80 FR 27318 - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Draft Guidance for Tobacco Retailers; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 92 (May 13, 2015)

Page Range		27318-27319
FR Document		2015-11538

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for tobacco retailers entitled ``Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.'' The draft guidance, when finalized, will represent FDA's current thinking with respect to imposing no-tobacco- sale orders (NTSOs) on retailers who have committed repeated violations of certain restrictions on the sale and distribution of tobacco products. This draft guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO.

Federal Register, Volume 80 Issue 92 (Wednesday, May 13, 2015)

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27318-27319]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11538]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0404]


Determination of the Period Covered by a No-Tobacco-Sale Order 
and Compliance With an Order; Draft Guidance for Tobacco Retailers; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for tobacco retailers entitled 
``Determination of the Period Covered by a No-Tobacco-Sale Order and 
Compliance With an Order.'' The draft guidance, when finalized, will 
represent FDA's current thinking with respect to imposing no-tobacco-
sale orders (NTSOs) on retailers who have committed repeated violations 
of certain restrictions on the sale and distribution of tobacco 
products. This draft guidance discusses, among other things, the period 
of time covered by an NTSO and a retailer's compliance with an NTSO.

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draft guidance before it begins work on the final version of the 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 June 29, 2015.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Center for Tobacco Products, Food and Drug 
Administration, 10903 New Hampshire Ave., Document Control Center, 
Bldg. 71, Rm. G335, 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 draft guidance may be 
sent. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Colleen Maschal, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, Bldg. 
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-
287-1373, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, President Obama signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) to give FDA authority to regulate the 
manufacture, marketing, and distribution of tobacco products to protect 
public health generally and to reduce tobacco use by minors. Section 
906(d) of the FD&C Act (21 U.S.C. 387f(d)) authorizes FDA to issue 
regulations that restrict the sale and distribution of tobacco products 
if FDA determines such regulations would be appropriate for the 
protection of the public health. Section 303(f)(8) of the FD&C Act (21 
U.S.C. 333(f)(8)) authorizes FDA to impose an NTSO against a person 
found to have committed repeated violations, at a particular retail 
outlet, of restrictions on the sale and distribution of tobacco 
products issued under section 906(d) of the FD&C Act, such as FDA's 
``Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents'' (21 CFR part 
1140). The term ``no-tobacco-sale order'' refers to an order 
prohibiting the sale of tobacco products at a retail outlet 
indefinitely or for a specified period of time under section 303(f)(8) 
of the FD&C Act. A ``repeated violation'' means ``at least 5 violations 
of particular requirements over a 36-month period at a particular 
retail outlet that constitute a repeated violation . . .'' (section 
103(q)(1)(A) of the Tobacco Control Act).
    FDA conducts inspections of retail outlets to evaluate compliance 
with the requirements of the FD&C Act and implementing regulations. 
This draft guidance discusses the period of time to be covered by an 
NTSO where there is evidence of ``repeated violations'' at a particular 
retail outlet. It also discusses a retailer's compliance with an NTSO. 
This draft guidance is meant to supplement FDA's guidances entitled 
``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco 
Retailers'' and ``Civil Money Penalties for Tobacco Retailers and No-
Tobacco-Sale Orders: Responses to Frequently Asked Questions.''

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 Agency's current thinking with respect to 
the period of time to be covered by NTSOs and retailers' compliance 
with NTSOs. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

[[Page 27319]]

III. Requests for Comments

A. General Information About Submitting Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document.

B. Public Availability of Comments

    Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on http://www.regulations.gov. This is 
determined by information indicating that the submission is written by 
an individual, for example, the comment is identified with the category 
``Individual Consumer'' under the field titled ``Category (Required),'' 
on the ``Your Information'' page on http://www.regulations.gov. For 
this docket, however, FDA will not be following this general practice. 
Instead, FDA will post on http://www.regulations.gov comments to this 
docket that have been submitted by individuals in their individual 
capacity. If you wish to submit any information under a claim of 
confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other 
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your state/province and country (if 
provided), the name of your representative (if any), and the category 
identifying you (e.g., individual, consumer, academic, industry). For 
written submissions submitted to the Division of Dockets Management, 
FDA will post the body of your comments on http://www.regulations.gov, 
but you can put your name and/or contact information on a separate 
cover sheet and not in the body of your comments.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the draft guidance at either http://www.regulations.gov or 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11538 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P

27318 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of Total
Number of burden per
Type of respondent Form name responses per burden
respondents response
respondent hours
(in hours)

General Public—Adults ..................... HIV-negative MSM In-Depth Inter- 105 1 1 105
view Guide—English.
General Public—Adults ..................... HIV-negative In-Depth Interview 45 1 1 45
Guide—Spanish.

Total ........................................... ........................................................... ........................ ........................ ........................ 192

Leroy A. Richardson, Hampshire Ave., Document Control the sale and distribution of tobacco
Chief, Information Collection Review Office, Center, Bldg. 71, Rm. G335, Silver products issued under section 906(d) of
Office of Scientific Integrity, Office of the Spring, MD 20993–0002. Send one self- the FD&C Act, such as FDA’s
Associate Director for Science, Office of the addressed adhesive label to assist that ‘‘Regulations Restricting the Sale and
Director, Centers for Disease Control and office in processing your request or
Prevention.
Distribution of Cigarettes and Smokeless
include a fax number to which the draft Tobacco to Protect Children and
[FR Doc. 2015–11512 Filed 5–12–15; 8:45 am] guidance may be sent. See the Adolescents’’ (21 CFR part 1140). The
BILLING CODE 4163–18–P SUPPLEMENTARY INFORMATION section for term ‘‘no-tobacco-sale order’’ refers to
information on electronic access to the an order prohibiting the sale of tobacco
draft guidance. products at a retail outlet indefinitely or
DEPARTMENT OF HEALTH AND Submit electronic comments on the
HUMAN SERVICES for a specified period of time under
draft guidance to http:// section 303(f)(8) of the FD&C Act. A
Food and Drug Administration www.regulations.gov. Submit written
‘‘repeated violation’’ means ‘‘at least 5
comments to the Division of Dockets
[Docket No. FDA–2015–D–0404] violations of particular requirements
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm. over a 36-month period at a particular
Determination of the Period Covered 1061, Rockville, MD 20852. Identify retail outlet that constitute a repeated
by a No-Tobacco-Sale Order and comments with the docket number violation . . .’’ (section 103(q)(1)(A) of
Compliance With an Order; Draft found in brackets in the heading of this the Tobacco Control Act).
Guidance for Tobacco Retailers; document. FDA conducts inspections of retail
Availability outlets to evaluate compliance with the
FOR FURTHER INFORMATION CONTACT:
AGENCY: Food and Drug Administration, Colleen Maschal, Center for Tobacco requirements of the FD&C Act and
HHS. Products, Food and Drug implementing regulations. This draft
ACTION: Notice. Administration, Document Control guidance discusses the period of time to
Center, Bldg. 71, Rm. G335, 10903 New be covered by an NTSO where there is
SUMMARY: The Food and Drug Hampshire Ave., Silver Spring, MD evidence of ‘‘repeated violations’’ at a
Administration (FDA) is announcing the 20993, 1–877–287–1373, particular retail outlet. It also discusses
availability of a draft guidance for colleen.maschal@fda.hhs.gov. a retailer’s compliance with an NTSO.
tobacco retailers entitled SUPPLEMENTARY INFORMATION: This draft guidance is meant to
‘‘Determination of the Period Covered supplement FDA’s guidances entitled
by a No-Tobacco-Sale Order and I. Background
‘‘Civil Money Penalties and No-
Compliance With an Order.’’ The draft On June 22, 2009, President Obama Tobacco-Sale Orders for Tobacco
guidance, when finalized, will represent signed the Family Smoking Prevention Retailers’’ and ‘‘Civil Money Penalties
FDA’s current thinking with respect to and Tobacco Control Act (Tobacco for Tobacco Retailers and No-Tobacco-
imposing no-tobacco-sale orders Control Act) (Pub. L. 111–31) into law.
(NTSOs) on retailers who have Sale Orders: Responses to Frequently
The Tobacco Control Act amended the Asked Questions.’’
committed repeated violations of certain Federal Food, Drug, and Cosmetic Act
restrictions on the sale and distribution (the FD&C Act) to give FDA authority to II. Significance of Draft Guidance
of tobacco products. This draft guidance regulate the manufacture, marketing,
discusses, among other things, the and distribution of tobacco products to FDA is issuing this draft guidance
period of time covered by an NTSO and protect public health generally and to consistent with FDA’s good guidance
a retailer’s compliance with an NTSO. reduce tobacco use by minors. Section practices regulation (21 CFR 10.115).
DATES: Although you can comment on 906(d) of the FD&C Act (21 U.S.C. The draft guidance, when finalized, will
any guidance at any time (see 21 CFR 387f(d)) authorizes FDA to issue represent the Agency’s current thinking
10.115(g)(5)), to ensure that the Agency regulations that restrict the sale and with respect to the period of time to be
considers your comment on this draft distribution of tobacco products if FDA covered by NTSOs and retailers’
asabaliauskas on DSK5VPTVN1PROD with NOTICES

guidance before it begins work on the determines such regulations would be compliance with NTSOs. It does not
final version of the guidance, submit appropriate for the protection of the create or confer any rights for or on any
either electronic or written comments public health. Section 303(f)(8) of the person and does not operate to bind
on the draft guidance by June 29, 2015. FD&C Act (21 U.S.C. 333(f)(8)) FDA or the public. An alternative
ADDRESSES: Submit written requests for authorizes FDA to impose an NTSO approach may be used if such approach
single copies of this draft guidance to against a person found to have satisfies the requirements of the
the Center for Tobacco Products, Food committed repeated violations, at a applicable statutes and regulations.
and Drug Administration, 10903 New particular retail outlet, of restrictions on

VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1

Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27319

III. Requests for Comments IV. Electronic Access Submit electronic comments on the
Persons with access to the Internet draft guidance to http://
A. General Information About www.regulations.gov. Submit written
Submitting Comments may obtain an electronic version of the
draft guidance at either http:// comments to the Division of Dockets
Interested persons may submit either www.regulations.gov or http:// Management (HFA–305), Food and Drug
electronic comments regarding this www.fda.gov/TobaccoProducts/ Administration, 5630 Fishers Lane, Rm.
document to http://www.regulations.gov GuidanceComplianceRegulatory 1061, Rockville, MD 20852.
or written comments to the Division of Information/default.htm. FOR FURTHER INFORMATION CONTACT:
Dockets Management (see ADDRESSES). It Sushanta Chakder, Center for Drug
Dated: May 8, 2015.
is only necessary to send one set of Evaluation and Research, Food and
Leslie Kux,
comments. Identify comments with the Drug Administration, 10903 New
Associate Commissioner for Policy. Hampshire Ave., Bldg. 22, Rm. 5108,
docket number found in brackets in the [FR Doc. 2015–11538 Filed 5–12–15; 8:45 am]
heading of this document. Silver Spring, MD 20993–0002, 301–
BILLING CODE 4164–01–P 796–0861.
B. Public Availability of Comments SUPPLEMENTARY INFORMATION:

Received comments may be seen in DEPARTMENT OF HEALTH AND I. Background
the Division of Dockets Management HUMAN SERVICES FDA is announcing the availability of
between 9 a.m. and 4 p.m., Monday a draft guidance for industry entitled
through Friday, and will be posted to Food and Drug Administration ‘‘Investigational Enzyme Replacement
the docket at http:// [Docket No. FDA–2015–D–1246] Therapy Products: Nonclinical
www.regulations.gov. As a matter of Assessment.’’
Agency practice, FDA generally does Investigational Enzyme Replacement This draft guidance provides sponsors
not post comments submitted by Therapy Products: Nonclinical and individuals involved in the design
individuals in their individual capacity Assessment; Draft Guidance for and implementation of nonclinical
on http://www.regulations.gov. This is Industry; Availability studies with recommendations on the
determined by information indicating AGENCY: Food and Drug Administration, nonclinical information needed to
that the submission is written by an HHS. support initiation of clinical trials,
individual, for example, the comment is ongoing clinical development, and
ACTION: Notice. eventual licensure or approval for
identified with the category ‘‘Individual
Consumer’’ under the field titled SUMMARY: The Food and Drug investigational ERT products. The
‘‘Category (Required),’’ on the ‘‘Your Administration (FDA or Agency) is recommendations in this guidance are
Information’’ page on http:// announcing the availability of a draft applicable to ERT products indicated for
www.regulations.gov. For this docket, guidance for industry entitled lysosomal storage diseases or other
however, FDA will not be following this ‘‘Investigational Enzyme Replacement diseases related to inborn errors of
general practice. Instead, FDA will post Therapy Products: Nonclinical metabolism.
on http://www.regulations.gov Assessment.’’ This draft guidance is Because of the wide array of clinical
comments to this docket that have been intended to advise the sponsors and indications, natural history of disease,
submitted by individuals in their individuals involved in the design and and product types, no single nonclinical
individual capacity. If you wish to implementation of nonclinical studies program can be designed to address all
submit any information under a claim of on the substance and scope of ERT products, and a case-by-case
confidentiality, please refer to 21 CFR nonclinical information needed to approach to both toxicological
10.20. support first-in-human clinical trials, evaluation and clinical development is
ongoing clinical development, and warranted to optimize and expedite
C. Information Identifying the Person eventual approval of enzyme drug development. Common nonclinical
Submitting the Comment replacement therapy (ERT) products for issues, such as the number of animal
the treatment of rare, life-threatening species needed for safety assessment,
Please note that your name, contact selection of animal models and duration
information, and other information conditions.
of the toxicology studies needed to
identifying you will be posted on http:// DATES: Although you can comment on
support first-in-human trials, and
www.regulations.gov if you include that any guidance at any time (see 21 CFR nonclinical study requirements for
information in the body of your 10.115(g)(5)), to ensure that the Agency ultimate licensure or market approval of
comments. For electronic comments considers your comment on this draft the ERT product, are addressed in this
submitted to http:// guidance before it begins work on the guidance.
www.regulations.gov, FDA will post the final version of the guidance, submit This guidance is intended as an
body of your comment on http:// either electronic or written comments adjunct to the ICH guidances for
www.regulations.gov along with your on the draft guidance by July 13, 2015. industry entitled ‘‘M3(R2) Nonclinical
state/province and country (if ADDRESSES: Submit written requests for Safety Studies for the Conduct of
provided), the name of your single copies of the draft guidance to the Human Clinical Trials and Marketing
representative (if any), and the category Division of Drug Information, Center for Authorization for Pharmaceuticals,’’
identifying you (e.g., individual, Drug Evaluation and Research, Food ‘‘M3(R2) Nonclinical Safety Studies for
asabaliauskas on DSK5VPTVN1PROD with NOTICES

consumer, academic, industry). For and Drug Administration, 10001 New the Conduct of Human Clinical Trials
written submissions submitted to the Hampshire Ave., Hillandale Building, and Marketing Authorization for
Division of Dockets Management, FDA 4th Floor, Silver Spring, MD 20993– Pharmaceuticals—Questions and
will post the body of your comments on 0002. Send one self-addressed adhesive Answers,’’ and ‘‘S6 Preclinical Safety
http://www.regulations.gov, but you can label to assist that office in processing Evaluation of Biotechnology-Derived
put your name and/or contact your requests. See the SUPPLEMENTARY Pharmaceuticals.’’
information on a separate cover sheet INFORMATION section for electronic This draft guidance is being issued
and not in the body of your comments. access to the draft guidance document. consistent with FDA’s good guidance

VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1

Document Created: 2015-12-16 07:47:17
Document Modified: 2015-12-16 07:47:17

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.
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 June 29, 2015.
Contact		Colleen Maschal, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877- 287-1373, colleen.mas[email protected]
FR Citation		80 FR 27318

80 FR 27318 - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Draft Guidance for Tobacco Retailers; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 92 (May 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration