based on 

prior experience with research that is 

similar to this proposed study. 

Screening potential participants for the 

2 pretests will occur with 762 

respondents (487 adults and 275 

adolescents) identified and recruited 

through the Internet panel. This brief 

screening will take an average of 2 

minutes (0.033 hours) per respondent. 

Each of the 2 pretests will consist of 50 

respondents (34 adults and 16 

adolescents) conducted during a single 

session and take an average of 15 

minutes (0.25 hours) per respondent. 

Screening potential participants for the 

main data collection will occur with 

19,082 respondents (11,925 adults and 

7,157 adolescents) identified and 

recruited through the same Internet 

panel as used for the pretests. This brief 

screening will take an average of 2 

minutes (0.033 hours) per respondent. 

Recent national estimates of the 

numbers of adolescent current cigarette 

smokers, adolescents who are 

susceptible to initiation of cigarette 

smoking, young adult current cigarette 

smokers, and older adult current 

cigarette smokers informed the 

estimates of 13.9 percent qualification 

rate for adults and 11.6 percent 

qualification rate for adolescents. 

Applying these estimates and other 

assumptions from previous experience 

conducting similar studies to the 

number of adolescents and adults to be 

screened results in the desired sample 

size for the main data collection of 2,500 

participants, of which 1,667 will be 

adults and 833 will be adolescents. The 

main data collection will occur with 

those 2,500 respondents during a single 

session. The main data collection will 

take an average of 15 minutes (0.25 

hours) per respondent. The total 

estimated burden is 1,305 hours (25 

hours + 25 hours + 630 hours + 625 

hours). 

Dated: September 14, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19901 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–3615] 

Administering the Hatch-Waxman 

Amendments: Ensuring a Balance 

Between Innovation and Access; 

Public Meeting; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

public meeting on ‘‘Administering the 

Hatch-Waxman Amendments: Ensuring 

a Balance Between Innovation and 

Access’’ for which the notice of public 

meeting appeared in the Federal 

Register of June 22, 2017. In the notice 

of public meeting, FDA requested 

comments concerning administration of 

the Hatch-Waxman Amendments to the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to help ensure that the 

intended balance between encouraging 

innovation in drug development and 

accelerating the availability to the 

public of lower cost alternatives to 

innovator drugs is maintained. The 

Agency is taking this action in response 

to a request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the notice of public meeting 

published June 22, 2017 (82 FR 28493). 

Submit either electronic or written 

comments by November 17, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 17, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 17, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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