80 FR 52299 - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 167 (August 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 167 (August 28, 2015)
| Page Range | 52299-52300 | |
| FR Document | 2015-21271 |
[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)] [Notices] [Pages 52299-52300] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21271] ----------------------------------------------------------------------- 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; 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 guidance for tobacco retailers entitled ``Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.'' The guidance represents 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 guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 guidance may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the 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, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 1-877- 287-1373, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for tobacco retailers entitled ``Determination of the Period Covered by a No- Tobacco-Sale Order and Compliance With an Order.'' 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 its implementing regulations. This 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 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.'' In the Federal Register of May 13, 2015 (80 FR 27318), FDA announced the availability of the draft guidance of the same title. FDA received comments on the draft guidance and those comments were considered as the guidance was finalized. 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 with respect to the period of time to be covered by NTSOs and retailers' compliance with NTSOs. 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. 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:// [[Page 52300]] 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 guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. Dated: August 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-21271 Filed 8-27-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices 52299
As indicated in table 1, we estimate Center for Tobacco Products, Food and an order prohibiting the sale of tobacco
that we will receive a total of Drug Administration, 10903 New products at a retail outlet indefinitely or
approximately 40 requests annually for Hampshire Ave., Document Control for a specified period of time under
the proposed ‘‘proper name’’ for Center, Bldg. 71, Rm. G335, Silver section 303(f)(8) of the FD&C Act. A
biological products submitted under Spring, MD 20993–0002. Send one self- ‘‘repeated violation’’ means ‘‘at least 5
section 351(a) of the PHS Act and 6 addressed adhesive label to assist that violations of particular requirements
requests annually for the proposed office in processing your request or over a 36-month period at a particular
‘‘proper name’’ for biosimilar products include a fax number to which the retail outlet that constitute a repeated
and interchangeable products submitted guidance may be sent. See the violation . . .’’ (section 103(q)(1)(A) of
under section 351(k) of the PHS Act. SUPPLEMENTARY INFORMATION section for the Tobacco Control Act).
The average burden per response information on electronic access to the FDA conducts inspections of retail
(hours) is based on the Agency’s guidance. outlets to evaluate compliance with the
experience with similar information Submit electronic comments on the requirements of the FD&C Act and its
collection requirements. guidance to http://www.regulations.gov. implementing regulations. This
Submit written comments to the guidance discusses the period of time to
IV. Electronic Access
Division of Dockets Management (HFA– be covered by an NTSO where there is
Persons with access to the Internet 305), Food and Drug Administration, evidence of ‘‘repeated violations’’ at a
may obtain the document at http:// 5630 Fishers Lane, Rm. 1061, Rockville, particular retail outlet. It also discusses
www.fda.gov/Drugs/Guidance MD 20852. Identify comments with the a retailer’s compliance with an NTSO.
ComplianceRegulatoryInformation/ docket number found in brackets in the This guidance is meant to supplement
Guidances/default.htm, http:// heading of this document. FDA’s guidances entitled ‘‘Civil Money
www.fda.gov/BiologicsBloodVaccines/ FOR FURTHER INFORMATION CONTACT: Penalties and No-Tobacco-Sale Orders
GuidanceComplianceRegulatory Colleen Maschal, Center for Tobacco for Tobacco Retailers’’ and ‘‘Civil
Information/default.htm, or http:// Products, Food and Drug Money Penalties for Tobacco Retailers
www.regulations.gov. Administration, Document Control and No-Tobacco-Sale Orders: Responses
Dated: August 25, 2015. Center, 10903 New Hampshire Ave., to Frequently Asked Questions.’’
Leslie Kux, Bldg. 71, Rm. G335, Silver Spring, MD In the Federal Register of May 13,
Associate Commissioner for Policy. 20993, 1–877–287–1373, 2015 (80 FR 27318), FDA announced the
CTPRegulations@fda.hhs.gov. availability of the draft guidance of the
[FR Doc. 2015–21383 Filed 8–27–15; 8:45 am]
SUPPLEMENTARY INFORMATION: same title. FDA received comments on
BILLING CODE 4164–01–P
the draft guidance and those comments
I. Background were considered as the guidance was
DEPARTMENT OF HEALTH AND FDA is announcing the availability of finalized.
HUMAN SERVICES a guidance for tobacco retailers entitled II. Significance of Guidance
‘‘Determination of the Period Covered
Food and Drug Administration by a No-Tobacco-Sale Order and This guidance is being issued
Compliance With an Order.’’ On June consistent with FDA’s good guidance
[Docket No. FDA–2015–D–0404] practices regulation (21 CFR 10.115).
