Listing of Ingredients in Tobacco Products; Guidance for Industry; Availability, 16866-16867 [2018-07973]

Download as PDF 16866 Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices Relatedly, the FD&C Act, as amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110– 85), requires FDA to collect user fees for 513(g) requests for information. The guidance document entitled ‘‘Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information’’ assists FDA staff and regulated industry by describing the user fees associated with 513(g) requests. The Medical Device User Fee Cover Sheet (Form FDA 3601), which accompanies the supplemental material described in this information collection is approved under OMB control number 0910–0511. In the Federal Register of November 21, 2017 (82 FR 55381) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received in response to the notice. We therefore retain the currently approved burden estimate for the information collection, which is as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours CDRH 513(g) requests ........................................................ CBER 513(g) requests ......................................................... 114 4 1 1 114 4 12 12 1,368 48 Total .............................................................................. ........................ ........................ ........................ ........................ 1,416 1 There are no capital costs of operating and maintenance costs associated with this collection off information. Respondents to the collection of information are mostly device manufacturers; however, anyone may submit a 513(g) request for information. The total number of annual responses is based on the average number of 513(g) requests received each year by the Agency. Dated: April 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–07980 Filed 4–16–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0524] Listing of Ingredients in Tobacco Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled ‘‘Listing of Ingredients in Tobacco Products.’’ The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: The announcement of the guidance is published in the Federal Register on April 17, 2018. DATES: VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: 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. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 • 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– 2009–D–0524 for ‘‘Listing of Ingredients in Tobacco Products.’’ 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 E:\FR\FM\17APN1.SGM 17APN1 Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the revised draft guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002. Send two selfaddressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Katherine Collins or Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 1–877–287–1373, email: CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: daltland on DSKBBV9HB2PROD with NOTICES I. Background We are announcing the availability of a revised guidance for industry entitled ‘‘Listing of Ingredients in Tobacco Products.’’ The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Tobacco Control Act. We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate given the requirement that ingredient listing submissions be submitted by May 8, 2018 (§ 10.115(g)(2)). We made this determination because FDA needs to timely communicate that the guidance presents a less burdensome policy that is consistent with the public health and VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 clarifies ways in which tobacco product manufacturers and importers can submit ingredient listing submissions as required by section 904(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387d(a)(1)). Although this guidance document is immediately effective, it remains subject to comment in accordance with FDA’s GGP regulation. The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C Act and provides FDA with the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health (Pub. L. 111– 31, 123 Stat. 1776). Among its many provisions, the Tobacco Control Act added section 904 to the FD&C Act, establishing requirements for tobacco product ingredient submissions. II. Significance of Guidance This revised guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on listing of ingredients in tobacco products. 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. This guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This revised guidance refers to previously approved collections of information found in FDA regulations. The revised draft guidance includes information and recommendations for how to provide ingredient listing submissions for tobacco products. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in section 904(a)(1) of the FD&C Act have been approved under OMB control number 0910–0650. IV. Electronic Access Persons with access to the internet may obtain an electronic version of the revised guidance at either https:// www.regulations.gov or https:// www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ default.htm. Use the FDA website listed in the previous sentence to find the most current version of the guidance. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 16867 Dated: April 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–07973 Filed 4–16–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0001] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2017. ADDRESSES: Copies are available at the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You also may access the docket at https:// www.regulations.gov for the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2017. Insert the docket number found in brackets in the heading of this document at https:// www.regulations.gov into the ‘‘Search’’ box, clear filter under Document Type (left side of screen), and check ‘‘Supporting and Related Material,’’ then Sort By Best Match (from the dropdown menu; top right side of screen), ‘‘ID Number (Z–A)’’ or Sort By Best Match (from the drop-down menu) ‘‘Title (A–Z),’’ also found in the heading of this document. FOR FURTHER INFORMATION CONTACT: Russell Fortney, Director, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1068. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2016, through September 30, 2017: Center for Biologics Evaluation and Research: Allergenic Products Advisory SUMMARY: E:\FR\FM\17APN1.SGM 17APN1

Agencies

[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16866-16867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07973]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0524]


Listing of Ingredients in Tobacco Products; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a revised final guidance for industry entitled 
``Listing of Ingredients in Tobacco Products.'' The revised guidance 
document is intended to assist persons making tobacco product 
ingredient submissions to FDA as required by the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES: The announcement of the guidance is published in the Federal 
Register on April 17, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time 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.
     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-2009-D-0524 for ``Listing of Ingredients in Tobacco Products.'' 
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

[[Page 16867]]

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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the revised draft 
guidance to the Center for Tobacco Products, Food and Drug 
Administration, Document Control Center, 10903 New Hampshire Ave., 
Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Collins or Deirdre Jurand, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002, 1-877-287-1373, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a revised guidance for 
industry entitled ``Listing of Ingredients in Tobacco Products.'' The 
revised guidance document is intended to assist persons making tobacco 
product ingredient submissions to FDA as required by the Tobacco 
Control Act.
    We are issuing this guidance consistent with our good guidance 
practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). We are 
implementing this guidance without prior public comment because we have 
determined that prior public participation is not feasible or 
appropriate given the requirement that ingredient listing submissions 
be submitted by May 8, 2018 (Sec.  10.115(g)(2)). We made this 
determination because FDA needs to timely communicate that the guidance 
presents a less burdensome policy that is consistent with the public 
health and clarifies ways in which tobacco product manufacturers and 
importers can submit ingredient listing submissions as required by 
section 904(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 387d(a)(1)). Although this guidance document is 
immediately effective, it remains subject to comment in accordance with 
FDA's GGP regulation.
    The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C 
Act and provides FDA with the authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect the public 
health (Pub. L. 111-31, 123 Stat. 1776). Among its many provisions, the 
Tobacco Control Act added section 904 to the FD&C Act, establishing 
requirements for tobacco product ingredient submissions.

II. Significance of Guidance

    This revised guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on listing of ingredients in tobacco 
products. 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. 
This guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This revised guidance refers to previously approved collections of 
information found in FDA regulations. The revised draft guidance 
includes information and recommendations for how to provide ingredient 
listing submissions for tobacco products. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in section 904(a)(1) of the FD&C 
Act have been approved under OMB control number 0910-0650.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the revised guidance at either https://www.regulations.gov 
or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Use the FDA website listed in the 
previous sentence to find the most current version of the guidance.

    Dated: April 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07973 Filed 4-16-18; 8:45 am]
 BILLING CODE 4164-01-P

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