83 FR 11754 - Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard; Availability; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 52 (March 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 52 (March 16, 2018)
| Page Range | 11754-11755 | |
| FR Document | 2018-05346 |
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)] [Notices] [Pages 11754-11755] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05346] ----------------------------------------------------------------------- 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; Availability; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft concept paper entitled ``Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.'' FDA seeks public comment on the draft concept paper regarding the potential for illicit trade markets to develop in response to a tobacco product standard. This draft concept paper is offered to stimulate dialogue around the subject of possible illicit trade in connection with tobacco product standards. DATES: Although you can comment at any time, to ensure that the Agency considers your comment on this draft concept paper, submit either electronic or written comments by June 14, 2018. ADDRESSES: You may submit 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: 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. [[Page 11755]] 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 ``Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.'' 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.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. Submit written requests for single copies of this draft concept paper to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 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 draft concept paper may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft concept paper. FOR FURTHER INFORMATION CONTACT: Christopher Griffiths, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft concept paper entitled ``Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.'' On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) was enacted. The Tobacco Control Act grants FDA authority to implement a wide variety of product standards impacting different characteristics of existing and future tobacco products. This draft concept paper describes aspects of the tobacco product market and consumer behavior that may be relevant to the development of illicit trade markets if FDA implements a tobacco product standard. FDA faces a complex task when assessing the potential for an illicit trade market to develop in response to a tobacco product standard. While it remains difficult to measure existing illicit trade markets and use existing data to reliably predict future illicit markets, it may be possible to isolate some of the key factors that may encourage or discourage illicit trade in tobacco products. This draft concept paper assists that effort by breaking down the potential mechanics of an illicit trade market into various components, and examining the factors that could support or hinder the establishment of a persistent illicit trade market in the face of an FDA tobacco product standard. This paper first discusses the legal authority and general approach to establishing tobacco product standards, and then discusses the different components of illicit trade markets, followed by relevant research in consumer behavior and potentially applicable economic research. FDA is providing notice and an opportunity to comment on this draft concept paper. Please provide evidence or other information supporting your comments. II. Electronic Access Persons with access to the internet may obtain an electronic version of the draft concept paper at either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: March 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-05346 Filed 3-15-18; 8:45 am] BILLING CODE 4164-01-P
![11754 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
(CSBG) Act requires states, including states and territories by revising burden will be minimal to the states to
the District of Columbia and the questions for clarity and system complete this the first year.
Commonwealth of Puerto Rico, and U.S. compatibility. It is not anticipated that Lastly, the request includes a survey
territories applying for CSBG funds to these revisions will cause any for the CSBG eligible entities (or sub-
submit an application and plan (CSBG additional burden to states as they have
grantees). The survey focuses on the
State Plan). The CSBG State Plan must been completing the automated plan for
customer service that the eligible
meet statutory requirements prior to three years. It is anticipated that the
states and territories being funded with burden will continue to diminish in entities receive from the CSBG states.
CSBG funds. Applicants have the option subsequent years due to improved pre- The survey is optional, and this will be
to submit a detailed plan annually or population and automation. the third time that the eligible entities
biannually. Entities that submit a In addition to the CSBG State Plan, that chose to submit will complete it.
biannual plan must provide an states will be requested to complete a Respondents: State Governments,
abbreviated plan the following year if CSBG Eligible Entity Master List in year including the District of Columbia and
substantial changes to the initial plan one, and then make updates as the Commonwealth of Puerto Rico, and
will occur. necessary in subsequent years. As the U.S. territories, and local level sub-
This request is to revise the states have the information about their grantees.
automated CSBG State Plan format for eligible entities (or sub-grantees), the
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
CSBG State Plan Application for States ......................................................... 56 1 31 1736
CSBG State Plan Eligible Entity List ............................................................... 56 1 1 56
CSBG ACSI Survey of Eligible Entities ........................................................... 1019 1 .15 152.85
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Electronic Submissions
Hours: 1,792 hours for states and HUMAN SERVICES Submit electronic comments in the
territories; 152.85 for eligible entities. following way:
Food and Drug Administration
Additional Information: Copies of the • Federal eRulemaking Portal:
proposed collection may be obtained by https://www.regulations.gov. Follow the
writing to the Administration for [Docket No. FDA–2018–N–0529] instructions for submitting comments.
