81 FR 60004 - Submission of Warning Plans for Cigars; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 169 (August 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 169 (August 31, 2016)
| Page Range | 60004-60005 | |
| FR Document | 2016-20913 |
[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)] [Notices] [Pages 60004-60005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20913] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2495] Submission of Warning Plans for Cigars; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Warning Plans for Cigars.'' The draft guidance, when finalized, will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan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 The draft guidance reiterates the required health warning statements and the requirements for random display and distribution that should be provided in cigar warning plans, and, when finalized, 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: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 29, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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 [[Page 60005]] 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 http://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 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 draft 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 (RYO), 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 (``deeming'') (section 901(b) of the FD&C Act (21 U.S.C. 387a)). 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 draft 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 Draft Guidance FDA is issuing this draft guidance 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 cigar warning plans. 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 draft guidance also refers to previously approved collections of information found in FDA regulations. 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 http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: August 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-20913 Filed 8-30-16; 8:45 am] BILLING CODE 4164-01-P
![60004 Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices
5600 Fishers Lane, Room 06N94B, DEPARTMENT OF HEALTH AND that if you include your name, contact
Rockville, MD 20857; Telephone (toll HUMAN SERVICES information, or other information that
free): (866) 403–3697; Telephone (local): identifies you in the body of your
(301) 427–1111; TTY (toll free): (866) Food and Drug Administration comments, that information will be
438–7231; TTY (local): (301) 427–1130; [Docket No. FDA–2016–D–2495] posted on http://www.regulations.gov.
Email: PSO@AHRQ.hhs.gov. • If you want to submit a comment
Submission of Warning Plans for with confidential information that you
SUPPLEMENTARY INFORMATION: Cigars; Draft Guidance for Industry; do not wish to be made available to the
Availability public, submit the comment as a
Background
written/paper submission and in the
The Patient Safety Act authorizes the AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
HHS. Submissions’’ and ‘‘Instructions’’).
listing of PSOs, which are entities or
component organizations whose ACTION: Notice of availability.
Written/Paper Submissions
mission and primary activity are to SUMMARY: The Food and Drug Submit written/paper submissions as
conduct activities to improve patient Administration (FDA) is announcing the follows:
safety and the quality of health care availability of a draft guidance for • Mail/Hand delivery/Courier (for
delivery. industry entitled ‘‘Submission of written/paper submissions): Division of
HHS issued the Patient Safety Rule to Warning Plans for Cigars.’’ The draft Dockets Management (HFA–305), Food
implement the Patient Safety Act. guidance, when finalized, will help and Drug Administration, 5630 Fishers
AHRQ administers the provisions of the those involved in the manufacture, Lane, Rm. 1061, Rockville, MD 20852.
Patient Safety Act and Patient Safety distribution, and sale of cigars in the • For written/paper comments
United States understand the new cigar submitted to the Division of Dockets
Rule relating to the listing and operation
warning plan requirements under FDA’s Management, FDA will post your
of PSOs. The Patient Safety Rule
final rule deeming these products to be comment, as well as any attachments,
authorizes AHRQ to list as a PSO an subject to the tobacco product except for information submitted,
entity that attests that it meets the authorities in the Federal Food, Drug, marked and identified, as confidential,
statutory and regulatory requirements and Cosmetic Act (the FD&C Act). The if submitted as detailed in
for listing. A PSO can be ‘‘delisted’’ if draft guidance reiterates the required ‘‘Instructions.’’
it is found to no longer meet the health warning statements and the Instructions: All submissions received
requirements of the Patient Safety Act requirements for random display and must include the Docket No. FDA–
and Patient Safety Rule, when a PSO distribution that should be provided in 2016–D–2495 for ‘‘Submission of
chooses to voluntarily relinquish its cigar warning plans, and, when Warning Plans for Cigars.’’ Received
status as a PSO for any reason, or when finalized, will help persons determine comments will be placed in the docket
a PSO’s listing expires. Section 3.108(d) who should submit a warning plan, and, except for those submitted as
of the Patient Safety Rule requires when a plan must be submitted, and ‘‘Confidential Submissions,’’ publicly
AHRQ to provide public notice when it what information should be included viewable at http://www.regulations.gov
removes an organization from the list of when submitting a plan. or at the Division of Dockets
federally approved PSOs. DATES: Although you can comment on Management between 9 a.m. and 4 p.m.,
AHRQ has accepted a notification any guidance at any time (see 21 CFR Monday through Friday.
10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To
from the QAISys, Inc., PSO number
considers your comment on this draft submit a comment with confidential
P0161, to voluntarily relinquish its information that you do not wish to be
status as a PSO. Accordingly, QAISys, guidance before it begins work on the
final version of the guidance, submit made publicly available, submit your
Inc. was delisted effective at 12:00 comments only as a written/paper
either electronic or written comments
Midnight ET (2400) on August 10, 2016. submission. You should submit two
on the draft guidance by September 29,
AHRQ notes that that QAISys, Inc. 2016. copies total. One copy will include the
submitted this request for voluntary information you claim to be confidential
ADDRESSES: You may submit comments
relinquishment following receipt of the with a heading or cover note that states
as follows:
Notice of Preliminary Finding of ‘‘THIS DOCUMENT CONTAINS
Deficiency sent on July 28, 2016. In Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
addition, QAISys, Inc., P0046, was Submit electronic comments in the Agency will review this copy, including
previously listed as a PSO in 2009; following way: the claimed confidential information, in
AHRQ accepted its request for voluntary • Federal eRulemaking Portal: http:// its consideration of comments. The
relinquishment in 2013. www.regulations.gov. Follow the second copy, which will have the
More information on PSOs can be instructions for submitting comments. claimed confidential information
obtained through AHRQ’s PSO Web site Comments submitted electronically, redacted/blacked out, will be available
at http://www.pso.AHRQ.gov. including attachments, to http:// for public viewing and posted on http://
www.regulations.gov will be posted to www.regulations.gov. Submit both
Sharon B. Arnold, the docket unchanged. Because your copies to the Division of Dockets
Deputy Director. comment will be made public, you are Management. If you do not wish your
solely responsible for ensuring that your name and contact information to be
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–20912 Filed 8–30–16; 8:45 am]
comment does not include any made publicly available, you can
BILLING CODE 4160–90–P
confidential information that you or a provide this information on the cover
third party may not wish to be posted, sheet and not in the body of your
such as medical information, your or comments and you must identify this
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any
confidential business information, such information marked as ‘‘confidential’’
as a manufacturing process. Please note will not be disclosed except in
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![Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices 60005
accordance with 21 CFR 10.20 and other tobacco product authority to cigars, DEPARTMENT OF HEALTH AND
applicable disclosure law. For more among other products (81 FR 28973). HUMAN SERVICES
information about FDA’s posting of Among the requirements that now apply
comments to public dockets, see 80 FR to cigars are health warning statements Food and Drug Administration
56469, September 18, 2015, or access prescribed under section 906(d) of the [Docket No. FDA–2016–D–0545]
the information at: http://www.fda.gov/ FD&C Act (21 U.S.C. 387f(d)), which
regulatoryinformation/dockets/ permits restrictions on the sale and Revised Recommendations for
default.htm. distribution of tobacco products that are Reducing the Risk of Zika Virus
Docket: For access to the docket to ‘‘appropriate for the protection of public Transmission by Blood and Blood
read background documents or the health.’’ The regulation specifies the Components; Guidance for Industry;
electronic and written/paper comments health warning statements to be Availability
received, go to http://
displayed and also requires the AGENCY: Food and Drug Administration,
www.regulations.gov and insert the
submission of warning plans that HHS.
docket number, found in brackets in the
provide for the random, equal display ACTION: Notice of availability.
heading of this document, into the
‘‘Search’’ box and follow the prompts and random distribution of the
statements on cigar packaging and SUMMARY: The Food and Drug
and/or go to the Division of Dockets Administration (FDA or Agency) is
Management, 5630 Fishers Lane, Rm. advertising.
announcing the availability of a
1061, Rockville, MD 20852. The draft guidance discusses the document entitled ‘‘Revised
Submit written requests for single regulatory requirements to submit Recommendations for Reducing the Risk
copies of this guidance to the Center for warning plans, who submits a warning of Zika Virus Transmission by Blood
Tobacco Products, Food and Drug plan, the scope of a warning plan, when and Blood Components; Guidance for
Administration, Document Control to submit a warning plan, what Industry.’’ The guidance document is
Center, Bldg. 71, Rm. G335, 10903 New information should be submitted in a notifying blood establishments that
Hampshire Ave., Silver Spring, MD warning plan, where to submit a collect Whole Blood and blood
20993–0002. Send one self-addressed warning plan, and what approval of a components, that FDA has determined
adhesive label to assist that office in warning plan means. Zika virus (ZIKV) to be a relevant
processing your request or include a fax transfusion-transmitted infection (RTTI)
number to which the guidance II. Significance of Draft Guidance and provides FDA’s assessment. The
document may be sent. See the guidance also provides
SUPPLEMENTARY INFORMATION section for
FDA is issuing this draft guidance
recommendations to reduce the risk of
information on electronic access to the consistent with FDA’s good guidance
transmission of ZIKV by Whole Blood
guidance. practices regulation (21 CFR 10.115).
and blood components. The guidance
FOR FURTHER INFORMATION CONTACT:
The draft guidance, when finalized, will applies to the collection of Whole Blood
Deirdre Jurand, Center for Tobacco represent the current thinking of FDA and blood components. The guidance
Products, Food and Drug on cigar warning plans. It does not does not apply to the collection of
Administration, 10903 New Hampshire establish any rights for any person and Source Plasma. The guidance
Ave., Document Control Center, Bldg. is not binding on FDA or the public. supersedes the February 2016 document
71, Rm. G335, 10903 New Hampshire You can use an alternative approach if entitled, ‘‘Recommendations for Donor
Ave., Silver Spring, MD 20993–0002, 1– it satisfies the requirements of the Screening, Deferral, and Product
877–287–1373, AskCTP@fda.hhs.gov. applicable statutes and regulations. Management to Reduce the Risk of
SUPPLEMENTARY INFORMATION: Transfusion-Transmission of Zika Virus:
III. Paperwork Reduction Act of 1995
Guidance for Industry’’ (February 2016
I. Background guidance), and the March 2016
This draft guidance also refers to
FDA is announcing the availability of previously approved collections of document entitled, ‘‘Questions and
a draft guidance for industry entitled information found in FDA regulations. Answers Regarding ‘Recommendations
‘‘Submission of Warning Plans for The collections of information in 21 for Donor Screening, Deferral, and
Cigars.’’ CFR part 1143 have been approved Product Management to Reduce the Risk
On June 22, 2009, the President under OMB control number 0910–0768. of Transfusion-Transmission of Zika
signed the Family Smoking Prevention Virus: Guidance for Industry’ ’’ no later
and Tobacco Control Act (Tobacco IV. Electronic Access than 12 weeks after the date of the
Control Act) (Pub. L. 111–31) into law. issuance of this guidance.
The Tobacco Control Act granted FDA Persons with access to the Internet Implementation of the guidance will be
important new authority to regulate the may obtain an electronic version of the immediate for blood establishments that
manufacture, marketing, and guidance at either http:// collect Whole Blood and blood
distribution of cigarettes, cigarette www.regulations.gov or http:// components in States and territories
tobacco, roll-your-own tobacco (RYO), www.fda.gov/TobaccoProducts/ with local transmission of ZIKV by
and smokeless tobacco products to Labeling/RulesRegulationsGuidance/ mosquitos, and will be phased in over
protect the public health and to reduce default.htm. 4 to 12 weeks in other States and
tobacco use by minors. Dated: August 25, 2016. territories using a tiered, risk-based
The Tobacco Control Act also gave approach. Blood establishments should
mstockstill on DSK3G9T082PROD with NOTICES
Leslie Kux,
FDA the authority to issue a regulation follow the recommendations in the
Associate Commissioner for Policy. February 2016 guidance until the
deeming all other products that meet the
statutory definition of a tobacco product [FR Doc. 2016–20913 Filed 8–30–16; 8:45 am] recommendations in the guidance
as subject to FDA regulatory authority BILLING CODE 4164–01–P document have been fully implemented.
(‘‘deeming’’) (section 901(b) of the FD&C DATES: The Agency is soliciting public
Act (21 U.S.C. 387a)). On May 10, 2016, comment, but is implementing this
FDA issued that rule, extending FDA’s guidance immediately because the
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Document Created: 2018-02-02 12:14:54
Document Modified: 2018-02-02 12:14:54
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 29, 2016. | |
| 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 60004 |
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