Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability, 52299-52300 [2015-21271]

Download as PDF Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices As indicated in table 1, we estimate that we will receive a total of approximately 40 requests annually for the proposed ‘‘proper name’’ for biological products submitted under section 351(a) of the PHS Act and 6 requests annually for the proposed ‘‘proper name’’ for biosimilar products and interchangeable products submitted under section 351(k) of the PHS Act. The average burden per response (hours) is based on the Agency’s experience with similar information collection requirements. IV. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or http:// www.regulations.gov. Dated: August 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–21383 Filed 8–27–15; 8:45 am] BILLING CODE 4164–01–P 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 selfaddressed 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, CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background 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. 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 notobacco-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 Lhorne on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:19 Aug 27, 2015 Jkt 235001 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 52299 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:// E:\FR\FM\28AUN1.SGM 28AUN1 52300 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices 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 Lhorne on DSK5TPTVN1PROD with NOTICES 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/ GuidanceComplianceRegulatory Information/default.htm. Dated: August 24, 2015. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration RIN 0906–AB08 340B Drug Pricing Program Omnibus Guidance Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ‘‘340B Drug Pricing Program’’ or the ‘‘340B Program.’’ This notice proposes guidance for covered entities enrolled in the 340B Program and drug manufacturers that are required by section 340B of the PHSA to make their drugs available to covered entities under the 340B Program. When finalized after consideration of public comments solicited by this notice, the guidance is intended to assist 340B covered entities and drug manufacturers in complying with the statute. DATES: Submit comments on or before October 27, 2015. ADDRESSES: You may submit comments, identified by the Regulatory Information Number (RIN) 0906–AB08, by any of the following methods. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions. The first is the preferred method. • Federal eRulemaking Portal: http:// www.regulations.gov. Follow instructions for submitting comments. This is the preferred method for the submission of comments. • Email: 340BGuidelines@hrsa.gov. Include RIN 0906–AB08 in the subject line of the message. • Mail: Krista Pedley, Director, Office of Pharmacy Affairs (OPA), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Mail Stop 08W05A, Rockville, Maryland 20857. All submitted comments will be available to the public in their entirety. FOR FURTHER INFORMATION CONTACT: CDR Krista Pedley, Director, OPA, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, Maryland 20857, or by telephone at (301) 594–4353. SUPPLEMENTARY INFORMATION: SUMMARY: [FR Doc. 2015–21271 Filed 8–27–15; 8:45 am] I. Background BILLING CODE 4164–01–P Section 602 of Public Law 102–585, the ‘‘Veterans Health Care Act of 1992,’’ enacted section 340B of the Public Health Service Act (PHSA) ‘‘Limitation VerDate Sep<11>2014 14:19 Aug 27, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 on Prices of Drugs Purchased by Covered Entities,’’ codified at 42 U.S.C. 256b. The intent of the 340B Program is to permit covered entities ‘‘to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.’’ H.R. REP. No. 102–384(II), at 12 (1992). Eligible covered entity types are defined in section 340B(a)(4) of the PHSA, and only include health care organizations that have certain Federal designations or receive funding from specific Federal programs. These include Federally Qualified Health Centers, Ryan White HIV/AIDS Program grantees, and certain types of hospitals and specialized clinics. Section 7101 of the Patient Protection and Affordable Care Act (Pub. L. 111–148) (‘‘Affordable Care Act’’) expanded the types of covered entities eligible to participate in the 340B Program. As of January 1, 2015, there were 11,530 registered covered entities participating in the 340B Program. Section 340B of the PHSA instructs HHS to enter into a pharmaceutical pricing agreement (PPA) with certain drug manufacturers. If a drug manufacturer signs a PPA, it agrees that the prices charged for covered outpatient drugs to covered entities will not exceed 340B ceiling prices as defined by statute. HRSA calculates the ceiling prices quarterly using pricing data reported to the Centers for Medicare & Medicaid Services (CMS). Pursuant to section 340B(a)(1) of the PHSA, the 340B ceiling price is calculated by subtracting the Unit Rebate Amount from the Average Manufacturer Price. As of January 1, 2015, there were 644 drug manufacturers participating in the 340B Program. When an eligible entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Since 1992, HHS has interpreted the statutory requirements of the 340B Program through guidances published in the Federal Register, typically after notice and opportunity for comment. HHS is proposing this omnibus guidance to provide increased clarity in the marketplace for all 340B Program stakeholders and strengthen HHS’s ability to administer the 340B Program effectively. This notice clarifies many current 340B Program guidances. HHS encourages all stakeholders to provide comments on this proposed guidance. In September 2010, HHS published two advanced notices of proposed rulemaking in the Federal Register, E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52299-52300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21271]


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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, CTPRegulations@fda.hhs.gov.

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