Children and Families, Office of Comments submitted electronically,
Draft Concept Paper: Illicit Trade in including attachments, to https://
Planning, Research and Evaluation, 330 Tobacco Products After
C Street SW, Washington, DC 20201. www.regulations.gov will be posted to
Implementation of a Food and Drug the docket unchanged. Because your
Attention Reports Clearance Officer. All Administration Product Standard;
requests should be identified by the title comment will be made public, you are
Availability; Request for Comments solely responsible for ensuring that your
of the information collection. Email
address: infocollection@acf.hhs.gov. comment does not include any
AGENCY: Food and Drug Administration,
confidential information that you or a
OMB Comment: OMB is required to HHS.
third party may not wish to be posted,
make a decision concerning the ACTION:Notice of availability; request such as medical information, your or
collection of information between 30 for comments. anyone else’s Social Security number, or
and 60 days after publication of this confidential business information, such
document in the Federal Register. SUMMARY: The Food and Drug as a manufacturing process. Please note
Therefore, a comment is best assured of Administration (FDA) is announcing the that if you include your name, contact
having its full effect if OMB receives it availability of a draft concept paper information, or other information that
within 30 days of publication. Written entitled ‘‘Illicit Trade in Tobacco identifies you in the body of your
comments and recommendations for the Products after Implementation of an comments, that information will be
proposed information collection should FDA Product Standard.’’ FDA seeks posted on https://www.regulations.gov.
be sent directly to the following: Office public comment on the draft concept • If you want to submit a comment
of Management and Budget, Paperwork paper regarding the potential for illicit with confidential information that you
Reduction Project, Email: OIRA_ trade markets to develop in response to do not wish to be made available to the
SUBMISSION@OMB.EOP.GOV, Attn: a tobacco product standard. This draft public, submit the comment as a
Desk Officer for the Administration for concept paper is offered to stimulate written/paper submission and in the
Children and Families. dialogue around the subject of possible manner detailed (see ‘‘Written/Paper
illicit trade in connection with tobacco Submissions’’ and ‘‘Instructions’’).
Robert Sargis, product standards.
Written/Paper Submissions
Reports Clearance Officer.
daltland on DSKBBV9HB2PROD with NOTICES
DATES: Although you can comment at
[FR Doc. 2018–05395 Filed 3–15–18; 8:45 am] Submit written/paper submissions as
any time, to ensure that the Agency
follows:
BILLING CODE 4184–27–P considers your comment on this draft
• Mail/Hand delivery/Courier (for
concept paper, submit either electronic
written/paper submissions): Dockets
or written comments by June 14, 2018.
Management Staff (HFA–305), Food and
ADDRESSES: You may submit comments Drug Administration, 5630 Fishers
as follows: Lane, Rm. 1061, Rockville, MD 20852.
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![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11755
• For written/paper comments Drug Administration, Document Control concept paper. Please provide evidence
submitted to the Dockets Management Center, Bldg. 71, Rm. G335, 10903 New or other information supporting your
Staff, FDA will post your comment, as Hampshire Ave., Silver Spring, MD comments.
well as any attachments, except for 20993–0002. Send one self-addressed
II. Electronic Access
information submitted, marked and adhesive label to assist that office in
identified, as confidential, if submitted processing your request or include a fax Persons with access to the internet
as detailed in ‘‘Instructions.’’ number to which the draft concept may obtain an electronic version of the
Instructions: All submissions received paper may be sent. See the draft concept paper at either https://
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION section for www.regulations.gov or https://
2018–N–0529 for ‘‘Illicit Trade in information on electronic access to the www.fda.gov/TobaccoProducts/
Tobacco Products after Implementation draft concept paper. Labeling/RulesRegulationsGuidance/
of an FDA Product Standard.’’ Received FOR FURTHER INFORMATION CONTACT: default.htm.
comments will be placed in the docket Christopher Griffiths, Center for Dated: March 12, 2018.
and, except for those submitted as Tobacco Products, Food and Drug
‘‘Confidential Submissions,’’ publicly Leslie Kux,
Administration, Document Control Associate Commissioner for Policy.
viewable at https://www.regulations.gov Center, Bldg. 71, Rm. G335, 10903 New
or at the Dockets Management Staff Hampshire Ave., Silver Spring, MD
[FR Doc. 2018–05346 Filed 3–15–18; 8:45 am]
between 9 a.m. and 4 p.m., Monday 20993–0002, 1–877–287–1373, email: BILLING CODE 4164–01–P
through Friday. CTPRegulations@fda.hhs.gov.
