83 FR 48625 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Cigarette Warnings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 187 (September 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48625-48628 | |
| FR Document | 2018-20913 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Notices] [Pages 48625-48628] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20913] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3552] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Cigarette Warnings AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study of cigarette warnings that is being conducted in support of the graphic label statement provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act). DATES: Submit either electronic or written comments on the collection of information by November 26, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 26, 2018. 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-2018-N-3552 for ``Experimental Study of Cigarette Warnings.'' 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 [[Page 48626]] 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.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. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Experimental Study of Cigarette Warnings OMB Control Number 0910--NEW I. Background The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food, Drug, and Cosmetic Act to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Section 201 of the Tobacco Control Act amends section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333) to require FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection 4(a)(1) of the FCLAA. Section 202(b) of the Tobacco Control Act further amends section 4 of the FCLAA by adding that the Secretary of Health and Human Services (Secretary), through notice and comment rulemaking, may adjust the text of any of the label requirements if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products. In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued a final rule entitled ``Required Warnings for Cigarette Packages and Advertisements,'' which specified nine images to accompany new textual warning statements for cigarettes. Although the rule was scheduled to become effective 15 months after it was issued, a panel of the U.S. Court of Appeals of the District of Columbia held, on August 24, 2012, that the rule in its current form violated the First Amendment. In a letter to Congress on March 15, 2013, the Attorney General reported FDA's intention to undertake research to support a new rulemaking consistent with the Tobacco Control Act. Various phases of research have been underway since 2013. The next phase of the research includes the study proposed here, which is an effort by FDA to collect data concerning responses to cigarette warnings placed on cigarette packages and advertisements for cigarettes. The health risks associated with the use of cigarettes are significant and far-reaching. Cigarette smoking is the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year. Smoking causes more deaths each year than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents combined (Ref. 1). In addition to lung cancer, heart disease, and chronic obstructive pulmonary disease, smoking also causes numerous other serious health conditions including several types of cancer, premature birth, low birth weight, respiratory illnesses, clogged arteries, reduced blood flow, diabetes, and vision conditions such as age-related macular degeneration and cataracts (Ref. 2). Approximately 37.8 million U.S. adults smoke cigarettes (Ref. 3) and 8.6 million Americans have at least one serious illness caused by smoking cigarettes (Ref. 4). Results from the 2016 National Survey on Drug Use and Health demonstrate that, each day in the United States, more than 2,300 youth under age 18 smoke their first cigarette, and nearly 400 youth become daily cigarette smokers (Ref. 5). If the current trajectory of smoking rates continues, 5.6 million children alive today will die prematurely as a result of smoking (Ref. 2). Providing the public with accurate information regarding the health consequences of cigarette use is critical in achieving FDA's mission to protect the public health. This Experimental Study of Cigarette Warnings is a voluntary online experiment. The purpose of the study is to assess whether new cigarette warnings increase public understanding of the negative health consequences of cigarette smoking. The study will collect [[Page 48627]] data from various groups of consumers, including adolescent current cigarette smokers aged 13 to 17 years, adolescent non-smokers who are susceptible to initiation of cigarette smoking aged 13 to 17 years, young adult current cigarette smokers and non-smokers aged 18 to 24 years, and older adult current cigarette smokers and non-smokers aged 25 years and older. The results will inform the Agency's efforts to implement the mandatory graphic warning label statements as required by section 4(d) of FCLAA. Study Overview: In this study, adolescent current cigarette smokers, adolescent non-smokers who are susceptible to initiation of cigarette smoking, young adult current cigarette smokers and non- smokers, and older adult current cigarette smokers and non-smokers will be recruited from an existing internet panel of more than 1.2 million people and screened for inclusion into the study. Participants who meet the inclusion criteria will be randomized into 1 of 17 conditions. In each condition, respondents will view one cigarette warning. In the 16 treatment conditions, participants will view 1 graphic health warning, containing a warning statement accompanied by a concordant color graphic depicting the negative health consequences of smoking described in the statement. In the control condition, participants will be randomized to view one of the four current Surgeon General's warnings, representing the current state of cigarette warnings in the United States. In all conditions, participants will view their assigned warnings both on a mock cigarette package and a mock cigarette advertisement, presented in a randomized order. There will be three sessions. During Session 1, participants will complete a baseline assessment about their beliefs about the negative health consequences of cigarette smoking. Next, they will be exposed to the stimuli (i.e., the warning based on condition assignment) and complete a set of items assessing (a) if the information presented in the warning was new; (b) self-reported learning from the warning; (c) if the warning was easy to understand; (d) if the warning was perceived to be a fact or an opinion; (e) if the warning was informative; (f) if