81 FR 28781 - Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 90 (May 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 90 (May 10, 2016)
| Page Range | 28781-28783 | |
| FR Document | 2016-10687 |
[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)] [Proposed Rules] [Pages 28781-28783] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10687] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1100, 1140, and 1143 [Docket No. FDA-2015-D-2496] Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.'' Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 11, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 [[Page 28782]] 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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-D-2496 for ``Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this draft guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: Colleen Lee, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 1-877-287-1373, [email protected]. With regard to the proposed collection of information: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.'' On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111- 31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and granted FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. Under section 901(b) of the FD&C Act (21 U.S.C. 387a(b)), FDA's tobacco product authorities in chapter IX of the FD&C Act apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary of Health and Human Services by regulation deems to be subject to chapter IX. Concurrently with issuing this draft guidance, FDA is publishing elsewhere in this issue of the Federal Register, its final rule, ``Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products'' (Deeming rule) to deem all products meeting the statutory definition of ``tobacco product'' in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), except accessories to newly deemed tobacco products, to be subject to chapter IX of the FD&C Act (21 U.S.C. 387 through 387u). Under section 910 of the FD&C Act (21 U.S.C. 387j), persons seeking to market a new tobacco product (as defined in section 910(a)(1) of the FD&C Act) must first submit a PMTA to FDA and obtain a marketing authorization order, unless FDA has issued an order that the new tobacco product is substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, or the new tobacco product is exempt from demonstrating substantial equivalence pursuant to the reasons outlined in section 905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)). The ENDS products that are the subject of this draft guidance likely would be considered new tobacco products. Given the relatively new presence of ENDS on the U.S. market, FDA anticipates that many manufacturers of these new tobacco products will seek a marketing authorization order by filing a PMTA. This draft guidance explains, among other things, products to which the guidance applies, when a PMTA is required, general procedures for review of an ENDS PMTA, what information the FD&C Act requires applicants to submit in a PMTA, and what information FDA recommends applicants submit in an ENDS PMTA to show whether permitting such new tobacco product to be marketed is appropriate for the protection of the public health. II. Significance of Draft Guidance FDA is issuing this draft guidance consistent with FDA's good guidance [[Page 28783]] practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on PMTAs for ENDS. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft guidance refers to collections of information described in FDA's Deeming rule, which this draft guidance is intended to interpret. The collections of information in the Deeming rule are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). As required by the PRA, FDA has published an analysis of the information collection provisions elsewhere in this issue of the Federal Register and has submitted them for OMB approval. IV. Electronic Access Persons with access to the Internet may obtain an electronic version of the draft guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: May 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-10687 Filed 5-5-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Proposed Rules 28781
comments to public dockets, see 80 FR amended by the Family Smoking DEPARTMENT OF HEALTH AND
56469, September 18, 2015, or access Prevention and Tobacco Control Act HUMAN SERVICES
the information at: http://www.fda.gov/ (‘‘Tobacco Control Act’’). The Deeming
regulatoryinformation/dockets/ rule extends FDA’s authority in Chapter Food and Drug Administration
default.htm. IX of the FD&C Act to include all
Docket: For access to the docket to tobacco products, except accessories of 21 CFR Parts 1100, 1140, and 1143
read background documents or the newly deemed tobacco products. The [Docket No. FDA–2015–D–2496]
electronic and written/paper comments Deeming rule also prohibits the sale of
received, go to http:// covered tobacco products to individuals Premarket Tobacco Product
www.regulations.gov and insert the under the age of 18, prohibits vending Applications for Electronic Nicotine
docket number, found in brackets in the machine sales unless sold in adult-only Delivery Systems; Draft Guidance for
heading of this document, into the Industry; Availability; Agency
facilities, and requires the display of
‘‘Search’’ box and follow the prompts Information Collection Activities;
health warning statements on cigarette
and/or go to the Division of Dockets Proposed Collection; Comment
tobacco, roll-your-own tobacco, and
Management, 5630 Fishers Lane, Rm. Request
1061, Rockville, MD 20852. covered tobacco product packages and
Submit written requests for single in advertisements. AGENCY: Food and Drug Administration,
copies of this guidance to the Center for In compliance with section 212 of the HHS.
Tobacco Products, Food and Drug Small Business Regulatory Enforcement ACTION: Notification of availability.
