The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry; Availability, 5583-5584 [2017-00969]
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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2010 (75 FR 4400), FDA issued the draft
guidance for industry ‘‘Assessment of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2010 draft guidance, and consideration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
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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