83 FR 16866 - Listing of Ingredients in Tobacco Products; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 74 (April 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 74 (April 17, 2018)
| Page Range | 16866-16867 | |
| FR Document | 2018-07973 |
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)] [Notices] [Pages 16866-16867] From the Federal Register Online [www.thefederalregister.org] [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.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. 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: CTPRegulations@fda.hhs.gov. 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
![16866 Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
Relatedly, the FD&C Act, as amended FDA staff and regulated industry by a 60-day notice requesting public
by the Food and Drug Administration describing the user fees associated with comment on the proposed collection of
Amendments Act of 2007 (Pub. L. 110– 513(g) requests. The Medical Device information. No comments were
85), requires FDA to collect user fees for User Fee Cover Sheet (Form FDA 3601), received in response to the notice.
513(g) requests for information. The which accompanies the supplemental
We therefore retain the currently
guidance document entitled ‘‘Guidance material described in this information
approved burden estimate for the
for Industry and Food and Drug collection is approved under OMB
control number 0910–0511. information collection, which is as
Administration Staff; User Fees for follows:
In the Federal Register of November
513(g) Requests for Information’’ assists
21, 2017 (82 FR 55381) FDA published
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
CDRH 513(g) requests ........................................................ 114 1 114 12 1,368
CBER 513(g) requests ......................................................... 4 1 4 12 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 ADDRESSES: You may submit either • For written/paper comments
information are mostly device electronic or written comments on submitted to the Dockets Management
manufacturers; however, anyone may Agency guidances at any time as Staff, FDA will post your comment, as
submit a 513(g) request for information. follows: well as any attachments, except for
The total number of annual responses is information submitted, marked and
Electronic Submissions identified, as confidential, if submitted
based on the average number of 513(g)
requests received each year by the Submit electronic comments in the as detailed in ‘‘Instructions.’’
Agency. following way: Instructions: All submissions received
• Federal eRulemaking Portal: must include the Docket No. FDA–
Dated: April 12, 2018.
https://www.regulations.gov. Follow the 2009–D–0524 for ‘‘Listing of Ingredients
Leslie Kux,
instructions for submitting comments. in Tobacco Products.’’ Received
Associate Commissioner for Policy. comments will be placed in the docket
[FR Doc. 2018–07980 Filed 4–16–18; 8:45 am]
Comments submitted electronically,
including attachments, to https:// and, except for those submitted as
BILLING CODE 4164–01–P
www.regulations.gov will be posted to ‘‘Confidential Submissions,’’ publicly
the docket unchanged. Because your viewable at https://www.regulations.gov
comment will be made public, you are or at the Dockets Management Staff
DEPARTMENT OF HEALTH AND between 9 a.m. and 4 p.m., Monday
HUMAN SERVICES solely responsible for ensuring that your
comment does not include any through Friday.