the warning grabbed their attention; and (g) if the warning made them think about the health risks of cigarette smoking. During Session 2 (1 to 2 days after Session 1), participants will be exposed to the same stimuli again (i.e., the warning based on condition assignment from Session 1), and complete a set of items assessing beliefs about the negative health consequences caused by cigarette smoking. During Session 3 (approximately 14 days after Session 2), participants will complete a delayed post-test on beliefs about the negative health consequences caused by cigarette smoking and items assessing recall of the warning. Prior to the main data collection, 2 sequential pretests, each with 50 participants, will take place to ensure correct programming of Session 1 and to identify any issues with the study design and implementation. Study outcomes include comparisons to assess the extent to which exposure to the graphic health warnings, relative to the text-only Surgeon General's warnings, provide new information, increase self- reported learning, change beliefs about the negative health consequences of cigarette smoking, increase thinking about the risks of smoking, as well as the extent to which the warnings are informative, easy to understand, factual, attention grabbing, and recalled. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response \2\ ---------------------------------------------------------------------------------------------------------------- Adult--Screener for pretest... 456 1 456 0.03 hours (2 14 minutes). Adult--Pretest................ 68 1 68 0.20 hours (12 14 minutes). Adult--Screener for main data 51,054 1 51,054 0.03 hours (2 1,532 collection. minutes). Adult--Main data collection (3 7,460 1 7,460 0.42 hours (25 3,133 sessions). minutes). rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total Adult Hours............. .............. .............. .............. ................ 4,693 Adolescent--Screener for 410 1 410 0.03 hours (2 12 pretest. minutes). Adolescent--Pretest........... 32 1 32 0.20 hours (12 6 minutes). Adolescent--Screener for main 29,487 1 29,487 0.03 hours (2 885 data collection. minutes). Adolescent--Main data 2,300 1 2,300 0.42 hours (25 966 collection (3 sessions). minutes). rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total Adolescent Hours........ .............. .............. .............. ................ 1,869 rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total Burden Hours........ .............. .............. .............. ................ 6,562 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ The hours per response are rounded to two decimal places. FDA's burden estimate is based on prior experience with research that is similar to this proposed study (OMB control number 0910-0848). Screening potential participants for the 2 pretests will occur with 866 respondents (456 adults and 410 adolescents) identified and recruited through the internet panel. Participants will complete the screening questionnaire through an email invitation. This brief screening will take an average of 2 minutes (0.03 hours) per respondent. If, based on this screening, participants qualify for the study, they will be automatically directed to begin the pretest. As previously mentioned, each of the 2 pretests conducted will consist of 50 respondents (34 adults and 16 adolescents in each) (100 total) during a single session and, we estimate an average of 12 minutes (0.20 hours) per respondent. Screening potential participants for the main data collection will occur with 80,541 respondents (51,054 adults and 29,487 adolescents) identified and [[Page 48628]] recruited through the same internet panel as used for the pretests. Participants will complete the screener questionnaire through an email invitation. This brief screening will take an average of 2 minutes (0.03 hours) per respondent. If, based on this screening, participants qualify for the study, they will be directed to begin Session 1. Recent national estimates of the numbers of adolescent current cigarette smokers, adolescents who are susceptible to initiation of cigarette smoking, young adult current cigarette smokers, and older adult current cigarette smokers informed the estimates of 14.6 percent qualification rate for adults and 7.8 percent qualification rate for adolescents. Applying these estimates and other assumptions from previous experience conducting similar studies to the number of adolescents and adults to be screened results in the desired sample size for the main data collection of 9,760 participants, of which 7,460 will be adults and 2,300 will be adolescents. The three sessions of the main data collection will take an average of 12 minutes (0.20 hours) for Session 1, 8 minutes (0.13 hours) for Session 2, and 5 minutes (0.08 hours) for Session 3, for a total of an estimated 25 minutes (0.42 hours) per respondent. The total estimated burden for the data collection is 6,561 hours (4,692 hours for adults + 1,869 hours for adolescents). II. References The following references are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. 1. Murphy, S.L., J. Xu, K.D. Kochanek. ``Deaths: Final Data for 2010''. National Vital Statistics Reports, 61(4):37-41, 2013. 2. U.S. Department of Health and Human Services. ``The Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General.'' Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. 3. Jamal, A., E. Phillips, A.S. Gentzke, et al. ``Current Cigarette Smoking Among Adults--United States, 2016''. MMWR Morbidity and Mortality Weekly Report, 67:53-59, 2018. 4. Centers for Disease Control and Prevention. ``Cigarette Smoking- Attributable Morbidity--United States, 2000''. MMWR Morbidity and Mortality Weekly Report, 52(35):842-844, 2003 5. Substance Abuse and Mental Health Services Administration (SAMHSA). See Table 4.10A in '' 2016 National Survey on Drug Use and Health: Detailed Tables.'' Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, Center for Behavioral Health Statistics and Quality; 2017. Dated: September 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20913 Filed 9-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48625
number: 021030004, SWIFT Number: Step Four—Please submit your be submitted on or before November 26,
FRNYUS33. application and a copy of the completed 2018. The https://www.regulations.gov
To send a check by a courier such as Animal Drug User Fee Cover Sheet to electronic filing system will accept
Federal Express, the courier must the following address: Food and Drug comments until 11:59 p.m. Eastern Time
deliver the check and printed copy of Administration, Center for Veterinary at the end of November 26, 2018.
the cover sheet to: U.S. Bank, Attn: Medicine, Document Control Unit Comments received by mail/hand
Government Lockbox 979033, 1005 (HFV–199), 7500 Standish Pl., delivery/courier (for written/paper
Convention Plaza, St. Louis, MO 63101. Rockville, MD 20855. submissions) will be considered timely
(Note: This address is for courier if they are postmarked or the delivery
delivery only. If you have any questions C. Product, Establishment, and Sponsor
service acceptance receipt is on or
concerning courier delivery, contact Fees
before that date.
U.S. Bank at 314–418–4013. This By December 31, 2018, FDA will issue
telephone number is only for questions invoices and payment instructions for Electronic Submissions
about courier delivery.) product, establishment, and sponsor Submit electronic comments in the
It is important that the fee arrives at fees for FY 2019 using this fee schedule. following way:
the bank at least a day or two before the Payment will be due by January 31, • Federal eRulemaking Portal:
application arrives at FDA’s CVM. FDA 2019. FDA will issue invoices in https://www.regulations.gov. Follow the
records the official application receipt November 2019 for any products, instructions for submitting comments.
date as the later of the following: The establishments, and sponsors subject to Comments submitted electronically,
date the application was received by fees for FY 2019 that qualify for fees including attachments, to https://
FDA’s CVM, or the date U.S. Bank after the December 2018 billing. www.regulations.gov will be posted to
notifies FDA that your payment in the the docket unchanged. Because your
Dated: September 20, 2018.
full amount has been received, or when comment will be made public, you are
the U.S. Treasury notifies FDA of Leslie Kux,
solely responsible for ensuring that your
receipt of an electronic or wire transfer Associate Commissioner for Policy. comment does not include any
payment. U.S. Bank and the U.S. [FR Doc. 2018–20911 Filed 9–25–18; 8:45 am] confidential information that you or a
Treasury are required to notify FDA BILLING CODE 4164–01–P third party may not wish to be posted,
within 1 working day, using the PIN such as medical information, your or
described previously. anyone else’s Social Security number, or
The tax identification number of FDA DEPARTMENT OF HEALTH AND confidential business information, such
is 53–0196965. (Note: In no case should HUMAN SERVICES as a manufacturing process. Please note
the payment for the fee be submitted to that if you include your name, contact
FDA with the application.) Food and Drug Administration
information, or other information that
B. Application Cover Sheet Procedures [Docket No. FDA–2018–N–3552] identifies you in the body of your
comments, that information will be
Step One—Create a user account and Agency Information Collection posted on https://www.regulations.gov.
password. Log on to the ADUFA website Activities; Proposed Collection; • If you want to submit a comment
at https://www.fda.gov/ForIndustry/ Comment Request; Experimental with confidential information that you
UserFees/AnimalDrugUserFeeAct Study of Cigarette Warnings do not wish to be made available to the
ADUFA/default.htm and, under Tools public, submit the comment as a
and Resources, click ‘‘The Animal Drug AGENCY: Food and Drug Administration,
HHS. written/paper submission and in the
User Fee Cover Sheet’’ and then select manner detailed (see ‘‘Written/Paper
‘‘Create ADUFA User Fee Cover Sheet.’’ ACTION: Notice.
Submissions’’ and ‘‘Instructions’’).
