82 FR 57993 - Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 235 (December 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 57993-57994 | |
| FR Document | 2017-26469 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 57993-57994] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26469] ----------------------------------------------------------------------- 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.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 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
![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 57993
data systems used for the electronic copy of the document. Please use the • Federal eRulemaking Portal:
transfer, storage, display, or conversion document number 17030 to identify the https://www.regulations.gov. Follow the
of medical device data; medical image guidance you are requesting. instructions for submitting comments.
storage devices, used to store or retrieve Comments submitted electronically,
IV. Paperwork Reduction Act of 1995
medical images electronically; medical including attachments, to https://
image communications devices, used to This draft guidance refers to www.regulations.gov will be posted to
transfer medical image data previously approved collections of the docket unchanged. Because your
electronically between medical devices; information found in FDA regulations. comment will be made public, you are
software that automates laboratory These collections of information are solely responsible for ensuring that your
workflow; and low-risk general wellness subject to review by the Office of comment does not include any
products. FDA intends to provide Management and Budget (OMB) under confidential information that you or a
clarification of its interpretation of the Paperwork Reduction Act of 1995 third party may not wish to be posted,
section 520(o)(1)(E) of the FD&C Act, (44 U.S.C. 3501–3520). The collections such as medical information, your or
which is for software functions intended of information in 21 CFR part 820 have anyone else’s Social Security number, or
to provide decision support for the been approved under OMB control confidential business information, such
diagnosis, treatment, prevention, cure, number 0910–0073; the collections of as a manufacturing process. Please note
or mitigation of disease or other information in 21 CFR part 807, subpart that if you include your name, contact
conditions (often referred to as clinical E, have been approved under OMB information, or other information that
decision support software) in a separate control number 0910–0120; the identifies you in the body of your
guidance document. Section 520(o)(2) of collections of information in 21 CFR comments, that information will be
the FD&C Act describes the regulation of part 803 have been approved under posted on https://www.regulations.gov.
a product with multiple functions, OMB control number 0910–0437; and • If you want to submit a comment
including at least one device function the collections of information in 21 CFR with confidential information that you
and at least one software function that parts 801 and 809 have been approved do not wish to be made available to the
is not a device. FDA also intends to under OMB control number 0910–0485. public, submit the comment as a
provide recommendations on the Dated: December 4, 2017. written/paper submission and in the
regulation of such products with Leslie Kux, manner detailed (see ‘‘Written/Paper
multifunctionality in a separate Associate Commissioner for Policy. Submissions’’ and ‘‘Instructions’’).
guidance document. [FR Doc. 2017–26442 Filed 12–7–17; 8:45 am] Written/Paper Submissions
II. Significance of Guidance BILLING CODE 4164–01–P
Submit written/paper submissions as
This draft guidance is being issued follows:
consistent with FDA’s good guidance • Mail/Hand delivery/Courier (for
DEPARTMENT OF HEALTH AND written/paper submissions): Dockets
practices regulation (21 CFR 10.115).
HUMAN SERVICES Management Staff (HFA–305), Food and
The draft guidance, when finalized, will
represent the current thinking of FDA Food and Drug Administration Drug Administration, 5630 Fishers
on ‘‘Changes to Existing Medical Lane, Rm. 1061, Rockville, MD 20852.
Software Policies Resulting from [Docket No. FDA–2009–D–0508] • For written/paper comments
Section 3060 of the 21st Century Cures submitted to the Dockets Management
Act.’’ It does not establish any rights for Registration and Product Listing for Staff, FDA will post your comment, as
any person and is not binding on FDA Owners and Operators of Domestic well as any attachments, except for
or the public. You can use an alternative Tobacco Product Establishments; information submitted, marked and
approach if it satisfies the requirements Guidance for Industry; Availability identified, as confidential, if submitted
of the applicable statutes and AGENCY: Food and Drug Administration, as detailed in ‘‘Instructions.’’