22, 2009, President Obama signed the
Family Smoking Prevention and The guidance represents the current
Determination of the Period Covered
Tobacco Control Act (Tobacco Control thinking of FDA with respect to the
by a No-Tobacco-Sale Order and
Act) (Pub. L. 111–31) into law. The period of time to be covered by NTSOs
Compliance With an Order; Guidance
Tobacco Control Act amended the and retailers’ compliance with NTSOs.
for Tobacco Retailers; Availability
Federal Food, Drug, and Cosmetic Act It does not establish any rights for any
AGENCY: Food and Drug Administration, (the FD&C Act) to give FDA authority to person and is not binding on FDA or the
HHS. regulate the manufacture, marketing, public. You can use an alternative
ACTION: Notice. and distribution of tobacco products to approach if it satisfies the requirements
protect public health generally and to of the applicable statutes and
SUMMARY: The Food and Drug reduce tobacco use by minors. Section regulations.
Administration (FDA) is announcing the 906(d) of the FD&C Act (21 U.S.C. III. Comments
availability of a guidance for tobacco 387f(d)) authorizes FDA to issue
retailers entitled ‘‘Determination of the regulations that restrict the sale and A. General Information About
Period Covered by a No-Tobacco-Sale distribution of tobacco products if FDA Submitting Comments
Order and Compliance With an Order.’’ determines such regulations would be Interested persons may submit either
The guidance represents FDA’s current appropriate for the protection of the electronic comments regarding this
thinking with respect to imposing no- public health. Section 303(f)(8) of the document to http://www.regulations.gov
tobacco-sale orders (NTSOs) on retailers FD&C Act (21 U.S.C. 333(f)(8)) or written comments to the Division of
who have committed repeated authorizes FDA to impose an NTSO Dockets Management (see ADDRESSES).
violations of certain restrictions on the against a person found to have It is only necessary to send one set of
sale and distribution of tobacco committed repeated violations, at a comments. Identify comments with the
products. This guidance discusses, particular retail outlet, of restrictions on docket number found in brackets in the
among other things, the period of time the sale and distribution of tobacco heading of this document.
covered by an NTSO and a retailer’s
Lhorne on DSK5TPTVN1PROD with NOTICES
products issued under section 906(d) of
compliance with an NTSO. the FD&C Act, such as FDA’s B. Public Availability of Comments
DATES: Submit either electronic or ‘‘Regulations Restricting the Sale and Received comments may be seen in
written comments on Agency guidances Distribution of Cigarettes and Smokeless the Division of Dockets Management
at any time. Tobacco to Protect Children and between 9 a.m. and 4 p.m., Monday
ADDRESSES: Submit written requests for Adolescents’’ (21 CFR part 1140). The through Friday, and will be posted to
single copies of this guidance to the term ‘‘no-tobacco-sale order’’ refers to the docket at http://
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![52300 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
www.regulations.gov. As a matter of DEPARTMENT OF HEALTH AND on Prices of Drugs Purchased by
Agency practice, FDA generally does HUMAN SERVICES Covered Entities,’’ codified at 42 U.S.C.
not post comments submitted by 256b. The intent of the 340B Program is
individuals in their individual capacity Health Resources and Services to permit covered entities ‘‘to stretch
on http://www.regulations.gov. This is Administration scarce Federal resources as far as
determined by information indicating RIN 0906–AB08 possible, reaching more eligible patients
that the submission is written by an and providing more comprehensive
individual, for example, the comment is 340B Drug Pricing Program Omnibus services.’’ H.R. REP. No. 102–384(II), at
identified with the category ‘‘Individual Guidance 12 (1992). Eligible covered entity types
are defined in section 340B(a)(4) of the
Consumer’’ under the field titled AGENCY: Health Resources and Services PHSA, and only include health care
‘‘Category (Required),’’ on the ‘‘Your Administration, HHS. organizations that have certain Federal
Information’’ page on http:// designations or receive funding from
ACTION: Notice.
www.regulations.gov. For this docket, specific Federal programs. These
however, FDA will not be following this SUMMARY: The Health Resources and include Federally Qualified Health
general practice. Instead, FDA will post Services Administration (HRSA) Centers, Ryan White HIV/AIDS Program
on http://www.regulations.gov administers section 340B of the Public grantees, and certain types of hospitals
comments to this docket that have been Health Service Act (PHSA), which is and specialized clinics. Section 7101 of
submitted by individuals in their referred to as the ‘‘340B Drug Pricing the Patient Protection and Affordable
individual capacity. If you wish to Program’’ or the ‘‘340B Program.’’ This Care Act (Pub. L. 111–148) (‘‘Affordable
submit any information under a claim of notice proposes guidance for covered Care Act’’) expanded the types of
confidentiality, please refer to 21 CFR entities enrolled in the 340B Program covered entities eligible to participate in
10.20. and drug manufacturers that are the 340B Program. As of January 1,
required by section 340B of the PHSA 2015, there were 11,530 registered
C. Information Identifying the Person to make their drugs available to covered covered entities participating in the
Submitting the Comment entities under the 340B Program. When 340B Program.
finalized after consideration of public Section 340B of the PHSA instructs
Please note that your name, contact comments solicited by this notice, the HHS to enter into a pharmaceutical
information, and other information guidance is intended to assist 340B pricing agreement (PPA) with certain
identifying you will be posted on http:// covered entities and drug manufacturers drug manufacturers. If a drug
www.regulations.gov if you include that in complying with the statute. manufacturer signs a PPA, it agrees that
information in the body of your DATES: Submit comments on or before the prices charged for covered
comments. For electronic comments October 27, 2015. outpatient drugs to covered entities will
submitted to http:// not exceed 340B ceiling prices as
ADDRESSES: You may submit comments,
www.regulations.gov, FDA will post the defined by statute. HRSA calculates the
identified by the Regulatory Information
body of your comment on http:// ceiling prices quarterly using pricing
Number (RIN) 0906–AB08, by any of the
www.regulations.gov along with your following methods. Please submit your data reported to the Centers for
state/province and country (if comments in only one of these ways to Medicare & Medicaid Services (CMS).
provided), the name of your minimize the receipt of duplicate Pursuant to section 340B(a)(1) of the
representative (if any), and the category submissions. The first is the preferred PHSA, the 340B ceiling price is
identifying you (e.g., individual, method. calculated by subtracting the Unit
consumer, academic, industry). For • Federal eRulemaking Portal: http:// Rebate Amount from the Average
written submissions submitted to the Manufacturer Price. As of January 1,
www.regulations.gov. Follow
Division of Dockets Management, FDA 2015, there were 644 drug
instructions for submitting comments.
will post the body of your comments on manufacturers participating in the 340B
This is the preferred method for the
http://www.regulations.gov, but you can Program.
submission of comments. When an eligible entity voluntarily
put your name and/or contact • Email: 340BGuidelines@hrsa.gov. decides to enroll and participate in the
information on a separate cover sheet Include RIN 0906–AB08 in the subject 340B Program, it accepts responsibility
and not in the body of your comments. line of the message. for ensuring compliance with all
• Mail: Krista Pedley, Director, Office provisions of the 340B Program,
IV. Electronic Access of Pharmacy Affairs (OPA), Health including all associated costs. Since
Persons with access to the Internet Resources and Services Administration 1992, HHS has interpreted the statutory
may obtain an electronic version of the (HRSA), 5600 Fishers Lane, Mail Stop requirements of the 340B Program
08W05A, Rockville, Maryland 20857. through guidances published in the
guidance at either http://
All submitted comments will be Federal Register, typically after notice
www.regulations.gov or http://
available to the public in their entirety. and opportunity for comment. HHS is
www.fda.gov/TobaccoProducts/
FOR FURTHER INFORMATION CONTACT: CDR proposing this omnibus guidance to
GuidanceComplianceRegulatory
Krista Pedley, Director, OPA, HRSA, provide increased clarity in the
Information/default.htm.
5600 Fishers Lane, Mail Stop 08W05A, marketplace for all 340B Program
Dated: August 24, 2015. Rockville, Maryland 20857, or by stakeholders and strengthen HHS’s
Leslie Kux, telephone at (301) 594–4353. ability to administer the 340B Program
Lhorne on DSK5TPTVN1PROD with NOTICES
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: effectively. This notice clarifies many
[FR Doc. 2015–21271 Filed 8–27–15; 8:45 am] current 340B Program guidances. HHS
I. Background
BILLING CODE 4164–01–P
encourages all stakeholders to provide
Section 602 of Public Law 102–585, comments on this proposed guidance.
the ‘‘Veterans Health Care Act of 1992,’’ In September 2010, HHS published
enacted section 340B of the Public two advanced notices of proposed
Health Service Act (PHSA) ‘‘Limitation rulemaking in the Federal Register,
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Document Created: 2015-12-15 11:04:38
Document Modified: 2015-12-15 11:04:38
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Colleen Maschal, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 1-877- 287-1373, [email protected] | |
| FR Citation | 80 FR 52299 |
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