82 FR 47534 - The Prohibition of Distributing Free Samples of Tobacco Products; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 196 (October 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 196 (October 12, 2017)
| Page Range | 47534-47535 | |
| FR Document | 2017-22045 |
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)] [Notices] [Pages 47534-47535] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22045] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-0113] The Prohibition of Distributing Free Samples of Tobacco Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``The Prohibition of Distributing Free Samples of Tobacco Products.'' The guidance provides information intended to assist tobacco product manufacturers, distributors, and retailers in complying with the regulations prohibiting the distribution of free samples of tobacco products. DATES: The announcement of the guidance is published in the Federal Register on October 12, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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-2017-D-0113 for ``The Prohibition of Distributing Free Samples of Tobacco Products; Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the 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. Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. [[Page 47535]] FOR FURTHER INFORMATION CONTACT: Paul Hart or Samantha Loh Collado, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373, email: CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``The Prohibition of Distributing Free Samples of Tobacco Products.'' Title 21 of the CFR 1140.16(d)(1) prohibits, with a limited exception, tobacco product manufacturers, distributors, and retailers from distributing or causing to be distributed any free samples of cigarettes, smokeless tobacco, or other tobacco products. This guidance finalizes the draft guidance of the same title, which was made available for public comment as noted in the Federal Register of January 18, 2017 (82 FR 5583), and describes, among other things, FDA's current thinking on how the prohibition of distributing free samples of tobacco products applies to non-monetary exchanges, coupons and discounts, membership and rewards programs, contests and games of chance, and the business-to-business exchange of free samples. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the prohibition of distributing free samples of tobacco products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons with access to the internet may obtain an electronic version of the guidance at either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: October 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22045 Filed 10-11-17; 8:45 am] BILLING CODE 4164-01-P
![47534 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
The estimated number of temporary guidance provides information intended those submitted as ‘‘Confidential
marketing permit applications and to assist tobacco product manufacturers, Submissions,’’ publicly viewable at
hours per response is an average based distributors, and retailers in complying https://www.regulations.gov or at the
on our experience with applications with the regulations prohibiting the Dockets Management Staff between 9
received for the past 3 years, and distribution of free samples of tobacco a.m. and 4 p.m., Monday through
information from firms that have products. Friday.
submitted recent requests for temporary DATES: The announcement of the • Confidential Submissions—To
marketing permits. Based on this guidance is published in the Federal submit a comment with confidential
information, we estimate that there will Register on October 12, 2017. information that you do not wish to be
be, on average, approximately 13 firms
ADDRESSES: You may submit either made publicly available, submit your
submitting requests for 2 temporary
electronic or written comments on comments only as a written/paper
marketing permits per year over the next
Agency guidances at any time as submission. You should submit two
3 years.
Thus, we estimate that 13 respondents follows: copies total. One copy will include the
will submit 2 requests for temporary information you claim to be confidential
Electronic Submissions with a heading or cover note that states
marketing permits annually pursuant to
§ 130.17(c). The estimated number of Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
respondents for § 130.17(i) is minimal following way: CONFIDENTIAL INFORMATION.’’ The
because this section is seldom used by • Federal eRulemaking Portal: Agency will review this copy, including
the respondents; therefore, the Agency https://www.regulations.gov. Follow the the claimed confidential information, in
estimates that there will be one or fewer instructions for submitting comments. its consideration of comments. The
respondents annually with two or fewer Comments submitted electronically, second copy, which will have the
requests for extension of the marketing including attachments, to https:// claimed confidential information
permit under § 130.17(i). The estimated www.regulations.gov will be posted to redacted/blacked out, will be available
number of hours per response is an the docket unchanged. Because your for public viewing and posted on
average based on the Agency’s comment will be made public, you are https://www.regulations.gov. Submit
experience and information from firms solely responsible for ensuring that your both copies to the Dockets Management
that have submitted recent requests for comment does not include any Staff. If you do not wish your name and
temporary marketing permits. We confidential information that you or a contact information to be made publicly
estimate that 13 respondents each will third party may not wish to be posted, available, you can provide this
submit 2 requests for temporary such as medical information, your or information on the cover sheet and not
marketing permits under § 130.17(c) and anyone else’s Social Security number, or in the body of your comments and you
that it will take a respondent 25 hours confidential business information, such must identify this information as
per request to comply with the as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
requirements of that section, for a total that if you include your name, contact as ‘‘confidential’’ will not be disclosed
of 650 hours. We estimate that one information, or other information that except in accordance with 21 CFR 10.20
respondent will submit two requests for identifies you in the body of your and other applicable disclosure law. For
extension of its temporary marketing comments, that information will be more information about FDA’s posting
permits under § 130.17(i) and that it will posted on https://www.regulations.gov. of comments to public dockets, see 80
take a respondent 2 hours per request to • If you want to submit a comment FR 56469, September 18, 2015, or access
comply with the requirements of that with confidential information that you the information at: https://www.gpo.gov/
section, for a total of 4 hours. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
Dated: October 6, 2017.