Administration, Document Control Fairness Act (Pub. L. 104–121), FDA is SUMMARY: The Food and Drug
Center, Bldg. 71, Rm. G335, 10903 New making available this SECG stating in Administration (FDA) is announcing the
Hampshire Ave., Silver Spring, MD plain language the legal requirements of availability of a draft guidance for
20993–0002. Send one self-addressed the Deeming final rule, set forth in 21 industry entitled ‘‘Premarket Tobacco
adhesive label to assist that office in CFR parts 1100, 1140, and 1143. Product Applications for Electronic
processing your request or include a fax Nicotine Delivery Systems.’’ Given the
number to which the guidance II. Significance of Guidance
relatively new presence of electronic
document may be sent. See the nicotine delivery systems (ENDS) on the
FDA is issuing this SECG as a level 2
SUPPLEMENTARY INFORMATION section for U.S. market and FDA’s final rule
guidance, consistent with FDA’s good
information on electronic access to the deeming these products to be subject to
guidance. guidance practices regulation (21 CFR
10.115). The guidance represents the the tobacco product authorities in the
FOR FURTHER INFORMATION CONTACT: Federal Food, Drug, and Cosmetic Act
current thinking of FDA on this topic.
Katherine Collins, Center for Tobacco (FD&C Act), FDA expects to receive
It does not establish any rights for any
Products, Food and Drug premarket tobacco product application
Administration, Document Control person and is not binding on FDA or the
(PMTA) submissions from
Center, Bldg. 71, Rm. G335, 10903 New public unless specific regulatory or
manufacturers of ENDS. This draft
Hampshire Ave., Silver Spring, MD statutory requirements are cited. You guidance is intended to assist persons
20993–2000, 1–877–287–1373, email: can use an alternative approach if it with their PMTA submissions for ENDS
AskCTP@fda.hhs.gov. satisfies the requirements of the products.
SUPPLEMENTARY INFORMATION:
applicable statutes and regulations. DATES: Although you can comment on
III. Electronic Access any guidance at any time (see 21 CFR
I. Background
10.115(g)(5)), to ensure that the Agency
FDA is announcing the availability of Persons with access to the Internet considers your comment on this draft
a guidance for industry entitled ‘‘FDA may obtain an electronic version of the guidance before it begins work on the
Deems Certain Tobacco Products guidance at either http:// final version of the guidance, submit
Subject to FDA Authority, Sales and www.regulations.gov or http://www.fda. either electronic or written comments
Distribution Restrictions, and Health gov/TobaccoProducts/Labeling/Rules on the draft guidance by July 11, 2016.
Warning Requirements for Packages and RegulationsGuidance/default.htm. ADDRESSES: You may submit comments
Advertisements, Small Entity as follows:
Dated: May 3, 2016.
Compliance Guide.’’ This guidance is
intended to help small businesses Leslie Kux, Electronic Submissions
understand and comply with FDA’s Associate Commissioner for Policy. Submit electronic comments in the
implementation of the final rule entitled [FR Doc. 2016–10684 Filed 5–5–16; 8:45 am] following way:
‘‘Deeming Tobacco Products To Be BILLING CODE 4164–01–P • Federal eRulemaking Portal: http://
Subject to the Federal Food, Drug, and www.regulations.gov. Follow the
Cosmetic Act, as Amended by the instructions for submitting comments.
Family Smoking Prevention and Comments submitted electronically,
Tobacco Control Act; Restrictions on the including attachments, to http://
Sale and Distribution of Tobacco www.regulations.gov will be posted to
Products and Required Warning the docket unchanged. Because your
Statements for Tobacco Products’’ comment will be made public, you are
(Deeming rule), which is published solely responsible for ensuring that your
ehiers on DSK5VPTVN1PROD with PROPOSALS
elsewhere in this edition of the Federal comment does not include any
Register. Specifically, this guidance is confidential information that you or a
intended to help small businesses third party may not wish to be posted,
understand how to comply with FDA’s such as medical information, your or
final rule deeming tobacco products to anyone else’s Social Security number, or
be subject to the Federal Food, Drug, confidential business information, such
and Cosmetic Act (‘‘FD&C Act’’), as as a manufacturing process. Please note
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![Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Proposed Rules 28783
practices regulation (21 CFR 10.115). regulation. This revised guidance, a Calculate User Fees for Domestic
The draft guidance, when finalized, will small entity compliance guide (SECG), Manufacturers and Importers of Tobacco
represent the current thinking of FDA replaces the SECG of the same name Products.’’ Received comments will be
on PMTAs for ENDS. It does not published on July 16, 2014. The revised placed in the docket and, except for
establish any rights for any person and SECG is intended to set forth in plain those submitted as ‘‘Confidential
is not binding on FDA or the public. language the requirements of the user Submissions,’’ publicly viewable at
You can use an alternative approach if fee regulations and to help small http://www.regulations.gov or at the
it satisfies the requirements of the businesses understand and comply with Division of Dockets Management
applicable statutes and regulations. the regulations. between 9 a.m. and 4 p.m., Monday
DATES: Submit either electronic or through Friday.
III. Paperwork Reduction Act of 1995 • Confidential Submissions—To
written comments on Agency guidances
This draft guidance refers to submit a comment with confidential
at any time.
collections of information described in information that you do not wish to be
FDA’s Deeming rule, which this draft ADDRESSES: You may submit comments
made publicly available, submit your
guidance is intended to interpret. The as follows: comments only as a written/paper
collections of information in the Electronic Submissions submission. You should submit two
Deeming rule are subject to review by copies total. One copy will include the
the Office of Management and Budget Submit electronic comments in the
information you claim to be confidential
(OMB) under the Paperwork Reduction following way: with a heading or cover note that states
Act of 1995 (PRA) (44 U.S.C. 3501– • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
3520). As required by the PRA, FDA has www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
published an analysis of the information instructions for submitting comments. Agency will review this copy, including
collection provisions elsewhere in this Comments submitted electronically, the claimed confidential information, in
issue of the Federal Register and has including attachments, to http:// its consideration of comments. The
submitted them for OMB approval. www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
IV. Electronic Access comment will be made public, you are redacted/blacked out, will be available
Persons with access to the Internet solely responsible for ensuring that your for public viewing and posted on http://
may obtain an electronic version of the comment does not include any www.regulations.gov. Submit both
draft guidance at either http:// confidential information that you or a copies to the Division of Dockets
www.regulations.gov or http:// third party may not wish to be posted, Management. If you do not wish your
www.fda.gov/TobaccoProducts/ such as medical information, your or name and contact information to be
Labeling/RulesRegulationsGuidance/ anyone else’s Social Security number, or made publicly available, you can
default.htm. confidential business information, such provide this information on the cover
as a manufacturing process. Please note sheet and not in the body of your
Dated: May 3, 2016.
that if you include your name, contact comments and you must identify this
Leslie Kux,
information, or other information that information as ‘‘confidential.’’ Any
Associate Commissioner for Policy. identifies you in the body of your information marked as ‘‘confidential’’
[FR Doc. 2016–10687 Filed 5–5–16; 8:45 am] comments, that information will be will not be disclosed except in
BILLING CODE 4164–01–P posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
DEPARTMENT OF HEALTH AND do not wish to be made available to the
HUMAN SERVICES comments to public dockets, see 80 FR
public, submit the comment as a 56469, September 18, 2015, or access
Food and Drug Administration written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
21 CFR Part 1150 Submissions’’ and ‘‘Instructions’’). default.htm.
Written/Paper Submissions Docket: For access to the docket to
[Docket No. FDA–2014–D–0917] read background documents or the
Submit written/paper submissions as electronic and written/paper comments
Requirements for the Submission of follows: received, go to http://
Data Needed To Calculate User Fees • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
for Domestic Manufacturers and written/paper submissions): Division of docket number, found in brackets in the
Importers of Tobacco Products; Small Dockets Management (HFA–305), Food heading of this document, into the
Entity Compliance Guide; Availability and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
HHS. • For written/paper comments Management, 5630 Fishers Lane, Rm.
ACTION: Notification of availability. submitted to the Division of Dockets 1061, Rockville, MD 20852.
Management, FDA will post your Submit written requests for single
SUMMARY: The Food and Drug comment, as well as any attachments, copies of this guidance to the Center for
Administration (FDA) is announcing the except for information submitted, Tobacco Products, Food and Drug
availability of a revised guidance for marked and identified, as confidential, Administration, Document Control
ehiers on DSK5VPTVN1PROD with PROPOSALS
industry entitled ‘‘Requirements for the if submitted as detailed in Center, Bldg. 71, Rm. G335, 10903 New
Submission of Data Needed to Calculate ‘‘Instructions.’’ Hampshire Ave., Silver Spring, MD
User Fees for Domestic Manufacturers Instructions: All submissions received 20993–0002. Send one self-addressed
and Importers of Tobacco Products; must include the Docket No. FDA– adhesive label to assist that office in
Small Entity Compliance Guide’’ for the 2014–D–0917 for ‘‘Small Entity processing your request or include a fax
final user fees rule published July 10, Compliance Guide: Requirements for number to which the guidance
2014, and for the new user fees the Submission of Data Needed To document may be sent. See the
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Document Created: 2016-05-10 05:18:49
Document Modified: 2016-05-10 05:18:49
| 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 | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 11, 2016. | |
| Contact | With regard to the draft guidance: Colleen Lee, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 1-877-287-1373, [email protected] | |
| FR Citation | 81 FR 28781 | |
| CFR Citation | 21
CFR
1100 21 CFR 1140 21 CFR 1143 |
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