82_FR_55837 82 FR 55613 - Tobacco Product Manufacturing Practice; Request for Comments

82 FR 55613 - Tobacco Product Manufacturing Practice; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 224 (November 22, 2017)

Page Range55613-55614
FR Document2017-25245

The Food and Drug Administration (FDA) is requesting public input on updated recommendations for regulations on good manufacturing practice for electronic nicotine delivery systems (ENDS) that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' ENDS recommendations). FDA is providing an opportunity for interested parties to comment on the tobacco companies' ENDS recommendations.

Federal Register, Volume 82 Issue 224 (Wednesday, November 22, 2017) 
[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55613-55614]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0227]


Tobacco Product Manufacturing Practice; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is requesting public 
input on updated recommendations for regulations on good manufacturing 
practice for electronic nicotine delivery systems (ENDS) that were 
submitted to FDA by a group of 13 tobacco companies (tobacco companies' 
ENDS recommendations). FDA is providing an opportunity for interested 
parties to comment on the tobacco companies' ENDS recommendations.

DATES: Submit electronic or written comments on the tobacco companies' 
ENDS recommendations by December 22, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 22, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 22, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

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-2013-N-0227 for ``Tobacco Product Manufacturing Practice; 
Establishment of a Public Docket.'' Received comments, those filed in a 
timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Center for Tobacco

[[Page 55614]]

Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law, 
amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and giving 
FDA authority to regulate tobacco product manufacturing, distribution, 
and marketing. The new provisions include, among other things, the 
authority to issue regulations related to tobacco product manufacturing 
practice in order to protect the public health and to assure that 
tobacco products are in compliance with the FD&C Act. Specifically, 
section 906(e) of the FD&C Act (21 U.S.C. 387f(e)) provides that in 
applying manufacturing restrictions to tobacco, the Secretary shall 
prescribe regulations (which may differ based on the type of tobacco 
product involved) requiring that the methods used in, and the 
facilities and controls used for, the manufacture, preproduction design 
validation (including a process to assess the performance of a tobacco 
product), packing, and storage of a tobacco product conform to current 
good manufacturing practice, or hazard analysis and critical control 
point methodology.
    On May 10, 2016, FDA published a final rule entitled ``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'' (81 FR 28974) (the 
deeming rule) that became effective on August 8, 2016. Under the 
deeming rule, newly deemed tobacco products, including ENDS, are now 
subject to the provisions of the Tobacco Control Act that apply 
automatically to all products that meet the statutory definition of a 
tobacco product in section 201(rr) of the FD&C Act (21 U.S.C. 321(r)).
    On January 10, 2012, industry stakeholders submitted 
recommendations for good manufacturing practice requirements (and a 
draft preamble) for tobacco products that were immediately subject to 
FDA's jurisdiction when the Tobacco Control Act went into effect. This 
January 10, 2012, letter was posted to this Docket No. FDA-2013-N-0227 
on March 12, 2013, as part of a request for comments on the 
recommendations contained in the letter. On June 7, 2017, a group of 13 
tobacco companies submitted to FDA: (1) Recommendations for good 
manufacturing practice requirements for ENDS and (2) an attachment 
letter with a meeting request (Ref. 1). The tobacco companies' ENDS 
recommendations are intended to supplement an earlier letter dated 
January 10, 2012. According to the June 7, 2017, letter, the tobacco 
companies' ENDS recommendations seek to account for the differences in 
manufacturing ENDS.
    FDA is providing an opportunity for all interested parties to 
comment only on the tobacco companies' ENDS recommendations submitted 
on June 7, 2017.

II. References

    The following reference has been placed on display in the Dockets 
Management Staff (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday and is available 
electronically at https://www.regulations.gov.

1. Proposed Good Manufacturing Practices Regulation to Account for 
FDA's Deeming Regulation and Request for Meeting, submitted to FDA, 
June 7, 2017.

    Dated: November 16, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25245 Filed 11-21-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices 55613 publishing this notice that summarizes (tobacco companies’ ENDS Staff, FDA will post your comment, as the following proposed collection(s) of recommendations). FDA is providing an well as any attachments, except for information for public comment: opportunity for interested parties to information submitted, marked and 1. Type of Information Collection comment on the tobacco companies’ identified, as confidential, if submitted Request: Extension of a currently ENDS recommendations. as detailed in ‘‘Instructions.’’ approved collection; Title of DATES: Submit electronic or written Instructions: All submissions received Information Collection: Fast Track comments on the tobacco companies’ must include the Docket No. FDA– Appeals Notices: NOMNC/DENC; Use: ENDS recommendations by December 2013–N–0227 for ‘‘Tobacco Product Providers shall deliver a Notice of 22, 2017. Manufacturing Practice; Establishment Medicare (Provider) Non-Coverage of a Public Docket.’’ Received ADDRESSES: You may submit comments (NOMNC) to beneficiaries, enrollees, or comments, those filed in a timely both beneficiaries and enrollees no later as follows. Please note that late, untimely filed comments will not be manner (see ADDRESSES), will be placed than two days prior to the end of in the docket and, except for those Medicare-covered services in skilled considered. Electronic comments must be submitted on or before December 22, submitted as ‘‘Confidential nursing facilities, home health agencies, Submissions,’’ publicly viewable at comprehensive outpatient rehabilitation 2017. The https://www.regulations.gov electronic filing system will accept https://www.regulations.gov or at the facilities, and hospices. Beneficiaries, Dockets Management Staff between 9 enrollees or both beneficiaries and comments until midnight Eastern Time at the end of December 22, 2017. a.m. and 4 p.m., Monday through enrollees will use this information to Friday. determine whether they want to appeal Comments received by mail/hand delivery/courier (for written/paper • Confidential Submissions—To the service termination to their Quality submit a comment with confidential Improvement Organization (QIO). If the submissions) will be considered timely considered timely if they are information that you do not wish to be beneficiaries, enrollees or both made publicly available, submit your beneficiaries decide to appeal, the postmarked or the delivery service acceptance receipt is on or before that comments only as a written/paper Medicare provider or health plan will submission. You should submit two send the QIO and appellant a Detailed date. copies total. One copy will include the Explanation of Non-Coverage (DENC) Electronic Submissions information you claim to be confidential detailing the rationale for the with a heading or cover note that states termination decision. Form Number: Submit electronic comments in the following way: ‘‘THIS DOCUMENT CONTAINS CMS–10123 and CMS–10124 (OMB CONFIDENTIAL INFORMATION.’’ The control number: 0938–0953); Frequency: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the Agency will review this copy, including Occasionally; Affected Public: Private the claimed confidential information, in sector—Business or other for-profits and instructions for submitting comments. Comments submitted electronically, its consideration of comments. The Not-for-profit institutions; Number of second copy, which will have the Respondents: 28,177; Total Annual including attachments, to https:// www.regulations.gov will be posted to claimed confidential information Responses: 6,017,832; Total Annual redacted/blacked out, will be available Hours: 1,111,196. (For policy questions the docket unchanged. Because your comment will be made public, you are for public viewing and posted on regarding this collection contact Janet https://www.regulations.gov. Submit Miller at 404–562–1799.) solely responsible for ensuring that your comment does not include any both copies to the Dockets Management Dated: November 17, 2017. confidential information that you or a Staff. If you do not wish your name and William N. Parham, III, third party may not wish to be posted, contact information to be made publicly Director, Paperwork Reduction Staff, Office such as medical information, your or available, you can provide this of Strategic Operations and Regulatory anyone else’s Social Security number, or information on the cover sheet and not Affairs. confidential business information, such in the body of your comments and you [FR Doc. 2017–25313 Filed 11–21–17; 8:45 am] as a manufacturing process. Please note must identify this information as BILLING CODE 4120–01–P that if you include your name, contact ‘‘confidential.’’ Any information marked information, or other information that as ‘‘confidential’’ will not be disclosed identifies you in the body of your except in accordance with 21 CFR 10.20 DEPARTMENT OF HEALTH AND comments, that information will be and other applicable disclosure law. For HUMAN SERVICES posted on https://www.regulations.gov. more information about FDA’s posting • If you want to submit a comment of comments to public dockets, see 80 Food and Drug Administration FR 56469, September 18, 2015, or access with confidential information that you [Docket No. FDA–2013–N–0227] do not wish to be made available to the the information at: https://www.gpo.gov/ public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- Tobacco Product Manufacturing written/paper submission and in the 23389.pdf. Practice; Request for Comments manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Submissions’’ and ‘‘Instructions’’). read background documents or the AGENCY: Food and Drug Administration, electronic and written/paper comments HHS. Written/Paper Submissions received, go to https:// ACTION: Notice; request for comments. www.regulations.gov and insert the asabaliauskas on DSKBBXCHB2PROD with NOTICES Submit written/paper submissions as SUMMARY: The Food and Drug follows: docket number, found in brackets in the Administration (FDA) is requesting • Mail/Hand delivery/Courier (for heading of this document, into the public input on updated written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts recommendations for regulations on Management Staff (HFA–305), Food and and/or go to the Dockets Management good manufacturing practice for Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, electronic nicotine delivery systems Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. (ENDS) that were submitted to FDA by • For written/paper comments FOR FURTHER INFORMATION CONTACT: a group of 13 tobacco companies submitted to the Dockets Management Matthew Brenner, Center for Tobacco VerDate Sep<11>2014 18:57 Nov 21, 2017 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\22NON1.SGM 22NON1