written/paper submission and in the
Anna K. Abram, Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper
Deputy Commissioner for Policy, Planning, read background documents or the
Submissions’’ and ‘‘Instructions’’).
Legislation, and Analysis. electronic and written/paper comments
[FR Doc. 2017–22053 Filed 10–11–17; 8:45 am] Written/Paper Submissions received, go to https://
BILLING CODE 4164–01–P Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
DEPARTMENT OF HEALTH AND written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
HUMAN SERVICES Management Staff (HFA–305), Food and and/or go to the Dockets Management
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Food and Drug Administration Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
[Docket No. FDA–2017–D–0113] • For written/paper comments Submit written requests for single
submitted to the Dockets Management copies of this guidance to the Center for
The Prohibition of Distributing Free Staff, FDA will post your comment, as Tobacco Products, Food and Drug
Samples of Tobacco Products; well as any attachments, except for Administration, Document Control
Guidance for Industry; Availability information submitted, marked and Center, Bldg. 71, Rm. G335, 10903 New
asabaliauskas on DSKBBXCHB2PROD with NOTICES
AGENCY: Food and Drug Administration, identified, as confidential, if submitted Hampshire Ave., Silver Spring, MD
HHS. as detailed in ‘‘Instructions.’’ 20993–0002. Send one self-addressed
ACTION: Notice of availability. Instructions: All submissions received adhesive label to assist that office in
must include the Docket No. FDA– processing your request or include a fax
SUMMARY: The Food and Drug 2017–D–0113 for ‘‘The Prohibition of number to which the guidance
Administration (FDA) is announcing the Distributing Free Samples of Tobacco document may be sent. See the
availability of a guidance for industry Products; Guidance for Industry; SUPPLEMENTARY INFORMATION section for
entitled ‘‘The Prohibition of Distributing Availability.’’ Received comments will information on electronic access to the
Free Samples of Tobacco Products.’’ The be placed in the docket and, except for guidance.
VerDate Sep<11>2014 22:35 Oct 11, 2017 Jkt 244001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1](https://thefederalregister.org/doc/82_FR_47730/page/1.svg)
![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47535
FOR FURTHER INFORMATION CONTACT: Paul DEPARTMENT OF HEALTH AND Written/Paper Submissions
Hart or Samantha Loh Collado, Center HUMAN SERVICES Submit written/paper submissions as
for Tobacco Products, Food and Drug follows:
Administration, 10903 New Hampshire Food and Drug Administration • Mail/Hand delivery/Courier (for
Ave., Document Control Center, Bldg. [Docket No. FDA–2017–D–5960] written/paper submissions): Dockets
71, Rm. G335, Silver Spring, MD 20993– Management Staff (HFA–305), Food and
0002, 877–287–1373, email: Respiratory Syncytial Virus Infection: Drug Administration, 5630 Fishers
CTPRegulations@fda.hhs.gov. Developing Antiviral Drugs for Lane, Rm. 1061, Rockville, MD 20852.
SUPPLEMENTARY INFORMATION:
Prophylaxis and Treatment; Draft • For written/paper comments
Guidance for Industry; Availability submitted to the Dockets Management
I. Background Staff, FDA will post your comment, as
AGENCY: Food and Drug Administration,
well as any attachments, except for
FDA is announcing the availability of HHS.
information submitted, marked and
a guidance for industry entitled ‘‘The ACTION: Notice of availability. identified, as confidential, if submitted
Prohibition of Distributing Free Samples as detailed in ‘‘Instructions.’’
