83 FR 48628 - Tobacco Product Application Review; Public Meeting; Request for Comments
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 | 48628-48630 | |
| FR Document | 2018-20904 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Notices] [Pages 48628-48630] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20904] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3504] Tobacco Product Application Review; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Tobacco Product Application Review.'' This meeting is intended to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: The 2-day public meeting will be held on October 22, 2018, from 8:30 a.m. to 4:30 p.m. and on October 23, 2018, from 8:30 a.m. to 3 p.m. Submit either electronic or written comments on this public meeting by December 7, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the Hilton Washington DC/ Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852, https://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html. You may submit comments as follows. Please note that late, untimely filed comments may not be considered. The https://www.regulations.gov electronic filing system will accept electronic comments until 11:59 p.m. Eastern Time on December 7, 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 December 7, 2018. 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-3504 for ``Tobacco Product Application Review.'' Received comments, 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 [[Page 48629]] 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: Darin Achilles, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 877- 287-1373, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public meeting to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the FD&C Act. FDA will present information about the tobacco product application review programs, including process improvements and observations that may inform further improvements in submissions and review processes. The meeting will include panels of FDA representatives, regulated industry representatives, and other stakeholders, and FDA will seek feedback from the public. This meeting is not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review. FDA expects that parties interested in attending this meeting include, but are not limited to, tobacco product manufacturers, including small business tobacco manufacturers, importers, distributors, wholesalers, and retailers; scientific and medical experts; Federal, State, and local government Agencies; and other interested stakeholders, such as academic researchers and public health organizations. In addition to the public meeting, FDA is opening a docket as another mechanism to receive feedback on the tobacco product application review process. Timely comments are appreciated to help inform FDA's efforts to continue to build an efficient product review program. FDA is open to receiving feedback and comments on all aspects of the product review process and is requesting specific comment on the following topics: Achieving greater efficiencies in review while continuing to protect public health [cir] Improving application content [cir] Streamlining review processes [cir] Refining electronic submission systems Reviewing applications for products that are rendered ``new'' due to changes made to comply with a product standard Facilitating applicant consultation with FDA prior to submitting applications [cir] Types of questions that would benefit from FDA feedback [cir] Meeting request and package content [cir] Process from meeting request through post-meeting minutes Transparent review process [cir] Aspects that are highly transparent [cir] Aspects that are not highly transparent [cir] Approaches to increase transparency Clarity and utility of information provided by FDA to applicants [cir] Means of communicating information to applicants [cir] Information that is most useful to applicants [cir] Timeliness of communication II. Topics for Discussion at the Public Meeting Topics to be addressed in the meeting include: An overview of the tobacco product marketing application types, including Substantial Equivalence Reports, Substantial Equivalence Exemption Requests, Premarket Tobacco Product Applications, and Modified Risk Tobacco Product Applications; Information required and that FDA recommends be included in a tobacco product marketing application; Administrative processes involved in the submission and review of a tobacco product marketing application; and Other topics relevant to tobacco product marketing applications, including tobacco product master files, meeting requests, grandfathered tobacco product review, and environmental assessments. III. Participating in the Public Meeting Registration: To register for the public meeting, please submit electronic registration requests at https://www.surveymonkey.com/r/FDACTPTobacco_Product_Application_Meeting. Requests for registration must include the prospective attendee's name, title, affiliation, and contact information. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting should register by 11:59 p.m. Eastern Time on October 5, 2018. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8 a.m. If registration reaches maximum capacity, FDA will post a notice closing registration at https://www.fda.gov/TobaccoProducts/NewsEvents/default.htm. If you need special accommodations because of disability, please email [email protected] or call 1-877-287-1373 (Option 5) at least 7 days before the meeting. Streaming Webcast of the Public Meeting: There will be a webcast for this public meeting. If you would like to attend the meeting via webcast, please submit electronic requests to register at https://www.surveymonkey.com/r/FDACTPTobacco_Product_Application_Meeting. Requests for registration must include the prospective attendee's name, title, affiliation, and contact information. [[Page 48630]] Archived Webcast and Transcripts: Please be advised that FDA will post the webcast along with complete transcripts on the internet at https://www.fda.gov/TobaccoProducts/NewsEvents/default.htm as soon as they are available. Dated: September 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20904 Filed 9-25-18; 8:45 am] BILLING CODE 4164-01-P
![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
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![48630 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
Archived Webcast and Transcripts: www.regulations.gov will be posted to https://www.regulations.gov. Submit
Please be advised that FDA will post the the docket unchanged. Because your both copies to the Dockets Management
webcast along with complete transcripts comment will be made public, you are Staff. If you do not wish your name and
on the internet at https://www.fda.gov/ solely responsible for ensuring that your contact information to be made publicly
TobaccoProducts/NewsEvents/ comment does not include any available, you can provide this
default.htm as soon as they are confidential information that you or a information on the cover sheet and not
available. third party may not wish to be posted, in the body of your comments and you
Dated: September 20, 2018. such as medical information, your or must identify this information as
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
Leslie Kux,
confidential business information, such as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. as a manufacturing process. Please note except in accordance with 21 CFR 10.20
[FR Doc. 2018–20904 Filed 9–25–18; 8:45 am] that if you include your name, contact and other applicable disclosure law. For
BILLING CODE 4164–01–P information, or other information that more information about FDA’s posting
identifies you in the body of your of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
HUMAN SERVICES • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
with confidential information that you 23389.pdf.
Food and Drug Administration do not wish to be made available to the Docket: For access to the docket to
[Docket No. FDA–2016–D–4317] public, submit the comment as a read background documents or the
written/paper submission and in the electronic and written/paper comments
Compounding and Repackaging of manner detailed (see ‘‘Written/Paper received, go to https://
Radiopharmaceuticals by Outsourcing Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Facilities; Guidance for Industry; docket number, found in brackets in the
Availability Written/Paper Submissions
heading of this document, into the
Submit written/paper submissions as
AGENCY: Food and Drug Administration, ‘‘Search’’ box and follow the prompts
follows:
HHS. and/or go to the Dockets Management
• Mail/Hand Delivery/Courier (for
ACTION: Notice of availability. Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
Rockville, MD 20852.
Management Staff (HFA–305), Food and
SUMMARY: The Food and Drug You may submit comments on any
Drug Administration, 5630 Fishers
Administration (FDA or Agency) is guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
announcing the availability of a final • For written/paper comments 10.115(g)(5)).
guidance for industry entitled submitted to the Dockets Management Submit written requests for single
‘‘Compounding and Repackaging of Staff, FDA will post your comment, as copies of the guidance to the Division of
Radiopharmaceuticals by Outsourcing well as any attachments, except for Drug Information, Center for Drug
Facilities.’’ Specifically, this guidance information submitted, marked and Evaluation and Research, Food and
sets forth FDA’s policy regarding identified, as confidential, if submitted Drug Administration, 10001 New
compounding and repackaging of as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
radiopharmaceuticals for human use by Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
entities that are registered with FDA as must include the Docket No. FDA– 0002. Send one self-addressed adhesive
outsourcing facilities. This guidance 2016–D–4317 for ‘‘Compounding and label to assist that office in processing
describes how FDA generally intends to Repackaging of Radiopharmaceuticals your requests. See the SUPPLEMENTARY
apply section 503B of the Federal Food, by Outsourcing Facilities.’’ Received INFORMATION section for electronic
Drug, and Cosmetic Act (FD&C Act) to comments will be placed in the docket access to the guidance document.
radiopharmaceuticals compounded by and, except for those submitted as FOR FURTHER INFORMATION CONTACT: Sara
outsourcing facilities, and it describes ‘‘Confidential Submissions,’’ publicly Rothman, Center for Drug Evaluation
the conditions under which FDA viewable at https://www.regulations.gov and Research, Food and Drug
generally does not intend to take action or at the Dockets Management Staff Administration, 10903 New Hampshire
for violations of certain provisions of between 9 a.m. and 4 p.m., Monday Ave., Bldg. 51, Silver Spring, MD, 301–
the FD&C Act when an outsourcing through Friday. 796–3110.
facility repackages • Confidential Submissions—To SUPPLEMENTARY INFORMATION:
radiopharmaceuticals. submit a comment with confidential
DATES: The announcement of the information that you do not wish to be I. Background
guidance is published in the Federal made publicly available, submit your FDA is announcing the availability of
Register on September 26, 2018. comments only as a written/paper a guidance for industry entitled
ADDRESSES: You may submit either submission. You should submit two ‘‘Compounding and Repackaging of
electronic or written comments on copies total. One copy will include the Radiopharmaceuticals by Outsourcing
Agency guidances at any time as information you claim to be confidential Facilities; Guidance for Industry.’’ In
follows: with a heading or cover note that states 2013, the Drug Quality and Security Act
‘‘THIS DOCUMENT CONTAINS created a new section, 503B, of the
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The FD&C Act (21 U.S.C. 353b), which
daltland on DSKBBV9HB2PROD with NOTICES
Submit electronic comments in the Agency will review this copy, including describes a new category of
following way: the claimed confidential information, in compounders called outsourcing
• Federal eRulemaking Portal: its consideration of comments. The facilities. Section 503B of the FD&C Act
https://www.regulations.gov. Follow the second copy, which will have the describes the conditions that must be
instructions for submitting comments. claimed confidential information satisfied for human drug products
Comments submitted electronically, redacted/blacked out, will be available compounded by or under the direct
including attachments, to https:// for public viewing and posted on supervision of a licensed pharmacist in
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Document Created: 2018-09-26 00:46:57
Document Modified: 2018-09-26 00:46:57
| 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 public meeting; request for comments. | |
| Dates | The 2-day public meeting will be held on October 22, 2018, from 8:30 a.m. to 4:30 p.m. and on October 23, 2018, from 8:30 a.m. to 3 p.m. Submit either electronic or written comments on this public meeting by December 7, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Darin Achilles, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 877- 287-1373, email: [email protected] | |
| FR Citation | 83 FR 48628 |
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