81 FR 96017 - Submission of Warning Plans for Cigars; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 250 (December 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 250 (December 29, 2016)
| Page Range | 96017-96018 | |
| FR Document | 2016-31586 |
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)] [Notices] [Pages 96017-96018] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31586] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2495] Submission of Warning Plans for Cigars; 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 guidance for industry entitled ``Submission of Warning Plans for Cigars.'' The guidance will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance reiterates the health warning statements and display and distribution requirements that should be provided in cigar warning plans and will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2016-D-2495 for ``Submission of Warning Plans for Cigars; Guidance for Industry.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New [[Page 96018]] Hampshire Ave., 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: Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Submission of Warning Plans for Cigars.'' On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product as subject to FDA regulatory authority under section 901(b) of the FD&C Act (21 U.S.C. 387a(b)). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to cigars, among other products (81 FR 28973). Among the requirements that now apply to cigars are health warning statements prescribed under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), which permits restrictions on the sale and distribution of tobacco products that are ``appropriate for the protection of public health.'' The regulation specifies the health warning statements to be displayed and also requires the submission of warning plans that provide for the random, equal display and random distribution of the statements on cigar packaging and advertising. The guidance discusses the regulatory requirements to submit warning plans, who submits a warning plan, the scope of a warning plan, when to submit a warning plan, what information should be submitted in a warning plan, where to submit a warning plan, and what approval of a warning plan means. 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 submission of warning plans for cigars. 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. 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 21 CFR part 1143 have been approved under OMB control number 0910-0768. IV. Electronic Access Persons with access to the Internet may obtain an electronic version of the guidance at either https://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31586 Filed 12-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96017
processor for a total of 24,000 records. entitled ‘‘Submission of Warning Plans except for information submitted,
We estimate the burden for the for Cigars.’’ The guidance will help marked and identified, as confidential,
preparation of each record to be .10 those involved in the manufacture, if submitted as detailed in
hours for a total burden of 2,400 hours. distribution, and sale of cigars in the ‘‘Instructions.’’
We estimate that all processors United States understand the new cigar Instructions: All submissions received
(15,000 processors) will maintain warning plan requirements under FDA’s must include the Docket No. FDA–
records of the calibration of process- final rule deeming these products to be 2016–D–2495 for ‘‘Submission of
monitoring instruments and the subject to the tobacco product Warning Plans for Cigars; Guidance for
performing of any periodic end-product authorities in the Federal Food, Drug, Industry.’’ Received comments will be
and in-process testing (§ 123.8(d)) at 47 and Cosmetic Act (the FD&C Act). The placed in the docket and, except for
records per processor for a total of guidance reiterates the health warning those submitted as ‘‘Confidential
705,000 records. We estimate the statements and display and distribution Submissions,’’ publicly viewable at
burden for the preparation of each requirements that should be provided in https://www.regulations.gov or at the
record to be .10 hours for a total burden cigar warning plans and will help Division of Dockets Management
of 70,500 hours. persons determine who should submit a between 9 a.m. and 4 p.m., Monday
We estimate that all processors warning plan, when a plan must be through Friday.
(15,000 processors) will maintain submitted, and what information should • Confidential Submissions—To
sanitation control records (§ 123.11(c)) be included when submitting a plan. submit a comment with confidential
at 280 records per processor for a total information that you do not wish to be
DATES: Submit either electronic or
of 4,200,000 records. We estimate the made publicly available, submit your
written comments on Agency guidances
burden for the preparation of each comments only as a written/paper
at any time. submission. You should submit two
record to be .10 hours for a total burden ADDRESSES: You may submit comments
of 420,000 hours. copies total. One copy will include the
as follows: information you claim to be confidential
We estimate that all importers (4,100
importers) will maintain records that Electronic Submissions with a heading or cover note that states
verify that the fish and fishery products ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
they offer for import into the United following way:
States were processed in accordance Agency will review this copy, including
• Federal eRulemaking Portal: the claimed confidential information, in
with the HACCP and sanitation https://www.regulations.gov. Follow the
provisions set forth in part 123 its consideration of comments. The
instructions for submitting comments. second copy, which will have the
(§ 123.12(c)). We estimate that 80 Comments submitted electronically, claimed confidential information
records will be prepared per importer including attachments, to https:// redacted/blacked out, will be available
for a total of 328,000 records. We www.regulations.gov will be posted to for public viewing and posted on
estimate the burden for the preparation the docket unchanged. Because your https://www.regulations.gov. Submit
of each record to be .10 hours for a total comment will be made public, you are both copies to the Division of Dockets
burden of 32,800 hours. solely responsible for ensuring that your Management. If you do not wish your
We estimate that 1 percent of all comment does not include any name and contact information to be
importers (41 importers) will require confidential information that you or a made publicly available, you can
new written verification procedures to third party may not wish to be posted, provide this information on the cover
verify compliance of imports such as medical information, your or sheet and not in the body of your
(§ 123.12(a)(2)). We estimate the burden anyone else’s Social Security number, or comments and you must identify this
for preparing the new procedures to be confidential business information, such information as ‘‘confidential.’’ Any
4 hours per importer for a total burden as a manufacturing process. Please note information marked as ‘‘confidential’’
of 164 hours. that if you include your name, contact will not be disclosed except in
Dated: December 21, 2016. information, or other information that accordance with 21 CFR 10.20 and other
Leslie Kux, identifies you in the body of your applicable disclosure law. For more
Associate Commissioner for Policy. comments, that information will be information about FDA’s posting of
[FR Doc. 2016–31424 Filed 12–28–16; 8:45 am] posted on https://www.regulations.gov. comments to public dockets, see 80 FR
BILLING CODE 4164–01–P
• If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND public, submit the comment as a default.htm.
HUMAN SERVICES written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to https://
[Docket No. FDA–2016–D–2495] Written/Paper Submissions
www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Submission of Warning Plans for
follows: heading of this document, into the
Cigars; Guidance for Industry;
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Availability
written/paper submissions): Division of and/or go to the Division of Dockets
AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
HHS. and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single
• For written/paper comments copies of this guidance to the Center for
SUMMARY: The Food and Drug submitted to the Division of Dockets Tobacco Products, Food and Drug
Administration (FDA) is announcing the Management, FDA will post your Administration, Document Control
availability of a guidance for industry comment, as well as any attachments, Center, Bldg. 71, Rm. G335, 10903 New
VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1](https://thefederalregister.org/doc/81_FR_96267/page/1.svg)
![96018 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
Hampshire Ave., Silver Spring, MD II. Significance of Guidance (OTC) drug monograph system for
20993–0002. Send one self-addressed This guidance is being issued botanical drugs. Although this guidance
adhesive label to assist that office in consistent with FDA’s good guidance does not intend to provide
processing your request or include a fax practices regulation (21 CFR 10.115). recommendations specific to botanical
number to which the guidance The guidance represents the current drugs to be marketed under biologics
document may be sent. See the thinking of FDA on submission of license applications (BLAs), many
SUPPLEMENTARY INFORMATION section for
warning plans for cigars. It does not scientific principles described in this
information on electronic access to the establish any rights for any person and guidance may also apply to these
guidance. is not binding on FDA or the public. products. This guidance replaces the
FOR FURTHER INFORMATION CONTACT: You can use an alternative approach if guidance for industry entitled
Deirdre Jurand, Center for Tobacco it satisfies the requirements of the ‘‘Botanical Drug Products’’ issued in
Products, Food and Drug applicable statutes and regulations. June 2004 and finalizes the August 2015
Administration, 10903 New Hampshire draft guidance entitled ‘‘Botanical Drug
Ave., Document Control Center, Bldg. III. Paperwork Reduction Act of 1995 Development.’’
71, Rm. G335, 10903 New Hampshire This guidance refers to previously DATES: Submit either electronic or
Ave., Silver Spring, MD 20993–0002, 1– approved collections of information written comments on Agency guidances
877–287–1373, AskCTP@fda.hhs.gov. found in FDA regulations. These at any time.
