Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Additional Materials; Reopening of the Comment Period, 60966-60968 [2019-24511]

Download as PDF 60966 Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Proposed Rules specific areas mandated by Congress in the GLB Act. (2) Efficiency, Competitiveness, and Financial Integrity of Markets The Proposal may reduce confusion and allow Covered Persons to design and maintain their policies and procedures to focus on the specified areas mandated by the GLB Act. This may allow Covered Persons to more efficiently utilize their resources in developing policies and procedures in compliance with § 160.30. In addition, consistent with the GLB Act, the Proposal will further align the consumer privacy regulations of the Commission, FTC, and SEC, which may lower costs for certain Covered Persons. (3) Price Discovery The Commission has not identified an impact on price discovery as a result of the Proposal. (4) Sound Risk Management The Commission has not identified an impact on sound risk management as a result of the Proposal. (5) Other Public Interest Considerations Consistent with the GLB Act, the Proposal will further align the consumer privacy regulations of the Commission, FTC, and SEC. 2. Request for Comments on CostBenefit Considerations The Commission invites public comment on its cost-benefit considerations, including the section 15(a) factors described above. Commenters are also invited to submit any data or other information that they may have quantifying or qualifying the costs and benefits of the Proposal with their comment letters. Section 15(b) of the CEA 20 requires the Commission to take into consideration the public interest to be protected by the antitrust laws and endeavor to take the least anticompetitive means of achieving the objectives of the CEA, as well as the policies and purposes of the CEA, in issuing any order or adopting any Commission rule or regulation (including any exemption under section 4(c) or 4c(b)), or in requiring or approving any bylaw, rule, or regulation of a contract market or registered futures association established pursuant to section 17 of the CEA. The Commission believes that the public interest to be protected by the U.S.C. 19(b). VerDate Sep<11>2014 16:51 Nov 08, 2019 List of Subjects in 17 CFR Part 160 Brokers, Consumer protection, Privacy, Reporting and recordkeeping requirements. For the reasons stated in the preamble, the Commodity Futures Trading Commission proposes to amend 17 CFR part 160 as set forth below: PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACHBLILEY ACT 1. The authority citation for part 160 continues to read as follows: ■ Authority: 7 U.S.C. 7b–2 and 12a(5); 15 U.S.C 6801, et seq., and sec. 1093, Pub. L. 111–203, 124 Stat. 1376. ■ D. Antitrust Considerations 20 7 antitrust laws is generally to protect competition. The Commission requests comment on whether the Proposal implicates any other specific public interest to be protected by the antitrust laws. The Commission has considered the Proposal to determine whether it is anticompetitive and has preliminarily identified no anticompetitive effects. The Commission requests comment on whether the Proposal is anticompetitive and, if it is, what the anticompetitive effects are. Because the Commission has preliminarily determined that the Proposal is not anticompetitive and has no anticompetitive effects, the Commission has not identified any less anticompetitive means of achieving the purposes of the CEA. The Commission requests comment on whether there are less anticompetitive means of achieving the relevant purposes of the CEA that would otherwise be served by adopting the Proposal. Jkt 250001 2. Revise § 160.30 to read as follows: § 160.30 Procedures to safeguard customer records and information. Every futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, and swap dealer subject to the jurisdiction of the Commission must adopt policies and procedures that address administrative, technical and physical safeguards for the protection of customer records and information. These policies and procedures must be reasonably designed to: (a) Insure the security and confidentiality of customer records and information; (b) Protect against any anticipated threats or hazards to the security or PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 integrity of customer records and information; and (c) Protect against unauthorized access to or use of customer records or information that could result in substantial harm or inconvenience to any customer. Issued in Washington, DC, on November 6, 2019, by the Commission. Christopher Kirkpatrick, Secretary of the Commission. Note: The following appendix will not appear in the Code of Federal Regulations. Appendix to Privacy of Consumer Financial Information—Commission Voting Summary On this matter, Chairman Tarbert and Commissioners Quintenz, Behnam, Stump, and Berkovitz voted in the affirmative. No Commissioner voted in the negative. [FR Doc. 2019–24581 Filed 11–8–19; 8:45 am] BILLING CODE 6351–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1141 [Docket No. FDA–2019–N–3065] RIN 0910–AI39 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Additional Materials; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; additional materials; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of August 16, 2019. The Agency is providing additional information in the docket and reopening the public comment period for 15 days to afford the public an opportunity to comment on this additional information. DATES: FDA is reopening the comment period on the proposed rule published August 16, 2019 (84 FR 42754). Submit either electronic or written comments by November 27, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 27, 2019. The https:// www.regulations.gov electronic filing system will accept comments until SUMMARY: E:\FR\FM\12NOP1.SGM 12NOP1 Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Proposed Rules 11:59 p.m. Eastern Time at the end of November 27, 2019. ADDRESSES: You may submit comments as follows. Comments received by mail/ hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–N–3065 for ‘‘Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 VerDate Sep<11>2014 16:51 Nov 08, 2019 Jkt 250001 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.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. FOR FURTHER INFORMATION CONTACT: Courtney Smith, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, email: CTPRegulations@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2019 (84 FR 42754), FDA published a proposed rule that will, once finalized, implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 60967 Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. This proposed rule, once finalized, will specify the color graphics that must accompany the new textual warning statements. The proposed new textual warnings include some that are specified in the Tobacco Control Act and some new textual warning statements that FDA is proposing to promote greater public understanding of the negative health consequences of cigarette smoking. FDA’s proposed cigarette warning rule was issued pursuant to a court-ordered schedule (see Am. Acad. Pediatrics v. FDA, No. 16–cv–11985, 2019 U.S. Dist. LEXIS 34946 (D. Mass. Mar. 5, 2019)), which, among other things, requires FDA to submit the proposed rule for publication by August 15, 2019, and to submit the final rule by March 15, 2020. As described in FDA’s proposed rule, in developing the new cigarette health warnings, FDA undertook a sciencebased, iterative research process. The proposed rule was informed by two quantitative consumer research studies, ‘‘Experimental Study on Warning Statements for Cigarette Graphic Health Warnings’’ (Office of Management and Budget (OMB) control number 0910– 0848) and ‘‘Experimental Study of Cigarette Warnings’’ (OMB control number 0910–0866), that assessed the extent to which FDA’s proposed warnings increase understanding of the negative health consequences of cigarette smoking. As part of developing and informing its research, FDA conducted various qualitative focus groups and interviews (‘‘qualitative studies’’) to test and refine image concepts and obtain feedback on which textual statements should be selected for further study. Qualitative studies are based on small samples, have exploratory aims and objectives, should not be viewed as nationally representative, and do not yield data that can be generalized. FDA did not originally include the qualitative study reports in the docket as FDA did not rely on these studies as part of the rulemaking. However, because the qualitative studies were used to inform further research, namely, the quantitative consumer research studies, FDA is making these additional materials available as well. FDA is placing additional materials in the docket and reopening the comment period for the proposed rule for 15 days to allow comment on the additional materials. The Agency believes that a 15-day reopening allows adequate time E:\FR\FM\12NOP1.SGM 12NOP1 60968 Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Proposed Rules for interested persons to submit comments on this additional information without significantly delaying rulemaking. FDA is adding the following materials to the docket for the proposed rule: • ‘‘Qualitative Study on Cigarettes and Smoking: Knowledge, Beliefs, and Misperceptions’’ (July 2015) (OMB control number 0910–0674, ‘‘Qualitative Study on Cigarettes and Smoking: Knowledge, Beliefs, and Misperceptions’’) • ‘‘Memorandum of Findings from Cognitive Testing of Spanish Warning Labels’’ (March 2016) • ‘‘FDA Graphic Health Warning Image Concept Testing’’ (June 2016) (OMB control number 0910–0796, ‘‘Qualitative Study of Perceptions and Knowledge of Visually Depicted Health Conditions’’) • ‘‘Qualitative Study on Consumer Perceptions of Cigarettes Health Warning Images’’ (April 2018) (OMB control number 0910–0796, ‘‘Qualitative Study on Consumer Perceptions of Cigarettes Health Warning Images’’) Dated: November 5, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–24511 Filed 11–8–19; 8:45 am] BILLING CODE 4164–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 70 [EPA–R07–OAR–2019–0532; FRL–10000– 21–Region 7] Air Plan Approval; Iowa, Kansas, Missouri, Nebraska and Approval of Operating Permit Program for Iowa and Nebraska; Definition of Chemical Process Plants Under State Prevention of Significant Deterioration Regulations and Operating Permit Programs Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve revisions to the State Implementation Plans (SIP) for Iowa, Kansas, Missouri and Nebraska and is also proposing to approve revisions to the Operating Permit Programs for Iowa and Nebraska. The SIP revisions incorporate changes to the definition of chemical process plants under the States’ Prevention of Significant Deterioration (PSD) regulations and change the same SUMMARY: VerDate Sep<11>2014 16:51 Nov 08, 2019 Jkt 250001 definition in the approved State operating permit programs. Consistent with an EPA regulation completed in 2007, this action approves several States’ rules that modify the definition of chemical process plant to exclude ethanol manufacturing facilities that produce ethanol by natural fermentation processes. This will clarify that the PSD major source applicability threshold in the SIPs for these ethanol plants is 250 tons per year (tpy) (rather than 100 tpy) and removes the requirement to include fugitive emissions when determining if the source is major for PSD. In addition, this action approves changes to Iowa’s and Nebraska’s Title V operating permit programs that remove the requirement to include fugitive emissions when determining if a source is major for Title V. The EPA concludes that the changes to the State rules described herein are approvable because they are consistent with EPA regulations governing State PSD and Title V programs and will not interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171 of the Clean Air Act (CAA)), or any other applicable requirement of the CAA. DATES: Comments must be received on or before December 12, 2019. ADDRESSES: You may send comments, identified by Docket ID No. EPA–R07– OAR–2019–0532 to https:// www.regulations.gov. Follow the online instructions for submitting comments. Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received will be posted without change to https:// www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the ‘‘Written Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: William Stone, Environmental Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number (913) 551–7714; email address stone.william@epa.gov. SUPPLEMENTARY INFORMATION: Throughout this document ‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA. Table of Contents I. Written Comments II. What is Being Addressed in this Document? III. Background A. PSD Permitting Thresholds for Chemical Processing Plants PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 B. Title V Permitting Thresholds for Chemical Processing Plants C. Ethanol Rule D. Petitions for Review and Reconsideration of the 2007 Ethanol Rule IV. What SIP Revisions are being Proposed by the EPA? V. What Operating Permit Plan Revisions are being Proposed by the EPA? VI. Have the Requirements for Approval of a SIP Revision Been Met? VII. What Action is the EPA Taking? VIII. Incorporation by Reference IX. Statutory and Executive Order Reviews I. Written Comments Submit your comments, identified by Docket ID No. EPA–R07–OAR–2019– 0532, at https://www.regulations.gov. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/ commenting-epa-dockets. II. What is being addressed in this document? The EPA is proposing to approve revisions to SIPs received by EPA from Iowa on November 15, 2007, Kansas on November 23, 2009, Missouri on December 7, 2009, and March 20, 2019, and Nebraska on August 28, 2007, and September 11, 2018. The EPA is also proposing to approve Iowa and Nebraska’s Operating Permit Program revisions. These revisions conform the State rules to changes to EPA regulations reflected in the EPA’s final rule entitled ‘‘Prevention of Significant Deterioration, Nonattainment New Source Review (NA NSR), and Title V: Treatment of Certain Ethanol Production Facilities Under the ‘‘Major Emitting Facility’’ Definition’’ (hereinafter referred to as the ‘‘2007 Ethanol Rule’’) as published in the Federal Register on May 1, 2007 (72 FR E:\FR\FM\12NOP1.SGM 12NOP1

Agencies

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Proposed Rules]
[Pages 60966-60968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24511]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

[Docket No. FDA-2019-N-3065]
RIN 0910-AI39


Tobacco Products; Required Warnings for Cigarette Packages and 
Advertisements; Additional Materials; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; additional materials; reopening of the comment 
period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the proposed rule that appeared in the 
Federal Register of August 16, 2019. The Agency is providing additional 
information in the docket and reopening the public comment period for 
15 days to afford the public an opportunity to comment on this 
additional information.

DATES: FDA is reopening the comment period on the proposed rule 
published August 16, 2019 (84 FR 42754). Submit either electronic or 
written comments by November 27, 2019. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before November 27, 2019. The https://www.regulations.gov electronic filing system will accept comments until

[[Page 60967]]

11:59 p.m. Eastern Time at the end of November 27, 2019.

ADDRESSES: You may submit comments as follows. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-3065 for ``Tobacco Products; Required Warnings for Cigarette 
Packages and Advertisements.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.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.

FOR FURTHER INFORMATION CONTACT: Courtney Smith, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2019 
(84 FR 42754), FDA published a proposed rule that will, once finalized, 
implement a provision of the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act) that requires FDA to issue 
regulations requiring color graphics depicting the negative health 
consequences of smoking to accompany new textual warning statements. 
The Tobacco Control Act amends the Federal Cigarette Labeling and 
Advertising Act of 1965 to require each cigarette package and 
advertisement to bear one of the new required warnings. This proposed 
rule, once finalized, will specify the color graphics that must 
accompany the new textual warning statements. The proposed new textual 
warnings include some that are specified in the Tobacco Control Act and 
some new textual warning statements that FDA is proposing to promote 
greater public understanding of the negative health consequences of 
cigarette smoking. FDA's proposed cigarette warning rule was issued 
pursuant to a court-ordered schedule (see Am. Acad. Pediatrics v. FDA, 
No. 16-cv-11985, 2019 U.S. Dist. LEXIS 34946 (D. Mass. Mar. 5, 2019)), 
which, among other things, requires FDA to submit the proposed rule for 
publication by August 15, 2019, and to submit the final rule by March 
15, 2020.
    As described in FDA's proposed rule, in developing the new 
cigarette health warnings, FDA undertook a science-based, iterative 
research process. The proposed rule was informed by two quantitative 
consumer research studies, ``Experimental Study on Warning Statements 
for Cigarette Graphic Health Warnings'' (Office of Management and 
Budget (OMB) control number 0910-0848) and ``Experimental Study of 
Cigarette Warnings'' (OMB control number 0910-0866), that assessed the 
extent to which FDA's proposed warnings increase understanding of the 
negative health consequences of cigarette smoking. As part of 
developing and informing its research, FDA conducted various 
qualitative focus groups and interviews (``qualitative studies'') to 
test and refine image concepts and obtain feedback on which textual 
statements should be selected for further study. Qualitative studies 
are based on small samples, have exploratory aims and objectives, 
should not be viewed as nationally representative, and do not yield 
data that can be generalized. FDA did not originally include the 
qualitative study reports in the docket as FDA did not rely on these 
studies as part of the rulemaking. However, because the qualitative 
studies were used to inform further research, namely, the quantitative 
consumer research studies, FDA is making these additional materials 
available as well.
    FDA is placing additional materials in the docket and reopening the 
comment period for the proposed rule for 15 days to allow comment on 
the additional materials. The Agency believes that a 15-day reopening 
allows adequate time

[[Page 60968]]

for interested persons to submit comments on this additional 
information without significantly delaying rulemaking.
    FDA is adding the following materials to the docket for the 
proposed rule:

 ``Qualitative Study on Cigarettes and Smoking: Knowledge, 
Beliefs, and Misperceptions'' (July 2015) (OMB control number 0910-
0674, ``Qualitative Study on Cigarettes and Smoking: Knowledge, 
Beliefs, and Misperceptions'')
 ``Memorandum of Findings from Cognitive Testing of Spanish 
Warning Labels'' (March 2016)
 ``FDA Graphic Health Warning Image Concept Testing'' (June 
2016) (OMB control number 0910-0796, ``Qualitative Study of Perceptions 
and Knowledge of Visually Depicted Health Conditions'')
 ``Qualitative Study on Consumer Perceptions of Cigarettes 
Health Warning Images'' (April 2018) (OMB control number 0910-0796, 
``Qualitative Study on Consumer Perceptions of Cigarettes Health 
Warning Images'')

    Dated: November 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24511 Filed 11-8-19; 8:45 am]
 BILLING CODE 4164-01-P
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