regulations. This guidance is not subject HHS. Instructions: All submissions received
to Executive Order 12866. ACTION: Notice of availability. must include the Docket No. FDA–
2009–D–0508 for ‘‘Registration and
III. Electronic Access SUMMARY: The Food and Drug Product Listing for Owners and
Persons interested in obtaining a copy Administration (FDA) is announcing the Operators of Domestic Tobacco Product
of the draft guidance may do so by availability of a revised guidance for Establishments.’’ Received comments
downloading an electronic copy from industry entitled ‘‘Registration and will be placed in the docket and, except
the Internet. A search capability for all Product Listing for Owners and for those submitted as ‘‘Confidential
Center for Devices and Radiological Operators of Domestic Tobacco Product Submissions,’’ publicly viewable at
Health guidance documents is available Establishments.’’ This guidance is https://www.regulations.gov or at the
at https://www.fda.gov/MedicalDevices/ intended to assist persons making Dockets Management Staff between 9
DeviceRegulationandGuidance/ tobacco product establishment a.m. and 4 p.m., Monday through
GuidanceDocuments/default.htm. registration and product listing Friday.
Guidance documents are also available submissions to FDA. • Confidential Submissions—To
at https://www.fda.gov/ DATES: The announcement of the submit a comment with confidential
BiologicsBloodVaccines/ guidance is published in the Federal information that you do not wish to be
GuidanceComplianceRegulatory Register on December 8, 2017. made publicly available, submit your
Information/default.htm or https:// comments only as a written/paper
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES: You may submit either
www.regulations.gov. Persons unable to electronic or written comments on submission. You should submit two
download an electronic copy of Agency guidances at any time as copies total. One copy will include the
‘‘Changes to Existing Medical Software follows: information you claim to be confidential
Policies Resulting from Section 3060 of with a heading or cover note that states
the 21st Century Cures Act’’ may send Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
an email request to CDRH-Guidance@ Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
fda.hhs.gov to receive an electronic following way: Agency will review this copy, including
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![57994 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
the claimed confidential information, in guidance is intended to assist persons section 905 of the FD&C Act (21 U.S.C.
its consideration of comments. The making tobacco product establishment 387e) by December 31, 2016. However,
second copy, which will have the registration and product listing in a guidance issued in September 2017,
claimed confidential information submissions to FDA. We are issuing this FDA announced that it does not intend
redacted/blacked out, will be available guidance consistent with our good to enforce these requirements with
for public viewing and posted on guidance practices (GGP) regulation respect to deemed products provided
https://www.regulations.gov. Submit (§ 10.115 (21 CFR 10.115)). We are the registration and product listing
both copies to the Dockets Management implementing this guidance without submissions were received by FDA on
Staff. If you do not wish your name and prior public comment because we have or before October 12, 2017.
contact information to be made publicly determined that prior public
participation is not feasible or II. Significance of Guidance
available, you can provide this
information on the cover sheet and not appropriate (§ 10.115(g)(2)). We made This guidance is being issued
in the body of your comments and you this determination given the upcoming consistent with FDA’s good guidance
must identify this information as deadline for product listing information practices regulation (21 CFR 10.115).
‘‘confidential.’’ Any information marked updates for owners and operators of The guidance represents the current
as ‘‘confidential’’ will not be disclosed tobacco product manufacturing thinking of FDA on registration and
except in accordance with 21 CFR 10.20 establishments. In addition, the product listing for owners and operators
and other applicable disclosure law. For compliance policy for certain product of domestic tobacco product
more information about FDA’s posting listing information updates set forth in establishments. It does not establish any
of comments to public dockets, see 80 this revised guidance presents a policy rights for any person and is not binding
FR 56469, September 18, 2015, or access to limit submissions consistent with the on FDA or the public. You can use an
the information at: https://www.gpo.gov/ public health. Although this guidance alternative approach if it satisfies the
fdsys/pkg/FR-2015-09-18/pdf/2015- document is immediately in effect, it requirements of the applicable statutes
23389.pdf. remains subject to comment in and regulations. This guidance is not
Docket: For access to the docket to accordance with FDA’s GGP regulation. subject to Executive Order 12866.
read background documents or the This revised guidance describes the
compliance policy for product listing III. Paperwork Reduction Act of 1995
electronic and written/paper comments
received, go to https:// information updates for deemed tobacco This guidance refers to previously
www.regulations.gov and insert the products for persons who owned or approved collections of information
docket number, found in brackets in the operated domestic manufacturing found in FDA regulations. These
heading of this document, into the establishments engaged in the collections of information are subject to
‘‘Search’’ box and follow the prompts manufacture of deemed products prior review by the Office of Management and
and/or go to the Dockets Management to August 8, 2016, and continued to Budget (OMB) under the Paperwork
Staff, 5630 Fishers Lane, Rm. 1061, own or operate such establishment(s) on Reduction Act of 1995 (44 U.S.C. 3501–
Rockville, MD 20852. or after August 8, 2016. With respect to 3520). The collections of information in
You may submit comments on any the deemed tobacco products listing section 905 of the FD&C Act have been
guidance at any time (see 21 CFR requirement, FDA does not intend to approved under OMB control number
10.115(g)(5)). enforce the requirement for persons who 0910–0650.
Submit written requests for single own or operate domestic manufacturing
establishments engaged in the IV. Electronic Access
copies of this guidance to the Center for
Tobacco Products, Food and Drug manufacture of deemed tobacco Persons with access to the internet
Administration, Document Control products to update product listing may obtain an electronic version of the
Center, 10903 New Hampshire Ave., information during the month of guidance at either https://
Bldg. 71, Rm. G335, Silver Spring, MD December 2017 provided they registered www.regulations.gov or https://
20993–0002. Send one self-addressed and listed their products by October 12, www.fda.gov/TobaccoProducts/
2017.1 As a result, registrants of deemed Labeling/RulesRegulationsGuidance/
adhesive label to assist that office in
products would update their product default.htm.
processing your request or include a Fax
listing by June 30, 2018, and complete
number to which the guidance Dated: December 4, 2017.
their next annual registration by
document may be sent. See the Leslie Kux,
December 31, 2018. If an establishment
SUPPLEMENTARY INFORMATION section for Associate Commissioner for Policy.
is engaged in the manufacture of both
information on electronic access to the
deemed tobacco products and tobacco [FR Doc. 2017–26469 Filed 12–7–17; 8:45 am]
guidance.
products originally regulated under the BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: Federal Food, Drug, and Cosmetic Act
Matthew Brenner, Center for Tobacco (the FD&C Act), FDA intends to enforce
Products, Food and Drug the registration and product listing DEPARTMENT OF HEALTH AND
Administration, Document Control information requirements for tobacco HUMAN SERVICES
Center, 10903 New Hampshire Ave., products originally regulated under the
Bldg. 71, Rm. G335, Silver Spring, MD FD&C Act. Food and Drug Administration
20993–0002, 1–877–287–1373, email: Owners or operators of establishments
CTPRegulations@fda.hhs.gov. [Docket No. FDA–2016–D–2483]
engaged in the manufacture of deemed
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION: products as of August 8, 2016, were first Software as a Medical Device: Clinical
required to register and submit deemed Evaluation; International Medical
I. Background product listing information under Device Regulators Forum; Guidance
FDA is announcing the availability of for Industry and Food and Drug
a revised guidance for industry entitled 1 Registration by such persons by October 12,
Administration Staff; Availability
‘‘Registration and Product Listing for 2017, satisfies the requirement in section 905(b) of
the FD&C Act that such persons register their
Owners and Operators of Domestic establishments annually on or before December 31, AGENCY: Food and Drug Administration,
Tobacco Product Establishments.’’ This 2017. HHS.
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Document Created: 2017-12-08 01:43:39
Document Modified: 2017-12-08 01:43:39
| 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 December 8, 2017. | |
| 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] | |
| FR Citation | 82 FR 57993 |
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