Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard; Availability; Request for Comments, 11754-11755 [2018-05346]

Download as PDF 11754 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices (CSBG) Act requires states, including the District of Columbia and the Commonwealth of Puerto Rico, and U.S. territories applying for CSBG funds to submit an application and plan (CSBG State Plan). The CSBG State Plan must meet statutory requirements prior to states and territories being funded with CSBG funds. Applicants have the option to submit a detailed plan annually or biannually. Entities that submit a biannual plan must provide an abbreviated plan the following year if substantial changes to the initial plan will occur. This request is to revise the automated CSBG State Plan format for states and territories by revising questions for clarity and system compatibility. It is not anticipated that these revisions will cause any additional burden to states as they have been completing the automated plan for three years. It is anticipated that the burden will continue to diminish in subsequent years due to improved prepopulation and automation. In addition to the CSBG State Plan, states will be requested to complete a CSBG Eligible Entity Master List in year one, and then make updates as necessary in subsequent years. As the states have the information about their eligible entities (or sub-grantees), the burden will be minimal to the states to complete this the first year. Lastly, the request includes a survey for the CSBG eligible entities (or subgrantees). The survey focuses on the customer service that the eligible entities receive from the CSBG states. The survey is optional, and this will be the third time that the eligible entities that chose to submit will complete it. Respondents: State Governments, including the District of Columbia and the Commonwealth of Puerto Rico, and U.S. territories, and local level subgrantees. ANNUAL BURDEN ESTIMATES Number of respondents Instrument CSBG State Plan Application for States ......................................................... CSBG State Plan Eligible Entity List ............................................................... CSBG ACSI Survey of Eligible Entities ........................................................... daltland on DSKBBV9HB2PROD with NOTICES Estimated Total Annual Burden Hours: 1,792 hours for states and territories; 152.85 for eligible entities. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. 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 Food and Drug Administration, HHS. Notice of availability; request for comments. ACTION: 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. SUMMARY: 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. DATES: [FR Doc. 2018–05395 Filed 3–15–18; 8:45 am] BILLING CODE 4184–27–P ADDRESSES: You may submit comments as follows: VerDate Sep<11>2014 21:54 Mar 15, 2018 56 56 1019 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 1 Average burden hours per response 31 1 .15 Total burden hours 1736 56 152.85 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. E:\FR\FM\16MRN1.SGM 16MRN1 daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices • 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.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. Submit written requests for single copies of this draft concept paper to the Center for Tobacco Products, Food and VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 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: CTPRegulations@fda.hhs.gov. 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 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 11755 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0045] Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). This meeting was announced in the Federal Register of January 23, 2018. The amendment is being made to reflect a change in the agenda for the open session of the meeting and to extend the amount of time allotted for the closed session. There are no other changes. DATES: The meeting will be held on March 22, 2018, from 8 a.m. to 6 p.m. FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240–402–3838, marieann.brill@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of January 23, 2018 (83 FR 3156), FDA announced that a meeting of the PAC and EMDAC would be held on March 22, 2018. SUMMARY: E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11754-11755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.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.
    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

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