• Confidential Submissions—To
Food and Drug Administration confidential information that you or a
submit a comment with confidential
third party may not wish to be posted,
information that you do not wish to be
such as medical information, your or
[Docket No. FDA–2009–D–0524] made publicly available, submit your
anyone else’s Social Security number, or
comments only as a written/paper
Listing of Ingredients in Tobacco confidential business information, such
submission. You should submit two
Products; Guidance for Industry; as a manufacturing process. Please note copies total. One copy will include the
Availability that if you include your name, contact information you claim to be confidential
information, or other information that with a heading or cover note that states
AGENCY: Food and Drug Administration, identifies you in the body of your
HHS. ‘‘THIS DOCUMENT CONTAINS
comments, that information will be CONFIDENTIAL INFORMATION.’’ The
ACTION: Notice of availability. posted on https://www.regulations.gov. Agency will review this copy, including
• If you want to submit a comment the claimed confidential information, in
SUMMARY: The Food and Drug with confidential information that you its consideration of comments. The
Administration (FDA or we) is do not wish to be made available to the second copy, which will have the
announcing the availability of a revised public, submit the comment as a claimed confidential information
final guidance for industry entitled written/paper submission and in the redacted/blacked out, will be available
‘‘Listing of Ingredients in Tobacco manner detailed (see ‘‘Written/Paper for public viewing and posted on
Products.’’ The revised guidance Submissions’’ and ‘‘Instructions’’). https://www.regulations.gov. Submit
document is intended to assist persons
Written/Paper Submissions both copies to the Dockets Management
making tobacco product ingredient
Staff. If you do not wish your name and
daltland on DSKBBV9HB2PROD with NOTICES
submissions to FDA as required by the Submit written/paper submissions as contact information to be made publicly
Family Smoking Prevention and follows: available, you can provide this
Tobacco Control Act (Tobacco Control • Mail/Hand delivery/Courier (for information on the cover sheet and not
Act). written/paper submissions): Dockets in the body of your comments and you
DATES: The announcement of the Management Staff (HFA–305), Food and must identify this information as
guidance is published in the Federal Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked
Register on April 17, 2018. Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed
VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1](https://thefederalregister.org/doc/83_FR_16940/page/1.svg)
![Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 16867
except in accordance with 21 CFR 10.20 clarifies ways in which tobacco product Dated: April 11, 2018.
and other applicable disclosure law. For manufacturers and importers can submit Leslie Kux,
more information about FDA’s posting ingredient listing submissions as Associate Commissioner for Policy.
of comments to public dockets, see 80 required by section 904(a)(1) of the [FR Doc. 2018–07973 Filed 4–16–18; 8:45 am]
FR 56469, September 18, 2015, or access Federal Food, Drug, and Cosmetic Act BILLING CODE 4164–01–P
the information at: https://www.gpo.gov/ (FD&C Act) (21 U.S.C. 387d(a)(1)).
fdsys/pkg/FR-2015-09-18/pdf/2015- Although this guidance document is
23389.pdf. immediately effective, it remains subject DEPARTMENT OF HEALTH AND
Docket: For access to the docket to to comment in accordance with FDA’s HUMAN SERVICES
read background documents or the GGP regulation.
electronic and written/paper comments Food and Drug Administration
received, go to https:// The Tobacco Control Act, enacted on
June 22, 2009, amends the FD&C Act [Docket No. FDA–2018–N–0001]
www.regulations.gov and insert the
docket number, found in brackets in the and provides FDA with the authority to Advisory Committees; Filing of Closed
heading of this document, into the regulate the manufacture, marketing, Meeting Reports
‘‘Search’’ box and follow the prompts and distribution of tobacco products to
and/or go to the Dockets Management protect the public health (Pub. L. 111– AGENCY: Food and Drug Administration,
Staff, 5630 Fishers Lane, Rm. 1061, 31, 123 Stat. 1776). Among its many HHS.
Rockville, MD 20852. provisions, the Tobacco Control Act ACTION: Notice.
You may submit comments on any added section 904 to the FD&C Act,
guidance at any time (see 21 CFR SUMMARY: The Food and Drug
establishing requirements for tobacco
10.115(g)(5)). Administration (FDA) is announcing
product ingredient submissions.
Submit written requests for single that, as required by the Federal
copies of the revised draft guidance to II. Significance of Guidance Advisory Committee Act, the Agency
the Center for Tobacco Products, Food has filed with the Library of Congress
This revised guidance is being issued the annual reports of those FDA
and Drug Administration, Document
Control Center, 10903 New Hampshire consistent with FDA’s good guidance advisory committees that held closed
Ave., Bldg. 71, Rm. G335, Silver Spring, practices regulation (21 CFR 10.115). meetings during fiscal year 2017.
