Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Draft Guidance for Tobacco Retailers; Availability, 27318-27319 [2015-11538]

Download as PDF 27318 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average burden per response (in hours) Number of responses per respondent Number of respondents Total burden hours Type of respondent Form name General Public—Adults ..................... 105 1 1 105 General Public—Adults ..................... HIV-negative MSM In-Depth Interview Guide—English. HIV-negative In-Depth Interview Guide—Spanish. 45 1 1 45 Total ........................................... ........................................................... ........................ ........................ ........................ 192 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015–11512 Filed 5–12–15; 8:45 am] BILLING CODE 4163–18–P 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No. FDA–2015–D–0404] Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Draft Guidance for Tobacco Retailers; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for tobacco retailers entitled ‘‘Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.’’ The draft guidance, when finalized, will represent FDA’s current thinking with respect to imposing no-tobacco-sale orders (NTSOs) on retailers who have committed repeated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 This draft guidance discusses, among other things, the period of time covered by an NTSO and a retailer’s compliance with an NTSO.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 29, 2015. ADDRESSES: Submit written requests for single copies of this draft guidance to the Center for Tobacco Products, Food and Drug Administration, 10903 New asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 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 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 https:// 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, colleen.maschal@fda.hhs.gov. 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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 NoTobacco-Sale Orders for Tobacco Retailers’’ and ‘‘Civil Money Penalties for Tobacco Retailers and No-TobaccoSale 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. E:\FR\FM\13MYN1.SGM 13MYN1 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices III. Requests for Comments A. General Information About Submitting Comments Interested persons may submit either electronic comments regarding this document to https://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. IV. 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/ GuidanceComplianceRegulatory Information/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 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 https:// www.regulations.gov. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on https://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 https:// www.regulations.gov. For this docket, however, FDA will not be following this general practice. Instead, FDA will post on https://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. asabaliauskas on DSK5VPTVN1PROD with NOTICES C. Information Identifying the Person Submitting the Comment Please note that your name, contact information, and other information identifying you will be posted on https:// www.regulations.gov if you include that information in the body of your comments. For electronic comments submitted to https:// www.regulations.gov, FDA will post the body of your comment on https:// 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 https://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. VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1246] Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.’’ This draft guidance is intended to advise the sponsors and individuals involved in the design and implementation of nonclinical studies on the substance and scope of nonclinical information needed to support first-in-human clinical trials, ongoing clinical development, and eventual approval of enzyme replacement therapy (ERT) products for the treatment of rare, life-threatening conditions. 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 July 13, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 27319 Submit electronic comments on the draft guidance to https:// 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. FOR FURTHER INFORMATION CONTACT: Sushanta Chakder, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5108, Silver Spring, MD 20993–0002, 301– 796–0861. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.’’ This draft guidance provides sponsors and individuals involved in the design and implementation of nonclinical studies with recommendations on the nonclinical information needed to support initiation of clinical trials, ongoing clinical development, and eventual licensure or approval for investigational ERT products. The recommendations in this guidance are applicable to ERT products indicated for lysosomal storage diseases or other diseases related to inborn errors of metabolism. Because of the wide array of clinical indications, natural history of disease, and product types, no single nonclinical program can be designed to address all ERT products, and a case-by-case approach to both toxicological evaluation and clinical development is warranted to optimize and expedite drug development. Common nonclinical issues, such as the number of animal species needed for safety assessment, selection of animal models and duration of the toxicology studies needed to support first-in-human trials, and nonclinical study requirements for ultimate licensure or market approval of the ERT product, are addressed in this guidance. This guidance is intended as an adjunct to the ICH guidances for industry entitled ‘‘M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals,’’ ‘‘M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals—Questions and Answers,’’ and ‘‘S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.’’ This draft guidance is being issued consistent with FDA’s good guidance E:\FR\FM\13MYN1.SGM 13MYN1

Agencies

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27318-27319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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, colleen.maschal@fda.hhs.gov.

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 https://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 https://www.regulations.gov. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on https://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 https://www.regulations.gov. For 
this docket, however, FDA will not be following this general practice. 
Instead, FDA will post on https://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 https://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to https://www.regulations.gov, FDA will post the body of your comment on https://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 https://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 https://www.regulations.gov or 
https://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
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