SUPPLEMENTARY INFORMATION: collections of information are subject to ADDRESSES: You may submit comments
review by the Office of Management and as follows:
I. Background Budget (OMB) under the Paperwork
FDA is announcing the availability of Reduction Act of 1995 (44 U.S.C. 3501– Electronic Submissions
a guidance for industry entitled 3520). The collections of information in Submit electronic comments in the
‘‘Submission of Warning Plans for 21 CFR part 1143 have been approved following way:
Cigars.’’ On June 22, 2009, the President under OMB control number 0910–0768. • Federal eRulemaking Portal:
signed the Family Smoking Prevention https://www.regulations.gov. Follow the
IV. Electronic Access
and Tobacco Control Act (Tobacco instructions for submitting comments.
Control Act) (Pub. L. 111–31) into law. Persons with access to the Internet Comments submitted electronically,
The Tobacco Control Act granted FDA may obtain an electronic version of the including attachments, to https://
important new authority to regulate the guidance at either https:// www.regulations.gov will be posted to
manufacture, marketing, and www.regulations.gov or http:// the docket unchanged. Because your
distribution of cigarettes, cigarette www.fda.gov/TobaccoProducts/ comment will be made public, you are
tobacco, roll-your-own tobacco, and Labeling/RulesRegulationsGuidance/ solely responsible for ensuring that your
smokeless tobacco products to protect default.htm. comment does not include any
the public health and to reduce tobacco Dated: December 23, 2016. confidential information that you or a
use by minors. Leslie Kux, third party may not wish to be posted,
The Tobacco Control Act also gave Associate Commissioner for Policy. such as medical information, your or
FDA the authority to issue a regulation anyone else’s Social Security number, or
[FR Doc. 2016–31586 Filed 12–28–16; 8:45 am]
deeming all other products that meet the confidential business information, such
BILLING CODE 4164–01–P
statutory definition of a tobacco product as a manufacturing process. Please note
as subject to FDA regulatory authority that if you include your name, contact
under section 901(b) of the FD&C Act information, or other information that
DEPARTMENT OF HEALTH AND
(21 U.S.C. 387a(b)). On May 10, 2016, identifies you in the body of your
HUMAN SERVICES
FDA issued that rule, extending FDA’s comments, that information will be
tobacco product authority to cigars, Food and Drug Administration posted on https://www.regulations.gov.
among other products (81 FR 28973). • If you want to submit a comment
Among the requirements that now apply [Docket No. FDA–2000–D–0103] with confidential information that you
to cigars are health warning statements do not wish to be made available to the
Botanical Drug Development;
prescribed under section 906(d) of the public, submit the comment as a
Guidance for Industry; Availability
FD&C Act (21 U.S.C. 387f(d)), which written/paper submission and in the
permits restrictions on the sale and AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
distribution of tobacco products that are HHS. Submissions’’ and ‘‘Instructions’’).
‘‘appropriate for the protection of public ACTION: Notice of availability.
health.’’ The regulation specifies the Written/Paper Submissions
health warning statements to be SUMMARY: The Food and Drug Submit written/paper submissions as
displayed and also requires the Administration (FDA or Agency) is follows:
submission of warning plans that announcing the availability of a • Mail/Hand delivery/Courier (for
provide for the random, equal display guidance for industry entitled written/paper submissions): Division of
and random distribution of the ‘‘Botanical Drug Development.’’ This Dockets Management (HFA–305), Food
statements on cigar packaging and guidance describes FDA’s current and Drug Administration, 5630 Fishers
advertising. thinking on appropriate development Lane, Rm. 1061, Rockville, MD 20852.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The guidance discusses the regulatory plans for botanical drugs to be • For written/paper comments
requirements to submit warning plans, submitted in new drug applications submitted to the Division of Dockets
who submits a warning plan, the scope (NDAs) and specific recommendations Management, FDA will post your
of a warning plan, when to submit a for submitting investigational new drug comment, as well as any attachments,
warning plan, what information should applications (INDs) to support future except for information submitted,
be submitted in a warning plan, where NDA submissions for botanical drugs. In marked and identified, as confidential,
to submit a warning plan, and what addition, this guidance provides general if submitted as detailed in
approval of a warning plan means. information on the over-the-counter ‘‘Instructions.’’
VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1](https://thefederalregister.org/doc/81_FR_96267/page/2.svg)
Document Created: 2016-12-29 01:58:47
Document Modified: 2016-12-29 01:58:47
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, [email protected] | |
| FR Citation | 81 FR 96017 |
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