55614 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices Products, Food and Drug this Docket No. FDA–2013–N–0227 on is establishing a docket for public Administration, 10903 New Hampshire March 12, 2013, as part of a request for comment on this document. Ave., Document Control Center, Bldg. comments on the recommendations DATES: The public meeting will be held 71, Rm. G335, Silver Spring, MD 20993– contained in the letter. On June 7, 2017, on January 9, 2018, from 8 a.m. to 5 p.m. 0002, email: CTPRegulations@ a group of 13 tobacco companies ADDRESSES: College Park Marriott Hotel fda.hhs.gov. submitted to FDA: (1) and Conference Center, Chesapeake SUPPLEMENTARY INFORMATION: Recommendations for good Ballroom, 3501 University Blvd. East, manufacturing practice requirements for Hyattsville, MD 20783. The conference I. Background ENDS and (2) an attachment letter with center’s telephone number is 301–985– On June 22, 2009, the Family a meeting request (Ref. 1). The tobacco 7300. Answers to commonly asked Smoking Prevention and Tobacco companies’ ENDS recommendations are questions about FDA Advisory Control Act (Pub. L. 111–31) (Tobacco intended to supplement an earlier letter Committee meetings may be accessed at: Control Act) was signed into law, dated January 10, 2012. According to https://www.fda.gov/ amending the Federal Food, Drug, and the June 7, 2017, letter, the tobacco AdvisoryCommittees/ Cosmetic Act (FD&C Act) and giving companies’ ENDS recommendations AboutAdvisoryCommittees/ FDA authority to regulate tobacco seek to account for the differences in ucm408555.htm. product manufacturing, distribution, manufacturing ENDS. FDA is providing an opportunity for FDA is establishing a docket for and marketing. The new provisions public comment on this meeting. The all interested parties to comment only include, among other things, the docket number is FDA–2017–N–6330. on the tobacco companies’ ENDS authority to issue regulations related to The docket will close on January 8, recommendations submitted on June 7, tobacco product manufacturing practice 2018. Submit either electronic or 2017. in order to protect the public health and written comments on this public to assure that tobacco products are in II. References meeting by January 8, 2018. Please note compliance with the FD&C Act. The following reference has been that late, untimely filed comments will Specifically, section 906(e) of the FD&C placed on display in the Dockets not be considered. Electronic comments Act (21 U.S.C. 387f(e)) provides that in Management Staff (see ADDRESSES) and must be submitted on or before January applying manufacturing restrictions to may be seen by interested persons 8, 2018. The https:// tobacco, the Secretary shall prescribe between 9 a.m. and 4 p.m., Monday www.regulations.gov electronic filing regulations (which may differ based on through Friday and is available system will accept comments until the type of tobacco product involved) electronically at https:// midnight Eastern Time at the end of requiring that the methods used in, and www.regulations.gov. January 8, 2018. Comments received by the facilities and controls used for, the mail/hand delivery/courier (for written/ manufacture, preproduction design 1. Proposed Good Manufacturing Practices Regulation to Account for FDA’s paper submissions) will be considered validation (including a process to assess Deeming Regulation and Request for timely if they are postmarked or the the performance of a tobacco product), Meeting, submitted to FDA, June 7, 2017. delivery service acceptance receipt is on packing, and storage of a tobacco or before that date. Dated: November 16, 2017. product conform to current good Comments received on or before manufacturing practice, or hazard Leslie Kux, December 22, 2017, will be provided to analysis and critical control point Associate Commissioner for Policy. the committee. Comments received after methodology. [FR Doc. 2017–25245 Filed 11–21–17; 8:45 am] that date will be taken into On May 10, 2016, FDA published a BILLING CODE 4164–01–P consideration by the Agency. final rule entitled ‘‘Deeming Tobacco You may submit comments as Products to be Subject to the Federal follows: Food, Drug, and Cosmetic Act, as DEPARTMENT OF HEALTH AND Amended by the Family Smoking HUMAN SERVICES Electronic Submissions Prevention and Tobacco Control Act; Submit electronic comments in the Food and Drug Administration Restrictions on the Sale and Distribution following way: of Tobacco Products and Required [Docket No. FDA–2017–N–6330] • Federal eRulemaking Portal: Warning Statements for Tobacco https://www.regulations.gov. Follow the Products’’ (81 FR 28974) (the deeming Bone, Reproductive and Urologic instructions for submitting comments. rule) that became effective on August 8, Drugs Advisory Committee; Notice of Comments submitted electronically, 2016. Under the deeming rule, newly Meeting; Establishment of a Public including attachments, to https:// deemed tobacco products, including Docket; Request for Comments www.regulations.gov will be posted to ENDS, are now subject to the provisions AGENCY: Food and Drug Administration, the docket unchanged. Because your of the Tobacco Control Act that apply HHS. comment will be made public, you are automatically to all products that meet ACTION: Notice; establishment of a solely responsible for ensuring that your the statutory definition of a tobacco public docket; request for comments. comment does not include any product in section 201(rr) of the FD&C confidential information that you or a Act (21 U.S.C. 321(r)). SUMMARY: The Food and Drug third party may not wish to be posted, asabaliauskas on DSKBBXCHB2PROD with NOTICES On January 10, 2012, industry Administration (FDA or Agency) such as medical information, your or stakeholders submitted announces a forthcoming public anyone else’s Social Security number, or recommendations for good advisory committee meeting of the confidential business information, such manufacturing practice requirements Bone, Reproductive and Urologic Drugs as a manufacturing process. Please note (and a draft preamble) for tobacco Advisory Committee. The general that if you include your name, contact products that were immediately subject function of the committee is to provide information, or other information that to FDA’s jurisdiction when the Tobacco advice and recommendations to the identifies you in the body of your Control Act went into effect. This Agency on FDA’s regulatory issues. The comments, that information will be January 10, 2012, letter was posted to meeting will be open to the public. FDA posted on https://www.regulations.gov. VerDate Sep<11>2014 18:57 Nov 21, 2017 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\22NON1.SGM 22NON1


Document Created: 2017-11-22 00:48:56
Document Modified: 2017-11-22 00:48:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments.
DatesSubmit electronic or written comments on the tobacco companies' ENDS recommendations by December 22, 2017.
ContactMatthew Brenner, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993- 0002, email: [email protected]
FR Citation82 FR 55613 
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