82 FR 5583 - The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 11 (January 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 11 (January 18, 2017)
| Page Range | 5583-5584 | |
| FR Document | 2017-00969 |
[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)] [Notices] [Pages 5583-5584] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00969] ----------------------------------------------------------------------- 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and Drug Administration [Docket No. FDA-2017-D-0113] The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry.'' The draft guidance, when finalized, would provide information intended to assist manufacturers, distributors, and retailers in complying with the regulations prohibiting the distribution of free samples of tobacco products. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 17, 2017. ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-D-0113 for ``The Prohibition of Distributing Free Samples of Tobacco Products.'' 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets [[Page 5584]] Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft 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 the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Paul Hart or Samantha Loh Collado, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry.'' Title 21 of the Code of Federal Regulations (CFR) section 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. The draft guidance describes, among other things, 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. FDA requests that interested parties submit comments concerning its draft interpretation of the prohibition of distributing free samples. II. Significance of Draft Guidance FDA is issuing this draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``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. III. Electronic Access Persons with access to the Internet may obtain an electronic version of the draft guidance at either https://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: January 11, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00969 Filed 1-17-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices 5583
This guidance provides important 58, Good Laboratory Practice for solely responsible for ensuring that your
recommendations to sponsors, Nonclinical Studies, has been approved comment does not include any
applicants, and potential applicants in under OMB control number 0910–0119. confidential information that you or a
the approaches to collecting data that third party may not wish to be posted,
III. Electronic Access
should comprise the abuse potential such as medical information, your or
assessment submitted in the marketing Persons with access to the Internet anyone else’s Social Security number, or
application to FDA if one is required may obtain the guidance at either http:// confidential business information, such
pursuant to § 314.50(d)(5)(vii). www.fda.gov/Drugs/Guidance as a manufacturing process. Please note
In the Federal Register of January 27, ComplianceRegulatoryInformation/ that if you include your name, contact
2010 (75 FR 4400), FDA issued the draft Guidances/default.htm or https:// information, or other information that
guidance for industry ‘‘Assessment of www.regulations.gov. identifies you in the body of your
Abuse Potential of Drugs.’’ Based on the Dated: January 12, 2017. comments, that information will be
2010 draft guidance, and consideration Leslie Kux, posted on https://www.regulations.gov.
of comments received from the public, • If you want to submit a comment
Associate Commissioner for Policy.
this guidance provides the Agency’s with confidential information that you
current thinking with respect to the [FR Doc. 2017–01024 Filed 1–17–17; 8:45 am] do not wish to be made available to the
scientific methods recommended to BILLING CODE 4164–01–P public, submit the comment as a
assess abuse potential. The guidance written/paper submission and in the
also adds more detailed discussion manner detailed (see ‘‘Written/Paper
about key questions and decision points DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
to consider during drug development HUMAN SERVICES
Written/Paper Submissions
that will likely determine the Food and Drug Administration
appropriate studies for sponsors and Submit written/paper submissions as
applicants to conduct to address the [Docket No. FDA–2017–D–0113] follows:
abuse potential of their new drug, • Mail/Hand delivery/Courier (for
inform appropriate labeling of the The Prohibition of Distributing Free written/paper submissions): Division of
product upon its approval, and allow a Samples of Tobacco Products; Draft Dockets Management (HFA–305), Food
thorough scientific and medical Guidance for Industry; Availability and Drug Administration, 5630 Fishers
evaluation to support scheduling Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments
decisions in accordance with the CSA. HHS.
In addition, this guidance takes into submitted to the Division of Dockets
ACTION: Notice of availability. Management, FDA will post your
consideration other guidance issued and
legislation enacted since 2010. SUMMARY: The Food and Drug comment, as well as any attachments,
This guidance is being issued Administration (FDA or Agency) is except for information submitted,
consistent with FDA’s good guidance announcing the availability of a draft marked and identified, as confidential,
practices regulation (21 CFR 10.115). guidance for industry entitled ‘‘The if submitted as detailed in
The guidance represents the current Prohibition of Distributing Free Samples ‘‘Instructions.’’
thinking of FDA on assessment of abuse Instructions: All submissions received
of Tobacco Products; Draft Guidance for
potential of drugs. It does not establish must include the Docket No. FDA–
Industry.’’ The draft guidance, when
any rights for any person and is not 2017–D–0113 for ‘‘The Prohibition of
finalized, would provide information
binding on FDA or the public. You can Distributing Free Samples of Tobacco
intended to assist manufacturers,
use an alternative approach if it satisfies Products.’’ Received comments will be
distributors, and retailers in complying
the requirements of the applicable placed in the docket and, except for
with the regulations prohibiting the
statutes and regulations. those submitted as ‘‘Confidential
distribution of free samples of tobacco
Submissions,’’ publicly viewable at
II. Paperwork Reduction Act of 1995 products.
https://www.regulations.gov or at the
This guidance refers to previously DATES: Although you can comment on Division of Dockets Management
approved collections of information that any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday
are subject to review by the Office of 10.115(g)(5)), to ensure that the Agency through Friday.
Management and Budget (OMB) under considers your comment on this draft • Confidential Submissions—To
the Paperwork Reduction Act of 1995 guidance before it begins work on the submit a comment with confidential
(44 U.S.C. 3501–3520). The collection of final version of the guidance, submit information that you do not wish to be
information in part 314, including either electronic or written comments made publicly available, submit your
§ 314.50(d)(5)(vii), has been approved on the draft guidance by February 17, comments only as a written/paper
under OMB control number 0910–0001. 2017. submission. You should submit two
The collection of information in 21 CFR ADDRESSES: You may submit comments copies total. One copy will include the
part 312 for investigational drugs has as follows: information you claim to be confidential
been approved under OMB control with a heading or cover note that states
number 0910–0014. The collection of Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
information in the guidance ‘‘Formal Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Meetings Between the FDA and following way: Agency will review this copy, including
Sponsors or Applicants of PDUFA • Federal eRulemaking Portal: the claimed confidential information, in
mstockstill on DSK3G9T082PROD with NOTICES
Products’’ has been approved under https://www.regulations.gov. Follow the its consideration of comments. The
OMB control number 0910–0429. The instructions for submitting comments. second copy, which will have the
collection of information in 21 CFR Comments submitted electronically, claimed confidential information
201.56 and 201.57, prescription drug including attachments, to https:// redacted/blacked out, will be available
labeling, has been approved under OMB www.regulations.gov will be posted to for public viewing and posted on
control number 0910–0572. The the docket unchanged. Because your https://www.regulations.gov. Submit
collection of information in 21 CFR part comment will be made public, you are both copies to the Division of Dockets
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![5584 Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
Management. If you do not wish your discounts, membership and rewards FOR FURTHER INFORMATION CONTACT: To
name and contact information to be programs, contests and games of chance, request more information on the
made publicly available, you can and the business-to-business exchange proposed project or to obtain a copy of
provide this information on the cover of free samples. FDA requests that the data collection plans and draft
sheet and not in the body of your interested parties submit comments instruments, email paperwork@hrsa.gov
comments and you must identify this concerning its draft interpretation of the or call the HRSA Information Collection
information as ‘‘confidential.’’ Any prohibition of distributing free samples. Clearance Officer at (301) 443–1984.
information marked as ‘‘confidential’’ II. Significance of Draft Guidance SUPPLEMENTARY INFORMATION: When
will not be disclosed except in
FDA is issuing this draft guidance submitting comments or requesting
accordance with 21 CFR 10.20 and other
consistent with FDA’s good guidance information, please include the
applicable disclosure law. For more
practices regulation (21 CFR 10.115). information request collection title for
information about FDA’s posting of
The draft guidance, when finalized, will reference.
comments to public dockets, see 80 FR
56469, September 18, 2015, or access represent the current thinking of FDA Information Collection Request Title:
the information at: http://www.fda.gov/ on ‘‘The Prohibition of Distributing Free NURSE Corps Loan Repayment Program
regulatoryinformation/dockets/ Samples of Tobacco Products.’’ It does OMB No. 0915–0140—Revision
default.htm. not establish any rights for any person Abstract: The NURSE Corps Loan
Docket: For access to the docket to and is not binding on FDA or the public. Repayment Program (NURSE Corps
read background documents or the You can use an alternative approach if LRP), formerly known as the Nursing
electronic and written/paper comments it satisfies the requirements of the Education Loan Repayment Program,
received, go to https:// applicable statutes and regulations. assists in the recruitment and retention
www.regulations.gov and insert the III. Electronic Access of professional Registered Nurses (RNs),
docket number, found in brackets in the including advanced practice RNs (e.g.,
heading of this document, into the Persons with access to the Internet
nurse practitioners, certified registered
‘‘Search’’ box and follow the prompts may obtain an electronic version of the
nurse anesthetists, certified nurse-
and/or go to the Division of Dockets draft guidance at either https://
midwives, clinical nurse specialists),
Management, 5630 Fishers Lane, Rm. www.regulations.gov or http://
dedicated to working at eligible health
1061, Rockville, MD 20852. www.fda.gov/TobaccoProducts/
care facilities with a critical shortage of
Submit written requests for single Labeling/RulesRegulationsGuidance/
nurses (i.e., a Critical Shortage Facility)
copies of the draft guidance to the default.htm.
or working as nurse faculty in eligible,
Center for Tobacco Products, Food and Dated: January 11, 2017. accredited schools of nursing, by
Drug Administration, Document Control Leslie Kux, decreasing the financial barriers
Center, Bldg. 71, Rm. G335, 10903 New Associate Commissioner for Policy. associated with pursuing a nursing
Hampshire Ave., Silver Spring, MD [FR Doc. 2017–00969 Filed 1–17–17; 8:45 am] education. The NURSE Corps LRP
20993–0002. Send one self-addressed BILLING CODE 4164–01–P provides loan repayment assistance to
adhesive label to assist the office in these nurses to repay a portion of their
processing your requests. See the qualifying educational loans in
SUPPLEMENTARY INFORMATION section for DEPARTMENT OF HEALTH AND exchange for full-time service at a
electronic access to the draft guidance HUMAN SERVICES public or private nonprofit Critical
document. Shortage Facility or in an eligible,
Health Resources and Services accredited school of nursing.
FOR FURTHER INFORMATION CONTACT: Paul
Administration
Hart or Samantha Loh Collado, Center Need and Proposed Use of the
for Tobacco Products, Food and Drug Agency Information Collection Information: The need and purpose of
Administration, Document Control Activities: Proposed Collection: Public this information collection is to obtain
Center, Bldg. 71, Rm. G335, 10903 New Comment Request; NURSE Corps information for NURSE Corps LRP
Hampshire Ave., Silver Spring, MD Loan Repayment Program applicants and participants. The
20993–0002, 1–877–287–1373, information is used to consider an
AskCTP@fda.hhs.gov. AGENCY: Health Resources and Services applicant for a NURSE Corps LRP
SUPPLEMENTARY INFORMATION: Administration (HRSA), Department of contract award and to monitor a
Health and Human Services. participant’s compliance with the
I. Background ACTION: Notice. service requirements. Individuals must
FDA is announcing the availability of submit an application to participate in
a draft guidance for industry entitled SUMMARY: In compliance with the the program. The application asks for
‘‘The Prohibition of Distributing Free requirement for opportunity for public personal, professional, educational, and
Samples of Tobacco Products; Draft comment on proposed data collection financial information required to
Guidance for Industry.’’ Title 21 of the projects of the Paperwork Reduction Act determine the applicant’s eligibility to
Code of Federal Regulations (CFR) of 1995, HRSA announces plans to participate in the NURSE Corps LRP.
section 1140.16(d)(1) prohibits, with a submit an Information Collection The semi-annual employment
limited exception, tobacco product Request (ICR), described below, to the verification form asks for personal and
manufacturers, distributors, and Office of Management and Budget employment information to determine if
retailers from distributing or causing to (OMB). a participant is in compliance with the
mstockstill on DSK3G9T082PROD with NOTICES
be distributed any free samples of DATES: Comments on this ICR should be service requirements. The Authorization
cigarettes, smokeless tobacco, or other received no later than March 20, 2017. to Release Employment Information
tobacco products. The draft guidance ADDRESSES: Submit your comments to form is now a self-certification within
describes, among other things, how the paperwork@hrsa.gov or mail the HRSA the NURSE Corps LRP application
prohibition of distributing free samples Information Collection Clearance process with applicants clicking a box.
of tobacco products applies to non- Officer, Room 14N–39, 5600 Fishers This decreases the overall time burden
monetary exchanges, coupons and Lane, Rockville, MD 20857. by eliminating a form and not increasing
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Document Created: 2018-02-01 15:19:20
Document Modified: 2018-02-01 15:19:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 17, 2017. | |
| Contact | Paul Hart or Samantha Loh Collado, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, [email protected] | |
| FR Citation | 82 FR 5583 |
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