The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry; Availability, 5583-5584 [2017-00969]

Download as PDF Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices mstockstill on DSK3G9T082PROD with NOTICES This guidance provides important recommendations to sponsors, applicants, and potential applicants in the approaches to collecting data that should comprise the abuse potential assessment submitted in the marketing application to FDA if one is required pursuant to § 314.50(d)(5)(vii). In the Federal Register of January 27, 2010 (75 FR 4400), FDA issued the draft guidance for industry ‘‘Assessment of Abuse Potential of Drugs.’’ Based on the 2010 draft guidance, and consideration of comments received from the public, this guidance provides the Agency’s current thinking with respect to the scientific methods recommended to assess abuse potential. The guidance also adds more detailed discussion about key questions and decision points to consider during drug development that will likely determine the appropriate studies for sponsors and applicants to conduct to address the abuse potential of their new drug, inform appropriate labeling of the product upon its approval, and allow a thorough scientific and medical evaluation to support scheduling decisions in accordance with the CSA. In addition, this guidance takes into consideration other guidance issued and legislation enacted since 2010. 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 assessment of abuse potential of drugs. 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. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collection of information in part 314, including § 314.50(d)(5)(vii), has been approved under OMB control number 0910–0001. The collection of information in 21 CFR part 312 for investigational drugs has been approved under OMB control number 0910–0014. The collection of information in the guidance ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products’’ has been approved under OMB control number 0910–0429. The collection of information in 21 CFR 201.56 and 201.57, prescription drug labeling, has been approved under OMB control number 0910–0572. The collection of information in 21 CFR part VerDate Sep<11>2014 17:41 Jan 17, 2017 Jkt 241001 58, Good Laboratory Practice for Nonclinical Studies, has been approved under OMB control number 0910–0119. III. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: January 12, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–01024 Filed 1–17–17; 8:45 am] BILLING CODE 4164–01–P 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. 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: SUMMARY: 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 5583 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 E:\FR\FM\18JAN1.SGM 18JAN1 5584 Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices mstockstill on DSK3G9T082PROD with NOTICES 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: https://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, AskCTP@fda.hhs.gov. 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 nonmonetary exchanges, coupons and VerDate Sep<11>2014 17:41 Jan 17, 2017 Jkt 241001 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. FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: 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 https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; NURSE Corps Loan Repayment Program Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). DATES: Comments on this ICR should be received no later than March 20, 2017. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N–39, 5600 Fishers Lane, Rockville, MD 20857. SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: NURSE Corps Loan Repayment Program OMB No. 0915–0140—Revision Abstract: The NURSE Corps Loan Repayment Program (NURSE Corps LRP), formerly known as the Nursing Education Loan Repayment Program, assists in the recruitment and retention of professional Registered Nurses (RNs), including advanced practice RNs (e.g., nurse practitioners, certified registered nurse anesthetists, certified nursemidwives, clinical nurse specialists), dedicated to working at eligible health care facilities with a critical shortage of nurses (i.e., a Critical Shortage Facility) or working as nurse faculty in eligible, accredited schools of nursing, by decreasing the financial barriers associated with pursuing a nursing education. The NURSE Corps LRP provides loan repayment assistance to these nurses to repay a portion of their qualifying educational loans in exchange for full-time service at a public or private nonprofit Critical Shortage Facility or in an eligible, accredited school of nursing. Need and Proposed Use of the Information: The need and purpose of this information collection is to obtain information for NURSE Corps LRP applicants and participants. The information is used to consider an applicant for a NURSE Corps LRP contract award and to monitor a participant’s compliance with the service requirements. Individuals must submit an application to participate in the program. The application asks for personal, professional, educational, and financial information required to determine the applicant’s eligibility to participate in the NURSE Corps LRP. The semi-annual employment verification form asks for personal and employment information to determine if a participant is in compliance with the service requirements. The Authorization to Release Employment Information form is now a self-certification within the NURSE Corps LRP application process with applicants clicking a box. This decreases the overall time burden by eliminating a form and not increasing E:\FR\FM\18JAN1.SGM 18JAN1

Agencies

[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5583-5584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://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, AskCTP@fda.hhs.gov.

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 
https://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
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