83 FR 26697 - Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 111 (June 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26697-26698 | |
| FR Document | 2018-12370 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26697-26698] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12370] ----------------------------------------------------------------------- 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.thefederalregister.org/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
![Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26697
Agency will review this copy, including • Device considerations also be webcast at the following site:
the claimed confidential information, in The Agency encourages health care https://collaboration.fda.gov/inhaleda
its consideration of comments. The providers, other U.S. Government ntibacterials/.
second copy, which will have the Agencies, academic experts, industry, If you have never attended a Connect
claimed confidential information and other stakeholders to attend this Pro event before, test your connection at
redacted/blacked out, will be available public workshop. https://collaboration.fda.gov/common/
for public viewing and posted on help/en/support/meeting_test.htm. To
https://www.regulations.gov. Submit III. Participating in the Public
get a quick overview of the Connect Pro
Workshop
both copies to the Dockets Management program, visit https://www.adobe.com/
Staff. If you do not wish your name and Registration: Registration is free and go/connectpro_overview. FDA has
contact information to be made publicly based on space availability, with verified the website addresses in this
available, you can provide this priority given to early registrants. document, as of the date this document
information on the cover sheet and not Persons interested in attending this publishes in the Federal Register, but
in the body of your comments and you public workshop must register online by websites are subject to change over time.
must identify this information as June 11, 2018, midnight Eastern Time. Transcripts: Please be advised that as
‘‘confidential.’’ Any information marked To register, please email complete soon as a transcript of the public
as ‘‘confidential’’ will not be disclosed contact information for each attendee, workshop is available, it will be
except in accordance with 21 CFR 10.20 including name, title, affiliation, accessible at https://
and other applicable disclosure law. For address, email, and telephone to www.regulations.gov. It may be viewed
more information about FDA’s posting InhaledAntibacterialsWorkshop2018@ at the Dockets Management Staff (see
of comments to public dockets, see 80 fda.hhs.gov. ADDRESSES). A link to the transcript will
FR 56469, September 18, 2015, or access Early registration is recommended also be available on the internet at
the information at: https://www.gpo.gov/ because seating is limited; therefore, https://www.fda.gov/FDAgov/Drugs/
fdsys/pkg/FR-2015-09-18/pdf/2015- FDA may limit the number of NewsEvents/ucm602331.htm.
23389.pdf. participants from each organization.
Registrants will receive confirmation Dated: June 4, 2018.
Docket: For access to the docket to
when they have been accepted. If time Leslie Kux,
read background documents or the
and space permit, onsite registration on Associate Commissioner for Policy.
electronic and written/paper comments
received, go to https:// the day of the public workshop will be [FR Doc. 2018–12341 Filed 6–7–18; 8:45 am]
www.regulations.gov and insert the provided beginning at 7:30 a.m. We will BILLING CODE 4164–01–P
docket number, found in brackets in the let registrants know if registration closes
heading of this document, into the before the day of the public workshop.
If you need special accommodations DEPARTMENT OF HEALTH AND
‘‘Search’’ box and follow the prompts
due to a disability, please contact Jessica HUMAN SERVICES
and/or go to the Dockets Management
Barnes or Lori Benner (see FOR FURTHER
Staff, 5630 Fishers Lane, Rm. 1061, Food and Drug Administration
INFORMATION CONTACT) no later than June
Rockville, MD 20852.
19, 2018.
FOR FURTHER INFORMATION CONTACT: Lori Requests for Oral Presentations: [Docket No. FDA–2018–N–0529]
Benner and/or Jessica Barnes, Center for During online registration you may
Drug Evaluation and Research, Food indicate if you wish to present during a Draft Concept Paper: Illicit Trade in
and Drug Administration, 10903 New public comment session or participate Tobacco Products After
Hampshire Ave., Bldg. 22, Rm. 6221, in a specific session, and which topic(s) Implementation of a Food and Drug
Silver Spring, MD 20993–0002, 301– you wish to address. We will do our Administration Product Standard;
796–1300. best to accommodate requests to make Extension of Comment Period
SUPPLEMENTARY INFORMATION: public comments. Individuals and
organizations with common interests are AGENCY: Food and Drug Administration,
I. Background HHS.
urged to consolidate or coordinate their
FDA is announcing a public presentations, and request time for a ACTION:Notice of availability; extension
workshop regarding the development of joint presentation, or submit requests for of comment period.
inhaled antibacterial drugs for CF and designated representatives to participate
non-CF bronchiectasis. As such, in the focused sessions. Following the SUMMARY: The Food and Drug
discussions will focus on challenges close of registration, we will determine Administration (FDA or the Agency) is
and potential paths forward for inhaled the amount of time allotted to each extending the comment period for the
antibacterial drugs pertaining to CF and presenter and the approximate time notice of availability (NOA) that
non-CF bronchiectasis. each oral presentation is to begin, and appeared in the Federal Register of
will select and notify participants by March 16, 2018. In the NOA, FDA
II. Topics for Discussion at the Public requested public comment on the draft
Workshop June 19, 2018. All requests to make oral
presentations must be received by the concept paper regarding the potential
FDA is particularly interested in close of registration on June 15, 2018. If for illicit trade markets to develop in
discussing challenges and selected for presentation, any response to a tobacco product standard.
considerations regarding CF and non-CF presentation materials must The Agency is taking this action in
bronchiectasis. Discussions are planned be emailed to response to a request for an extension to
amozie on DSK3GDR082PROD with NOTICES1
around the following topics for each of InhaledAntibacterialsWorkshop2018@ allow interested persons additional time
the disease areas: fda.hhs.gov no later than June 21, 2018. to submit comments.
• Trial design challenges No commercial or promotional material DATES: FDA is extending the comment
• Trial endpoints will be permitted to be presented or period on the NOA published March 16,
• Trial populations, duration of distributed at the public workshop. 2018 (83 FR 11754). Submit either
therapy, duration of microbiologic Streaming Webcast of the public electronic or written comments by July
testing and followup workshop: This public workshop will 16, 2018.
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![26698 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
ADDRESSES: You may submit comments Received comments, those filed in a regarding the potential for illicit trade
as follows. Please note that late, timely manner (see ADDRESSES), will be markets to develop in response to a
untimely filed comments will not be placed in the docket and, except for tobacco product standard. The Agency
considered. Electronic comments must those submitted as ‘‘Confidential received a request for a 90-day
be submitted on or before July 16, 2018. Submissions,’’ publicly viewable at extension of the comment period for the
The https://www.regulations.gov https://www.regulations.gov or at the NOA. The request conveyed concern
electronic filing system will accept Dockets Management Staff between 9 that the current 90-day comment period
comments until midnight Eastern Time a.m. and 4 p.m., Monday through does not allow sufficient time to
at the end of July 16, 2018. Comments Friday. develop a meaningful or thoughtful
received by mail/hand delivery/courier • Confidential Submissions—To response to the NOA.
(for written/paper submissions) will be submit a comment with confidential FDA has considered the request and
considered timely if they are information that you do not wish to be is extending the comment period for the
postmarked or the delivery service made publicly available, submit your NOA for 30 days, until July 16, 2018.
acceptance receipt is on or before that comments only as a written/paper The Agency believes that a 30-day
date. submission. You should submit two extension allows adequate time for
copies total. One copy will include the interested persons to submit comments
Electronic Submissions information you claim to be confidential without creating significant delay.
Submit electronic comments in the with a heading or cover note that states Dated: June 5, 2018.
following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: Leslie Kux,
CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including Associate Commissioner for Policy.
instructions for submitting comments. the claimed confidential information, in [FR Doc. 2018–12370 Filed 6–7–18; 8:45 am]
Comments submitted electronically, its consideration of comments. The BILLING CODE 4164–01–P
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available DEPARTMENT OF HEALTH AND
comment will be made public, you are for public viewing and posted on HUMAN SERVICES
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any Food and Drug Administration
both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and [Docket Nos. FDA–2011–N–0231; FDA–
third party may not wish to be posted, contact information to be made publicly 2014–N–0996; FDA–2010–N–0161; FDA–
such as medical information, your or available, you can provide this 2017–N–5624; FDA–2011–N–0085; FDA–
anyone else’s Social Security number, or 2013–D–0575; and FDA–2016–N–3710]
information on the cover sheet and not
confidential business information, such in the body of your comments and you Agency Information Collection
as a manufacturing process. Please note must identify this information as Activities; Announcement of Office of
that if you include your name, contact ‘‘confidential.’’ Any information marked Management and Budget Approvals
information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20 AGENCY: Food and Drug Administration,
comments, that information will be and other applicable disclosure law. For HHS.
posted on https://www.regulations.gov. more information about FDA’s posting ACTION: Notice.
• If you want to submit a comment of comments to public dockets, see 80
with confidential information that you FR 56469, September 18, 2015, or access SUMMARY: The Food and Drug
do not wish to be made available to the the information at: https://www.gpo.gov/ Administration (FDA) is publishing a
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- list of information collections that have
written/paper submission and in the 23389.pdf. been approved by the Office of
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Management and Budget (OMB) under
Submissions’’ and ‘‘Instructions’’). read background documents or the the Paperwork Reduction Act of 1995.
Written/Paper Submissions electronic and written/paper comments FOR FURTHER INFORMATION CONTACT: Ila
received, go to https:// S. Mizrachi, Office of Operations, Food
Submit written/paper submissions as www.regulations.gov and insert the and Drug Administration, Three White
follows: docket number, found in brackets in the Flint North, 10A–12M, 11601
• Mail/Hand delivery/Courier (for heading of this document, into the Landsdown St., North Bethesda, MD
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts 20852, 301–796–7726, PRAStaff@
Management Staff (HFA–305), Food and and/or go to the Dockets Management fda.hhs.gov.
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852. SUPPLEMENTARY INFORMATION: The
Rockville, MD 20852.
• For written/paper comments following is a list of FDA information
FOR FURTHER INFORMATION CONTACT: collections recently approved by OMB
submitted to the Dockets Management
Staff, FDA will post your comment, as Christopher Griffiths or Nate Mease, under section 3507 of the Paperwork
well as any attachments, except for Center for Tobacco Products, Food and Reduction Act of 1995 (44 U.S.C. 3507).
information submitted, marked and Drug Administration, 10903 New The OMB control number and
identified, as confidential, if submitted Hampshire Ave., Silver Spring, MD expiration date of OMB approval for
amozie on DSK3GDR082PROD with NOTICES1
as detailed in ‘‘Instructions.’’ 20993, 1–877–287–1373, AskCTP@ each information collection are shown
Instructions: All submissions received fda.hhs.gov. in table 1. Copies of the supporting
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: In the statements for the information
2018–N–0529 for ‘‘Draft Concept Paper: Federal Register of March 16, 2018, collections are available on the internet
Illicit Trade in Tobacco Products after FDA published an NOA with a 90-day at https://www.reginfo.gov/public/do/
Implementation of a Food and Drug comment period to request public PRAMain. An Agency may not conduct
Administration Product Standard.’’ comment on the draft concept paper or sponsor, and a person is not required
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Document Created: 2018-06-08 01:21:58
Document Modified: 2018-06-08 01:21:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability; extension of comment period. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 26697 |
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