• Confidential Submissions—To
submit a comment with confidential SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND
information that you do not wish to be I. Background HUMAN SERVICES
made publicly available, submit your
comments only as a written/paper FDA is announcing the availability of Food and Drug Administration
submission. You should submit two a draft concept paper entitled ‘‘Illicit
copies total. One copy will include the Trade in Tobacco Products after [Docket No. FDA–2018–N–0045]
information you claim to be confidential Implementation of an FDA Product
with a heading or cover note that states Standard.’’ On June 22, 2009, the Family Pediatric Advisory Committee and the
‘‘THIS DOCUMENT CONTAINS Smoking Prevention and Tobacco Endocrinologic and Metabolic Drugs
CONFIDENTIAL INFORMATION.’’ The Control Act (Pub. L. 111–31) (Tobacco Advisory Committee; Amendment of
Agency will review this copy, including Control Act) was enacted. The Tobacco Notice
the claimed confidential information, in Control Act grants FDA authority to
its consideration of comments. The implement a wide variety of product AGENCY: Food and Drug Administration,
second copy, which will have the standards impacting different HHS.
claimed confidential information characteristics of existing and future ACTION: Notice.
redacted/blacked out, will be available tobacco products. This draft concept
for public viewing and posted on paper describes aspects of the tobacco SUMMARY: The Food and Drug
https://www.regulations.gov. Submit product market and consumer behavior Administration (FDA) is announcing an
both copies to the Dockets Management that may be relevant to the development amendment to the notice of meeting of
Staff. If you do not wish your name and of illicit trade markets if FDA the Pediatric Advisory Committee (PAC)
contact information to be made publicly implements a tobacco product standard. and the Endocrinologic and Metabolic
available, you can provide this FDA faces a complex task when Drugs Advisory Committee (EMDAC).
information on the cover sheet and not assessing the potential for an illicit trade This meeting was announced in the
in the body of your comments and you market to develop in response to a Federal Register of January 23, 2018.
must identify this information as tobacco product standard. While it The amendment is being made to reflect
‘‘confidential.’’ Any information marked remains difficult to measure existing a change in the agenda for the open
as ‘‘confidential’’ will not be disclosed illicit trade markets and use existing session of the meeting and to extend the
except in accordance with 21 CFR 10.20 data to reliably predict future illicit amount of time allotted for the closed
and other applicable disclosure law. For markets, it may be possible to isolate session. There are no other changes.
more information about FDA’s posting some of the key factors that may DATES: The meeting will be held on
of comments to public dockets, see 80 encourage or discourage illicit trade in March 22, 2018, from 8 a.m. to 6 p.m.
FR 56469, September 18, 2015, or access tobacco products. This draft concept
paper assists that effort by breaking FOR FURTHER INFORMATION CONTACT:
the information at: https://www.gpo.gov/
down the potential mechanics of an Marieann Brill, Office of the
fdsys/pkg/FR-2015-09-18/pdf/2015-
illicit trade market into various Commissioner, Food and Drug
23389.pdf.
Docket: For access to the docket to components, and examining the factors Administration, 10903 New Hampshire
read background documents or the that could support or hinder the Ave., Bldg. 32, Rm. 5154, Silver Spring,
electronic and written/paper comments establishment of a persistent illicit trade MD 20993, 240–402–3838,
received, go to https:// market in the face of an FDA tobacco marieann.brill@fda.hhs.gov, or FDA
www.regulations.gov and insert the product standard. This paper first Advisory Committee Information Line,
docket number, found in brackets in the discusses the legal authority and general 1–800–741–8138 (301–443–0572 in the
heading of this document, into the approach to establishing tobacco Washington, DC area). Please call the
daltland on DSKBBV9HB2PROD with NOTICES
‘‘Search’’ box and follow the prompts product standards, and then discusses Information Line for up-to-date
and/or go to the Dockets Management the different components of illicit trade information on this meeting.
Staff, 5630 Fishers Lane, Rm. 1061, markets, followed by relevant research SUPPLEMENTARY INFORMATION: In the
Rockville, MD 20852. in consumer behavior and potentially Federal Register of January 23, 2018 (83
Submit written requests for single applicable economic research. FR 3156), FDA announced that a
copies of this draft concept paper to the FDA is providing notice and an meeting of the PAC and EMDAC would
Center for Tobacco Products, Food and opportunity to comment on this draft be held on March 22, 2018.
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Document Created: 2018-03-16 01:12:16
Document Modified: 2018-03-16 01:12:16
| 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; request for comments. | |
| Dates | Although you can comment at any time, to ensure that the Agency considers your comment on this draft concept paper, submit either electronic or written comments by June 14, 2018. | |
| Contact | Christopher Griffiths, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email: [email protected] | |
| FR Citation | 83 FR 11754 |
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