Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard; Extension of Comment Period, 26697-26698 [2018-12370]

Download as PDF Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 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/201523389.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: Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993–0002, 301– 796–1300. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public workshop regarding the development of inhaled antibacterial drugs for CF and non-CF bronchiectasis. As such, discussions will focus on challenges and potential paths forward for inhaled antibacterial drugs pertaining to CF and non-CF bronchiectasis. amozie on DSK3GDR082PROD with NOTICES1 II. Topics for Discussion at the Public Workshop FDA is particularly interested in discussing challenges and considerations regarding CF and non-CF bronchiectasis. Discussions are planned around the following topics for each of the disease areas: • Trial design challenges • Trial endpoints • Trial populations, duration of therapy, duration of microbiologic testing and followup VerDate Sep<11>2014 16:53 Jun 07, 2018 Jkt 241001 • Device considerations The Agency encourages health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders to attend this public workshop. III. Participating in the Public Workshop Registration: Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register online by June 11, 2018, midnight Eastern Time. To register, please email complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to InhaledAntibacterialsWorkshop2018@ fda.hhs.gov. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop. If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION CONTACT) no later than June 19, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 19, 2018. All requests to make oral presentations must be received by the close of registration on June 15, 2018. If selected for presentation, any presentation materials must be emailed to InhaledAntibacterialsWorkshop2018@ fda.hhs.gov no later than June 21, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the public workshop: This public workshop will PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 26697 also be webcast at the following site: https://collaboration.fda.gov/inhaleda ntibacterials/. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/FDAgov/Drugs/ NewsEvents/ucm602331.htm. Dated: June 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–12341 Filed 6–7–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0529] Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability (NOA) that appeared in the Federal Register of March 16, 2018. In the NOA, FDA requested public comment on the draft concept paper regarding the potential for illicit trade markets to develop in response to a tobacco product standard. 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 NOA published March 16, 2018 (83 FR 11754). Submit either electronic or written comments by July 16, 2018. SUMMARY: E:\FR\FM\08JNN1.SGM 08JNN1 26698 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 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 July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 16, 2018. 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. ADDRESSES: amozie on DSK3GDR082PROD with NOTICES1 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: • 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– 2018–N–0529 for ‘‘Draft Concept Paper: Illicit Trade in Tobacco Products after Implementation of a Food and Drug Administration Product Standard.’’ VerDate Sep<11>2014 16:53 Jun 07, 2018 Jkt 241001 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/201523389.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: Christopher Griffiths or Nate Mease, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1–877–287–1373, AskCTP@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2018, FDA published an NOA with a 90-day comment period to request public comment on the draft concept paper PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 regarding the potential for illicit trade markets to develop in response to a tobacco product standard. The Agency received a request for a 90-day extension of the comment period for the NOA. The request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the NOA. FDA has considered the request and is extending the comment period for the NOA for 30 days, until July 16, 2018. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without creating significant delay. Dated: June 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–12370 Filed 6–7–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–N–0231; FDA– 2014–N–0996; FDA–2010–N–0161; FDA– 2017–N–5624; FDA–2011–N–0085; FDA– 2013–D–0575; and FDA–2016–N–3710] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUMMARY: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required SUPPLEMENTARY INFORMATION: E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26697-26698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0529]


Draft Concept Paper: Illicit Trade in Tobacco Products After 
Implementation of a Food and Drug Administration Product Standard; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability (NOA) that 
appeared in the Federal Register of March 16, 2018. In the NOA, FDA 
requested public comment on the draft concept paper regarding the 
potential for illicit trade markets to develop in response to a tobacco 
product standard. 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 NOA published March 
16, 2018 (83 FR 11754). Submit either electronic or written comments by 
July 16, 2018.

[[Page 26698]]


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 July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 16, 2018. 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 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-2018-N-0529 for ``Draft Concept Paper: Illicit Trade in Tobacco 
Products after Implementation of a Food and Drug Administration Product 
Standard.'' 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: Christopher Griffiths or Nate Mease, 
Center for Tobacco Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 1-877-287-1373, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2018, 
FDA published an NOA with a 90-day comment period to request public 
comment on the draft concept paper regarding the potential for illicit 
trade markets to develop in response to a tobacco product standard. The 
Agency received a request for a 90-day extension of the comment period 
for the NOA. The request conveyed concern that the current 90-day 
comment period does not allow sufficient time to develop a meaningful 
or thoughtful response to the NOA.
    FDA has considered the request and is extending the comment period 
for the NOA for 30 days, until July 16, 2018. The Agency believes that 
a 30-day extension allows adequate time for interested persons to 
submit comments without creating significant delay.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12370 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P
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