For security reasons, each firm
SUMMARY: The Food and Drug Written/Paper Submissions
submitting an application will be
Administration (FDA or Agency) is
assigned an organization identification Submit written/paper submissions as
announcing an opportunity for public
number, and each user will also be follows:
comment on the proposed collection of
required to set up a user account and • Mail/Hand Delivery/Courier (for
certain information by the Agency.
password the first time you use this site. written/paper submissions): Dockets
Under the Paperwork Reduction Act of
Online instructions will walk you Management Staff (HFA–305), Food and
1995 (PRA), Federal Agencies are
through this process. Drug Administration, 5630 Fishers
Step Two—Create an Animal Drug required to publish notice in the
Lane, Rm. 1061, Rockville, MD 20852.
User Fee Cover Sheet, transmit it to Federal Register concerning each • For written/paper comments
FDA, and print a copy. After logging proposed collection of information and submitted to the Dockets Management
into your account with your user name to allow 60 days for public comment in Staff, FDA will post your comment, as
and password, complete the steps response to the notice. This notice well as any attachments, except for
required to create an Animal Drug User solicits comments on an experimental information submitted, marked and
Fee Cover Sheet. One cover sheet is study of cigarette warnings that is being identified, as confidential, if submitted
needed for each animal drug application conducted in support of the graphic as detailed in ‘‘Instructions.’’
or supplement. Once you are satisfied label statement provision of the Family Instructions: All submissions received
that the data on the cover sheet are Smoking Prevention and Tobacco must include the Docket No. FDA–
accurate and you have finalized the Control Act (the Tobacco Control Act). 2018–N–3552 for ‘‘Experimental Study
daltland on DSKBBV9HB2PROD with NOTICES
cover sheet, you will be able to transmit DATES: Submit either electronic or of Cigarette Warnings.’’ Received
it electronically to FDA and you will be written comments on the collection of comments, those filed in a timely
able to print a copy of your cover sheet information by November 26, 2018. manner (see ADDRESSES), will be placed
showing your unique PIN. ADDRESSES: You may submit comments in the docket and, except for those
Step Three—Send the payment for as follows. Please note that late, submitted as ‘‘Confidential
your application as described in section untimely filed comments will not be Submissions,’’ publicly viewable at
IX.A of this document. considered. Electronic comments must https://www.regulations.gov or at the
VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1](https://thefederalregister.org/doc/83_FR_48812/page/1.svg)
![48628 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
recruited through the same internet 5. Substance Abuse and Mental Health Comments received by mail/hand
panel as used for the pretests. Services Administration (SAMHSA). See delivery/courier (for written/paper
Participants will complete the screener Table 4.10A in ’’ 2016 National Survey submissions) will be considered timely
questionnaire through an email on Drug Use and Health: Detailed
if they are postmarked or the delivery
Tables.’’ Rockville, MD: U.S. Department
invitation. This brief screening will take of Health and Human Services, service acceptance receipt is on or
an average of 2 minutes (0.03 hours) per SAMHSA, Center for Behavioral Health before December 7, 2018.
respondent. If, based on this screening, Statistics and Quality; 2017.
participants qualify for the study, they Electronic Submissions
Dated: September 21, 2018. Submit electronic comments in the
will be directed to begin Session 1.
Recent national estimates of the Leslie Kux, following way:
numbers of adolescent current cigarette Associate Commissioner for Policy. • Federal eRulemaking Portal:
smokers, adolescents who are [FR Doc. 2018–20913 Filed 9–25–18; 8:45 am] https://www.regulations.gov. Follow the
susceptible to initiation of cigarette BILLING CODE 4164–01–P instructions for submitting comments.
smoking, young adult current cigarette Comments submitted electronically,
smokers, and older adult current including attachments, to https://
cigarette smokers informed the DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to
estimates of 14.6 percent qualification HUMAN SERVICES the docket unchanged. Because your
rate for adults and 7.8 percent comment will be made public, you are
qualification rate for adolescents. Food and Drug Administration solely responsible for ensuring that your
Applying these estimates and other [Docket No. FDA–2018–N–3504] comment does not include any
assumptions from previous experience confidential information that you or a
conducting similar studies to the Tobacco Product Application Review; third party may not wish to be posted,
number of adolescents and adults to be Public Meeting; Request for Comments such as medical information, your or
screened results in the desired sample anyone else’s Social Security number, or
AGENCY: Food and Drug Administration,
size for the main data collection of 9,760 confidential business information, such
HHS.
participants, of which 7,460 will be as a manufacturing process. Please note
ACTION: Notice of public meeting; that if you include your name, contact
adults and 2,300 will be adolescents.
request for comments. information, or other information that
The three sessions of the main data
collection will take an average of 12 SUMMARY: The Food and Drug identifies you in the body of your
minutes (0.20 hours) for Session 1, 8 Administration (FDA) is announcing a comments, that information will be
minutes (0.13 hours) for Session 2, and public meeting entitled ‘‘Tobacco posted on https://www.regulations.gov.
5 minutes (0.08 hours) for Session 3, for Product Application Review.’’ This • If you want to submit a comment
a total of an estimated 25 minutes (0.42 meeting is intended to improve public with confidential information that you
hours) per respondent. The total understanding and provide FDA do not wish to be made available to the
estimated burden for the data collection feedback on the policies and processes public, submit the comment as a
is 6,561 hours (4,692 hours for adults + for submitting and reviewing tobacco written/paper submission and in the
1,869 hours for adolescents). product marketing applications, manner detailed (see ‘‘Written/Paper
including the general scientific Submissions’’ and ‘‘Instructions’’).
II. References
principles relevant to various Written/Paper Submissions
The following references are on application pathways, to assist those
display at the Dockets Management Staff Submit written/paper submissions as
considering submitting marketing follows:
(see ADDRESSES) and are available for applications for tobacco products under
viewing by interested persons between • Mail/Hand Delivery/Courier (for
the Federal Food, Drug, and Cosmetic written/paper submissions): Dockets
9 a.m. and 4 p.m., Monday through Act (FD&C Act).
Friday; they are also available Management Staff (HFA–305), Food and
DATES: The 2-day public meeting will be Drug Administration, 5630 Fishers
electronically at https://
held on October 22, 2018, from 8:30 Lane, Rm. 1061, Rockville, MD 20852.
www.regulations.gov.
a.m. to 4:30 p.m. and on October 23, • For written/paper comments
1. Murphy, S.L., J. Xu, K.D. Kochanek. 2018, from 8:30 a.m. to 3 p.m. Submit submitted to the Dockets Management
‘‘Deaths: Final Data for 2010’’. National either electronic or written comments
Vital Statistics Reports, 61(4):37–41, Staff, FDA will post your comment, as
2013.
on this public meeting by December 7, well as any attachments, except for
2. U.S. Department of Health and Human 2018. See the SUPPLEMENTARY information submitted, marked and
Services. ‘‘The Health Consequences of INFORMATION section for registration date identified, as confidential, if submitted
Smoking: 50 Years of Progress. A Report and information. as detailed in ‘‘Instructions.’’
of the Surgeon General.’’ Atlanta, GA: ADDRESSES: The public meeting will be Instructions: All submissions received
U.S. Department of Health and Human held at the Hilton Washington DC/ must include the Docket No. FDA–
Services, Centers for Disease Control and Rockville Hotel & Executive Meeting 2018–N–3504 for ‘‘Tobacco Product
Prevention, National Center for Chronic
Disease Prevention and Health Center, 1750 Rockville Pike, Rockville, Application Review.’’ Received
Promotion, Office on Smoking and MD 20852, https://www3.hilton.com/en/ comments, filed in a timely manner (see
Health; 2014. hotels/maryland/hilton-washington-dc- ADDRESSES), will be placed in the docket
3. Jamal, A., E. Phillips, A.S. Gentzke, et al. rockville-hotel-and-executive-meeting- and, except for those submitted as
‘‘Current Cigarette Smoking Among ctr-IADMRHF/index.html. ‘‘Confidential Submissions,’’ publicly
daltland on DSKBBV9HB2PROD with NOTICES
Adults—United States, 2016’’. MMWR You may submit comments as viewable at https://www.regulations.gov
Morbidity and Mortality Weekly Report, follows. Please note that late, untimely or at the Dockets Management Staff
67:53–59, 2018. filed comments may not be considered.
4. Centers for Disease Control and
between 9 a.m. and 4 p.m., Monday
Prevention. ‘‘Cigarette Smoking- The https://www.regulations.gov through Friday.
Attributable Morbidity—United States, electronic filing system will accept • Confidential Submissions—To
2000’’. MMWR Morbidity and Mortality electronic comments until 11:59 p.m. submit a comment with confidential
Weekly Report, 52(35):842–844, 2003 Eastern Time on December 7, 2018. information that you do not wish to be
VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1](https://thefederalregister.org/doc/83_FR_48812/page/4.svg)
Document Created: 2018-09-26 00:47:49
Document Modified: 2018-09-26 00:47:49
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by November 26, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 48625 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR