Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability, 57993-57994 [2017-26469]

Download as PDF Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices data systems used for the electronic transfer, storage, display, or conversion of medical device data; medical image storage devices, used to store or retrieve medical images electronically; medical image communications devices, used to transfer medical image data electronically between medical devices; software that automates laboratory workflow; and low-risk general wellness products. FDA intends to provide clarification of its interpretation of section 520(o)(1)(E) of the FD&C Act, which is for software functions intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of disease or other conditions (often referred to as clinical decision support software) in a separate guidance document. Section 520(o)(2) of the FD&C Act describes the regulation of a product with multiple functions, including at least one device function and at least one software function that is not a device. FDA also intends to provide recommendations on the regulation of such products with multifunctionality in a separate guidance document. sradovich on DSK3GMQ082PROD with NOTICES II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.’’ 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. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm or https:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 copy of the document. Please use the document number 17030 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. 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 21 CFR part 820 have been approved under OMB control number 0910–0073; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437; and the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910–0485. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26442 Filed 12–7–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0508] Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. DATES: The announcement of the guidance is published in the Federal Register on December 8, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 57993 • 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–0508 for ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ 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 E:\FR\FM\08DEN1.SGM 08DEN1 sradovich on DSK3GMQ082PROD with NOTICES 57994 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this 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 one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Matthew Brenner, 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 FDA is announcing the availability of a revised guidance for industry entitled ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ This VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. 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 (§ 10.115(g)(2)). We made this determination given the upcoming deadline for product listing information updates for owners and operators of tobacco product manufacturing establishments. In addition, the compliance policy for certain product listing information updates set forth in this revised guidance presents a policy to limit submissions consistent with the public health. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA’s GGP regulation. This revised guidance describes the compliance policy for product listing information updates for deemed tobacco products for persons who owned or operated domestic manufacturing establishments engaged in the manufacture of deemed products prior to August 8, 2016, and continued to own or operate such establishment(s) on or after August 8, 2016. With respect to the deemed tobacco products listing requirement, FDA does not intend to enforce the requirement for persons who own or operate domestic manufacturing establishments engaged in the manufacture of deemed tobacco products to update product listing information during the month of December 2017 provided they registered and listed their products by October 12, 2017.1 As a result, registrants of deemed products would update their product listing by June 30, 2018, and complete their next annual registration by December 31, 2018. If an establishment is engaged in the manufacture of both deemed tobacco products and tobacco products originally regulated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA intends to enforce the registration and product listing information requirements for tobacco products originally regulated under the FD&C Act. Owners or operators of establishments engaged in the manufacture of deemed products as of August 8, 2016, were first required to register and submit deemed product listing information under 1 Registration by such persons by October 12, 2017, satisfies the requirement in section 905(b) of the FD&C Act that such persons register their establishments annually on or before December 31, 2017. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 section 905 of the FD&C Act (21 U.S.C. 387e) by December 31, 2016. However, in a guidance issued in September 2017, FDA announced that it does not intend to enforce these requirements with respect to deemed products provided the registration and product listing submissions were received by FDA on or before October 12, 2017. II. Significance of Guidance This 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 registration and product listing for owners and operators of domestic tobacco product establishments. 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 guidance refers to previously approved collections of information found in FDA regulations. 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 905 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 guidance at either https:// www.regulations.gov or https:// www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ default.htm. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26469 Filed 12–7–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–2483] Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57993-57994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26469]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]


Registration and Product Listing for Owners and Operators of 
Domestic Tobacco Product Establishments; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry entitled ``Registration 
and Product Listing for Owners and Operators of Domestic Tobacco 
Product Establishments.'' This guidance is intended to assist persons 
making tobacco product establishment registration and product listing 
submissions to FDA.

DATES: The announcement of the guidance is published in the Federal 
Register on December 8, 2017.

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-0508 for ``Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments.'' 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

[[Page 57994]]

the claimed confidential information, in its consideration of comments. 
The second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, 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

    FDA is announcing the availability of a revised guidance for 
industry entitled ``Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments.'' This guidance 
is intended to assist persons making tobacco product establishment 
registration and product listing submissions to FDA. 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 (Sec.  
10.115(g)(2)). We made this determination given the upcoming deadline 
for product listing information updates for owners and operators of 
tobacco product manufacturing establishments. In addition, the 
compliance policy for certain product listing information updates set 
forth in this revised guidance presents a policy to limit submissions 
consistent with the public health. Although this guidance document is 
immediately in effect, it remains subject to comment in accordance with 
FDA's GGP regulation.
    This revised guidance describes the compliance policy for product 
listing information updates for deemed tobacco products for persons who 
owned or operated domestic manufacturing establishments engaged in the 
manufacture of deemed products prior to August 8, 2016, and continued 
to own or operate such establishment(s) on or after August 8, 2016. 
With respect to the deemed tobacco products listing requirement, FDA 
does not intend to enforce the requirement for persons who own or 
operate domestic manufacturing establishments engaged in the 
manufacture of deemed tobacco products to update product listing 
information during the month of December 2017 provided they registered 
and listed their products by October 12, 2017.\1\ As a result, 
registrants of deemed products would update their product listing by 
June 30, 2018, and complete their next annual registration by December 
31, 2018. If an establishment is engaged in the manufacture of both 
deemed tobacco products and tobacco products originally regulated under 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA intends to 
enforce the registration and product listing information requirements 
for tobacco products originally regulated under the FD&C Act.
---------------------------------------------------------------------------

    \1\ Registration by such persons by October 12, 2017, satisfies 
the requirement in section 905(b) of the FD&C Act that such persons 
register their establishments annually on or before December 31, 
2017.
---------------------------------------------------------------------------

    Owners or operators of establishments engaged in the manufacture of 
deemed products as of August 8, 2016, were first required to register 
and submit deemed product listing information under section 905 of the 
FD&C Act (21 U.S.C. 387e) by December 31, 2016. However, in a guidance 
issued in September 2017, FDA announced that it does not intend to 
enforce these requirements with respect to deemed products provided the 
registration and product listing submissions were received by FDA on or 
before October 12, 2017.

II. Significance of Guidance

    This 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 registration and product listing for owners 
and operators of domestic tobacco product establishments. 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 guidance refers to previously approved collections of 
information found in FDA regulations. 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 905 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 guidance at either https://www.regulations.gov or 
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26469 Filed 12-7-17; 8:45 am]
BILLING CODE 4164-01-P

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