of Tobacco Products.’’ Title 21 of the SUMMARY: The Food and Drug
Administration (FDA or Agency) is Instructions: All submissions received
CFR 1140.16(d)(1) prohibits, with a must include the Docket No. FDA–
limited exception, tobacco product announcing the availability of a draft
guidance for industry entitled 2017–D–5960 for ‘‘Respiratory Syncytial
manufacturers, distributors, and Virus Infection: Developing Antiviral
retailers from distributing or causing to ‘‘Respiratory Syncytial Virus Infection:
Developing Antiviral Drugs for Drugs for Prophylaxis and Treatment;
be distributed any free samples of Draft Guidance for Industry;
cigarettes, smokeless tobacco, or other Prophylaxis and Treatment.’’ The
purpose of this draft guidance is to Availability.’’ Received comments will
tobacco products. This guidance be placed in the docket and, except for
assist sponsors in all phases of antiviral
finalizes the draft guidance of the same those submitted as ‘‘Confidential
drug development for prophylaxis and
title, which was made available for Submissions,’’ publicly viewable at
treatment of disease caused by
public comment as noted in the Federal https://www.regulations.gov or at the
respiratory syncytial virus (RSV)
Register of January 18, 2017 (82 FR Dockets Management Staff between 9
infection.
5583), and describes, among other a.m. and 4 p.m., Monday through
things, FDA’s current thinking on how DATES: Submit either electronic or Friday.
the prohibition of distributing free written comments on the draft guidance • Confidential Submissions—To
samples of tobacco products applies to by December 11, 2017 to ensure that the submit a comment with confidential
non-monetary exchanges, coupons and Agency considers your comment on this information that you do not wish to be
discounts, membership and rewards draft guidance before it begins work on made publicly available, submit your
programs, contests and games of chance, the final version of the guidance. comments only as a written/paper
and the business-to-business exchange ADDRESSES: You may submit comments submission. You should submit two
of free samples. on any guidance at any time as follows: copies total. One copy will include the
information you claim to be confidential
II. Significance of Guidance Electronic Submissions with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
This guidance is being issued
following way: CONFIDENTIAL INFORMATION.’’ The
consistent with FDA’s good guidance
• Federal eRulemaking Portal: Agency will review this copy, including
practices regulation (21 CFR 10.115). https://www.regulations.gov. Follow the the claimed confidential information, in
The guidance represents the current instructions for submitting comments. its consideration of comments. The
thinking of FDA on the prohibition of Comments submitted electronically, second copy, which will have the
distributing free samples of tobacco including attachments, to https:// claimed confidential information
products. It does not establish any rights www.regulations.gov will be posted to redacted/blacked out, will be available
for any person and is not binding on the docket unchanged. Because your for public viewing and posted on
FDA or the public. You can use an comment will be made public, you are https://www.regulations.gov. Submit
alternative approach if it satisfies the solely responsible for ensuring that your both copies to the Dockets Management
requirements of the applicable statutes comment does not include any Staff. If you do not wish your name and
and regulations. This guidance is not confidential information that you or a contact information to be made publicly
subject to Executive Order 12866. third party may not wish to be posted, available, you can provide this
III. Electronic Access such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
Persons with access to the internet confidential business information, such must identify this information as
may obtain an electronic version of the as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
guidance at either https:// that if you include your name, contact as ‘‘confidential’’ will not be disclosed
www.regulations.gov or https:// information, or other information that except in accordance with 21 CFR 10.20
www.fda.gov/TobaccoProducts/ identifies you in the body of your and other applicable disclosure law. For
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Labeling/RulesRegulationsGuidance/ comments, that information will be more information about FDA’s posting
default.htm. posted on https://www.regulations.gov. of comments to public dockets, see 80
• If you want to submit a comment FR 56469, September 18, 2015, or access
Dated: October 5, 2017.
with confidential information that you the information at: https://www.gpo.gov
Anna K. Abram, do not wish to be made available to the /fdsys/pkg/FR-2015-09-18/pdf/2015-
Deputy Commissioner for Policy, Planning, public, submit the comment as a 23389.pdf.
Legislation, and Analysis. written/paper submission and in the Docket: For access to the docket to
[FR Doc. 2017–22045 Filed 10–11–17; 8:45 am] manner detailed (see ‘‘Written/Paper read background documents or the
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
VerDate Sep<11>2014 22:35 Oct 11, 2017 Jkt 244001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1](https://thefederalregister.org/doc/82_FR_47730/page/2.svg)
Document Created: 2018-10-25 10:05:51
Document Modified: 2018-10-25 10:05:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on October 12, 2017. | |
| Contact | Paul Hart or Samantha Loh Collado, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373, email: [email protected] | |
| FR Citation | 82 FR 47534 |
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