MD 20993–0002. Send two self- The guidance represents the current ADDRESSES: Copies are available at the
addressed adhesive labels to assist that thinking of FDA on listing of ingredients Dockets Management Staff (HFA–305),
office in processing your requests. See in tobacco products. It does not Food and Drug Administration, 5630
the SUPPLEMENTARY INFORMATION section establish any rights for any person and Fishers Lane, Rm. 1061, Rockville, MD
for electronic access to the guidance is not binding on FDA or the public. 20852, 240–402–7500. You also may
document. You can use an alternative approach if access the docket at https://
it satisfies the requirements of the www.regulations.gov for the annual
FOR FURTHER INFORMATION CONTACT:
applicable statutes and regulations. This reports of those FDA advisory
Katherine Collins or Deirdre Jurand,
guidance is not subject to Executive committees that held closed meetings
Center for Tobacco Products, Food and
Order 12866. during fiscal year 2017. Insert the
Drug Administration, Document Control
docket number found in brackets in the
Center, 10903 New Hampshire Ave., III. Paperwork Reduction Act of 1995 heading of this document at https://
Bldg. 71, Rm. G335, Silver Spring, MD
This revised guidance refers to www.regulations.gov into the ‘‘Search’’
20993–0002, 1–877–287–1373, email:
box, clear filter under Document Type
CTPRegulations@fda.hhs.gov. previously approved collections of
(left side of screen), and check
SUPPLEMENTARY INFORMATION: information found in FDA regulations.
‘‘Supporting and Related Material,’’
The revised draft guidance includes then Sort By Best Match (from the drop-
I. Background
information and recommendations for down menu; top right side of screen),
We are announcing the availability of how to provide ingredient listing ‘‘ID Number (Z–A)’’ or Sort By Best
a revised guidance for industry entitled submissions for tobacco products. These Match (from the drop-down menu)
‘‘Listing of Ingredients in Tobacco collections of information are subject to ‘‘Title (A–Z),’’ also found in the heading
Products.’’ The revised guidance review by the Office of Management and of this document.
document is intended to assist persons Budget (OMB) under the Paperwork
making tobacco product ingredient FOR FURTHER INFORMATION CONTACT:
Reduction Act of 1995 (44 U.S.C. 3501– Russell Fortney, Director, Advisory
submissions to FDA as required by the 3520). The collections of information in
Tobacco Control Act. Committee Oversight and Management
section 904(a)(1) of the FD&C Act have Staff, Food and Drug Administration,
We are issuing this guidance
been approved under OMB control 10903 New Hampshire Ave., Silver
consistent with our good guidance
number 0910–0650. Spring, MD 20993–0002, 301–796–1068.
practices (GGP) regulation (§ 10.115 (21
CFR 10.115)). We are implementing this IV. Electronic Access SUPPLEMENTARY INFORMATION: Under
guidance without prior public comment section 10(d) of the Federal Advisory
because we have determined that prior Persons with access to the internet Committee Act (5 U.S.C. app.) and 21
public participation is not feasible or may obtain an electronic version of the CFR 14.60(d), FDA has filed with the
appropriate given the requirement that revised guidance at either https:// Library of Congress the annual reports
daltland on DSKBBV9HB2PROD with NOTICES
ingredient listing submissions be www.regulations.gov or https:// for the following FDA advisory
submitted by May 8, 2018 www.fda.gov/TobaccoProducts/ committees that held closed meetings
(§ 10.115(g)(2)). We made this Labeling/RulesRegulationsGuidance/ during the period October 1, 2016,
determination because FDA needs to default.htm. Use the FDA website listed through September 30, 2017:
timely communicate that the guidance in the previous sentence to find the Center for Biologics Evaluation and
presents a less burdensome policy that most current version of the guidance. Research:
is consistent with the public health and Allergenic Products Advisory
VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1](https://thefederalregister.org/doc/83_FR_16940/page/2.svg)
Document Created: 2018-04-17 02:53:07
Document Modified: 2018-04-17 02:53:07
| 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. | |
| Dates | The announcement of the guidance is published in the Federal Register on April 17, 2018. | |
| 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] | |
| FR Citation | 83 FR 16866 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR